PRIM&R recently submitted comments in response to the National Institutes of Health's (NIH’s) proposal to amend its Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, which was published in the Federal Register on August 17, 2018. Although the title of the announcement is a mouthful, we encourage readers to read our comments, as the proposal has important implications for public engagement around the ethical and social implications of emerging genetic research.

In a New England Journal of Medicine Perspective article the Director of the NIH, Dr. Francis S. Collins, and the Commissioner of the Food and Drug Administration (FDA), Dr. Scott Gottlieb, explain that the government released the proposal to streamline oversight of human gene transfer research (HGT), given that, according to them, the current regulatory framework now appropriately addresses safety issues. They suggest that the proposal will also “reduce the duplicative oversight burden” associated with the submission and reporting requirements of the FDA and the NIH, and with overlapping review requirements among the FDA, IRBs, and institutional biosafety committees (IBCs). In our comments, we note that we agree that the federal government should eliminate redundant regulatory requirements that add nothing to the protection of human research subjects.

However, we take significant issue with the proposed changes to the mandate, purpose, and scope of the Recombinant DNA Advisory Committee (RAC).

The RAC was originally established to address both known and unknown risks presented by new technologies. Today, human gene therapy technology continues to evolve, and some cases—such as the ability to affect the germline—raise new and more complex ethical issues. The unique role played by the RAC as originally conceived is at least as essential now as it was 45 years ago. The NIH's proposal removes any mention of the RAC's composition, responsibilities, and transparency features from the NIH Guidelines. The agency promises that a new charter for the RAC is forthcoming. However, we are concerned that, in proposing to scale back the RAC’s role, the agency is failing to recognize how the RAC‘s independence, special expertise, and transparency make it uniquely positioned to identify, consider, and address ethical and social implications of the newest genetic technologies and foster public understanding of, and trust in, emerging genetic science.

Nowhere is this more apparent than with respect to the NIH’s proposal to remove the RAC’s protocol review authority and make it solely an advisory committee. The publicly available review of protocols by the RAC allows for important public deliberation about whether certain types of human subjects research—for instance, research on germline editing—should be initiated in the first place. This type of review is an important complement to local IRB and IBC review.

PRIM&R concludes its comments with a request that NIH leadership preserve the RAC’s status as a public forum and provide more detail about its future plans for the RAC.

The NIH is asking interested parties to send their comments to SciencePolicy@od.nih.gov. Due to technical issues, the National Institutes of Health (NIH) extended their public comment period to October 25, 2018. We also encourage and welcome you to share your thoughts on our comments or the NIH proposal by leaving a comment below.

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One thought on “PRIM&R Comments on NIH’s Proposal to Amend Guidelines on Research Involving Recombinant or Synthetic Nucleic Acid Molecules

  1. William L Freeman

    PRIM&R & Director Hurley,
    Thank you for your submission.
    Your comment correctly agrees with the need to streamline current duplicating reviews. But your comment also correctly points out, the NIH proposal has the following fatal flaws, expressed in my language:
    1] It proposes that we accept both its change of the RAC plus a promised revised “RAC” — without revealing what that revised RAC will be. (Say WHAT! In the vernacular, such a sale is called being asked to “buy a pig in a poke.”)
    2] It proposes to totally ignore or reject NASEM’s 5 strong recommendations #s 7.1 to 7.5 in Chapter 7 in the 2017 NAP report. It provides not a single substantive reason to ignore or reject those 5 strong recommendations, in either the proposal itself nor the article in the New England Journal of Medicine. (The latter cited the NAP 2014 report, but not NASEM’s 2017 report.)