history of research ethics ppt

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History of Research Ethics

This website is intended to give a brief description of the development of human subjects’ regulations and requirements in the United States. More in-depth coverage of this topic is available through Collaborative Institutional Training Initiative training.

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Nuremberg Code

A well-known chapter in the history of research with human subjects opened on Dec. 9, 1946, when an American military tribunal opened criminal proceedings against 23 leading German physicians and administrators for their willing participation in war crimes and crimes against humanity. Among the charges were that German physicians conducted medical experiments on thousands of concentration camp prisoners without their consent. Most of the subjects of these experiments died or were permanently crippled as a result. As a direct result of the trial, the Nuremberg Code was established in 1948, stating that “The voluntary consent of the human subject is absolutely essential,” making it clear that subjects should give consent and that the benefits of research must outweigh the risks. Although it did not carry the force of law, the Nuremberg Code was the first international document which advocated voluntary participation and informed consent.

Thalidomide

In the late 1950s, thalidomide was approved as a sedative in Europe; it was not approved in the United States by the FDA. The drug was prescribed to control sleep and nausea throughout pregnancy, but it was soon found that taking this drug during pregnancy caused severe deformities in the fetus. Many patients did not know they were taking a drug that was not approved for use by the FDA, nor did they give informed consent. Some 12,000 babies were born with severe deformities due to thalidomide. U.S. Senate hearings followed and in 1962 the so-called “Kefauver Amendments” to the Food, Drug, and Cosmetic Act were passed into law to ensure drug efficacy and greater drug safety. For the first time, drug manufacturers were required to prove to the FDA the effectiveness of their products before marketing them.

Tuskegee Syphilis Study (1932-1972)

An equally well-known chapter in history occurred during a research project conducted by the U.S. Public Health Service. Six hundred low-income African-American males, 400 of whom were infected with syphilis, were monitored for 40 years. Free medical examinations were given; however, subjects were not told about their disease. Even though a proven cure (penicillin) became available in the 1950s, the study continued until 1972 with participants being denied treatment. In some cases, when subjects were diagnosed as having syphilis by other physicians, researchers intervened to prevent treatment. Many subjects died of syphilis during the study. The study was stopped in 1973 by the U.S. Department of Health, Education, and Welfare only after its existence was publicized and it became a political embarrassment. In 1997, under mounting pressure, President Clinton apologized to the study subjects and their families.

Declaration of Helsinki

In 1964, the World Medical Association established the “Declaration of Helsinki,” which provides recommendations guiding medical doctors in biomedical research involving human subjects. The declaration governs international research ethics and defines rules for “research combined with clinical care” and “non-therapeutic research.” The Declaration of Helsinki was revised in 1975, 1983, 1989, and 1996 and is the basis for effective clinical practices used today.

• Research with humans should be based on the results from laboratory and animal experimentation
• Research protocols should be reviewed by an independent committee prior to initiation
• Informed consent from research participants is necessary
• Research should be conducted by medically/scientifically qualified individuals
• Risks should not exceed benefits

National Research Act (1974)

Because of the publicity from the Tuskegee Syphilis Study, the National Research Act of 1974 was passed. The National Research Act created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. This commission was tasked with identifying the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects. It was also tasked with developing guidelines that should be followed to assure that such research is conducted in accordance with these ethical principles. The commission drafted the Belmont Report, a foundational document in for the ethics of human subjects research in the United States.

