Author: Kherlen Martin

On May 6, 2024, the White House Office of Science and Technology Policy (OSTP) released an expanded and unified Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential.

This new U.S. Government-wide policy, which combines the current dual use research of concern and enhanced potential pandemic pathogen oversight frameworks, expands the scope of research requiring additional scrutiny and strengthens our partnership with institutions to ensure robust review and oversight.

NIH will work closely with the biomedical research community as we move towards the policy’s year effective date. We encourage the biomedical research community to review OSTP’s extensive guidance developed to assist with implementation (http://aspr.hhs.gov/S3/Documents/USG-Policy-for-Oversight-of-DURC-and-PEPP-May2024-508.pdf)

Dr. Monica Bertagnolli, NIH Director, issued a statement upon the Policy’s release which can viewed at: https://www.nih.gov/about-nih/who-we-are/nih-director/statements/statement-release-usg-policy-oversight-dual-use-research-concern-pathogens-enhanced-pandemic-potential

Do you like a fast-paced environment where your work drives evidence-based policies to support the health of the Nation?  If so, a career in the NIH Office of Science Policy (OSP) might be the place for you.  OSP works across the biomedical research enterprise to ensure NIH policy evolves in tandem with rapidly advancing science and technology.

The successful candidate will work on a broad range of cross-cutting biomedical research issues affecting NIH, focusing specifically on those affecting the clinical research enterprise. Specific duties would involve reviewing, analyzing, evaluating, and participating in the development of new Federal policies to promote the coordination, standardization, and streamlining of federal requirements pertaining to clinical research, with a specific focus on enhancing protections for participants in clinical research.

This vacancy will be open until April 15, 2024.  Full information on how to apply can be found at:

• NIH-OD-DE-24-12352367                                                    
  Applicants without prior Federal service, Federal employees without competitive service status, or those with status.
• NIH-OD-MP-24-12352364
  Current and former Federal employees with competitive status, those eligible for noncompetitive consideration, and certain veterans eligible under the Veterans Employment Opportunity Act of 1998 (VEOA).

Please contact OSP Chief of Staff, Kelly Fennington at [email protected], with any questions.  Also, you can follow us on X: @NIH_OSP

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NIH has revised the NIH Guidelines to specify biosafety practices for research involving gene drive modified organisms (GDMOs) in contained research settings.  These revisions include: 

Specifying the minimum containment requirement for research involving GDMOs;  

Articulating considerations for risk assessment and additional responsibilities for Institutional Biosafety Committees (IBCs) and Biosafety Officers 

NIH previously published a Request for Information (RFI) in August 2023 seeking public input on proposed revisions. The proposed revisions were informed by recommendations contained in the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC) report, Gene Drives in Biomedical Research.   

The revised version of the NIH Guidelines is available at https://osp.od.nih.gov/wp-content/uploads/NIH_Guidelines.htm. To assist IBCs, biosafety professionals, and investigators with implementation of these changes, OSP has developed a reference document to help ensure the safe and responsible conduct of research involving GDMOs in contained research settings.   Questions may be sent to [email protected].  Also, please consider following us on X @NIH_OSP.

The NIH Office of Science Policy has published a summary of proceedings from its workshop on Transforming Discoveries into Products: Maximizing NIH’s Levers to Catalyze Technology Transfer. This workshop focused on how NIH approaches patenting and licensing inventions from its intramural research program. Throughout the workshop, panelists, presenters, and the public explored how NIH decides what to patent and license, who NIH partners with, and how NIH negotiates those agreements.

The summary of the workshop, along with the webcast of the meeting and other associated meeting materials, can be found on the workshop website.

Please contact OSP at [email protected] with any questions.  If you are not yet a subscriber to this listserv, please sign up here. Also, you can follow us on X: @NIH_OSP