To many scientists, the name Asilomar is synonymous with an historic event in the regulation of biotechnology. In 1975, experts from around the globe convened at the Asilomar conference center in California to discuss the promise and potential perils of an exciting and emerging technique, recombinant DNA technology. The discussion laid the foundation for the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) The NIH Guidelines, aimed at ensuring the safe conduct of this burgeoning area of research, also gave rise to the Recombinant DNA Advisory Committee (known simply as “the RAC”), an expert group comprising scientists, ethicists, public health experts, biosafety officials, and more, charged with providing advice to the NIH on matters related to recombinant DNA technology. In the late 1980s, the RAC took on a new role: advising NIH on the promising but very new area of human gene transfer research.
Forty years after Asilomar, recombinant DNA technology is ubiquitous in both basic and clinical research settings. As scientific understanding of recombinant DNA technology has evolved, so have the requirements that govern its use. With this in mind, NIH has been examining the current oversight system for human gene transfer experiments and whether the review processes can be streamlined. To help craft a policy that maximizes scientific advances while ensuring public safety and trust, NIH asked the Institute of Medicine (IOM) to assess the role of the RAC in the oversight of human gene transfer research. The IOM noted in its report that the RAC has served a valuable role, but concluded that the current level of oversight over each individual human gene transfer protocol is no longer justifiable. The NIH agreed with this assessment and began developing a proposal for revising the process.
I am delighted to announce that today the proposal to simplify the human gene transfer protocol review process has been published in the Federal Register for public comment. In short, NIH is proposing that protocols should only be reviewed by the RAC if an institutional oversight body (such as an Institutional Review Board or an Institutional Biosafety Committee) requests review because the proposed research is sufficiently novel.
This change is in keeping with current practice, as these committees have played a large role in overseeing this research for decades and have the expertise needed to ensure research is conducted in accordance with the highest scientific, safety, and ethical standards.
I encourage research stakeholders to provide feedback on the proposal during the 45 day comment period. Once NIH has considered all input, a final notice outlining the changes will be posted. Until then, the current requirements are still applicable. This represents an important science policy principle: As science evolves, so must the policies that govern it.
I look forward to hearing your comments.