Why Keeping Detailed IRB Minutes Is Important

Institutional review boards (IRBs) must keep meticulous written minutes describing their activities, deliberations, and decisions, generally in more detail than most other committees in an organization. IRBs often develop minutes templates, worksheets, checklists, and other mechanisms to help make sure that they handle and record all required issues. Detailed IRB minutes are important for several reasons.


For one, regulations call for IRB minutes to be completed and maintained. Both the DHHS (45 CFR 46.115) and FDA (21 CFR 56.115) regulations require “minutes of IRB meetings which shall be in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution.” And indeed, common findings in both OHRP determination letters and FDA warning letters indicate that these requirements must be followed. For example, OHRP determination letters point out that “the minutes of meetings failed to document the vote on all IRB actions including the number of members voting for, against, and abstaining,” “the minutes of IRB meetings should document separate deliberations, actions, and votes for each protocol that requires continuing review by the convened IRB,” and “the minutes of meetings for all the IRBs often failed to document the basis for requiring changes in research.” In fact, the latest summary, titled Recent Compliance Oversight Determinations, lists failure to follow the regulations concerning IRB minutes as a common finding.¹ The FDA uses a standard paragraph that can be found in numerous recent warning letters: “The IRB failed to prepare and maintain minutes of IRB meetings in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution.” So, compliance with the regulations should drive HRPPs to produce adequate minutes.

Two AAHRPP Elements address IRB records: Element II.5.A., which deals with adequate IRB records, and Element II.5.B., which deals with IRB minutes. AAHRPP includes the DHHS and FDA regulatory requirements, but it also covers documenting protocol-specific determinations, such as for waivers of the consent process or decisions required in Subparts B, C, and D. The AAHRPP Elements also incorporate specific Department of Veterans Affairs requirements for VA facilities and their academic affiliates. AAHRPP site visitors review minutes to ensure that they are complete. They also interview IRB chairs and members about minutes. It is a common finding that minutes do not reflect the full breadth of discussion on controverted issues and protocol-specific determinations. Thus, adequate IRB minutes are also part of accreditation requirements.

Keeping complete minutes enhances the protection of research participants. Good minutes, along with sound IRB records, give IRB chairs, members, and staff—both current and future—an accurate and complete record of decision making. Studies often last many years, perhaps even 10 or 20 for some longitudinal studies. It is vital for IRB members and staff to be able to look at the minutes and other records and to understand precisely why decisions were made. For example, a new [future] IRB chair might examine a continuing review application and ask, “Why did we grant a waiver of consent for this research?” or “Why were women of childbearing age excluded from this protocol?” Future IRB members should be able to look back and find these answers. The answers might affirm the reasons for continuing such determinations, or they might spur a change. Different methodologies or equipment, or new data or experiences, might propel a change in the decisions made previously. Knowing the reasons behind the earlier determinations is important to future decisions and determinations. Given that IRB chairs and members rotate on and off of IRBs and IRB staff turns over, keeping good minutes and records is essential.

On the surface, the level of detail required in IRB minutes might appear picky and arbitrary. While complying with regulations and avoiding the potential problems of noncompliance are reasons enough for maintaining adequate IRB minutes, detailed and complete minutes are also important to current and future IRB review. They play a significant role in helping to protect participants in research and maintain a high-quality research program.


1. Division of Research Oversight, Office of Human Research Protections. Recent Compliance Oversight Determinations. http://www.hhs.gov/ohrp/compliance/findings/index.html#H42 Accessed 9/23/2011.