Institutional Review Entity (DURC)

Mission/Goals

The Johns Hopkins Institutional Review Entity (IRE) assesses life sciences research that may fall under the definition of Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP) as established by the United States Government Policy for Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential.

If a research project is determined to meet the Policy’s definition of Category 1 or Category 2 research, the IRE will work with the PI on a Risk-Benefit Analysis and a Risk Mitigation Plan for approval by the appropriate funding agency. Once approved, the IRE and the PI will provide ongoing compliance oversight through the life of the project.

Background

It is the policy of the U.S. Government that federally funded intramural or extramural research that meets the scope of Category 1 or Category 2 research within this Policy is subject to federal and institutional oversight. The purpose of this oversight is to preserve the benefits of such research while minimizing the biosafety and biosecurity risks, including risks that the knowledge, information, products, or technologies generated by the research could be used in a manner that results in harm to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.

Research oversight is a critical component of effective biosafety and biosecurity practices and the responsible conduct of research involving biological agents and toxins. The intent of research oversight is to increase the awareness of researchers, research institutions, and federal funding agencies about the biosafety and biosecurity concerns associated with certain types of research and to ensure that appropriate risk mitigation measures are in place to prevent biosafety incidents (e.g., unintended personal exposure or release of an agent outside of containment) or biosecurity incidents (e.g., theft or intentional misuse of information, knowledge, products, or technology).

Institutions and investigators who receive federal funding are required, as a condition of that funding, to comply with the rules established by the US Government for DURC.

Compliance with The United States Government Policy for Dual Use Research of Concern and Pathogens with Pandemic Potential is in force beginning May 6, 2025.

An Implementation Guidance document provided by the United States Government is available here:

Implementation Guidance for the United States Government Policy for Dual Use Research of Concern and Pathogens with Pandemic Potential.