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NIH Stakeholder Map

mapping out the hierarchies within both the U.S. and E.U. stakeholders.

Maximillian Lehman

on 26 July 2011

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Transcript of NIH Stakeholder Map

NIH Stakeholder Map U.S. Stakeholders E.U. Stakeholders HHS (FDA)
Food and Drug Administration Department of Health and Human Services (OGHA)
Office of
Global Health Affairs Office of the Secretary (OPHS)
Office of Public Health Science (OHRP)
Office for Human Research Protections (SACHRP)
Secretary's Advisory Committee on Human Research (OGC)
Office of the
General Council (CDC)
Centers for
Disease Control White House
Office of Science and Technology Policy Department of State
Office of the Science & Technology Adviser (CDMRP)
Congressionally Directed Medical Research Programs (IOM)
Institute of Medicine Staff Offices Operating Divisions CTTI
Clinical Trials Transformation Initiative (NIH)
National Institutes
of Health Trans-NIH Committees related to BTCR Medical Executive Committee NIAID National Institute of Allergy and Infectious Diseases Office of Global Research Fogarty International Center NCI National Cancer Institute INSIGHT Funds International Network for Strategic Initiatives in Global HIV Trials International Coordinating Committees Sydney Washington (NCHECR) National Centre in HIV Epedimiology and Clinical Research London (MCR) Medical Research Council Copenhagen (CHIP) Copenhagen HIV Programme (CPCRA) Community Programs for Clinical Research Medical Executive Committee NIH Stakeholder Map Key Contacts: Jesper Grarup DVM, CHIP Director of Administration and Jens D. Lundgren M.D., University of Copenhagen, CHIP Director
CHIP is a separate research unit at University of Copenhagen with the continued aim of executing front-line HIV-research
Works primarily with the aid of public grants from the EU and NIH but also has cooperation with the pharmaceutical industry
A non-profit research department working strictly for the benefit of science and not for any special interests INSIGHT
International Network for Strategic Initiatives in Global HIV Trials http://insight.ccbr.umn.edu/index.php Based at Veteran's Affairs medical center affiliated with George Washington University
Obtains evidence to properly inform healthcare providers and people living with HIV on the most appropriate use of available HIV therapies in diverse populations across the spectrum of HIV diseases Key Contacts
INSIGHT Executive Committee Members: Beverly Alston, M.D.; H. Clifford Lane, M.D.; Jens D. Lundgren M.D., University of Copenhagen, CHIP Director; James D. Neaton Ph.D., University of Minnesota; Janet H. Darbyshire, Head of the MRC Clinical Trials Unit and Joint Director for UK Clinical Research Network
Jesper Grarup DVM, CHIP Director of Administration

The mission of INSIGHT is to develop strategies for the optimization of treatment (antiretroviral and immunomodulatory therapies as well as interventions to prevent and treat complications of HIV and antiretroviral therapies) to prolong disease-free survival in a demographically, geographically, and socioeconomically diverse population of individuals infected with HIV.

Each ICC has its own funding model NCHECR
National Centre in HIV Epidemiology and Clinical Research http://www.nchecr.unsw.edu.au/ CHIP
Copenhagen HIV Programme Relationship to Other Stakeholders
INSIGHT consists of 4 International Coordinating Centers: CHIP (Copenhagen), MRC (London), NCHECR (Sydney), CPCRA (Washington)

Areas of Responsibility
One of six HIV/AIDS clinical trials networks funded by NIAID.

Clinical Research Infrastructure and Capacity http://www.cphiv.dk/INSIGHT/tabid/305/Default.aspx MRC
Medical Research Council http://www.mrc.ac.uk/About/index.htm CPCRA
Community Programs for Clinical Research on AIDS http://www.cpcra.org/index.htm Key People: Janet H. Darbyshire, Head of the MRC Clinical Trials Unit and Joint Director for UK Clinical Research Network
Publicly-funded organization dedicated to improving human health and supporting world-class research across the entire spectrum of medical sciences
Works closely with NHS and UK Health Departments, research councils, industy and other stakeholders
Receives annual ‘grant-in-aid’ funding from Parliament
Externally supports medical research by providing grants and awards to scientists and by funding research centers in partnership with universities
Internally supports medical research through its own facilities Affiliated with the University of New South Wales
Carries out research on HIV treatments, ART toxicities, and preventive strategies
Receives its core funding through the Australian Government Department of Health and Ageing
Primary functions relate to the coordination of national surveillance programs, clinical research and clinical trials
Also involved in training and policy programs U.S. Stakeholders CDC
Centers for Disease Control http://www.cdc.gov/about/ http://www.hhs.gov/ophs/index.html OPHS
Office of Public Health and Science Office of the Secretary Key Contacts
Secretary, Kathleen Sebelius, M.P.A.
Deputy Secretary, Bill Corr, J.D.

The Department of Health and Human Services (HHS) is the United States government's principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. Relation to Other Stakeholders
The head office in HHS
Subordinate offices within the Office of the Secretary and 11 additional agencies report to the Secretary

Areas of Responsibility
Regulatory oversight of the system for the protection of human subjects in biomedical and behavioral research supported or conducted by the Department of Health and Human Services.

Type of Authority
Regulatory and Funding (OGC)
Office of the
General Council IOM
Institute of Medicine http://www.iom.edu/About-IOM.aspx Key Contacts
President, Harvey V. Fineberg. M.D., Ph.D.

