Some links will work for NIAID staff only.
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Standard Operating Procedure Table of Contents
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Purpose
To ensure that investigators take training in protecting 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
- 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.
- 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 take
a look at the Human Subjects SOPs.
Grantees
- 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 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 Cindy McDermott, cm550v@nih.gov, 301-594-7456.
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
How to Write a Human Subjects Grant Application
Human Subjects questions and answers
Human Subjects Research Requirements SOP and other Human Subjects SOPs
NIAID's Human Subjects, Clinical Research Web page
Policy Guidance OHRP
Web page
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
Trans
NIAID Clinical Research Toolkit
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