MEMORANDUM OF UNDERSTANDING
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
THE FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
OFFICE OF SURVEILLANCE AND EPIDEMIOLOGY
HARVARD MEDICAL SCHOOL
DEPARTMENT OF POPULATION MEDICINE
The Food and Drug Administration (FDA) and the Harvard Medical School, Department of Population Medicine(Harvard), share interests in promoting scientific progress through exchange of scientific capital in promoting postmarket safety surveillance research. Both institutions foresee benefits from the mutual exchange of training and research expertise that will enhance FDA’s existing postmarket safety system and future expansion of drug safety surveillance and monitoring systems. This Memorandum of Understanding(MOU) establishes the terms for collaboration to promote these shared interests, which can be pursued through various programs including collaborative education and research.
FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the Act) as amended (21 U.S.C.301). 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 and cosmetics. 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 within Harvard will contribute to FDA’s mission.
Harvard’s research mission is to collect, synthesize, and analyze institutional data to fulfill mandatory reporting requirements and support University decision-making. Harvard’s medical faculty conducts research in numerous locations around Boston. Six academic basic science departments are housed in and around the 1906 quadrangle that is the nucleus of Harvard Medical School. Most are appointed to these departments based at 17 affiliated institutions, including teaching hospitals. Here, 50 clinical departments conduct vast amounts of basic and clinical research. The Quad area also houses two social science departments and the Department of Ambulatory Care and Prevention, a joint venture with Harvard Pilgrim Health Care, a major HMO:
- Partnering with the research community to create a culture of high achievement;
- Promoting shared responsibility, the ethical conduct of research, and compliance;
- Enhancing researchers’ abilities to obtain and manage grants;
- Investing strategically in promising research and researchers;
- Creating integrated services, transparent research administration, infrastructure, and streamlined processes;
- Advocating for the needs of the Harvard University, Department of Population Medicine research community;
- Broadening awareness of the value of the Harvard University, Department of Population Medicine research;
- Developing strong relations with sponsors;
- Enhancing the ability to perform research in a global community, and
- Supporting strong infrastructure for interdisciplinary 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 Harvard. The types of initiatives expected to develop from this MOU include:
- Advancing student education and matriculation into the health, biomedical and applied science professions. One of the mechanisms to enroll students, post-doctoral trainees and residents from Harvard into the joint fellowship program at the FDA is through the , Center for Drug Evaluation and Research (CDER) Oak Ridge Institute for Science and Education (ORISE) fellowship program. Faculty sabbaticals may be covered under ORISE if applicable. If prospective fellows or faculty members enter the program through the ORISE fellowship program mechanism, CDER and Harvard will adhere to the CDER ORISE Fellowship rules. 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.
- Opportunities for FDA staff to serve as adjunct faculty or on advisory boards;
- Opportunities to convene joint meetings for education and research;
- Research collaborations;
- Cooperative international initiatives, and
- Access to unique facilities and equipment for scientific endeavors.
Under this MOU, joint efforts will be undertaken to obtain extramural funds 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 a contract, grant or cooperative agreement with the Harverd to the extent authorized by law and available appropriations. The terms and conditions of any such awards will comply with applicable federal law and regulations, and shall be negotiated and executed by appropriate representatives of institutions within Harvard and FDA.
IV. General Provisions:
- 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.
- Institutions within Harvard and FDA may decide to enter Cooperative Research and Development Agreements (CRADA) specific to particular collaborative projects. The terms of such CRADAs will address Intellectual Property rights.
- Proprietary and nonpublic information will not be disclosed under this MOU, unless such disclosure is governed by appropriate confidentiality disclosure agreements or to the extent such disclosure is permitted by law.
- 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. The Harvard individuals participating in activities under this MOU on FDA property will comply with all applicable federal statutes and regulations.
- It is recognized that occasionally FDA and institutions within Harvard share 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 compliant with all applicable federal requirements.
V. Resource Obligations:
This MOU represents the broad outline of how FDA and Harvard intend to collaborate in areas of mutual interest. All activities that may be undertaken by this MOU are subject to available 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.
IV. VI. Liaison Officers:
Individual's name: Richard Platt, MD, MSc
Organization: Department of Population Medicine
Harvard Medical School
Title: Professor and Chair
Address: 93 Worcester Road
Wellesley, MA 02481
Telephone Number: 617-509-9912
B. Food and Drug Administration:
Individual's name: Gerald J. Dal Pan, MD, MHS
Organization: Food and Drug Administration
Title: Director, Office of Surveillance and Epidemiology
Address: 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Telephone Number: 301-796-2380
Each Party may designate new liaisons by notifying the other Party's administrative liaison in writing. If 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 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, Harvard and the institutions within the UW operate.
Signed by: Signed by:Director, CDER
APPROVED FOR HARVARD PILGRIM HEALTH CARE INSTITIUTE
APPROVED FOR THE U.S. FOOD AND DRUG ADMINISTRATION
Signed by:Director, CDER