Current Regulations

In 1981, the Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) issued regulations based on the Belmont Report. The DHHS issued the Code of Federal Regulations (CFR) Title 45 (public welfare), Part 46 (protection of human subjects). The FDA issued CFR Title 21 (food and drugs), Parts 50 (protection of human subjects), and 56 (Institutional Review Boards). In 1991, the core DHHS regulations (45 CFR Part 46, Subpart A) were formally adopted by more than a dozen other departments and agencies that conduct or fund research involving human subjects as the Federal Policy for the Protection of Human Subjects, or the “Common Rule.” In 1991, the Department of Veterans Affairs promulgated this same rule at 38 CFR Part 16. Today, the 1991 version of the “Federal Policy,” as it is known, is widely shared by federal departments and agencies. The main elements of the Common Rule include the following:

• requirements for assuring compliance by research institutions;
• requirements for researchers obtaining and documenting informed consent;
• requirements for Institutional Review Board (IRB) membership, function, operations, review of research, and record keeping; and
• additional protections for certain vulnerable research subjects (pregnant women, prisoners, and children)

In addition, certain federally sponsored and much privately sponsored research is subject to the regulations of the Food and Drug Administration (FDA) at 21 CFR Parts 50 and 56. FDA regulations confer protections on human subjects in research when a drug, device, biologic, food additive, color additive, electronic product, or other test article subject to FDA regulation is involved. FDA regulations and the provisions of the Common Rule are largely congruent, although some significant differences exist. Both the Common Rule and the FDA regulations provide protections for human subjects in research.

• National Institutes of Health, Regulations and Ethical Guidelines
• History of Human Subjects Research and IRB Oversight

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Research Ethics & Integrity

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History of research Ethics - PowerPoint PPT Presentation

History of research Ethics

History of research ethics origin of international guidelines 291 ... – powerpoint ppt presentation.

