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  1. FDA Memoranda of Understanding

MOU 225-18-014

MOU 225-18-014

Memorandum of Understanding Between the Food and Drug Administration and the Office for Human Research Protections

I. Purpose

This Memorandum of Understanding (MOU) between the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) provides a framework for coordination and collaborative efforts between these two organizations which are both components of the U.S. Department of Health and Human Services (HHS). This MOU also provides the principles and procedures by which information exchanges between FDA and OHRP shall take place.

II.  Authority

FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the Act) as amended (21 U.S.C. 301, et seq.). Under this authority, FDA conducts inspections and data audits designed to monitor all aspects of the conduct and reporting of FDA regulated research through the Bioresearch Monitoring (BIMO) Program.

OHRP conducts its activities under the authority of Title 5 of the United States Code (5 U.S.C 301; 42 U.S.C. 00v-3(b); and 42 U.S.C. 289). Under this authority, OHRP conducts evaluations of Human Research Protection Programs (HRPP) for research supported or conducted by the Department of Health and Human Services.

III. Background

Both FDA and OHRP exist and work to protect 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, cosmetics, tobacco, and medical products, including drugs, biological products, animal drugs, and medical devices. In fulfilling its responsibilities under the Act, FDA, among other things, directs its activities toward promoting and protecting the public health by assuring the safety, efficacy, and security of drugs, veterinary products, medical devices and radiological products and the safety and security of foods, dietary supplements, and cosmetics. FDA also has responsibility for regulating the manufacturing, marketing and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. Among its duties relating to clinical research, FDA approves pre-market applications, monitors post-marketing adverse events, and conducts inspections of a variety of entities involved in clinical and nonclinical studies of both pre-market and post-market research. Paramount among these duties is an FDA obligation to protect the rights, safety, and welfare of subjects involved in clinical research subject to FDA regulations. FDA also initiates civil and criminal litigation to enforce applicable laws and regulations. To accomplish its mission, FDA must stay abreast of the latest developments in research and communicate with stakeholders about complex scientific and public health issues.

OHRP’s mission is to provide leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by the HHS. To fulfill this mission, OHRP maintains regulatory oversight of institutions and Institutional Review Boards (IRBs), provides advice, clarification, and guidance on ethical and regulatory issues in biomedical and social-behavioral research, and develops educational programs and materials. Additionally, OHRP reviews allegations of noncompliance involving human subject research projects conducted or supported by HHS or that are otherwise subject to the regulations, and determines whether to conduct a for-cause compliance evaluation. OHRP also conducts a program of not-for-cause surveillance evaluations of institutions, and responds to incident reports from assured institutions.

FDA's and OHRP’s respective missions to protect the rights, safety, and welfare of subjects involved in research require both organizations to collaborate in order to facilitate the efficient use of limited federal resources dedicated to research oversight (e.g., by harmonizing regulations and guidance). At times, FDA or OHRP may possess information that could be useful to the other organization's regulation of IRBs. Timely sharing of such information between OHRP and FDA is therefore critical to protecting the public health.

IV. General Provisions for Data Sharing

As public health organizations within HHS, there are no legal prohibitions that preclude FDA or OHRP from sharing with each other many of the records that are about IRBs and in the possession of either organization. FDA and OHRP agree that there should be a presumption in favor of full and free sharing of relevant information between FDA and OHRP. Both organizations recognize, however, that all non-public information sharing between FDA and OHRP, whether in writing or orally, must be protected from any disclosure not authorized by law or regulation. See e.g., 18 U.S.C. §1905; 21 U.S.C. §331(j); 21 CFR Parts 20 and 21; 42 U.S.C. §241(d); 42 CFR Parts 5 and 5b.

Safeguards are important to protect shared non-public information, such as trade secrets and confidential commercial information; identities of study participants and other personal privacy information; privileged and/or pre-decisional agency information; research proposals, progress reports, and/or unpublished data; or national security information. Such safeguards also help ensure compliance by FDA and OHRP with other applicable laws and regulations.

