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

Related procedure: Select Agent Awards SOP

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 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.
  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. Follow the NIAID Select Agent Research Awards Process.

Institute Review

  1. NIAID 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 the NIAID 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 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 the NIAID OERPO policy officer via the NIH Secure Email and File Transfer System (not CDC or USDA as indicated in the instructions).
    2. Completed NIAID Attachment A: Non-U.S. Institution’s Procedure for Personnel Security Risk Assessment.
    3. Information provided on APHIS/CDC Form 1 and NIAID Attachment A will be reviewed during the laboratory assessment. Every foreign laboratory will be reviewed every three years after the initial review.
    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.
    6. 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 the NIAID OERPO policy officer (not CDC or USDA).
  2. CDC conducts the initial review of the information submitted by the facility responsible official, performs the foreign laboratory site reviews, checks that remediations suggested by the site review 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 the ISARG 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 review is needed every three years after the initial review.
  3. NIH funds cannot be used for work involving select agents or toxins at foreign institutions without written approval from ISARG.

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

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