clinical research law firm

Clinical Trials & Research

Bringing your research goals to life.

​Companies engaging in clinical trials are subject to a complex web of regulatory requirements, as well as significant ethical and practical concerns. Any misstep can result in cost escalation and delay with the potential to derail product development. Mintz’s clinical research team partners with clients to help them satisfy this vast set of legal and practical requirements while advancing their programs in a compliant manner. 

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Chambers USA 2024

Health Law Practice recognized Nationally and in Massachusetts, Washington, DC and California.

Legal 500 United States

Practice recommended in Health Care: Life Sciences, Health Care: Service Providers

BTI Industry Power Rankings

Recognized as a “Leading Core Firm” in the health care industry

Modern Healthcare 2024

Modern Healthcare Top Healthcare Law Firms 2024 Data Dive by the numbers.

U.S. News and Best Lawyers®

Nationally ranked Tier 1 for Health Care

Our Experience

Mintz Guides Company Through Clinical Trials Program

Lab Establishes Data Repository to Support Cancer Care

Biotech Client Initiates Two Phase 1b/2a Clinical Trials

Our approach.

We provide regulatory, strategic, and practical advice to companies involved with preclinical, clinical, and basic research. We also work with academic medical centers and research staff participating in sponsored clinical research or initiating their own studies. We routinely assist with issues related to study structure and related regulatory and contractual matters, the Institutional Review Board (IRB), Institutional Animal Care and Use (IACUC), biosafety monitoring and related committee review processes. And we advise on issues related to federal grant applications and regulatory compliance, uses and disclosure of health information and personal data for research purposes, and access to and use of tissue and other biological materials for research. We also counsel investors in transactions involving FDA-regulated companies.

• Drafting and review of research consent forms, HIPAA authorizations, recruitment materials, and other participant-facing forms
• Guidance to help ensure successful product development, approval, launch, and marketing efforts
• Preparation for and progress through the Institutional Review Board or Ethics Committee, Institutional Animal Care and Use Committee, Biosafety Monitoring Committee, and Stem Cell Research Oversight Committee review processes
• Risk management advice following adverse events
• Life Sciences Practice
• FDA Practice
• Intellectual Property Practice
• Corporate & Securities Practice
• Litigation Practice

Our attorneys collaborate with your team to help you meet regulatory challenges while advancing your business objectives.

Dianne J. Bourque

[email protected], +1.617.348.1614.

Joanne S. Hawana

Washington, dc, + 1.202.434.7349.

Kate F. Stewart

+1.617.348.4868.

Benjamin M. Zegarelli

+1.212.692.6261, our insights.

FDA Issues Guidance Addressing COVID-19 Interference with Clinical Trials

March 21, 2020 | blog |.

Key Vote in FDA Commissioner Confirmation Process Set for December 3rd

December 2, 2019 | blog |, first indicators of fda’s policy decision on cbd and cannabis-derived ingredients: “only limited data” and “real risks”, november 26, 2019 | blog |, news & press.

Changing Legal Environment Adds Uncertainty to ACLA Lawsuit Against FDA Over LDT Rule

In fda authorization of malaria drugs for covid-19, some see politics at play, what fda has done so far in response to covid-19.

Clarifying the Clinical Trials Process for Drugs and Biologics

Is your organization prepared for today’s clinical research.

FDA Outlook: What to Expect in 2022

Related practices.

• FDA Regulatory
• Health Information Privacy & Security
• Health Care Compliance, Fraud & Abuse, and Regulatory Counseling

Related Industries

• Life Sciences
• Hospitals & Health Systems

Related areas of focus:

Clinical research & trials, focused on keeping clients on track..

To make it to market, new drugs and medical devices must first undergo clinical research and trials. Husch Blackwell negotiates the often complicated contracts that frame these trials. We advise clients on drafting informed consents that meet all regulatory requirements, as well as on interactions with institutional review boards concerning protocols and study monitoring.

For trials supported by the National Institutes of Health or other government agencies or grants, we carefully craft the proper trial documentation to ensure regulatory compliance, protect intellectual property interests, and minimize business liability exposure.

Representative Experience

• Created and implemented an administrative review process for human research studies for a large health system, including development of related policies and procedures.
• Advised clinical trial and institutional review boards (IRBs) on compliance matters.
• Served as legal counsel to a health system’s IRB. Attended IRB meetings; provided legal guidance; and reviewed clinical trial agreements, fee agreements, business associate agreements, and nondisclosure agreements.
• Advised pharmaceutical companies and device manufacturers on Food and Drug Administration (FDA) and state regulatory requirements.
• Organized and supervised clinical trials for early-stage biotechnology company.
• Prepared and negotiated biotechnology-related agreements, including clinical research agreements, noncompete agreements, and confidentiality agreements.
• Led top-to-bottom review and enhancement of medical device manufacturer’s compliance program, including clinical trials and investigation policies, procedures, and implementation.
• Drafted and negotiated clinical trial agreements with principal investigators, institutions, sponsors, SMOs, and CROs.
• Created legal entities to serve as providers, SMOs, and CROs.
• Drafted and negotiated royalty agreements between manufacturers and physicians.
• Prepared policies and procedures for IRBs and providers administering clinical trials.
• Created medical director and consulting agreements between sponsors and physicians.

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Key Contact

Peter J. Enko

The Husch Blackwell attorneys were fierce and tireless advocates for Virtus. In the face of aggressive actions by our competitors and FDA regulators, they developed and executed a legal plan that protected an important market for us. They have my gratitude and highest recommendation.

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• Clinical Trials / Human Subjects Research

Clinical Trial Agreement (CTA) Provisions should be carefully reviewed and negotiated to insure the party’s interests are protected. The roles, responsibilities, and liabilities of each party must be delineated before any trial is undertaken. Intellectual property (IP) rights, including those related to the product, the delivery system, any improvements a well as data ownership and publication rights are key considerations. In addition to negotiating interests and risks and protecting IP, requirements for FDA and country-specific regulatory submissions and audits must be met. Whether you need help negotiating CTAs, CRO Service Agreements, Strategic Alliance Agreements, Material Transfer Agreements, clinical trial supply and distribution agreements, or coordinating development of clinical trial protocols, our approach is modeled on the best practices of major pharmaceutical companies. Frier Levitt assists different stakeholders in the clinical trial industry to make the contracting part of clinical trials a manageable and controllable process. We apply efficiencies and create solutions to improve timelines while maintaining quality of the contracts involved.

Contact Us Today

Clinical research implicates an overwhelming number of legal and ethical issues, including contract considerations, informed consent, patient privacy and HIPAA concerns, budgeting and billing compliance, and financial disclosures.

Frier Levitt understands the unique challenges facing physician-investigators, who often lack administrative support and whose primary focus is on substantive care for patients. The regulations governing human subject research are multifaceted and complex and the missteps can result in severe consequences.

Frier Levitt attorneys have an in depth knowledge of the rules and FDA regulations surrounding human subjects research and regularly counsel physicians and academic institutions on the controversial and complex legal issues intertwined with scientific development. We can help you or your institution navigate the broad range of topics that arise in the clinical trials setting and develop processes and procedures to ensure that your clinical trial, or your participation in a sponsored trial, is fully compliant with applicable laws and regulations.

Our multidisciplinary team of attorneys understands not only the rules and FDA regulations governing clinical research, but is also well versed in Federal and State anti-kickback and fraud and abuse laws that are often, and sometimes unknowingly, implicated in the clinical research setting. We assist clinical researchers with all facets of a clinical trial including:

• Negotiating and drafting clinical trial agreements and other contracts with study sponsors to ensure compliance with Federal and State law
• Assistance with budget development and establishing procedures to ensure billing compliance with Medicare and other third-party payor requirements
• Preparing Institutional Review Board (IRB) submissions
• Drafting Patient Informed Consent Forms and HIPAA Agreements
• Patient Recruitment
• Conflict of Interest Disclosures
• Data Integrity
• Intellectual Property
• Ensuring adherence to the principles of Good Clinical Practices (GCPs)

Contact Frier Levitt today for assistance with your clinical research needs.