The Institute of Medicine serves as adviser to the nation to improve health

Not available but is the health arm of the National Academy of Sciences, an independent, nonprofit made up of more than 2,000 individuals, members, and nonmembers who volunteer their time, knowledge, and expertise Relation to Other Stakeholders
Provide unbiased and authoritative advice to decision makers and the public
Many studies undertaken by IOM are the result of mandates from Congress, requests from federal agencies or independent organizations

Areas of Responsibility
Helps those in government and the private sector make informed health decisions by providing reliable evidence
Through over 100 activities, brings together experts and stakeholders around biomedical and health research issues
Conducts consensus studies by committees carefully composed to ensure the requisite expertise and to avoid conflicts of interest
Tasks are developed with the study’s sponsor, which may be a government agency, a foundation, or an independent organization.
Actual tasks are carried out in private and independently

Type of Authority
Advisory http://cdmrp.army.mil/aboutus.shtml Mission
Promote innovative research, recognizing untapped opportunities, creating partnerships, and guarding the public trust

Total congressional appropriations from FY 92-09 = $5.4 Billion
The CDMRP budget is not included in the overall DOD budget, but rather is added after budget approval by members of the House or Senate in repsonse to requests by consumer advocates. Relation to Other Stakeholders
Organization within the U.S. Army Medical Research & Material Command within the U.S. Army within the Department of Defense but not part of the DOD's core mission

Areas of Responsibility
Manages Congressional Special Interest Medical Research Programs (CSI) encompassing breast, prostate, and ovarian cancers, neurofibromatosis, military health, and other specified areas
For more research programs: http://cdmrp.army.mil/researchprograms.shtml

Type of Authority
Funding CDMRP
Congressionally Directed Medical Research Programs U.S. Department of State Office of the Science & Technology Adviser http://www.state.gov/g/stas/ Key Contacts
Special Adviser, Nina V. Federoff, PhD

The mission of the Science and Technology Adviser is to ensure that comprehensive, accurate, and current scientific and technologic expertise are available in timely fashion to the Secretary and senior Department officials in support of the design and implementation of U.S. foreign policy. Relation to Other Stakeholders
Overseen by Under Secretary for democracy and global affairs
Reports directly to the Secretary of State and administrator of USAID

Areas of Responsibility
Facilitates bilateral and multilateral scientific cooperation between the U.S. and foreign countries
Promotes the establishment and consolidation of science and technology capacity in developing countries
Enhances science and technology literacy and capacity of the Department of State
Builds partnerships with the U.S. science and technology community
Provides accurate scientific and technological advice to the Department
Shapes a global perspective on emerging scientific and technological developments

Type of Authority
Advisory Relation to other Stakeholders
Established by a Congressional mandate to advise the President on science and technology
In partnership with OMB, OSTP advises the President on: the federal R&D budget, and shaping R&D priorities across federal agencies

Areas of Responsibility
Leads interagency efforts around policy and budget
Works with non-federal stakeholders toward this end

Type of Authority
OSTP helps drive science and technology policymaking Key Contacts
Director, John P. Holdren, Ph.D.
Assistant Director, Social Behavioral Sciences (Acting) and Assistant Director, Life Sciences, Diane DiEuliis, Ph.D.

Provide accurate scientific advice to the President
Ensure Executive policies are scientifically sound
Coordinate the Executive Branch's scientific work

Advised for FY11 a budget of $66 billion in nondefense R&D White House
Office of Science and Technology Policy http://www.whitehouse.gov/administration/eop/ostp/about http://dhhs.gov/ogc/ Key Contacts
Acting General Counsel, Mark B. Childress, J.D.
Staff Lawyer, Susan Sherman, J.D., MHS
Deputy Associate General Counsel, Barbara M. McGarey, J.D. Public Health Division Staff Position
Associate General Counsel, David E. Benor
Deputy Associate General Counsel, David A. Naimon

We strive to advance the Department's goal of protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. Relationship to Other Stakeholders
Provides quality representation and legal advice on a wide range of highly visible national issues
Is composed of three divisions: Ethics, Food and Drug, and Public Health (which includes NIH)

Areas of Responsibility
Provides legal services to HHS to support the development and implementation of HHS programs

Advisory and legal guidance NIH
National Institutes of Health http://www.niaid.nih.gov/about/whoWeAre/Pages/moreWhoWeAre.aspx HHS
Department of Health and Human Services http://www.hhs.gov/about/ Key Contacts
Assistant Secretary for Health, Howard Koh, M.D., M.P.H.

Mobilizing Leadership in Science and Prevention for a Healthier Nation Relation to Other Stakeholders
Comprised of 13 core public health offices and the Commissioned Corps

Areas of Responsibility
Supports, strengthens, and provides leadership to the nation’s system for protecting volunteers in research that is conducted or supported by HHS
Office of Research Integrity within OPHS monitors institutional investigations of research misconduct and facilitates the responsible conduct of research (RCR) through educational, preventive, and regulatory activities
Commissioned Corps conducts and supports cutting-edge biomedical research

Type of Authority
Funding and Regulatory Mission
CDC Mission is collaborating to create the expertise, information, and tools that people and communities need to protect their health – through health promotion, prevention of disease, injury and disability, and preparedness for new health threats.

FY 2011 = $10.6 billion Relation to Other Stakeholders
One of the major operating components of the Department of Health and Human Services
ATSDR is a division of CDC

Areas of Responsibility
Seeks to accomplish its mission through several activities including: detecting and investigating health problems, conducting research to enhance prevention, implementing prevention strategies, and providing leadership and training

Type of Authority
Funding http://www.hhs.gov/about/ U.S. Senate Committee on Homeland Security & Governmental Affairs: Permanent Subcommittee on Investigations http://hsgac.senate.gov/public/index.cfm?FuseAction=Home.Home Key Contacts
Sen. Joe Lieberman (ID-CT), Committee Char
Sen. Carl Levin (D-MI), Subcommittee Chair

The committee shall be referred all proposed legislation, messages, petitions, memorials, and other matters relating to intergovernmental relations, among other areas. The committee shall have the duty, among others, of studying the efficiency, economy, and effectiveness of all agencies and departments of the Government. Relation to Other Stakeholders
Investigates noncompliance of entities with U.S. rules, regulations, and laws

