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Human Subjects Research Training SOP

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This standard operating procedure (SOP) includes the following sections: Purpose, Procedure, Contacts, Links.

Purpose

To ensure that investigators comply with the federal mandate to take training in the protection of human subjects.

Procedure

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:

Applicants and Grantees

  • Complete training in the protection of human subjects for yourself and all personnel involved in the design or conduct of human subject research. You have two options:
    • Training provided by your institution.
    • NIH's Protecting Human Research Participants training, which takes approximately three hours to complete and consists of seven modules on principles, regulations, policies, and guidance related to research using human subjects.
  • If your Notice of Award includes a restrictive term, do not conduct any human subjects research with federal funds—even if you have completed your training in the protection of human subjects.
  • For new or renewal applications, provide the following information as part of your just-in-time documents:
    • List of all personnel in the application involved in the design or conduct of human subjects research, including those located at consortium, subaward, fee-for-service, consultant, or alternative performance sites.
    • Title and one-sentence description of the training course.
    • Signature of the authorized organizational representative (AOR).
  • For progress reports, provide documentation that anybody who is new to the award or newly involved in the design or conduct of human subjects research has received human subjects research training.

Program Staff

  • For new or renewal applications and administrative actions, identify awardees and performance sites engaged in human subjects research and confirm all personnel involved have submitted their documentation.
  • For progress reports, identify anybody new to the award or newly involved in the design or conduct of human subjects research and ensure training certification is included in the progress report.

Grants Staff

  • For new or renewal applications and administrative actions:
    • Identify awardees and performance sites engaged in human subject research and confirm all personnel involved have submitted their documentation.
    • Include a restrictive term on the Notice of Award in the following circumstances:
      • Grantee cannot comply with human subjects training requirements.
      • Chief Grants Management Officer or official guidance instructs you to do so.
  • For progress reports:
    • Review previous Notice of Award and confirm all human subjects restrictions have been addressed.
    • If a restriction remains, contact the AOR immediately to resolve and confirm no human subjects activity was completed during the restricted period.
    • Identify anybody new to the award or newly involved in the design or conduct of human subjects research and ensure training certification is included.

Contacts

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

If you have knowledge to share or want more information on this topic, email deaweb@niaid.nih.gov with the title of this page or its URL and your question or comment. Thanks for helping us clarify and expand our knowledge base.

Links

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