Defining Research with Human Subjects

A study is considered research with human subjects if it meets the definitions of both research AND human subjects, as defined in the federal regulations for protecting research subjects.

Research.  A systematic inquiry designed to answer a research question or contribute to a field of knowledge, including pilot studies and research development.

Human subject:  A living individual about whom an investigator (whether professional or student) conducting research:

  • Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
  • Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

The following sections will explain some of the words in the previous definitions.

The regulatory language:

A systematic inquiry designed to answer a research question or contribute to a field of knowledge, including pilot studies and research development.

The explanation:

Understanding what constitutes a systematic inquiry varies among disciplines and depends on the procedures and steps used to answer research questions and how the search for knowledge is organize and structured.

Pilot Studies and Research Development

Pilot studies are designed to conduct preliminary analyses before committing to a full-blown study or experiment.

Research development includes activities such as convening a focus group consisting of members of the proposed research population to help develop a culturally appropriate questionnaire.

Practical applications:

  • You are conducting a pilot study or other activities preliminary to research; or
  • You have designed a study to collect information or biospecimens in a systematic way to answer a research question; or
  • You intend to study, analyze, or otherwise use existing information or biospecimens to answer a research question.

Human Subjects

Human subjects are living individuals about whom researchers obtain information or biospecimens through interaction, intervention, or observation of private behavior, to also include the use, study, and analysis of said information or biospecimens.

Obtaining, using, analyzing, and generating identifiable private information or identifiable biospecimens that are provided to a researcher is also considered to be human subjects.

To meet the definition of human subjects, the data being collected or used are about people. Asking participants questions about their attitudes, opinions, preferences, behavior, experiences, background/history, and characteristics, or analyzing demographic, academic or medical records, are just some examples of human subjects data.

  • Interacting with people to gather data about them using methods such as interviews, focus groups, questionnaires, and participant observation; or
  • Conducting interventions with people such as experiments or manipulations of subjects or subjects' environments; or
  • Observing or recording behavior, whether in-person and captured in real time or in virtual spaces, like social media sites (e.g., Twitter) or online forums (e.g., Reddit); or
  • Obtaining existing information about individuals, such as students’ school records or patients’ health records, or data sets provided by another researcher or organization.

Interactions and Interventions

Interventions are manipulations of the subject or the subject's environment, for example is a behavioral change study using text messages about healthy foods.

Interactions include communication or interpersonal contact between investigator and participant.

A study may include both interventions and interactions.

Interactions and interventions do not require in-person contact, but may be conducted on-line.

Private Information

Private information  includes information or biospecimens: 1) about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place; 2) that has been provided for specific purposes by an individual; and 3) that the individual can reasonably expect will not be made public (for example, a medical record).

Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for the information to constitute research involving human subjects.

The regulations are clear that it is the subjects’ expectations that determine what behaviors, biospecimens, and identifiable information must be considered private. Subjects’ understanding of what privacy means are not universal, but are very specific and based on multiple interrelated factors, such as the research setting, cultural norms, the age of the subjects, and life experiences. For example, in the United States, health records are considered private and protected by law, but in some countries, health information is not considered private but are of communal concern. 

Identifiable Information

The identity of the subject is associated with the data gathered from the subject(s) existing data about the subjects. Even if the data (including biospecimens) do not include direct identifiers, such as names or email addresses, the data are considered identifiable if names of individuals can easily be deduced from the data.

If there are keys linking individuals to their data, the data are considered identifiable.

Levels of Review

Not all projects that meet the definition of research with human subjects need review by the actual committee. For example, projects that pose  negligible risk to participants may be reviewed and recommended for approval by IRB staff ; other projects may need to undergo review and approval by at least one member of the IRB committee or a quorum of the full board. Determination as to the need for review should always be made by the IRB staff.

Examples of Studies That MAY Meet the Definition of Research with Human Subjects

The following examples will likely require further consultation with an IRB staff member.

Analysis of existing information with no identifiers

If researchers have no interaction with human subjects, but will be conducting a secondary analysis of existing data without individual identifiers, the analysis of those data may not be research with human subjects. 

Expert consultation

Key words in the definition of a human subject are "a living individual about whom" a researcher obtains, uses, studies, analyzes, or generates information. People can provide you information that is not about them but is important for the research. For example, a researcher may contact non-governmental organizations to ask about sources of funding.

Program evaluations and quality improvement studies

Program evaluations are generally intended to query whether a particular program or curriculum meets its goals. They often involve pre- and post-surveys or evaluations.

Some program evaluations include a research component. If data are collected about the characteristics of the participants to analyze the relationship between demographic variable and success of the program, the study may become research with human subjects.  Research question:  Are there different learning outcomes associated with different levels of participant confidence?

Classroom research

Classes designed to teach research methods such as fieldwork, statistical analysis, or interview techniques, may assign students to conduct interviews, distribute questionnaires, or engage in participant observation. If the purpose of these activities is solely pedagogical and are not designed to contribute to a body of knowledge, the activities do not meet the definition of research with human subjects. 

Vignettes: Applying the Definitions

Art in Cambodia

An art history student wants to study art created by Cambodians in response to the massacres committed by the Khmer Rouge. The art she will study includes paintings, sculpture, video, and the performing arts.

Much of the research will be archival, using library and online resources. In addition, she will visit Cambodia. While there, she will speak with several museum curators for assistance locating and viewing art collections related to the massacres.

Is this research with human subjects?

No. Although the student will speak with curators, they are not the subjects of her research and she is not interested in learning anything about them. They will, in effect, serve as local guides.

What would make the study research with human subjects?

The student interviews people as they interact with art to understand the role of the arts in evoking and/or coming to terms with traumatic past events. She interviews people who view the art, such as visitors to museums, and discusses what the art means to them. She may collect information about their experiences during the genocide and compare those experiences with their reactions to the art. 

Bank-Supported Micro-Finance in Chile

A researcher is interested in the practice of microfinance in the Chilean Mapuche community. She meets with bankers and asks about the criteria for granting loans, the demographics of the people who receive loans, the types of businesses to which the bank prefers to grant loans, how many loans they give, the payback rates, and other data about the bank’s loan practices.

No. Although the researcher is interviewing bankers, the bankers are only providing information about their banking practices and are not providing any information about themselves. The questions are about “what” rather than “about whom.” The bankers are not human subjects. This type of interview is sometimes referred to as expert consultation.

The researcher explores the impact of small loans, both intended and unintended, on the recipients of the loans. The researcher interviews the recipients of the loans and gathers information from them about their lives before and after they received funding, how the loans affected their relationships with family members and other community members, the impact of the loans on their aspirations, and so on. He asks “about whom” questions designed to understand the impact of micro-loans.

Developing Teaching Materials

A researcher goes to a country in which the infrastructure has been severely damaged to help rebuild schools. The student interviews community members about what curricular materials they need, develops some materials, and teaches a math class.

No. Although interviews are conducted, the intent of interviewing is to assist in resource development rather than answer a research question designed to contribute to a field of knowledge.

If the researcher does pre- and post-testing to assess student learning in his class, is this research with human subjects?

No. The intent is to find out if the materials are effective. This is sometimes referred to as program assessment.

What would make this research with human subjects?

The researcher studies the impact of nutrition and personal variables on learning. He assesses the nutritional composition of the local diet, assesses students’ general health, and compares those data with test scores. He also measures motivation, family composition, and other characteristics of the students using written questionnaires.

Water Conservation

A researcher wants to find out if the campus water conservation program is effective. She will gather some information about water volume usage from the University engineering department. She will also survey residential students about their water usage habits over the last six months, their perceptions of the campus drought education program, and their reactions to the incentives offered by the program (water-saving competitions, free water-saving devices, etc.) She will report her findings to the program’s steering committee and administrators.

No. Although the researcher will systematically survey other students and will be collecting information about them, her intention is to assess the effectiveness of the conservation program.

The researcher designs an online survey to collect information that may help understand factors that influence the residential students’ responses to the conservation program. She asks questions about green attitudes and behaviors, positions on social and political issues, as well as motivation and narcissism.

Campus IRB Guides

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Types of Human Subjects Research

On this page, analysis of existing data or specimens, observational studies, interventional studies.

If you're using private information, data, or specimens, your research may be exempt from the Code of Federal Regulations 45 Part 46. You may refer to the NIH Office of Extramural Research (OER) decision tool or consult with your institutional review board (IRB) or independent ethics committee (IEC). The NIDCR evaluates each project independently to determine oversight needs and whether the NIDCR Clinical Terms of Award (CToA) applies.

Toolkit for Analysis of Existing Data

In an observational study, the investigator simply records observations and analyzes data, without assigning participants to a specific intervention or treatment. These studies may focus on observation of risk factors, natural history, variations in disease progression or disease treatment without delivering or assigning an intervention. They often assess specific health characteristics of the enrolled human subjects by collecting medical/dental history, exposure, or clinical data; obtaining biospecimens (e.g., for biomarker or genomic analyses); or obtaining photographic, radiographic or other images from research subjects.

Toolkit for Observational Studies

The NIH defines an intervention as a manipulation of the subject or the subject's environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints. The NIH further defines a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

Toolkit for Interventional Studies

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A Practical Guide to Writing Quantitative and Qualitative Research Questions and Hypotheses in Scholarly Articles

Edward barroga.

1 Department of General Education, Graduate School of Nursing Science, St. Luke’s International University, Tokyo, Japan.

Glafera Janet Matanguihan

2 Department of Biological Sciences, Messiah University, Mechanicsburg, PA, USA.

The development of research questions and the subsequent hypotheses are prerequisites to defining the main research purpose and specific objectives of a study. Consequently, these objectives determine the study design and research outcome. The development of research questions is a process based on knowledge of current trends, cutting-edge studies, and technological advances in the research field. Excellent research questions are focused and require a comprehensive literature search and in-depth understanding of the problem being investigated. Initially, research questions may be written as descriptive questions which could be developed into inferential questions. These questions must be specific and concise to provide a clear foundation for developing hypotheses. Hypotheses are more formal predictions about the research outcomes. These specify the possible results that may or may not be expected regarding the relationship between groups. Thus, research questions and hypotheses clarify the main purpose and specific objectives of the study, which in turn dictate the design of the study, its direction, and outcome. Studies developed from good research questions and hypotheses will have trustworthy outcomes with wide-ranging social and health implications.

INTRODUCTION

Scientific research is usually initiated by posing evidenced-based research questions which are then explicitly restated as hypotheses. 1 , 2 The hypotheses provide directions to guide the study, solutions, explanations, and expected results. 3 , 4 Both research questions and hypotheses are essentially formulated based on conventional theories and real-world processes, which allow the inception of novel studies and the ethical testing of ideas. 5 , 6

It is crucial to have knowledge of both quantitative and qualitative research 2 as both types of research involve writing research questions and hypotheses. 7 However, these crucial elements of research are sometimes overlooked; if not overlooked, then framed without the forethought and meticulous attention it needs. Planning and careful consideration are needed when developing quantitative or qualitative research, particularly when conceptualizing research questions and hypotheses. 4

There is a continuing need to support researchers in the creation of innovative research questions and hypotheses, as well as for journal articles that carefully review these elements. 1 When research questions and hypotheses are not carefully thought of, unethical studies and poor outcomes usually ensue. Carefully formulated research questions and hypotheses define well-founded objectives, which in turn determine the appropriate design, course, and outcome of the study. This article then aims to discuss in detail the various aspects of crafting research questions and hypotheses, with the goal of guiding researchers as they develop their own. Examples from the authors and peer-reviewed scientific articles in the healthcare field are provided to illustrate key points.

DEFINITIONS AND RELATIONSHIP OF RESEARCH QUESTIONS AND HYPOTHESES

A research question is what a study aims to answer after data analysis and interpretation. The answer is written in length in the discussion section of the paper. Thus, the research question gives a preview of the different parts and variables of the study meant to address the problem posed in the research question. 1 An excellent research question clarifies the research writing while facilitating understanding of the research topic, objective, scope, and limitations of the study. 5

On the other hand, a research hypothesis is an educated statement of an expected outcome. This statement is based on background research and current knowledge. 8 , 9 The research hypothesis makes a specific prediction about a new phenomenon 10 or a formal statement on the expected relationship between an independent variable and a dependent variable. 3 , 11 It provides a tentative answer to the research question to be tested or explored. 4

Hypotheses employ reasoning to predict a theory-based outcome. 10 These can also be developed from theories by focusing on components of theories that have not yet been observed. 10 The validity of hypotheses is often based on the testability of the prediction made in a reproducible experiment. 8

Conversely, hypotheses can also be rephrased as research questions. Several hypotheses based on existing theories and knowledge may be needed to answer a research question. Developing ethical research questions and hypotheses creates a research design that has logical relationships among variables. These relationships serve as a solid foundation for the conduct of the study. 4 , 11 Haphazardly constructed research questions can result in poorly formulated hypotheses and improper study designs, leading to unreliable results. Thus, the formulations of relevant research questions and verifiable hypotheses are crucial when beginning research. 12

CHARACTERISTICS OF GOOD RESEARCH QUESTIONS AND HYPOTHESES

Excellent research questions are specific and focused. These integrate collective data and observations to confirm or refute the subsequent hypotheses. Well-constructed hypotheses are based on previous reports and verify the research context. These are realistic, in-depth, sufficiently complex, and reproducible. More importantly, these hypotheses can be addressed and tested. 13

There are several characteristics of well-developed hypotheses. Good hypotheses are 1) empirically testable 7 , 10 , 11 , 13 ; 2) backed by preliminary evidence 9 ; 3) testable by ethical research 7 , 9 ; 4) based on original ideas 9 ; 5) have evidenced-based logical reasoning 10 ; and 6) can be predicted. 11 Good hypotheses can infer ethical and positive implications, indicating the presence of a relationship or effect relevant to the research theme. 7 , 11 These are initially developed from a general theory and branch into specific hypotheses by deductive reasoning. In the absence of a theory to base the hypotheses, inductive reasoning based on specific observations or findings form more general hypotheses. 10

TYPES OF RESEARCH QUESTIONS AND HYPOTHESES

Research questions and hypotheses are developed according to the type of research, which can be broadly classified into quantitative and qualitative research. We provide a summary of the types of research questions and hypotheses under quantitative and qualitative research categories in Table 1 .

Quantitative research questionsQuantitative research hypotheses
Descriptive research questionsSimple hypothesis
Comparative research questionsComplex hypothesis
Relationship research questionsDirectional hypothesis
Non-directional hypothesis
Associative hypothesis
Causal hypothesis
Null hypothesis
Alternative hypothesis
Working hypothesis
Statistical hypothesis
Logical hypothesis
Hypothesis-testing
Qualitative research questionsQualitative research hypotheses
Contextual research questionsHypothesis-generating
Descriptive research questions
Evaluation research questions
Explanatory research questions
Exploratory research questions
Generative research questions
Ideological research questions
Ethnographic research questions
Phenomenological research questions
Grounded theory questions
Qualitative case study questions

Research questions in quantitative research

In quantitative research, research questions inquire about the relationships among variables being investigated and are usually framed at the start of the study. These are precise and typically linked to the subject population, dependent and independent variables, and research design. 1 Research questions may also attempt to describe the behavior of a population in relation to one or more variables, or describe the characteristics of variables to be measured ( descriptive research questions ). 1 , 5 , 14 These questions may also aim to discover differences between groups within the context of an outcome variable ( comparative research questions ), 1 , 5 , 14 or elucidate trends and interactions among variables ( relationship research questions ). 1 , 5 We provide examples of descriptive, comparative, and relationship research questions in quantitative research in Table 2 .

Quantitative research questions
Descriptive research question
- Measures responses of subjects to variables
- Presents variables to measure, analyze, or assess
What is the proportion of resident doctors in the hospital who have mastered ultrasonography (response of subjects to a variable) as a diagnostic technique in their clinical training?
Comparative research question
- Clarifies difference between one group with outcome variable and another group without outcome variable
Is there a difference in the reduction of lung metastasis in osteosarcoma patients who received the vitamin D adjunctive therapy (group with outcome variable) compared with osteosarcoma patients who did not receive the vitamin D adjunctive therapy (group without outcome variable)?
- Compares the effects of variables
How does the vitamin D analogue 22-Oxacalcitriol (variable 1) mimic the antiproliferative activity of 1,25-Dihydroxyvitamin D (variable 2) in osteosarcoma cells?
Relationship research question
- Defines trends, association, relationships, or interactions between dependent variable and independent variable
Is there a relationship between the number of medical student suicide (dependent variable) and the level of medical student stress (independent variable) in Japan during the first wave of the COVID-19 pandemic?

Hypotheses in quantitative research

In quantitative research, hypotheses predict the expected relationships among variables. 15 Relationships among variables that can be predicted include 1) between a single dependent variable and a single independent variable ( simple hypothesis ) or 2) between two or more independent and dependent variables ( complex hypothesis ). 4 , 11 Hypotheses may also specify the expected direction to be followed and imply an intellectual commitment to a particular outcome ( directional hypothesis ) 4 . On the other hand, hypotheses may not predict the exact direction and are used in the absence of a theory, or when findings contradict previous studies ( non-directional hypothesis ). 4 In addition, hypotheses can 1) define interdependency between variables ( associative hypothesis ), 4 2) propose an effect on the dependent variable from manipulation of the independent variable ( causal hypothesis ), 4 3) state a negative relationship between two variables ( null hypothesis ), 4 , 11 , 15 4) replace the working hypothesis if rejected ( alternative hypothesis ), 15 explain the relationship of phenomena to possibly generate a theory ( working hypothesis ), 11 5) involve quantifiable variables that can be tested statistically ( statistical hypothesis ), 11 6) or express a relationship whose interlinks can be verified logically ( logical hypothesis ). 11 We provide examples of simple, complex, directional, non-directional, associative, causal, null, alternative, working, statistical, and logical hypotheses in quantitative research, as well as the definition of quantitative hypothesis-testing research in Table 3 .

Quantitative research hypotheses
Simple hypothesis
- Predicts relationship between single dependent variable and single independent variable
If the dose of the new medication (single independent variable) is high, blood pressure (single dependent variable) is lowered.
Complex hypothesis
- Foretells relationship between two or more independent and dependent variables
The higher the use of anticancer drugs, radiation therapy, and adjunctive agents (3 independent variables), the higher would be the survival rate (1 dependent variable).
Directional hypothesis
- Identifies study direction based on theory towards particular outcome to clarify relationship between variables
Privately funded research projects will have a larger international scope (study direction) than publicly funded research projects.
Non-directional hypothesis
- Nature of relationship between two variables or exact study direction is not identified
- Does not involve a theory
Women and men are different in terms of helpfulness. (Exact study direction is not identified)
Associative hypothesis
- Describes variable interdependency
- Change in one variable causes change in another variable
A larger number of people vaccinated against COVID-19 in the region (change in independent variable) will reduce the region’s incidence of COVID-19 infection (change in dependent variable).
Causal hypothesis
- An effect on dependent variable is predicted from manipulation of independent variable
A change into a high-fiber diet (independent variable) will reduce the blood sugar level (dependent variable) of the patient.
Null hypothesis
- A negative statement indicating no relationship or difference between 2 variables
There is no significant difference in the severity of pulmonary metastases between the new drug (variable 1) and the current drug (variable 2).
Alternative hypothesis
- Following a null hypothesis, an alternative hypothesis predicts a relationship between 2 study variables
The new drug (variable 1) is better on average in reducing the level of pain from pulmonary metastasis than the current drug (variable 2).
Working hypothesis
- A hypothesis that is initially accepted for further research to produce a feasible theory
Dairy cows fed with concentrates of different formulations will produce different amounts of milk.
Statistical hypothesis
- Assumption about the value of population parameter or relationship among several population characteristics
- Validity tested by a statistical experiment or analysis
The mean recovery rate from COVID-19 infection (value of population parameter) is not significantly different between population 1 and population 2.
There is a positive correlation between the level of stress at the workplace and the number of suicides (population characteristics) among working people in Japan.
Logical hypothesis
- Offers or proposes an explanation with limited or no extensive evidence
If healthcare workers provide more educational programs about contraception methods, the number of adolescent pregnancies will be less.
Hypothesis-testing (Quantitative hypothesis-testing research)
- Quantitative research uses deductive reasoning.
- This involves the formation of a hypothesis, collection of data in the investigation of the problem, analysis and use of the data from the investigation, and drawing of conclusions to validate or nullify the hypotheses.

