FDA Makes Institutional Review Board Draft Guidance Available

By Anne Marie Murphy & Benjamin K. Wolf* –

On June 12, 2012, FDA announced the availability of a draft guidance, titled “Considerations When Transferring Clinical Investigation Oversight to Another IRB” (“FDA Draft Guidance”).  This is the first time FDA has provided through guidance specific direction to the entities (including the original and receiving institutional review boards, or IRBs, the sponsor of the clinical investigation, and the clinical investigator) involved in the transfer of a study from one IRB to another.  Generally, the same IRB (a group formally designated by an institution to review, approve the initiation of, and to conduct periodic review of biomedical research of human subjects) maintains continued oversight of clinical trials at a research site.  However, an IRB or study sponsor may need to transfer a clinical trial for reasons including institutional reassessment or reorganization, natural disaster, or disqualification of the IRB. 

The Office for Human Research Protections (“OHRP”) made available its own draft guidance, titled “Considerations in Transferring a Previously Approved Research Project to a New IRB or Research Institution” (“OHRP Draft Guidance”), which, despite some minor variations from the FDA Draft Guidance, is meant to harmonize with the FDA Draft Guidance.  The Federal Register notice announcing the OHRP Draft Guidance can be found here.

The Agency suggests a non-exhaustive list of eight steps that should be addressed, as appropriate, prior to IRB transfer.  They are:

1. Identifying those studies for which IRB oversight is being transferred; 
2. Ensuring the availability and retention of pertinent records; 
3. Establishing an effective date for transfer of oversight, including records, for the clinical investigation(s); 
4. Conducting a review of the study(ies) by the receiving IRB, where appropriate, before it accepts responsibility for the study(ies);
5. Confirming or establishing the date for the next continuing review; 
6. Determining whether the consent form needs to be revised; 
7. Notifying the key parties; and
8. Updating IRB registration information.

Each of these steps is designed to ensure a smooth transition between IRBs and the continued observance of all regulations pertaining to IRB oversight—including continuous oversight by an IRB, document retention, and providing contact information for the IRB to FDA.

FDA is accepting comments on the Draft Guidance until August 13, 2012.

*  Summer Associate

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