See the Glossary for more terms.
This SOP is for grants only.
This standard operating procedure (SOP) includes the following sections: Purpose, Procedure, Contacts, and Links.
To ensure that institutions receiving an HHS grant for human subjects research have an institutional Federalwide Assurance (FWA).
To determine whether your project qualifies as human subjects research, see the Decision Trees for Human Subjects Requirements. NIH sets policies for human subjects research according to federal law 45 CFR 46, Protection of Human Subjects, which applies to all domestic and international grants.
Institutions that are awarded funds for human subjects research are considered to be engaged in human subjects research and must have an approved FWA even if another institution performs the human subjects activities through a subaward.
For the full list of certification and assurance requirements, go to the Human Subjects Research Requirements SOP.
Before institutions may receive HHS support for non-exempt human subjects research, they must have an FWA approved by the HHS Office for Human Research Protections (OHRP). If the research is exempt, they do not need an FWA.
Do not conduct human subjects research before obtaining an OHRP-approved FWA. A principal investigator who conducts human subjects research without a valid FWA may face serious repercussions.
To get an FWA, follow these steps:
Go to Reviewers of Assurances and IRB Registrations to find the OHRP assurance coordinator for your state.
Applicants with questions should contact the appropriate program officer. See Communicating With NIAID—How to Get Help.
If you have knowledge to share or want more information on this topic, email firstname.lastname@example.org with this link and your message. Thanks for helping us clarify and expand our knowledge base.
Assurance Process - FAQs, OHRP
Guidance on Extension of an FWA to Cover Collaborating Individual Investigators and Introduction of the Individual Investigator Agreement
NIAID Human Subjects Application and Grant Handbook
Human Subjects Questions and Answers
Human Subjects SOPs
NIAID's Human Subjects Resources
NIH Grants Policy Statement, Human Subjects
OHRP: Assurances and IRB Registration and Guidance Topics
Policy Guidance, OHRP
Trans NIAID Clinical Research Toolkit
Last Updated March 17, 2015
Last Reviewed January 19, 2016