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  1. Academic MOUs

MOU 225-15-006

MEMORANDUM OF UNDERSTANDING
BETWEEN U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
AND MOREHOUSE SCHOOL OF MEDICINE

 

I.  Purpose
 
The Food and Drug Administration (FDA), U.S. Department of Health and Human Services, and the Morehouse School of Medicine (MSM) .(Atlanta, Georgia) share interests in promoting scientific progress through exchange of scientific capital in diverse fields of science that affect human and animal health and medicine. Both institutions foresee benefits from scientific training for academicians and students to foster a well-grounded foundation in interdisciplinary science on which scientific learning can grow. This Memorandum of Understanding (MOV) establishes the terms for collaboration and to promote shared interests in various science-based academic initiatives, fellowships, and student internships.
 
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, directs its activities toward promoting and protecting the public health by assuringthe 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.
 
Morehouse Schoolof Medicine (MSM), located in Atlanta, Georgia, is among the nation's leading educators of primary care physicians,and was recently recognized as the top institution  among U.S. medical schools for our social mission. Our faculty and alumni are noted in their fields for excellence in teaching, research, and public policy. MSM is dedicated to improving the health and well-being of individuals and communities; 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 people of color and the underserved urban and rural populations in Georgia and the nation.
 
MSM awards the Doctor of Medicine, Doctor of Philosophy in Biomedical Sciences (Ph.D.), Master of PublicHealth (M.P.H.), Master of Sciencein Medical Sciences (MSMS), Master of Science in Biomedical Research (MSBR), Master of Science in Clinical Research (MSCR), and the Master of Science in Biomedical Technology (MSBT) degrees. MSM is home to world-renowned centers and institutes: The Cardiovascular Research Institute; The Center of Excellence on Health Disparities; The National Center for Primary Care; The Neuroscience Institute (NI); Prevention ResearchCenter (PRC); Research Core Facility and The Satcher Health Leadership Institute (SHU).
 
III.  Substance of Agreement
 
This MOU forms the basis for development of scientific collaborations, outreach and educational initiatives and intellectual partnerships between FDAand MSM. The types of initiatives expected to develop from this MOU include:
 
1.       Advancing student education and matriculation into the health and biomedical science professions. One of the mechanisms to enroll students/post-doctoral trainees/residents from MSM into the joint fellowship program at the FDA is through the Oak Ridge Institute for Scienceand Education (ORISE) fellowship program. Faculty sabbatical may also be covered under ORISE if applicable. If prospective fellows or faculty members enter the program through the ORISE fellowship program mechanism, the Office of Minority Health and MSM will adhere to the ORISE Fellowship rules and regulations. Fellows or faculty members entering the program must agree to adhere to the term of appointment that will be outlined in an offer of appointment letter.
 
2.       Opportunities for FDA staff to serve as adjunct faculty or on advisory boards;
 
3.       Opportunities to convene joint meetings for education and research;
 
4.       Researchcollaborations;
 
5.       Cooperative international initiatives; and
 
6.       Accessing unique facilities and equipment for scientific endeavors.
 
IV.     Under this MOU, joint efforts will be undertaken to obtain grants and other 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 into a contract, grant, or cooperative agreement with MSM 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 MSM and FDA.
 
V.  General Provisions
 
1.      "Invention” refers to any subject matter or discovery patentable under Title 35 of the United States Code and conceived or first reduced to practice under the activities of the MOU. "Intellectual Property" refers to patents, patent applications, expertise, trade secrets, copyrights and computer programs either used or developed under the activities of the MOU. Rights to Inventions or Intellectual Property developed under the MOU will be addressed in separate project-specific development and implementation agreements among the Parties. lnventorship will be governed by U.S. law. In the caseof sole inventorship, ownership will be governedby the policies of the employer of the Invention. In the case of joint lnventorship, ownership of Inventions will be jointly owned. Inventions made under a Federal grant or contract will be subject to the Bayh-Dole Act. Accordingly, all MSM employees who work on any project under the MOU shall be required to sign an agreement that effects a present assignment of their future inventions to MSM. No Party, by virtue of their participation in activities under the MOU, will be required to disclose or license intellectual property to the other Party.
 
