Notice Number: NOT-OD-18-218
Release Date: August 16, 2018
National Institutes of Health (NIH)
Today, the National Institutes of Health released a proposal to amend the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) to streamline oversight for human gene transfer clinical research protocols (i.e., gene therapy research) and reduce duplicative reporting requirements already captured within the existing regulatory framework. Specifically, NIH proposes removing the NIH protocol submission, review and reporting requirements under Appendix M of the NIH Guidelines. Furthermore, the NIH proposes to modify the roles and responsibilities of the Recombinant DNA Advisory Committee (RAC).
During this comment period and effective immediately, the NIH will no longer accept new human gene transfer protocols for the protocol registration process under the NIH Guidelines, or convene the RAC to review individual human gene transfer protocols. The NIH Office of Science Policy will also not accept annual reports, safety reports, amendments or other documentation for any previously registered human gene transfer protocols under the NIH Guidelines. The roles and responsibilities of Institutional Biosafety Committees (IBCs) at the local level will continue as described in the NIH Guidelines. These trials remain subject to FDA and other clinical trial regulations, and only after FDA, IBC, and other relevant approvals are in place can these protocols proceed. During this time, IBCs and Institutional Review Boards (IRBs) will not be required to submit documentation to the NIH assessing whether a particular protocol meets the criteria for RAC review.
The full proposal can be found in the the Federal Register. Comments on the proposal will be accepted until October 16, 2018, and can be made electronically by visiting:
Please direct inquiries about this Notice to:
National Institutes of Health
Office of Science Policy