Research questions in qualitative research

Unlike research questions in quantitative research, research questions in qualitative research are usually continuously reviewed and reformulated. The central question and associated subquestions are stated more than the hypotheses. 15 The central question broadly explores a complex set of factors surrounding the central phenomenon, aiming to present the varied perspectives of participants. 15

There are varied goals for which qualitative research questions are developed. These questions can function in several ways, such as to 1) identify and describe existing conditions ( contextual research question s); 2) describe a phenomenon ( descriptive research questions ); 3) assess the effectiveness of existing methods, protocols, theories, or procedures ( evaluation research questions ); 4) examine a phenomenon or analyze the reasons or relationships between subjects or phenomena ( explanatory research questions ); or 5) focus on unknown aspects of a particular topic ( exploratory research questions ). 5 In addition, some qualitative research questions provide new ideas for the development of theories and actions ( generative research questions ) or advance specific ideologies of a position ( ideological research questions ). 1 Other qualitative research questions may build on a body of existing literature and become working guidelines ( ethnographic research questions ). Research questions may also be broadly stated without specific reference to the existing literature or a typology of questions ( phenomenological research questions ), may be directed towards generating a theory of some process ( grounded theory questions ), or may address a description of the case and the emerging themes ( qualitative case study questions ). 15 We provide examples of contextual, descriptive, evaluation, explanatory, exploratory, generative, ideological, ethnographic, phenomenological, grounded theory, and qualitative case study research questions in qualitative research in Table 4 , and the definition of qualitative hypothesis-generating research in Table 5 .

Qualitative research questions
Contextual research question
- Ask the nature of what already exists
- Individuals or groups function to further clarify and understand the natural context of real-world problems
What are the experiences of nurses working night shifts in healthcare during the COVID-19 pandemic? (natural context of real-world problems)
Descriptive research question
- Aims to describe a phenomenon
What are the different forms of disrespect and abuse (phenomenon) experienced by Tanzanian women when giving birth in healthcare facilities?
Evaluation research question
- Examines the effectiveness of existing practice or accepted frameworks
How effective are decision aids (effectiveness of existing practice) in helping decide whether to give birth at home or in a healthcare facility?
Explanatory research question
- Clarifies a previously studied phenomenon and explains why it occurs
Why is there an increase in teenage pregnancy (phenomenon) in Tanzania?
Exploratory research question
- Explores areas that have not been fully investigated to have a deeper understanding of the research problem
What factors affect the mental health of medical students (areas that have not yet been fully investigated) during the COVID-19 pandemic?
Generative research question
- Develops an in-depth understanding of people’s behavior by asking ‘how would’ or ‘what if’ to identify problems and find solutions
How would the extensive research experience of the behavior of new staff impact the success of the novel drug initiative?
Ideological research question
- Aims to advance specific ideas or ideologies of a position
Are Japanese nurses who volunteer in remote African hospitals able to promote humanized care of patients (specific ideas or ideologies) in the areas of safe patient environment, respect of patient privacy, and provision of accurate information related to health and care?
Ethnographic research question
- Clarifies peoples’ nature, activities, their interactions, and the outcomes of their actions in specific settings
What are the demographic characteristics, rehabilitative treatments, community interactions, and disease outcomes (nature, activities, their interactions, and the outcomes) of people in China who are suffering from pneumoconiosis?
Phenomenological research question
- Knows more about the phenomena that have impacted an individual
What are the lived experiences of parents who have been living with and caring for children with a diagnosis of autism? (phenomena that have impacted an individual)
Grounded theory question
- Focuses on social processes asking about what happens and how people interact, or uncovering social relationships and behaviors of groups
What are the problems that pregnant adolescents face in terms of social and cultural norms (social processes), and how can these be addressed?
Qualitative case study question
- Assesses a phenomenon using different sources of data to answer “why” and “how” questions
- Considers how the phenomenon is influenced by its contextual situation.
How does quitting work and assuming the role of a full-time mother (phenomenon assessed) change the lives of women in Japan?
Qualitative research hypotheses
Hypothesis-generating (Qualitative hypothesis-generating research)
- Qualitative research uses inductive reasoning.
- This involves data collection from study participants or the literature regarding a phenomenon of interest, using the collected data to develop a formal hypothesis, and using the formal hypothesis as a framework for testing the hypothesis.
- Qualitative exploratory studies explore areas deeper, clarifying subjective experience and allowing formulation of a formal hypothesis potentially testable in a future quantitative approach.

Qualitative studies usually pose at least one central research question and several subquestions starting with How or What . These research questions use exploratory verbs such as explore or describe . These also focus on one central phenomenon of interest, and may mention the participants and research site. 15

Hypotheses in qualitative research

Hypotheses in qualitative research are stated in the form of a clear statement concerning the problem to be investigated. Unlike in quantitative research where hypotheses are usually developed to be tested, qualitative research can lead to both hypothesis-testing and hypothesis-generating outcomes. 2 When studies require both quantitative and qualitative research questions, this suggests an integrative process between both research methods wherein a single mixed-methods research question can be developed. 1

FRAMEWORKS FOR DEVELOPING RESEARCH QUESTIONS AND HYPOTHESES

Research questions followed by hypotheses should be developed before the start of the study. 1 , 12 , 14 It is crucial to develop feasible research questions on a topic that is interesting to both the researcher and the scientific community. This can be achieved by a meticulous review of previous and current studies to establish a novel topic. Specific areas are subsequently focused on to generate ethical research questions. The relevance of the research questions is evaluated in terms of clarity of the resulting data, specificity of the methodology, objectivity of the outcome, depth of the research, and impact of the study. 1 , 5 These aspects constitute the FINER criteria (i.e., Feasible, Interesting, Novel, Ethical, and Relevant). 1 Clarity and effectiveness are achieved if research questions meet the FINER criteria. In addition to the FINER criteria, Ratan et al. described focus, complexity, novelty, feasibility, and measurability for evaluating the effectiveness of research questions. 14

The PICOT and PEO frameworks are also used when developing research questions. 1 The following elements are addressed in these frameworks, PICOT: P-population/patients/problem, I-intervention or indicator being studied, C-comparison group, O-outcome of interest, and T-timeframe of the study; PEO: P-population being studied, E-exposure to preexisting conditions, and O-outcome of interest. 1 Research questions are also considered good if these meet the “FINERMAPS” framework: Feasible, Interesting, Novel, Ethical, Relevant, Manageable, Appropriate, Potential value/publishable, and Systematic. 14

As we indicated earlier, research questions and hypotheses that are not carefully formulated result in unethical studies or poor outcomes. To illustrate this, we provide some examples of ambiguous research question and hypotheses that result in unclear and weak research objectives in quantitative research ( Table 6 ) 16 and qualitative research ( Table 7 ) 17 , and how to transform these ambiguous research question(s) and hypothesis(es) into clear and good statements.

VariablesUnclear and weak statement (Statement 1) Clear and good statement (Statement 2) Points to avoid
Research questionWhich is more effective between smoke moxibustion and smokeless moxibustion?“Moreover, regarding smoke moxibustion versus smokeless moxibustion, it remains unclear which is more effective, safe, and acceptable to pregnant women, and whether there is any difference in the amount of heat generated.” 1) Vague and unfocused questions
2) Closed questions simply answerable by yes or no
3) Questions requiring a simple choice
HypothesisThe smoke moxibustion group will have higher cephalic presentation.“Hypothesis 1. The smoke moxibustion stick group (SM group) and smokeless moxibustion stick group (-SLM group) will have higher rates of cephalic presentation after treatment than the control group.1) Unverifiable hypotheses
Hypothesis 2. The SM group and SLM group will have higher rates of cephalic presentation at birth than the control group.2) Incompletely stated groups of comparison
Hypothesis 3. There will be no significant differences in the well-being of the mother and child among the three groups in terms of the following outcomes: premature birth, premature rupture of membranes (PROM) at < 37 weeks, Apgar score < 7 at 5 min, umbilical cord blood pH < 7.1, admission to neonatal intensive care unit (NICU), and intrauterine fetal death.” 3) Insufficiently described variables or outcomes
Research objectiveTo determine which is more effective between smoke moxibustion and smokeless moxibustion.“The specific aims of this pilot study were (a) to compare the effects of smoke moxibustion and smokeless moxibustion treatments with the control group as a possible supplement to ECV for converting breech presentation to cephalic presentation and increasing adherence to the newly obtained cephalic position, and (b) to assess the effects of these treatments on the well-being of the mother and child.” 1) Poor understanding of the research question and hypotheses
2) Insufficient description of population, variables, or study outcomes

a These statements were composed for comparison and illustrative purposes only.

b These statements are direct quotes from Higashihara and Horiuchi. 16

VariablesUnclear and weak statement (Statement 1)Clear and good statement (Statement 2)Points to avoid
Research questionDoes disrespect and abuse (D&A) occur in childbirth in Tanzania?How does disrespect and abuse (D&A) occur and what are the types of physical and psychological abuses observed in midwives’ actual care during facility-based childbirth in urban Tanzania?1) Ambiguous or oversimplistic questions
2) Questions unverifiable by data collection and analysis
HypothesisDisrespect and abuse (D&A) occur in childbirth in Tanzania.Hypothesis 1: Several types of physical and psychological abuse by midwives in actual care occur during facility-based childbirth in urban Tanzania.1) Statements simply expressing facts
Hypothesis 2: Weak nursing and midwifery management contribute to the D&A of women during facility-based childbirth in urban Tanzania.2) Insufficiently described concepts or variables
Research objectiveTo describe disrespect and abuse (D&A) in childbirth in Tanzania.“This study aimed to describe from actual observations the respectful and disrespectful care received by women from midwives during their labor period in two hospitals in urban Tanzania.” 1) Statements unrelated to the research question and hypotheses
2) Unattainable or unexplorable objectives

a This statement is a direct quote from Shimoda et al. 17

The other statements were composed for comparison and illustrative purposes only.

CONSTRUCTING RESEARCH QUESTIONS AND HYPOTHESES

To construct effective research questions and hypotheses, it is very important to 1) clarify the background and 2) identify the research problem at the outset of the research, within a specific timeframe. 9 Then, 3) review or conduct preliminary research to collect all available knowledge about the possible research questions by studying theories and previous studies. 18 Afterwards, 4) construct research questions to investigate the research problem. Identify variables to be accessed from the research questions 4 and make operational definitions of constructs from the research problem and questions. Thereafter, 5) construct specific deductive or inductive predictions in the form of hypotheses. 4 Finally, 6) state the study aims . This general flow for constructing effective research questions and hypotheses prior to conducting research is shown in Fig. 1 .

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Research questions are used more frequently in qualitative research than objectives or hypotheses. 3 These questions seek to discover, understand, explore or describe experiences by asking “What” or “How.” The questions are open-ended to elicit a description rather than to relate variables or compare groups. The questions are continually reviewed, reformulated, and changed during the qualitative study. 3 Research questions are also used more frequently in survey projects than hypotheses in experiments in quantitative research to compare variables and their relationships.

Hypotheses are constructed based on the variables identified and as an if-then statement, following the template, ‘If a specific action is taken, then a certain outcome is expected.’ At this stage, some ideas regarding expectations from the research to be conducted must be drawn. 18 Then, the variables to be manipulated (independent) and influenced (dependent) are defined. 4 Thereafter, the hypothesis is stated and refined, and reproducible data tailored to the hypothesis are identified, collected, and analyzed. 4 The hypotheses must be testable and specific, 18 and should describe the variables and their relationships, the specific group being studied, and the predicted research outcome. 18 Hypotheses construction involves a testable proposition to be deduced from theory, and independent and dependent variables to be separated and measured separately. 3 Therefore, good hypotheses must be based on good research questions constructed at the start of a study or trial. 12

In summary, research questions are constructed after establishing the background of the study. Hypotheses are then developed based on the research questions. Thus, it is crucial to have excellent research questions to generate superior hypotheses. In turn, these would determine the research objectives and the design of the study, and ultimately, the outcome of the research. 12 Algorithms for building research questions and hypotheses are shown in Fig. 2 for quantitative research and in Fig. 3 for qualitative research.

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EXAMPLES OF RESEARCH QUESTIONS FROM PUBLISHED ARTICLES

  • EXAMPLE 1. Descriptive research question (quantitative research)
  • - Presents research variables to be assessed (distinct phenotypes and subphenotypes)
  • “BACKGROUND: Since COVID-19 was identified, its clinical and biological heterogeneity has been recognized. Identifying COVID-19 phenotypes might help guide basic, clinical, and translational research efforts.
  • RESEARCH QUESTION: Does the clinical spectrum of patients with COVID-19 contain distinct phenotypes and subphenotypes? ” 19
  • EXAMPLE 2. Relationship research question (quantitative research)
  • - Shows interactions between dependent variable (static postural control) and independent variable (peripheral visual field loss)
  • “Background: Integration of visual, vestibular, and proprioceptive sensations contributes to postural control. People with peripheral visual field loss have serious postural instability. However, the directional specificity of postural stability and sensory reweighting caused by gradual peripheral visual field loss remain unclear.
  • Research question: What are the effects of peripheral visual field loss on static postural control ?” 20
  • EXAMPLE 3. Comparative research question (quantitative research)
  • - Clarifies the difference among groups with an outcome variable (patients enrolled in COMPERA with moderate PH or severe PH in COPD) and another group without the outcome variable (patients with idiopathic pulmonary arterial hypertension (IPAH))
  • “BACKGROUND: Pulmonary hypertension (PH) in COPD is a poorly investigated clinical condition.
  • RESEARCH QUESTION: Which factors determine the outcome of PH in COPD?
  • STUDY DESIGN AND METHODS: We analyzed the characteristics and outcome of patients enrolled in the Comparative, Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension (COMPERA) with moderate or severe PH in COPD as defined during the 6th PH World Symposium who received medical therapy for PH and compared them with patients with idiopathic pulmonary arterial hypertension (IPAH) .” 21
  • EXAMPLE 4. Exploratory research question (qualitative research)
  • - Explores areas that have not been fully investigated (perspectives of families and children who receive care in clinic-based child obesity treatment) to have a deeper understanding of the research problem
  • “Problem: Interventions for children with obesity lead to only modest improvements in BMI and long-term outcomes, and data are limited on the perspectives of families of children with obesity in clinic-based treatment. This scoping review seeks to answer the question: What is known about the perspectives of families and children who receive care in clinic-based child obesity treatment? This review aims to explore the scope of perspectives reported by families of children with obesity who have received individualized outpatient clinic-based obesity treatment.” 22
  • EXAMPLE 5. Relationship research question (quantitative research)
  • - Defines interactions between dependent variable (use of ankle strategies) and independent variable (changes in muscle tone)
  • “Background: To maintain an upright standing posture against external disturbances, the human body mainly employs two types of postural control strategies: “ankle strategy” and “hip strategy.” While it has been reported that the magnitude of the disturbance alters the use of postural control strategies, it has not been elucidated how the level of muscle tone, one of the crucial parameters of bodily function, determines the use of each strategy. We have previously confirmed using forward dynamics simulations of human musculoskeletal models that an increased muscle tone promotes the use of ankle strategies. The objective of the present study was to experimentally evaluate a hypothesis: an increased muscle tone promotes the use of ankle strategies. Research question: Do changes in the muscle tone affect the use of ankle strategies ?” 23

EXAMPLES OF HYPOTHESES IN PUBLISHED ARTICLES

  • EXAMPLE 1. Working hypothesis (quantitative research)
  • - A hypothesis that is initially accepted for further research to produce a feasible theory
  • “As fever may have benefit in shortening the duration of viral illness, it is plausible to hypothesize that the antipyretic efficacy of ibuprofen may be hindering the benefits of a fever response when taken during the early stages of COVID-19 illness .” 24
  • “In conclusion, it is plausible to hypothesize that the antipyretic efficacy of ibuprofen may be hindering the benefits of a fever response . The difference in perceived safety of these agents in COVID-19 illness could be related to the more potent efficacy to reduce fever with ibuprofen compared to acetaminophen. Compelling data on the benefit of fever warrant further research and review to determine when to treat or withhold ibuprofen for early stage fever for COVID-19 and other related viral illnesses .” 24
  • EXAMPLE 2. Exploratory hypothesis (qualitative research)
  • - Explores particular areas deeper to clarify subjective experience and develop a formal hypothesis potentially testable in a future quantitative approach
  • “We hypothesized that when thinking about a past experience of help-seeking, a self distancing prompt would cause increased help-seeking intentions and more favorable help-seeking outcome expectations .” 25
  • “Conclusion
  • Although a priori hypotheses were not supported, further research is warranted as results indicate the potential for using self-distancing approaches to increasing help-seeking among some people with depressive symptomatology.” 25
  • EXAMPLE 3. Hypothesis-generating research to establish a framework for hypothesis testing (qualitative research)
  • “We hypothesize that compassionate care is beneficial for patients (better outcomes), healthcare systems and payers (lower costs), and healthcare providers (lower burnout). ” 26
  • Compassionomics is the branch of knowledge and scientific study of the effects of compassionate healthcare. Our main hypotheses are that compassionate healthcare is beneficial for (1) patients, by improving clinical outcomes, (2) healthcare systems and payers, by supporting financial sustainability, and (3) HCPs, by lowering burnout and promoting resilience and well-being. The purpose of this paper is to establish a scientific framework for testing the hypotheses above . If these hypotheses are confirmed through rigorous research, compassionomics will belong in the science of evidence-based medicine, with major implications for all healthcare domains.” 26
  • EXAMPLE 4. Statistical hypothesis (quantitative research)
  • - An assumption is made about the relationship among several population characteristics ( gender differences in sociodemographic and clinical characteristics of adults with ADHD ). Validity is tested by statistical experiment or analysis ( chi-square test, Students t-test, and logistic regression analysis)
  • “Our research investigated gender differences in sociodemographic and clinical characteristics of adults with ADHD in a Japanese clinical sample. Due to unique Japanese cultural ideals and expectations of women's behavior that are in opposition to ADHD symptoms, we hypothesized that women with ADHD experience more difficulties and present more dysfunctions than men . We tested the following hypotheses: first, women with ADHD have more comorbidities than men with ADHD; second, women with ADHD experience more social hardships than men, such as having less full-time employment and being more likely to be divorced.” 27
  • “Statistical Analysis
  • ( text omitted ) Between-gender comparisons were made using the chi-squared test for categorical variables and Students t-test for continuous variables…( text omitted ). A logistic regression analysis was performed for employment status, marital status, and comorbidity to evaluate the independent effects of gender on these dependent variables.” 27

EXAMPLES OF HYPOTHESIS AS WRITTEN IN PUBLISHED ARTICLES IN RELATION TO OTHER PARTS

  • EXAMPLE 1. Background, hypotheses, and aims are provided
  • “Pregnant women need skilled care during pregnancy and childbirth, but that skilled care is often delayed in some countries …( text omitted ). The focused antenatal care (FANC) model of WHO recommends that nurses provide information or counseling to all pregnant women …( text omitted ). Job aids are visual support materials that provide the right kind of information using graphics and words in a simple and yet effective manner. When nurses are not highly trained or have many work details to attend to, these job aids can serve as a content reminder for the nurses and can be used for educating their patients (Jennings, Yebadokpo, Affo, & Agbogbe, 2010) ( text omitted ). Importantly, additional evidence is needed to confirm how job aids can further improve the quality of ANC counseling by health workers in maternal care …( text omitted )” 28
  • “ This has led us to hypothesize that the quality of ANC counseling would be better if supported by job aids. Consequently, a better quality of ANC counseling is expected to produce higher levels of awareness concerning the danger signs of pregnancy and a more favorable impression of the caring behavior of nurses .” 28
  • “This study aimed to examine the differences in the responses of pregnant women to a job aid-supported intervention during ANC visit in terms of 1) their understanding of the danger signs of pregnancy and 2) their impression of the caring behaviors of nurses to pregnant women in rural Tanzania.” 28
  • EXAMPLE 2. Background, hypotheses, and aims are provided
  • “We conducted a two-arm randomized controlled trial (RCT) to evaluate and compare changes in salivary cortisol and oxytocin levels of first-time pregnant women between experimental and control groups. The women in the experimental group touched and held an infant for 30 min (experimental intervention protocol), whereas those in the control group watched a DVD movie of an infant (control intervention protocol). The primary outcome was salivary cortisol level and the secondary outcome was salivary oxytocin level.” 29
  • “ We hypothesize that at 30 min after touching and holding an infant, the salivary cortisol level will significantly decrease and the salivary oxytocin level will increase in the experimental group compared with the control group .” 29
  • EXAMPLE 3. Background, aim, and hypothesis are provided
  • “In countries where the maternal mortality ratio remains high, antenatal education to increase Birth Preparedness and Complication Readiness (BPCR) is considered one of the top priorities [1]. BPCR includes birth plans during the antenatal period, such as the birthplace, birth attendant, transportation, health facility for complications, expenses, and birth materials, as well as family coordination to achieve such birth plans. In Tanzania, although increasing, only about half of all pregnant women attend an antenatal clinic more than four times [4]. Moreover, the information provided during antenatal care (ANC) is insufficient. In the resource-poor settings, antenatal group education is a potential approach because of the limited time for individual counseling at antenatal clinics.” 30
  • “This study aimed to evaluate an antenatal group education program among pregnant women and their families with respect to birth-preparedness and maternal and infant outcomes in rural villages of Tanzania.” 30
  • “ The study hypothesis was if Tanzanian pregnant women and their families received a family-oriented antenatal group education, they would (1) have a higher level of BPCR, (2) attend antenatal clinic four or more times, (3) give birth in a health facility, (4) have less complications of women at birth, and (5) have less complications and deaths of infants than those who did not receive the education .” 30

Research questions and hypotheses are crucial components to any type of research, whether quantitative or qualitative. These questions should be developed at the very beginning of the study. Excellent research questions lead to superior hypotheses, which, like a compass, set the direction of research, and can often determine the successful conduct of the study. Many research studies have floundered because the development of research questions and subsequent hypotheses was not given the thought and meticulous attention needed. The development of research questions and hypotheses is an iterative process based on extensive knowledge of the literature and insightful grasp of the knowledge gap. Focused, concise, and specific research questions provide a strong foundation for constructing hypotheses which serve as formal predictions about the research outcomes. Research questions and hypotheses are crucial elements of research that should not be overlooked. They should be carefully thought of and constructed when planning research. This avoids unethical studies and poor outcomes by defining well-founded objectives that determine the design, course, and outcome of the study.

