Assurance Process FAQs

HHS human subject protection regulations and policies require that any institution engaged in non-exempt human subjects research conducted or supported by HHS must submit a written assurance of compliance to OHRP. The Federalwide Assurance (FWA) is the only type of assurance of compliance accepted and approved by OHRP. FWAs also are approved by the Office for Human Research Protections (OHRP) for federalwide use, which means that other federal departments and agencies that have adopted the Federal Policy for the Protection of Human Subjects (also known as the Common Rule) may rely on the FWA for the research that they conduct or support. Institutions engaging in research conducted or supported by non-HHS federal departments or agencies should consult with the sponsoring department or agency for guidance regarding whether the FWA is appropriate for the research in question.

An assurance of compliance is a written document submitted by an institution (not an Institutional Review Board) that is engaged in non-exempt human subjects research conducted or supported by HHS. Through the assurance of compliance, an institution commits to HHS that it will comply with the requirements set forth in the regulations for the protection of human subjects at 45 CFR part 46. The Federalwide Assurance is the only type of assurance of compliance accepted and approved by OHRP.

All institutions engaged in human subjects research that is not exempt from the regulations, and is conducted or supported by any HHS agency must be covered by an Office for Human Research Protections-approved assurance of compliance. The Federalwide Assurance (FWA) is the only type of assurance of compliance accepted and approved by OHRP.

An institution may extend its FWA to cover a collaborating individual investigator under certain conditions using the sample Individual Investigator Agreement or a comparable agreement developed by the institution.

In general, an institution is considered to be engaged in human subjects research when its employees or agents:

  1. obtain data about living individuals for research purposes through intervention or interaction with them,
  2. obtain individually identifiable private information for research purposes (45 CFR 46.102(d),(f)); or
  3. obtain the informed consent of human subjects..

Employees and agents, including students, are individuals performing institutionally designated activities and acting on behalf of the institution or exercising institutional authority or responsibility.

In general, an institution is considered to be engaged in human subjects research whenever it receives a direct HHS award to support such research, even if all of the human subjects activities will be performed by agents or employees of another institution. In general, simply informing potential subjects about a research study is not considered engagement in research. Also, providing written information about a research study, including how to contact the investigators for information and enrollment, and seeking and obtaining prospective subjects' permission for investigators to contact them are not considered engagement in research. However, obtaining informed consent from a research participant is considered engagement in research.

[For details, please see OHRP guidance on this topic at: http://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-engagement-of-institutions/index.html, specifically, Section (B)(4).]

The Federalwide Assurance (FWA) is the only type of assurance of compliance accepted and approved by OHRP for institutions engaged in non-exempt human subjects research conducted or supported by HHS. Under an FWA, an institution commits to HHS that it will comply with the requirements set forth in 45 CFR part 46, as well as the Terms of Assurance.

FWAs also are approved by OHRP for federalwide use, which means that other federal departments and agencies that have adopted the Federal Policy for the Protection of Human Subjects (also known as the Common Rule) may rely on the FWA for the research that they conduct or support. Institutions engaging in research conducted or supported by non-HHS federal departments or agencies should consult with the sponsoring department or agency for guidance regarding whether the FWA is appropriate for the research in question.

There is a single version of the FWA and the Terms of Assurance for domestic (U.S.) institutions and international (non-U.S.) institutions.

The FWA covers all non-exempt human subjects research at the submitting institution that is HHS-conducted or -supported or funded by any other federal department or agency that has adopted the Common Rule and relies upon the FWA. It is not project specific. Domestic institutions may voluntarily extend their FWA to cover all human subjects research at the submitting institution regardless of the source of support for the particular research activity.

The Federalwide Assurance (FWA) is effective for 5 years and must be renewed every 5 years, even if no changes have occurred, in order to maintain an active FWA. The institution must update its FWA within 90 days after changes occur regarding the legal name of the institution, the Human Protections Administrator, or the Signatory Official. Any renewal or update that is submitted electronically, and approved by OHRP, begins a new 5-year effective period.

The key features of the Federalwide Assurance (FWA) are the following:

  1. The identifying information for the institution filing the FWA, the Human Protections Administrator (or a reliable point of contact) at the institution, and the institutional official signing the FWA;
  2. A list of the institution’s legal components that operate under different names that will be covered by the FWA and the city and state or country where the component is located. (legal components are generally defined as parts of your institution that may be viewed as separate organizations, but remain part of the legal entity or institution, for example, ABC University can list its XYZ University Hospital, KLM School of Public Health, and EFG Institute for International Studies as components);
  3. A statement of ethical principles to be followed in protecting human subjects of research;
  4. An applicability statement indicating that the FWA applies whenever the institution becomes engaged in human subjects research conducted or supported by any United States (U.S.) federal department or agency that has adopted the U.S. Federal Policy for Protectionof Human Subjects (known as the Common Rule), unless the research is exempt from Common Rule requirements or a Common Rule agency or department determines the research will be conducted under a separate assurance of compliance. U.S. institutions may voluntarily extend the Common Rule or 45 CFR part 46 to all research conducted by the institution regardless of the source of support;
  5. An assurance of compliance indicating that the institution will comply with the Terms of the FWA.  An institution outside of the U.S. also must assure that it will comply with one or more procedural standards whenever it engages in research covered by the FWA. A list of 6 such standards is included or an institution can submit another standard for the protection of human subjects that is recognized by the Common Rule departments and agencies. (See Terms of Assurance, section 3(b));
  6. The designation of all internal IRBs that will review the research covered by the FWA. If the institution has no internal IRB, it must designate the external IRB that reviews all research covered by the FWA.  If the institution relies upon multiple external IRBs, the institution should designate the external IRB that reviews the largest percentage of the research covered by the FWA.  All IRBs designated on an institution’s FWA must be registered [http://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/irb-registration/index.html] with OHRP before the FWA can be approved).  Please note that all IRBs reviewing research covered by an instituion’s FWA must be registered whether or not they are designated on the institution’s FWA;
  7. Whenever the Institution relies upon an IRB operated by another institution or organization for review of research covered by the FWA, the institution must ensure that this arrangement is documented by a written agreement between the institution and the other organization or institution operating the IRB. The agreement must outline their relationship and include a commitment that the IRB will adhere to the requirements of the Institution’s FWA.  OHRP’s sample IRB Authorization Agreement may be used for this purpose, or the parties involved may develop their own agreement.  This agreement must be kept on file at both institutions/organizations and made available to OHRP or any U.S. federal department or agency conducting or supporting research covered by the FWA upon request;

The signature of an official authorized to represent the institution, identified on the FWA as Signatory Official. The Signatory Official must assure that human subjects research to which the FWA applies is conducted in accordance with the Terms of Assurance.  The Signatory Official must electronically sign the FWA using the electronic submission system available through the OHRP website at:http://ohrp.cit.nih.gov/efile/, unless the institution lacks the ability to submit its FWA electronically.The Signatory Offical typically is someone at the level of President, Chief Executive Officer, Chief Operating Officer, Director General, or Chancellor.

No. There is a single version of the FWA and the Terms of Assurance for U.S. and non-U.S. institutions.

OHRP is sometimes asked whether, if an international institution selects a procedural standard under the FWA that has less stringent requirements than 45 CFR part 46, the institution may disregard the more stringent requirements of 45 CFR part 46.

It is current OHRP policy that in the absence of an OHRP determination that a procedural standard affords protections equivalent to the protections provided by 45 CFR part 46, the requirements of 45 CFR part 46 must be applied to all research conducted or supported by HHS.

As described in a July 7, 2006 Federal Register notice (71 FR 38645) it is OHRP’s position that if an international institution selects a procedural standard under its FWA other than 45 CFR part 46, any requirements of 45 CFR part 46 still must be satisfied for non-exempt human subject research that is conducted or supported by HHS.

For example, the International Conference on Harmonization E-6 Guidelines for Good Clinical Practice (ICH-GCP-E6) do not specifically limit use of expedited review for research undergoing continuing review by the IRB. For research conducted or supported by HHS, if an international institution selected ICH-GCP-E6 as its primary procedural standard on its FWA, the IRB may only use an expedited review procedure to conduct continuing review of HHS-conducted or supported research if the research qualifies for expedited review as provided for under HHS regulations at 45 CFR 46.110.

Please note that the statements above pertain to compliance with the requirements of 45 CFR part 46 for non-exempt human subjects research that is conducted or supported by HHS. If the institution needs guidance regarding implementation of the Common Rule and/or other applicable U.S. federal regulations for research that is not conducted or supported by HHS, the institution should contact appropriate officials at the U.S. federal department or agency conducting or supporting the research.

Employees and agents of the institution holding an approved FWA are covered whenever they are involved in the conduct of research covered by the FWA. Employees and agents, including students, are individuals performing institutionally designated activities and acting on behalf of the institution or exercising institutional authority or responsibility.

An institution holding an OHRP-approved FWA (hereafter referred to as the assured institution) may extend the applicability of its FWA to cover two types of collaborating individual investigators: collaborating independent investigators and collaborating institutional investigators.

