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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 ensure that the grantee is aware of NIAID's select agents 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.

Institute Review

  1. NIAID Office of Research Training and Special Programs 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.
    2. Information provided on Form 1 will be reviewed during the laboratory visit. Every foreign laboratory will be visited.
    3. Information about any restricted experiments with select agents to be conducted in the foreign laboratory.
    4. 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.
    5. 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.
  2. CDC represents NIAID to perform foreign laboratory visits of NIAID awards that include foreign institutions.
  3. ISARG reviews each CDC laboratory visit report, and institutional personnel security risk assessment policy. ISARG members are federal employees with experience in select agent research or policies.

Outcome of NIAID Review

  1. ISARG makes a recommendation to the DEA director whether satisfactory select agent compliance has been met and whether the restriction should be waived.
  2. After the DEA director approves, the restricted funds can be used. A laboratory revisit is needed every three years.

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 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 January 09, 2013

Last Reviewed January 09, 2013