Biosafety at NIH and Beyond….A Shared Responsibility

Co-Authored by Carrie Wolinetz and Deborah Wilson

Following this week’s release of the Office of Science and Technology Policy’s joint memo on biosafety and biosecurity, coming at the tail end of National Biosafety Stewardship Month, it seems like an excellent time to discuss how NIH helps ensure the research we conduct at our own facilities as well as the research we fund across the globe is done safely.

Here at NIH, the NIH Division of Occupational Health and Safety (DOHS) is responsible for overseeing the day-to-day operations of a large and diverse biosafety program. A committed team of biosafety professionals helps ensure that the vital research being carried out by NIH is being done safely. To manage the unique challenges associated with the NIH intramural program, DOHS must be flexible in order to adapt to the changing research landscape.  Recently, DOHS has instituted changes to NIH policies for working with and storing potentially hazardous biological agents including human, plant, and/or animal infectious agents, poisons and toxins. These are significant changes to the way NIH has been doing business for almost four decades. Although NIH registers, reviews, and approves all active work with human pathogens and research involving non-exempt recombinant nucleic acids, it became clear we also needed to re-evaluate and optimize the methods used for keeping track of all biological agents that might have been stored in laboratories or repositories. In addition to support received from senior NIH management, a plan for interactions and information sharing was developed.  A continuous, open dialogue with NIH’s safety committees, such as the institutional biosafety committee (IBC), was also essential to invoking changes to long-standing programs and processes.

In support of the biosafety programs of the institutions that NIH funds, the NIH Office of Science Policy (OSP) conducts an extensive program of outreach and education on topics related to biosafety.  One of the signature programs in OSP is our extramural site visit program for grantee institutions.   The aim of these educational visits is to enable NIH to have a face to face dialog with institutions and to assist IBCs with their programs of biosafety oversight.  The visit includes a review of the policies and procedures that the institution is implementing to ensure the safe conduct of recombinant or synthetic nucleic acid research.  To date, OSP has visited over 110 institutions, and a write up of the program received the 2015 Richard C. Knudsen Memorial Publication Award from the American Biological Safety Association.

OSP has also used the information we have gathered from our site visits to develop a body of information on best practices, in particular the IBC Self-Assessment tool which institutions can use to evaluate their own IBC program.  We encourage all institutions to use the self-assessment tool, which addresses all of the major requirements of the NIH Guidelines.

These are just of few examples NIH is doing to ensure essential biomedical research is conducted safely.  Biosafety is a shared responsibility for all those involved in the research enterprise.  The close and collaborative relationship between the DOHS and OSP help ensure that NIH is at the top of the class with respect to biosafety oversight.  To learn more about NIH’s intramural biosafety program, please visit  More information on how NIH engages our extramural grantee institutions with respect to biosafety can be found at: /office-biotechnology-activities

RADM Deborah Wilson, Dr.P.H., is the Director of the Division of Occupational Health and Safety at NIH