Areas of Responsibility
Studies or investigates the efficiency and economy of operations of all branches of the Government
Studies or investigates the compliance or noncompliance of entities with the rules, regulations, and laws governing the various governmental agencies and their relationships with the public

Type of Authority
Legislative, congressional, and investigative U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, HHS, and Education http://appropriations.house.gov/index.php?option=com_content&view=article&id=87&Itemid=23 Key Contacts
Dave Obey (D-WI), Committee Chair and Labor, HHS, and Education Subcommittee Chair
Todd Tiahrt (R-KS), Subcommittee Ranking Member Relation to Other Stakeholders
Jurisdiction includes HHS (except FDA)
FDA is under the jurisdiction of the agriculture committee
The White House OSTP is under the jurisdiction of the Commerce, Jusitice and Science subcommittee

Areas of Responsibility
Appropriation of the revenue for the support of the Government
Rescissions of appropriations contained in appropriations Acts
Transfers of unexpected balances
Bills and joint resolutions reported by other committees that provide new entitlement authority

Type of Authority
Legislative, congressional, and allocates government funds U.S. House of Representatives Committee on Energy and Commerce, Subcommittee on Health and Subcommittee on Oversight and Investigations http://energycommerce.house.gov/ Key Contacts
Henry Waxman (D-CA), Committee Chair
Frank Pallone, Jr. (D-NJ), Chair for Subcommittee on Health

Oversight of agency's departments and programs relating to energy, commerce, health and telecommunications Relation to Other Stakeholders
Jurisdiction includes biomedical research and development and public health and quarantine

Subcommittee Areas of Responsibility
Public health and quarantine; hospital construction; mental health and research; biomedical programs and health protection in general, including Medicaid and national health insurance
Food and drugs
Drug abuse

Type of Authority
Legislative, congressional, oversight Key Contacts
Sen. Tom Harkin (D-IA), Committee Chair
Sen. Michael B. Enzi (R-WY), Ranking Member

Broad jurisdiction over U.S. health care, education, employment, and retirement policies
Shall be referred all proposed legislation, messages, petitions, memorials, and other matters relating to the following subjects (among others): 1) Measures relating to education, labor, health, and public welfare, 2) Biomedical research and development, and 3) Public health
Shall also study, review, and report on matters relating to health, education and training, and public welfare Relation to Other Stakeholders
Oversees most HHS components

Areas of Responsibility
Encompasses most of the agencies, institutes, and programs of HHS, including FDA,CDC, NIH, the Administration on Aging, SAMHSA, and AHRQ
Also oversees public health and health insurance statutes to address emerging threats and changing patterns in the healthcare industry

Type of Authority
Legislative, congressional, oversight U.S. Senate Committee on
Health, Education, Labor and Pensions http://help.senate.gov/ U.S. Congress Key Contacts
Chair, Medical Executive Committee, H. Clifford Lane, M.D.

The Medical Executive Committee acts as the organizational body which oversees the functions and duties of the Medical Staff. It is empowered to act for the Staff and to coordinate all activities and policies of the Staff, its Departments and Committees. Relationship to Other Stakeholders
Comprised of the various clinical directors of the NIH intramural clinical research programs and other senior medical and administrative staff
The MEC chair is an Ex Officio member of the NIH Advisory Board for Clinical Research

Areas of Responsibility
Was charged by NIH Intramural Working Group/BTCR initiative with addressing barriers to clinical research in NIH
Advises the Clinical Center Director and develops policies governing standards of medical care in the Clinical Center
Represents and acts for the Medical Staff and other clinical professionals in the Clinical Center, and enforces the rules and policies of the Clinical Center
Meets twice a month

Advising, representative and enforcement Key Contacts
NIH Director, Francis S. Collins, M.D., Ph.D.
Director of Office of Biotechnology Activities , Amy Patterson, M.D.
Associate Director for CRpac, Phil Budashewitz, R.Ph., M.A. CAPT
Associate Director for FDA Relations for CRpac, Kathy Kopnisky, Ph.D.
Consultant for CRpac, Stuart Nightingale, M.D.
Sarah Carr
Chair of the International Research Working Group, Susan Shurin, M.D., NHLBI
Chair of the Iinternational Research Working Group, Alan Guttmacher, M.D., NHGRI

NIH’s mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce the burdens of illness and disability.

FY 2010 = $31,000,000,000 Relationship to Other Stakeholders
Comprised of the Office of the Director and 27 Institutes and Centers
An Operating Division of HHS (Like CDC and FDA)

Areas of Responsibility
Responsible for setting policy for NIH and for planning, managing, and coordinating the programs and activities of all the NIH components
Provides overall leadership to NIH activities in both scientific and administrative matters, and plays an active role in shaping the agency's research agenda and outlook
Responsible for providing leadership to the institutes for identifying needs and opportunities, especially for efforts that involve several institutes
Responsible for stimulating specific areas of research throughout NIH and for planning and supporting research and related activities

Funding and Coordinating U.S. Senate Committee on Appropriations: Subcommittee on Labor, HHS, and Education http://appropriations.senate.gov/sc-labor.cfm Key Contacts
Sen. Daniel K. Inouye (D-HI), Committee Chair
Sen. Tom Harkin (D-IA), Subcommittee Chair

To control the appropriations process, as well as to ensure better management of government spending by giving one committee the sole responsibility to examine executive agency budget estimates Relation to Other Stakeholders
Jurisdiction includes HHS (except FDA)
FDA is under the jurisdiction of the agriculture committee
The White House OSTP is under the jurisdiction of the Commerce, Jusitice and Science subcommittee

Areas of Responsibility
Draft legislation to allocate funds to government agencies within their jurisdictions
Review the President's budget request, hear testimony from government officials, and draft the spending plans for the coming fiscal year
Subcommittee work gets passed to the full Appropriations Committee, which may review and modify the bills and forward them to the full Senate for consideration.

