MEMORANDUM OF UNDERSTANDING BETWEEN THE
UNIVERSITY OF NEBRASKA
COLLEGE OF PUBLIC HEALTH
THE FOOD AND DRUG ADMINISTRATION
The United States Food and Drug Administration (FDA) and The University of Nebraska Medical Center (UNMC), share interests in promoting scientific progress through exchange of scientific capital in public health, epidemiology and research.This Memorandum of Understanding (MOU) forms the basis for the initial relations between FDA and UNMC for sabbaticals, research and scientific education.
FDA identified the strategic goal to expand agency efforts to meet the needs of special populations. FDA supports the premise that therapeutic breakthroughs and clear and timely public health information should be available to all Americans.There are numerous challenges to achieving this goal. For example, historically ethnic and racial minorities have been underrepresented in clinical trials, making it difficult to assess whether a medical product will be safe and effective for them. Assuring that products are safe and effective for people with rare diseases is challenging, because the patient populations are too small to support standard clinical trials. FDA is committed to addressing these issues through targeted scientific programs and culturally sensitive outreach efforts.
The Office of Minority Health (OMH) advances FDA’s regulatory mission in addressing the reduction of racial and ethnic health disparities and in achieving the highest standard of health for all. The Office provides leadership and direction in identifying agency actions that can help reduce health disparities, including the coordination of efforts across the Agency. The Office of Minority Health serves as the principal advisor to the Commissioner on minority health and health disparities.
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, 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, tobacco products, 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 UNMC will contribute to FDA’s mission.
The University of Nebraska Medical Center is nationally recognized for excellence in professional medical education. The University of Nebraska Medical Center is the only public academic health sciences center in the state. UNMC is located in Omaha on one of four campuses of the larger University of Nebraska.The school offers enhanced medical education tracks for students who want specialized training in areas including aging, HIV, preventive medicine, rural medicine programs, and underserved healthcare. UNMC is the professional and scientific home of determined, brilliant researchers who work at the forefront of field such as transplant medicine, cancer, neurodevelopment and genomics. With collaboration from an engaged community of skilled professionals and access to world-class facilities, UNMC researchers indentify and focus on critical questions that lead to new knowledge life-changing therapies. Breakthroughs like stem cell transplantation to treat cancer have proven critical to Nebraska, the nation and the world. UNMC’s College of Public Health promotes optimal health and well-being through robust education, research and service in collaboration with communities in Nebraska, across the country and around the world.The College of Public Health strives to accomplish the UNMC triple mission of education, research and outreach.The College addresses various issues facing Nebraska, including health promotion and disease prevention, environmental health and safety, health care delivery, and biosecurity and biopreparedness.
III. Substance of Agreement:
This MOU forms the basis for development of scientific collaborations, outreach and educational initiatives between FDA and UNMC to explore health disparities in regulatory science. The types of initiatives expected to develop from this MOU include:
- Opportunity to apply for a joint fellowship program at the FDA to advance student and faculty education. One of the mechanisms to enroll students/post-doctoral trainees/residents from the UNMC into the joint fellowship program at the FDA is through the CDER Oak Ridge Institute for Science and Education (ORISE) fellowship program.If prospective fellows or faculty enter the program through the ORISE fellowship mechanism, the Office of Minority Health and UNMC will adhere to the CDER ORISE Fellowship rules and regulations. Fellows or faculty members entering the program must agree to the ORISE terms of appointment which will be outlined in an offer of appointment letter;
- Opportunities for UNMC faculty training in the regulatory science pathways;
- Opportunities for FDA staff to serve as adjunct faculty or on advisory boards;
- Opportunities to convene joint meetings for education and research, and;
- Research and evaluation collaborations.
Under this MOU, joint efforts will be undertaken to obtain grants and other extramural funds to support collaborative health disparities 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 supplemental agreements with UNMC to the extent authorized by law and available appropriations.The terms and conditions of any such agreements will be compliant with applicable federal law and regulations, and shall be negotiated and executed by appropriate representatives of institutions within UNMC and FDA.
IV. General Provisions:
- Confidentiality – Access to non-public information shall be governed by separate Confidentiality Disclosure Agreements in which the Parties will agree and certify in writing that they shall not further release, publish or disclose such information and that they shall protect such information in accordance with the provisions of 21 U.S.C. 331(j), 21 U.S.C. 360j(c), 18 U.S.C. 1905, and other pertinent laws and regulations governing the confidentiality of such information.No proprietary data, trade secrets or patient confidential information shall be disclosed among the Parties unless permitted by applicable law.
- Conflict of Interest – Participants in activities under this MOU who are not U.S. Government employees will be expected to abide by conflict of interest rules and policies as specified by FDA. This may require participants to disclose their financial holdings and those of their spouse and minor children, and may limit their ability to accept gifts and have employment with entities that are substantially regulated by FDA.The Parties will be advised of any potential conflict so conflicting assignments can be avoided consistent with the HHS/FDA requirements. If before or performing the activities under the MOU, the Parties believe that a potential or actual conflict exists, the Parties must notify the appropriate authorities within their respective institutions and contact the designated FDA officials listed on the MOU so the necessary actions can be undertaken. A determination will be made by FDA on whether a conflict of interest exists and how to resolve or mitigate it. Parties to the MOU will avoid activities or relationships that would cause a reasonable person to question the impartiality of their actions.
- Intellectual Property Rights – Institutions within UNMC 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.
- Security – 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. UNMC individuals participating in activities under this MOU on FDA property will comply with all applicable federal statutes and regulations.
- As research projects are developed, details will be agreed to in advance under other agreements as appropriate and in compliance with all applicable federal requirements.
V. Resource Obligations:
This MOU represents the broad outline of the FDA and UNMC’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 available personnel and resources. 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 UNMC operate.
VI. Liaison Officers:
The individual to whom all inquiries to University of Nebraska Medical Center should be addressed is:
A. For the University of Nebraska Medical Center:
FDA’s Office of Minority Health is the lead for this MOU. The individual to whom all inquiries to FDA should be addressed is:
B. For the Food and Drug Administration:
Michelle Yeboah, DrPH
Office of Minority Health
10903 New Hampshire Avenue, Silver Spring, MD 20993
Each Party may designate new liaisons by notifying the other Party's liaison officers in writing. If an individual designated as a liaison under this agreement becomes unavailable to fulfill their functions, the Parties will name a new liaison within two weeks and notify the other Party through the designated administrative liaison.
VII. Term, Termination, and Modification:
This agreement will be effective when accepted by all participating parties. This agreement may be modified or terminated by mutual written consent by both parties or may be terminated by either party upon a 60-day advance written notice to the other.
Signed by: H. Dele Davies, MD Signed by: Jesse L. Goodman, MD, MPH
APPROVED AND ACCEPTED FOR UNIVERSITY OF NEBRASKA MEDICAL CENTER
Vice Chancellor for Academic Affairs Chief Scientist, UNMC
Date: June 28, 2012
APPROVED AND ACCEPTED FOR THE FOOD AND DRUG ADMINISTRATION
Chief Scientist, FDA
Date: June 6, 2012
Signed by: H. Dele Davies, MD
Signed by: Jesse L. Goodman, MD, MPH