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  1. Academic MOUs

Memorandum of Understanding Between U.S. Department of Health and Human Services, Food and Drug Administration, Office of the Chief Scientist, Office of Minority Health; and Yale University

I. Purpose

The United States Food and Drug Administration (FDA) and Yale University (New Haven, Connecticut), share interests in promoting scientific progress through exchange of scientific capital in public health, epidemiology and research. Both institutions foresee benefits from scientific training for community members, patient communities, health care providers, academicians, and students to foster a well-grounded foundation in interdisciplinary science on which scientific learning can grow. This Memorandum of Understanding (MOU) forms the basis for the initial relations between FDA and Yale University (Yale) to promote shared interests in various science-based academic initiatives, fellowships, internships, sabbaticals, research and scientific education.

II. Background

FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the Act) as amended (21 U.S.C. § 301 et seq.). In fulfilling its responsibilities under the Act, FDA, among other things, promotes and protects the public health by ensuring the safety, efficacy, and security of drugs, veterinary products, medical devices and radiological products, and the safety and security of foods 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. 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. Increased development of research, education and outreach partnerships with Yale University will greatly contribute to FDA's mission.

Yale University and the Yale School of Medicine (YSM) has long been known for its world-class basic biomedical sciences such as Cell Biology, Genetics, Immunobiology, and Molecular Physiology, where research has led to fundamental insights into human biology, and for its core facilities including state-of-the-art genomics, proteomics, high-resolution human imaging, and high-throughput RNAi and chemical screening. During the past 10 years, these strengths have served as a foundation to develop increasingly successful programs in translational and clinical investigation. Overall, YSM has nearly 1,500 teaching (ladder) faculty, 700 research faculty, and more than 1,500 postgraduate fellows with appointments in 29 basic science and clinical departments. Clinically, Yale is the largest referral center in southern New England, with more than 1,200 university and affiliated physicians providing advanced care in over 100 specialties. YSM is dedicated to improving the health and well-being of individuals and communities by increasing the participation of diverse and historically under represented or underserved populations in clinical research; increasing the diversity of the health professional and scientific workforce; and addressing primary healthcare needs through programs in education, research, and service, with emphasis on racial and ethnic minorities and underrepresented or underserved populations in Connecticut and the nation.

III. Substance of Agreement

This MOU forms the basis for the development of scientific collaborations, outreach and educational initiatives, and intellectual partnerships between FDA and Yale University. The types of initiatives expected to develop from this MOU include, but are not necessarily limited to, the following:

1. Collaborations to cultivate and advance the Yale Cultural Ambassadors Program and the engagement of community partners to increase participation of diverse and historically under represented or underserved populations in clinical research.
2. Advancing education and participation of diversity of the health professional and scientific workforce in health and biomedical science research, including clinical trials. This may include activities to address primary healthcare needs through programs in education, research, and service such as participation in clinical research education and awareness efforts; curriculum development; the development of mentorship programs; training of HCPs to participate in research as investigators; development of programs to promote education and career awareness of research, health and scientific workforce opportunities for diverse and historically under represented or underserved populations; and other activities aimed at the promotion of best practices in the area.
3. Advancing student education and matriculation into the health and biomedical science professions. One of the mechanisms is to enroll students/post-doctoral trainees/residents from Yale into a joint fellowship program at the FDA. This may include student internships, and faculty sabbatical, if applicable. If prospective fellows or faculty members enter the program, the Office of Minority Health and Yale will adhere to all applicable internship/fellowship rules and regulations. Interns, fellows or faculty members entering any such programs must agree to adhere to the term of appointment that will be outlined in an offer of appointment letter.
4. Opportunities for FDA staff to serve as adjunct faculty or on advisory boards;                                                                                                                                                                                          
5. Opportunities to convene joint meetings for education and research;
6. Opportunities for Yale students, trainees, and faculty training in the regulatory science pathways;
7. Research and evaluation collaborations;
8. Cooperative international initiatives; and
9. Accessing unique facilities and equipment for scientific endeavors.

Under this MOU, FDA and Yale University intends to seek opportunities to participate together in collaborative research and training, as permitted under appropriate statutory authority. Before any specific collaboration is initiated or implemented, the Participants intend to identify priorities and topics of mutual interest and develop separate, written arrangements for collaboration and resource-sharing. The Participants intend that, when applicable, these arrangements incorporate by reference this MOU.

IV. General Provisions: The Participants intend that:

1. Rights to any inventions resulting from collaborative research will be determined by the separate written research arrangements governing the effort, based on current U.S. Government patent regulations and any other applicable statutes and regulations.
2. Yale University and FDA may decide to enter Cooperative Research and Development Agreements (CRADA) for specific collaborative projects. The terms of such CRADAs will address Intellectual Property rights.
3. Proprietary and/or nonpublic information may not be disclosed under this MOU, unless such disclosure is governed by appropriate confidentiality and disclosure arrangements, or except to the extent that such disclosure is permitted by U.S. federal law.
4. Each Participant will comply with the other Participant's security procedures and policies regarding access to and use of facilities. Either Participant may restrict or limit access to its property and facilities at any time and for any reason. The Participants intend that individuals participating in activities under this MOU on FDA property comply with applicable U.S. federal law.
5. It is recognized that from time to time, FDA and Yale University may share expenses and may request compensation to one Participant by the other. The Participants intend that, as research projects are developed, details of how costs are to be shared shall be agreed to in advance under appropriate contractual mechanisms and in compliance with all applicable U.S. federal requirements.

V. Resource Obligations:

This MOU represents the broad outline of the intent of FDA and Yale University to collaborate in areas of mutual interest. It does not create binding, enforceable obligations against any Participant. All activities that may be undertaken under this 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 Participants and does not affect the ability of the Participants to enter other agreements or arrangements related to this MOU.

VI. Liaison Officers:

A. For the Yale University
Tesheia H. Johnson, MBA, MHS
Associate Director of Clinical Research for Yale School of Medicine
Deputy Director and Chief Operations Officer for Yale Center for Clinical Investigation
2 Church Street South, Suite 114
New Haven, CT 06519
Phone: (203) 785-3482
Fax: (203) 737-2480
B. For the U.S. Food and Drug Administration:

CAPT Richardae Araojo, Pharm.D., MS
Associate Commissioner for Minority Health
Director, Office of Minority Health
U.S. Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993
Phone: (301) 796-1152

Each Participant may designate new liaisons at any time by notifying the other Participant's administrative liaison in writing. If, at any time, an individual designated as a liaison under this agreement becomes unavailable to fulfill those functions, the Participant previously represented by that individual should name a new liaison within two (2) weeks and notify the other Participant through the designated administrative liaison.

VII.  Term, Termination, and Modification:

This MOU, when accepted by both Participants, will be effective upon the date of the last signature. It may be modified or terminated by mutual written consent of the parties or may be terminated by either party upon 60-days written notice to the other.

VIII.  Statutes, Regulations, Rules, and Policies:

This MOU and all associated arrangements will be subject to the applicable statutes, regulations, rules, and policies under which FDA and the institutions within Yale University operate.

Approved and Accepted for Yale University

Maneesha Joshi, JD
Lead Contract Manager
Yale University, Office of Sponsored Projects
March 23, 2018

Approved and Accepted for the Food and Drug Administration

CAPT Richardae Araojo, Pharm.D., MS
Associate Commissioner for Minority Health
March 21, 2018

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