Page:Interim Staff Report on Investigation into Risky MPXV Experiment at the National Institute of Allergy and Infectious Diseases.pdf/56

As prepared Jeffrey Potts, MPH, CBSP

My name is Jeff Potts, and I am currently the Chief of the Biorisk Management Branch within the NIH Division of Occupational Health and Safety. The DOHS, which resides within the Office of the Director, provides leadership in the development and implementation of occupational health policies, standards, and procedures applicable to biomedical research that is conducted throughout our intramural program. Specifically, the Biorisk Management Branch is responsible for providing regulatory compliance oversight and expert guidance to the NIH community for matters involving research with high-consequence pathogens. Among other activities, the Biorisk Management branch is responsible for implementing the NIH Select Agent Program and administering the NIH Institutional Biosafety Committee and Institutional Review Entity.

Compliance with, and constant oversight over, the implementation of biosafety standards is extremely important to our mission. At NIH, all research involving human, plant, or animal pathogens as well as experiments involving recombinant or synthetic nucleic acid molecules, are reviewed and assessed by the IBC and if applicable, the IRE. Together, these committees review submitted proposals to ensure compliance with the NIH Guidelines, the BMBL, USG Policies involving Dual Use Research of Concern and the USG P3CO framework. The NIH has been a leader in this effort starting back in 2009 and most recently, evaluating our review process against the proposed recommendations of the NSABB.

Dr. Moss does not have approval to perform the specific experiments identified as the “Clade I study”. If Dr. Moss formally proposes this line of research in the future, it would be subject to a rigorous evaluation and review by the committees which I have already mentioned. This process would be true of any formally proposed research at NIH. Our office is fully committed to ensuring compliance with all applicable regulations and policies. We will continue to monitor this research and future regulatory changes for any impact that it might have on our internal review processes.