The requesting organization will comply with the following conditions:

a. The requesting organization will limit the dissemination of shared non-public information it receives to internal unit offices and/or employees that have been identified in its written request. If the requesting organization determines that employees other than those identified in the original request have a need to know the requested information, then an update to the request letter will be supplied to the sharing organization before the requesting organization distributes the information to those employees. The unit official who signs the request letter will be responsible for ensuring that there are no inappropriate recipients of the information.

b. The requesting organization will agree in writing, by using the model request letter (or a reasonable, mutually agreed upon variation), not to disclose any shared non-public information in any manner not authorized by law or regulation, including disclosure in publications and public meetings. If the requesting organization wishes to disclose shared information that the sharing organization has designated as non-public, the requesting organization will ask the sharing organization whether the information’s non-public status has changed, and if so, will first obtain written confirmation and permission from the sharing organization before disclosing that information. If the requesting organization receives a Freedom of Information Act (FOIA) request for shared information, the requesting organization will: (a) refer the FOIA request to the information-sharing contact person or designee for the sharing organization to respond directly to the FOIA requester regarding the releaseability of the information, and (b) notify the FOIA requester of the referral and that a response will issue directly from the sharing organization. The requesting organization will leave all final disclosure decisions up to the sharing organization, including decisions on whether the records are responsive and whether they must be disclosed. Accordingly, the requesting organization will not indicate to the FOIA requester whether the sharing organization has responsive records or releasable records.

c. The sharing organization will include a transmittal letter along with any agency information shared. The transmittal letter will indicate the type of information (e.g., confidential commercial information, personal privacy, pre-decisional, etc.). A model transmittal letter is attached. The shared documents containing non-public information should be stamped “Do not disclose without permission of FDA [or OHRP]” whichever is applicable.

d. The requesting organization will promptly notify the contact person or designee of the sharing organization of any attempt by a third party to obtain shared non-public information by compulsory process, including, but not limited to, a FOIA request, subpoena, discovery request, or litigation complaint or motion.

e. The requesting organization will notify the sharing organization before complying with any judicial order that compels the release of shared non-public information, so that the organizations may determine the appropriate measures to take, including, where appropriate, legal action.

V. Substance of Agreement and Responsibilities of Each Organization

A. Coordination and Collaboration Relative to Public Health Activities

It is mutually agreed that:

1. When appropriate, FDA and OHRP will coordinate and collaborate with the other organization to protect and improve the public health through regulation of IRBs. To achieve this, each organization may utilize the expertise, resources, and relationships of the other organization in order to increase its own capability and readiness to respond to emerging situations involving regulation of IRBs.

2. Each organization will designate central contact points to which communications dealing with matters covered by this agreement should be referred.

3. FDA and OHRP will participate in periodic joint meetings, as needed, to promote better communication and understanding of statutory responsibilities, regulations, and policies, and to address questions and problems that may arise.

4. Each organization will notify the other organization as soon as possible when issues of mutual concern become evident.

5. When appropriate, each organization will collaborate and/or coordinate with the other organization in investigations of mutual concern pertaining to IRBs and impacting the IRB’s oversight of the conduct of studies involving human subjects. Such collaboration and coordination may include providing alerts to the other organization when issues are identified; providing technical advice in areas of recognized expertise; providing results of analysis; coordinating health protection messages and recommendations provided to the public; making available expert witnesses or subject matter experts; and exchanging information as described in Section V.B of this MOU.

6. When appropriate, each organization will communicate with the other before or upon issuing IRB-related press or scientific releases, publications, or correspondence that may have a significant impact on the other organization.

7. Each organization will refer its proposed regulations and guidance documents that may have a significant impact on the other organization for review and comment by that organization before publication.

8. Each organization will, to the extent feasible, inform the other of planned IRB inspections conducted by FDA and Human Research Protections Program (HRPP) evaluations conducted by OHRP 1 Recognizing that sharing of information may not always be feasible (e.g., for-cause investigations), FDA and OHRP will endeavor to promptly inform the other about significant IRB inspections and HRPP evaluations.

