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MOU 225-24-017

MEMORANDUM OF UNDERSTANDING
Between the
FOOD AND DRUG ADMINISTRATION,
OFFICE OF THE CHIEF SCIENTIST and the
NATIONAL INSTITUTES OF HEALTH

I. PURPOSE

The U.S. Food and Drug Administration (FDA), Office of the Chief Scientist (OCS), and the National Institutes of Health (NIH) are both agencies of the Department of Health and Human Services (HHS), and hereinafter also referred to as the “Party” or “Parties.”  The primary purpose of this Memorandum of Understanding (MOU) is to enhance knowledge and efficiency regarding FDA research involving human subjects by facilitating service of NIH employees on FDA’s Institutional Review Board (IRB).  This MOU constitutes the written agreement under which coordination, collaborative efforts, and information exchanges, in the context of NIH employees’ service on the FDA IRB (hereafter referred to as “NIH Members”), will take place between FDA and NIH.    

II. BACKGROUND

Both FDA and NIH work to protect and promote the public health but have different statutory mandates and responsibilities.

FDA is a regulatory agency responsible for protecting the public health through the regulation of food, tobacco products, cosmetics, and medical products, including drugs, biological products, animal drugs, and medical devices. FDA administers the Federal Food, Drug, and Cosmetic Act and relevant sections of the Public Health Service Act, among other statutes. Among its duties, FDA reviews pre-market applications, conducts inspections of manufacturing facilities, and monitors post-marketing adverse events. FDA also initiates civil and criminal litigation to enforce applicable laws and regulations.  To accomplish its mission, FDA must, among other things, stay abreast of the latest and emerging developments in research.  As part of fulfilling its statutory mandates and responsibilities, FDA conducts or supports certain research involving human subjects and has established an IRB to provide oversight of such research consistent with the requirements for IRB review and approval under 45 C.F.R. part 46 and 21 C.F.R. part 56.  The IRB must include at least one member who is not otherwise affiliated with FDA. 45 C.F.R. 46.107(c); 21 C.F.R. 56.107(d).  In addition, among other things, the IRB must be sufficiently qualified through the experience, expertise, and diversity of its members to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. 45 C.F.R. 46.107(a); 21 C.F.R. 56.107(a). Having IRB members that are not affiliated with FDA with expertise in scientific and/or ethical considerations relevant to research involving human subjects enhances the FDA IRB’s review and helps advance FDA’s mission.

NIH is the primary U.S. Federal agency for biomedical research.  The NIH mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability.  In support of this mission, NIH conducts pioneering biomedical research in its own laboratories and facilities, supports and funds the research of non-Federal scientists in universities, medical schools, hospitals, and research institutions throughout the country and abroad, trains the next generation of research investigators, and disseminates medical research information.  Service on the FDA’s IRB as part of the NIH Members’ official duties will help facilitate the conduct of ethical research and enhance NIH Members’ understanding of the regulatory and ethical framework for IRB oversight of clinical research consistent with NIH’s mission. 

III. SUBSTANCE OF AGREEMENT AND RESPONSIBILITY OF EACH AGENCY

A. Responsibilities

Subject to compliance with applicable laws, regulations, policies, and privileges, including those relating to conflict of interest, medical peer review, and the protection of research participant data, it is agreed upon that the following are the responsibilities of the Parties:

1. Each Party will establish a principal point of contact (identified as the “Liaison Officer” in Section V) at each agency to facilitate any actions carried out under this MOU with respect to service of one or more NIH Members on FDA’s IRB and related activities;

2. The Parties will jointly establish, through email or other written communication, the specific procedures and safeguards necessary to implement this MOU;

3. FDA/OCS will communicate to the NIH Liaison Officer and any NIH Member the administrative requirements for and responsibilities of serving as a member of FDA’s IRB (such as training requirements, IRB procedures, and/or expected time commitment). None of these requirements or responsibilities will contradict the terms of this agreement.

