MEMORANDUM OF UNDERSTANDING BETWEEN
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
THE FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
AND DUKE UNIVERSITY
The United States Food and Drug Administration (FDA) and Duke University (the Parties) share interests in promoting scientific progress through exchange of scientific capital in an effort to enhance the assessment of safety and efficacy of FDA-regulated products. Both institutions foresee benefits from the mutual exchange of training and research expertise through joint participation in education and training programs involving the Oak Ridge Institute for Science and Education (ORISE) Fellowship Program. This Memorandum of Understanding (MOU) establishes the terms for collaboration to promote these shared interests, which can be pursued through a variety of programs including collaborative education and research.
FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the FD&C Act). In fulfilling its responsibilities under the FD&C 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 and cosmetics, as well as advancing the public health through regulation of tobacco products. To accomplish its mission, FDA must stay abreast of the latest developments in research and also communicate with stakeholders about complex scientific and public health issues. Increased development of research, education and outreach partnerships with Duke will greatly contribute to FDA’s mission.
Duke University (Duke), a nonprofit, research, education and healthcare institution is an organization for and on behalf of its Duke Translational Medicine Institute (DTMI), whose mission it is to develop and share knowledge that improves the care of patients around the world through innovative clinical research.
III. Substance of Agreement:
This MOU forms the basis for development of scientific collaborations, outreach and educational initiatives and intellectual partnerships between FDA and Duke. The types of initiatives expected to develop from this MOU include:
A. Advancing student education and matriculation into the health and biomedical science professions though enrolling students, post-doctoral trainees, and residents from Duke into the joint program at the FDA through the Center for Drug Evaluation and Research (CDER) ORISE fellowship program. Faculty sabbatical may be covered under ORISE if applicable. If prospective fellows or faculty members enter the program through the CDER ORISE Fellowship program mechanism, CDER and Duke will adhere to the CDER ORISE Fellowship rules, which will be provided to Duke upon commencement of the program. Fellows or faculty members entering the program must agree to adhere to the term of appointment which will be outlined in an offer of appointment letter.
B. Opportunities for FDA staff to serve as adjunct faculty or on advisory boards;
C. Opportunities to convene joint meetings for education and research; and
D. Research collaborations.
Under this MOU, joint efforts will be undertaken to support collaborative research and training as permitted under appropriate statutory authority. Before any specific collaboration is initiated or implemented, the Parties shall identify priorities, topics of mutual interest, and develop separate, written agreements for collaboration and sharing of resources. Where applicable, these agreements shall incorporate by reference this MOU. FDA may enter into a contract, grant or cooperative agreement with Duke to the extent authorized by law and available appropriations. The terms and conditions of any such awards will be in accordance with applicable federal law and regulations, and shall be negotiated and executed by appropriate representatives of institutions within Duke and FDA.
IV. General Provisions:
A. Rights to any inventions resulting from collaborative research will be determined by the separate written research agreements governing the effort, based on current U.S. Government patent regulations and any other applicable statutes and regulations.
B. Institutions within Duke and FDA may decide to enter into Cooperative Research and Development Agreements (CRADA) specific to particular collaborative projects. The terms of such CRADAs will address Intellectual Property rights.
C. Proprietary and/or nonpublic information will not be disclosed under this MOU, unless such disclosure is permitted by law and is governed by appropriate confidentiality disclosure agreements.
D. Each Party will comply with the other Party's security procedures and policies regarding access to and use of facilities. Either Party may restrict or limit access to its property and facilities at any time and for any reason. Duke individuals participating in activities under this MOU on FDA property will comply with all applicable federal statutes and regulations.
E. It is recognized that from time to time FDA and institutions within Duke will be sharing in expenses and may require compensation of either Party by the other. As research projects are developed, details of how costs are to be shared will be agreed to in advance under other contractual mechanisms as appropriate and in compliance with all applicable federal requirements.
V. Resource Obligations:
This MOU represents the broad outline of the FDA and Duke’s intent to collaborate in areas of mutual interest. It does not create binding, enforceable obligations against any Party. All activities that may be undertaken by 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 Parties and does not affect the ability of the Parties to enter other agreements or arrangements related to this MOU. This MOU and all associated agreements will be subject to the applicable policies, rules, regulations and statutes under which FDA and Duke University operate.
VI. Liaison Officers:
FDA’s Center for Drug Evaluation and Research (CDER) is the lead center for this MOU. The individual to whom all inquiries to FDA should be addressed is:
Padmaja Mummaneni, PhD
Center for Drug Evaluation and Research, Office of Translational Sciences, Office of Clinical Pharmacology
Consumer Safety Officer, Regulatory Health Project Manager, Contract Officer Representative (COR)
10903 New Hampshire Avenue, FDA White Oak Building 51, Room 2164
Silver Spring, MD 20993-0002
The individual to whom all inquiries to Duke should be addressed is:
Gavin Foltz, J.D.
Associate Dean and Executive Director
Office of Research Contracts
Duke University School of Medicine
P.O. Box 104025
Durham, NC 27710
Each Party may designate new liaisons at any time by notifying the other Party'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 Parties will name a new liaison within 2 weeks and notify the other Party through the designated administrative liaison.
VII. Term, Termination, and Modification:
This agreement becomes effective upon acceptance by both Parties and will continue in effect for five (5) years. It may be renewed by mutual written agreement of both Parties. It may be modified at any time by mutual written agreement of both Parties. It may be terminated by either Party upon 60-day advance written notice to the other.
VIII. Statutes, Regulations, Rules, and Policies
This MOU and all associated agreements will be subject to the applicable statutes, regulations, rules, and policies under which FDA, Duke, and the institutions within Duke operate.
ACCEPTED AND APPROVED FOR THE FOOD AND DRUG ADMINISTRATION
Janet Woodcock, MD
Director, Center for Drug Evaluation and Research
U.S. Food and Drug Administration
August 3, 2017
ACCEPTED AND APPROVED FOR DUKE UNIVERSITY
Gavin Foltz, J.D.
Dean and Executive Director
Office of Research Contracts
Duke University Medical School
August 3, 2017