The FDA and the Office for Human Research Protections (OHRP) have launched a joint effort to prepare draft guidance on how to record the activities of institutional review boards (IRBs).
The guidance, which provides advice for institutions as well as all IRBs, covers how to prepare and document IRB activities via the minutes of a convened meeting. The minutes should include summaries of what occurred during the meeting—along with findings, determinations, and a detailed list of who attended and who was absent—and provide documentation of the IRB’s compliance and regulatory requirements.
“Minutes should be detailed enough for OHRP and FDA to be able to determine compliance with the applicable regulations,” the guidance states. “The minutes should serve as a central repository for IRB decisions on proposed research activities.”
Both organizations are offering more details in the record of minutes and on the type and amount of information that should be provided in documenting the actions taken by an IRB.
“I think a lot of people were surprised when FDA and OHRP issued their guidance … as there was not a lot of foreshadowing that this guidance was coming,” said David Borasky, vice president of quality management at WIRB-Copernicus Group. “Frankly, for large IRBs like ours, we do a lot of expedited review and this is asking IRBs to add a lot of details to the minutes, which in my opinion is not necessary.”
In their draft guidance, both organizations cited warning letters and determination letters to IRBs that failed to prepare and maintain adequate minutes. Examples of noncompliance concerns were: missing minutes from meeting; minutes that lacked sufficient detail to show the vote on actions taking by the IRB, including the number of members voting for, against and abstaining; incomplete minutes with voting actions listed as “passed unanimously”; minutes that do not clearly indicate, or contain discrepancies about, what the IRB approved; multiple sets of minutes, maintained by the IRB, with different information for the same meeting; and minutes that fail to include a summary of the discussion of controverted issues.
“We recommend that IRBs document their findings and determinations in the minutes, or elsewhere in the IRB records (e.g., IRB reviewer form/checklist, database entries or other forms of physical or electronic records),” the guidance states. “The minutes should make clear which members, if any, participated in the convened meeting via an alternative mechanism such as telephone or video conferencing.”
The quest for greater accuracy also includes the role of invited consultants. It should be listed with a brief description of the consultants’ expertise, since they cannot vote at the meeting. Additionally, the guidance recommends the minutes should state that the consultant did not vote on the study. Similarly, if guests are attending a convened meeting, “the minutes should be clear that the nonmember or guest did not participate in the deliberation and voting.”
As for the need by the FDA and OHRP to issue its nonbinding draft guidance on the IRB meeting minutes, Quorum Review CEO Cami Gearhart said there probably are smaller IRBs that may not have the resources to comply with the regulations or lack the personnel needed to keep the detailed record the FDA and OHRP are recommending.
“I think there are IRBs who struggle with these requirements, as they are fairly complex to maintain, but I am not surprised that the FDA and OHRP are trying to provide guidance to IRBs for day-to-day obligations,” said Gearhart. “Central IRBs, like ours, have the luxury of volume and being able to maintain the detailed records that the FDA and OHRP require.”
Rafaella Hart, vice president of IRB services at Biomedical Research Alliance of New York (BRANY), suggested that the draft guidance, in order to ensure that regulatory processes are met, is largely aimed at reducing the number of smaller IRBs with greater reliance on central or regional IRBs.
“To my way of thinking, this probably is a move to require a single IRB that will review multi-centered trials and where there are sufficient guidelines on existing requirements as we move toward a place where there is more uniformity,” said Hart. “This does help harmonize the requirements of OHRP and the FDA. There will still be specific tweaking in the final recommendations, but this spells out a need for standardization.”
The proposed guidance on how to document IRB activities follows a recent proposal by the Department of Health and Human Services (HHS) to shorten informed consents along with greater use of central IRBs and broader biospecimen consent for unspecified future research. The HHS plan would rely on mandatory use of central IRBs for many federally funded studies, although the requirement does not bind any site to participating in such a study.
The IRB guidance draft from the FDA and OHRP also breaks down what should be included with regard to informed-consent studies involving children, along with emergency research, device studies, studies involving pregnant women and neonates, and studies of prisoners and other considerations.
In addition, the guidance states that controverted issues that cause controversy and dispute among IRB membership during a meeting must be part of the meeting minutes by having sufficient detail to show the discussion of the issues and their resolution.
Comments and suggestions regarding the draft guidance are due Jan. 6, 2016, while any suggestions to the proposed HHS rule changes are due Dec. 7 of this year.
Ronald Rosenberg is a former business and science reporter for The Boston Globe. He has written features for New Scientist and Inc. magazine. His lengthy journalism career includes editing an award-winning weekly newspaper in Cornwall, N.Y. Ron also was a media relations specialist for the science faculty at Boston University, and a Knight Science Journalism Fellow at the Massachusetts Institute of Technology.
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