November 30, 2001

NIH Publishes Changes in Safety Reporting Requirements

The NIH Nov. 19 published amendments to the NIH Guidelines for Research Involving Recombinant DNA Molecules to improve the reporting and analysis of serious adverse events in human gene transfer research. This action is the product of an extensive process of review and commentary by the public, two specially convened NIH working groups, the Recombinant DNA Advisory Committee, and various federal agencies. The substantive aspects of this notice remain the same as last proposed in December 2000. The four components of these amendments are the following:

• The NIH is modifying the scope of serious adverse events that are reportable on an expedited basis. Expedited reporting will be required for those serious adverse events that are unexpected and associated with the use of the gene transfer product. The amendments also clarify the timing for the reporting of these events. Note: These and other changes that concern adverse event and annual reporting requirements are not yet effective. The OMB is soliciting comments on the paperwork burden associated with this change in policy, per the Paperwork Reduction Act.
• The amendments clarify how the NIH handles information submitted in serious adverse event reports and annual reports that is labeled trade secret or confidential commercial information.
• The changes explicitly prohibit the submission of individually-identifiable patient information in serious adverse event and annual reports.
• The NIH is also establishing a working group of the NIH Recombinant DNA Advisory Committee (RAC), to be known as the NIH Gene Transfer Safety Assessment Board (GTSAB). The GTSAB will enhance the analysis of safety information from gene transfer studies and report on its findings to the RAC, thereby disseminating this important information to the scientific and patient communities, as well as the general public.

Information: Andrew Quon, AAMC Division of Biomedical and Health Sciences Research, 202-828-0485.