PURPOSE OF THIS POLICY

This Policy implements the United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (“USG Policy”). The USG Policy supersedes earlier United States Government Policy for dual use research of concern and potential pandemic pathogen oversight, i.e., the 2012 Federal DURC Policy, 2014 Institutional DURC Policy, and 2017 P3CO Framework. This Policy applies to all research, regardless of funding source, conducted at any Colorado State University (CSU) Location that may involve or potentially involve Dual Use Research of Concern (DURC) or Pathogens with Enhanced Pandemic Potential (PEPP), which is life sciences research that can be reasonably anticipated to provide knowledge, information, products, or technologies that could be intentionally misused to pose a significant threat, with broad potential consequences, to public health and safety, agriculture, food security, economic security, or national security. On a case-by-case basis, potential DURC/PEPP research not falling into Category 1 or 2 could also be subject to this Policy.

APPLICATION OF THIS POLICY

This policy applies to all persons employed by or acting on behalf of the University.

EXEMPTIONS FROM THIS POLICY

None.

DEFINITIONS USED IN THIS POLICY

CSU adopts the definitions provided in the USG Policy.

POLICY STATEMENT

CSU adopts the USG Policy for the institutional review and oversight of life sciences research that is within Category 1 and Category 2. Guidance on oversight implementation can be found in the USG Implementation Guidance (USG Guidance).

This CSU Policy is intended to comply with federal requirements for review of Category 1 and Category 2 research to:

• strengthen the institutional review and oversight by the University of specifically defined life sciences research,
• identify potential Category 1 and Category 2 research,
• develop and implement risk mitigation where appropriate,
• set forth instructions for individuals and committees at CSU who are responsible for the implementation of CSU’s requirements with respect to Category 1 and Category 2 research, and
• preserve the benefits of dual use life sciences research while minimizing the risk that outputs of such research would be intentionally used for harmful purposes.

In addition, CSU will follow the recommendations in the policy and review potential DURC/PEPP research that falls outside of the current policy on an as needed basis. In the event that research is found to be potential DURC/PEPP, the process described in this policy will be utilized.

POLICY PROVISIONS

Applicability

This policy and its oversight requirements apply to all Life Sciences research being performed at Colorado State University. CSU is committed to providing appropriate oversight for research that is within Category 1 and Category 2. Therefore, this Policy applies to any such research, regardless of funding source. On a case-by-case basis, potential DURC/PEPP research not falling into Category 1 or 2 could also be subject to this Policy. Non-compliance with this Policy may result in suspension, limitation, or termination of Life Sciences research at the institution.

Scope of Oversight Required Under this Policy

Category 1 and Category 2 Research Oversight Framework

The oversight framework for Category 1 and Category 2 research is provided in Section 5 of the USG Policy.

Responsibilities

CSU Vice President for Research (VPR) is responsible for ensuring compliance with this Policy, unless the VPR designates the responsibility to another institutional officer. The VPR must establish the Institutional Review Entity (IRE) in compliance with this Policy and designate an individual to serve as the Institutional Contact for Dual Use Research.

Institutional Contact for Dual Use Research (ICDUR) are the designated officials responsible for compliance implementation, including establishing appropriate procedures, documentation and training. ICDURs act as liaisons with the relevant U.S. funding agencies.

Principal Investigators of research projects must:

1. Be knowledgeable about, comply with, and follow all applicable institutional and U.S. government policies, requirements, and regulations for oversight of use, movement, and modifications of biological agents and toxins that may fall under Category 1 or Category 2 research.
2. Assess the research at the proposal stage, and continuously throughout the research progress, to reasonably anticipate if it will fall within the scope of Category 1 or Category 2 research.
3. Work with the IRE to draft a risk-benefit assessment and risk mitigation plan for Category 1 or Category 2 research and conduct Category 1 and Category 2 research in accordance with the provisions identified in the approved risk mitigation plan.
4. Comply with any local campus procedures implementing this Policy and any extramural contract and grant terms and conditions supporting their research

COMPLIANCE WITH THIS POLICY

Failure to comply with this Policy subjects the individual to potential criminal and civil penalties as well as University sanctions. Violations also subject the University to potentially serious sanctions, including loss of federal funding, and monetary penalties. The Office of Research Collaboration and Compliance (ORCC) will facilitate compliance through management and administration of standard operation procedures drafted and approved by the IRE.

REFERENCES

United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential – released May 4, 2024

USG Policy for Institutional Oversight of Life Science Dual Use Research of Concern – released September 24, 2014

United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern (“March 2012 DURC Policy”)

Training on the US Government Policy for Institutional Oversight of Life Sciences Dual Research of Concern

Department of Health and Human Services (DHHS) general information on the USG Dual Use Research Policy

Institutional Biosafety Committee

Biosafety Office

CDC Biosafety in Microbiological and Biomedical Laboratories

CSU Policy: Export Control

IBC Dual Use Research of Concern (DURC)

PROCEDURES, FORMS AND TOOLS

Institutional forms and procedures for review of research within Category 1 and Category 2 at CSU are available on the CSU/IBC DURC webpage.

An Implementation Guide, entitled "IMPLEMENTATION GUIDANCE for the United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential”, has been developed by the NIH. 

APPROVAL

Approved by Anthony A. Frank, President, September 18, 2015

Revision approved by Lynn Johnson, Vice President for University Operations on February 17, 2020

Revision approved by Brendan Hanlon, Vice President for University Operations, on January 10, 2023

Revision approved by Brendan Hanlon, Vice President for University Operations, on March 17, 2025