Type of Authority
Legislative, congressional, allocate government funds Fogarty International Center for Advanced Study in the Health Sciences http://www.fic.nih.gov/about/index.htm Key Contacts
Director, Fogarty International Center and Associate Director for International Research, NIH, Roger I. Glass, M.D., Ph.D. PubMed Citations
Europe and European Union Issues Within the Division of International Relations: Rob Lyerla, Ph.D., CAPT
Sr. Public Health Advisor, Robert Eiss

The Fogarty International Center is dedicated to advancing the mission of the National Institutes of Health by supporting and facilitating global health research conducted by U.S. and international investigators, building partnerships between health research institutions in the U.S. and abroad, and training the next generation of scientists to address global health needs.

FY 2010 budget = $69,227,000 Relationship to Other Stakeholders
The Fogarty International Center is the international component of the NIH

Areas of Responsibility
Addresses the global health challenges through innovative and collaborative research and training programs
Supports and advances the NIH mission through international partnerships
Serves as a bridge between the NIH and the greater global health community

Funding and Facilitating NIAID
National Institute of Allergy and Infectious Diseases http://www.niaid.nih.gov/about/whoWeAre/Pages/moreWhoWeAre.aspx Key Contacts
Director, Anthony S. Fauci, M.D.
Principal Deputy Director, Hugh Auchincloss, Jr., M.D.
Deputy Director for Clinical Research and Special Projects also Director of DCR, H. Clifford Lane, M.D.

The National Institute of Allergy and Infectious Diseases (NIAID) conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases.

FY 2010 = $4,816,276,000 Relationship to Other Stakeholders
One of the institutes within NIH

Areas of Responsibility
Include funding, technical assistance, project management, and liaisons between researchers and the government

Funding and Research NCI
National Cancer Institute http://www.cancer.gov/aboutnci Relationship to Other Stakeholders
NCI is part of NIH which is within HHS
The NCI Office of International Affairs coordinates worldwide activities including: liaising with foreign agencies, coordinating cancer research activities, planning and implementing scientist exchange programs, sponsoring international workshops, and disseminating cancer information.

Areas of Responsibility
Involved in World Health Organization's global cancer prevention and control resolution
Supports and coordinates research projects conducted by universities, hospitals, research foundations, and businesses domestically and abroad
Supports education and training in basic and clinical science and basic and clinical research related to cancer
Supports a national network of cancer centers
Collaborates with national and foreign organizations and institutions engaged in cancer research

Funding and Training Key Contacts
Head - Gynecologic Cancer Therapeutics and Quality of Cancer Care Therapeutics, Edward L. Trimble, M.D. MPH
Associate Branch Chief for Clinical Trials Technology, Michael Montello, Ph.D., MBA, CAPT
Head - Gastrointestinal and Neuroendocrine Cancers Therapeutics, Jack Welch, M.D., Ph.D.

The National Cancer Institute coordinates the National Cancer Program, which conducts and supports research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients.

FY 2009 = $4,966,927,000 OGR
Office of Global Research http://www.niaid.nih.gov/about/organization/odoffices/omo/ogr/Pages/default.aspx Relationship to Other Stakeholders
Within the Office of Science Management and Operations which is within the Office of the Director of the NIAID

Areas of Responsibility
Maintains a comprehensive knowledge base of the Institute's research programs and policies
In coordination with the Fogarty International Center (FIC), identifies relevant programs of other Federal domestic agencies, bilateral research agencies and organizations, multilateral research organizations, and voluntary agencies involved in international health activities
Advises the Institute Director on program relationships and opportunities for collaboration
Serves as NIAIDs point of contact with FIC, WHO, the State Department, and CDC
Coordinates NIAID's intramural and extramural biomedical research on infectious and immunological diseases world-wide
Organizes and coordinates cross-cutting NIAID international activities that complement Division activities and addresses unmet needs

Advising and Facilitating Key Contacts
Associate Director for International Research Affairs, F. Gray Handley, M.S.P.H.
Director of OGR, Steven T. Smith

The Office of Global Research coordinates and supports collaborative international research programs which focus upon selected infectious diseases of substantial health importance in developing countries. DPCPSI
Division of Program Coordination, Planning, and Strategic Initiatives Key Contacts

The NIH Intramural Working Group (IWG) launched this initiative to identify and reduce barriers to efficient and effective NIH-sponsored clinical research. Relationship to Other Stakeholders
Within NIH/OD
Launched by the NIH Intramural Working Group
Charged Medical Executive Committee with addressing BTCR

Areas of Responsibility
Identifying emerging scientific opportunities, rising public health challenges, or scientific knowledge gaps that merit further research
Developing and applying resources (e.g. databases, analytic tools, and methodologies) and producing specifications for new resources in support of portfolio analyses and priority setting in scientific areas across NIH
Assisting the NIH to address areas of emerging scientific opportunities and public health challenges effectively
Planning, supporting, and providing technical assistance in the development of program evaluations

Advisory SACHRP
Secretary's Advisory Committee on Human Research Protections http://www.hhs.gov/ohrp/ OHRP
Office for Human Research Protections http://www.hhs.gov/ohrp/sachrp/index.html Key Contacts
Director, Jerry A. Mennikoff, M.D., J.D.
Associate Director Regulatory Affairs, Michael Carome, M.D., F.A.C.P., CAPT
Senior Advisor to the Director, Ivor Pritchard, Ph.D.
Team Leader Policy, Julie Kaneschiro
Director of the Division of Policy and Assurances, Irene Stith-Coleman, Ph.D.

Provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by HHS. OHRP helps ensure this by providing clarification and guidance, developing educational programs and materials, maintaining regulatory oversight, and providing advice on ethical and regulatory issues in biomedical and behavioral research. Relation to Other Stakeholders
Within the OPHS
Oversees all U.S. government funded clinical research both domestically and abroad.