Clinical Trials/Human Subjects Research insights

Defending the Inventory Shortfall: More Complex than First Appears On-Demand Webinar Replay September 17, 2021

Are You a Victim of Clinical Trial Fraud? If So, What Are Your Rights and Obligations? June 13, 2022

Clinical Trials/Human Subjects Research | Articles

Community Oncology Alliance (COA) 2024 Payer Exchange Summit September 9, 2024

Let us help you find solutions .

Subject Healthcare Law Pharmacy Law How did you hear about us? Webinar Article Referral Source LinkedIn Twitter Instagram Google Word of Mouth

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Area of focus

Clinical Trials

Our clinical trials team helps clients bring new drugs, biotechnology products, and medical devices to market. We provide specialized advice to companies big and small through their entire journey – from nascent proof-of- concept studies and process development to seeking regulatory approval and managing product life cycles. With a cross-disciplinary approach, a deep talent bench, and our knowledge of and contacts within U.S., European Union, and Asian government agencies, we ensure a comprehensive,...

Representative experience

Multiple clients on the impact of COVID-19 on clinical trials, such as patient travel to clinical sites and potential force majeure claims from clinical trial vendors.

Coordinate the defense of a manufacturer of implantable class III medical devices against alleged liability in clinical trials after a voluntary worldwide product withdrawal.

Conduct regulatory due diligence on an acquisition target that helps drug companies and contract research organizations recruit subjects for clinical trials.

A large academic medical center in planning and overseeing a privileged audit of its global clinical trial network to evaluate compliance with FDA’s Good Clinical Practice regulations.

Conduct research and practical advice to Amarin across 11 countries to address worldwide patient privacy and vital status concerns for its cardiovascular outcomes trial.

LabCorp on its US$1.2bn acquisition of Chiltern, a research organization focused on clinical services, and its US$371m purchase of Sequenom, a pioneer in noninvasive prenatal testing.

Biotech and pharma companies in evaluating and addressing significant data integrity and GCP compliance concerns raised in their clinical trials.

A leading European biotech company on the roll-out of a Phase III clinical trial throughout 21 countries.

Prepare and negotiate domestic and international clinical trial agreements and other sponsored research agreements.

Protect numerous pharma and biotechnology clients to prepare and negotiate domestic and international clinical trial agreements and other sponsored research agreements.

Horizons Guide

New French template agreement for clinical trials: more standardization, less simplification

21 August 2024

Two updates to the French national clinical trial template agreements (Convention Unique) were published on August 5, 2024. They update the previous templates to take into account evolving...

Breaking News for Breakthrough Devices: CMS Finalizes Transitional Coverage for Emerging Technologies Pathway

14 August 2024

On August 7, 2024, the Centers for Medicare & Medicaid Services (CMS) released a Final Notice for Transitional Coverage for Emerging Technologies (TCET) (Final Notice). The...

FDA promotes user fee waiver options for combination products

07 August 2024

The U.S. Food and Drug Administration (FDA) published a revision of its final guidance on “Application User Fees for Combination Products,” replacing guidance of the same name...

Insights and Analysis

Q2/2024 Life Science Law Update – Key developments for pharma & device companies in EU

29 July 2024

The Q2/24 Life Science and Health Care Law Update covers key trends in the EU and Big Five (France, Germany, Italy, Spain, UK) in life sciences regulatory, corporate, compliance,...

New SoHO Regulation published in the EU Official Journal

18 July 2024

Regulation (EU) 2024/1938 on standards of quality and safety for substances of human origin intended for human application (SoHO Regulation) was yesterday published in the Official Journal...

Safe harbor for voluntary corrections of drug or device “misinformation” clarified in FDA guidance

17 July 2024

The U.S. Food and Drug Administration (FDA) issued the revised draft guidance, “Addressing Misinformation About Medical Devices and Prescription Drugs,” which clarifies how...

Key contacts

Robert F. Church

Partner Los Angeles

Meredith Manning

Partner Washington, D.C.

Anishiya Abrol

Counsel Washington, D.C.

Elizabeth A. McGuire

Counsel Los Angeles

Dr. Tina Welter-Birk

Counsel Munich

• Lawyers by practice group

Useful Links

Related sectors, related practices, related areas of focus.

CLINICAL RESEARCH

A new drug or medical device must go through clinical trials before it can be publicly marketing. Federal guidelines and regulations are intended to protect human research subjects who participate in these clinical trials. Our legal team provides counsel to manufacturers and entrepreneurs in the start-up phase of a new drug or medical device to ensure compliance with informed consent and other clinical research legal rules.

Our legal advice can include:

• Advising on Data Privacy and Security Issues
• Coordinating Development of Clinical Trial Protocols
• Clinical Trial Agreements
• Confidentiality Agreements
• Joint Venture Agreements
• Material Transfer Agreement
• Research Consortia Agreements
• Sponsored Research Agreements
• Strategic Alliance Agreements
• Preparing Research Informed Consent Documents
• Providing Regulatory FDA Compliance Advice
• Reviewing Fraud and Abuse Issues in Research Programs

For more information about our Clinical Trials legal practice, contact our Legal Team.

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Biotechnology & Life Sciences Concierge Medical Practices Cosmetics Companies Dietary Supplement Companies Digital & Mobile Health Companies Emerging Healthcare Technologies Healthcare Facilities Medical Groups, Medical Centers Medical Management (MSOs) Medical Spas Nurses Telemedicine Ventures

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• How Mergers and Acquisitions Affect Employees
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Healthcare and Clinical Research

The healthcare industry is one of the more complex and important industries in the United States. Whether providing health care, paying for health care, developing information technology, researching and developing new medical drugs and devices through clinical research, or otherwise providing services or goods, entities in the healthcare sector are subject to complex regulatory and business risks at multiple levels. Companies in the healthcare industry require cost-effective and proactive approaches to ensure success in this competitive space. We provide clients with timely and practical counsel to not only help companies reach business objectives but also potentially avoid costly legal pitfalls. The team of attorneys at Kendall PC has a deep understanding of the industry sector, enabling us to work closely with clients to tackle tough issues and bridge the gap between industry challenges and desirable outcomes. 

Additionally, our clinical trials team helps bring new pharmaceutical, medical device, and biotechnology products to market. Clinical research is an essential component of the healthcare industry and, as such, is subject to an intricate web of regulatory requirements and ethical and efficacy concerns. Our leading research specialists advise companies of all sizes on complying with applicable regulatory requirements and industry best practices across the board, from clinical contracting and Good Clinical Practice (GCP) to Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliance and reimbursement advice. 

Contact Kendall PC today online or at (484) 414-4093 . We serve healthcare and clinical research companies of all sizes and stages of development throughout the United States and across the globe. 

When disputes arise, Kendall PC’s litigation team works to preserve our clients’ interests, assets, and reputations quickly and efficiently. Our multidisciplinary team provides comprehensive counsel in the most complex and high-stakes disputes, including: 

• Healthcare litigation
• Settlement discussions
• Anti-Kickback Statute litigation 
• Healthcare Fraud Statute litigation
• Responsible Corporate Officer Doctrine disputes
• US False Claims Act litigation
• Physician Self-Referral (Stark) Law litigation
• Consumer class action and other consumer-related litigation
• Development, production, sale, and distribution disputes 
• Breach of commercial contracts
• Licensing disputes

Mass Tort and Toxic Tort Defense 

The mass tort and toxic tort defense team of attorneys at Kendall PC is comprised of experienced litigators who have defended cases on every level. We have served as national coordinating counsel in state and federal courts throughout the country. Kendall PC has demonstrated past performance including successful exclusions of general causation experts via Daubert hearings and trials, defending petitions to create Multidistrict Litigation (MDL) in nationwide products liability actions, conducting expert discovery and mapping strategies to obtain important early substantive motion victories for our clients. 

Healthcare and Clinical Compliance 

The healthcare and clinical compliance team of attorneys at Kendall PC advises on a wide range of compliance topics to guide healthcare and clinical research companies through the evolving legal compliance requirements and governmental oversight employed by the U.S. Food and Drug Administration (FDA), U.S. Federal Trade Commission (FTC), U.S. Health and Human Services (HHS), and Department of Justice (DOJ). We provide compliance guidance and fraud and abuse counseling to the full range of healthcare and clinical providers and suppliers, including:

• Hospitals and health systems
• Academic medical centers
• Specialty, post-acute, and long-term care providers
• Behavioral health providers
• Health plans
• Contract research organizations (CROs)
• Medical societies
• Physician practices

We provide practical, efficient solutions rooted in sophisticated knowledge of each client’s individual business gleaned through deep immersion in the industry and decades of first-hand experience. Our team works with our clients to implement effective and cost-efficient compliance strategies tailored to protect our clients’ interests. 