• Origin of International Guidelines
• Edward Jenner (1789) Smallpox Vaccine
• Claude Bernard (1865) Ethical Maxims
• Louis Pasteur (1885) Rabies Vaccine
• Walter Reed (1900) Yellow Fever
• Nazi doctors conducted as many as 30 different type of experiments on concentration-camp inmates
• performed these studies without the consent of the victims
• Who suffered indescribable pain, mutilation, permanent disability, or in many cases death as a result
• High altitude experiments conducted in low pressure chambers that approximate pressure at extremely high altitudes
• In concentration camps (Dachau) and killing camps (Auschwitz)
• Photo in evidence presented at the trial of an injury caused by phosphorous experiment to test ointments to treat burn
• subjects remained in ice tanks for 3 hours, severely chilled and rewarmed of the body was then attempted
• Sea water experiment subjects deprived of food and given chemically treated water
• Epidemic jaundice experiment subjects infected with jaundice
• Sterilization of subjects by means of x ray, surgery and drugs
• Spotted fever (typhus) germs infected healthy subjects to develop vaccine
• Poison mixed with food or subjects shot with poison bullets to investigate effects of various poisons.
• Incendiary bomb experiments Burns inflicted on subjects by using phosporous from bombs then treated with various drug preparations
• Bone, nerve, muscle transplantation from one person to another
• 23 German physicians
• performing medical experiments upon concentration camp inmates and other living human subjects, without their consent, in the course of which experiments the defendants committed the murders, brutalities, cruelties, tortures, atrocities, and other inhuman acts.
• 11 supplemental trials
• 23 Nazi physicians were charged with conducting inhuman experiments on German civilians and nationals of other countries
• 16 defendants were convicted
• 7 were sentenced to death
• Developed by International Military Tribunal
• The judgment included a set of standards knows as the Nuremberg Code, an ethical yardstick.
• First internationally recognized code of research ethics
• As part of the verdict, the Court enumerated some rules for "Permissible Medical Experiments", now known as the Nuremberg Code. These rules include
• voluntary consent
• benefits outweigh risks
• ability of the subject to terminate participation
• Informed consent from volunteers must be obtained without coercion.
• Human experiments should be based upon prior animal experimentation.
• Anticipated results should justify the experiment.
• Only qualified scientists should conduct research.
• Physical and mental suffering should be avoided.
• There should be no expectation of death or disabling injury from the experiment.
• 22 Elderly patients
• some with dementia, some spoke only Yiddish
• The participants were not informed that the injected material contained live cancer cells
• No review committee and no approval was sought from attending MDs providing care.
• Need for informed consent in research
• guardians not asked for permission
• consent deceptive, inadequate, not translated
• Thalidomide was approved as a sedative in Europe in the late 1950s.
• The FDA never approved the drug, but samples were sent to US doctors.
• By 1961 thalidomide was shown to be very harmful to the fetus, interfering with the normal development of arms and legs.
• These events lead to the passage of the Drug Amendments of 1962 to the Food, Drug and Cosmetic Act
• This was the first US statues that required subjects be informed of a drugs experimental nature and to consent before starting the research study
• The study was on obedience and humans response to authority.
• The subjects were deceived as to the nature of the study and were told it was a teacher/ learner experiment.
• The teachers were told to give the subject an electrical shock for missed answers.
• Informed consent had not been obtained because of the Deception
• Federal regulations specifically allow for deception in research, but only in limited conditions and only with IRB approval
• Extreme psychological stress experienced by most subjects
• Adopted by the 18th World Medical Assembly, Helsinki, Finland, 1964
• Revised by the World Medical Assembly in Tokyo, Japan in 1975, in Venice, Italy in 1983, and in Hong Kong in 1989 and the 48th General Assembly, Somerset West, Republic of South Africa, October 1996 and 2000 (Edinburgh, Scotland). added by the WMA General Assembly, Washington 2002.
• It is the mission of the physician to safeguard the health of the people
• Medical progress is based on research which ultimately must rest in part on experimentation involving human subjects
• Respect for Persons people are not a means to an end researchers have duty to protect life, health, privacy and dignity of research participants
• Standard of care must be best available, even for control group
• Proxy consent and assent for vulnerable populations
• 800 Children - Willowbrook State School for the Mentally Retarded
• Newly admitted mentally disabled children were inoculated with infectious hepatitis
• Objective to determine the period of infectivity for the disease
• Researchers injected students with mild form of hepatitis
• Parents were not informed of the risks
• Benefit of study for participants better hospital facilities and care for the children
• coercion of parents
• 22 published medical studies presenting risk to subjects without their knowledge or approval
• Published in some of the most prestigious journals and conducted at some of the most prestigious institutions
• perform heart catheterizations on patients getting a bronchoscopy look at breathing passages through a tube
• placebo control groups in life-threatening diseases with known effective treatments several
• randomize soldiers with strep throat to penicillin vs. treatments known-to-be-ineffective ineffective treatment may lead to rheumatic heart disease
