A select agent is a biological agent or toxin that has the potential to pose a severe threat to public health and safety, animal or plant health, or animal or plant product.

All domestic and foreign grants, cooperative agreements, and contracts that possess, use, or transfer select agents comply with NIAID and federal select agent policies as described here. NIAID also has special procedures for international awards.

If you’re looking for research topic ideas, check out NIAID priorities at Emerging Infectious Diseases/Pathogens. Many of those pathogens qualify as select agents.

Are You Planning Experiments With Select Agents?

First check if the work you plan involves a select agent or toxin. Use the Federal Select Agent Program’s up-to-date list of Select Agents and Toxins, which also lists exemptions, restricted experiments, and permissible amounts.

Then use the Flowchart for NIAID Select Agent Research Awards. The first slide walks you through the approval process for research using select agents and the second slide describes the restricted experiment review process for non-U.S. awardees.

If you do plan work with a select agent or toxin, describe the select agent use including restricted experiments in your application’s Research Plan (for grants) or technical proposal (for contracts).

Get more detail by reading the NIAID policy explanation below.

NIAID Select Agents Award Explanatory Statement for Awardee Institutions and Program Staff

All U.S. institutions and individuals that possess, use, or transfer select agents and toxins are required to adhere to the Federal Select Agent Program Regulations.

This policy also extends to research involving the select agents and toxins identified in the Select Agents and Toxins List of the Federal Select Agent Program as posing a severe threat to human and/or animal health, plant health, or animal and plant products.

These regulations establish requirements regarding registration, security risk assessments, safety plans, security plans, emergency response plans, training, transfers, record keeping, inspections, and notifications.

NIH has established a policy for the use of NIH funds for research involving select agents. NIAID is implementing this policy using the Select Agent Terms of Award for NIAID Grants or Select Agent Language for Solicitations and Contracts, which are included in any grant, cooperative agreement, or contract in which select agents are or will be used. The terms and conditions of award are in the accompanying document.

Awards to U.S. Institutions

Awards to U.S. institutions for research involving select agents will contain a Term of Award requiring registration with the Centers for Disease Control and Prevention (CDC) of HHS or Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture, depending on the agent, prior to using NIH funds for such research.

Awards to non-U.S. (Foreign) Institutions

Awards to non-U.S. institutions for research involving select agents will contain a Term of Award requiring U.S. review and approval of safety and security measures and practices prior to use of NIH funds for such research. An NIH-chaired committee of U.S. federal employees (including representatives of NIH grants and scientific program management, CDC, U.S. Department of Justice and other federal intelligence agencies, and U.S. Department of State) will assess the policies and procedures for comparability to the U.S. requirements described in 42 CFR Part 73.

Toward this end, awardee institutions must be willing to provide key information delineating any laws, regulations, policies, and procedures applicable to the institution for the safe and secure possession, use, and transfer of select agents. This includes concise summaries of safety, security, and training plans, and applicable laws, regulations, and policies.

For security risk assessments, awardee institutions must be willing to provide the names of all individuals who will have access to the select agents and procedures for ensuring that only approved and appropriate individuals have access to select agents that are the subject of the NIH award.

Awards to U.S. Institutions With Foreign Components

Awards to U.S. institutions with non-U.S. components for research involving select agents will contain a Term of Award (or a Special Contract Requirements Clause under Section H in the case of contract awards) requiring U.S. review and approval of safety and security measures and practices prior to use of NIH funds for such research.

An NIH-chaired committee of U.S. federal employees (including representatives of NIH grants and scientific program management, CDC, U.S. Department of Justice and other federal intelligence agencies, and U.S. Department of State) will assess the policies and procedures for comparability to the U.S. requirements described in the Federal Select Agent Program Regulations.

Toward this end, the U.S. awardee institution must be willing to provide key information delineating any laws, regulations, policies, and procedures applicable to the foreign institution for the safe and secure possession, use, and transfer of select agents. This includes concise summaries of safety, security, and training plans, and applicable laws, regulations and policies.

For security risk assessments, awardee institutions must be willing to provide the names of all individuals at the foreign institution who will have access to the select agents and procedures for ensuring that only approved/appropriate individuals have access to select agents that are the subject of the NIH award.

Additional Information for Awards That Include Foreign Institutions

If your award includes a foreign institution, read the questions and answers below as well as the following:

• Select Agent Research Review and Approval for Procedure for Grants That Include Foreign Institutions
• Select Agent Review and Approval Procedure for New and Existing Contracts That Include Foreign Institutions

More Information

Find more information on relevant NIAID research at Biodefense and Related Programs and Biodefense and Emerging Infectious Diseases.