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Human Subjects Certifications: Training

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Standard Operating Procedure Table of Contents

Purpose

To ensure that investigators take training in the protection of human subjects.

Procedure

NIH sets policies for human subjects research according to federal law 45 CFR 46, Protection of Human Subjects. All NIH-funded domestic and international grantees conducting human subjects research must comply.

If your grant application includes human subjects research, you must comply with human subjects requirements. Once awarded, NIH considers your institution engaged in human subjects research even if another institution performs the human subjects activities for you.

Applicants and PIs

  • If your human subjects application falls within the fundable range, you will need to obtain training in the protection of human subjects for your PI and key personnel.
  • NIAID will request documentation of the training in the protection of human subjects just-in-time, after the application is approved for funding and before NIH issues an award. See the Just-in-Time SOP.
    • Send us a letter using our Sample Letter to Document Training in the Protection of Human Subjects.
    • List all persons in the application involved in the design and conduct of NIH-funded human subjects research, including those on consortiums or subawards; the title and one-sentence description of the course; and the signature of the authorized organizational representative.
  • Certification of IRB or IEC approval is also required. See the Human Subjects Certifications: IRB or IEC SOP.
  • To learn more about certification and assurance requirements go to the Human Subjects SOPs.

Grantees and PIs

  • Submit this certification of training once for the project period (the length of a grant).
  • For new key personnel who join the project following award, submit a certification of training in your progress report.
  • Do not conduct human subjects research if your award has a term restricting human subjects research. If you do, NIAID will reduce the award amount, and you will not be able to use any data you obtained during that time.

Program Staff

  • Identify awardees and performance sites.
  • Review progress reports. If new key personnel have joined the project, make sure they provide their certification of training in the protection of human subjects.

Grants Staff

  • Issue awards only after you receive the required certifications.
  • Issue a restricted award only at the end of the fiscal year when there is not enough time to get the certifications.
    • Follow up on restricted awards and issue a revised award once the required certifications have been approved.
    • If human subjects research was conducted during the restricted period, reduce the award accordingly.
  • For progress reports, ensure that new key personnel have submitted a certification of human subjects training.

Contacts

Grantees: Contact the program officer or grants management specialist listed on your Notice of Award.

For questions about using OHRP's electronic submission system, contact your regional or country coordinator.

For questions about training in the protection of human subjects, contact Ann Devine, 301-402-5601.

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 Application and Grant Handbook

Human Subjects questions and answers

Human Subjects Research Requirements SOP and other Human Subjects SOPs

NIAID Human Subjects Resources portal

Policy & Guidance OHRP

Protecting Human Research Participants

Requirement for Education on the Protection of Human Subjects—Frequently Asked Questions, NIH Web page

Research Ethics Training Curriculum from Family Health International

Responsible Conduct of Research: Training

Trans NIAID Clinical Research Toolkit

 

Last Updated September 25, 2013

Last Reviewed September 25, 2013