See the Glossary for more terms.
Some links will work for NIAID staff only.
This SOP is for grants only.
This standard operating procedure (SOP) includes the following sections: Purpose, Procedure, Contacts, and Links.
To ensure that investigators protect human subjects by having their applications reviewed by an institutional review board (IRB) for domestic applications or independent ethics committee (IEC) for foreign applications.
NIH sets policies for human subjects research according to federal law 45 CFR 46, Protection of Human Subjects. All domestic and international grantees funded by NIH and conducting human subjects research must comply.
To determine whether your project qualifies as human subjects research, go to Decision Trees for Human Subjects Requirements and read the following:
If your application proposes 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.
Often residing in local institutions, IRBs and IECs independently determine whether projects are human subjects research or are exempt according to 45 CFR Part 46.101(b).
Their responsibilities include the following:
The IRB or IEC chairperson or designated member reviews the research, retaining all authority except disapproval, which requires the full IRB or IEC.
In May 2004, HHS issued guidance for IRBs, IECs, investigators, and research institutions to avoid financial conflicts of interest that could harm human subjects. See Financial Relationships and Interests in Research Involving Human Subjects.
Grantees: Contact the appropriate 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.
If you have knowledge to share or want more information on this topic, email email@example.com.
FAQs on IRB Registration OHRP Web page
NIAID Human Subjects Application and Grant Handbook, an All About Grants tutorial
Human Subjects Questions and Answers
Human Subjects Research Requirements SOP and other Human Subjects SOPs
Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable, FDA document
NIAID Human Subjects Resources
OHRP: Assurances and IRB Registration and Guidance Topics
OHRP's Step-by-Step Instructions for Registering an IRB or IEC
Trans-NIAID Clinical Research Toolkit
Last Updated October 29, 2014
Last Reviewed January 19, 2016