Warning letters issued by FDA in recent months highlight the importance of documentation in IRB operations. Although written procedures are required by regulation, they are not sufficient by themselves. As FDA noted in one recent letter, “Maintaining records, as required under the regulations, provides significant evidence of whether the procedures utilized by the IRB are adequately protecting the human subjects of the clinical investigations that the IRB is reviewing.”
Two IRBs have been cited in 2012 for significant issues related to membership documentation. Problems identified by FDA inspectors included:
- Insufficient (or nonexistent) documentation of members’ names, representative capacity, institutional affiliation and qualifications to serve on the IRB
- Failing to record attendance at convened meetings
- Conducting business at convened meetings without a quorum, defined as a majority of the IRB’s membership, including at least one non-scientist
- Allowing a board member and their alternate to count toward quorum and vote at the same meeting
- Allowing individuals who were not on the IRB’s current membership roster to participate as voting members and be counted toward quorum
- Inaccurate or missing vote counts in meeting minutes
InfoEd’s Human Subjects module includes tools to help IRBs and other compliance committees manage membership rosters and related information, such as member qualifications. Electronic meeting tools facilitate capturing vote counts and attendance in sufficient detail to document who participated in the review of each agenda item. This information can be included automatically in the meeting minutes, if desired, saving time and reducing the potential for error. These features are also available in the Lab Animals and Environmental Safety modules.
If you would like more information, please submit an information request form.