Gene Therapy May Have Revised Oversight

The National Institutes of Health (NIH) will stop requiring special review of gene therapy trials (H/T ScienceInsider) currently conducted by the Recombinant DNA Advisory Committee (RAC).  NIH Director Francis Collins justified the decision, which is based on recommendations from a study it requested of the Institute of Medicine, by noting the progress in the field since the formation of the RAC over 40 years ago, as well as the additional regulatory reviews in place for this kind of research.  The RAC would remain to review special kinds of gene therapy trials, provided they meet the following requirements:

  1. The protocol review could not be adequately performed by other regulatory and oversight processes (for example, the institutional review boards, institutional biosafety committees, and the FDA).
  2. One or more of the following criteria are satisfied:
    • Protocol uses a new vector, genetic material, or delivery method that represents a first-in-human experience, thus representing unknown risk.
    • Protocol relies on preclinical safety data that were obtained using a new preclinical model system of unknown and unconfirmed value.
    • Proposed vector, gene construct, or method of delivery is associated with possible toxicities that are not widely known and that may render it difficult for local and federal regulatory bodies to evaluate the protocol rigorously.

I understand the idea that the RAC likely conducts a certain amount of review that is redundant.  Given the challenges facing other bodies with NIH-relevant ethics responsibilities, I would certainly understand if anyone took pause in response to the decision.  Especially since the NIH has yet to decide whether to follow another IOM recommendation – to replace the RAC with another body focused on gene therapy and other kinds of risky research.

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