National Institute of Health (NIH) issued a notice seeking comment on a proposal to amend the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines). As part of the proposal, NIH would remove the protocol submission, review, and reporting requirements of the NIH Guidelines and modify the roles and responsibilities of the Recombinant DNA Advisory Committee (RAC).
Effective immediately, and during the comment period noted above, the following interim steps will be followed:
1. The NIH will no longer
a. accept new human gene transfer protocols for the protocol registration process per the old NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines),
b. convene the RAC to review individual human gene transfer protocols.
c. accept annual reports, safety reports, amendments or other documentation for any previously registered human gene transfer protocols under the NIH Guidelines.
2. The roles and responsibilities of IBCs at the local level will continue as described in the NIH Guidelines.
3. The clinical studies that needed RAC oversight will 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.
What does this mean for investigators?
All Human Gene Transfer studies must still be reviewed and approved by both the UCSF Institutional Biosafety Committee (IBC) and the Institutional Review Board (IRB) before the human subject enrollment period for a given study may begin.
The proposal can be found at: https://osp.od.nih.gov/biotechnology/nih-guidelines/.
Comments will be accepted until October 16, 2018, and can be made at: https://osp.od.nih.gov/comment-form-nih-guidelines/.
We will inform you after the NIH finalizes this policy change. Please contact either of us if you have questions.
Peili Zhu, Biosafety Officer, Peilie.Zhu@ucsf.edu
Laurie Herraiz, IRB Director, Laurie.firstname.lastname@example.org