Notice Number: NOT-OD-15-017
Key Dates
Release Date: November 21, 2014
None
Issued by
National Institutes of Health (NIH)
Purpose
On September 24, 2014, the Federal Government issued a Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (hereafter referred to as “the Policy”). Institutions have one year (until September 24, 2015) to establish the necessary infrastructure to come into full compliance with the Policy. The purpose of this Guide Notice is to make institutions aware of the Policy’s issuance and to describe NIH’s expectations for implementation of the Policy regarding research projects funded by NIH grants and cooperative agreements.
Background
Dual use research of concern (DURC) is defined as “life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.” Despite its value and benefits, some products of research may be misused for harmful purposes. The fundamental aim of this oversight policy is to preserve the benefits of life sciences research while minimizing the risk of misuse of the knowledge, information, products, or technologies provided by such research.
The Policy applies to all research projects (regardless of funding source) that involve one or more of 15 listed agents and toxins and are conducted at or sponsored by an organization that receives Federal support for life sciences research. The Policy requires that institutions review research involving these agents to determine whether it can be anticipated to result in specified experimental effects, and if so, whether these projects constitute DURC. The Policy specifies the responsibilities of Principal Investigators, the Institutional Contact for Dual Use Research of Concern, the Institutional Review Entity, and the grantee institution with respect to research subject to the Policy.
NIH Policy and Implementation
This policy applies to all New and Renewal awards issued on applications submitted on or after January 25, 2015, and to all non-competing continuation awards issued on or after January 25, 2015. Institutions must then implement the Policy by September 25, 2015. NIH grantee institutions and their investigators conducting life sciences research subject to the Policy have a number of responsibilities that they must fulfill. This Notice does not recapitulate all of them, but highlights a few. Institutions should reference the actual policy, available at http://www.phe.gov/s3/dualuse, for a comprehensive listing of those requirements.
Notably, by September 24, 2015, institutions must establish a standing Institutional Review Entity (IRE). Starting on that date, the IRE will be required to identify DURC as described by the scope of the Policy and assess such research for the benefits and risks associated with its conduct and communication. This assessment must be performed when research (regardless of the source of funding) is identified that involves one or more of the 15 agents and toxins listed in the Policy and are conducted at or sponsored by an organization that receives Federal support for life sciences research.
If research funded by NIH is assessed by the IRE for DURC potential, the institution will be required to notify the Grants Management Official listed on the Notice of Award of the results of the IRE review process within 30 days. In instances when the research is determined to be DURC, NIH will work with the institutions and investigators conducting the research to develop an appropriate risk mitigation plan to minimize the risk of misuse of the knowledge, information, products, or technologies generated by the research. This may be implemented through a term of award. If, during the course of conducting research, the research becomes DURC, the grantee will be required to inform NIH immediately of the change in DURC status and to develop a risk mitigation plan as outlined above. The institution will be responsible for ensuring that DURC is conducted in accordance with the approved risk mitigation plan. Within 30 calendar days of identifying non-compliance, the institution will have to report to NIH any instances of noncompliance with the Policy, as well as measures undertaken by the institution to prevent recurrences of similar situations of noncompliance.
If an institution subject to the policy identifies any non-US Government (USG) funded research as DURC, notification should be made within 30 days to the NIH Program on Biosecurity and Biosafety Policy (See contact details listed below). Failure of NIH grantees to comply with the Policy and any special award terms and conditions may result in an enforcement action as outlined in the NIH Grants Policy Statement, “Section 8.5, Special Award Conditions and Enforcement Actions” available at: https://grants.nih.gov/grants/policy/policy.htm#gps.
Resources
To assist institutions in implementing the Policy, the USG has developed “A Companion Guide to the USG Policies for Oversight of Life Sciences Dual Use Research of Concern” (Companion Guide). The Companion Guide offers tools that promote the understanding and identification of DURC, risk assessment and development of risk mitigation plans and risk management processes, the responsible communication of DURC, and training and education on the DURC issue.
Additional educational tools and resources can be found on the U.S. Government Science, Safety, Security (S3) website: http://www.phe.gov/s3/dualuse.
Inquiries
Inquires about this notice should be directed to:
Program on Biosecurity and Biosafety Policy
Office of the Director
National Institute of Health
Telephone: 301-496-9838
Email: [email protected]
Inquiries regarding specific grant applications or projects that may be subject to this policy should be directed to the assigned Program Official of the relevant NIH Institute or Center.
General inquiries about the Policy should be directed to:
White House Office of Science and Technology
Email: [email protected]
and Human Services (HHS)