This agreement does not preclude NIH or FDA/OCS from entering into other agreements which may set forth procedures for special programs which can be handled more efficiently and expertly by other agreements.

B. General Principles and Procedures for the Exchange of Non-Public Information

Subject to compliance with applicable laws, regulations, policies, and privileges, including those relating to conflict of interest, medical peer review, and the protection of research participant data, FDA/OCS and NIH agree that the following principles and procedures will govern the exchange of nonpublic information between the two agencies.

As fellow agencies within HHS, FDA and NIH can generally share information in the possession of either agency with each other, recognizing that certain types of disclosures may be prohibited by law or may be contrary to agency policy. Both Parties recognize and acknowledge, however, that it is essential that any confidential information that is shared between FDA and NIH, whether in writing or orally, cannot be further shared unless authorized by law. See e.g., 21 U.S.C. § 331(j); 18 U.S.C. § 1905; 5 U.S.C. § 552; 5 U.S.C. § 552a; 42 U.S.C. § 241(d); 21 C.F.R. Parts 20 and 21; 45 C.F.R. Parts 5 and 5b. Such safeguards are important to protect the interests of, among others, owners and submitters of trade secrets and confidential commercial information; research participant identities and other personally identifiable information; privileged and/or pre-decisional agency records; and information protected for national security reasons. Such safeguards also help ensure FDA's and NIH’s compliance with applicable laws, regulations, and policies.

C. Information Exchanges: Review of Research

1. FDA IRB members may be assigned to serve as the primary or secondary reviewer for a particular research submission discussed at a convened IRB meeting or to conduct an expedited review of a research submission. In advance of assigning an NIH Member to conduct such reviews, a member of FDA’s HSP Program Management Staff will transmit to the NIH Member a preview summary of the research at issue. This preview will, among other things, if appropriate, identify relevant drugs, biological products, devices, tobacco products, or other FDA-regulated articles that are being studied in the research at issue. The NIH Member will review the Conflict of Interest considerations outlined in Appendix A and take action as necessary.

2. In advance of any scheduled FDA IRB meeting, a member of FDA’s HSP Program Management Staff will transmit to the NIH Member(s) the anticipated agenda items to be discussed at the meeting. This transmittal will, among other things, if appropriate, identify relevant drugs, biological products, tobacco products, or other FDA-regulated articles being studied in the research being discussed. The NIH Member(s) will review the Conflict of Interest considerations in Appendix A and take action as necessary.

3. When FDA’s HSP Program Management Staff transmit the information described above in C.1. or C.2, they will clearly label the materials as follows: “This document may contain non-public information. Do not disclose without permission of FDA/OCS.”

4. Any NIH Member participating in a meeting of the FDA IRB or otherwise participating in the review of research submitted to the IRB (e.g., conducting an expedited review) agrees not to further disclose any materials the member receives from FDA in conjunction with the research being reviewed by the FDA IRB. As such, any NIH Member of the FDA IRB cannot further disclose such materials, the FDA IRB’s discussion of those materials, or the information contained in them, to any other employee or affiliate of NIH, except with the prior written permission of the FDA IRB or as may be required by law.

D. FOIA And Other Third-Party Requests for Shared Information

If either Party receives a FOIA request for information or documents shared by the other Party, in connection with the service of an NIH Member on FDA’s IRB, the parties shall consult about how best to respond to the FOIA request prior to responding to the FOIA requester.  All actions taken under this paragraph must be in compliance with 45 C.F.R. 5.25.  

The Parties shall also consult before responding to or complying with any attempt by a third party, including requests by Congress, the Office of Inspector General, or the Government Accountability Office, to obtain shared non-public information by processes, including, but not limited to a voluntary request, subpoena, discovery request, or litigation complaint or motion.  Such consultation may help the Parties determine the appropriate measures to take, including, where appropriate, legal action.

