MEMORANDUM OF UNDERSTANDING
BETWEEN THE INOVA HEART AND VASCULAR INSTITUTE
AND THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
The United States Food and Drug Administration (FDA) and the Inova Heart and Vascular Institute (IHVI) share interests in promoting scientific progress through exchange of scientific capital in cardio-vascular education, training, and research. Both institutions foresee benefits from the mutual exchange. This MOU outlines the collaborative framework within which existing and new mutually agreed upon programs and activities, consortia, and consensus development between the parties can be implemented, and outlines 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 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, 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 within the Inova Heart and Vascular Institute will greatly contribute to FDA’s mission.
IHVI is a part of the Inova Health System that includes the Inova Fairfax Hospital. Inova Hospital is the largest hospital in Northern Virginia and the flagship hospital of Inova Health System. Inova Fairfax Hospital is also home to a neonatal intensive care unit as well as a dedicated pediatric intensive care unit, oncology unit, an adolescent medicine unit, and centers for cardiac surgery and pediatric surgery. Inova has access to a number of tools to help better provide personalized, precision medicine for heart failure patients. The Inova Health System became one of the first hospital systems in the U.S. to implant a contemporary monitoring device to treat heart failure.
III. Substance of Agreement:
This MOU establishes a framework for development of reciprocal scientific collaborations, outreach, educational initiatives, and intellectual partnerships that may interest FDA and IHVI. The scope of collaborations that is anticipated from this MOU may include:
1. Fellows or faculty members entering the program must agree to adhere to the terms of appointment which will be outlined in an offer of appointment letter;
2. Opportunities to serve as adjunct faculty or on advisory boards;
3. Opportunities to convene joint meetings for education and research;
4. Share clinical, practical and applied experiences among medical and allied health professionals, scientists, and engineers;
5. Research collaborations;
6. Cooperative international initiatives, and
7. Accessing unique facilities and equipment for scientific endeavors.
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 this MOU by reference. The terms and conditions of any such agreements will be in accordance with applicable federal law and regulations, and shall be negotiated and executed by appropriate representatives of IHVI and FDA.
IV. General Provisions:
A. “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. U.S. law will govern inventorship. In the case of sole inventorship, ownership will be governed by the policies of the employer of the Invention. In the case of joint Inventorship, 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 IHVI 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 IHVI. 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.”
B. IHVI 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 governed by appropriate confidentiality disclosure agreements or to the extent such disclosure is permitted by law.
D. Each Party will comply with the other Party's security procedures and policies regarding access to and use of facilities. Either party may either restrict or limit access to its property and facilities at any time and for any reason. IHVI individuals participating in activities under this MOU on FDA property will comply with all applicable federal statutes and regulations.
E. 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.
F. 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 that conflicting assignments can be avoided consistent with the HHS/FDA requirements. If at any time prior to or during the performance of 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 official listed on the MOU so that the necessary action can be undertaken. A determination will be made by FDA as to whether a conflict of interest exists and, if so, as to how to resolve or mitigate it. Parties to the MOU will make every effort to avoid activities or relationships that would cause a reasonable person to question the impartiality of their actions.
G. Patient Privacy Act: The Parties agree that any use or disclosure of protected health information (“PHI”) will be consistent with the requirements of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and the privacy regulations in 45 CFR Parts 160 and 164 (the “HIPAA Regulations”), and other applicable federal and state laws and regulations.
V. Resource Obligations:
This MOU represents the broad outline of the FDA and IHVI’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. 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. 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.
VI. Liaison Officers:
A. For the Inova Heart and Vascular Institute
Inova Heart and Vascular Institute
3300 Gallows Road, Falls Church, VA, 22042
Telephone Number: (703) 776-3068
B. For the Food and Drug Administration:
Director, External Expertise and Partnerships
10903 New Hampshire Avenue
White Oak Building 66, Room 5414
Silver Spring, MD 20993
Telephone Number: (301) 796-2537
VII. Term, Termination, and Modification:
This agreement, when accepted by all participating parties, will have an effective period of performance of five (5) years from the date of the latest signature and may be modified or terminated by mutual written consent by both parties or may be terminated by either party upon a sixty (60) day advance written notice to the other party.
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 and the IHVI operate.
APPROVED AND ACCEPTED FOR
INOVA HEART AND VASCULAR INSTITUTE
Christopher O'Connor, M.D.
CEO and Executive Director, IHVI
November 1, 2016
APPROVED AND ACCEPTED FOR
FOOD AND DRUG ADMINISTRATION
Robert M. Califf, M.D.
Commissioner of Food and Drugs
October 4, 2016