NIH Guidelines

[NEW] FAQs – Interim Laboratory Biosafety Guidance for Research with SARS-CoV-2 and IBC Requirements under the NIH Guidelines

[NEW] Release of Client-Owned Animals After Participation in Research Subject to the NIH Guidelines

Amendments to Streamline Review of Gene Therapy Trials and Transform the RAC to NExTRAC – April 2019

On August 16, 2018, the NIH Director issued a statement describing a proposal to streamline the federal framework for oversight of gene therapy. This proposal, which was developed in conjunction with the Food and Drug Administration, included amending the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) to eliminate duplicative review and reporting requirements for human gene transfer protocols. The statement also describes NIH’s effort to refocus the role of the NIH Recombinant DNA Advisory Committee (RAC) to be closer to its original mandate – a transparent forum for science, safety, and ethics of emerging biotechnologies. After a 60-day public comment period, the NIH Guidelines have been updated to reflect these changes and the RAC has been renamed the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC).

The charter of the NExTRAC reflects the shift in focus of the committee while embracing the continuity of this important advisory committee.

Federal Register Notice

Charter of the NExTRAC

NIH Director’s Statement

Under the Poliscope Blog

NIH Guide to Grants and Contracts Notice

The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) detail safety practices and containment procedures for basic and clinical research involving recombinant or synthetic nucleic acid molecules, including the creation and use of organisms and viruses containing recombinant or synthetic nucleic acid molecules.

IBC Self-Assessment Tool

Incident Reporting

The NIH Guidelines require that any significant problems, violations, or any significant research-related accidents and illnesses” be reported to OSP within 30 days. Appendix G of the NIH Guidelines specifies certain types of accidents that must be reported on a more expedited basis. Specifically, Appendix G-II-B-2-k requires that spills and accidents in BL2 laboratories resulting in an overt exposure must be immediately reported to the OSP (as well as the IBC). In addition, Appendices G-II-C-2-q and G-II-D-2-k require that spills or accidents occurring in high containment (BL3 or BL4) laboratories resulting in an overt or potential exposure must be immediately reported to OSP (as well as the IBC and BSO).

IBC RMS and Registration Information

The Institutional Biosafety Committee Registration Management System (IBC-RMS) supports the online submission of IBC registrations and annual registration updates. IBC-RMS users can access the system to keep track of their institution’s registration status, view IBCs currently registered with OSP, and access important compliance guidance relating to the NIH Guidelines. The IBC-RMS also allows users to send policy questions directly to OSP through the Web interface.

2020-05-14T15:40:23-04:00