SAFETYmatters - Proposed Changes to Gene Therapy Trials

Article published 08/23/18
 

The NIH is requesting comments on a proposal to amend the NIH Guidelines as related to oversight of gene therapy research.

On August 16, 2018, the National Institutes of Health (NIH) issued a notice in the Federal Register requesting comments on a proposal to amend the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines).  The proposed changes will streamline the oversight of human gene transfer clinical studies (gene therapy research) and reduce duplicative reporting requirements.  The changes will affect requirements outlined in Appendix M of the NIH Guidelines and will also modify the roles and responsibilities of the Recombinant DNA Advisory Committee (RAC).  Comments should be submitted by October 16, 2018.  Additional information, including how to submit comments, can be found on NIH’s page here.