MOU 225-05-6000
Memorandum of Understanding Between
The United States Food and Drug Administration
Center for Devices and Radiological Health
and Brigham and Women's Hospital
Department of Medicine
Boston, Massachusetts
The United States Food and Drug Administration (FDA) and Brigham and Women's Hospital (BWH) have a shared interest in alleviating human suffering caused by disease and a commitment to advancing scientific knowledge. Both organizations are actively engaged in the exchange of scientific resources with national and international entities in diverse fields of science that directly and indirectly affect human and animal health and medicine. Brigham and Women's Hospital, a teaching affiliate of Harvard Medical School, is a world leader in patient care, medical education, and research. The vision of BWH, "…creating a premier, patient-focused, integrated healthcare delivery system…" is consistent with a fundamental part of FDA's mission to protect and promote public health. Both institutions endorse scientific training for government employees, academicians and students to establish a solid foundation on which scientific learning will grow.
This Memorandum of Understanding (MOU) establishes terms of collaboration between FDA and BWH to support these shared interests and will begin with an initiative entitled: The FDA Brigham Elective Program for Residents in the Department of Medicine. This initiative will add a unique aspect to the training being provided to the next generation of health care professionals. Through the guidelines stated in this MOU, third year residents will have the opportunity to enhance their educational experience in the Department of Medicine by participating in a CDRH MDFP rotation that will focus on medical device regulation and approval. Other opportunities such as: sabbaticals, pre-doctoral and post-doctoral fellowships and student internships will be explored as this partnership develops.
Each party agrees to maintain non-public Proprietary/Confidential Information. Proprietary/Confidential Information shall not be disclosed, copied, reproduced or otherwise made available to any person or entity without the consent of the owning Party except as required under courts order or the freedom of information Act (5U.S.C. 552). Parties participating in this MOU will further declare that they will be disqualified from participating in any FDA decisions regarding approval of products that may result directly from activities conducted under this MOU.
I. Food and Drug Administration
For this initiative, FDA CDRH via the Medical Device Fellowship Program (MDFP) participants may include BWH residents, fellows and faculty or staff. FDA CDRH via the Medical Device Fellowship Program (MDFP) will provide BWH the following:
• Opportunities to participate in training courses and seminars at FDA or web based training provided through FDA CDRH and the CDRH Staff College, as resources permit.
• Opportunities to explore collaborative research with CDRH faculty, residents, and staff, laboratories or affiliated facilities.
• Frequent communication with CDRH faculty and staff in the Department of Medicine via face-to-face meetings, conference calls or teleconferences.
• Welcome to faculty, staff, and residents wishing to visit FDA
• Communication of this collaborative effort through web pages, press releases, teleconferences, informal conversations with colleagues, faculty and students, joint conferences and symposiums
• Office space and/or laboratory facilities, as needed for research and review activities.
In addition to above, FDA CDRH via the Medical Device Fellowship Program will provide BWH Department of Medicine faculty and staff the following:
• Opportunities for candidates to serve as CDRH Medical Device Fellows or Visiting Scholars.
• Opportunities for faculty to spend a sabbatical with the agency with terms of the sabbatical to be negotiated between the individual and the agency.
• Opportunities to apply for sabbatical salary support. Requests must coincide with the current federal fiscal year.
• Opportunity to attend didactic courses and other training.
• Opportunity to obtain in-depth training in device review practices and policy via a 3 month residential training session.
• Opportunity to conduct reviews of medical devices and provide consultations, as appropriate, in their area of expertise from their home office.
In addition to the above, FDA CDRH via the Medical Device Fellowship Program will provide BWH Department of Medicine candidates the following, as part of the FDA Brigham Elective Residency Program:
• BWH will pre-select the candidates that will be permitted to apply.
• FDA will select the participants, using mutually agreed upon criteria.
• Both parties will agree on a training/regulatory work plan of at least three (3) months in length.
• Consistent with BWH and FDA rules and regulations, and negotiated on a case-by-case basis, FDA mentors can, where appropriate, participate in other aspects of the resident's educational program at BWH.
• As appropriate, openness and welcome to candidates interested in an opportunity to rotate through FDA centers, to obtain short-term training and hands-on experience.
Participants in this program will not be permitted to serve on device advisory panels reviewing a product for which they provided consultative or review services. Participants will agree that they will be disqualified from any FDA decisions regarding approval of products that result directly from activities conducted under this MOU. The statutory provisions about former post federal employment restrictions will apply to the participants in this program.
II. BRIGHAM and WOMEN'S HOSPITAL; Boston, MA
BWH will provide FDA CDRH personnel the following:
• Laboratory and/or office space as needed.
