IPPCR 2018: Legal Issues in Clinical Research

Summary

Carrie Kennedy, a senior attorney with the HHS Office of the General Counsel, discusses legal issues in clinical research, focusing on informed consent, the evolution of advanced directives, and surrogate decision-making. She also addresses children's research, confidentiality, privacy, authorship rights, and legal liability for federal and nonfederal researchers. The talk outlines the legal framework, including the Common Rule and the Belmont Report's ethical principles, and provides insights into consent processes, advanced directives, and the handling of medical records and privacy under the Privacy Act and HIPAA.

Takeaways

• 📜 Informed consent is a foundational principle in both medical care and research, ensuring patients understand procedures, treatments, and associated risks.
• 🏛️ The legal framework for clinical research in the U.S. is based on the Constitution, followed by laws passed by Congress, executive orders, regulations, and federal policies.
• 📚 The HHS regulations at 45 CFR 46, particularly the Common Rule in Subpart A, govern research involving human subjects, and are implemented by the Office for Human Research Protections (OHRP).
• 🔍 Informed consent requires clear communication about the nature of the research, duration, purpose, risks, benefits, and the voluntary nature of participation.
• 👶 Special considerations are required for research involving children, including obtaining assent from the child and consent from parents or legal guardians.
• 📝 Medical records and research records at NIH are distinct, with strict rules on accuracy, timeliness, and confidentiality, guided by the Privacy Act and other regulations.
• 🛡️ The Privacy Act and HIPAA govern the disclosure of personal information, ensuring patient privacy and outlining circumstances under which information can be shared without explicit consent.
• 🖋️ Authorship in research publications should reflect significant contributions to the study, with specific policies guiding the assignment of authorship.
• ⚖️ The Federal Tort Claims Act (FTCA) provides immunity to federal employees from personal liability for negligence claims arising from their official duties, with the government assuming responsibility.
• 🏥 Advanced directives and surrogate decision-making are crucial for patients who cannot make their own medical decisions, with specific legal frameworks guiding these processes.

Q & A

What is the role of Carrie Kennedy as a senior attorney with the HHS?

Carrie Kennedy serves as a senior attorney with the HHS, Office of the General Counsel, specifically with the NIH branch. Her role involves advising the National Institutes of Health on legal issues, particularly in the areas of human subjects research and the clinical center, which is the NIH research hospital.

What are the objectives of the lecture presented by Carrie Kennedy?

The objectives of the lecture are to discuss the history and elements of informed consent for clinical and research care, summarize the evolution of advanced directives and surrogate decision-making, address research-specific issues regarding children, and examine legal issues related to medical records, confidentiality, privacy, authorship rights, and legal liability for federal and nonfederal clinical researchers at the NIH clinical center.

Can you explain the legal framework in the United States as presented by Carrie Kennedy?

The legal framework in the United States is structured with the Constitution at the highest level, followed by laws or acts passed by Congress which are codified in the United States Code (USC). Below that are executive orders by the president, regulations passed by federal agencies as authorized by law, and finally, federal policies.

What is the significance of 45 CFR 46 in the context of the lecture?

45 CFR 46 refers to the Code of Federal Regulations specific to the Department of Health and Human Services (HHS). It contains the HHS regulations governing the protection of human subjects in research. Part A of these regulations is often called the Common Rule, which is followed by 15 other agencies and is crucial for the discussion on informed consent and human subjects research.

What is the Belmonte Report and its relevance to human subjects research?

The Belmonte Report was formed in 1978 by the first bio-ethics commission in the United States. It identified three fundamental ethical principles for human subjects research: respect for persons, beneficence, and justice. These principles have significantly influenced the development of regulations and ethical considerations in research involving human subjects.

How does the revised Common Rule affect informed consent?

The revised Common Rule, effective January 2019, includes changes to informed consent aimed at increasing autonomy and understanding of individual subjects. It introduces requirements such as presenting key information first, providing sufficient detail to inform subjects' decisions, and including additional elements like the use of identifiable private information for future research, potential commercial profit, and the return of clinically relevant information.

What is the concept of 'broad consent' as introduced in the revised Common Rule?

Broad consent is an option introduced in the revised Common Rule that allows for the collection of identifiable private information or bio-specimens with the consent of the subject for storage, maintenance, and use in future research. The purpose of future use can be stated broadly or narrowly, providing flexibility for institutions and researchers.

What are the legal considerations for obtaining informed consent in research?

In research, informed consent must be voluntary, and the disclosure must include relevant information that is comprehensible to the participant. The consent process involves explaining the research purpose, duration, procedures, risks, benefits, and the participant's right to withdraw at any time without penalty.

Who can provide consent for a child participating in research?

For children participating in research, consent is generally sought from both parents or legal guardians. However, Institutional Review Boards (IRBs) can approve consent from only one parent for lower-risk research. In certain circumstances, such as foster care, the legal authority to consent may lie with a court or Child Protective Services.

What is the difference between a guardian and a legally authorized representative in the context of research?

A guardian is appointed by a court to make decisions for an individual who is deemed incapable. A legally authorized representative, as defined in the HHS and FDA regulations, is a person or entity authorized under law to consent on behalf of a subject for their participation in research. This can include parents, legal guardians, or entities like child protective services or the court.

How does the concept of 'assent' apply to children in research?

Assent is the process of obtaining affirmative agreement from children who are not of legal age to provide formal consent. While children cannot legally consent to participate in research, they can be asked to assent, indicating their willingness to participate after being provided with appropriate information about the study.

What are the legal implications of the Federal Tort Claims Act (FTCA) for NIH employees?

The Federal Tort Claims Act (FTCA) allows the U.S. government to be sued in certain circumstances, providing an exclusive remedy for those with complaints against the government and its employees. Under FTCA, the government provides immunity to employees from claims of negligence related to their scope of employment. If a claim is filed and results in damages, the government, rather than the individual employee, would be responsible for the payout.

What is the role of the Institutional Review Board (IRB) in the context of research?

The Institutional Review Board (IRB) is a group tasked with overseeing and ensuring that the protocol submitted to them and approved meets the regulatory requirements for the protection of human subjects. They review research proposals to ensure that they adhere to ethical principles and regulations, including informed consent and the protection of privacy and confidentiality.

How does the Privacy Act impact the handling of medical records at the NIH Clinical Center?

The Privacy Act prohibits the disclosure of records that can be retrieved by an individual's name or identifying number to third parties without the written consent of the individual, unless one of the 12 disclosure exceptions in the Act applies. This means that medical records at the NIH Clinical Center are generally not disclosed without patient consent, and any disclosure must be limited and follow strict guidelines.

What are the considerations for authorship and data rights in research publications?

Authorship is generally based on significant contributions to the conceptualization, design, execution, and/or interpretation of the study. Data rights for research conducted within the NIH intramural program are typically the property of the federal government, with protections for both researchers and the government. For extramural research, where NIH funds outside institutions, data rights may vary and are subject to specific agreements.

How does the Health Insurance Portability and Accountability Act (HIPAA) apply to research and clinical care?

HIPAA applies to covered entities and requires that individuals give authorization for the use or disclosure of Protected Health Information (PHI). While NIH itself is not a covered entity, many collaborators and partners may be subject to HIPAA. HIPAA aims to balance the need for information exchange for clinical and research purposes with the protection of patient privacy.