Within these areas, our work typically encompasses: 

• Policy development and implementation 
• Compliance training
• Risk assessments, audits, and gap analysis 
• Day-to-day “help desk” compliance support
• Industry benchmarking 
• Due diligence and monitoring processes

Regulatory Counsel

Kendall PC’s regulatory practice has deep U.S. and global experience providing regulatory counseling and advice on all areas of healthcare and clinical research regulation. Healthcare remains one of the most highly regulated industries with rules governing relationships, revenue cycle, and organizational structure. Our regulatory team excels at providing advisory services to support the healthcare and clinical sectors. We bring experience to assist our clients in navigating the complex compliance and regulatory landscape. We provide specialized advice to healthcare systems, CROs, physician practices, and others to ensure that their operations are in compliance with the Physician Self-Referral (Stark) Law, Anti-Kickback Statute, False Claims Act, Civil Monetary Penalty, and GCP laws and regulations. Additionally, our cross-disciplinary team of attorneys supports clients in developing practical strategies throughout their entire journey, from nascent proof-of-concept studies and process development to clinical trial design to seeking regulatory approval to post-marketing. 

We have extensive experience providing assistance to clients on matters relating to: 

• Common Rule matters
• HIPAA and FTC data privacy matters
• US Food and Drug Administration (FDA) compliance matters
• Regulatory approval pathway strategies
• Clinical trial design 
• Good Clinical Practice (GCP) matters 
• FDA Advisory Committee matters and dispute resolution
• Government sales and contracting disputes
• Reimbursement strategies
• Availability market exclusivity assessments
• Promotional, reimbursement, marketing, distribution, and pricing strategies
• Labeling and advertising matters
• Manufacturing processes
• Recall, correction, removal, and supply chain Issues
• Comparative effectiveness research
• Export and import matters
• Product modifications 
• Quality system regulation issues
• Medicare, Medicaid, and other federal health care program coverage and reimbursement
• Sunshine compliance
• State distribution compliance matters
• State license registration matters 
• State price reporting matters 
• 483 Observations and Warning Letters

Government Investigations

Kendall PC handles investigations across a range of law enforcement agencies, including the U.S. attorney’s offices, the DOJ, and state attorneys general. We have extensive experience in defending biotechnology companies in government investigations into alleged violations under the Federal Food, Drug and Cosmetic Act, the Anti-Kickback Statute and state and federal False Claims Acts, among others. Our government investigations team handles complex multiagency government investigations, including managing parallel investigations by federal and state government entities and settlement and corporate integrity agreement (CIA) discussions and negotiations. 

Our government investigations team of attorneys counsel clients on the following government investigation matters: 

• Suspensions and debarments
• Anti-Kickback Statute 
• FDA Form 483 and Warning Letter Responses
• Foreign Corrupt Practices Act, UK Bribery Act, and other fraud and corruption matters investigations 
• False Claims Act investigations
• Deferred prosecution agreements 
• US federal and state government civil investigative demands and administrative subpoenas
• Corporate Integrity Agreement (CIA) negotiations
• Billing and coding practices
• Biologics price reporting practices, including discounting and rebate practices 
• Medicare, Medicaid, and other US healthcare program matters

Internal Investigations 

The seasoned internal investigations attorneys at Kendall PC have wide-ranging experience in conducting internal investigations for an array of publicly traded and private organizations and entities. Our internal investigations team possesses cross-disciplinary regulatory, corporate, commercial compliance, and litigation know-how to assist clients with these sensitive and highly complex matters. We work with our clients to assess potential exposure, reduce costs and damages, and resolve issues expediently to bring the investigation to an acceptable end. Our attorneys also guide entities post-investigation to successfully maintain reputation and goodwill and retain business.

Our internal investigations team has experience in investigations concerning: 

• Audit committee inquiries into illegal or improper conduct
• Corporate governance, risk management practices, and compliance programs
• Diligence in connection with M&A transactions
• Export compliance
• The False Claims Act, qui tam actions, and government contract billing
• The Foreign Corrupt Practices Act
• Restatements
• Section 10A
• Shareholder and other derivative demands
• Special litigation committees
• Whistleblower and other investigations under Sarbanes-Oxley
• Healthcare fraud 
• FDA violations

Commercial Contracting 

Kendall PC’s commercial contracting practice combines legal knowledge with deep sector experience to cover the full spectrum of commercial and business law issues companies must address on a daily basis with a myriad of relationships and contracts that bind them to their suppliers, customers, licensors, distributors, and other strategic partners. These complexities are intensified by the regulatory obligations that impact every facet of operations within the healthcare and clinical sectors. 

We provide support to business entities in their commercial contracting needs, including: 

• Provider and managed care contracts and exclusive contracts
• Real estate transactions
• Clinical trial agreements
• License agreements
• Arrangements of sale between exempt and for-profit organizations 
• Clinical research collaboration agreements with government bodies, industry partners, and academic institutions 
• Manufacturing and supply
• Master service agreements
• Software as a service (SaaS) 
• Product development
• Sales and distribution
• Logistics and Warehousing
• Intellectual Property Agreements 
• Logistics and warehousing

Data Protection and Privacy

Data protection and privacy requirements have become central to the success of healthcare and clinical research sectors. Kendall PC lawyers advise clients across virtually all healthcare sectors on privacy and security compliance matters. The data protection and privacy team at Kendall PC focuses on the evolving business technological and legal issues relating to the security and privacy of networks and data. We counsel on the development of privacy and data security policies and procedures, structuring healthcare information technology ventures, and training employees on the disclosure of information and ongoing compliance monitoring. We represent healthcare and clinical research clients in counseling, transactions, investigations, government relations, and responses to data breach and security incidents. Additionally, we provide clients with acute analysis of and timely guidance on rapidly developing federal rules and regulations, congressional legislation, and other federal policies issued by healthcare oversight agencies critical to their healthcare and clinical research business objectives. 

Our team has extensive experience in data protection and privacy matters including the application of: 

• EU General Data Protection Regulation (GDPR)
• California Consumer Privacy Act (CCPA) / California Privacy Rights Act (CRPA)
• Health Insurance Portability and Accountability Act (HIPAA)
• Health Information Technology for Economic and Clinical Health (HITECH) Act
• Federal Trade Commission (FTC) Act
• Children’s Online Privacy Protection Act (COPPAA)
• CAN-SPAM Act 
• US state security breach notification law compliance
• Medical privacy law matters
• Information disclosure and compliance training 

Business Startup, Formation, and Corporate Governance

Starting or expanding a business is a complicated endeavor that must be done correctly to ensure future growth. This complexity is exacerbated by the introduction of the regulatory requirements in the healthcare and clinical research industry. Our team reviews your healthcare startup or expansion with both industry trends and your business goals in mind.

The team of attorneys at Kendall PC represents all sectors of the healthcare and clinical research industry in their business startup, formation, and corporate governance needs, including: 

• Corporate formation and structure, addressing complexities resulting from state-specific statutes and the conflict between federal and state law 
• Public companies and filings with Securities and Exchange Commission (SEC) and other agencies
• Capital formation activities
• Mergers and acquisitions 
• Affiliation structure, legal due diligence, and state and federal approval processes 
• Joint venture and strategic alliances, including those involving for-profit and nonprofit entities
• Physician alignment strategies 
• Partnership and operating agreements

Contact Kendall PC Today

To learn more about how our team of healthcare and clinical research attorneys can help your company, contact Kendall PC today online or at (484) 414-4093 . We serve companies of all sizes throughout the United States and across the globe.

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News & Articles

Stay connected and informed on the issues that matter most to your business. Our News & Articles section covers numerous legal topics related to commercialization, litigation, compliance, privacy, and more. Our News & Articles are provided by Kendall PC for educational and informational purposes only and are not intended and should not be construed as legal advice. Our News & Articles are considered advertising under applicable state laws.

