HHS’ Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) have simultaneously released notices seeking comments on draft guidance documents regarding the transfer of previously approved research projects to another Institutional Review Board (IRB) or research institution. These guidances were released as part of a joint effort between the FDA and OHRP to “harmonize the agencies’ regulatory requirements and guidance for human subjects research.” The FDA draft guidance and the OHRP draft guidance are largely the same, but have minor differences due primarily to formatting and differences between the FDA’s and OHRP’s jurisdictions.
The guidance documents address the following topics:
- Regulatory background for research project transfer;
- Transfer of oversight of a research project from an internal IRB to an external IRB, or an external IRB to another external IRB, when the project remains at the same institution;
- Transfer of oversight of a research project from one internal IRB to another internal IRB; and
- Transfer of oversight of a research project when the project is transferred to a newly engaged institution.
Both draft guidance documents recommend that the transfer process use a written agreement between the original and receiving IRBs that covers a number of specific items, such as the date of transfer, record retention, and whether consent forms need revision.
Comments are due by August 13, 2012. FDA and OHRP intend to work together in developing final guidances to ensure harmonization.