stage indicator - apply for a grant

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

Related procedure: Select Agent Awards SOP

Preparing for Award

  1. Program officers identify applications with select agents on the Program Officer Checklist and determine if select agent work will occur at a foreign institution. Follow the NIAID Select Agent Research Awards Process for additional steps.
  2. Grants management staff place a Select Agent Terms of Award for NIAID Grants on relevant awards to ensure that the grantee is aware of NIAID select agent policy, which states that no funds can be used for select agent work until it is reviewed and approved by the NIAID Division of Extramural Activities (DEA) director. See the Select Agent Awards SOP.

Institute Review

  1. NIAID’s Office of Extramural Research Policy and Operations (OERPO) requests that the principal investigator and responsible official at the foreign institution provide the following information for review by CDC’s Division of Select Agents and Toxins (DSAT) and the NIH-chaired Interagency Select Agent Review Group (ISARG):
    1. Completed APHIS/CDC Form 1 Registration for Possession, Use, and Transfer of Select Agents and Toxins based on the select agents being used in the grant. Foreign institutions cannot register electronically like U.S. institutions do. Therefore, NIAID will provide the appropriate APHIS/CDC Form 1 to the foreign institution for completion via the Federal Select Agent Program (FSAP) eFSAP system.
      • The FSAP also maintains Select Agents and Toxins lists, exclusions, and other information needed to fulfill select agent requirements.
      • The grantee institution's signing official and the responsible official (or alternate) named on APHIS/CDC Form 1 must ensure that facilities meet their institution's requirements to work safely with select agents, only authorized personnel have access to select agents, and the institution keeps records of select agents transferred to and from its facilities.
    2. Completed NIAID Attachment A: Non-U.S. Institution’s Procedure for Personnel Security Risk Assessment. NIAID will provide this form to the foreign institution for completion.
    3. If restricted experiments are to be conducted with select agents at a foreign laboratory, a Request To Conduct a Restricted Experiment must also be submitted. The Restricted Experiment Guidance Document has information concerning restricted experiments with select agents and how to make a Request To Conduct a Restricted Experiment or Transfer of a Product Resulting From a Restricted Experiment.
  2. Because foreign institutions do not register with the Federal Select Agent Program as U.S. institutions do, they will receive a request to submit all required forms mentioned above directly to the NIAID OERPO policy officer through the NIH Secure Email and File Transfer (SEFT) Service (not via the eFSAP system or to the CDC or USDA as indicated in FSAP instructions to U.S. institutions) to initiate the NIAID foreign institution review process.
  3. NIAID’s CDC DSAT representative conducts the initial review of the APHIS/CDC Form 1, NIAID Attachment A, and other information submitted by the institution’s responsible official. After this, CDC performs a site visit to assess whether the foreign institution’s policies for the possession, use, or transfer of select agents, and assurance from the institutional responsible official, demonstrate that processes comparable to that described for U.S. institutions in 42 CFR 73 are in place and will be administered on behalf of all select agent work sponsored by NIH funds.
  4. ISARG, whose members are federal employees with experience in select agent research or policies, reviews the CDC report and submitted Attachment A to determine whether the laws, regulations, policies, and procedures applicable to that foreign institution for the safe and secure possession, use, and/or transfer of select agents are comparable to U.S. select agent regulations.
  5. NIH funds cannot be used for work involving select agents at foreign institutions without the recommendation of the ISARG and written approval by the DEA director. Based on the ISARG recommendation, the DEA director may waive funding restrictions on the proposed research. After the DEA director approves, the foreign institution can use the restricted funds.
  6. Every foreign laboratory will be reviewed at a minimum of every three years after the initial review. As part of this reassessment, CDC will check that any required remediations are implemented at the foreign institution and review updates as required for NIAID awards that include foreign institutions. The ISARG will review the new CDC report and make a recommendation to the DEA director on whether to continue the use of funds for the foreign select agent research.

For more information and contacts, refer to the Select Agent Awards SOP.

Content last reviewed on