Disclosure: The authors have no potential conflicts of interest to disclose.

Author Contributions:

  • Conceptualization: Barroga E, Matanguihan GJ.
  • Methodology: Barroga E, Matanguihan GJ.
  • Writing - original draft: Barroga E, Matanguihan GJ.
  • Writing - review & editing: Barroga E, Matanguihan GJ.

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How to appropriately choose research subjects

Affiliation.

  • 1 Consulting Center of Biomedical Statistics, Academy of Military Medical Sciences, Beijing 100850, China. [email protected]
  • PMID: 21419075
  • DOI: 10.3736/jcim20110303

The research subject is the first key element of the three key elements in the research design. An appropriate selection of research subjects is crucial to the success of the research. This article summarizes the general principles for the selection of research subjects, the types and numbers of research subjects and the common mistakes that researchers tend to make in the selection of the research subjects. This article also provides the methodology suggestions for the selection of research subjects.

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Research Is an Activity and a Subject of Study: A Proposed Metaconcept and Its Practical Application

Allison Hosier *

Information literacy instruction based on the ACRL Information Literacy Competency Standards for Higher Education tends to focus on basic research skills. However, research is not just a skill but also a subject of study. The ACRL Framework for Information Literacy for Higher Education opens the door to integrating the study of research into information literacy instruction via its acknowledgement of the contextual nature of research. This article introduces the metaconcept that research is both an activity and a subject of study. The application of this metaconcept in core LIS literature is discussed and a model for incorporating the study of research into information literacy instruction is suggested.

Introduction

Studies have shown that students’ confidence in their research skills often does not match their proficiency with those skills. 1 Students seem to believe that their facility with search engines is sufficient for any research-related task they may be faced with. In believing this, what students fail to realize is that while the information-seeking skills they have developed are certainly valuable in some situations, they are less so in others.

Instructors of composition courses face a similar dilemma. Students believe that writing is nothing more than a basic skill and often fail to appreciate the importance of rhetorical context to the writing process. In an effort to resolve this, instructors help students familiarize themselves with different genres of writing via the study of writing itself. As a result, students may begin to recognize that basic skills are not enough to meet the expectations for writing in every context. The most successful student writers are ones who are able to recognize themselves as novices in some of these contexts. 2 These student writers will also begin to see that writing is not just an activity but also a subject of study. 3

Students who learn about research through information literacy instruction may not have the opportunity to experience a similar epiphany about the research process. This is because common models of information literacy instruction are primarily skills-based with a particular focus on application. There is little if any time to devote to teaching students about the contextual nature of research or how to study a research product for evidence of conventions related to these contexts.

If information literacy instruction is typically skills-based, it is likely because the ACRL Information Literacy Competency Standards for Higher Education (the Standards ) is a skills-based document, as are similar documents that have shaped how information literacy has been taught until now. The Standards guidelines in particular fail to address the contextual nature of research in a meaningful way, thus limiting opportunities to introduce this important concept in the classroom.

The advent of the ACRL Framework for Information Literacy for Higher Education (the Framework ) marks a shift from skills-based thinking about information literacy to concept-based thinking. Because of this shift, information literacy instructors now have the option to expand their teaching beyond the application of basic research skills. The Framework ’s attention to context in particular can be used to create a model of instruction that involves the study of research in addition to the application of research skills. In this way, students will better recognize that research, like writing, is both an activity and a subject of study.

The purpose of this article is threefold. The first is to propose the metaconcept that research is both an activity and a subject of study. This metaconcept has long been present in the literature in the library and information science field but has been largely absent from information literacy instruction. The second goal of this study is dto discuss how the influence of the Standards led to the skills-based model of information literacy instruction while suggesting that the Framework ’s attention to context provides a path for reshaping such instruction around the study of research. Third, a model for integrating this metaconcept into information literacy instruction will be presented.

These ideas were initially inspired by Adler-Kassner and Wardle’s edited volume Naming What We Know: Threshold Concepts of Writing Studies . Just as Adler-Kassner and Wardle and their collaborators aimed to articulate what writing studies experts know about their subject to improve conversations with students and other nonexperts, the application of the ideas in the present study can lead to better discussions about information literacy with those who in the past may not have fully understood its value.

Defining Research

Before getting to the heart of this paper’s argument, it may be helpful to first establish more clearly what, exactly, is meant by “research.”

In their “Policy for Protection of Human Research Subjects,” the Office for Human Research Protections defines research as a systematic investigation intended to contribute to generalizable knowledge. 4 Institutional Review Boards commonly use this definition to guide researchers applying for approval to pursue research involving human subjects.

The Standards also portrays research as an investigation, one that likely involves the use of library resources. The prescribed steps for the research process include the identification of a gap in knowledge, the identification and evaluation of relevant sources, and the ethical use of those sources. 5

In the Framework , research is alluded to as a “reflective discovery of information” in the expanded definition of information literacy. 6 This journey of reflective discovery is intended to lead to the creation of new knowledge.

Information-seeking is a concept related closely to research that takes into consideration contexts beyond the scientific and academic ones that are the primary concern of the above definitions. Wilson describes information-seeking as a behavior that “arises as a consequence of a need perceived by an information user who…makes demands upon formal or informal information sources or services, which result in success or failure to find relevant information.” 7

It is necessary to define research broadly in a discussion of research as both an activity and a subject of study, because the study of research can take many forms and context is always a consideration. For this reason, the understanding of research in this paper will encompass the following:

  • Research is any formal or informal process that is undertaken to fill a gap in knowledge, build on existing knowledge, or create new knowledge.
  • Goals of research include but are not limited to answering a research question, testing a hypothesis, or satisfying curiosity.
  • Research involves investigation of some kind. This investigation may be formal, such as an exhaustive literature review or the careful implementation of the scientific method, or it may be informal, such as a brief Google search. More formal research investigations may be qualitative or quantitative in nature.
  • The research process is often iterative rather than linear.
  • The results of research may be captured in a research product or a set of research products. The products of research can take many forms, including but not limited to: formally published research studies, dissertations, conference proceedings, creative works, presentations, speeches, news and magazine articles, and blog posts.
  • Research products often include evidence of research in some way, whether it is a list of citations, a detailed description of methodology, a quote from an interview subject, a list of acknowledgements, a verbal allusion to a source of information (as in a speech), or contextual links (as in an online blog post).

Research envisioned through an information literacy lens is often academic in nature. This type of research will be referred to as “academic research” throughout this paper. Table 1 outlines additional terms that will be used to refer to different types of research where necessary. This is not intended as a definitive list of research genres but rather a guide that will serve to clarify certain points. Note that some types of research may overlap with others.

TABLE 1

Outline of Types of Research

Type of Research

Description

Example Research Products

Example Evidence of Research

Academic Research

Most often performed by professors and students in academic environments. Often involves the use of library resources but not always. May be disciplinary in nature.

Scholarly articles, research papers, dissertations, theses

Detailed literature reviews and citations

Creative Research

Performed as part of the process of producing a creative work

Novels, popular nonfiction, a performance

Notes on sources; lists of acknowledgements and credits

Personal Research

Undertaken to satisfy a personal information need or to satisfy curiosity

Social media posts, blog entries

Contextual links, informal notes on sources used (if any)

Professional Research

Required as part of a job in a particular field

News articles, presentations, reports, memos

Quotes from interview subjects, brief citations (formal or informal) to sources

Scientific Research

Follows the scientific method

Peer-reviewed articles, research studies and reports

Cited sources, detailed descriptions of methodology

Research Is a Subject of Study

A study of research is one in which the products or processes of research are analyzed to better understand some aspect of research itself. This is most directly seen in studies that observe actual research behaviors or evaluate specific research products. The study of research also has an influence on other areas of inquiry. Context is often key to studies of research.

The study of research is most prevalent in literature found in the library and information science (LIS) field. However, it also has relevant applications in other fields. This section will first summarize areas of inquiry directly and indirectly related to the study of research that can be found in LIS literature. A few relevant examples from the related field of writing studies will also be mentioned. Brief consideration will then be given to a relevant example from the field of psychology.

The Study of Research in Library and Information Science

Researchers in library and information science study the processes and products of research to improve systems and services, to understand how those systems and services are used, to analyze collections, to measure the impact of research-related instruction, to trace the development of a research topic over time, and more. These areas of inquiry are studied in a variety of contexts using a range of methods and populations. The study of research is relevant to virtually every specialization in library and information science. It is not an exaggeration to say that if you open any of the core journals in this field, such as those identified in a 2014 study by Nixon, 8 you are likely to find at least one article that is concerned directly or indirectly with the study of research in some way, shape, or form.

The study of research is a theme that has long been present in LIS literature but can be difficult to locate because until now it has not generally been named as such. The metaconcept introduced here gives us a novel lens through which to view our work and begin to articulate what we know about research as both an activity and a subject of study in a new way. When this lens is applied to content analyses and literature reviews, which are fairly common in LIS literature 9 and are themselves an example of the study of research, these works can serve as a valuable proxy for identifying topics related to the study of research in our field. An analysis by Tuomaala, Jarvelin, & Vakkari from 2014 may be most useful in this respect for the present discussion. 10 The breakdown of topics and subtopics the authors created for their study is specific enough to begin to see shades of the research-as-subject metaconcept. In their analysis, the authors found that information seeking, which includes subtopics such as information use and information management, accounted for 12.3 percent of the LIS literature in 2005, the most recent year considered for the study. The study of research also has applications related to studies of information storage and retrieval, a separate topic that includes subtopics such as cataloging and the testing of retrieval systems. More than 30 percent of the articles published that year related to this topic. Other potentially relevant areas from Tuomaala, Jarvelin, and Vakkari’s study include research on user education (1.7%), citation patterns (6.5%), and webometrics (2.9%).

What does the study of research in LIS look like? For one, it is often concerned with context. Researchers seek to gain important insights into how different populations seek or use information in different contexts. Some of the populations studied in recent issues of core LIS journals include disadvantaged adolescents, Catholic clergy, linguists, and poultry farmers, to name just a few. 11 Contexts of interest found in recent literature include not just academic or scholarly ones 12 but also personal, as in studies of everyday life information seeking, 13 and professional, as in studies of how information is accessed and used in various workplace environments. 14 Those who study the products of research may be interested in understanding how researchers cite data, what common themes can be found in the research on a particular subject, or how the content of one type of research product might distinguish it from another type of research product. 15 In all of these cases, context matters to the researcher.

Context also matters to those whose work may be informed by the study of research though research itself is not the direct object of study. For example, the work of collection management researchers must be informed at least in part by how a particular population uses the collection in question. 16 Usability studies may be primarily concerned with issues of design, but the researcher must also take into account the context in which the resource being tested will actually be used. 17 A study of a library’s physical space must include some consideration for the research and information-seeking activities that users conduct in that space, which will be different depending on details such as the type and size of the library as well as the population it serves. 18 Researchers who create algorithms or implement other methods to improve the effectiveness of information retrieval systems must have some understanding of the needs and behaviors of the system’s front-end users. 19 Though the examples cited are all from recent literature, they represent areas of inquiry that have developed over a long period of time.

In the past, the study of academic research as conducted by students has been of particular concern to those who teach information literacy. Leckie, for example, comments on how typical research assignments reflect an expert approach to research that may be inaccessible to novice student researchers. 20 Information literacy instruction is also often informed by studies that establish an understanding of students’ research behavior, including their method of strategic satisficing, 21 why they prefer certain resources and tools over others, 22 and why their choices do not always match expert expectations of quality and reliability. 23 Understanding gaps between the research skills librarians teach and the ones that are actually used in the workplace, as in Head, Van Hoeck, Eschler, and Fullerton, is another area of inquiry that has gained importance over time. 24

Among these studies of the products and processes of academic research are arguments for teaching students about the contextual nature of research. Fister advocates for creating a better awareness of the rhetorical aspects of research, 25 an idea that was later put into action by Davidson and Crateau. 26 Simmons proposes applying genre theory and critical information literacy to research instruction so that librarians can position themselves as discourse mediators, studying and teaching the conventions of research in different disciplines as anthropologists study and teach the practices of different cultures. 27 Harris makes a similar argument: “Before we make assumptions about how to assist communities of learning, we may also need to define and navigate the social, political, and cultural characteristics of that community.” 28

The study of research touches nearly every aspect of the library and information science field, in one form or another. But, as Faix points out, experts in other fields also take part in scholarly conversations about research. 29 This includes related fields such as writing studies, where authors like Brent and North approach the study of research from a composition perspective. 30 However, the study of research is also relevant to researchers in more scientific fields, which are often considered outside the scope of information literacy instruction. Though this paper focuses primarily on information literacy instruction, the overall argument is that such instruction would be more effective if it involved the study of research to help students appreciate the contextual nature of the research process. This means expanding our thinking about research beyond the library-based academic notions we have favored so far. For this reason, a relevant example of the study of research in psychology is provided in the next section.

The Study of Replicability and Reproducibility in Psychology

The methods, goals, and motivations of scientific research are considered to be distinct from the ones described by documents such as the Standards and the Framework . That this is the case serves as further evidence in support of the importance of context to the research process. However, scientific researchers have also been known to turn inward and examine the processes and products of research as it is represented in their fields.

In the field of psychology, the work done as part of the Reproducibility Project is particularly relevant to the present discussion. As part of this project, a team of researchers attempted to replicate the results of 100 psychological studies. 31 Their findings led them to create a set of recommendations for how to improve the research and publication process in their field to better promote replicability. One of these recommendations was to teach students to study research publications in their fields to evaluate the evidence used and learn to see potential methodological flaws.

The findings of this project inspired a number of responses. Some researchers studied the methods undertaken by those who worked on the project and used these analyses to question or criticize the results. 32 Others turned to conversations about whether replicability and reproducibility should be goals of psychological research in the first place. 33 There are also studies, 34 published since then, that seek to establish whether there are methods that can be used to improve the replicability of a study and others 35 that recommend new approaches to evaluating replicability itself. A similar study to investigate the reproducibility of cancer biology research is also being undertaken. 36

From these discussions, it becomes clear that research is not just an activity but also a subject of study for researchers in LIS and other fields. This metaconcept has important connections to the contextual nature of research. Both ideas are essential to learning about research in a meaningful way. Despite this, information literacy instruction tends to be generally skills-based with little or no discussion of these ideas. The reason for this may be that, for many, models of information literacy instruction have been built around the Standards , a document that places priority on teaching research skills over research-related concepts.

The Importance of Context: Limitations of the Standards and New Opportunities

As stated earlier, the Standards is a skills-based document. When considering the historical context of this document, its focus on the activity of research makes sense. Information literacy had developed over time from a job skill to one that was more closely related to research. Meanwhile, bibliographic instruction had also shifted from the original concept-based approaches to ones that focused more on teaching students basic access skills. 37 The Standards simply reflected these ways of thinking.

The Standards was also developed at a time when academic librarians were seeking to stake a place for themselves in the missions of their institutions, which had become more closely tied to the employability of their graduates. 38 For such institutions, learning outcomes became the favored way of gauging the success of a particular program. One of the Standards ’ stated goals is to provide measurable learning outcomes for information literacy. 39 To be measurable, learning outcomes must be based on what can be observed. It is much easier to measure the development of skills than it is to measure changes in a student’s worldview.

The limitations of the Standards have been well documented over time. 40 One of the main shortcomings of the Standards has always been in its failure to acknowledge the importance of context to the research process. More accurately, the Standards assume a single research context: that of library-based academic research. The closest the document comes to referencing the contextual nature of research is the occasional gesture toward discipline-specific research, which is still a highly academic notion (see table 2). Despite the aspiration of the Standards toward transferability, 41 research studies that have tested this idea tend to have mixed results. 42 In other words, despite its stated intentions, what the document is really doing is, as Mark points out, reflecting a tendency in the academy to measure expertise by one’s ability to adopt the conventions of academia. 43

TABLE 2

Explicit References to Research Context and Discipline in the ACRL Standards

Standard

Performance Indicator and Outcome

Standard 1: The information-literate student determines the nature and extent of the information needed.

2b: Recognizes that knowledge can be organized into disciplines that influence the way information is accessed

2e: Differentiates between primary and secondary sources, recognizing how their use and importance vary with each discipline

3b: Considers the feasibility of acquiring a new language or skill (such as foreign or discipline-based) to gather needed information and to understand its context

Standard 2: The information-literate student accesses needed information effectively and efficiently.

2c: Selects controlled vocabulary specific to the discipline or information retrieval source

2f: Implements the search using investigative protocols appropriate to the discipline

Standard 3: The information-literate student evaluates information and its sources critically and incorporates selected information into his or her knowledge base and value system.

2d: Recognizes the cultural, physical, or other context within which the information was created and understands the impact of context on interpreting the information

4d: Tests theories with discipline-appropriate techniques (examples: simulators, experiments)

Standard 4: The information-literate student, individually or as a member of a group, uses information effectively to accomplish a specific purpose.

1d: Manipulates digital text, images, and data, as needed, transferring them from their original locations and formats to a new context

Standard 5: The information-literate student understands many of the economic, legal, and social issues surrounding the use of information and accesses and uses information ethically and legally.

No explicit reference

Because the Standards does not adequately take into account the contextual nature of research, neither does Standards -based information literacy instruction. Instead, such instruction focuses primarily if not exclusively on teaching students the basic skills associated with library-based academic research. We know this because influential tools created to standardize the assessment of information literacy learning, such as the Information Literacy VALUE rubrics and the learning goals suggested by the Middle States Commission of Higher Education, reflect it. 44 We also know this because studies of syllabi for credit-bearing information literacy courses show that the most common topics taught as part of these courses are skills-based. 45

The influence of the Standards has had a noticeable effect on the way librarians think about teaching information literacy. When asked by Hofer, Townsend, and Brunetti about the most common “stuck places” students encountered when learning about research, the answers given by the librarians who participated in the study were concerned almost exclusively with academic research skills. 46 One place where a more contextual view of research shows through is in the respondents’ stated desire to help students better understand how the process of information creation might differ from one discipline to another.

The Standards has also had an effect on how information literacy is perceived by those outside the library field. When Gullikson asked nonlibrary faculty at what academic level they would expect students to have achieved individual learning outcomes from the Standards , the majority of those who responded indicated that they would expect students to have mastered these skills in the early part of their careers in higher education, if not before. 47 Standards- based information literacy, in the eyes of nonlibrarians, is at best seen as what Norgaard calls “a mere look up skill.” 48

The Standards provides no path to introducing students to the contextual nature of research. Because of this, the idea that research is both an activity and a subject of study became lost in our information literacy instruction and our thinking about information literacy instruction despite the fact that it remained a prevalent theme in our professional literature. In insisting on the importance of context to the research process, 49 the Framework gives us a way to change our thinking and our instruction.

Each of the Framework ’s six frames is infused with implicit and explicit references to the contextual nature of research (see table 3). In fact, the only frame in which the word “context” does not appear in one form or another is “Research as Inquiry,” which still manages to highlight the importance of distinguishing between processes of inquiry intended to meet different needs.

TABLE 3

Explicit References to the Importance of Context in the ACRL Framework

Frame

Relevant reference

Authority Is Constructed and Contextual

Information resources reflect their creators’ expertise and credibility, and are evaluated based on the information need and the context in which the information will be used.

