Wednesday, September 14, 2011

Fulfilling Regulatory Responsibilities and Protecting Human Participants in Research

Institutional Review Boards, IRB chairs and members, and IRB staff are charged with fulfilling two important responsibilities. First, they make decisions and act to protect human participants in research. Second, they fulfill the regulatory responsibilities related to research involving human participants on behalf of their institution.

Regulations, be they from the Department of Health and Human Services, the Food and Drug Administration, or state- or country-specific laws, were designed with the protection of human participants in research in mind. However, many requirements—for example, reporting non-compliance to regulatory agencies—do not directly or even indirectly serve to protect participants, although organizations must fulfill the requirements to be compliant. Furthermore, while regulations provide the framework for conducting IRB meetings or reviewing research by the expedited process, these actions in and of themselves do not protect participants. Rather it is the convened IRB or IRB reviewers, who through thoughtful deliberation, discussion, and determinations, make decisions that respect participants and ensure protections are provided to them in each specific research project. No regulations specify what constitutes an adequate ethical discussion of a particular issue. Yet IRBs must grapple with these intricate and complex concerns and develop appropriate solutions in a timely manner.

Here is a classic example: With respect to non-compliance, HHS regulations state that an organization must have “written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the department or agency head…any serious or continuing noncompliance with this policy or the requirements or determinations of the IRB.” That is the only mention of non-compliance in the HHS regulations. Obviously, reporting by itself does not protect participants. The IRB must investigate allegations of non-compliance and make decisions and take actions to protect participants, according to the degree of harm or potential harm. The regulatory requirement is then to decide whether the non-compliance is “serious or continuing” and, if so, to report it.

AAHRPP Accreditation Standards go beyond the regulations. The Standards complement and complete the regulations, add details, and even enforce the intent of the regulations when intent is not explicit. For instance, while the regulations state that “each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution,” IRB staff argue that non-affiliated members have to be on the roster but that they are not required to attend an IRB meeting. Indeed some IRBs rarely have an unaffiliated member present at meetings. AAHRPP contends that the non-affiliated member has an important role to play for transparency and to provide an outside voice, and that this member should be in attendance at most, if not all, meetings.

Thus, accreditation helps organizations achieve their dual purposes of complying with regulatory requirements designed to protect human research participants. Complying with the regulations is essential to conducting research and enhances funding opportunities and preserves the reputation of the organization as a quality research site. But it is also vital to maintain an effective and efficient human research protection program that makes considered ethical decisions. Regulatory and ethical responsibilities work hand in hand to build a quality research program.

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