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

Preparing for Award

  1. 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's select agent policy, which states that no funds can be used for select agent work until it is reviewed and approved by the NIAID DEA director. See the Select Agent Awards SOP.
  2. Program officers identify applications with select agents on the Program Officer Checklist and determine if select agent work will occur at a foreign institution. See Flowchart for NIAID Select Agent Research Awards (PowerPoint).

Institute Review

  1. NIAID Office of Extramural Research Policy and Operations 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 Registration for Possession, Use, and Transfer of Select Agents and Toxins based on the select agent or agents being used.
      • The Federal Select Agent Program also maintains Select Agents and Toxins that has information needed to fulfill select agent requirements.
      • Because the form will not be used for registration with the Federal Select Agent Program, send completed forms by email to NIAID DEA Policy Shop, (not CDC or USDA as indicated in the instructions).
    2. Information provided on Form 1 will be reviewed during the laboratory visit. Every foreign laboratory will be visited.
    3. Information about policies for possession, use, 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.
    4. 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, that only authorized personnel have access to select agents, and that the institution keeps records of select agents transferred to and from its facilities.
    5. If restricted experiments are to be conducted, submit a Request to Conduct a Restricted Experiment in addition to Form 1. 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. If restricted experiments are to be conducted in a foreign laboratory, complete a Request to Conduct a Restricted Experiment and email it to NIAID DEA Policy Shop (not CDC or USDA).
  2. CDC conducts the initial review of the information submitted by the facility responsible official, performs the foreign laboratory site visits, checks that remediations suggested by the site visit are completed, and reviews updates as required for NIAID awards that include foreign institutions.
  3. ISARG, whose members are federal employees with experience in select agent research or policies, reviews the CDC report and the institutional personnel security risk assessment policy to assure that laws, regulations, policies, and procedures applicable to that institution for the safe and secure possession, use, and/or transfer of select agents have been met.

Outcome of NIAID Review

  1. Based on ISARG’s recommendation, the DEA director may waive funding restrictions on the proposed research.
  2. After the DEA director approves, the institution can use the restricted funds. A laboratory revisit is needed every three years.
  3. NIH funds cannot be used for work involving select agents or toxins at foreign institutions without written approval from ISARG.

More Information

If your research project involves a restricted experiment with a select agent, see slide two of the Flowchart for NIAID Select Agent Research Awards (PowerPoint).

Find more information on NIAID's Biodefense and Select Agents portal.

Last Updated April 30, 2015

Last Reviewed April 30, 2015