Fwd: Important Message about the NIH Guidelines

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Chris Santos-Lang

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Apr 26, 2019, 10:14:53 AM4/26/19

to diy...@googlegroups.com, CSA Ethics Working Group

Recent development in the oversight of human gene transfer research...

Forwarding to DIYbio and CSA Ethics lists.

---------- Forwarded message ---------
From: Bayha, Ryan (NIH/OD) [E] <bay...@od.nih.gov>
Date: Fri, Apr 26, 2019 at 8:56 AM
Subject: Important Message about the NIH Guidelines
To: Bayha, Ryan (NIH/OD) [E] <bay...@od.nih.gov>

Dear Colleagues:

Today, the National Institutes of Health (NIH) finalized a proposal to amend the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) to streamline the oversight of gene therapy research. This proposal, which was developed in conjunction with the Food and Drug Administration, included amending the NIH Guidelines to eliminate duplicative review and reporting requirements for human gene transfer protocols and refocuses the role of the NIH Recombinant DNA Advisory Committee (RAC) as a transparent forum for science, safety, and ethics of emerging biotechnologies. After a 60-day public comment period, the NIH Guidelines have been updated to reflect these changes and the RAC has been renamed the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC).

Please note that the roles and responsibilities of Institutional Biosafety Committees (IBCs) to review gene therapy protocols have been modified so that they are consistent with the review of other research covered under the NIH Guidelines. Gene therapy protocols remain subject to Food and Drug Administration (FDA) and other clinical trial regulations, and only after FDA, Institutional Biosafety Committee, Institutional Review Boards, and other relevant approvals are in place can these protocols proceed.

Please also note the HGTpro...@od.nih.gov mailbox previously listed in the NIH Guidelines is no longer operational. All questions should instead be sent to NIHGui...@od.nih.gov

For more information about these important changes, please see the following NIH resources.