[Authority] is contextual in that the information need may help to determine the level of authority required.

An understanding of this concept enables novice learners to critically examine all evidence—be it a short blog post or a peer-reviewed conference proceeding—and to ask relevant questions about origins, context, and suitability for the current information need.

Novice learners may need to rely on basic indicators of authority, such as type of publication or author credentials, where experts recognize schools of thought or discipline-specific paradigms.

[Learners who are developing their information-literate abilities] understand that many disciplines have acknowledged authorities in the sense of well-known scholars and publications that are widely considered “standard,” and yet, even in those situations, some scholars would challenge the authority of those sources.

Information Creation as Process

Experts recognize that information creations are valued differently in different contexts, such as academia or the workplace.

[Learners who are developing their information-literate abilities] articulate the traditional and emerging processes of information creation and dissemination in a particular discipline.

[Learners who are developing their information-literate abilities] monitor the value that is placed upon different types of information products in varying contexts.

Information Has Value

The value of information is manifested in various contexts, including publishing practices, access to information, the commodification of personal information, and intellectual property laws.

Research as Inquiry

No explicit reference

Scholarship as Conversation

[Learners who are developing their information-literate abilities] suspend judgment on the value of a particular piece of scholarship until the larger context for the scholarly conversation is better understood.

Searching as Strategic Exploration

Experts realize that information searching is a contextualized, complex experience that affects, and is affected by, the cognitive, affective, and social dimensions of the searcher.

[N]ovice learners tend to use few search strategies, while experts select from various search strategies, depending on the sources, scope, and context of the information need.

Of course, the Framework, like the Standards , is also a product of ACRL and so, as Foasberg points out, its contexts of interest are still primarily academic in nature. 50 No doubt research is currently underway to test the transferability of the Framework . In the meantime, it is not difficult to imagine how the six frames could apply to nonacademic forms of research. For example, negotiating a meaning from varying perspectives, as described in the “Scholarship as Conversation” frame, is as of much concern to those conducting personal, professional, or creative research as it is to those conducting academic research. Those who follow the investigative steps of the scientific method can likely find relevance in the idea of “Research as Inquiry.”

It may be true that not every threshold concept will apply to every research context. For some, that might be seen as a shortcoming of the present argument. However, it is worth remembering that the Framework is intended to be a flexible document, making it clear that there is room for more threshold concepts than those identified in the original version. 51 Further, in establishing a set of threshold concepts related to writing studies, Adler-Kassner and Wardle and their collaborators identified 37 threshold concepts, some of which may be more applicable to the study and activity of certain genres of writing than others. Granted, this work is not intended for broad implementation the way the Framework is, but both documents are of a similar spirit. 52

As stated earlier, students often enter the information literacy classroom unable to recognize that, while the skills and knowledge they have developed are valuable in some research contexts, they may be less so in others. For information literacy instructors, this has been a significant barrier, one that the Standards provided no meaningful way to overcome. The metaconcept that has been established here gives us a lens through which to understand research as not just an activity but also a subject of study. The Framework provides a path to pass on this knowledge to students by introducing them to the importance of context to the research process. The next section describes how a common model for composition instruction could be adapted for this purpose.

A Suggested Model for Practical Application

In Standards -based information literacy instruction, students are introduced to the conventions of academic research at the same time that they are expected to apply those conventions. They are expected to do this correctly without ever having seen or studied an example of such research, except perhaps one provided by their instructor for informational purposes. Badke criticizes this approach, colorfully stating, “teaching application without teaching method and philosophy is akin to showing someone how to steer and use the brakes on a car without teaching overall driving technique and the rules of the road.” 53

In writing studies, there is a similar expectation that, as Sommers and Saltz put it, students will “become master builders while they are still apprentices.” 54 However, composition instruction does not generally begin and end with application the way information literacy instruction does. Instead, students first study a selected example of a genre of writing to learn about the conventions of that genre and then attempt to apply those conventions in their own work. Information literacy instruction could benefit from emulating this structure.

Rather than organizing an information literacy course around units based on skills, sources, or tools, the course could be organized instead around different research contexts. More work may need to be done to determine what exactly those contexts can or should be or whether the conventions, goals, and motivations of those contexts can be said to represent “genres” as the term is understood by researchers of genre theory. 55 However, a general information literacy course could conceivably be organized around units on academic research, personal research, professional research, creative research, scientific research, and more.

In this approach, research skills like those described by the Standards would still be valuable but would only be taught after students first had the opportunity to study an example piece of research. Similar to the work of some professionals who study research, students could closely examine the types of sources used and think about the roles those sources play in the author’s research. They might also study the way the author gives credit to those sources, perhaps noticing that, in some research contexts, credit is given through formal citation while in others it is done through contextual links, quotes from interview subjects, or some other way. By doing this, students would learn how the conventions of research change from context to context. They may begin to develop a more realistic view of how much more there is to learn beyond the skills they already have and why it is worth learning.

As an illustration of how a unit in a course designed like this would work, consider that in a composition course students might first be given Letter from a Birmingham Jail by Martin Luther King Jr. as an example of persuasive writing. They would study this piece before trying to emulate King’s rhetorical moves in their own work.

In a unit on academic research in an information literacy course, students might first be given an example research essay or scholarly article. Rather than studying the writing, they would look at the evidence of research in the source. They might be asked to notice how the author uses citations or footnotes and includes a list of sources at the end. Attention might be drawn to the nature of the sources the author used, and critical thought might be given to why he or she made those choices. A student could also be asked to comment on how each source was used in the example piece: to add new information, to present and answer a contradicting view, to pull a quote, and so on.

The same could be done with units on other types of research. In a different unit, a personal blog post could be used as an example of personal research in which the evidence of research might appear as contextual links rather than formal citations. Or a news article could be studied as an example of journalistic or professional research in which quotes from sources with firsthand knowledge of an event are privileged over other types of sources. Even King’s Letter could be used as an example of research. In this piece, King borrows ideas from and makes reference to Socrates and the Bible to support his ideas. He also relies on the authority granted to him by his own personal experience with the issues he is discussing. 56

After studying the conventions of a genre of research through an example piece, students could then be taught the skills needed to complete the type of research each product represents. As a culminating project, students could be required to create a research product of their own that follows the conventions they learned about and then reflect on the ways that they used or challenged those conventions in their own work.

What is described above would be most appropriate for a general information literacy course taught at the undergraduate level. Instructors who teach more advanced or discipline-based information literacy could adapt this approach to suit their students’ needs and interests. For example, such instruction could focus more closely on the evaluation of research as it is most often represented in a field of study or profession. Students could be taught to see flaws in an author’s methodology, reasoning, or use of sources. They might also benefit from reviewing studies of information behavior of relevant populations to gain an understanding of how these populations interact with and create information in various settings. Instructors could invite students to think critically about the research practices in their fields and reflect on areas of potential improvement.

Caveats and Potential Concerns

It is necessary at this point to acknowledge that the common model for teaching composition described earlier is not without its critics in that field. Connors, for example, argues that using genres and modes to teach writing is more of a convenience to the instructor than a reflection of how writing actually works. 57 Hillocks makes the case that using genre and form to teach composition neglects the importance of inquiry and teaching students how to work with content. 58

In implementing a similar model for information literacy instruction, information literacy instructors may also have concerns. Foremost among these may be a reluctance to teach research outside the discipline-agnostic academic context of past Standards -based instruction. To do so, it has been argued in the past, would be to tread on the toes of disciplinary faculty who are the rightfully recognized experts on research in their fields of study and also perhaps to stray outside our professional strengths. 59 In response to this, it must be acknowledged that disciplinary faculty have been valuable partners in teaching information literacy in the past and could continue to be so in this new approach. As far as professional strengths, the Standards may have been limited to library-based academic research but the study of research in the LIS field is not, showing that contexts outside academia are, in fact, within our professional domain. Even if they were not, librarians tend to portray themselves as research experts as a way of communicating their value to their institutions. Taking advantage of the ways in which researchers in our own field have cultivated an understanding of how research works in a variety of contexts can only enhance our ability to label ourselves this way.

Another possible area of concern might be one anticipated by Townsend, Brunetti, and Hofer who acknowledge that threshold concepts like the ones found in the Framework tend to privilege certain ways of thinking. 60 Information literacy instructors may feel that the study of research is for professionals only and that teaching it to students would set up an expectation that, to be successful researchers, they need to become junior librarians or junior professors. However, it is worth noting that the goal of composition instruction, which involves both the study and practice of writing, is to teach students to be competent writers with an appreciation for rhetorical context. They are introduced to expert ways of thinking as a way of expanding their worldview but are not expected to become published (or even publishable) authors as a result of what they learn.

Finally, there may be some question of whether teaching students the conventions associated with different research contexts and then expecting them to follow those conventions stifles creativity by inviting conformity to existing systems. In answer to this, it could be argued that using the conventions of research as a teaching tool opens the door to conversations about why those conventions exist in the first place and in what ways they uphold what Beilin refers to as the “knowledge regime.” 61 Teaching students to think critically about the research that goes into creating a particular research product would enable them to more clearly see how the recontextualization process that is part of all research is subject to the inherent biases and worldviews of the author. 62 Even more important, as observed by Simmons, when students learn about generic conventions, they may learn to see themselves as having “the potential to effect changes in the conventions instead of simply learning to conform to the established patterns.” 63 In other words, learning “the rules” is also the first step in learning how to break those rules and challenge the systems that created them in meaningful and interesting ways.

Current models of information literacy instruction that treat research as nothing more than a basic skill do not serve students well. They also do not serve information literacy well. Research is not a basic skill that can be mastered for a lifetime in the space of a single instruction session. It is an activity that relies heavily on rhetorical context. It is also a subject of study with areas of inquiry in which context is often a large consideration. To paraphrase Wardle and Adler-Kassner, 64 a successful researcher is someone who cultivates an understanding of the expectations associated with research in a given context and then meaningfully engages with those expectations. Such a researcher is both a consumer and a creator of information.

The metaconcept introduced in this article, that research is both an activity and a subject of study, is an attempt to name something that has been present in LIS literature all along but for which there has been no room in information literacy instruction in the past. Future work to identify the ways in which this metaconcept has manifested itself in the literature in our field will be valuable in helping us to articulate the value of our work in a new way. In the meantime, it could serve as a useful frame for transforming information literacy instruction and enhancing the reputation of information literacy as something more than a basic skill.

1. Valeria E. Molteni and Emily K. Chan, “Student Confidence/Overconfidence in the Research Process,” Journal of Academic Librarianship 41, no. 1 (2015): 2–8.

2. Nancy Sommers and Laura Saltz, “The Novice as Expert: Writing the Freshman Year,” College Composition and Communication 56, no. 1 (2004): 124–49.

3. Elizabeth Wardle and Linda Adler-Kassner, “Metaconcept: Writing Is an Activity and a Subject of Study,” in Naming What We Know: Threshold Concepts of Writing Studies , eds. Linda Adler-Kassner and Elizabeth Wardle (Boulder: University Press of Colorado, 2015), 15–16.

4. Office for Human Research Protection, “Basic HHS Policy for Protection of Human Research Subjects” (2009), available online at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html [accessed 23 January 2018].

5. ACRL Information Literacy Competency Standards for Higher Education , “Information Literacy Defined” (2000), available online at www.ala.org/acrl/standards/informationliteracycompetency [accessed 23 January 2018].

6. ACRL Framework for Information Literacy for Higher Education , “Introduction” (2015), available online at www.ala.org/acrl/standards/ilframework [accessed 23 January 2018].

7. T.D. Wilson, “Models in Information Behaviour Research,” Journal of Documentation 55, no. 3 (1999): 251.

8. Judith M. Nixon, “Core Journals in Library and Information Science: Developing a Methodology for Ranking LIS Journals,” College & Research Libraries 75, no. 1 (2014): 66–90.

9. Examples include: Stephen E. Atkins, “Subject Trends in Library and Information Science Research, 1975–1984,” Library Trends 36, no. 4 (Spring 1988): 633–58; Lois Buttlar, “Analyzing the Library Periodical Literature: Content and Authorship,” College & Research Libraries 52, no. 1 (Jan. 1991): 38–53; Gloria S. Cline, ” College & Research Libraries : Its First Forty Years,” College & Research Libraries 43, no. 3 (1982): 208–32; Gregory A. Crawford, ”The Research Literature of Academic Librarianship: A Comparison of College & Research Libraries and Journal of Academic Librarianship ,” College & Research Libraries 60, no. 3 (1999): 224–30; Amy VanScoy and Cady Fontana, “How Reference and Information Services is Studied: Research Approaches and Methods,” Library & Information Science Research 38, no. 2 (2016): 94–100.

10. Otto Tuomaala, Kalervo Jarvelin, and Pertti Vakkari, “Evolution of Library and Information Science, 1965–2005: Content Analysis of Journal Articles,” Journal of the Association for Information Science & Technology 65, no. 7 (2014): 1446–62.

11. Steven Buchanan and Lauren Tuckerman, “The Information Behaviours of Disadvantaged and Disengaged Adolescents,” Journal of Documentation 72, no. 3 (2016): 527–48; Jacob Dankasa, “Mapping the Everyday Life Information Needs of Catholic Clergy: Savolainen’s ELIS Model Revisited,” Journal of Documentation 72, no. 3 (2016): 549–68; Maja Krtalic, Sanjica Faletar Tanackovic, and Damir Hasenay, “Linguists as Newspaper Users: Perceptions and Experiences,” Library and Information Science Research 38, no. 2 (2016): 108–16; Grace Msoffe and Patrick Ngulube, “Farmers’ Access to Poultry Management Information in Selected Areas of Tanzania,” Library and Information Science Research 38, no. 3 (2016): 82–90.

12. Examples include: Nancy Falciani-White, “Understanding the ‘Complexity of Experience’: Modeling Faculty Research Practices,” Journal of Academic Librarianship 42, no. 2 (2016): 118–26; Christopher V. Hollister, “An Exploratory Study on Post-tenure Research Productivity Among Academic Librarians,” Journal of Academic Librarianship 42, no. 4 (2016): 368–81; Sloan Komissarov and James Murray, “Factors That Influence Undergraduate Information-seeking Behavior and Opportunities for Student Success,” Journal of Academic Librarianship 42, no. 4 (2016): 423–49; Carol Sabbar and Iris Xie, “Language in the Information-Seeking Context: A Study of U.S. Scholars Using Non-English Sources,” Journal of Documentation 72, no. 1 (2016): 103–26.

13. Examples include: Lisa M. Given et al., “Watching Young Children ‘Play’ with Information Technology: Everyday Life Information Seeking in the Home,” Library and Information Science Research 38, no. 4 (2016): 344–52; Helena Känsäkoski and Maija-Leena Huotari, “Applying the Theory of Information Worlds Within a Health Care Practise in Finland,” Journal of Documentation 72, no. 2 (2016): 321–41; Reijo Savolainen, “Approaches to Socio-Cultural Barriers to Information Seeking,” Library and Information Science Research 38, no. 1 (2016): 52–59.

14. Examples include: Elham Sayyad Abdi, Helen Partridge, and Christine Bruce, “Web Designers and Developers’ Experience of Information Literacy: A Phenomenographic Study,” Library and Information Science Research 38, no. 4 (2016): 353–59; Rebecca Lea French and Kirsty Williamson, “The Information Practices of Welfare Workers: Conceptualizing and Modelling Information Bricolage,” Journal of Documentation 72, no. 4 (2016): 737–54; Ayse Göker et al., “Expeditions Through Image Jungles: The Commercial Use of Image Libraries in an Online Environment,” Journal of Documentation 72, no. 1 (2016): 5–23.

15. Examples related to each theme mentioned include: Nicolas Robinson-Garcia, Evaristo Jimenez-Contreras, and Daniel Torres-Salinas, “Analyzing Data Practices Using the Data Citation Index,” Journal of the Association for Information Science & Technology 67, no. 12 (2016): 2964–75; Angela Dresselhaus, “Literature of Acquisitions in Review, 2012–2013,” Library Resources & Technical Services 60, no. 3 (2016): 169–81; and Dian Walster, Deborah H. Charbonneau, and Kafi Kumasi, “Finding and Reading Reports of Research: How Academic Librarians Can Help Students Be More Successful,” Journal of Academic Librarianship 42, no. 6 (2016): 732–38.

16. Examples include: Cheryl D. Bain et al., “Using WorldShare Collection Evaluation to Analyze Physical Science and Engineering Monograph Holdings by Discipline,” Collection Management 41, no. 3 (2016): 133–51; Michael Hughes, “A Long-Term Study of Collection Use Based on Detailed Library of Congress Classification, a Statistical Tool for Collection Management Decisions,” Collection Management 41, no. 3 (2016): 152–67; Blanca Rodriguez-Bravo and Francisco Rodriguez-Sedano, “Trends in Library Collection Circulation in Spanish Universities,” Library Resources & Technical Services 60, no. 4 (2016): 248–58.

17. Examples include: Kelsey Renee Brett, Ashley Lierman, and Cherie Turner, “Lessons Learned: A Primo Usability Study,” Information Technology and Libraries 35, no. 1 (2016): 7–25; Reese Hoi Yin Fung, Dickson K.W. Chiu, Eddie H.T. Ko, Kevin K.W. Ho, and Patrick Lo, “Heuristic Usability Evaluation of University of Hong Kong Libraries’ Mobile Website,” Journal of Academic Librarianship 42, no. 5 (2016): 581–94; Joanne Oud, “Accessibility of Vendor-Created Database Tutorials for People with Disabilities,” Information Technology and Libraries 35, no. 4 (2016): 7–18; Kyunghye Yoon et al., “An Exploratory Study of Library Website Accessibility for Visually Impaired Users,” Library & Information Science Research 38, no. 3 (2016): 250–58.

18. Examples include: Çağrı Imamoğlu and Meltem Ö. Gürel, “‘Good Fences Make Good Neighbors’: Territorial Dividers Increase User Satisfaction and Efficiency in Library Study Spaces,” Journal of Academic Librarianship 42, no. 1 (2016): 65–73; Vera Lux, Robert J. Snyder, and Colleen Boff, “Why Users Come to the Library: A Case Study of Library and Non-Library Units,” Journal of Academic Librarianship 42, no. 2 (2016): 109–17; Silas M. Oliveira, “Space Preferences at James White Library: What Students Really Want,” Journal of Academic Librarianship 42, no. 4 (2016): 355–67.

19. Examples include: Edward Kai Fung Dang, Robert W.P. Luk, and James Allan, “A Context-Dependent Relevance Model,” Journal of the Association for Information Science & Technology 67, no. 3 (2016): 582–93; Bo Xu, Hongfei Lin, and Yuan Lin, “Assessment of Learning to Rank Methods for Query Expansion,” Journal of the Association for Information Science & Technology 67, no. 6 (2016): 1345–57.

20. Gloria J. Leckie, (1996). “Desperately Seeking Citations: Uncovering Faculty Assumptions About the Undergraduate Research Process,” Journal of Academic Librarianship 22, no. 3 (1996): 201–08.

21. Claire Warwick et al., “Cognitive Economy and Satisficing in Information Seeking: A Longitudinal Study of Undergraduate Information Behavior,” Journal of the American Society for Information Science & Technology 60, no. 12 (2009): 2402–15.

22. James P. Purdy, “Why First-Year College Students Select Online Research Resources as Their Favorite,” First Monday 17, no. 9 (2012).

23. Kyung-Sun Kim and Sei-Ching Joanna Sin, “Selecting Quality Sources: Bridging the Gap Between the Perception and Use of Information Sources,” Journal of Information Science 37, no. 2 (2011): 178–88.

24. Allison J. Head, Michele Van Hoeck, Jordan Eschler, and Sean Fullerton, “What Information Competencies Matter in Today’s Workplace?” Library and Information Research 37, no. 114 (2013): 75–104.

25. Barbara Fister, “Teaching the Rhetorical Dimensions of Research,” Research Strategies 11, no. 4 (1993): 211–19.

26. Jeanne R. Davidson and Carole Anne Crateau. “Intersections: Teaching Research Through a Rhetorical Lens,” Research Strategies 16, no. 4 (1998): 245–57.

27. Michelle Holschuh Simmons, “Librarians as Disciplinary Discourse Mediators: Using Genre Theory to Move toward Critical Information Literacy,” portal: Libraries and the Academy 5, no. 3 (2005): 297–311.

28. Benjamin R. Harris, “Communities as Necessity in Information Literacy Development: Challenging the Standards,” Journal of Academic Librarianship 34, no. 3 (2008): 250.