Areas of Responsibility
Provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by HHS
Oversees compliance with HHS regulations 45 CFR Part 46 and takes regulatory action if necessary
Provides guidance to individuals and institutions conducting HHS supported human subjects research
Provides training to institutions involved in international research, to help ensure that ethical protections are afforded to those who participate in research outside the United States
Provides quality improvement assurance consultations to international institutions
Prepares and disseminates policies and guidance and interpretations of requirements
Provides management and support services for SACHRP

Type of Authority
Regulatory Key Contacts
Chair of SACHRP, Barbara Bierer, M.D. Harvard Medical School
Co-Chair of Subcommitee on Harmonization, Mark Barnes, J.D., LL.M. Harvard University
Co-Chair of Subcommitee on Harmonization, David Forster, J.D., M.A. CIP
Member of Subcommitee on Harmonization, Robert Califf, M.D., Duke University
Co-Chair of Subcommittee Subpart A, Daniel Nelson, M.S., CIP University of North Carolina at Chapel Hill

The Secretary’s Advisory Committee on Human Research Protections shall provide expert advice and recommendations to the Secretary and the Assistant Secretary for Health (ASH) on issues and topics pertaining to or associated with the protection of human research subjects.

Estimated annual cost is $657,907 which includes operations and staff support Relation to Other Stakeholders
Overseen by OHRP
Between voting members and Ex Officio members there are representatives from government, academia, and industry
NIH Ex Officio member is Amy Patterson (delegated to Phil Budashewitz)

Areas of Responsibility
Advises the Secretary as to how to improve the quality of the system of human research protection programs, including the responsibilities of PIs, IRBs, administrators, and institutional officials, and the role of OHRP and other offices within HHS
Charter will expire on October 1, 2010

Type of Authority
Advisory Medical Executive Committee http://www.cc.nih.gov/about/welcome/governance/committee.shtml FDA
Food and Drug Administration http://www.fda.gov/AboutFDA/default.htm Clinical Trials Transformation Initiatitve https://www.trialstransformation.org/ Key Contacts
Co-chair, Vice Chancellor for Clinical Reasearch at Duke University, Robert M. Califf, M.D., MACC
Co-Chair, Acting Associate Center Director for Medical Policy at FDA, Rachel E. Behrman, M.D., MPH
Executive Director, CTTI, Ex Officio Member Duke Translational Medicine Institute, Judith M. Kramer, M.D.

To identify practices that through broad adoption will increase the quality and efficiency of clinical trials

Unknown but funded by Duke University, FDA, and membership fees Relation to Other Stakeholders
Under an agreement with FDA, Duke University serves as the host for the public-private partnership aimed at improving the quality and efficiency of clinical trials
Member organizations come from several different categories of stakeholders (academia, pharmaceutical industry, government, professional societies, etc.)
Amy Patterson is both the Executive Committee’s and the Steering Committee’s liaison to NIH
Jerry Menikoff is the Steering Committee’s liaison to OHRP

Areas of Responsibility
Generates evidence about how to improve the design and execution of clinical trials so that they accomplish their intended purpose
Seeks to identify practice improvements that can be applied internationally
Current projects: Clinical Trials Monitoring and Serious Adverse Event Reporting

Type of Authority
Advisory Key Contacts
Commissioner of Food and Drugs, Margaret A. Hamburg, M.D.
Principal Deputy Commissioner, Joshua M. Sharfstein, M.D.
Senior Advisor for Clinical Science, Office of the Commissioner, David A. Lepay, M.D., Ph.D.
Deputy Commissioner for International Programs, Murray Lumpkin, MD, M.Sc.
Associate Commissioner for International Programs, Mary Lou Valdez, MSM
Acting Assistant Commissioner, Office of Policy, Leslie Kux
Director of Scientific Investigations (CDER), Cynthia Kleppinger, M.D.
Patricia Beers Block
Deputy Director for Clinical Science, Center for Drug Evaluation and Research, Bob Temple
Director, Division of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, Leslie Ball
Michelle O’Malley

The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

FY 2010 = $3.2 billion Relation to Other Stakeholders
FDA is an agency within the Department of Health and Human Services. It consists of six product centers, one research center, and two offices.
NIAID interacts primarily with Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER)

Areas of Responsibility
Ensures that the following are safe and accurately represented to the public: food, human and veterinary drugs, biological products, medical devices, cosmetics, and electronic products that emit radiation.

Type of Authority
Regulatory and Funding OGHA
Office of Global Health Affiars http://www.globalhealth.gov/ Key Contacts
Director, Nils Daulaire, M.D., MPH
Director of Europe and Eurasia, Mary L. Madell

To promote the health of the world’s population by advancing the Secretary’s and the Department of Health and Human Services’ global strategies and partnerships, thus serving the health of the people of the United States Relation to Other Stakeholders
Within the Office of the Secretary of HHS

Areas of Responsibility
OGHA is the focal point for HHS global health activities
Represents HHS to other Federal agencies, international organizations, multilateral institutions, the private sector, and other governments on international health matters
Clears all documents related to international health
Reviews and approves all HHS international travel
Promotes cooperative health programs in other nations
Manages the health attaché program