2.      Institutions within MSM 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.
 
3.      Access to non-public information shall be governed by separate Confidentiality Disclosure Agreementsin 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 21U.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.
 
4.      Each Party will comply with the other Party's security procedures and policies regarding access to and use of facilities. Party may either restrict or limit access to its property and facilities at any time and for any reason. MSM individuals participating in activities under this MOU on FDA property will comply with all applicable federal statutes and regulations.
 
5.      It is recognized that from time to time FDA and institutions within MSM 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 asappropriate and in compliance with all applicable federal requirements.
 
VI.  Resource Obligations
 
This MOU represents the broad outline of the FDA and MSM'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 into 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 MSM operate.
 
VII.  Further Information:
 
1.      Citizenship and security clearance:
 
Individuals participating in the MOU will be United States citizens or permanent residents. Regarding the latter, federal restrictions will be adhered to Information may be obtained from participants by the agency for security clearance or accessto FDA facilities and office. Information obtained may be re-disclosed to other Federal agencies for the above purposes and in fulfillment of official responsibilities to the extent, law permits such disclosure.
 
2.      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 spouseand 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 and FDA requirements. If before or during performing activities under the MOU, the Partiesor the program participant believes that a potential or actual conflict exists, the Parties or participant must notify the appropriate authorities within their respective institutions and contact the designated FDA official listed on the MOU so the necessary action/s can be undertaken. A determination will be made by FDA on whether a conflict of interest exists and, if so, how to resolve or mitigate it. Parties to the MOU will act to avoid activities or relationships that would cause a reasonable person to question the impartiality of their actions.
 
3.      Nonpublic Information:
 
All participants in this program must recognize that information to which they have access that contains any of the following types of information must be protected from unauthorized disclosure: (1) confidential commercial information, such as the information that would be protected from public disclosure under Exemption 4 of the Freedom of Information Act (FOIA); (2) personal privacy information, such as the information that would be protected from public disclosure under Exemption 6 or 7(c) of ; or (3) information that is otherwise protected from public disclosure by Federal statutes and their implementing regulations (e.g., Trade Secrets Act (18 U.S.C.§1905), the PrivacyAct (5 U.S.C.§552a), the Freedom of Information FOIA Act (5 U.S.C.§552), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301et seq.), and the Health Insurance Portability and Accountability Act (HIPAA), Pub. L.104-191) and the Family Educational Rights and Privacy Act (FERPA) (20 U.S.C.1232g; 34 CFR Part 99).
 
VIII.  Liaison Officers:
 
Morehouse Schoolof Medicine
       
Sandra Harris-Hooker, Ph.D.
Vice President and Executive Vice Dean
for Research and Academic Administration
Morehouse School of Medicine
 
Food and Drug Administration
 
Jonca Bull, M.D., Director
Office of Minority Health
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, Maryland 20993
301-796-8000
 
IX.  Terms, Termination, Modification
 
 This agreement will be effective when accepted by all participating partners. This agreement may be modified or terminated by mutual writtenconsent by the partners or may be terminated by either Partner upon a 60-day advance written notice to the other.
 
Approved and Accepted:
 
Food and Drug Administration
 
Stephen M. Ostroff
Acting Director, FDA Office of Chief Scientist
Office of Chief Scientist
 
December 22, 2014
 
Jonca Bull, M.D.
Director, FDA Office of Minority Health
 
December 18, 2014
 
Morehouse School of Medicine
 
Sandra Harris-Hooker, Ph.D.
Vice President and Executive Vice Dean
for Research and Academic Administration
Morehouse School of Medicine
 
October 28, 2014