29. Allison Faix, “Assisting Students to Identify Sources: An Investigation,” Library Review 53, no. 8/9 (2014): 624–36.

30. Doug Brent, “Crossing Boundaries: Co-Op Students Relearning to Write,” College Composition and Communication 63, no. 4 (2012): 558–92; Sarah North, “Different Values, Different Skills? A Comparison of Essay Writing by Students from Arts and Science Backgrounds,” Studies in Higher Education 30, no. 5 (2005): 517–33.

31. Jens B. Asendorpf et al., “Recommendations for Increasing Replicability in Psychology,” European Journal of Personality 27, no. 2 (2013): 108–19.

32. Examples include: Shane W. Bench et al., “Does Expertise Matter in Replication? An Examination of the Reproducibility Project: Psychology,” Journal of Experimental Social Psychology 68 (2017): 181–84; and Alexander Etz and Joachim Vandekerckhove, “A Bayesian Perspective on the Reproducibility Project: Psychology,” Plos One 11, no. 2 (2016): 1–12.

33. Wolfgang Stroebe, “Are Most Published Social Psychological Findings False?” Journal of Experimental Social Psychology 66 (2016): 134–44.

34. Examples include: Mark J. Brandt et al., “The Replication Recipe: What Makes for a Convincing Replication?” Journal of Experimental Social Psychology 50 (2014): 217–24; and Sean Grant, Lukasz Cybulski, and Evan Mayo-Wilson, “Improving Transparency and Reproducibility through Registration: The Status of Intervention Trials Published in Clinical Psychology Journals,” Journal of Consulting and Clinical Psychology 84, no. 9 (2016): 753–67.

35. Uri Simonsohn, “Small Telescopes: Detectability and the Evaluation of Replication Results,” Psychological Science 26, no. 5 (2015): 559–69.

36. Timothy M. Errington et al., “Science Forum: An Open Investigation of the Reproducibility of Cancer Biology Research,” eLife 3 (2014).

37. Shirley J. Behrens, “A Conceptual Analysis and Historical Overview of Information Literacy,” College & Research Libraries 55, no. 4 (1994): 309–22; Frances L. Hopkins, “A Century of Bibliographyic Instruction: The Historical Claim to Professional and Academic Legitimacy,” College & Research Libraries 43, no. 3 (1982): 192–98; Mary F. Salony, “The History of Bibliographic Instruction: Changing Trends From Books to the Electronic World,” Reference Librarian 24, no. 51 (1995): 31–51.

38. Emily Drabinski, “Toward a Kairos of Library Instruction,” Journal of Academic Librarianship 40, no. 5 (2014): 480–85; Heidi L.M. Jacobs, “Information Literacy and Reflective Pedagogical Praxis,” Journal of Academic Librarianship 34, no. 3 (2008): 256–62.

39. ACRL Standards , “Information Literacy and Assessment.”

40. Notable examples of such thinking include: James Elmborg, “Critical Information Literacy: Implications for Instructional Practice,” Journal of Academic Librarianship 32, no. 2 (2006): 192–99; Edward K. Owusu-Ansah, “Information Literacy and the Academic Library: A Critical Look at a Concept and the Controversies Surrounding It,” Journal of Academic Librarianship 29, no. 4 (2003): 219–30; Troy A. Swanson, “Applying a Critical Pedagogical Perspective to Information Literacy Standards,” Community & Junior College Libraries 12, no. 4 (2004): 65–78: Eamon Tewell, “A Decade of Critical Information Literacy: A Review of the Literature,” Communications in Information Literacy 9, no. 1 (2015): 24–43.

41. ACRL Standards , “Information Literacy Defined”; ACRL Standards , “Information Literacy and Higher Education.”

42. Examples include: Brent, “Crossing Boundaries”; Jason Eyre, “Context and Learning: The Value and Limits of Library-Based Information Literacy Teaching,” Health Information and Libraries Journal 29, no. 4 (2012): 344–48; and Kaye Towlson and Nathan Rush, “Carving the Information Literacy Niche Within Graduate Employability ,” New Review of Academic Librarianship 19, no. 3 (2013): 300–15.

43. Amy E. Mark, “Privileging Peer Review: Implications for Undergraduates ,” Communications in Information Literacy 5, no. 1 (2011): 4–8.

44. Association of American Colleges & Universities, “Information Literacy VALUE Rubric” (2010), available online at https://www.aacu.org/value/rubrics/information-literacy [accessed 23 January 2018]; Middle States Association of Colleges and Schools Commission on Higher Education, Developing Research & Communication Skills: Guidelines for Information Literacy Instruction (Philadelphia: Middle States Commission on Higher Education, 2003).

45. Paul L. Hrycaj, “An Analysis of Online Syllabi for Credit-Bearing Library Skills Courses,” College & Research Libraries 67, no. 6 (2006): 525–35; Rachael E. Elrod, Elise D. Wallace, and Cecilia B. Sirigos, “Teaching Information Literacy: A Review of 100 Syllabi,” Southeastern Librarian 60, no. 3 (2012): 8–15.

46. Amy R. Hofer, Lori Townsend, and Korey Brunetti, “Troublesome Concepts and Information Literacy: Investigating Threshold Concepts for IL Instruction,” portal: Libraries and the Academy 12, no. 4 (2012): 387–405.

47. Shelley Gullikson, “Faculty Perceptions of ACRL’s Information Literacy Competency Standards for Higher Education,” Journal of Academic Librarianship 32, no. 6 (2006): 583–92.

48. Rolf Norgaard, “Writing Information Literacy: Contributions to a Concept,” Reference & User Services Quarterly 43, no. 2 (2003): 126.

49. ACRL Framework , “Introduction.”

50. Nancy M. Foasberg, “From Standards to Frameworks for IL: How the ACRL Framework Addresses Critiques of the Standards ,” portal: Libraries and the Academy 15, no. 4 (2015): 708.

51. ACRL Framework , “Introduction.”

52. Elizabeth Wardle and Linda Adler-Kassner, “Naming What We Know: The Project of This Book,” in Naming What We Know: Threshold Concepts of Writing Studies, eds. Linda Adler-Kassner and Elizabeth Wardle (Boulder: University Press of Colorado, 2015), 8.

53. William Badke, “A Rationale for Information Literacy as a Credit-Bearing Discipline ,” Journal of Information Literacy 2, no. 1 (2008).

54. Sommers and Saltz, “The Novice as Expert,” 132.

55. Amy J. Devitt, Writing Genres (Carbondale: Southern Illinois University Press, 2004).

56. Martin Luther King, Jr., Letter from a Birmingham Jail , available online at https://kinginstitute.stanford.edu/king-papers/documents/letter-birmingham-jail [accessed 23 January 2018].

57. Robert J. Connors, “The Rise and Fall of the Modes of Discourse,” College Composition and Communication 32, no. 4 (1981): 444–55.

58. George Hillocks, Jr., “The Focus on Form vs. Content in Teaching Writing,” Research in the Teaching of English 40, no. 2 (2005): 238–48.

59. Richard Feinberg and Christine King, “Short-Term Library Skill Competencies: Arguing for the Achievable,” College & Research Libraries 49, no. 1 (1988): 24–28.

60. Lori Townsend, Korey Brunetti, and Amy R. Hofer, “Threshold Concepts and Information Literacy,” portal: Libraries and the Academy 11, no. 3 (2011): 853–69.

61. Ian Beilin, “Beyond the Threshold: Conformity, Resistance, and the ACRL Information Literacy Framework for Higher Education,” In the Library with the Lead Pipe (Feb. 25, 2015), available online at www.inthelibrarywiththeleadpipe.org/2015/beyond-the-threshold-conformity-resistance-and-the-aclr-information-literacy-framework-for-higher-education/ [accessed 26 October 2018].

62. Christine Pawley, “Information Literacy: A Contradictory Coupling,” Library Quarterly 73, no. 4 (2003): 422–52.

63. Simmons, “Librarians as Disciplinary Discourse Mediators,” 302.

64. Wardle and Adler-Kassner, “Metaconcept,” 16.

* Allison Hosier is Information Literacy Librarian in the University Libraries at the University at Albany, State University of New York; email: [email protected] . ©2019 Allison Hosier, Attribution-NonCommercial ( http://creativecommons.org/licenses/by-nc/4.0/ ) CC BY-NC.

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Methodology

Research Methods | Definitions, Types, Examples

Research methods are specific procedures for collecting and analyzing data. Developing your research methods is an integral part of your research design . When planning your methods, there are two key decisions you will make.

First, decide how you will collect data . Your methods depend on what type of data you need to answer your research question :

  • Qualitative vs. quantitative : Will your data take the form of words or numbers?
  • Primary vs. secondary : Will you collect original data yourself, or will you use data that has already been collected by someone else?
  • Descriptive vs. experimental : Will you take measurements of something as it is, or will you perform an experiment?

Second, decide how you will analyze the data .

  • For quantitative data, you can use statistical analysis methods to test relationships between variables.
  • For qualitative data, you can use methods such as thematic analysis to interpret patterns and meanings in the data.

Table of contents

Methods for collecting data, examples of data collection methods, methods for analyzing data, examples of data analysis methods, other interesting articles, frequently asked questions about research methods.

Data is the information that you collect for the purposes of answering your research question . The type of data you need depends on the aims of your research.

Qualitative vs. quantitative data

Your choice of qualitative or quantitative data collection depends on the type of knowledge you want to develop.

For questions about ideas, experiences and meanings, or to study something that can’t be described numerically, collect qualitative data .

If you want to develop a more mechanistic understanding of a topic, or your research involves hypothesis testing , collect quantitative data .

Qualitative to broader populations. .
Quantitative .

You can also take a mixed methods approach , where you use both qualitative and quantitative research methods.

Primary vs. secondary research

Primary research is any original data that you collect yourself for the purposes of answering your research question (e.g. through surveys , observations and experiments ). Secondary research is data that has already been collected by other researchers (e.g. in a government census or previous scientific studies).

If you are exploring a novel research question, you’ll probably need to collect primary data . But if you want to synthesize existing knowledge, analyze historical trends, or identify patterns on a large scale, secondary data might be a better choice.

Primary . methods.
Secondary

Descriptive vs. experimental data

In descriptive research , you collect data about your study subject without intervening. The validity of your research will depend on your sampling method .

In experimental research , you systematically intervene in a process and measure the outcome. The validity of your research will depend on your experimental design .

To conduct an experiment, you need to be able to vary your independent variable , precisely measure your dependent variable, and control for confounding variables . If it’s practically and ethically possible, this method is the best choice for answering questions about cause and effect.

Descriptive . .
Experimental

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Research methods for collecting data
Research method Primary or secondary? Qualitative or quantitative? When to use
Primary Quantitative To test cause-and-effect relationships.
Primary Quantitative To understand general characteristics of a population.
Interview/focus group Primary Qualitative To gain more in-depth understanding of a topic.
Observation Primary Either To understand how something occurs in its natural setting.
Secondary Either To situate your research in an existing body of work, or to evaluate trends within a research topic.
Either Either To gain an in-depth understanding of a specific group or context, or when you don’t have the resources for a large study.

Your data analysis methods will depend on the type of data you collect and how you prepare it for analysis.

Data can often be analyzed both quantitatively and qualitatively. For example, survey responses could be analyzed qualitatively by studying the meanings of responses or quantitatively by studying the frequencies of responses.

Qualitative analysis methods

Qualitative analysis is used to understand words, ideas, and experiences. You can use it to interpret data that was collected:

  • From open-ended surveys and interviews , literature reviews , case studies , ethnographies , and other sources that use text rather than numbers.
  • Using non-probability sampling methods .

Qualitative analysis tends to be quite flexible and relies on the researcher’s judgement, so you have to reflect carefully on your choices and assumptions and be careful to avoid research bias .

Quantitative analysis methods

Quantitative analysis uses numbers and statistics to understand frequencies, averages and correlations (in descriptive studies) or cause-and-effect relationships (in experiments).

You can use quantitative analysis to interpret data that was collected either:

  • During an experiment .
  • Using probability sampling methods .

Because the data is collected and analyzed in a statistically valid way, the results of quantitative analysis can be easily standardized and shared among researchers.

Research methods for analyzing data
Research method Qualitative or quantitative? When to use
Quantitative To analyze data collected in a statistically valid manner (e.g. from experiments, surveys, and observations).
Meta-analysis Quantitative To statistically analyze the results of a large collection of studies.

Can only be applied to studies that collected data in a statistically valid manner.

Qualitative To analyze data collected from interviews, , or textual sources.

To understand general themes in the data and how they are communicated.

Either To analyze large volumes of textual or visual data collected from surveys, literature reviews, or other sources.

Can be quantitative (i.e. frequencies of words) or qualitative (i.e. meanings of words).

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subjects study research

If you want to know more about statistics , methodology , or research bias , make sure to check out some of our other articles with explanations and examples.

  • Chi square test of independence
  • Statistical power
  • Descriptive statistics
  • Degrees of freedom
  • Pearson correlation
  • Null hypothesis
  • Double-blind study
  • Case-control study
  • Research ethics
  • Data collection
  • Hypothesis testing
  • Structured interviews

Research bias

  • Hawthorne effect
  • Unconscious bias
  • Recall bias
  • Halo effect
  • Self-serving bias
  • Information bias

Quantitative research deals with numbers and statistics, while qualitative research deals with words and meanings.

Quantitative methods allow you to systematically measure variables and test hypotheses . Qualitative methods allow you to explore concepts and experiences in more detail.

In mixed methods research , you use both qualitative and quantitative data collection and analysis methods to answer your research question .

A sample is a subset of individuals from a larger population . Sampling means selecting the group that you will actually collect data from in your research. For example, if you are researching the opinions of students in your university, you could survey a sample of 100 students.

In statistics, sampling allows you to test a hypothesis about the characteristics of a population.

The research methods you use depend on the type of data you need to answer your research question .

  • If you want to measure something or test a hypothesis , use quantitative methods . If you want to explore ideas, thoughts and meanings, use qualitative methods .
  • If you want to analyze a large amount of readily-available data, use secondary data. If you want data specific to your purposes with control over how it is generated, collect primary data.
  • If you want to establish cause-and-effect relationships between variables , use experimental methods. If you want to understand the characteristics of a research subject, use descriptive methods.

Methodology refers to the overarching strategy and rationale of your research project . It involves studying the methods used in your field and the theories or principles behind them, in order to develop an approach that matches your objectives.

Methods are the specific tools and procedures you use to collect and analyze data (for example, experiments, surveys , and statistical tests ).

In shorter scientific papers, where the aim is to report the findings of a specific study, you might simply describe what you did in a methods section .

In a longer or more complex research project, such as a thesis or dissertation , you will probably include a methodology section , where you explain your approach to answering the research questions and cite relevant sources to support your choice of methods.

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Between-Subjects vs. Within-Subjects Study Design

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Editor at Simply Psychology

BA (Hons) Psychology, Princeton University

Julia Simkus is a graduate of Princeton University with a Bachelor of Arts in Psychology. She is currently studying for a Master's Degree in Counseling for Mental Health and Wellness in September 2023. Julia's research has been published in peer reviewed journals.

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In a within-subject design, each participant experiences all experimental conditions, whereas, in a between-subject design, different participants are assigned to each condition, with each experiencing only one condition.

experimental design

Within-subjects (or repeated-measures) is an experimental design in which all study participants are exposed to the same treatments or independent variable conditions.

In within-subjects studies, the participants are compared to one another, so there is no control group. The data comparison occurs within the group of study participants, and each participant serves as their own baseline.

In a between-subjects design (or between-groups, independent measures), the study participants are divided into groups, and each group is exposed to one treatment or condition.

Each participant is only assigned to a single treatment. This should be done by random allocation , ensuring that each participant has an equal chance of being assigned to one group.

The differences between the two groups are then compared to a control group that does not receive any treatment. The groups that undergo a treatment or condition are typically called the experimental groups.

  • In a within-subjects design, all participants receive every treatment. 
  • In a between-subjects design, participants only receive one treatment.

Design Similarities

  • Both types of study designs tend to be used to assess the impact of a treatment or condition on a given study population.
  • The goal of both types of studies is to compare several test conditions in a single study.
  • Both within-subjects designs and between-subjects designs have a group of subjects that serve as study participants and are exposed to a given treatment.
  • Both experimental designs are utilized in quantitative studies and aim to result in findings that are statistically likely to generalize to a whole population.
  • Between-subjects and within-subjects design both have an independent variable that is manipulated or controlled by the study’s investigators and a dependent variable that is measured. 
  • Random assignment is essential for both types of designs.

Design Differences

  •  In a within-subjects design, all participants receive all treatments. In a between-subjects design, participants receive only one treatment.
  • In a within-subjects design, the participants are compared to each other, so there is no control group. In a between-subjects design, there is a control group that doesn’t receive any treatment and serves as a source of comparison for the treatment groups. 
  • Between-subjects designs require significantly more participants than within-subjects designs in order to detect a statistically significant difference between the two conditions. In within-subjects designs, on the other hand, fewer participants are required as each participant provides a data point for each level of the independent variable. A similar experiment in a between-subject design would require twice as many participants as a within-subject design. This means that they also require more resources and funding to recruit a larger sample, administer sessions, and cover costs.
  • Between-subjects designs tend to be easier and quicker to administer as each participant is only given one treatment. In contrast, within-subjects designs take longer to implement because every participant is given multiple treatments.
  • Within-subjects designs are vulnerable to fatigue and carryover effects. Participant fatigue occurs when participants become tired, bored, or unmotivated after taking part in multiple treatments in a row. Carryover effects are when the act of having participants take part in one condition impacts the performance or behavior on all other conditions. With between-subjects design, though, participants are exposed to fewer conditions, so fatigue and carryover effects are less of a challenge.
  • Because different participants provide data for each condition in between-subjects designs, individual differences among participants may threaten internal validity. Within-subjects designs are less affected by individual differences among participants because the participants are compared to themselves and thus higher statistical power can be achieved.

What is a 2×2 within subject design?

A 2×2 within-subjects design is one in which there are two independent variables each having two different levels. This design allows researchers to understand the effects of two independent variables (each with two levels) on a single dependent variable.

When would you use a within-subjects design?

You typically would use a within-subjects design when you want to investigate a causal or correlational relationship between variables with a relatively small sample.

The primary goal of a within-subjects design is to determine if one treatment condition is more effective than another.

Within-subjects are typically used for longitudinal studies or observational studies conducted over an extended period.

When should a within-subjects design not be used?

A within-subjects design should not be used if researchers are concerned about the potential interferences of practice effects. 

If the researcher is interested in treatment effects under minimum practice, the within-subjects design is inappropriate because subjects are providing data for two of the three treatments under more than minimum practice.

When should you use a between-subjects design?

Between-subjects designs are used when you have multiple independent variables. This type of design enables researchers to determine if one treatment condition is superior to another.

A between-subjects design is also useful when you want to compare groups that differ on a key characteristic.

This key characteristic would be the independent variable, with varying levels of the characteristic differentiating the groups from each other.

When can a between-subjects design not be used?

Between-subjects cannot be used with small sample sizes because they will not be statistically powerful enough.

Between-subjects studies require at least twice as many participants as a within-subject design, which also means twice the cost and resources. When funding is limited,  between-subjects design can likely not be used.

Can I use a within- and between-subjects design in the same study?

Yes. Between-subjects and within-subjects designs can be combined in a single study when you have two or more independent variables (a factorial design).

Factorial designs are a type of experiment where multiple independent variables are tested.

Each level of one independent variable (a factor) is combined with each level of every other independent variable to produce different conditions.

Is between-subjects or within-subjects design more powerful?

Within-subjects designs have more statistical power due to the lack of variation between the individuals in the study because participants are compared to themselves.

A between-subjects design would require a large participant pool in order to reach a similar level of statistical significance as a within-subjects design.

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1000+ FREE Research Topics & Title Ideas

subjects study research

Select your area of interest to view a collection of potential research topics and ideas.

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PS – You can also check out our free topic ideation webinar for more ideas

How To Find A Research Topic

If you’re struggling to get started, this step-by-step video tutorial will help you find the perfect research topic.

Research Topic FAQs

What (exactly) is a research topic.

A research topic is the subject of a research project or study – for example, a dissertation or thesis. A research topic typically takes the form of a problem to be solved, or a question to be answered.

A good research topic should be specific enough to allow for focused research and analysis. For example, if you are interested in studying the effects of climate change on agriculture, your research topic could focus on how rising temperatures have impacted crop yields in certain regions over time.

To learn more about the basics of developing a research topic, consider our free research topic ideation webinar.

What constitutes a good research topic?

A strong research topic comprises three important qualities : originality, value and feasibility.