Type of Authority
Coordinates and represents HHS global health Office of Global Health Affairs
OGHA Key Contacts
Director, Centers for Disease Control and Prevention, Thomas R. Frieden, M.D., MPH
Principal Deputy Director of CDC/ATSDR, Ileana Arias, Ph.D.
Deputy Director for Operations, Office of Public Health Preparedness and Response, Lynn Austin, Ph.D.
Director of Center for Global Health, Kevin M. DeCock, M.D., F.R.C.P. (UK), D.T.M.&H
Division of Global HIV/AIDS (DGA Director): Deborah (Debbi) Birx, M.D.
Division of Parasitic Diseases and Malaria (DPDM Director): Mark Eberhard, Ph.D.
National Center for Emerging and Zoonotic Infectious Diseases: Thomas Hearn, Ph.D. (acting director)
National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention: Kevin Fenton, M.D., Ph.D.
National Center for Immunization and Respiratory Diseases: Anne Schuchat, M.D. (RADM, USPHS) Department of Health and Human Services Department of Health and Human Services HHS Office of General Council HHS Office of General Council National Institutes of Health National Institutes of Health NIH Fogarty International Center NIH Fogarty International Center NIH Medical Executive Committee NIH Medical Executive Committee NIH Division of Program Coordination, Planning, and Strategic Initiatives NIH Division of Program Coordination, Planning, and Strategic Initiatives HHS Office of Public Health and Science HHS Office of Public Health and Science Secretary's Advisory Committee on Human Research Protections Secretary's Advisory Committee on Human Research Protections HHS Office of Global Health Affairs HHS Office of Global Health Affairs Food and Drug Administration Food and Drug Administration Clinical Trials Transformation Initiatitve Clinical Trials Transformation Initiatitve Centers for Disease Control Centers for Disease Control Centers for Disease Control U.S. Department of State Office of the Science & Technology Adviser U.S. Department of State Office of the Science & Technology Adviser U.S. Department of State Office of the Science & Technology Adviser U.S. Department of State Office of the Science & Technology Adviser Congressionally Directed Medical Research Programs Congressionally Directed Medical Research Programs Institute of Medicine Institute of Medicine HHS National Institute of Allergy and Infectious Diseases HHS National Institute of Allergy and Infectious Diseases NIAID Office of Global Research NIAID Office of Global Research Medical Research Council OPHS Office for Human Research Protections HHS Office for Human Research Protections Community Programs for Clinical Research on AIDS Copenhagen HIV Programme National Centre in HIV Epidemiology and Clinical Research International Network for Strategic Initiatives in Global HIV Trials International Network for Strategic Initiatives in Global HIV Trials ICH
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Mission
The purpose is to make recommendations on ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration
The objective is greater efficiency, reduction of duplicate testing, elimination of unnecessary delays, and increased availability of new medicines http://www.ich.org/cache/compo/276-254-1.html International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Relationship to Other Stakeholders
Brings together the regulatory authorities and experts from the pharmaceutical industry within Europe, Japan, and the United States to discuss scientific and technical aspects of product registration
The six founding members include the EU Commission, FDA, and PhRMA
The Observers are WHO, EFTA, and Health Canada

Areas of Responsibility
A joint initiative involving both regulators and industry as equal partners in the scientific and technical discussions of the testing procedures which are required to ensure and assess the safety, quality, and efficacy of medicines
The focus of ICH has been on the technical requirements for medicinal products containing new drugs.

Coordinating and harmonizing OECD
Organisation for Economic Co-Operation and Development UN/WHO
United Nations/World Health Organzation G20
Group of Twenty ESF
European Science Foundation DG Trade
Directorate General for Trade European Commission U.K. Organizations DG Research
Directorate General for Research SURE
Policy Changes Committee ECRIN
European Clinical Infrastructure Network EU Governmental Structure NIHR
National Institute of Health Research ENVI
Environment, Public Health and Food Safety Committee European Parliament MRC
Medical Research Council ICREL
Impact on Clinical Research of European Legislation CHMP
Committee for Medicinal Products for Human Use Council of the European Union Department of Health CTSU Oxford
Clinical Trials Service Unit Oxford EMA
European Medicines Agency EMRC
European Medical Research Councils ECDC
European Centre for Disease Prevention and Control DG SANCO
Directorate General for Health and Consumer Affairs EFGCP
European Forum for Good Clinical Practice Legislation SURE
Policy Changes Committee EFSA
European Food Safety Authority ENVI
Environment, Public Health and Food Safety Committee European Council http://www.ema.europa.eu/ema/index.jsp?curl=pages/home/Home_Page.jsp&murl=&mid= Key People
Executive Director, Thomas Lönngren
Head of Human Medicines Development and Evaluation, Patrick Le Courtois

The mission of the European Medicines Agency is to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public and animal health

FY09 = €194.4 million
On average, 75% of EMA’s budget is derived from fees and charges, and 25% from the EU contribution for public health issues Relationship to Other Stakeholders
Has its own legal identity and operates independently of the EU institutions

Areas of Responsibility
Protects and promotes public and animal health through the evaluation and supervision of medicines
Evaluates medicines developed by pharmaceutical companies for use in the EU
Coordinates existing Member State scientific resources including the evaluation, supervision, and pharmacovigilance of medicinal products
Provides independent, science-based recommendations on the quality, safety, and efficacy of medicines.
Applies efficient and transparent evaluation procedures to help bring new medicines to the market by means of a single, EU-wide marketing authorisation granted by the European Commission
Implements measures for continuously supervising the quality, safety, and efficacy of authorised medicines to ensure that their benefits outweigh their risks
Provides scientific advice and incentives to stimulate the development and improve the availability of innovative new medicines

Type of Authority
Advisory http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000095.jsp&murl=menus/about_us/about_us.jsp&mid=WC0b01ac0580028c7a Areas of Responsibility
Prepares EMA’s opinions on all questions concerning medicines for human use
Conducts initial assessments of medicines for which an EU-wide marking authorisation is sought. Also responsible for several post-authorisation and maintenance activities, including modifications or variations to existing marketing authorisations
Arbitrates disagreements between Member States concerning marketing authorizations of a particular medicine
Provides assistance to companies researching and developing new medicines
Prepares scientific and regulatory guidelines for the pharmaceuticals industry
Cooperates with international partners on regulatory harmonisation Background
Consists of the Heads of State or Government of the Member States, together with the President of the European Council and the President of the Commission
President has a 2.5 year term with a two term limit