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Wiggin and Dana LLP — Attorneys At Law

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Clinical Research

Our clients range from startups needing clinical research transactional and regulatory advice, to established biotechnology, pharmaceutical and medical device companies needing a broad range of ongoing legal support. We counsel our clients on the complex array of legal issues affecting clinical research activities. We understand the dynamics of relationships involving governmental agencies, industry sponsors, medical and academic collaborators, principal investigators, and institutional review boards (IRBs).

The clinical research contracting process can be daunting. Our team of attorneys routinely counsel clients regarding, and assist in negotiating, various agreements including service agreements with contract research organizations, clinical trial agreements with institutions and investigators, and a broad spectrum of other clinical research agreements including sponsored research, investigator-initiated research, and federal collaborative research.

The numerous US laws and regulations aimed at curbing health care fraud are intended partly to ensure the integrity of research projects, research data, the health and safety of research subjects, and the proper use of federal grants. Research compliance has therefore become a priority for organizations sponsoring or conducting research or providing services to research participants. When issues arise, we represent clients in litigation and government investigations involving clinical-research issues, and we advise clients in conducting internal investigations and voluntary disclosures concerning research matters.

Our clinical research legal services include:

• Informed consent
• Conflicts of interest
• Fraud and abuse
• Research Agreements, including clinical trial, sponsored research, and investigator-initiated research
• Research misconduct
• Billing and reimbursement
• Government investigations
• Privacy, including HIPAA and other applicable state and federal laws, and the EU’s General Data Privacy Regulation (GDPR)

Wiggin and Dana Attorneys Named to The Best Lawyers in America® 2025

2024 new england legal awards recognizes wiggin and dana litigation department and multiple attorneys, chambers high net worth 2024 honors wiggin and dana lawyers and private client services practice, wiggin and dana continues south florida growth with addition of restructuring partner tamara van heel, the legal 500 u.s. 2024 guide names wiggin and dana a top u.s. law firm in appellate, m&a, venture capital and emerging companies and outsourcing, chambers usa 2024 recognizes 24 wiggin and dana lawyers and 11 practices in the usa-nationwide and connecticut editions, privacy overview.

Clinical Research

• Insights & Events

Regulatory laws that govern clinical research, which is one of the most-regulated areas of the healthcare industry. Our lawyers represent hospitals, physicians, and other healthcare providers and advise institutional review boards to provide straightforward, clear guidance that enables them to navigate these complex laws to achieve their objectives without violating legal or ethical standards.

With our regulatory work, our attorneys provide experienced counsel that is sensitive to the unique human and legal concerns related to clinical research. We have a long track record of using our approach with clients to ensure adherence to all applicable federal and state laws, including regulations on human subject protection, FDA and OHRP requirements, HIPAA, and other patient privacy issues.

We understand that the business side of clinical research is just as essential as the investigations themselves. Our attorneys excel at assisting clients in drafting and negotiating research agreements with study sponsors and providing advice on the coverage and billing of study services.

Bradley also partners with institutional review boards to provide guidance on adherence to “Common Rule” human subject protection requirements, review protocols, and informed consent documents; attend IRB meetings; draft policies designed to comply with regulatory requirements; advise on FDA and OHRP requirements; counsel on HIPAA issues related to research; and fulfill other obligations under federal law.

It all starts with an idea. The potential to change the future of health.  We craft and negotiate your clinical trial contracts from start to finish. We also facilitate your life cycle changes along the way. 

We know the clinical trials space inside out. From refreshing your in-house form or drafting new templates to fully managing and negotiating directly with or on behalf of sites , we make your contracting process quicker and easier.

Risk counseling on a daily basis. Examine and draft indemnification, subject injury, limitation of liability, insurance and cybersecurity to each client’s unique circumstances.

Deep experience with clinical trials contracting vendors. Draft, evaluate and negotiate CRO, EDC, cloud host, core lab and CEC services agreements to name a few.

Evaluate and negotiate HIPAA compliance terms, HIPAA authorizations and Business Associate Agreements.  Perform data mapping for vendor relationships and tailor contracts accordingly.

Review, draft and counsel on informed consent. Target subject injury, costs, data rights, CTA and budget consistency, and risk mitigation .

Counsel sponsors on individual consulting agreements. Prepare and negotiate national principal investigator, medical monitor, regulatory consultant and study monitor agreements.

Guide sponsors on oversight committees and IRBs relationships. Draft and negotiate committee membership and IRB indemnification agreements, and review charters.

Counsel on data rights, publication, intellectual property, indemnification, budgets and more. Prepare and negotiate IITs.

Structure payments from manufacturers to healthcare providers to help reduce Anti-Kickback Statute and False Claims Act risk. Navigate compliance with fraud & abuse, and financial disclosure.

Draft and negotiate sponsored research, material transfer and pre-clinical testing agreements. Counsel on protection of business assets.

Navigate confidentiality obligations in relation to HIPAA, data protection and cybersecurity issues. Draft, review and negotiate confidentiality agreements.

Advise on publication issues including CTAs, publications committees, independence & bias, clinicaltrials.gov, ICMJE and data sharing.

Assess and advise on remote study monitoring (rSDV) agreements, end user license and other technology agreements. Coordinate with risk mitigation terms of CTA.

THERAPEUTIC AREAS

We work with companies and institutions that are determined to solve a variety of life-threatening and impairing conditions. here is some of our our experience :, negotiations experience.

Our industry and site clients alike value our extensive experience negotiating with research institutions.  

We regularly draft, negotiate and finalize clinical research contracts, Business Associate Agreements and more.  

How can we help streamline your contract negotiations?

our integrated approach

We feel that the best way to serve you is to provide a cohesive, interdisciplinary approach to clinical research. Knowledge of contract law is not enough. We infuse your contracts with clinical research contracting norms, regulatory compliance, technology law, data protection and practical business considerations.

Let’s talk about contracts to operationalize your clinical research.

We handle all aspects of the contracting process so that you can launch your investigations.

Clinical Trials

We counsel clients on a wide array of complex issues relating to clinical trials. In particular, Sidley lawyers regularly advise clients on both the FDA regulatory and healthcare issues presented by clinical investigations of new drugs and medical devices (including biological products regulated as drugs and medical devices). One of the distinguishing factors of our clinical trials practice is the extent to which our healthcare lawyers and our FDA lawyers coordinate with each other.

Sidley Updates Clinical Trial Enrollment: OIG Approves Another Patient Cost-Sharing Proposal Designed to Increase Socioeconomic Diversity March 29, 2022 Global Life Sciences Update

We routinely advise on such essential FDA regulatory matters as whether an investigational new drug exemption (IND) or investigational device exemption (IDE) is required and how the FDA’s commercialization rules apply to standard-of-care products used in trials. We are also called upon to evaluate and advise on high-stakes matters presented in the context of FDA inspections of clinical investigations at academic medical centers and special considerations presented by investigations of novel technologies such as pancreatic islet cells.

In the healthcare context, clinical investigations raise challenging questions related to reimbursement. We routinely address concerns associated with whether products that have passed clinical muster will win formulary approval based on trial results and outcomes. We are also very experienced in compliance requirements and with federal and state statutes governing fraud and abuse in this area. Moreover, as evidenced by the relatively recent proliferation of clinical trial disclosure requirements at the state and federal levels, an increasing number of government entities are becoming involved in establishing regulatory expectations for drug and medical device companies engaged in clinical research. We work to ensure that the myriad regulatory issues presented by the investigational administration of new medical technologies are thoroughly and efficiently addressed.

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Clinical Research

We are passionate about ensuring access to ethical clinical trials for all patients because we truly believe that this is what leads to cures for cancer, heart disease and other rare medical diseases. To improve patient care, it is essential for us to provide legal guidance to healthcare organizations and people who are leading the charge on clinical trials during a time when the United States healthcare system is undergoing rapid and vast change.

Our Services:

President Tara Cowell’s expertise in clinical research for enterprises spans the last 20 years. She was a member and chair for over 10 Institutional Review Boards (IRB), including Children’s  IRBs.

