NIAID Select Agent Research Review and Approval Procedure for New and Continuing Grants That Include Foreign Institutions

Preparing for award

1. Program officers identify applications with select agents on the program officer checklist.
2. Grants management staff place a Select Agent Terms of Award for NIAID Grants on relevant awards to:
   1. Ensure that the grantee is aware of NIAID's select agents policy, which indicates that no funds on select agent work can be used until it is reviewed and approved by the NIAID Interagency Select Agent Review Group. See the Select Agent Awards SOP.
   2. Provide the application number to the Office of International Extramural Activities (OIEA) in DEA.

Institute review

3. OIEA requests that the principal investigator and responsible official at the foreign institution provide the following information for review by the NIAID Interagency Select Agent Review Group (ISARG):
   1. Completed Form 1 Application for Laboratory Registration for Possession, Use, and Transfer of Select Agents and Toxins based on the select agent or agents being used. The National Select Agents Registry Program also maintains the HHS and USDA Select Agents and Toxins as well as information to help in determining which forms to complete.
      • Because the form will not be used for registration with the National Select Agents Registry Program, completed forms must be sent to NIAID, not CDC or USDA as indicated in the instructions.
      • Information provided on Form 1 will be reviewed during the laboratory inspection. Every foreign laboratory will be inspected.
   2. Information about policies for possession, use, and/or transfer of select agents, and assurance from the institutional responsible official that a process (comparable to that described in 42 CFR 73 for U.S. institutions) is in place and will be administered on behalf of all select agent work sponsored by NIH funds.
      • Institutions that currently do not have a policy equivalent to 42 CFR 73 must provide information delineating any laws, regulations, policies, and procedures applicable to the institution for the safe and secure possession, use, and/or transfer of select agents. If needed, an NIAID contractor can assist in gathering and submitting information.
   3. The institutional responsible official and the alternate responsible official must certify that facilities meet their institution's requirements to work safely with select agent(s), that only authorized personnel have access to select agents, and the institution keeps records of select agents transferred to and from their facilities.
4. CDC performs foreign laboratory inspections of NIAID awards that include foreign institutions.
5. ISARG reviews each awardee's research project, laboratory inspection report, and institutional policies and certification. ISARG members are federal employees with experience in select agent research or policies.

Outcome of NIAID review

6. ISARG makes a recommendation to the DEA director whether satisfactory select agent compliance has been met and whether the restriction should be waived.

Continuing and existing awards

For continuing grants or awards made before July 2003, when NIAID implemented this process, the principal investigator and responsible official were encouraged to quickly submit information described in Item 3 above. The principal investigator did not have to stop performing the research in the interim.

More information

If your research involves select agents, find more information in NIAID's Biodefense and Biosecurity portal.