Key People
President of the European Council: Herman Van Rompuy (Belgium), took office in 2010 Relationship to Other Stakeholders
Has no formal legislative power but provides general political directions and priorities for the EU
Role within the EU Government
Defines the EU's policy agenda and drives integration among Member States
Advisory and executive guidance Background
The EU's executive body.
Proposes new European laws to Parliament and the Council of the EU
Manages the day-to-day business of implementing EU policies and spending EU funds.
Enforces European law jointly with the Court of Justice
Represents the EU internationally
Within EU structure Parliament can veto the European Commission
President has a five year renewable term

Key People
President of the European Commission: José Manuel Barroso (Portugal), elected in 2004 and 2009

FY10: €141.5 billion, FY11: €142.6 billion Relationship to Other Stakeholders
Accountable to EU Parliament
The Commission's staff is organized into Directorates-General (DGs) including: DG SANCO, DG Research, and, DG Trade, DG Enterprise and Industry.
Role within the EU Government
Executive Branch
Policy and oversight http://ec.europa.eu/index_en.htm http://www.european-council.europa.eu/the-institution.aspx?lang=en\ Background
Drafts and passes legislation jointly with the Council of the European Union.
President serves 2.5 year terms
Members serve 5 year terms

Key People
President of the European Parliament: Jerzy Buzek (Poland), elected in 2009 Relationship to Other Stakeholders
Can veto any decisions of the European Commission and can force the entire Commission to resign
Has joint power with the Council of the European Union over the annual budget of the EU

Role within the EU Government
Is the community institution that represents the peoples of the Member States of the European Union.

Legislative http://www.europarl.europa.eu/parliament/public/staticDisplay.do?language=EN&id=146 Areas of Responsibility
Environmental policy, environmental protection measures, food safety issues, and public health, in particular: Areas of Responsibility
Define Parliament's political priorities for the post-2013 Multiannual Financial Framework (MFF), both in legislative terms and budgetary terms
Estimate the financial resources necessary for the Union to attain its objectives
Define the duration of the next MFF
Propose a structure for the future MFF indicating the main areas of Union activity
Submit guidelines for allocation of resources that align with the priorities and proposed structure Background
The ministers of the Member States form the Council of the European Union. Depending on the issue, each country will be represented by the minister responsible for that subject (foreign affairs, finance, social affairs, transport, agriculture, etc.)
The presidency of the Council of the EU rotates every six months among EU member states

Key People
Prime Minister of Belgium and Current President of the Council of the EU (July-Dec 2010): Yves Leterme

FY10 = € 633.5 million Relationship to Other Stakeholders
Works cooperatively with the EU Commission to ensure coherence in the EU’s actions

Role within the EU Government
Drafts and passes European laws jointly with the European Parliament in many policy areas
Coordinates the broad economic policies of the Member States
Concludes international agreements between the EU and other countries or international organizations
Approves the EU’s budget, jointly with the European Parliament
Develops the EU’s Common Foreign and Security Policy (CFSP), based on guidelines set by the European Council
Coordinates cooperation between the national courts and police forces in criminal matters

Legislative Key Contacts
Director of Public Health and Risk Assessment, Dr. Andrezej Rys
Medicinal Products for Human Use, Stefan Fuehring
Head of the Food Safety, Health and Consumer Affairs (FSHCA) for the EU Delegation to the U.S., Bernard Merkel

Europe working for healthier, safer, more confident citizens Relationship to Other Stakeholders
The following agencies of the European Union are linked to DG-SANCO:
(1) European Food Safety Authority (EFSA), which the European Commission consults for questions concerning the safety of food products
(2) European Centre for Disease Prevention and Control (ECDC), which helps the European Union combat communicable diseases and other serious health threats

Areas of Responsibility
Ensures that the policies and laws for which DG SANCO is responsible are applied and enforced in a way that benefits citizens
Addresses problems related to Health and Consumer Affairs directly through proposals or indirectly through supporting Member State authorities
Strives to work closely with the Council of the EU and the European Parliament

Regulatory Relationship to Other Stakeholders
Works closely with other Commission departments such as the Joint Research Centre, the DG Information Society, DG Energy and Transport, DG Environment, DG Enterprise, and DG SANCO

Areas of Responsibility
Biotechnology, generic tools, and technologies for human health
Translating research for human health
Optimising the delivery of health care to European citizens
Responsible for several health related research areas, with several cross cutting focus areas
International cooperation, an important aspect of FP7 and an integral part of Theme 1 on Health Research

Funding, regulatory Key People
Director General, Robert Jan-Smits
Director Health, Ruxandra Draghia-Akli
Head of Unit on Medical and Public Health Research, Manuel Hallen
Head of Unit on Infectious Diseases, Péteris Zilvagis

Develop the EU’s policy in research and technological development including health
Coordinate European research activities with those of the Member States
Support public debate about research-related issues http://ec.europa.eu/dgs/health_consumer/weare_en.htm EFPIA
European Federation of Pharmaceutical Industries and Associations Programmes and specific actions in the field of public health
Pharmaceutical and cosmetic products
Health aspects of bioterrorism
The European Agency for the Evaluation of Medicinal Products and the European Centre of Disease Prevention and Control http://www.efsa.europa.eu/ http://www.ecdc.europa.eu/en/Pages/home.aspx Mission
Provides independent scientific advice and clear communication on existing and emerging risks as part of the EU’s risk assessments regarding food and feed safety Mission
Aims to strengthen Europe’s defenses against infectious diseases http://www.consilium.europa.eu/showPage.aspx?lang=en http://ec.europa.eu/dgs/research/index_en.html Key People
Director General, David O’Sullivan

Through the EU's trade policy secures prosperity, solidarity, and security in Europe and around the globe Relationship to Other Stakeholders
Deals extensively with trading partners’ governments and businesses
Works closely with other services of the EU Commission to deliver coherent policies that strengthen both internal and external economic agendas

Areas of Responsibility
Leads efforts to widen access to vital medicines in developing countries and striking the right balance between the intellectual property rights of pharmaceutical companies and the need to ensure that medicines are available for poor countries facing public health crises.
Negotiates bilateral, regional, or multilateral agreements
Monitors and ensures the implementation of international agreements
Maintains tiered pricing, compulsory licensing, customs enforcement pertaining to access to medicines
Ensures that EU legislation in the area of sanitary and phytosanitary rules meets the EU's international obligations.