In this capacity, she was dedicated to ensuring the protection of human subjects’ research participants, reviewed proposed studies, and raised questions and concerns to improve research studies for the protection of patients. Some of these studies resulted in treatments and cures for diseases.

• Guidance on waivers and exemption requirements
• HIPAA and Privacy guidance for research
• Policy drafting for IRBs

Cowell has reviewed research agreements for all medical specialties, ensuring that they protect the hospitals and investigators participating in the trials, as well as the research subjects. Our services include:

• Review Non-Disclosure Agreement process and template (including issues around non-employed physicians)
• Review Clinical Trial agreements (CTA)
• Prepare CTA templates
• Prepare Master Agreements between the parties for hospitals using the same sponsor for multiple trials
• Develop compliant, yet simple arrangements to allow payments to sub-investigators who are not employed while avoiding Stark and other legal risks
• Draft and review agreements for non-research services that are paid for by clinical trial sponsors

Ensuring the safety of clinical research patients is the highest priority, and having in place appropriate policies and training for providers is critical. In this area, our services include:

• Guidance and policies on humanitarian use devices
• Guidance on emergency exceptions
• Special requirements for vulnerable populations including children
• Advice for Investigational Device Exemptions (IDE)
• Advice for Investigational New Drug Applications (IND)

Animal research is an important component to help provide cures for patients in the future. Our services include:

• Draft and review animal research policies
• Provide guidance on animal research questions

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Medical Research/Clinical Trials and Risk Management

The attorneys in Baker Donelson's Health Law Department have experience representing institutions and investigators in every major stage of the clinical research process.

Why Baker Donelson?

Practice overview.

Navigating the intricate landscape of clinical research requires experience in a myriad of legal and regulatory domains. From managing complex contracts to understanding global regulations, bringing innovative products to market demands seasoned guidance. Baker Donelson offers tailored support to pharmaceutical and life science entities, institutions, CROs, and SMOs. Our focus on compliance, coupled with our experience in navigating diverse regulatory frameworks, ensures seamless progress through each stage of the clinical trial journey.

Our seasoned health care team at Baker Donelson excels in managing the legal intricacies of clinical research for a diverse clientele, spanning startups to industry leaders. With extensive experience representing institutions and investigators across all major stages of clinical research, including Phase I safety evaluations to Phase IV post-marketing studies, our clients range from medical device and pharmaceutical companies to Principal Investigators (PIs), Clinical Research Organizations (CROs), Site Management Organizations (SMOs), Institutional Review Boards (IRBs), and service providers. We streamline contracting processes, negotiating agreements with stakeholders like clinical research sites, laboratories, sponsors, CROs, and vendors. We also advise on U.S. Food and Drug Administration (FDA) and U.S. Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) compliance requirements and provide comprehensive support for establishing and managing clinical trial programs.

With a pragmatic approach, we ensure trials stay on schedule from a legal and compliance perspective while safeguarding our clients against future liabilities. Offering advice on risk management and compliance to both in house departments and executives, we address areas such as insurance, indemnification, confidentiality, data privacy, and intellectual property.

Our Health Law Department comprises leaders who have built a multidisciplinary team with wide-ranging experience in law and business. We stay abreast of legal developments such as the Sunshine Act and business trends shaping the clinical research landscape, ensuring our clients remain competitive and compliant in an ever-evolving environment. Our experience spans a breadth of critical areas:

• Negotiating complex arrangements among biopharmaceutical companies, research sites, CROs, and vendors;
• Crafting and reviewing agreements, including master service agreements, clinical trial agreements, and informed consent forms;
• Partnering with pharmaceutical and life science companies across various research stages;
• Accelerating clinical site engagement and study subject enrollment in collaboration with in-house legal departments;
• Developing template agreements and playbooks for efficient negotiation of clinical trial agreements;
• Assuming legal functions for pharmaceutical companies and facilitating site enrollment processes;
• Navigating global privacy laws, including GDPR, for data transfer in marketing applications; and
• Assisting with negotiation and revision of indemnification obligations amidst geopolitical conflicts.

Baker Donelson is dedicated to supporting our clients through every phase of their clinical research endeavors. We are your trusted partner in achieving your clinical research objectives while mitigating risks and maximizing opportunities for success.

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• Insights | Clinical Trial Attorney

The Vital Role of A Clinical Trial Attorney In Pharmaceutical Research

• July 23, 2023

The development of new drugs and treatments is a complex and lengthy process that involves many different stakeholders. One of the most important players in this process is the clinical trial attorney . Clinical trial attorneys play a vital role in ensuring that clinical trials are conducted in a compliant and ethical manner, and that the rights of participants are protected.

Lovell Law Group’s Clinical Trial Legal Services

Lovell Law Group is a boutique law firm that specializes in clinical trial law. We have a team of experienced attorneys who are dedicated to providing our clients with the legal guidance they need to conduct successful and compliant clinical trials. Our services include:

• Navigating complex regulatory frameworks
• Mitigating legal risks and liability
• Drafting and reviewing trial protocols
• Informed consent and participant protection
• Data privacy and intellectual property protection
• Resolving legal challenges and disputes

The Crucial Contributions of Clinical Trial Attorneys

Clinical trial attorneys make a number of crucial contributions to the pharmaceutical research process. These include:

• Navigating Complex Regulatory Frameworks

The conduct of clinical trials is subject to a complex web of federal and state regulations. These regulations are designed to protect the safety and rights of clinical trial participants, as well as to ensure the integrity of the data generated by clinical trials. Clinical trial attorneys have the expertise to help clients understand and comply with these regulations.

Clinical trial attorneys must also be aware of the specific regulations that apply to the type of clinical trial being conducted. For example, there are different regulations for clinical trials involving drugs, biologics, and medical devices.

• Mitigating Legal Risks and Liability

Clinical trials involve a number of potential legal risks, such as liability for participant injuries. Clinical trial attorneys can help clients mitigate these risks by:

• Drafting and reviewing trial protocols that are compliant with all applicable regulations
• Obtaining informed consent from participants in a way that complies with all applicable regulations
• Ensuring that data is collected and stored in a secure manner
• Developing contingency plans in case of unexpected events

Clinical trial attorneys can also help clients defend against legal challenges that arise from clinical trials. For example, if a participant is injured in a clinical trial, the attorney may be able to defend the client against a lawsuit by arguing that the trial was conducted in a compliant and ethical manner.

• Contract Negotiations And Agreements

Clinical trials often involve complex contractual arrangements between sponsors, investigators, and other parties. Clinical trial attorneys have the expertise to negotiate and draft these agreements in a way that protects the interests of all parties involved.

Some of the key contractual agreements that clinical trial attorneys may be involved in include:

• The clinical trial agreement between the sponsor and the investigator
• The data sharing agreement between the sponsor and the investigator
• The intellectual property agreement between the sponsor and the investigator

Clinical trial attorneys can help clients negotiate these agreements in a way that ensures that all parties are aware of their rights and obligations. They can also help clients resolve any disputes that arise during the course of a clinical trial.

Key Responsibilities of Clinical Trial Attorneys

In addition to the contributions listed above, clinical trial attorneys also have a number of key responsibilities. These include:

• Drafting and reviewing trial protocols. Trial protocols are the documents that set out the details of a clinical trial. Clinical trial attorneys must ensure that these protocols are compliant with all applicable regulations and that they protect the rights of participants.
• Informed consent and participant protection. Clinical trial participants must be given informed consent before they can participate in a clinical trial. This means that they must be given a clear and complete explanation of the risks and benefits of the trial. Clinical trial attorneys must ensure that informed consent is obtained in a way that is compliant with all applicable regulations.
• Data privacy and intellectual property protection. Clinical trial data is often confidential and may be protected by intellectual property laws. Clinical trial attorneys must ensure that this data is protected from unauthorized disclosure.
• Resolving legal challenges and disputes. Clinical trials can sometimes give rise to legal challenges and disputes. Clinical trial attorneys must be able to resolve these challenges and disputes in a way that protects the interests of their clients.

