Human Subjects Federalwide Assurances

This SOP is for grants only.

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 in 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 PI who conducts human subjects research without a valid FWA may face serious repercussions.

To get an FWA, follow these steps:

• Go to OHRP's Assurances Web page for basic information and to see whether your institution is registered.
• Negotiate a single institutional FWA with OHRP, following a two-step process:
  1. Ensure that any institutional review board (IRB) or independent ethics committee (IEC) cited in the assurance application is registered with OHRP. Read the Human Subjects Certifications: IRB or IEC SOP for details.
  2. Complete an FWA application.
• Go to Registration of an Institutional Review Board or Independent Ethics Committee to register, update, or renew a Federalwide Assurance.
• Update the FWA when changes occur and renew it every three years. For information and instructions, see Update and Renewal of Domestic or International Federalwide Assurances.

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 subject 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 a 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 Contact Staff for 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

FAQs on Assurances OHRP Web page

Guidance on Extension of an FWA to Cover Collaborating Individual Investigators and Introduction of the Individual Investigator Agreement

How to Write a Human Subjects Application

Human Subjects questions and answers

Human Subjects SOP list

NIAID's Human Subjects and Clinical Research Web page

NIH Grants Policy Statement, Human Subjects

OHRP: Assurances and IRB Registration and Guidance Topics, section of OER Web page

Policy Guidance OHRP Web page

Trans NIAID Clinical Research Toolkit