At a glance
See below for requirements related to the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern.
Overview
Research oversight is a critical component of effective biosafety and biosecurity practices and the responsible conduct of research involving biological agents and toxins. As part of ongoing updates and assessments of existing policies, the United States Government (USG) released the U.S. Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (herein referred to as the DURC/PEPP Policy), which merges, revises, and supersedes the United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern (2012 Federal DURC Policy), the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (2014 Institutional DURC Policy), the Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight (2017 OSTP P3CO Policy Guidance), and the Department of Health and Human Services (HHS) Framework for Guiding Funding Decisions about Proposed Research Involving Enhanced Potential Pandemic Pathogens (2017 HHS P3CO Framework). To better streamline implementation, the new DURC/PEPP Policy defines and outlines oversight requirements for two categories of research at USG-funded institutions — "Category 1 research" involving dual use research of concern (DURC), and "Category 2 research" involving pathogens with enhanced pandemic potential (PEPP), as defined therein.
The DURC/PEPP Policy expands oversight of DURC to a wider scope of agents including all Select Agents and Toxins, all Risk Group 4 and most Risk Group 3 agents listed in the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), and biological agents added during future updates to the DURC/PEPP Policy Implementation Guidance. There will be new oversight roles for researchers, applicants, recipients, CDC, and HHS. The DURC/PEPP Policy addresses the identification and mitigation of biosafety, biosecurity, and information risks associated with manipulation of certain pathogens that could cause significant harm to society, be it accidental or intentional. Updates reflect the evolving nature of scientific and technological risks.
Per the DURC/PEPP Policy, CDC will not fund Category 1 or Category 2 research in countries identified by the USG as posing risks (hereafter, "Countries of Concern"). The current Countries of Concern, listed in the DURC/PEPP Policy Implementation Guidance, are the Democratic People's Republic of Korea (DPRK), the Islamic Republic of Iran, the Russian Federation, the People's Republic of China (along with the Special Administrative Regions of Hong Kong and Macau, for the purposes of this policy), Cuba, Syria, and Venezuela. This list is subject to change as determined by the USG.
It is the responsibility of all CDC applicants and recipients, through their Principal Investigators (PD/PIs) and other Senior/Key Personnel ("researchers") named in the application, to assess whether or not their research, for which CDC funding is received or sought, falls under the scope of Category 1 and/or Category 2 research. Applicants and recipients seeking to conduct research within the scope of this policy will be required to have an Institutional Review Entity (IRE) and an Institutional Contact for Dual Use Research (ICDUR). Composition and responsibilities of the IRE and ICDUR are outlined in the DURC/PEPP Policy. Researchers must work with their IRE to develop a risk-benefit assessment and risk mitigation plan, as needed, that must be approved by CDC before this work can begin or continue. Once awarded, recipients, through their PD/PIs, must carry out and oversee research according to the approved plan. Recipients and applicants are expected to develop necessary infrastructure and personnel to comply with the DURC/PEPP Policy.
CDC strongly recommends institutions begin training relevant staff on the DURC/PEPP Policy. Non-compliance with this Policy may result in suspension, limitation, restriction, or termination of U.S. Government (USG) funding, or loss of future USG funding opportunities for the non-compliant USG-funded research project and of USG funds for other life sciences research at the institution, consistent with existing regulations and policies governing USG funded research and may subject the institution to other potential penalties under applicable laws and regulations.