Selecting The Right Clinical Trial Attorney

Selecting the right clinical trial attorney is an important decision, as this person will be responsible for representing your interests in a complex and legally challenging environment. Here are three key factors to consider when making your selection:

A. Evaluating Relevant Experience and Expertise

The first step is to make sure that the attorney has the necessary experience and expertise in the field of clinical trials. This includes a deep understanding of the regulatory landscape, as well as the specific legal issues that arise in clinical trials. You should also ask about the attorney’s experience with the type of clinical trial you are involved in, as well as their experience with the specific drug or device being studied.

B. Client Testimonials and Success Stories

Another way to assess an attorney’s experience and expertise is to read client testimonials and success stories. This can give you a sense of how the attorney has handled other cases, as well as the level of service they provide to their clients.

C. Effective Communication and Collaboration

In addition to experience and expertise, it is also important to choose an attorney who is effective at communicating and collaborating. This is especially important in the context of clinical trials, as there are often many different parties involved in the process. You want to make sure that the attorney you choose is able to clearly communicate with you, as well as with other stakeholders, such as the sponsor, the principal investigator, and the IRB.

Clinical trial attorneys play a vital role in the pharmaceutical research process. They help to ensure that clinical trials are conducted in a compliant and ethical manner, and that the rights of participants are protected. If you are involved in the development of new drugs or treatments, it is important to consult with a clinical trial attorney to ensure that your trials are conducted in a legally sound manner.

If you are looking for a clinical trial attorney, please contact Lovell Law Group. We have a team of experienced attorneys who are dedicated to providing our clients with the legal guidance they need to conduct successful and compliant clinical trials. We would be happy to discuss your specific needs and answer any questions you may have.

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Our attorneys from across the Firm represent pharmaceutical and medical device manufacturers, clinical research organizations (“CROs”) and other life sciences companies. These companies range in size from small start-ups to publicly traded multinational corporations, and include manufacturers of brand name and generic drugs, as well as those developing new chemical entities (“NCEs”).

McElroy Deutsch has assisted companies in all phases of their clinical studies, including discovery, preclinical, toxicology and Phases I, II, and III.  Our pharmaceutical lawyers also have counseled clients on the regulatory and liability aspects of clinical pharmacology units (“CPUs”), including issues of state licensure, retention of physician investigators, procedures and requirements of sponsors governing the use of investigational new drugs, development and review of investigative review board (“IRB”) protocols, as well as issues of privacy, confidentiality and informed consent in connection with the use of human subjects.

Our law firm’s representation of CROs has been national in scope and includes litigation and consultation concerning actions arising from alleged breach of study agreement, breach of protocols, standard operating procedures and industry practices, as well as other study-related FDA issues. Our lawyers also have provided representation on issues arising from improper billing practices, antitrust allegations, wholesale pricing of drugs and workplace discrimination.

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Our pharmaceutical lawyers have conducted seminars for and offered counseling to pharmaceutical companies relating to drug liability trends in the United States, the prevention and detection of Medicare fraud and abuse issues, compliance with the federal anti-kickback statute and false claims act, sales and marketing guidelines promulgated by the Office of Inspector General, and internal safeguards for pharmaceutical billing/pricing practices. Our law firm also has assisted our pharmaceutical and life sciences clients with issues involving the Medicare Part D prescription drug coverage program, the Medicaid drug rebate program, and the 340B drug pricing program, as well as the review, development and implementation of corporate compliance programs, and environmental, health and safety policies and guidance for their manufacturing plants.

In addition, our pharmaceutical attorneys serve as both lead counsel and approved outside counsel for companies such as Abbott Laboratories, Bayer Corporation, Knoll Pharmaceutical Company, and Sanofi-Sythelabo in litigation involving claims of personal injury and wrongful death due to alleged defective pharmaceutical products. Our lawyers have also served as lead counsel in the Baycol and Phenylpropanolamine certified mass-tort litigations in New Jersey and have defended Aventis Pharmaceuticals in contaminated polio vaccine (SV40 virus) cases.

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Adapting clinical research during the covid-19 pandemic.

By Ryan M. Ivey

Introduction

Many sectors of the economy have ground to a halt in the effort to curtail the COVID-19 pandemic (the “Pandemic”), and the clinical research industry is not immune to the effects of these business shutdowns. While the Pandemic has suspended more than 440 clinical trials, affecting as many as 200,000 people, 1 many clinical trial sponsors, investigators and institutional review boards ("IRBs") are left with tough questions and decisions regarding the continuity or adaptation of the investigations they are funding and/or overseeing. As citizens move through the most restrictive phase of stay-at-home orders towards “safer at home” guidelines and “soft re-openings” of businesses and cities, the long-term effects of the Pandemic on clinical trials are not yet fully understood.

Acknowledging this reality, the Food and Drug Administration (“FDA”) released a guidance document entitled, “ FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency ” (the “Guidance”) for the clinical research industry, investigators, and IRBs, and continues to provide regular updates. The Guidance aims to assist sponsors in making decisions that assure the safety of trial participants, maintain compliance with good clinical practice (“GCP”), and minimize risks to trial integrity during the Pandemic. While the Guidance contains non-binding recommendations only, it presents considerations for sponsors, investigators, and IRBs in deciding whether and how to move clinical trials forward, including amending protocols to permit remote or decentralized conduct, and creating or amending existing policies to address social distancing guidelines and state and local stay-at-home orders. Many in the industry are seeking to implement sustainable alternatives to in-person visits and administration of clinical protocols. As of the date of this writing, the Guidance was most recently updated on Thursday, April 16, 2020, to answer new frequently asked questions (“FAQs”) from sponsors and investigators, discussed below.

The Guidance contains many insightful questions and potentially helpful recommendations. While a full read-through is encouraged to help understand if any such recommendations apply to a particular scenario, a sampling of relevant FAQs presented to FDA, and its resulting recommendations, are summarized below:

What key factors should sponsors consider when deciding whether to continue administering or using an investigational product that appears to be providing benefit to the trial participant during the COVID-19 public health emergency?

Per the Guidance, a sponsor deciding whether to continue administering or using such a product during the Pandemic should carefully consider whether a trial participant appears to be benefitting from treatment with the investigational product, whether there are reasonable alternative treatments, the seriousness of the disease or condition being treated, and the risks involved in switching to an alternative treatment (if necessary). If there are individual trial participants for whom discontinuing the investigational product might present a substantial risk, then the sponsor should consider amending the protocol (after discussion with the relevant review division) to limit investigational product use to those trial participants with apparent benefit and discontinue investigational product use to other participants. In all cases, if a trial participant is discontinued from an investigational therapy, it is important that there be appropriate management of the trial participant after discontinuation.

Can a sponsor initiate virtual clinical trial visits for monitoring patients without contacting FDA if there is an assessment by the sponsor and investigator that these visits are necessary for the safety of the trial participant and it will not impact data integrity?

Per the Guidance, FDA regulations allow for changes to be made to the investigational plan or protocol without prior FDA review or approval, if the change is intended to eliminate an apparent immediate hazard or to protect the life and well-being of trial participants. 2 Therefore, changes in the investigational plan or protocol conduct necessary to immediately assure trial participant and clinical investigator safety, such as conducting telephone or video contact visits for safety monitoring rather than on-site visits, can be immediately implemented with subsequent review by the IRB and notification to FDA. Since this reflects a protocol deviation (until the amendment is approved), documentation of the required deviations, as described above, would generally be acceptable (i.e., a document that lists each deviation, study reference ID, patient ID, and date). For example, documenting that all protocol-specified visits will be done by telephone contact rather than on-site visits, and that procedures requiring in-person visits will either not be conducted, or performed by other means (specified, as appropriate). Since the change to telephone or video contact visits would likely result in some protocol-required procedures not being conducted, the sponsor must evaluate the potential impact on trial participant safety and consider how to mitigate risks to trial participants and clinical investigators, including the need to discontinue the investigational product.

How do I obtain informed consent from a patient unable to travel to a clinical trial site where electronic informed consent is not an option?

Per the Guidance, when investigators do not have electronic informed consent capabilities, methods of obtaining informed consent other than a face-to-face consent interview may still be acceptable if those methods allow for an adequate exchange of information and documentation, and a method to ensure that the signer of the consent form is the person who plans to enroll as a subject in the clinical investigation or is the legally authorized representative of the subject. For example, the consent form may be sent to the trial participant or the trial participant’s legally authorized representative by facsimile or e-mail, and the consent interview may then be conducted by telephone when the trial participant or trial participant’s legally authorized representative can read the consent form during the discussion. Alternatively, the trial participant may bring the signed and dated consent form to his/her next visit to the clinical site, if restrictions on traveling to the clinical trial site are alleviated, or mail it to the clinical investigator.