• Proactive efforts in establishing collaborative research efforts.
• Continuing and frequent communication with BWH staff, to include face-to-face communication and teleconferences.
• Welcome to FDA staff wishing to visit relevant BWH programs and laboratories.
• Communication of this collaborative effort through web pages, press releases, informal conversations with colleagues, faculty and students, joint conferences and symposiums.
• Adjunct faculty appointments in relevant BWH programs or departments, for those FDA staff members working with BWH residents, and/or assisting in teaching at BWH.
• Encouragement of graduate students/residents to elect short-term opportunities in FDA review divisions and laboratories.
• Opportunities to apply for the Deland Fellowship Program in Health care and Society with BWH.
• Opportunity to attend graduate courses.
• Opportunity to visit and receive short term training at the BWH consistent with standard BWH policies, resources permitting.
III. In the FDA Brigham Elective Program for Residents, FDA and BWH will work cooperatively to give participants a better understanding of the medical product approval process, relevant FDA regulations and legislation, and the types of applications submitted for review.
IV. Coverances
Patent, license, and other legal instruments will be prepared in accordance with federal law and BWH policy, and written notice referencing the policies will beprovided to the individual prior to entering on duty with FDA. BWH and FDA may decide to enter into a Cooperative Research and Development Agreement (CRADA) at a future time to conduct collaborative research and projects of mutual interest. The terms of such a CRADA will address Intellectual Property rights.
This MOU forms the basis for the initial relations between FDA and BWH for fellowship opportunities, sabbaticals, research, and scientific education. However, as this collaborative effort progresses, it is anticipated that new and wider areas of mutual interest may be included in expansions of this document.
V. Finances and Resources
BWH and FDA agree that this MOU does not commit either to make specific levels of financial or personnel support or to provide specific office or laboratory space for the programs and that the provision of such support will be based on available resources and provided in accordance with the rules, regulations and laws under which FDA operates and the policies of BWH.
VI. Citizenship and Security Clearance
BWH individuals participating in the MOU will be United States Citizens or Permanent Residents. Regarding the latter, all federal restrictions will be adhered to. Information may be obtained for security clearance or access to FDA facilities and offices. The information obtained may be re-disclosed to other Federal agencies for the above purposes and in fulfillment of official responsibilities to the extent that such disclosure is permitted by law.
VII. Protection of Non-Public Information
Residents, fellows, faculty and students appointed to a position at FDA will be required to sign a Commitment to Protect Non-Public Information agreement. Whereas access to privileged information in the files of the Food and Drug Administration is required in the performance of official duties, the party 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 privileged information.
VIII. Conflict of Interest
Individuals must be free of conflict prior to performing his or her duties. Residents, fellows, faculty and students selected as a fellow or visiting scholar with FDA will be required to sign a Conflict of Interest Clearance agreement. Pursuant to the Ethics in Government Act of 1978, the parties may also be asked to file a financial disclosure report. The person responsible for the participants assignments will be advised of any potential conflict so that conflicting assignments can be avoided, consistent with the agency's needs. If at anytime prior to or during the performance of the assigned duties, the program participant believes that a potential or actual conflict exists, the individual must notify his or her supervisor and the FDA contact person indicated below on this agreement. A determination will be made by FDA/CDRH as to whether a conflict of interest exists and if real, how to resolve or mitigate it. Participants in the program will avoid activities or relationships that would cause a reasonable person to question the impartiality of his or her actions.
VIII. Contact
The individual to whom all inquiries to FDA should be addressed is:
Nancy J. Pluhowski, MPA
Director, Medical Device Fellowship Program (MDFP)
Food and Drug Administration (FDA)
Center for Devices and Radiological Health (CDRH)
9200 Corporate Blvd (HFZ-1)
Rockville, MD 20850
Phone: (301)827-2890
FAX: (301)443-1343
Email: nancy.pluhowski@fda.hhs.gov
The individual to whom all inquiries to BWH should be addressed is:
Joseph Loscalzo, M.D., Ph.D
Chairman, Department of Medicine
Brigham and Women's Hospital
75 Francis Street
Boston, MA 02155
Phone: (617) 732-6340
FAX: (617) 732- 6439
Email: jloscalzo@partners.org
Approved and Accepted
for Brigham and Women's Hospital
Signed by: Joseph Loscalzo, M.D., Ph.D.
Chairman, Department of Medicine
Date: April 13, 2006
Signed by: Joel Katz, M.D.
Co-Director, Residency Program
Date: April 10, 2006
Approved and Accepted
for the Food and Drug Administration
Signed by: Daniel Schultz, M.D.
Director, Center for Devices and Radiological Health
Date: May 9, 2006