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Human Subjects Federalwide Assurances

This SOP is for grants only.

Standard Operating Procedure Table of Contents

Purpose

To ensure that institutions receiving an HHS grant for human subjects research have an institutional Federalwide Assurance (FWA).

Procedure

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.

Applicant Institutions

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:

Program Officers

  • Identify performance sites other than the grantee that will require an FWA.
  • Notify the grants management specialist immediately if you find out that a grantee has conducted human subjects research without an approved assurance.
    • Work with the grantee to determine what human subjects research was involved.
    • Work with the grants management specialist and the NIH Grants Policy office to determine next steps.
    • Grantees who perform human subjects research without an FWA may face termination, withholding of funds, reduction of grant budget, or may be forced to pay back funds already spent.

Grants Staff

  • Never issue an award to an institution without an OHRP-approved FWA except at the end of the fiscal year when there is not enough time to negotiate an assurance. For institutions without an FWA, restrict the award.
  • Follow up on restricted awards and issue a revised award once an FWA has been approved.

Contacts

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 deaweb@niaid.nih.gov with this link and your message. Thanks for helping us clarify and expand our knowledge base.

Links

Assurance Process - FAQs OHRP Web page

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 SOP list

NIAID's Human Subjects Resources Web page

NIH Grants Policy Statement, Human Subjects

Lock icon: This link will not work for public visitors.OHRP: Assurances and IRB Registration and Guidance Topics

Policy Guidance OHRP Web page

Trans NIAID Clinical Research Toolkit

Last Updated February 14, 2013

Last Reviewed February 14, 2013