9. Each organization will inform the other of final organizational determinations related to IRB inspections that FDA conducts and HRPP evaluations that OHRP conducts.

10. FDA and OHRP agree that each initial request for information will be made by and transmitted to the Agency central point of contact designated according to Section V.A.2 of this MOU.

11.  Each organization reserves the right to redact shared information as deemed necessary.

12. This agreement does not preclude OHRP and FDA from entering into other agreements or special programs.

13. FDA and OHRP agree to promptly notify the other of any actual or suspected unauthorized disclosure of information shared under this MOU.

B. Principles and Procedures for the Exchange of Information That is Not Publicly Available

To facilitate the sharing of IRB information with each other, FDA and OHRP will implement procedures to ensure, at a minimum, that such sharing of information is indeed appropriate and that the recipient organization appropriately guards the confidentiality of all nonpublic information received. Both parties are committed to responding to requests for information in a complete and timely manner, consistent with budgetary and resource constraints, and the extent permitted by law, regulation, and agency policy and practice. Each organization will be responsible for preventing unauthorized disclosure of confidential information provided by the other, so long as the organization that provides the information conveys the confidential nature of the information, in accordance with the terms of this MOU, or the receiving organization otherwise has knowledge that such information is confidential.
 

There are separate procedures, as described below, for routine requests for information and for emergency requests. FDA and OHRP agree to respond to each other’s requests for information in a timely manner.

1. Routine Requests for Non-Public Information

a. The requesting organization must demonstrate, in writing, why it needs the requested information (i.e., need-to-know demonstration). This demonstration should consist of a summary that describes in detail the information requested (to facilitate identification of relevant records) and a brief statement of the purpose for which the information is needed. This request must state which internal organization offices and/or individuals need the information. A model request letter is attached.

b. The organization receiving the request for information must, based upon the sufficiency of the need-to-know demonstration described in Section V.B.l.a above, determine whether it is appropriate to share the requested information with the requesting organization. If an organization decides that it is not appropriate to share information with the requesting organization, it must describe to the requesting organization the reasons for such decision.

c. The requesting organization agrees that it must comply with the following conditions:

  • The requesting organization must limit the dissemination of shared information it receives to those within the requesting organization who have been identified in its request.
  • The requesting organization must agree in writing not to publicly disclose any shared information in any manner including publications and public meetings. If the requesting organization wishes to disclose shared information, including information that it believes is publicly releasable, it must first request and obtain the written permission of the organization that has shared the information.
  • If the requesting organization receives a request under the FOIA for the shared information, the requesting organization will refer the request to the information-sharing organization for it to respond directly to the requestor regarding the releaseability of the information. In such cases, the organization making the referral will notify the requestor that a referral has been made and that a response will be issued directly from the other organization.
  • The organization that shares information with the requesting organization must include a transmittal letter, along with any records exchanged. The transmittal letter must indicate the type of information being shared (e.g., FDA’s planned IRB inspections and OHRPs HRPP evaluations.). A model transmittal letter is attached.
  • The requesting organization must promptly notify the appropriate office of the information-sharing organization when there is any attempt to obtain shared information by compulsory process, including but not limited to, a FOIA request, subpoena, discovery request, or litigation complaint or motion.
  • The requesting organization must notify the information-sharing organization before complying with any judicial order that compels the release of such information so that the organizations may determine the appropriate measures to take, including where appropriate the filing of a motion or an appeal with the court.

2. Emergency Requests for Non-Public Information

In cases where the requesting organization has a need to obtain certain information about IRBs as soon as possible due to emergency circumstances such as critical research conducted during an outbreak of communicable disease, FDA and OHRP may utilize the following procedures for the sharing of information. These procedures are intended for use only in the case of an emergency and are not appropriate for routine requests for information.

a. The requesting organization must indicate orally or in writing to the organization in possession of the relevant information, the need to obtain certain information as soon as possible due to the existence of emergency circumstances. The requesting organization must provide a description of the emergency circumstances.

b. The requesting organization must agree orally or in writing to protect from unauthorized public disclosure, all information that is shared, according to all applicable laws and regulations.

c. If the organization in possession of the requested records determines the existence of an emergency, the need-to-know demonstration and determination described above in Section V.B.1.a and V.B.1.b is waived. However, once the requesting organization has obtained the information it seeks, it must comply with those procedures set forth in Section V.B.1.c.