  1. A collaborating independent investigator is:
    1. not otherwise an employee or agent of the assured institution;
    2. conducting collaborative research activities outside the facilities of the assured institution; and
    3. not acting as an employee of any institution with respect to his or her involvement in the research being conducted by the assured institution.
  2. A collaborating institutional investigator is:
    1. not otherwise an employee or agent of the assured institution;
    2. conducting collaborative research activities outside the facilities of the assured institution;
    3. acting as an employee or agent of an institution that does not hold an OHRP-approved FWA with respect to his or her involvement in the research being conducted by the assured institution; and employed by, or acting as an agent of, an institution that does not hold an OHRP-approved FWA and does not routinely conduct human subjects research.

The extension of an assured institution’s FWA to cover a collaborating individual investigator should be documented using an Individual Investigator Agreement (IIA) or another similar agreement developed by the institution holding the FWA (see http://www.hhs.gov/ohrp/regulations-and-policy/guidance/extension-of-institutional-fwa-via-individual-investigator-agreement/index.html for OHRP’s guidance on the use of the IIA and the link to the sample IIA document).

If HHS-conducted or -supported human subjects research activities routinely occur at a non-assured institution, the institution should obtain an OHRP-approved FWA, and the IIA (or similar agreements) should not be used. Also, if the non-assured institution is the primary awardee for an HHS-supported award providing support for non-exempt human subjects research, the institution must obtain its own OHRP-approved FWA. If an institution is uncertain about the need for its own FWA, it should consult with OHRP.

NOTE: All previous types of sample agreements to cover an independent investigator [i.e., Agreement for Independent Investigators (AII), Non-Institutional Investigator Agreement (NIA), and Unaffiliated Investigator Agreement (UIA)] have been replaced by the sample Individual Investigator Agreement (IIA). Previously executed AIIs, NIAs, and UIAs may remain in effect until all applicable research that has already been initiated is completed or until the previous agreement has been replaced by a new Individual Investigator Agreement modeled on the OHRP sample IIA, or by a comparable written agreement developed by an assured institution.

Institutions must submit all FWAs (including new submissions, updates, and renewals) electronically using the electronic submission system available through the OHRP website at http://ohrp.cit.nih.gov/efile/, unless an institution lacks the ability submit electronically.  If an institution believes it lacks the ability to submit its FWA electronically, please contact OHRP by telephone or email (see http://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/contact/index.html) and explain why the institution cannot submit its FWA electronically. 

The FWA application will only be considered complete by OHRP when it is completed in its entirety, signed by the Signatory Official, and dated. Additionally, the IRB(s) designated on the FWA must be registered with OHRP before the FWA can be approved.

The instructions for submitting an FWA (new submission, update, and renewal) may be found at http://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/fwas/index.html.

The FWA Signatory Official should be a high-level institutional official who has the authority to represent the institution named in the Federalwide Assurance (FWA), as well as all the institutional components listed in the FWA. Entities that the Signatory Official is not authorized to represent may not be covered under the FWA. This person is usually the President, Chief Executive Officer, Chief Operating Officer, Director General, or Chancellor.

The intent in requiring that the Signatory Official be a high-level individual is two-fold. First, OHRP encourages institutions to promote a culture of conscience for the ethical conduct of human subjects research at the highest level within the institution. Second, the Signatory Official should be at a level of responsibility that would allow authorization of necessary administrative or legal action should that be required. OHRP recommends that the Signatory Official not be the chair or member of any IRB designated under the FWA.

If you have questions about submitting an FWA, you should contact the Assurance Coordinator assigned to your state or international region (see the OHRP website at http://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/contact/index.html).

You may track the receipt of an FWA on the Office for Human Research Protections website at http://ohrp.cit.nih.gov/search/. Here you will find information about when the FWA was received, as well as which Assurance Coordinator is reviewing it and how to contact that person.

With electronic submission of your institution’s Federalwide Assurance (FWA), which is required unless your institution lacks the ability to submit its FWA electronically, the Signatory Official, Human Protections Administrator, and the individual who submitted the FWA will receive an automatically generated email when OHRP approves the FWA.  A copy of the approved FWA will be attached to that email.

When the Office for Human Research Protections (OHRP) receives a request from an FWA institution for guidance regarding implementation of the Common Rule for human subjects research conducted or supported by another department or agency that has adopted the Common Rule, OHRP will direct the requestor to contact appropriate officials at the other department or agency. When the requestor seeking guidance regarding a specific research project does not identify the conducting or supporting department or agency, OHRP will qualify its response with a statement that if the research is supported by another department or agency the requestor should also consult with appropriate officials at the supporting department or agency. If the requestor at the FWA institution and appropriate officials at the conducting or supporting department or agency mutually agree to seek OHRP input on the matter, OHRP staff will be available to provide guidance.

If human subjects research conducted or supported by a non-HHS Common Rule department or agency involves collaborating institutions that do not hold an FWA or other applicable OHRP-approved assurance of compliance for federalwide use, OHRP does not require the collaborating institutions to obtain FWAs, but an FWA may be required by the non-HHS department or agency conducting or supporting the human subjects research.

