Rules and Regulations. Notice of Actions Under the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines)

Agency: National Institutes of Health (NIH), PHS, DHHS
Action: Notice of Actions Under the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines)
Citation: 65 FR (No. 196) · FR Doc. 00-25891

Summary

This notice describes amendments to the NIH Guidelines regarding research participant enrollment in human gene transfer studies and the submission of study protocols for NIH Recombinant DNA Advisory Committee (RAC) review. NIH's goal in making these modifications to the NIH Guidelines is to ensure that no research participant is enrolled in a human gene transfer study until the RAC review process has been completed, IBC and IRB approvals have been obtained, and applicable regulatory authorization(s) have been obtained. The NIH is modifying the requirements for protocol submission to the NIH Office of Biotechnology Activities (OBA) for RAC review so that clinical trial proposals: 1) may be submitted for RAC review prior to local Institutional Review Board (IRB) approval; and 2) must be submitted to the NIH OBA for RAC review and the RAC review process completed prior to local Institutional Biosafety Committee (IBC) approval. In the case of clinical trial proposals that are reviewed publicly and lead to specific recommendations from the RAC with regard to the protocol, the NIH will send written RAC recommendations to the Principal Investigator and the IBC and the IRB within 10 working days of public RAC review and discussion. Once the local IBC is in receipt of the RAC recommendations, the IBC may proceed with its protocol approval process. Investigators may initiate research participant enrollment when they have obtained final IBC and IRB approvals and all applicable regulatory authorization(s). No later than 20 working days after enrollment of the first research participant, the investigator must have provided to NIH OBA: (1) the final protocol, as approved by the local IRB and IBC and as authorized by the FDA along with the IND number; (2) the NIH grant number(s), if applicable; (3) a copy of the IRB and IBC approvals; (4) as applicable, a written response addressing each of the RAC recommendations resulting from public review and discussion of the protocol; and (5) the date of the initiation of the trial.