I am a study monitor and am unable to conduct on-site monitoring visits due to the COVID-19 public health emergency. May I remotely perform the site monitoring visit? What recommendations does FDA have for how I can remotely perform source document review?

Per the Guidance, FDA regulations do not prescribe how sponsors must conduct clinical monitoring 3 and are therefore compatible with a range of approaches to monitoring that may vary depending on multiple factors. Therefore, certain aspects of site monitoring visits may be done remotely if technically feasible. FDA understands that there may be deviations from the timing of on-site monitoring visits set forth in the trial monitoring plan and procedures, and that sponsors may consider ways to replace on-site monitoring visits with remote monitoring visits during the Pandemic. Further, there may be components of an on-site monitoring visit, as outlined in the trial monitoring plan, that cannot be completed remotely. The sponsor should therefore consider using a risk-based approach to prioritize sites for remote monitoring, including as many study sites as feasible (and with a frequency as close to that described in the site monitoring plan as feasible).

The decision regarding which sites to prioritize for remote monitoring should be guided by centralized monitoring or other information available about site performance (e.g., frequency and severity of protocol deviations previously identified during monitoring visits or currently identified by centralized monitoring, number of randomized active trial participants, experience of site staff, known history of prior major audit or inspection findings). During remote monitoring, the study monitor should focus on trial activities that are essential to the safety of trial participants, clinical investigators and data reliability. Remote monitoring activities, including remote review of source documents, should be documented in the same level of detail as on-site monitoring activities, and any resulting actions to address issues identified from the remote source document review should be consistent with procedures and processes described in the study monitoring plan. 4

Notwithstanding these challenging and uncertain times, clinical research stakeholders are collaborating and innovating to try to ensure new or improved therapeutics continue to be developed in areas of unmet need. In response, FDA is attempting to provide timely recommendations to sponsors, investigators and IRBs for the adaptation of clinical trials during the Pandemic on a regular basis. Ultimately, FDA remains interested in securing and maintaining (1) the safety of trial participants, and (2) the clinical and statistical integrity of the trial.

Not surprisingly, many of the recommendations are highly fact-specific and dependent upon the nature and context of a particular clinical trial. Accordingly, sponsors, investigators and IRBs that are facing these types of decisions regarding whether and how to continue or adapt a clinical trial should consider reading the Guidance fully and consulting with the overseeing IRB and/or FDA, or other clinical, regulatory, and legal advisors, as appropriate. We will continue to monitor FDA guidance as it becomes available, so please check back for future updates on this topic.

https://www.npr.org/sections/health-shots/2020/04/11/832210606/coronovirus-pandemic-brings-hundreds-of-u-s-clinical-trials-to-a-halt

See 21 CFR 56.108(a)(4), 312.30(b)(2)(ii), and 812.35(a)(2).

See 21 CFR 312.50, 312.53(d), 312.56(a), 812.40, 812.43(d), and 812.46.

“FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency,” at 19-20.

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Business Associates and Clinical Research: Resolving a HIPAA Compliance Conundrum

By Kimberly J. Kannensohn and Paige Dowdakin

While health care providers, academic medical centers, and research institutions well understand the fundamentals of the Health Insurance Portability and Accountability Act (“HIPAA”) and its implementing regulations, these organizations often lack the resources and time to focus on the more complex and counterintuitive aspects of the law. This is particularly true in the area of clinical research. Although much has been written about the institutional review board (“IRB”) approval process and issues surrounding the requirement to obtain HIPAA-compliant authorizations from research subjects, the literature regarding the application of HIPAA to other components of clinical research is much less robust.

The goal of this article is to define, from a HIPAA perspective, the role of organizations that use patient information to perform functions supportive of research, including clinical functions and data management activities. More specifically, we will examine when such entities qualify as business associates under HIPAA and when their functions fall outside the bounds of the law.

I. HIPAA defines the circumstances in which a covered entity and a business associate must enter into a business associate agreement.

Individuals, organizations, and agencies that qualify as “covered entities” under HIPAA must protect the privacy and security of health information and must provide individuals with certain rights with respect to their health information ( see 45 C.F.R. §164.500). Under HIPAA, a covered entity is a health plan, a health care clearinghouse, or a health care provider who transmits health information in electronic form in connection with a transaction covered by HIPAA (see 45 C.F.R. §160.103). A business associate is an individual or entity, other than a member of a covered entity’s workforce, who creates, receives, maintains, or transmits protected health information (“PHI”) in order to perform “covered functions” on behalf of a covered entity. Id. In order for a business associate to provide services to a covered entity, the covered entity and the business associate must enter into (i) a written services agreement that describes the duties and responsibilities of both parties to the arrangement; and (ii) a “business associate agreement” or addendum that requires the business associate to safeguard PHI and to comply with the privacy and security provisions of HIPAA (the “HIPAA Rules”) as applicable to business associates ( see 45 C.F.R. §§164.502(e); 164.504(e)).

A. Under the HIPAA Privacy Rule, a business associate agreement is only required in connection with the performance of a covered function or certain defined activities on behalf of a covered entity, excluding research.

Under the HIPAA Privacy Rule, a business associate agreement is only required where a person or entity (i) creates, receives, maintains, or transmits PHI in order to conduct a “covered function” on behalf of a covered entity; or (ii) performs one of the services listed in the definition of business associate ( see 45 C.F.R. §164.103). Covered functions are defined as ‘‘those functions of a covered entity the performance of which makes the entity a health plan, health care provider, or health care clearinghouse.” Id. In other words, covered functions are activities integral to the identity of the entity. The Office for Civil Rights of the Department of Health and Human Services (“OCR”) has identified payment and health care operations as examples of activities that are integral to an entity’s identity as a health care provider, health plan or health care clearinghouse ( see OCR Frequently Asked Question No. 239 (Dec. 19, 2002)).

In contrast, research is not a function that renders an entity a health care provider, health plan or health care clearinghouse. Instead, research is an additional activity, outside of the integral functions of a covered entity, in which a covered entity may elect to engage. Research is defined by the Privacy Rule as a “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge” ( see 45 C.F.R. §164.501). An entity need not engage in such systematic investigation to qualify as a health plan, health care provider or health care clearinghouse and, in fact, most health care providers, health plans, and health care clearinghouses do not perform research. Thus, research does not qualify as a covered function under HIPAA, and, thus, its performance by a third party on behalf of a covered entity does not render the third party a business associate of the covered entity under HIPAA.

In addition, research is not listed as one of the services performed by business associates in the definition of “business associate” under the HIPAA Privacy Rule. These services include claims processing or administration; data analysis, processing, or administration; utilization review; quality assurance; patient safety activities; billing; benefit management; practice management; repricing; legal; actuarial; accounting; consulting; data aggregation; management accreditation; or financial services ( see 45 C.F.R. §160.103). Research is notably absent from this list of business associate activities. Accordingly, under the language of the Privacy Rule, an entity that receives patient information pursuant to a permissible disclosure from a covered entity in order to perform research or assist a covered entity with the performance of research is not engaged in an activity recognized by the Privacy Rule as a business associate service. Such an entity is therefore not a business associate under HIPAA and need not enter into a business associate agreement with a covered entity in order to receive PHI from the covered entity and perform the agreed upon work.

B. The OCR has repeatedly indicated that disclosures of PHI for the purpose of research do not create a business associate relationship under HIPAA.

In the final version of an amendment to the HIPAA Standards for Privacy of Individually Identifiable Health Information, which was published on Aug. 14, 2002 (67 Fed. Reg. 53,181 at 53,252), the OCR directly addressed the question of whether research activities are covered functions under HIPAA, explicitly stating that “ research is not a covered function or activity .” In the same rulemaking, the OCR clarified that “disclosures from a covered entity to a researcher for research purposes as permitted by the Rule do not require a business associate contract. This remains true even in those instances where the covered entity has hired the researcher to perform research on the covered entity’s own behalf because research is not a covered function or activity.”

