Helping Research Professionals

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OHRP Issues Single IRB Draft Guidance

On July 1, 2022, OHRP posted a draft guidance document for public comment entitled “Use of a Single Institutional Review Board for Cooperative Research.” The draft guidance will be open for public comment until August 30, 2022. The recently posted draft guidance provides further detail on the 2018 Requirements (45 CFR 46.114(b)(1)) for the use of a single IRB in cooperative (multisite) research projects. Topics addressed in the draft guidance include clarification on when an institution must rely on a single IRB, exceptions to the single IRB requirement pursuant to 45 CFR 46.114(b)(2), the process of determining which IRB will be the IRB of record for a specific project, and whether a single IRB can be used for projects not required to follow the 2018 Requirements. In addition, the draft...

IND Safety Reports and IRBs

HRP recently engaged in extensive correspondence with the FDA regarding the following statements that appeared in one of the later iteration’s of the FDA’s guidance document “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency”: Where an IND safety report is required to be submitted to FDA under 21 CFR 312.32, the investigator must [emphasis added] also send that IND safety report to the IRB. The IRB may have additional reporting requirements regarding COVID-19 during the clinical trial. And In addition, investigators are required under 21 CFR 312.66 to report all “unanticipated problems involving risk to human subjects or others” to the IRB. FDA considers a serious and unexpected adverse event that meets the criteria for sponsor reporting to FDA...