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Aug2016

On August 2, 2016, the Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) jointly released draft guidance on institutional review board (IRB) written procedures. The guidance is “intended for…IRBs and institutions responsible for review and oversight of human subject research under the HHS or FDA regulations, or both.”

The draft guidance also reminds IRBs subject to both DHHS and FDA regulations (45 CFR Part 46 and 21 CFR Parts 50 and 56, respectively) that they must comply with the regulatory requirements of both agencies on IRB written procedures for specific function areas including: reporting findings to the institution, conducting initial and continuing review of research, and ensuring prompt reporting of suspensions or terminations of IRB approval.

When the guidance is finalized, it will supersede OHRP’s 2011 “Guidance on Written IRB Procedures” and FDA’s 1998 “Appendix H:  A Self-Evaluation Checklist for IRBs,” originally part of FDA’s Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors.

As a reminder, guidance, unlike regulation, does not establish legally enforceable responsibilities. Guidance describes the agencies’ “current thinking on a topic,” and the agencies’ commentary in a guidance document should be read as recommendations unless regulatory or statutory requirements are mentioned.

In the draft guidance, the agencies acknowledge that IRBs’ written procedures will vary depending on factors such as the type of research study to be reviewed, administrative practices, and local and state regulations and laws. To assist IRBs in developing and maintaining written procedures that are appropriate for their specific contexts, the guidance provides an "IRB Written Procedures Checklist" that identifies the relevant regulatory requirements and provides recommendations for additional topics that should be included in the written procedures.

The agencies caution against IRB written procedures that “simply reiterate the regulations.” Instead, the agencies recommend that IRB written procedures “be sufficiently detailed” so that IRB members and staff “understand how to carry out their duties consistently and effectively in ways that ensure that the rights and welfare of subjects are protected, and that the IRB operates in compliance with the Regulations.” Written procedures that include “step-by-step operational details” will also, they point out, provide regulators with a better understanding of how an IRB is fulfilling its regulatory duties.

The first four sections of the Checklist begin with the applicable regulatory requirements. The fifth section focuses on further considerations and other suggestions for procedures/polices. There are 59 points where the agencies ask if the IRB has a written procedure.

In a sign of the times, the Checklist recommends language on “procedures used to determine which studies qualify for cooperative review, the role of the institution and the institution’s IRB in this type of review process, and documenting arrangements in written agreements.” It also recommends language on “how the IRB determines whether provisions to monitor data collected are adequate to ensure the safety of subjects, and provisions to protect the privacy of subjects and confidentiality of the data are adequate, where appropriate.”

Five noteworthy topics about which the Checklist recommends IRBs have written policies, but which did not appear in one or both of documents it supersedes, include:

  • Handling complaints from subjects
  • How the IRB “assesses provisions for translations of the informed consent form for non-English speaking subjects”
  • “Managing investigator conflict of interest”
  • How the IRB “determines whether the selection of subjects is equitable” (inclusion/exclusion criteria)
  • “Contingency plans for transferring oversight of one or more studies to another institution or IRB in the event that the IRB is unable to continue oversight of the study”

Interestingly, language in OHRP’s  2011 guidance on “procedures for ensuring that the IRB possesses sufficient knowledge of the local research context” is not reflected in the new draft guidance. However, the Checklist does ask if there is a written procedure for the use of consultants.

This is the second time in recent months that OHRP and FDA have released joint draft guidance. (In November 2015, OHRP and FDA jointly released draft guidance on IRB meeting minutes.) OHRP and FDA’s harmonization of guidance in this area will simplify the process by which IRBs who are answerable to both the DHHS and FDA can comply with both sets of regulations.

OHRP and FDA are accepting comments until October 3, 2016, and we encourage all stakeholders to submit their comments.

And tell us…what do you think about the draft guidance? Leave a comment below.

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