• NIH Director and Surgeon General requested that the National Advisory Health Council review human subject protections
• Council recommended prior institutional review for PHS supported research to
• Protect of the rights and welfare of the subjects
• Assure appropriate methods of informed consent
• Determine acceptable balance of risks and benefits
• Adopted as Public Health Service policy in 1966
• Beginnings of the Institutional Review Board (IRB)
• ?DHHS - 45 CFR Part 46(The Common Rule )
• ? FDA - 21 CFR (First developed and promulgated 1962-1966)
• Part 50 (Informed Consent)
• Part 56 (IRBs)
• Part 312 (Drugs)
• Part 812 (Devices)
• Department of Education
• 34 CFR Part 97
• NIH assurance (FWA)
• requirements for assuring compliance by research institutions
• requirements for researchers obtaining and documenting informed consent
• requirements for Institutional Review Board (IRB) membership, function, operations, review of research, and record keeping.
• additional protections for certain vulnerable research subjects-- pregnant women, prisoners, and children
• Composition and function of a local institutional review board (IRB)
• Criteria for IRB approval of proposals
• Requirements regarding informed consent
• US Public Health Service study on natural history of syphilis
• 399 black men with syphillis were recruited. they were mostly illiterate
• They were not Informed about their disease, the nature of the study, the risk to the partner
• Offers for free examination ,medicines, insurance, hot meal, transportation.
• No treatment for the disease.
• To strengthen validity and gain more data
• A control group of 201 black men were added
• An autopsies of deceased subjects
• No informed about the purpose of the study
• Government doctors were examining people for bad blood
• Several bills to regulate research were introduced in congress in 1973
• Senator Edward Kennedy held hearings on Experimentation with human subjects, the study was stopped and treatment was given as needed
• Government would pay all medical expenses for the survivors, their wives and children who were born with congenital syphillis
• President Clinton issued a formal apology to the subjects and their families.
• Regulations for the protection of human subjects
• Requirement for informed consent
• Review research by the institutional review boards
• Created the commission for the protection of human subjects of Biomedical and Behavioral research
• Identifying the basic ethical principles
• Develop guidelines to assure that the research is conducted in accordance with those principles
• Consider the boundaries between medical practice and research
• Role of assessment of risk and benefit
• Selection of subjects
• Nature and definition of informed consent
• Basic Ethical Principles
• Respect for Persons
• Individual autonomy
• Protection of individuals with reduced autonomy
• Beneficence
• Maximize benefits and minimize harms
• Equitable distribution of research costs and benefits
• Their scope reflects the changes, the advances and the controversies that have characterized biomedical research ethics.
• CIOMS Guidelines are designed to be of use to countries in defining national policies on the ethics of biomedical research involving human subjects,
• provides guidance for the proper application of the principles of the Declaration of Helsinki and focuses particularly on research sponsored by or initiated in developed countries and carried out in developing countries.
• The CIOMS-WHO Guidelines added, among other things, a requirement for review and approval of all proposed research by an "ethical review committee"
• ICH GCP Guideline 1996
• UNAIDS guidance document Ethical consideration in HIV Preventive Vaccine research, 2000
• WHO Operational Guidelines for Ethics Committees that review Biomedical research, 2000
• WHO Surveying and Evaluating Ethical Review practices,2002
• Operational Guidelines for Ethics Committees That Review Biomedical Research
• the last accepted at the 59th WMA General Assembly in Seoul, South Korea in 2008.
• includes a number of important human research ethics codes of practice
• defines ethical principles
• provides little guidance on the governance, operation and responsibilities of a human ethics committee (Ethics Committee, EC)
• not a legally binding instrument in international law.
• The Declaration should be seen as an important human research guidance document, but it cannot overrule local regulations and laws.
• provides guidance on how an EC should operate and describes the responsibilities of the committee
• covers topics such as composition, function, operations, procedures, responsibilities, record keeping, contents of informed consent, and adverse event reporting
• Based on the ICH GCP, an EC must develop its own written standard operating procedure (SOP)
• EC SOPs often refer to the ICH GCP as well as to local legal requirements and guidelines
• In the ethics review of human research projects and conduct of research
• researchers and EC members must be aware of both the institutional requirements and the applicable laws
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• ????? ? ?????????????????????????????????????????? ?????????????????????????????????????????????????? ???? ????????????????????????????????????????????? ?????????????????????????????????????????????????? ??????????????????????????????????????? ?????????????????????????????????????????????????? ?????
• ????? ?? ???????????????? ? ????????? ? ?????????????????????????????????????????????????? ????????? ?????????????????? ????????????????????? ?????????????????????
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• ?.?.? ???????????????????????????????????????????? ???????????????? ???
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• ????????????????????????????????????? ???????????????????????????????????????????
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A BRIEF HISTORY OF ETHICAL THOUGHT - ETHICAL THEORIES - Lesson 3 a.pptx

