See the Glossary for more terms.
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This standard operating procedure (SOP) includes the following sections: Purpose, Procedure, Contacts, Links.
To ensure that investigators comply with the federal mandate to take training in the protection of human subjects.
NIH-funded domestic and international grantees conducting human subjects research must comply with federal law 45 CFR 46, Protection of Human Subjects, which requires all personnel involved in the design or conduct of human subjects research to receive training in the protection of human subjects.
This requirement applies to all human subjects research, i.e., both exempted and non-exempted human subjects code classifications.
NIH considers an institution engaged in human subjects research even if another institution performs the human subjects activities on the grant.
NIAID requests certification of training in the protection of human subjects as part of its just-in-time request, after the application is approved for funding and before NIH issues an award. See the Just-in-Time SOP.
Human subjects training certification is valid for the duration of the award.
See the following SOPs for information about other human subjects requirements:
Grantees: Contact the program officer or grants management specialist listed on your Notice of Award.
For questions about training in the protection of human subjects, contact Julia Shriner.
Chief Grants Management Officer—Mary Kirker
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NIAID Human Subjects Resources, including:
Policy & Guidance OHRP
Frequently Asked Questions on human subjects research requirement for education
Research Ethics Training Curriculum from Family Health International
Responsible Conduct of Research: Training
Last Updated November 24, 2014
Last Reviewed November 24, 2014