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Memorandum of Understanding Between the U.S. Department of Health And Human Services, Food And Drug Administration, Office of Women’s Health, and the Society for Clinical Research Sites

I. Purpose

This Memorandum of Understanding (MOU) establishes the terms for collaboration to promote these shared interests, which can be pursued through a variety of programs including collaborative education and research.   The United States Food and Drug Administration (FDA) and the Society for Clinical Research Sites, Inc. (SCRS) (the Parties) share interests in promoting scientific progress through exchange of scientific capital in developing and convening professional education and outreach initiatives to promote the inclusion of diverse women in clinical trials. The anticipated outcomes of this project are to develop a series of continuing education webinars/workshops, outreach activities and related materials to increase visibility and access to FDA clinical trials resources; and to promote best practices for clinical trials design, recruitment, and data analyses among the FDA’ stakeholder networks and SCRS’s. Both institutions foresee benefits from the mutual exchange of training and research expertise in clinical pharmacology and translational science. 

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 assuring the safety, efficacy, and security of drugs, veterinary products, and medical devices and the safety and security of foods, dietary supplements, cosmetics, and radiological products.  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 Society for Clinical Research Sites will greatly contribute to FDA’s mission.

SCRS was founded in 2012 in response to the growing need for a trade organization to represent the global clinical research site community. The goals of SCRS include providing sites with resources, mentorship, and best practices. SCRS represents over 9,000 sites in 47 countries. SCRS unifies the voice of the global clinical research site community for greater site sustainability and support sites and other stakeholders by providing active and ongoing dialogue and content exchange. 

III. Substance of Agreement:

FDA’s OWH launched the Diverse Women in Clinical Trials Initiative in January 2016 to raise awareness about the importance of the participation of diverse women in clinical trials and to share best practices about clinical trials design, recruitment, and data analyses. The initiative includes an awareness campaign, scientific workshops, and training/ resources for investigators.  OWH partners with the National Institutes of Health and other public and private partners to conduct outreach and promote dialogue among consumers, health professionals, health advocates, and researchers.

This MOU forms the basis for development of scientific collaborations, outreach and educational initiatives and intellectual partnerships between FDA and the Society for Clinical Research Sites.
This partnership offers OWH and SCRS an opportunity to jointly promote and present best practices related to increasing the number of women and other subpopulations in clinical trials. 
FDA OWH and SCRS will collaborate to develop a series of professional education trainings and conduct outreach to promote FDA Clinical Trials resources.

A. FDA OWH Responsibilities for this project will include:

1. Co-development and provide strategic input on the professional education webinar series and conference workshop on mutually agreed upon topics.
2. Collaborative identification of speakers internal or external to FDA, if needed for the professional education activities.
3. Public access to free copies of existing FDA OWH publications and digital resources on the participation of women in clinical trials.
4. Provision of strategic input on the development of outreach activities and disseminate OWH clinical trials publications at outreach events.
5. Promotion of the professional education webinars and outreach activities through its existing digital and print channels (e.g., website social media, e-mail and print flyers).
B. SCRS Responsibilities for this project will include:

1. Conduct of background research and co-develop a series of three (3) professional education online webinars on mutually agreed upon topics.
2. Hosting and presenting each live webinar through its digital webinar platform on designated dates. The webinars will be provided at no cost to the public (SCRS members and non-members). 
3. Provision of one contact hour credit to each registered attendee who meets all webinar requirements for each live webinar
4. Posting each webinar on the SCRS website for ongoing use free of charge for one year.  Thereafter, SCRS may use the video for other educational and non-commercial purposes.
5. Co-development of a workshop for registered attendees at its annual conference on mutually agreed upon topics.
6. Promotion OWH Women in Clinical Trials materials to its network of SCRS clinical research community sites.
7. Working with select member sites to plan and conduct web-based activities and a conference workshop.
8. Retain intellectual property rights for proprietary platforms used in developing the webinars.

IV. General Provisions:

A. Rights to any inventions resulting from collaborative research will be determined by the separate written research agreements governing the effort, based on current U.S. Government patent regulations and any other applicable statutes and regulations.
B. Under this MOU, FDA and the Society for Clinical Research Sites will seek opportunities to participate together in 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 a contract, grant, co-sponsorship agreement or cooperative agreement with the Society for Clinical Research Sites 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 the Society for Clinical Research Sites and FDA.
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 restrict or limit access to its property and facilities at any time and for any reason. The Society for Clinical Research Sites’ individuals participating in activities under this MOU on FDA property will comply with all applicable federal statutes and regulations.
E. It is recognized that from time to time FDA and institutions within the Society for Clinical Research Sites 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 as appropriate and in compliance with all applicable federal requirements.
F. All activities within the scope of this Agreement must comply with Section 508 of the Rehabilitation Act (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 (P.L. 105-220), August 7, 1998.

V. Resource Obligations 

This MOU represents the broad outline of the FDA and the SCRS’s intent to collaborate in areas of mutual interest.  All activities that may be undertaken by this MOU are subject to the availability of personnel, resources, and funds.  This MOU does not create binding, enforceable obligations against any Party.  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. 

VI. Liaison Officers

A. Society for Clinical Research Sites

Russell Kemmerle
VP & general Counsel
10326-B Baltimore National Pike
Ellicott City, MD 21042
410-696-5080 x 121

B. Food and Drug Administration: 

Pamela Scott, PhD
Deputy Director and Director, Research and Development
Office of Women’s Health
10903 New Hampshire Avenue, WO, Bldg. 32/2326
Silver Spring, MD 20993

Each Party may designate new liaisons by notifying the other Party's liaison in writing.  If an individual designated as a liaison under this agreement becomes unavailable to fulfill those functions, the Party affected will name a new liaison within two (2) weeks and notify the other Party through the designated liaison.

VII. Term, Termination, and Modification

This agreement, when accepted by all partners, will have an effective period of performance from the date of the latest signature until one-year and may be modified or terminated by mutual written consent the partners or may be terminated by either Partner(s) upon a 60-day advance written notice to the other.

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, the Society for Clinical Research Sites, and the institutions within the Society for Clinical Research Sites operate.

IX. Approvals:

Marsha Henderson      
Assistant Commissioner for Women’s Health
U.S. Food and Drug Administration
March 3, 2018

Christine Pierre, President     
Society for Clinical Research Sites, Inc.
March 2, 2018


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