IV. NAME AND ADDRESS OF PARTICIPATING PARTIES

A. U.S. Food and Drug Administration, Office of the Chief Scientist
10903 New Hampshire Ave, Bldg. 1
Attn: HSP Program Management Staff
Silver Spring, Maryland 20993
HSPPMS@fda.hhs.gov

B. U.S. National Institutes of Health, Office of Science Policy
6705 Rockledge Dr., Suite 630
Attn: Director, Division of Clinical and Healthcare Research Policy
Bethesda, Maryland 20892
SciencePolicy@od.nih.gov

V. LIAISON OFFICERS

A. Contact for FDA:

Karina M. Cooper, JD, MSW
FDA Institutional Review Board Administrator
Office of the Chief Scientist, Office of the Commissioner
U.S. Food and Drug Administration
Karina.Cooper@fda.hhs.gov

B. Contact for NIH:

Adam C. Berger, PhD Director,
Division of Clinical and Healthcare Research Policy
Office of Science Policy, Office of the Director
National Institutes of Health
adam.berger@nih.gov

VI. PERIOD OF AGREEMENT

This MOU will become effective on the date of the last signatory to the agreement. This agreement may be modified or terminated by mutual written consent by the Federal Partners or may be terminated by either Federal Partner upon a 30 day advance written notice to the other. The parties will review this MOU every 5 years to determine whether it should be revised, renewed, or cancelled.

Attachments

Appendix A – Guidelines for Conflict-of-Interest Considerations 

APPROVED AND ACCEPTED FOR FOOD AND DRUG ADMINISTRATION BY: 

/s/
David Strauss, M.D., Ph.D.
Acting Chief Scientist
Food and Drug Administration
Date: 10/16/2024

APPROVED AND ACCEPTED FOR NIH BY: 

/s/
Lawrence A. Tabak, D.D.S., Ph.D.
Principal Deputy Director
National Institutes of Health
Date: 09/27/2024

Appendix A 

Guidelines for Conflict-of-Interest Considerations

Reference: MOU 225-24-017

FDA and NIH have a unique relationship.  When both agencies are acting in their capacity as public health agencies, they may broadly share information and expertise subject to compliance with applicable laws, regulations, and policies, as both are components of the Department of Health and Human Services.  However, in some circumstances, such as when NIH is conducting a clinical trial, FDA may regulate NIH and its formal or informal affiliates.  In such circumstances, potential conflict-of-interest issues may arise. An NIH Member may also have a personal interest, such as a financial interest, that raises potential conflict-of-interest issues.

The following questions are designed to help illustrate these issues for the Parties to this MOU.

  • Does the NIH Member have any formal or informal affiliations, such as a Cooperative Research and Development Agreements (CRADA) or a research collaboration agreement, with FDA-regulated industry or academic institutions that have an interest in the research under FDA IRB review?  For example, where the FDA IRB is reviewing research to help inform how FDA regulates a type of medical device, is the NIH Member the principal investigator in a clinical trial studying such a medical device that is supplied by a member of FDA-regulated industry?
  • Does the NIH Member, or any of the members of his or her immediate family, have any intellectual property interest, such as royalty/fee sharing rights in a technology owned or assigned to a non-federal entity, or any financial interest, such as stock holdings, in any of the drugs, devices, or other articles being studied  in the research under review by the FDA IRB or in any of the entities conducting or sponsoring such research?

Affected NIH Members are expected to exercise discretion, consult their NIH Ethics Official as appropriate or when required by NIH policy and, if necessary, recuse themselves from the relevant portion of the IRB meeting(s) or from review of a particular research submission.  Any such recusal(s) will be documented in accordance with the FDA IRB’s Standard Operating Procedures (SOPs). No FDA IRB member may participate in the IRB’s initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.  45 CFR 46.107(d); 21 CFR 56.107(e). Notwithstanding the above, no documentation by FDA or FDA’s IRB will include the rationale for any recusal of any NIH Member.

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