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MOU 225-05-6001

Memorandum of Understanding

Between
The United States Food and Drug Administration
Center for Devices and Radiological Health (CDRH) 

and

Duke University (DU)
and
Duke University Health System, Inc. (DUHS)

Durham, NC

 

The United States Food and Drug Administration (FDA) and Duke University Medical Center (DUMC) have a shared interest in scientific progress and advancing the frontiers of medicine. Both organizations are actively engaged in the exchange of scientific information in diverse fields of science that affect human and animal health and medicine. Duke University's mission includes a commitment to help those who suffer, cure disease and promote health through sophisticated medical research and thoughtful patient care. This mission is consistent with a fundamental part of FDA's mission- to protect and promote the public health. Both institutions endorse scientific training for government employees, academicians and students to establish a strong foundation in interdisciplinary science and medicine.

 

This Memorandum of Understanding (MOU) establishes terms of collaboration between FDA and DUMC to support these shared interests and will begin with an initiative entitled: The FDA DUMC 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 Medical Device Fellowship Program (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 protect 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 court order or the Freedom of Information Act (5 U.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, CDRH MDFP participants may include DUMC residents, fellows and faculty or staff. FDA CDRH will provide DUMC Department of Medicine participants 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 FDA CDRH faculty, residents, and staff, laboratories or affiliated facilities.

Frequent communication with CDRH faculty and staff 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 symposia.

 

Office space and/or laboratory facilities, as needed for research and review activities.

 

Opportunities for candidates to serve as a 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.

 

Opportunity to obtain in-depth training in device review practices and policy via a 3 - 6 month residential training session.

 

Opportunity to participate in reviews of medical devices and provide consultations, as appropriate, in their area of expertise from their home office after 6 months residential training session.

 

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 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 and post federal employment restrictions will apply to the participants in this program.

 

II. DU and DUHS; Durham, NC

DU and DUHS 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 DUMC faculty and staff, to include face-to-face communication and teleconferences.

 

Welcome to FDA staff wishing to visit relevant DUMC programs and laboratories.

 

Communication of this collaborative effort through web pages, press releases, informal conversations with colleagues, faculty and students, joint conferences and symposia.

 

Adjunct faculty appointments in relevant DUMC programs or departments for those FDA staff members working with DUMC residents and/or assisting in teaching at DUMC.

 

Encouragement of graduate students/residents to elect short-term opportunities in FDA review divisions and laboratories.

Opportunity to attend graduate courses.

 

Opportunity to visit and receive short term training at the DUMC consistent with standard DUMC policies, resources permitting.

 

In addition to the above, FDA CDRH via the MDFP will provide DUMC Department of Medicine candidates the following, as part of the FDA DUMC Elective Program for Residents:

 

DUMC 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 DUMC 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 DUMC.

 

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 and post federal employment restrictions will apply to the participants in this program.

 

III. Purpose

In the FDA DUMC Elective Program for Residents, FDA and DUMC 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 DUMC policy, and written notice referencing the policies will beprovided to the individual prior to entering duty with FDA. DUMC 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 DUMC for fellowship opportunities, sabbaticals, research, and scientific education. However, as this collaborative effort progresses, it is anticipated that new areas of mutual interest may be included in expansions of this document.

 

V. Finances and Resources

DUMC and FDA agree that this MOU does not commit either party 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 DUMC.

 

VI. Citizenship and Security Clearance

DUMC 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 from participants by the agency 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.

 

VI. 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.

 

VII. 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 any time 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. Contacts

The individual to whom all inquiries to FDA should be addressed is:

V. Michelle Chenault, Ph.D.
Associate Director, Medical Device Fellowship Program
Food and Drug Administration (FDA)
Center for Devices and Radiological Health (CDRH)
9200 Corporate Blvd (HFZ-1)
Rockville, MD 20850
Phone: (301)827-2889
FAX: (301)443-1353
Email: vmc @cdrh.fda.gov

 

The individual to whom all inquiries regarding the FDA DUKE University Medical Center; Department of Medicine Elective Residency Program:

Diana B. McNeill, MD
Director, Residency Training Program
Department of Medicine
Duke University Medical Center
DN Box 3158
Durham, NC 27710
Phone: (919) 684-3841
FAX: (919) 668-1559
Email: mcnei006@mc.duke.edu

Approved and Accepted
for Duke University

Signed by: Gordon Williams
Vice Chancellor for Operations-DUMC

Date: September 11, 2006

Approved and Accepted
for Duke University Health System, Inc.

Signed by: Malcolm Isley
Associate Vice President, Network Services

Date: September 4, 2006

Approved and Accepted
for Duke University Health System, Inc.

Signed by: William J. Fulkerson, M.D.
Vice President, Acute Care Division

Date: September 7, 2006

Approved and Accepted
for the Food and Drug Administration

Signed by: Daniel G. Schultz, M.D.
Director, Center for Devices Radiological Health (CDRH)

Date: September 18, 2006