  • Originality – a good topic explores an original area or takes a novel angle on an existing area of study.
  • Value – a strong research topic provides value and makes a contribution, either academically or practically.
  • Feasibility – a good research topic needs to be practical and manageable, given the resource constraints you face.

To learn more about what makes for a high-quality research topic, check out this post .

What's the difference between a research topic and research problem?

A research topic and a research problem are two distinct concepts that are often confused. A research topic is a broader label that indicates the focus of the study , while a research problem is an issue or gap in knowledge within the broader field that needs to be addressed.

To illustrate this distinction, consider a student who has chosen “teenage pregnancy in the United Kingdom” as their research topic. This research topic could encompass any number of issues related to teenage pregnancy such as causes, prevention strategies, health outcomes for mothers and babies, etc.

Within this broad category (the research topic) lies potential areas of inquiry that can be explored further – these become the research problems . For example:

  • What factors contribute to higher rates of teenage pregnancy in certain communities?
  • How do different types of parenting styles affect teen pregnancy rates?
  • What interventions have been successful in reducing teenage pregnancies?

Simply put, a key difference between a research topic and a research problem is scope ; the research topic provides an umbrella under which multiple questions can be asked, while the research problem focuses on one specific question or set of questions within that larger context.

How can I find potential research topics for my project?

There are many steps involved in the process of finding and choosing a high-quality research topic for a dissertation or thesis. We cover these steps in detail in this video (also accessible below).

How can I find quality sources for my research topic?

Finding quality sources is an essential step in the topic ideation process. To do this, you should start by researching scholarly journals, books, and other academic publications related to your topic. These sources can provide reliable information on a wide range of topics. Additionally, they may contain data or statistics that can help support your argument or conclusions.

Identifying Relevant Sources

When searching for relevant sources, it’s important to look beyond just published material; try using online databases such as Google Scholar or JSTOR to find articles from reputable journals that have been peer-reviewed by experts in the field.

You can also use search engines like Google or Bing to locate websites with useful information about your topic. However, be sure to evaluate any website before citing it as a source—look for evidence of authorship (such as an “About Us” page) and make sure the content is up-to-date and accurate before relying on it.

Evaluating Sources

Once you’ve identified potential sources for your research project, take some time to evaluate them thoroughly before deciding which ones will best serve your purpose. Consider factors such as author credibility (are they an expert in their field?), publication date (is the source current?), objectivity (does the author present both sides of an issue?) and relevance (how closely does this source relate to my specific topic?).

By researching the current literature on your topic, you can identify potential sources that will help to provide quality information. Once you’ve identified these sources, it’s time to look for a gap in the research and determine what new knowledge could be gained from further study.

How can I find a good research gap?

Finding a strong gap in the literature is an essential step when looking for potential research topics. We explain what research gaps are and how to find them in this post.

How should I evaluate potential research topics/ideas?

When evaluating potential research topics, it is important to consider the factors that make for a strong topic (we discussed these earlier). Specifically:

  • Originality
  • Feasibility

So, when you have a list of potential topics or ideas, assess each of them in terms of these three criteria. A good topic should take a unique angle, provide value (either to academia or practitioners), and be practical enough for you to pull off, given your limited resources.

Finally, you should also assess whether this project could lead to potential career opportunities such as internships or job offers down the line. Make sure that you are researching something that is relevant enough so that it can benefit your professional development in some way. Additionally, consider how each research topic aligns with your career goals and interests; researching something that you are passionate about can help keep motivation high throughout the process.

How can I assess the feasibility of a research topic?

When evaluating the feasibility and practicality of a research topic, it is important to consider several factors.

First, you should assess whether or not the research topic is within your area of competence. Of course, when you start out, you are not expected to be the world’s leading expert, but do should at least have some foundational knowledge.

Time commitment

When considering a research topic, you should think about how much time will be required for completion. Depending on your field of study, some topics may require more time than others due to their complexity or scope.

Additionally, if you plan on collaborating with other researchers or institutions in order to complete your project, additional considerations must be taken into account such as coordinating schedules and ensuring that all parties involved have adequate resources available.

Resources needed

It’s also critically important to consider what type of resources are necessary in order to conduct the research successfully. This includes physical materials such as lab equipment and chemicals but can also include intangible items like access to certain databases or software programs which may be necessary depending on the nature of your work. Additionally, if there are costs associated with obtaining these materials then this must also be factored into your evaluation process.

Potential risks

It’s important to consider the inherent potential risks for each potential research topic. These can include ethical risks (challenges getting ethical approval), data risks (not being able to access the data you’ll need), technical risks relating to the equipment you’ll use and funding risks (not securing the necessary financial back to undertake the research).

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Information for Research Subjects

Learn about becoming a research participant at the University of Rochester

True to the University of Rochester’s Mission Statement, ‘Learn, Discover, Heal, Create—and Make the World Ever Better’, research has been a long-standing tradition at the University of Rochester . Our researchers are among the nation’s leaders across a wide range of fields, including medicine, human behavior, education, politics, optics and economics.

Find an open research study

Faqs: participating in research.

Participating in research can be a fun and exciting way to give back to your community, but it doesn’t necessarily come without risk. Becoming a research participant is an important decision that should be taken seriously.

Background and overview

Research studies are done to discover new information or to answer a question about how we learn, behave, and function. Some studies might involve simple tasks like completing a survey, being observed among a group of people, or participating in a group discussion. Other studies, sometimes called clinical trials, involve more risky procedures like testing a new drug or medical device.

Each research study has its own set of criteria to determine who can participate. This depends on the research question being asked and may include restrictions based on age, behaviors, health status, or other traits.

Deciding to participate

Research is designed to benefit society. This might include learning how to live healthier lives, how to better treat conditions or diseases, why we do the things we do, or how we learn and develop. And while there are several reasons why people choose to participate in research, most people participate based on the possibility of helping themselves or others.

It’s important to understand that you may not directly benefit from participating in research. In fact, with a lot of research, you will not receive any benefit. For some types of research however, there may be a possibility that you could receive benefit, but there is no guarantee.

Most studies involve some risk, though the risks can range from very small to very serious. Some examples of risks include:

  • side effects or reactions to experimental drugs, treatments, or procedures
  • feeling anxious or uncomfortable
  • breach in confidentiality or invasion of privacy.

Side effects or other risks you might experience may be temporary or go away with treatment, but in rare cases they may be permanent, cause disability, or be life threatening. There may also be risks in participating that we don’t know about.

To start, you will be given information about the study so that you can make an informed decision about whether or not to participate. You will also be given an opportunity to ask questions about the study. This process is called informed consent . Before you can start the study, you need to agree to participate (i.e., consent). Participation is always voluntary.

Once you provide consent, the specific procedures or activities you’ll be asked to complete can vary widely and depend on what is being studied. Regardless, all the activities you will be asked to complete will be described during the consent process.

Before you agree to be in the study, make sure you have a solid understanding of the following:

  • the voluntary nature of the study
  • why the study is being done
  • who is doing the study
  • the procedures, activities, tests, or treatments involved (including how long they will take, how often they have to be completed, and whether there are any other treatment options available rather than being in the study)
  • potential risks, discomforts, or side effects
  • potential benefits to participating, if any
  • how your privacy will be protected
  • how long your participation will last
  • what will happen if you are injured while participating
  • the costs to you, if any
  • what to do if you change your mind about participating
  • whom to contact with questions, concerns, or problems

Each study is different, so time requirements will vary. Some may require very little of your time, perhaps only 5–10 minutes, while others may require multiple visits over an extended period of time, sometimes up to several years. Your time commitment for a particular study will be described during the consent process.

informed consent

Informed consent is the process of telling interested individuals what is involved in taking part in a specific research study. Typically, this includes:

  • reviewing written information
  • giving the potential volunteer time to review this information while considering participation (taking it home to review with friends or family, if desired)
  • discussing the information verbally
  • answering any questions

Once all of the information is provided to you and your questions are answered, you will then be asked to decide whether or not to take part in the study.

All decisions are voluntary, and you must provide your agreement (i.e., consent) before any study activities can begin. Usually, this involves signing a consent form. Although, for some studies, verbally agreeing to participate may be sufficient.

Once you provide consent to be in the study, you will continue to receive important information about your participation throughout the study.

It’s important to understand what is involved in taking part in a research study and to carefully consider what that means for you. Research can pose risks to your health, safety, and welfare, so it’s important to understand exactly what those risks are.

It’s also important to understand that taking part in research is voluntary. You make the decision about whether or not to participate, and if you agree to take part, you can always change your mind later.

State law determines who can provide consent. In New York State, only individuals 18 years of age and older can provide consent. Minors, based on their age and ability, are usually asked for their agreement to participate in research, but their parent or legal guardian must also provide their permission to participate. Other special considerations are also made when a minor is a ward of the state or adults are unable to make decisions for themselves.

If you have questions about who can or cannot provide consent, be sure to ask the study team.

The following key points are most important about informed consent:

  • Being in a study is voluntary—it is your choice.
  • If you join a study, you can change your mind and stop at any time.
  • If you have questions about anything that is not clear to you, you can ask them at any point of time before, during, or after the study.
  • If you feel you need more time or information to make an informed decision about whether or not to take part in the study, do not hesitate to ask for it.

Subject Protections

Research studies involving humans must be approved and monitored by an Institutional Review Board (IRB). An IRB is a committee of individuals responsible for reviewing research to ensure adequate protections are in place to protect the people who take part.

For each study reviewed, the IRB checks to see that:

  • there is a good reason to conduct the study
  • the risks related to participating are the least possible
  • the risks related to participating are reasonable given the knowledge that will be gained from conducting the study
  • the plan for selecting subjects to participate is fair
  • subjects will be provided enough information about the study

Protecting the information you provide to researchers is a high priority, particularly if you provide health-related or sensitive information.

As part of the IRB approval process described above, all researchers must provide a plan to adequately protect the information they plan to collect in order for the study to be approved. This might include assigning a code to the information collected instead of using your name or other identifiable information and storing the information in a secure manner.

You are free to withdraw from a research study at any time, for any reason. Your relationship with the hospital, clinic, academic institution, or employer will not be affected and you will not lose any benefits to which you are entitled.

Note that in some cases, a researcher may decide to end your participation in the study early. This may happen if the study is no longer in your best interest, if you can no longer complete study activities, or if the study ends early for some other reason.

Additional participant resources

Downloadable information.

  • Participating in Research Overview
  • Informed Consent

External resources

  • About Research Participation (Department of Health & Human Service)
  • Children & Clinical Studies (National Heart, Lung & Blood Institute)
  • Clinical Research Trials and You (National Institutes of Health)

University research studies

  • Search UR Health Research
  • Join the UR Health Research Volunteer Registry to be contacted for future studies
  • Follow UR Health Research on Facebook
  • CenterWatch Clinical Trials Search
  • ClinicalTrials.gov
  • National Institutes of Health List of Registries
  • ResearchMatch

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Report an issue, concern, or complaint

If you have participated in University of Rochester research and would like to report an issue, concern or complaint about the research you, or a family member, has participated in, please do so via our feedback form.

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About Human Subjects Research

On this page:

Human Subjects Research defined

About the type of research epa conducts and funds.

  • Controlled exposure studies
  • Currently enrolling controlled exposure studies

How EPA protects human subjects

Ethics of exposing humans to known toxic substances or carcinogens, approval process for human subjects research at epa.

  • Requirements for Human Subjects Review Official (HSRRO) approval

National Academy of Sciences (NAS) review of EPA's research studies

EPA Regulation, codified at 40 CFR Part 26, defines the terms research and human subject as follows: 

Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. [40 CFR 26.102(l)]. Human subject means a living individual about whom an investigator (whether professional or student) conducting research (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

It is very important to make the human subjects research determination by proceeding in a particular order: research, and then if the project meets the definition of research per 40 CFR 26.102(l), then one must evaluate if human subjects (40 CFR 26.102(l)) are involved. This is because if your project does not constitute research, then it does not matter if the project involves human subjects! Only if a project is both considered research AND involves human subjects (both according to the federal definitions) is the project then considered human subjects research and subject to additional oversight. EPA does not allow investigators to make their own determinations regarding whether an activity involves human subjects research. Please refer to your institutions policies and procedures regarding these human subjects research determinations. 

EPA conducts and funds a wide variety of human subjects research (HSR). Some examples of HSR at the EPA include fish consumption surveys, surveys on household practices or demographics, analysis of biological specimens, use of focus groups, controlled exposure studies and epidemiology studies.

Each of the study examples listed above serves a particular research need. For example, epidemiology studies enable researchers to learn more about environmental exposure that individuals encounter in everyday life. The National Epidemiological and Environmental Assessment of Recreational (NEEAR) water study is an example of an epidemiological study in which researchers investigated the human health effects associated with exposure to pollutants at recreational swimming sites. The goal of the study was to evaluate whether real-time water quality measurement techniques could be utilized to alert and prevent beachgoers from entering the water and possibly becoming ill if high levels of pollutants were being recorded. Results were intended to enable EPA's Office of Water to develop new state and federal guidance for water quality indicators of fecal contamination.

Another category of human subjects research that is often utilized in EPA studies is survey research. Any time researchers administer a survey, questionnaire, or other data collection instrument, they are interacting with human subjects.  If the data that researchers collect from subjects constitutes research per 40 CFR 26.102(l), and the data is about the subjects themselves, then the research meets the definition of human subjects per 40 CFR 26, and further review by the Human Research Protection Program (HRPP) is required. Even if a survey is completely anonymous, if people are providing information about themselves, it still may constitute human subjects research, and is subject to review by a member of the HRPP at the institution/agency.  For example, if a researcher passes out anonymous surveys on a beach and asks about the individual's frequency of swimming at the beach or opinion about the cleanliness of the water, it qualifies as human subjects research since the researcher is systematically investigating swimming frequency and will generalize the knowledge gained, and the individual is answering questions about themselves. Often, survey research is just one component of a larger study, but it is still subject to review by the institution’s HRPP. 

A final example of human subjects research at the EPA is controlled exposure research. EPA conducts controlled exposure studies for example, a study to evaluate the  effects of  particulate matter (PM)  to understand the biological pathways by which air pollution particles exert their effects. Scientists can extrapolate the results from these studies to understand how PM may lead to illness in at-risk populations such as individuals with heart or lung disease. These studies help EPA fulfill its legal requirements to establish a  National Ambient Air Quality Standard  that protects Americans from the harmful effects of PM. 

Controlled exposure studies 

We can (and do) learn much from research in test tubes or using animal or computer models. But these are not all equally good predictors of ways the human body is affected by common pollutants. Even epidemiological studies rely heavily on statistical inferences and assumptions, and there are some things researchers can only learn by interacting directly with people, controlling variables and methods to allow firm conclusions to be drawn. 

Over the years, scientific research with human subjects has provided much valuable information to help characterize and control risks to public health. This type of research enables investigators to test the effectiveness of insect repellants, measure the rates and pathways of human processing of environmental chemicals, measure occupational exposure of workers to chemicals, and measure the effects of a substance on exposed human subjects. EPA’s program offices use results from these studies to support decisions and set regulations such as National Ambient Air Quality Standards, water quality criteria and drinking water standards, cleanup levels, and pesticide registration.

Other types of human subjects research are intended to collect information about an individual’s behavior, opinions, and/ or characteristics in order to contribute to generalizable knowledge. Examples include surveys, focus groups, and interviews.

The focus of controlled exposure research is to gain a better understanding of changes in the body that are associated with exposure to the substance that is being studied. By understanding exactly how commonly-occurring pollutants affect various people, the EPA can make appropriate recommendations to Congress and other State and Local governments about enacting laws that protect us and our environment.

Controlled exposure research also contributes to testing the effectiveness of insect repellents, measuring the rates and pathways of human processing of environmental chemicals, measuring occupational exposure of workers to chemicals, and measuring the effects of a substance on exposed human subjects. These studies advance the EPA’s understanding of the links between the environment and human health so that the Agency can carry out its mission of protecting human health and the environment. 

What controlled exposure studies are currently enrolling?

Clinical Studies in Environmental Health

EPA follows strict safety protocols for all of its studies to protect the health and safety of volunteers, including engineering controls for the facility and protocols for the medical oversight of the exposures. In addition, all EPA research is conducted in compliance with federal regulations and best practices in ethics. The primary regulation that governs human subjects research at EPA is 40 CFR Part 26 Subpart A. It is known as the "Common Rule" because 18 federal departments and agencies have agreed to hold this regulation "in common."

All human subjects research is evaluated by an administrative body, known as an Institutional Review Board (IRB), which is designated with protecting the rights and welfare of human research subjects in research activities. IRB authority is codified at 40 CFR 26. The IRB has the authority to approve, require modifications in (to secure approval), or disapprove all research activities that fall within its jurisdiction. 

  • EPA Regulation 40 CFR 26, including the Common Rule 
  • Products and Publications

In 2006, the EPA amended its regulation at 40 CFR Part 26 to include additional protections for vulnerable subjects within its subparts.  Subpart B of the regulation is a ban on intentional exposure research  involving pregnant women, nursing women, and children. Research involving intentional exposure of a human subject is defined in 40 CFR Part 26.202 as the “…study of a substance in which the exposure to the substance experienced by a human subject participating in the study would not have occurred but for the human subject’s participation in the study.”

Subparts C and D  of 40 CFR Part 26 seek to ensure that  vulnerable subjects are protected in observational research.  Subpart C provides additional protections for observational research conducted with pregnant women as participants. Subpart D adds protections for observational research conducted or supported by EPA involving children as participants. Observational research is defined in 40 CFR Part 26.302 as any human research that does not meet the definition of research involving intentional exposure of a human subject. 

The distinction between intentional exposure research and observational research is extremely important for EPA researchers in the development and approval process for studies involving human subjects. Since intentional exposure research involving pregnant women, nursing women, and children is banned, researchers must pay close attention to the details of their study in order to ensure that it does not meet the definition of intentional exposure if the study involves these protected populations.

EPA also added special regulations at 40 CFR Part 26, subparts K-Q, which are related to the review of third-party pesticide research involving human participants. These regulations were updated in 2013. For more information, please see the links below. 

  • Protections for Subjects in Human Research with Pesticides 

EPA holds a Federal-Wide Assurance (FWA), which is an assurance of compliance that covers the engagement of the Agency in any Human Subjects Research conducted or supported by any Common Rule agency, including EPA. This assurance covers all Agency components and therefore provides a basis for the participation of EPA personnel anywhere in the Agency in HSR under conditions that are compliant with applicable regulations.  

  • Federal-Wide Assurance (FWA) #00012755  

EPA Order 1000.17 A (Policy and Procedures on Protection of Human Subjects in EPA Conducted or Supported Research) establishes EPA procedures and responsibilities for implementing the requirements set forth in 40 CFR Part 26. The Order requires that all human subjects research conducted or supported by EPA must either be approved or be acknowledged as exempt research by the EPA Human Subjects Research Review Official (HSRRO) before any work involving human subjects research can begin. Preliminary (or “conditional”) review by the HSRRO is not required, but can be requested, for any research project, contract, grant application, cooperative agreement, cooperative research and development agreement (CRADA), interagency agreement or any formal agreement involving EPA support of such studies. The Order describes the requirements for review, as well as the responsibilities of all parties involved in EPA research in protecting the rights and welfare of human research subjects.  

  • EPA Order 1000.17 A

EPA’s Office of Research and Development published SEAOES as a resource document for researchers to consult as they develop and conduct observational human exposure studies. EPA Order 1000.17 A requires that all human observational exposure studies conducted or supported by EPA adhere to the principles set forth in SEAOES. SEAOES provides information on regulatory requirements, sound scientific practices, and ethical issues to consider when performing observational human exposure studies. 

The International Agency for Research on Cancer (IARC) has labeled outdoor air pollution and diesel exhaust as “carcinogenic to humans”, These classifications are based on studies examining the risk from high level lifetime cumulative exposures.

There are many factors considered under the IARC cancer classifications. A critical factor is the intensity and duration of exposure. It is important to make the distinction between lifetime (or long-term) exposure to uncontrolled levels of pollutants, and the very short-term exposure to controlled levels of pollutants that occurs in experimental studies. For example, the risk of smoking two packs of cigarettes every day for thirty years is very different from smoking a single cigarette which does not increase risk in any meaningful way.   

The controlled human-inhalation exposure studies that EPA conducts last only a few hours.  According to a recently released committee report from the National Academies of Sciences, EPA controlled exposure  “studies add very little cumulative lifetime pollutant exposures … any increase in chronic disease risk, such as from lung cancer, resulting from experimental exposures would be vanishingly small”.  At the same time, the NAS acknowledged the benefits from conducting these studies by providing unique information that cannot be obtained from other studies and impacting NAAQS reviews and regulations.

