Read the Federal Register posting here.
From the NIH:
The NIH Office of Biotechnology Activities (NIH OBA) proposes to revise the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) to streamline review of certain human gene transfer trials that present a low biosafety risk. Specifically, the NIH OBA proposes to remove the requirement that institutional biosafety committees (IBCs) review and approve certain human gene transfer clinical trials that use plasmids and certain attenuated, non-integrating viral vectors, provided the clinical trial follows an initial study in humans that was previously approved by an IBC registered with the OBA. This initial trial will have established the safety of the proposed dose of the gene transfer product (vector and transgene) in a comparable population (adults or children). The initial study should have been conducted in the same country as the proposed study to control for potential variability in infectious disease backgrounds of the participants.
An initial IBC review is important to evaluate the safety of the product and to set standards for administration; however, for well-characterized vectors, in the absence of any unexpected toxicities in the initial study, subsequent biosafety assessments may not provide any additional information. While a single IBC review does not pose an undue burden, as the gene transfer field advances and more Phase II and Phase III multisite trials are developed, the time, effort and expense associated with multiple IBC reviews can be significant without adding commensurate value in the form of additional recommendations to protect the health and safety of the subject, health care worker, and community.
IBCs play a critical role in the evaluation of new products and their review can inform other oversight bodies, such as Institutional Review Boards. However, given the competing demands on IBCs, this change will provide IBCs with the option of focusing their efforts on those clinical trials where review will be most productive. While IBCs will no longer be required to review all clinical trials using the same product, each institution can implement its own policies regarding the need to review such trials and the information that a principal investigator (PI) should submit regarding the safety of the previous trial. For example, an institution may designate the Biological Safety Officer and the IBC Chair to review data from the initial trial and determine whether a subsequent trial using the same agent meets the exemption criteria outlined herein. The institution may also set its own policies regarding the need for the PI to inform the IBC about enrollment, any relevant new biosafety findings, and completion of the trial.
This policy will only exempt human gene transfer clinical trials from IBC review under Section III-C-1. It does not apply to basic, nonclinical research. In addition, it does not create an exemption from registration of the trial with the NIH OBA or the Recombinant DNA Advisory Committee (RAC) review and reporting requirements. By continuing to require registration and reporting on these trials, the NIH OBA will be able to continue to monitor adverse events or incident reports of accidental exposures by health care workers delivering these agents and, if necessary, provide information regarding these events to investigators, IBCs, and the public. The NIH OBA will also be able to assess whether this change in policy has any adverse impact on the biosafety of gene transfer trials.
Comments:
Comments may be submitted to the NIH OBA by email at oba@od.nih.gov; by fax to 301-496-9839; or by mail to the NIH Office of Biotechnology Activities, National Institutes of Health, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892-7985. All written comments received in response to this notice will be available for public inspection in the NIH Office of Biotechnology Activities, 6705 Rockledge Drive, Suite 750, Bethesda, Maryland, weekdays between the hours of 8:30 a.m. and 5:00 p.m
Dates:
All comments should be submitted by June 12, 2013.