VI. Resource Obligations:

All activities undertaken pursuant to the MOU are subject to the availability of personnel, resources, and funds. This MOU does not affect or supersede any existing or future agreements or arrangements among the Partners. This MOU does not create binding, enforceable obligations against any Party. This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which FDA and OHRP operate.

VII. Name and Address of Participating Organizations

A. Food and Drug Administration
Department of Health and Human Services
10903 New Hampshire Avenue
Silver Spring, Maryland 20993

B. Office for Human Research Protections
Department of Health and Human Services
1101 Wootton Parkway
Rockville, Maryland 20852

VIII. Liaison Officers

A. Contact for FDA:
David Glasgow
Office of Bioresearch Monitoring Operations
Food and Drug Administration
12420 Parklawn Dr.
Elem 4202
Rockville, MD 20857
David.Glasgow@fda.hhs.gov
ORABIMOInspectionPOC@fda.hhs.gov
(301) 796-5403

B. Contact for OHRP:
Lisa Buchanan, MAOM
Division of Compliance Oversight
Office for Human Research Protections
Department of Health and Human Services
1101 Wootton Parkway, Suite 200
Rockville, Maryland 20852
(240) 453-6900

IX. Period of Agreement

This agreement will be effective when accepted by FDA and OHRP. This agreement may be modified or terminated by mutual written consent by FDA and OHRP or may be terminated by either partner upon a 120-day advance written notice to the other.

Attachments

Approved and Accepted for the Food and Drug Administration

/s/

Chrissy Cochran
Director, Office of Bioresearch Monitoring Operations
Food and Drug Administration

March 19, 2018

/s/

Jerry Menikoff, M.D., J.D.
Director, Office for Human Research Protections

March 19, 2018

 


Footnote

1. OHRP considers HRPP evaluations to include compliance evaluations of IRBs, clinical investigators and Institutional Officials. Compliance determinations related to these inspections are the sole responsibility of the organization that conducted the inspection; however, technical expertise from either organization may be sought when needed during the review of the inspectional findings.


Attachments

Model Language for Request from OHRP to FDA

The Office for Human Research Protections (OHRP) is requesting the following information about Institutional Review Board(s) from the Food and Drug Administration (FDA) for the following purposes: [Identify information and purpose]

Or

OHRP hereby requests the following information about Institutional Review Board(s) from FDA for the following purposes: [Identify information and purpose]
OHRP agrees that it will not publicly disclose any such information that FDA shares with it without prior written permission from FDA and that it will comply with the principles and procedures set forth in the Memorandum of Understanding on information sharing between OHRP and FDA. Applicable laws and regulations may prohibit the disclosure of such information. See for example, 21 U.S.C. §33l(j); 18 U.S.C. §1905; 21 C.F.R. Parts 20 and 21; 45 C.F.R. Parts 5 and 5b; and 42 U.S.C. §241(d).

OHRP will limit dissemination of any shared information to the following OHRP Divisions and/or employees: [Identify division(s) and/or employee(s)].

Name Date

[Signature and Date by OHRP official with requisite responsibility and authority.]


Model Language for Request from FDA to OHRP

The Food and Drug Administration (FDA) is requesting the following information about Institutional Review Board(s) from the Office for Human Research Protections (OHRP) for the following purposes: [Identify information and purpose]

Or

FDA hereby requests the following information about Institutional Review Board(s) from OHRP for the following purposes: [Identify information and purpose]

FDA agrees that it will not publicly disclose any such information that OHRP shares with it without prior written permission from OHRP and that it will comply with the principles and procedures set forth in the Memorandum of Understanding on information sharing between FDA and OHRP. Applicable laws and regulations may prohibit the disclosure of such information. See, for example, 21 U.S.C. §331(j); 18 U.S.C. §1905; 21 C.F.R. Parts 20 and 21; 45 C.F.R. Parts 5 and 5b; and 42 U.S.C. §241(d).