The OCR reiterated this position in the Omnibus Final Rule implementing the Health Information Technology for Economic and Clinical Health Act (“HITECH Act”) and the Genetic Information Non-Discrimination Act of 2008 (“GINA”) (the “Omnibus Rule”), which was published on Jan. 25, 2013 (78 Fed. Reg. 5,566 at 5,575). In the Omnibus Rule, the OCR clarified that a “person or entity is a business associate only in cases where the person or entity is conducting a function or activity regulated by the HIPAA Rules on behalf of a covered entity, [and] [t]hus, an external researcher is not a business associate of a covered entity by virtue of its research activities, even if the covered entity has hired the researcher to perform the research.”

C. A third party that performs functions supportive of research on behalf of a covered entity is not a business associate even if those activities involve data management or the performance of clinical functions.

Patient Registries . Research institutions commonly use outside vendors to place data generated during the course of a clinical trial into databases or repositories, which are then used for a variety of purposes, including tracking patient outcomes. A vendor hosting a data repository in connection with clinical research may receive a request from a participating research institution to enter into a business associate agreement. However, even if the data elements in the registry are identifiable, if the registry is being maintained for the purposes of current or future research, the vendor does not qualify as a business associate of the research institution under HIPAA and the parties need not enter into a business associate agreement ( see National Institutes of Health, “Research Repositories, Databases, and the HIPAA Privacy Rule” (Jan. 2004)). It is important for the parties to confirm that appropriate patient authorizations for disclosure have been obtained, and it is certainly reasonable for the research institution to confirm that the entity hosting the registry will maintain the data securely, but the vendor would not constitute a business associate of the research institution under HIPAA in hosting the data repository.

Clinical Activities . Perhaps the most significant source of confusion stems from the fact that certain entities that conduct activities supportive of research on behalf of covered entities actually perform clinical functions. For example, an academic medical center or other research institution participating in a drug study may hire a third party company to perform certain phlebotomy activities in connection with required laboratory testing. In these cases, the third party vendor may receive or gather individually identifiable health information regarding the research subjects. Although the vendor is receiving or collecting such patient information, as applicable, those activities are integral to the research and derived from its requirements ( see Johns Hopkins Medicine, “HIPAA Questions and Answers Relating to Research” (2015)). Thus, such activities are part of the research enterprise. They do not constitute the performance of a covered function or other activity that would render the vendor a business associate, and, accordingly, they do not require the covered entity and the vendor to enter into a business associate agreement.

II. A researcher or clinical vendor may, in some circumstances, be considered a business associate of a covered entity.

A person or entity is a business associate only in cases where the person or entity is conducting a function or activity regulated by the HIPAA Rules on behalf of a covered entity ( see 78 Fed. Reg. 5,566 at 5,575). As explained above, research is not a covered function, and, accordingly, a vendor that provides services solely in support of research activities is not a business associate. However, the business associate provisions of HIPAA may be triggered if the vendor performs a function, activity, or service for a covered entity that does constitute a covered function or otherwise qualifies as a service provided by a business associate under the definition of business associate set forth in the Privacy Rule.

For instance, a clinical vendor may fall within the definition of business associate if it creates a de-identified data set for a covered entity. The HIPAA Privacy Rule regulates the creation of de-identified information. Id. Specifically, de-identification falls within the scope of a covered entity’s “health care operations” ( see 45 C.F.R. §§164.501, 164.514). Accordingly, the process of de-identifying PHI constitutes the performance of a covered function or activity that is regulated by the HIPAA Rules. If a covered entity uses a clinical vendor to de-identify PHI on the covered entity’s behalf, even if the covered entity intends to use the de-identified data for research purposes, then a business associate relationship is created, as the act of de-identifying PHI is a covered function under HIPAA ( see 78 Fed. Reg. 5,566 at 5,575).

III. The question of whether an authorization is required to disclose PHI is distinct from the question of whether the use of PHI to perform services on behalf of a covered entity necessitates the execution of a business associate agreement.

Under HIPAA, a covered entity must obtain an authorization from a patient in order to disclose PHI for any purpose except: (i) treatment, payment, or health care operations; and (ii) disclosures made in accordance with one of the specific regulatory exceptions to the authorization requirement set forth in the Privacy Rule ( see 45 C.F.R. §164.512). In order to disclose PHI for the purposes of research, a covered entity must obtain a HIPAA-compliant authorization from each research subject ( see 45 C.F.R. §164.508.). Obtaining these authorizations is a standard component of any clinical research protocol involving human subjects. Thus, even though research is not a covered function under HIPAA, patient authorization must be obtained in order for a covered entity to disclose PHI for the purposes of research.

It is important to remember, however, that the determination of whether an authorization is needed by a covered entity to disclose PHI for research (or any other purpose) is separate and apart from the determination of whether the person or entity to whom the patient information will be disclosed is a business associate of a covered entity under HIPAA. If a covered entity intends to disclose patient information to a support organization so that the support organization can create a patient registry to be used for future research, the covered entity must have a valid authorization from each patient to disclose the patient’s information, even though the support organization is performing functions integral to research and is not a business associate of the covered entity under HIPAA.

On the other hand, if an academic medical center wishes to disclose PHI to a data analytics firm so that the data analytics firm may de-identify the data, and the academic medical center intends to use the de-identified data to assess patient outcomes or for some other operational purpose, the academic medical center and the data analytics firm must enter into a business associate agreement. However, under HIPAA, patient authorization is not required for the disclosure because the academic medical center is disclosing PHI to the data analytics firm for de-identification, an activity that qualifies as health care operations and is thus exempt from the authorization requirement under HIPAA.

IV. Conclusion

A vendor who performs research or functions supportive of research and receives PHI from a research institution to perform those functions is not, by virtue of those activities alone, a business associate of the research institution. The business associate provisions of HIPAA are only triggered where a person or entity creates, receives, maintains, or transmits PHI in order to conduct a “covered function” on behalf of a covered entity, or performs one of the services listed in the definition of “business associate” in the HIPAA Privacy Rule. Research is not a covered function under HIPAA and research is not listed under the definition of business associate as one of the functions that a business associate may perform. Accordingly, a vendor that receives PHI from a covered entity to perform research or functions supportive of research, but has no other relationship with the covered entity, is not a business associate of the covered entity, and the covered entity and the vendor are not required to enter into a business associate agreement in order for the vendor to perform the work.

Nonetheless, a researcher or clinical vendor may, in some circumstances, be considered a business associate of a covered entity if the researcher or vendor performs a function, activity, or service for a covered entity that constitutes a “covered function” or otherwise qualifies as a service provided by a business associate under the definition of business associate set forth in the Privacy Rule, such as de-identifying PHI. As a vendor’s performance of certain types of services on behalf of a covered entity may give rise to a business associate relationship, open and continuous dialogue between sponsors, research institutions, and vendors is critical. This will ensure that participants in clinical research activities correctly characterize their relationships, execute business associate agreements where required, and, most importantly, appropriately safeguard patient data.

This article has been prepared for informational purposes only and does not constitute legal advice. This article and the information contained herein is not intended to create, and receipt of it does not in any way establish, a lawyer-client relationship. Readers should not act upon this information without seeking advice from professional advisers.

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Hot Topics in Data Governance: Artificial Intelligence (AI) and Clinical Research

Epstein Becker Green will host a private continuing legal education (CLE) event led by attorneys Kate Gallin Heffernan , Alaap Shah , Daniella Lee , and Elizabeth Scarola. The program will consist of three sessions.

The first session will provide a high-level overview of how AI is revolutionizing the healthcare industry, from predictive analytics to personalized medicine. The second session will examine the ethical and legal frameworks governing these data initiatives and strategies for mitigating associated risks. Topics will include AI Governance, Clinical Research, F&A Considerations, and Data Governance. The program will conclude with a roundtable discussion regarding AI and research.

To request additional information about or to register for this complimentary event, please contact Elizabeth Scarola .

Event Detail

• Academic and Clinical Research
• Data Asset Management
• Health Care
• Life Sciences
• Privacy, Cybersecurity & Data Asset Management
• Artificial Intelligence
• Health Care Industry
• Life Sciences Industry
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