For such situations, while obtaining an FWA would be one option for the collaborating institutions to comply with the assurance of compliance requirement of the Common Rule §__.103(a) [http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html#46.103], obtaining an FWA would not be required by HHS. When requests for guidance on this topic are received by OHRP, OHRP will refer the requestor to appropriate officials at the conducting or supporting Common Rule department or agency for assistance in deciding on an appropriate assurance mechanism.

The Office for Human Research Protections (OHRP) receives reports from institutions holding a Federalwide Assurance (FWA) of:

  1. unanticipated problems involving risks to subjects or others;
  2. serious or continuing noncompliance with the Common Rule or the requirements or determinations of the IRB; or
  3. suspension or termination of IRB approval.

If the human subjects research is conducted or supported by a Common Rule department or agency other than HHS, OHRP will not forward the report(s) to that other agency. However, OHRP will remind the FWA-holding institution in writing of the institution’s responsibility to notify the conducting or supporting department or agency head in accordance with the requirements of §__.103(b)(5) [http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html#46.103] of the Common Rule.

When the allegations or indications of noncompliance (complaints) are limited solely to the research activities conducted or supported by another Common Rule department or agency, for Human Research Protections (OHRP) will refer the matter to appropriate officials at the other department or agency for further investigation and action, as appropriate. OHRP’s Division of Compliance Oversight (DCO) will not be involved in the conduct of the investigation unless the relevant department or agency requests OHRP’s involvement. When the other department or agency completes its investigation without OHRP involvement, a report on the outcome of the investigation should be provided to OHRP.

The current U.S. system of protection for human research subjects is heavily influenced by the Belmont Report, written in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report outlines the basic ethical principles in research involving human subjects. In 1981, with this report as foundational background, HHS and FDA revised and made as compatible as possible - under their respective statutory authorities - their existing human subjects regulations. With leadership from HHS, the Federal Policy for the Protection of Human Subjects or the “Common Rule” was published in 1991 and codified in separate regulations by 15 Federal departments and agencies, as listed below (each agency includes in its chapter of the Code of Federal Regulations [CFR] section numbers and language that are identical to those of 45 CFR part 46, subpart A).

  • Department of Agriculture (7 CFR part 1c)
  • Department of Commerce (15 CFR part 27)
  • Department of Defense (32 CFR part 219)
  • Department of Education (34 CFR part 97)
  • Department of Energy (10 CFR part 745)
  • Department of Health and Human Services (45 CFR part 46 subpart A)
  • Department of Housing and Urban Development (24 CFR part 60)
  • Department of Justice (28 CFR part 46)
  • Department of Veterans Affairs (38 CFR part 16)
  • Department of Transportation (49 CFR part 11)
  • Consumer Product Safety Commission (16 CFR part 1028)
  • Environmental Protection Agency (40 CFR part 26)
  • Agency for International Development (22 CFR part 225)
  • National Aeronautics and Space Administration (14 CFR part 1230)
  • National Science Foundation (45 CFR part 690)

In addition, the Central Intelligence Agency must comply with all subparts of 45 CFR part 46 under Executive Order 12333. And, in accordance with the Intelligence Reform and Terrorism Protection Act of 2004 (P.L. 108-458, Section 8306), the Department of Homeland Security adopted policies implementing the protections for human subjects under 45 CFR part 46 for the research that it conducts or supports.

For all participating departments and agencies the Common Rule outlines the basic provisions for IRBs, informed consent, and Assurances of Compliance. HHS has developed additional regulations for the human subjects research it conducts or supports that apply to particular special populations: 45 CFR part 46 subparts B-D apply to research involving pregnant women, human fetuses, and neonates (subpart B), prisoners (subpart C), and children (subpart D).

Several non-HHS federal departments and agencies have additional regulations in place for research involving special populations or for human subjects research in general.

Yes, whenever non-U.S. institutions are engaged in non-exempt HHS-supported or -conducted human subjects research, the HHS human subjects protection regulations, 45 CFR part 46, apply.

Please see: http://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/fwas/fwa-protection-of-human-subjecct/index.html

No, OHRP's approval of an institution's assurance of compliance does not mean that OHRP has determined that the institution is complying with the requirements of the HHS Protection of Human Subjects regulations, 45 CFR part 46. It means that an institution has submitted all of the documentation OHRP requires to constitute a commitment by the institution to comply with the requirements of 45 CFR part 46 when its employees or agents engage in non-exempt human subjects research conducted or supported by HHS or other research covered by the assurance of compliance. The Federalwide Assurance is the only type of assurance of compliance accepted and approved by OHRP.