There have never been any permanent adverse effects as a result of EPA research.

Every project involving human subjects research conducted or supported by the EPA goes through multiple levels of approval. The specific path for review differs slightly depending on the origin of the research, but all human subjects research projects must be approved by the Human Subjects Research Review Official (HSRRO) before any work involving human subjects can begin.

EPA's approval process guidelines exceed what is generally accepted and required by universities, industry, and other government agencies. In those organizations, human subjects research is often proposed by an investigator, reviewed by a supervisor, and finally, reviewed by an Institutional Review Board (IRB). Research conducted or supported by EPA, on the other hand, has additional levels of oversight. For example, projects that are conducted or funded by the EPA are reviewed by the Program, Office, or Region’s Human Subjects Officer (HSO) prior to submission to the HSRRO for their review. HSRRO. Controlled human exposure studies conducted at EPA's Office or Research and Development (ORD) undergo multiple levels of both internal and external review.

Requirements for Human Subjects Research Review Official (HSRRO) approval

The HSRRO's responsibility is to ensure that all human subjects research conducted or supported by EPA are in compliance with EPA regulations for protection of human subjects in research. All human subject research conducted or funded by EPA must be approved by the HSSRO before work can begin.

The HSRRO makes certain that a variety of components are in place before giving their approval. For example, the HSRRO must review proof of external oversight of the study; specifically, IRB approval and documentation. The HSRRO also reviews the research plan to ensure that researchers are using best practices in study design and methodology. The HSRRO pays close attention to the description of subject selection to ensure that it is equitable and reviews the informed consent process to confirm that subjects are respected. The HSRRO is interested in ensuring that subjects will learn the goals of the project and expectations of participation before providing their voluntary consent to participate. Finally, the HSRRO confirms that the value of the research to society justifies the risk to research subjects and that researchers take precautions to minimize risks to subjects. 

Please note that if pregnant women, nursing women, or children are likely to be included as subjects of a study, the HSRRO will closely review the study to determine whether it involves intentional exposure. Human subject research involving intentional exposure of pregnant women, nursing women, or children is prohibited pursuant to 40 CFR 26.203, "Notwithstanding any other provision of this part, under no circumstances shall EPA conduct or support research involving intentional exposure of any human subject who is a pregnant woman (and therefore her fetus), a nursing woman, or a child." Studies in which researchers intervene to reduce or mitigate the level of exposure to a substance that participants would otherwise experience, and do not administer a dose of a substance or deliberately cause or bring about participants' exposure to a substance, generally would not fall into the category of intentional exposure research.  If the substance in question is not regulated by the EPA, then it will not constitute intentional exposure research as defined at 40 CFR 26. 202. 

In addition to complying with the applicable federal regulations, EPA conducted or supported studies must also comply with EPA Oder 1000.17A, Policy and Procedures on Protection of Human Subjects in EPA Conducted or Supported Research. 

To obtain approval or a concurrence of exemption by the HSRRO, researchers must submit the IRB-approved research package (including evidence of IRB approval) or documentation of exemption, and all correspondence between the IRB and the researcher(s).   If you are an EPA researcher, you can find more information about required documentation for each project type and instructions on how to submit your project for HSRRO review on the Program in Human Research Ethics and Oversight's (PHREO) intranet site.

If you are applying for a human subjects research grant you can find specific information on the request for agreement. 

  • EPA Research Grants Site

For other parties interested in requirements for human subjects review at EPA,  please contact the HSRRO . 

In 2015, the EPA sought independent expert advice from the NAS to address scientific issues and provide guidance on the conduct of EPA's controlled human exposure studies. NAS established the Committee on Assessing Toxicologic Risks to Human Subjects Used in Controlled Exposure Studies of Environmental Pollutants. The committee released its final report  Controlled Human Inhalation-Exposure Studies at EPA  on March 28, 2017.

The committee reviewed contributions to EPA’s Integrated Science Assessments for ozone and particulate National Ambient Air Quality Standards (NAAQS), Institutional Review Board (IRB) applications, informed consent forms, peer-reviewed publications, adverse event reports, and the presentations and materials provided by EPA and other interested parties. The committee report was peer-reviewed according to the procedures used by the NAS.

The committee report indicated that:

  • EPA studies have provided unique and critical contributions to the science base supporting NAAQS decisions.
  • Risks of serious adverse events posed to study subjects are unlikely to be large enough to warrant concern, but it is never possible to conclude there is no risk.  Study exposures add very little to cumulative lifetime pollutant exposures and any increase in chronic disease risk, such as lung cancer, resulting from experimental exposures is vanishingly small.
  • Controlled human inhalation-exposure studies should continue to be undertaken cautiously when a study is expected to provide additional policy-relevant knowledge that cannot be obtained by other means, and it is reasonably foreseeable that study subjects’ risks will not exceed transient and reversible responses.
  • The committee report provided additional recommendations to EPA in the prioritization and conduct of future studies.

The report is available to the public at:

  • Scientific Leadership Home
  • Risk Assessment Support
  • Human Subjects Research
  • Peer Review
  • Public Access

The Council on Undergraduate Research

Engaging Archaeology: 25 Case Studies in Research Practice

Scholarship and Practice of Undergraduate Research Journal

  • Journal Home
  • Submissions

More Articles in this Issue

Student research showdown: a research communication competition.

Student researchers are rarely trained to explain their work to a general audience but must do so throughout their careers. To assist undergraduate researchers in building this skill, the Student Research Showdown—a research video and presentation competition—was created at the University of Texas at Austin. Students create brief videos on which their peers vote, and the top video creators face off with presentations and are awarded prizes by a panel of judges. Students reflect on their experiential learning as they construct a narrative that disseminates their findings, communicates impact, and serves as a sharable testament to their success. Indirect measures indicate that students improve their research communication skills by participating in this event.

Social and Human Capital Influences on Undergraduate Researchers’ Disciplinary Identity: The Case of Social and Natural Scientists

Disciplinary identity, or connection to a particular academic discipline, is constructed through a developmental process across a scholar’s academic life course. Using unique data from an online survey of students at four different types of colleges and universities, this study investigates the extent to which disciplinary identity among undergraduate researchers is connected to their human and social capital and differs between social and natural scientists. Disciplinary identity for natural scientists is correlated with mentoring, being a first-generation student, and having a disability, whereas disciplinary identity for social scientists is correlated with only one factor: grit. Implications for institutions and undergraduate programs desiring to enhance the connection between students and their fields of study are discussed.

Leveraging the Role of Library Partnerships to Understand Undergraduate Research Contributions to Humanities Scholarship: A Case Study

The library and the Undergraduate Research Opportunity Program at the University of Michigan partnered in an investigation of student-faculty research collaboration in the humanities. The authors found that providing early opportunities for undergraduates to collaborate on such projects was highly beneficial for both students and faculty mentors. Students contributed and gained invaluable skills in an experience they stated was more meaningful than that of a conventional classroom, whereas faculty mentors could juggle multiple projects, benefit from students’ technological skills, and articulate the salience of their research processes and their work. The authors also discuss the role of the library as a crucial catalyst in changing the perception of the humanities at higher education institutions, particularly as it exposes students to research projects and professions within the library.

Knowledge Makers: Indigenous Undergraduate Researchers and Research

As higher education institutions seek to provide further scope for diversity in their practices, there is space opening up for Indigenous undergraduate research. This article reflects on the Knowledge Makers program, an Indigenous undergraduate research initiative based in British Columbia, Canada. The Knowledge Makers program shows what is possible when an Indigenous approach is used to mentor Indigenous undergraduate students and offers promising practices for increasing Indigenous researchers and research, such as drawing on the knowledge of Indigenous ancestors, valuing Indigenous research methodologies, using a strengths-based approach, performing research as a type of service, and committing to legacy.

Undergraduate Research Highlights – Spring 2019

Establishing a statewide celebration of undergraduate research: history and lessons learned.

The Florida Undergraduate Research Conference (FURC) is an annual multidisciplinary conference that enables student scholars to present their research, network with other students, and attend professional development seminars. FURC has been held since 2011 and has featured more than 2,100 student presentations with participation from a broad array of institutions within the state. Survey data indicate that FURC is the first conference presentation for the majority of participants and that participation in the conference is associated with several positive outcomes. This article describes the history, structure, and planning of the conference and as well provides survey and outcome data that may assist other states and geographic areas as they consider forming their own conferences.

Learning “Scholarship as Conversation” by Writing Book Reviews

The ability of undergraduate students to write for scholarly audiences is contingent upon their capacity to recognize that scholarship is a kind of conversation. For a student, writing an academic book review is a near ideal yet generally underutilized opportunity to learn this lesson. Through analysis of previously published book reviews coproduced with students, the authors identify actionable practices to transform the process of writing book reviews from an undervalued, lone activity into a viable form of undergraduate research. Publishing coauthored book reviews may aid students seeking admission to graduate school and faculty seeking promotion. In the end, writing book reviews with students is an opportunity for faculty and librarians to pass along the important lesson that scholarship is an important, inclusive conversation.

A Peer Research Consultant Program: Feasibility and Outcomes

The authors discuss their study of the Peer Research Consultant (PRC) program at California State University, San Bernardino. During the 2016–2017 academic year, 13 courses, with 853 students enrolled, participated in the PRC program. Program participants completed pre and post-measures assessing demographic information, perceptions of skill level, and perceived gains following program participation. Students who participated in the PRC program showed an increase in overall course grades (M = 3.11) compared to those who did not (M = 2.82; p < 0.05). Similar findings were observed among under-represented minority (URM) students who participated (M = 3.05) and those who did not (M = 2.73, p < 0.05). Program participants reported high satisfaction with the program and improved confidence in skills

Introduction – Spring 2019

Table of contents – spring 2019.

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SPUR advances knowledge and understanding of novel and effective approaches to mentored undergraduate research, scholarship, and creative inquiry by publishing high-quality, rigorously peer reviewed studies written by scholars and practitioners of undergraduate research, scholarship, and creative inquiry. The SPUR Journal is a leading CUR member benefit. Gain access to all electronic articles by joining CUR.

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New study claims bloodstains on Shroud of Turin consistent with torture of Christ

Shroud of Turin featuring positive L and negative R digital filters Credit Dianelos Georgoudis via Wikimedia Commons CNA 8 3 15

By Tyler Arnold

Washington, D.C. Newsroom, Aug 27, 2024 / 14:45 pm

A new study  from an Italian researcher that analyzes the blood on the Shroud of Turin argues that the stains are consistent with the torture and crucifixion of Jesus Christ as described in the Gospels. 

Giulio Fanti — a professor of mechanical and thermal measurements at the University of Padua — claims that a macroscopic and microscopic analysis of the bloodstains accurately reflects “the physical conditions relating to Jesus Christ” that are “consistent with the description of Jesus Christ in the holy Bible and, in particular, within the four canonical Gospels.”

Fanti has authored more than 50 studies on the Shroud of Turin and has published books on the subject as well. The shroud, a burial cloth that many believe was used to wrap the body of Christ after his death on the cross, has been the subject of significant academic debate in the past few decades, with some defending its authenticity and others asserting that it is a medieval forgery.

The shroud is imprinted with the body and face of a man wearing a crown of thorns and is covered in bloodstains. It is held in the Chapel of the Holy Shroud in Turin, Italy, where many Catholics venerate it as a holy relic of Christ’s crucifixion. The Vatican does not have an official position on its authenticity. 

According to Fanti’s study, the bloodstains on the side and the front of the shroud show blood flowing in three different directions: vertical with the body in an upright position, inclined at a 45-degree angle, and horizontal with the corpse resting on its side. Fonti asserts that “the single rivulets show a sudden change of their direction; it is probable that the blood flows streamed when the corpse was moved.” 

The study adds that the three distinct colors of blood suggest three “different types of blood,” which are “postmortem blood leakage” from moving the body, the less evident ones that appear to be “premortem bloodstains” that likely occurred “when Jesus was still nailed to the cross,” and “leaks of blood serum.” It adds that the stains appear to show scourge marks consistent with the scourging at the pillar and that the quantity of blood matches the amount of blood that would have resulted from the wounds described in the Gospels.

Pope Francis with the Shroud of Turin in the Cathedral of St. John the Baptist, Turin, Italy, on June 21, 2015. Credit: Vatican Media

Additionally, nanoparticles found in the blood “recognized as creatinine” are consistent with “the very heavy torture suffered by Jesus,” according to the study. It adds that “the high level of urea hypothesized” in some of the blood “implies renal … malfunction or blockage, which is a condition compatible with intense flagellation … in the area of the kidneys, causing microcytic anemia.” 

“This microcytic anemia, also increased by prolonged fasting, suggests the extreme difficulties Jesus had in exchanging oxygen, which most likely resulted in extremely labored breathing,” the study continues.

Farm Bill

The farm bill: What Catholics need to know

“Jesus had to heavily increase his breathing,” the study adds, “and, consequently, increase the frequency of his heartbeats, which prompted a heart attack as the main cause of his death.”

Father Robert Spitzer, a Jesuit priest and president of the  Magis Center of Reason and Faith , told CNA that “all of these indications [found in Fanti’s study] coincide with the crucifixion of Jesus Christ.” Spitzer has been a strong supporter of the authenticity of the Shroud of Turin.

Father Robert J. Spitzer, SJ, is among the experts featured in the documentary

Spitzer said that the creatinine in the blood “generally indicates a heavy polytrauma [severe injuries in multiple locations],” adding that “the blood came from a person who had undergone tremendous heavy polytrauma.”

“The man certainly was struggling to breathe [as well],” Spitzer said, citing the findings in the study. “He had undergone real tortures. …You can tell that he lost a tremendous amount of blood … especially from the whipping — the scourging that he received.”

According to Spitzer, the blood evidence points to the “unique crucifixion of Jesus on the cross.” In defending the authenticity of the shroud, he said “a medieval forger” could not have possibly anticipated 21st-century scientific studies of the cloth: “[He] certainly would not have used the hematic serum of a victim who experienced a heavy polytrauma.”

Spitzer referenced other recent studies to defend the authenticity of the Shroud of Turin, particularly  the 2022 wide-angle X-ray scattering analysis  published by Italian researchers at the National Research Council in Bari. The team of researchers was led by Liberato De Caro.

(Story continues below)

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The study used wide-angle X-ray scattering to examine the natural aging of cellulose in a sample of the Shroud of Turin, which determined that the age of the fabric should be about 2,000 years old — consistent with the period in which Christ died. The findings conflicted with a famous  1988 carbon dating study , which placed the age of the Shroud of Turin in the 13th or 14th century. 

Spitzer told CNA that the X-ray scattering is “a really ideal dating test” and that it “really adds a credibility to the other data that has been garnered.” He also referenced studies that analyze pollen DNA, saying the Shroud of Turin “had to be in the open air for … three to four centuries at least” in the area of northern Judea and Jerusalem to account for the pollen from indigenous plants.

Additionally, Spitzer criticized the 1988 carbon dating study as unreliable, alleging contamination can affect carbon dating and that the researchers only took material from a small portion of the shroud rather than taking multiple samples from different parts of the shroud. He noted that the Shroud of Turin was damaged in a fire in the 1500s and repaired with material from that era and asserted that the fabric used in the carbon dating study “definitely is not the same as the linen cloth that the rest of the shroud is made of” but instead fabric added during the repair in the Middle Ages.

Despite the public debate about its authenticity, the Shroud of Turin continues to attract pilgrims from around the world and remains the subject of public interest.

The shroud was  honored at the National Eucharistic Congress  just last month at the Indiana Convention Center in Indianapolis with a 14-foot replica and a high-tech educational exhibit.

The National Shroud of Turin Exhibit at the 2024 National Eucharistic Congress in Indianapolis. Credit: Ursula Murua/EWTN News

The shroud also reentered the public spotlight last week when  the New York Post published  an image created with artificial intelligence meant to recreate the face of Jesus Christ based on the imprint on the Shroud of Turin. In 2022, the Museum of the Bible in Washington, D.C.,  hosted an exhibit  on the Shroud of Turin for five months.

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Research: Why Inclusive Hiring Must Include Refugees

  • Betina Szkudlarek

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Six ways companies of any size can engage this overlooked talent pool.

When companies seek to engage in more inclusive recruitment, they often overlook recruitment initiatives focused on refugees. The number of global refugees, asylum seekers, and others in need of international protection surpassed 50.3 million people at the end of 2023, per the U.N. Refugee Agency. The authors cite their findings from two of their studies: first, that managers who have never recruited from this group tend to not only undervalue the benefits of this talent pool, but also hold various misconceptions and biases around recruiting and hiring refugees; and second, that traditional recruitment processes prevent managers from tapping into non-traditional talent pools. From their studies based on conversations with managers, talent leaders, and job seekers from refugee backgrounds, the authors offer 6 ways companies can better recruit from this talent pool: scrutinize your hiring criteria, be proactive and creative with recruitment, reevaluate your selection processes, consider utilizing external support, reach out to industry peers, and think of inclusive recruitment beyond direct recruitment.

As organizations seek to be more inclusive in their recruitment and hiring practices, one area they can improve upon is expanding their talent acquisition playbook to include refugees.

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  • BS Betina Szkudlarek , PhD, is Professor of International Management at the University of Sydney Business School, Australia. Betina is a world-renowned expert on refugee workforce integration and cross-cultural management and a Strategic Sustainability and Growth Consultant with the United Nations Alliance of Civilizations. She has a strong corporate presence and wide experience in researching, consulting and training in various areas linked to diversity management and global leadership. Her research has been featured by the Wall Street Journal, BBC, and ABC, among others. Her work in the domain of refugee workforce integration and SDG impact has been recognised with multiple prizes, including the United Nations Award for Excellence in SDG Integration (UN PRME Global Forum, New York 2023).
  • EL Eun Su Lee , PhD, is Assistant Professor in Management at the University of Newcastle, Australia. Her research focuses on migrants’ integration journeys in foreign countries and the role of stakeholders in facilitating such integrative efforts. Her work has been published in top-tier international journals such as Human Resource Management Journal and International Journal of Management Reviews. Eun Su has also won a number of international awards with Prof Szkudlarek; these prestigious awards include AIB Insights Award for Actionable Insights (Miami, 2022), NBS Research Impact on Practice Award and International HRM Scholarly Award (Seattle, 2022).

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Harvard neurology expert reveals study on how religious fundamentalism impacts the brain

Sarah K. Burris

Sarah K. Burris

Senior editor, sarah burris is a long-time veteran of political campaigns, having worked as a fundraiser and media director across the united states. she transitioned into reporting while working for rock the vote, future majority and wiretap magazine, covering the millennial generation's perspective during the presidential elections. as a political writer, burris has had bylines at cnn, salon.com, bnr, and alternet and serves as a senior digital editor for rawstory.com..

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Harvard neurology expert reveals study on how religious fundamentalism impacts the brain

People with brain lesions are more susceptible to religious fundamentalism, according to a study authored by a Harvard University neurology instructor.

Michael Ferguson, an instructor at Harvard Medical School, published a paper along with several other academic experts on brain research about the impact of religious fundamentalism on those with brain lesions.

Brain lesions aren't isolated to brain tumors. Those with congenital disorders, degenerative brain diseases like Alzheimer's, Lewy body dementia, and Parkinson's can add to brain cell death or malfunction, The Cleveland Clinic explains . There are also immune and inflammatory conditions, such as multiple sclerosis or lupus, that can lead to lesions in the brain. Problems like epilepsy, a stroke, traumatic brain injury or brain aneurysms can all cause brain lesions.

Read Also: A neuroscientist explains how religious fundamentalism hijacks the brain

"The whole brain functional connectivity pattern was then correlated with religious fundamentalism scores on a voxelwise basis," wrote Ferguson in a thread on X using a number of illustrations.

"Even when applying a conservative family-wise error multiple comparison correction, we found robust neuroanatomical clusters that were statistically significant in their associations with religious fundamentalism scores," he said.

The survey looked at two data sets, one with lesions and one without. They could reproduce the same patterns in both sets, making them believe the results were "real."

He went on to say that the researchers had "cross-validation" in that they could see one dataset predicted fundamentalism scores for another.

"Lastly, we explored whether our religious fundamentalism brain network resembled the neuroanatomy associated with various neurobehavioral conditions," he continued.

"The strongest similarities to the neuroanatomy linked with confabulation and criminal behavior," he said.

Confabulations are fake or distorted memories that aren't made with any deception. The individual believes they're real, however.

As for crimes, the comparisons for behavior came from violent crimes like assault, rape, and murder.

"Although highly sensitive, these results may shed light on pathways through which religious fundamentalism can, in some cases, convert to outgroup hostility," Ferguson explained.

These researchers didn't only look at one particular religion but across all religions.