Working with my students, and thinking in a reflective material, this productions is based in class material, subject Professional Ethics for Engineers that is the based to our book about this interesting topic. Kind of research in the way of action reseach and Text Pedagogy approaches. Professor JC González M.Ed.

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History of Medical Ethics

Jul 18, 2014

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History of Medical Ethics. PH 350 Norwich University Spring 2010. Learning Objectives. To understand early medicinal thought, especially the concept of paternalism To highlight some of the major events in history that developed patient autonomy To review the goals of medicine

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History of Medical Ethics PH 350 Norwich University Spring 2010

Learning Objectives • To understand early medicinal thought, especially the concept of paternalism • To highlight some of the major events in history that developed patient autonomy • To review the goals of medicine • To understand the major principles of modern-day medical ethics

Early Medicinal Thought • Paternalism -Medical treatment as a father/child relationship -Guiding principle: physician decides what is best for the patient and tries to follow that course of action -Focus: patient care and outcomes, not the patient’s needs or rights -Argument: maximum patient benefit can only be achieved when the doctor makes the final decision

Paternalism…Continued • Types of Paternalism -Positive vs. Negative Positive = promotes the patient’s good Negative = seeks to prevent an existing harm -Soft vs. Hard Soft = appeals to the patient’s values Hard = applies another’s values over the patient -Direct vs. Indirect Direct = benefits the patient who has been restricted Indirect = benefits a person other than the one restricted

The Father of Medicine • Hippocrates -Rejected medical views of his time -Based his medical practice on observations and study of the human body -Believed that illness has a rational explanation -Treated body as a whole unit, not just parts -Founded a medical school on the island of Cos, Greece to teach his beliefs

Hippocratic Oath • Original vs. Contemporary -language and content has been updated to fit modern beliefs about medicine -spells out physician responsibilities to both the patient and the medical profession

Evolution to Autonomy • Making the shift from paternalism -Patient given opportunity to determine benefit vs. harm - The Patient’s Bill of Rights -Questions being raised regarding the patient’s wishes as to what is ethical -How much do you tell the patient? -Do they even want to know?

Notable Cases in History • Nuremberg Code: 1946 -Limits on medical research following Nazi testing of hypothermia & antimicrobial agents -Subjects were put in ice tanks for 3 hours, wounds were inflicted & purposely infected with bacteria -Concepts of informed consent, avoiding all unnecessary physical & mental suffering, proper preparation & facilities, ability for subjects to opt out, basing human experiments on results of animal testing

Notable Cases…Continued • Tuskegee Syphilis Study: 1929 -Use of placebos in studies -Participants were illiterate, black sharecroppers thought to have “bad blood” -Deaths, chronic illness, and transmission to wives & children resulted

Notable Cases…Continued • Nancy Cruzan: 1983 -Was maintained in a persistent vegetative state for several years -Parents requested that artificial hydration and nutrition be withdrawn -Courts rule in their favor, but healthcare team appeals the decision -Incompetent patients need to be protected by law -Encouraged the development of advance directives and appointment of a health care proxy to carry out patient’s wishes

Goals of Medicine • Relieve suffering - Example: The use of Chloroform and Ether Chloroform was used more often because it was faster acting, less was needed to put someone under, and it was non-flammable. However, it was more dangerous than using Ether. The risk of drug overdose was greater with Chloroform.

Goals…Continued • Promote health - Flintstones Vitamins - Acne Treatment - Weight loss

Goals…Continued • To cure disease and preserve life 1900 – Average life expectancy was 49 2003 – Average Life expectancy is 78 • Vaccinations Definition: “A preparation of a weakened or killed pathogen, such as a bacterium or virus, or of a portion of the pathogen's structure that upon administration stimulates antibody production or cellular immunity against the pathogen but is incapable of causing severe infection.” -Swine Flu • Cures - Breast Cancer

Principles of Medical Ethics • Confidentiality -HIPAA (Health Insurance Portability & Accountability Act) • Honesty -Telling patients what they need to know • Justice -Treating all patients without discrimination • Gatekeeping -Patients access to medicine through doctors • Report impaired colleagues

Principles…Continued • Avoid sexual relations with patients • Conflicts of interest • Scope of practice -Range of responsibility, abilities • Gaming the system -Using patients to make more money

Thank you to all of our viewers! The End Produced by: J. Bielski, H. Black, V. Bruce, & J. Davis

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