FDA will limit dissemination of any shared information to the following FDA offices and/or employees:
 [Identify office(s) and/or employee(s)].

Name Date

[Signature and Date by FDA official with requisite responsibility and authority.]


Model Transmittal letter from OHRP to FDA

This letter accompanies organizational records that the Office for Human Research Protections (OHRP) is sharing with the Food and Drug Administration (FDA) in response to FDA's request, dated [INSERT DATE]. These records contain one or more of the following categories of non-public information, including information the public disclosure of which may be prohibited by law:

[OHRP checks applicable items below]

__ Information related to planned, ongoing, or completed inspections or HRPP evaluation;
__ Information related to a complaint or its assessment;
__ Trade secrets;
__ Confidential commercial or financial information;
__ Information the disclosure of which would constitute a clearly unwarranted invasion of personal privacy;
__ Information subject to the Privacy Act;
__ Intra-agency records;
__ Records or information compiled for law enforcement purposes;
__ Information protected for national security reasons;
__ Subject matter expert/consultant; or
__ Other: ________________________________________

FDA must notify the appropriate division within OHRP if there are any attempts to obtain shared information by compulsory process, including but not limited to, Freedom of Information Act requests, subpoenas, discovery requests, and litigation complaints or motions.

FDA must notify OHRP before complying with any judicial order that compels the release of such information so that FDA and/or OHRP may take appropriate measures, including filing a motion with the court or an appeal.

FDA has agreed, by this letter or e-mail and by a signed request letter dated [INSERT DATE], not to publicly disclose the above-described information without prior written permission of OHRP. FDA acknowledges that applicable laws and regulations may prohibit the disclosure of such information. See, for example, 21 U.S.C. §331(j); 18 U.S.C. §1905; 21 C.F.R. Parts 20 and 21; 45 C.F.R. Parts 5 and 5b; and 42 U.S.C. §241(d). FDA also agrees to comply with the principles and procedures set forth in the [insert date] Memorandum of Understanding between FDA and OHRP.

Model Transmittal letter from FDA to OHRP

This letter accompanies agency records that the Food and Drug Administration (FDA) is sharing with the Office for Human Research Protections (OHRP) in response to OHRP's request, dated [INSERT DATE]. These agency records contain one or more of the following categories of non-public information, including information the public disclosure of which may be prohibited by law:

[FDA checks applicable items below]

__ Information related to planned, ongoing, or completed IRB inspections
__ Information related to a complaint or its assessment
__ Trade secrets;
__ Confidential commercial or financial information;
__ Information the disclosure of which would constitute a clearly unwarranted invasion of personal privacy;
__ Information subject to the Privacy Act;
__ Intra-agency records;
__ Records or information compiled for law enforcement purposes;
__ Information protected for national security reasons;
__ Subject matter experts/consultant; or
__ Other: ____________________________________________

OHRP must notify the appropriate office within FDA if there are any attempts to obtain shared information by compulsory process, including but not limited to, Freedom of Information Act requests, subpoenas, discovery requests, and litigation complaints or motions.

OHRP must notify FDA before complying with any judicial order that compels the release of such information so that FDA and/or OHRP may take appropriate measures, including filing a motion with the court or an appeal.

OHRP has agreed, by this letter or e-mail and by a signed request letter dated [INSERT DATE], not to publicly disclose the above-described information without prior written permission of FDA. OHRP acknowledges that applicable laws and regulations may prohibit the disclosure of such information. See, for example, 21 U.S.C.§33l(j); 18 U.S.C.§1905; 21 C.F.R. Parts 20 and 21; 45 C.F.R. Parts 5 and 5b; and 42 U.S.C. §241(d). OHRP also agrees to comply with the principles and procedures set forth [insert date] Memorandum of Understanding between FDA and OHRP.