Read the full study here.

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Do you think vice president kamala harris should be the next president, kamala harris and tim walz to sit down for 1st joint interview.

Democratic presidential nominee Kamala Harris and running mate Tim Walz will sit down for their first joint interview with reporters, according to a report.

Harris and Walz plan to speak with CNN on Thursday , according to the outlet. Anchor Dana Bash will conduct the interview, which will air at 9 p.m. Eastern Time that day.

The debate comes as the Harris campaign prepares for a planned Sept. 10 debate with Republican presidential nominee Donald Trump .

ALSO READ: From Nixon to Trump: How the GOP has weaponized 'othering' for political gain

'Not messing around': Experts praise 'smart' Jack Smith for whittling down Trump case

Legal experts believe that special counsel Jack Smith has made the federal election interference case against former President Donald Trump far stronger in his superseding indictment revealed Tuesday, as it is now compliant with the Supreme Court's ruling earlier this summer that presidents have a presumption of immunity from prosecution for official acts.

Smith, who this week also appealed the dismissal of his other case against Trump over classified documents in Florida, tweaked the charges to remove references that Trump tried to order the Justice Department to carry out corrupt acts to obstruct the election. The references couldn't be proven under the Supreme Court's ruling because they rely on evidence that is immune from review.

However, the indictment still contains most other lines of evidence that it previously had.

"On a quick read, I believe this is aimed at bringing the indictment into more conformity with the Supreme Court’s decision in Trump v. US — essentially by removing the bits in the previous indictment about corrupting the DOJ, which SCOTUS said were absolutely immune," wrote attorney Luppe B. Luppen, known on X as @nycsouthpaw.

"Smart," wrote national security lawyer Bradley Moss. "All of this would arguably be inadmissible now under the SCOTUS ruling. No reason to bother keeping it in."

"Jack Smith is not going anywhere," wrote former federal prosecutor Barbara McQuade. "Here is his just-filed superseding indictment against Trump in election interference case, conforming the allegations to SCOTUS’s immunity decision."

"Jack Smith has officially filed a superseding indictment in Washington, D.C. clearing the way for the criminal charges against Trump to move forward in lieu of the recent Supreme Court decision," wrote lawyer and Democratic activist Aaron Parnas. "The Special Counsel is not messing around."

"The superseding indictment returned today in Washington reflects an effort by prosecutors to remove portions of the original indictment that would be immune from prosecution under the Supreme Court's presidential immunity ruling," wrote Lawfare's Anna Bower.

Meanwhile, Georgia State University constitutional law professor Anthony Michael Kreis believes Smith's new indictment could have impacts on another of the criminal cases against Trump.

"The Special Counsel's superseding indictment disproportionately relies on Trump's actions in Georgia for evidence of unlawful conspiracies as conduct that falls outside the scope of presidential immunity, emphasizing his status as a candidate," he wrote. "This will be an important roadmap for Judge McAfee whenever the case returns to Fulton County Superior Court and similar rulings on presidential immunity and Supremacy Clause matters have to be decided."

Harris and Trump have equal favorability in NC — but Robinson faces a wider margin: poll

Vice President Kamala Harris and former President Donald Trump enjoy nearly equal favorability ratings among North Carolina’s registered voters, according to an Elon Poll released Tuesday.

About 44% of voters had very favorable or somewhat favorable impressions of Harris, and 46% had very favorable or somewhat favorable impressions of Trump. Each was viewed unfavorably by half the voters.

In the governor’s race, Republican Lt. Gov. Mark Robinson favorability lagged far behind that of Democratic Attorney General Josh Stein. Robinson was viewed favorably by 30% and unfavorably by half the voters. Stein was viewed favorably by 44% of voters and unfavorably by 29%.

More Republicans than Democrats said they would split their votes for president and governor. Sixteen percent of Republicans said they would split their tickets, while 6% of Democrats said they would select candidates of different parties.

This is the first Elon Poll of the 2024 election year. The poll was conducted from Aug. 2-9, after President Joe Biden dropped out of the race but before the Democratic National Convention.

North Carolina’s status as a swing state is sometimes questioned, considering Republican presidential candidates have won three times in a row, Professor Jason Husser, Elon University Poll director, said in a news release.

“Our data show that North Carolina’s electoral votes remain up for grabs by either party, but winning those votes will involve navigating a divided, complex and engaged electorate,” Husser said.

More than half of the respondents said the events of the summer, including the assassination attempt on Trump and Biden’s decision to drop out, made them more interested in voting.

The poll reveals racial and gender divides in both the presidential and gubernatorial races.

Half of male voters had favorable impressions of Trump, while 39% of male voters had favorable impressions of Harris.

Among women, 47% had favorable impressions of Harris, while 43% viewed Trump favorably.

Seventy-two percent of Black voters had favorable impressions of Harris, while 17% had favorable impressions of Trump.

Fifty-four percent of white voters had favorable impressions of Trump, while 35% of white voters said the same of Harris.

Stein’s favorability far outpaces Robinson’s with women and Black voters. Twenty-three percent of women have favorable impressions of Robinson, while 46% have favorable impressions of Stein.

Favorable views among men are about the same for each candidate: 40% for Robinson and 41% for Stein.

Robinson is the state’s first Black lieutenant governor. In his speech at the Republican National Convention, he talked about becoming the state’s first Black governor. Most Black voters, however, view him unfavorably.

Sixty-four percent of Black voters had unfavorable impressions of Robinson, while 14% had favorable impressions.

Sixty-five percent of Black voters had favorable impressions of Stein, while 5% viewed him unfavorably.

The state’s economy emerged as the top issue influencing voters’ choice for governor. Ninety percent said it was extremely or very important.

Democrats and Republicans reported vastly different experiences with their personal finances over the last three years.

Forty percent of Democrats said their personal financial situations had improved since Biden took office, while 17% said they had gotten worse.

For Republicans, 3% said their personal financial situations had improved since Biden took office, and 80% said they had gotten worse.

Elon University Poll sponsored the survey and the firm YouGov conducted it. The poll had a sample size of 800 and a 3.86% margin of error.

NC Newsline is part of States Newsroom, a nonprofit news network supported by grants and a coalition of donors as a 501c(3) public charity. NC Newsline maintains editorial independence. Contact Editor Rob Schofield for questions: [email protected] . Follow NC Newsline on Facebook and X .

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Rudy Giuliani finds a new low: platforming a Nazi

No candidate age limits: democratic delegates, from nixon to trump: how the gop has weaponized 'othering' for political gain.

Copyright © 2024 Raw Story Media, Inc. PO Box 21050, Washington, D.C. 20009 | Masthead | Privacy Policy | Manage Preferences | Debug Logs For corrections contact [email protected] , for support contact [email protected] .

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Pursuing the secrets of a stealthy parasite

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Sebastian Lourido wears a lab coat with his name, and stands in a lab with blue-lit equipment.

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Toxoplasma gondii , the parasite that causes toxoplasmosis, is believed to infect as much as one-third of the world’s population. Many of those people have no symptoms, but the parasite can remain dormant for years and later reawaken to cause disease in anyone who becomes immunocompromised.

Why this single-celled parasite is so widespread, and what triggers it to reemerge, are questions that intrigue Sebastian Lourido, an associate professor of biology at MIT and member of the Whitehead Institute for Biomedical Research. In his lab, research is unraveling the genetic pathways that help to keep the parasite in a dormant state, and the factors that lead it to burst free from that state.

“One of the missions of my lab to improve our ability to manipulate the parasite genome, and to do that at a scale that allows us to ask questions about the functions of many genes, or even the entire genome, in a variety of contexts,” Lourido says.

There are drugs that can treat the acute symptoms of Toxoplasma infection, which include headache, fever, and inflammation of the heart and lungs. However, once the parasite enters the dormant stage, those drugs don’t affect it. Lourido hopes that his lab’s work will lead to potential new treatments for this stage, as well as drugs that could combat similar parasites such as a tickborne parasite known as Babesia, which is becoming more common in New England.

“There are a lot of people who are affected by these parasites, and parasitology often doesn’t get the attention that it deserves at the highest levels of research. It’s really important to bring the latest scientific advances, the latest tools, and the latest concepts to the field of parasitology,” Lourido says.

A fascination with microbiology

As a child in Cali, Colombia, Lourido was enthralled by what he could see through the microscopes at his mother’s medical genetics lab at the University of Valle del Cauca. His father ran the family’s farm and also worked in government, at one point serving as interim governor of the state.

“From my mom, I was exposed to the ideas of gene expression and the influence of genetics on biology, and I think that really sparked an early interest in understanding biology at a fundamental level,” Lourido says. “On the other hand, my dad was in agriculture, and so there were other influences there around how the environment shapes biology.”

Lourido decided to go to college in the United States, in part because at the time, in the early 2000s, Colombia was experiencing a surge in violence. He was also drawn to the idea of attending a liberal arts college, where he could study both science and art. He ended up going to Tulane University, where he double-majored in fine arts and cell and molecular biology.

As an artist, Lourido focused on printmaking and painting. One area he especially enjoyed was stone lithography, which involves etching images on large blocks of limestone with oil-based inks, treating the images with chemicals, and then transferring the images onto paper using a large press.

“I ended up doing a lot of printmaking, which I think attracted me because it felt like a mode of expression that leveraged different techniques and technical elements,” he says.

At the same time, he worked in a biology lab that studied Daphnia , tiny crustaceans found in fresh water that have helped scientists learn about how organisms can develop new traits in response to changes to their environment. As an undergraduate, he helped develop ways to use viruses to introduce new genes into Daphnia . By the time he graduated from Tulane, Lourido had decided to go into science rather than art.

“I had really fallen in love with lab science as an undergrad. I loved the freedom and the creativity that came from it, the ability to work in teams and to build on ideas, to not have to completely reinvent the entire system, but really be able to develop it over a longer period of time,” he says.

After graduating from college, Lourido spent two years in Germany, working at the Max Planck Institute for Infection Biology. In Arturo Zychlinksy’s lab, Lourido studied two bacteria known as Shigella and Salmonella , which can cause severe illnesses, including diarrhea. His studies there helped to reveal how these bacteria get into cells and how they modify the host cells’ own pathways to help them replicate inside cells.

As a graduate student at Washington University in St. Louis, Lourido worked in several labs focusing on different aspects of microbiology, including virology and bacteriology, but eventually ended up working with David Sibley, a prominent researcher specializing in Toxoplasma .

“I had not thought much about Toxoplasma before going to graduate school,” Lourido recalls. “I was pretty unaware of parasitology in general, despite some undergrad courses, which honestly very superficially treated the subject. What I liked about it was here was a system where we knew so little — organisms that are so different from the textbook models of eukaryotic cells.”

Toxoplasma gondii belongs to a group of parasites known as apicomplexans — a type of protozoans that can cause a variety of diseases. After infecting a human host, Toxoplasma gondii  can hide from the immune system for decades, usually in cysts found in the brain or muscles. Lourido found the organism especially intriguing because as a 17-year-old, he had been diagnosed with toxoplasmosis. His only symptom was swollen glands, but doctors found that his blood contained antibodies against Toxoplasma .

“It is really fascinating that in all of these people, about a quarter to a third of the world’s population, the parasite persists. Chances are I still have live parasites somewhere in my body, and if I became immunocompromised, it would become a big problem. They would start replicating in an uncontrolled fashion,” he says.

A transformative approach

One of the challenges in studying Toxoplasma is that the organism’s genetics are very different from those of either bacteria or other eukaryotes such as yeast and mammals. That makes it harder to study parasitic gene functions by mutating or knocking out the genes.

Because of that difficulty, it took Lourido his entire graduate career to study the functions of just a couple of Toxoplasma genes. After finishing his PhD, he started his own lab as a fellow at the Whitehead Institute and began working on ways to study the Toxoplasma genome at a larger scale, using the CRISPR genome-editing technique.

With CRISPR, scientists can systematically knock out every gene in the genome and then study how each missing gene affects parasite function and survival.

“Through the adaptation of CRISPR to Toxoplasma , we’ve been able to survey the entire parasite genome. That has been transformative,” says Lourido, who became a Whitehead member and MIT faculty member in 2017. “Since its original application in 2016, we’ve been able to uncover mechanisms of drug resistance and susceptibility, trace metabolic pathways, and explore many other aspects of parasite biology.”

Using CRISPR-based screens, Lourido’s lab has identified a regulatory gene called BFD1 that appears to drive the expression of genes that the parasite needs for long-term survival within a host. His lab has also revealed many of the molecular steps required for the parasite to shift between active and dormant states.

“We’re actively working to understand how environmental inputs end up guiding the parasite in one direction or another,” Lourido says. “They seem to preferentially go into those chronic stages in certain cells like neurons or muscle cells, and they proliferate more exuberantly in the acute phase when nutrient conditions are appropriate or when there are low levels of immunity in the host.”

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Experiments identified one gene, which the researchers named Bradyzoite-Formation Deficient 1 (BFD1), as the only gene both sufficient and necessary to prevent the transition from tachyzoite to bradyzoite stages of T. gondii infection. The findings may inform research into potential therapies for toxoplasmosis, or even a vaccine.

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August 27, 2024

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Risk for dementia found to be similar with SGLT2 inhibitors, dulaglutide in type 2 diabetes

by Elana Gotkine

Risk for dementia similar with SGLT2 inhibitors, dulaglutide in T2DM

For older adults with type 2 diabetes, the risk for dementia seems similar with sodium-glucose cotransporter 2 (SGLT2) inhibitors and the glucagon-like peptide 1 receptor agonist (GLP-1 RA) dulaglutide, according to a study published online Aug. 27 in the Annals of Internal Medicine .

Bin Hong, from the School of Pharmacy at Sungkyunkwan University in Suwon, South Korea, and colleagues compared the risk for dementia between SGLT2 inhibitors and dulaglutide in a target trial emulation study using nationwide health care data for South Korea obtained between 2010 and 2022.

Participants were aged 60 years or older with type 2 diabetes and were initiating treatment with SGLT2 inhibitors (12,489 patients; 51.9 percent dapagliflozin and 48.1 percent empagliflozin) or dulaglutide (1,075 patients).

The researchers found that during a median follow-up of 4.4 years, the primary outcome event of presumed clinical onset of dementia occurred in 69 and 43 participants in the SGLT2 and dulaglutide groups, respectively, with an estimated risk difference of −0.91 percentage points (95 percent confidence interval, −2.45 to 0.63) and estimated risk ratio of 0.81 (95 percent confidence interval, 0.56 to 1.16).

"In conclusion, we found little difference in the risk for dementia for SGLT2 inhibitors compared with dulaglutide in our data," the authors write. "However, whether these findings generalize to newer GLP-1 RAs is uncertain."

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  2. What is Human Subjects Research?

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  3. Definition of Human Subjects Research

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  4. Methodology tutorial

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  5. General characteristics of the study subjects.

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COMMENTS

  1. Human Subjects Research Design

    Human subjects research is at the intersection of these two federal definitions and must obtain Institutional Review Board approval before starting, regardless of the type of design involved. The topic of a human research study varies and can include building a theory or hypothesis, determining patient satisfaction, or testing a medication ...

  2. Definition of Human Subjects Research

    According to 45 CFR 46 , a human subject is "a living individual about whom an investigator (whether professional or student) conducting research: Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or. Obtains, uses, studies, analyzes, or ...

  3. Human subject research

    Medical human subject research often involves analysis of biological specimens, epidemiological and behavioral studies and medical chart review studies. [1] A specific, and especially heavily regulated, type of medical human subject research is the " clinical trial ", in which drugs, vaccines and medical devices are evaluated.)

  4. Why Human Subjects Research Protection Is Important

    Background: Institutional review boards (IRBs), duly constituted under the Office of Human Research Protection, have the federally mandated responsibility of reviewing research involving human subjects to ensure that a proposed protocol meets the appropriate ethical guidelines before subjects may be enrolled in any study. The road leading to the current regulations and ethical considerations ...

  5. Defining Research with Human Subjects

    A study is considered research with human subjects if it meets the definitions of both research AND human subjects, as defined in the federal regulations for protecting research subjects. Research. A systematic inquiry designed to answer a research question or contribute to a field of knowledge, including pilot studies and research development.

  6. What Is a Research Design

    A research design is a strategy for answering your research question using empirical data. Creating a research design means making decisions about: Your overall research objectives and approach. Whether you'll rely on primary research or secondary research. Your sampling methods or criteria for selecting subjects. Your data collection methods.

  7. Types of Human Subjects Research

    The NIH defines an intervention as a manipulation of the subject or the subject's environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints. The NIH further defines a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more ...

  8. A Practical Guide to Writing Quantitative and Qualitative Research

    INTRODUCTION. Scientific research is usually initiated by posing evidenced-based research questions which are then explicitly restated as hypotheses.1,2 The hypotheses provide directions to guide the study, solutions, explanations, and expected results.3,4 Both research questions and hypotheses are essentially formulated based on conventional theories and real-world processes, which allow the ...

  9. Types of Research Designs Compared

    Laboratory experiments have higher internal validity but lower external validity. Fixed design vs flexible design. In a fixed research design the subjects, timescale and location are set before data collection begins, while in a flexible design these aspects may develop through the data collection process.

  10. How to appropriately choose research subjects

    An appropriate selection of research subjects is crucial to the success of the research. This article summarizes the general principles for the selection of research subjects, the types and numbers of research subjects and the common mistakes that researchers tend to make in the selection of the research subjects. This article also provides the ...

  11. Human Subjects Research

    Pre-Award and Post-Award Processes. Learn about the process of applying for a grant, cooperative agreement, or R&D contract, as it relates to the involvement of human subjects research. Find useful resources on how to prepare your Protection of Human Subjects section, and learn about next steps after submitting your grant application or proposal.

  12. PDF What is Research and What it isn't? And Who is Human Subject Anyway

    subjects research that is funded by H HS (or other Common Rule agencies and departments) Note: The regulatory framework provides a baseline standard for human research protections. Mere compliance does NOT mean that the research study is necessarily protective or free from ethical concerns! 4

  13. Research is an Activity and a Subject of Study: A Proposed Metaconcept

    Research Is a Subject of Study. A study of research is one in which the products or processes of research are analyzed to better understand some aspect of research itself. This is most directly seen in studies that observe actual research behaviors or evaluate specific research products. The study of research also has an influence on other ...

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    Several research topics and questions indicate when using a narrative approach is appropriate. The key criterion of narrative research is storytelling (Fraser, 2004). A narrative study can be conducted with a single participant, such as with a biographical study or an autoethnography, or with several people who share common experiences, using ...

  15. Research Methods

    In descriptive research, you collect data about your study subject without intervening. The validity of your research will depend on your sampling method. In experimental research, you systematically intervene in a process and measure the outcome. The validity of your research will depend on your experimental design.

  16. NIH Investigator Manual for Human Subjects Research

    Human subject (2018 HHS Common Rule) means a living individual about whom an investigator (whether professional or student) conducting research: Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. Human subject (FDA) means an individual who is or becomes a participant in research, either ...

  17. Between-Subjects vs. Within-Subjects Study Design

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  18. List of academic fields

    An academic discipline or field of study is known as a branch of knowledge. ... (Joint Academic Classification of Subjects) from Higher Education Statistics ... Fields of research classification. Fields of Knowledge, a zoomable map allowing the academic disciplines and sub-disciplines in this article be visualised. Interactive Historical Atlas ...

  19. 1000+ Research Topics & Research Title Examples For Students

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  20. Information for Research Subjects

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  21. Subject of Study

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  22. Case Study Methodology of Qualitative Research: Key Attributes and

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  23. About Human Subjects Research

    EPA conducts and funds a wide variety of human subjects research (HSR). Some examples of HSR at the EPA include fish consumption surveys, surveys on household practices or demographics, analysis of biological specimens, use of focus groups, controlled exposure studies and epidemiology studies. Each of the study examples listed above serves a ...

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    The previous research studies and systematic evaluations also confirmed its effectiveness as an external treatment for KOA [12, 13]. ... The subjects and assessors will be blinded to subjects' allocations. The acupuncturist will do not take part in assessments or data entry. Data will be analyzed by an independent statistician (Figure 1).

  29. Pursuing the secrets of a stealthy parasite

    Sebastian Lourido, MIT associate professor of biology, studies the genetic pathways that help to keep the parasite Toxoplasma gondii in a dormant state. He is an affiliate of the Whitehead Institute for Biomedical Research.

  30. Risk for dementia found to be similar with SGLT2 inhibitors

    For older adults with type 2 diabetes, the risk for dementia seems similar with sodium-glucose cotransporter 2 (SGLT2) inhibitors and the glucagon-like peptide 1 receptor agonist (GLP-1 RA ...