Regulatory Relationship to Other Stakeholders
Brings European researchers together to network and share their knowledge for the benefit of European research
Currently has 79 member organisations from 30 European countries

Areas of Responsibility
Facilitates cooperation and collaboration in European science specifically in Science Strategy, Science Synergy, Science Management
Has five scientific standing committees: SCH, LESC, EMRC, PESC, SCSS

Networking facilitation Mission
ESF's core purpose is to promote high quality science at a European level

Funding is provided by its member organizations http://ec.europa.eu/trade/ http://www.esf.org/about-us/who-we-are.html Key Contacts
Head of Unit, Medical Sciences, Stephane Berghmans
Science Officer, Medical Sciences, Kirsten Steinhausen
Chair, Professor Liselotte (Lotte) Højgaard (MD., DMSc.), member of the Danish Political Research Council, University of Copenhagen

Promote innovative medical research and its clinical application towards improved human health

Overall budget unknown but the following four countries each contribute more than 10% of the ESF General Budget: France, Germany, Italy and the United Kingdom Relationship to Other Stakeholders
A standing committee under ESF consisting of 37 medical research councils in 30 European countries

Areas of Responsibility
Focuses on medical research to gain a better understanding of the causes of complex diseases improve resulting in improved human health
One programme, EUROCORES, focuses on Pan-European Clinical Trials

Advisory http://www.esf.org/nc/research-areas/medical-sciences.html Mission
Its purpose is to promote Good Clinical Practice and encourage the practice of common, high-quality standards in all stages of biomedical research throughout Europe

Budget unknown, but is a non-profit organisation Relationship to Other Stakeholders
Projects include representatives from patient groups, ethics committees, academic & industry research enterprises, regulatory officials, and those concerned to develop Good Clinical Practice in Europe
Participating organisations include: European Commission, European Parliament, EORTC, EMA, ESF, CESP, EPPOSI, EuropaBio, EFPIA, ICH, BARQA, ACRP, WMA, CIOMS, the Faculty of Pharmaceutical Medicine, BCPM, and several UN organisations involved in health research

Areas of Responsibility
Promotes the highest standards for GCP
Promotes open discussion on critical issues in biomedical research and health
Promotes education and awareness leading to the application of rigorous ethical and scientific requirements in clinical research
Facilitates the transfer of knowledge and skills across disciplines and sectors
Promotes a renewed emphasis on human values in research involving human participants

Facilitation http://www.efgcp.be/default.asp?L1=1&L2=0 Key People
Project Coordinator, Ingrid Klingmann

Its aim was to measure and analyse the direct and indirect impact of the EU CTD and related legislation in the EU on all categories of clinical research and on the different stakeholders, including commercial and non-commercial sponsors, ethics committees, and competent authorities
Final report was published June 2009

Received funding from FP7 Relationship to Other Stakeholders
Under EFGCP’s coordination, ECRIN, EORTC, the Hospital Clínic of Barcelona, and the Ethics Committee of the Medical University of Vienna collaborated on this project

Areas of Responsibility
Designed to measure the impact of the EU CTD on academic institutions and industry, including SMEs, that face major difficulties, especially as it relates to fulfilling sponsor responsibilities

Informational http://www.ctsu.ox.ac.uk/ Key People
BHF Professor of Medicine and Epidemiology, Rory Collins FMed Sci FRCP
Professor of Medical Statistics and Epidemiology, Sir Richard Peto FRS Hon FRCP

Coordinates large-scale randomised and observational studies in order to investigate the causes, prevention, and treatment of premature death and disability in developed and developing countries Relationship to Other Stakeholders
Research institute within the Nuffield Department of Clinical Medicine of the Medical Sciences Division at Oxford University in the United Kingdom

Areas of Responsibility
Studies the causes and treatment of chronic diseases and other major conditions in developed and developing countries

Type of Authority
Coordinating and conducting research http://www.mrc.ac.uk/index.htm Key People
Director of the MRC Clinical Trials Unit and Director of the Hub for Trials Methodology, Mahesh Parmar
Head of the MRC Clinical Trials Unit and Joint Director of the UK Clinical Research Network (UKCRN) Coordinating Centre, Janet Darbyshire (Retired)

Encourage and support research to improve human health
Produce skilled researchers
Advance and disseminate knowledge and technology to improve the quality of life and economic competitiveness of the UK
Promote dialogue with the public about medical research

2008/09: £704.2 million on research
Receives ‘grant-in-aid’ funding from Parliament Relationship to Other Stakeholders
Consists of 30 Units (28 in the UK, 2 in Africa), 3 Institutes, and 22 Centres. The Units support long-term research, the Institutes provide an environment for the riskiest and most innovative research, and the Centres are partnerships with UK universities to develop centres of excellence
Funds the following initiatives: researchers in universities and hospitals, postgraduate training awards
Works closely with the Health Departments, the other UK research councils, industry and other stakeholders to identify and respond to the UK’s health needs.
Has its own affiliated company, MRC Technology, which works with industry to translate our scientists’ findings into tangible health benefits

Areas of Responsibility
Is independent in its choice of which research to support, even though it is government-funded
Provides research grants and career awards to scientists in UK universities and hospitals
Funds research centres both in house and in partnership with universities
Has several research areas, one of which is translational research, which aims to increase the scale and speed of progress from scientific discovery to clinical benefit
Attracts and trains first-rate researchers
Promotes the translation of basic research discoveries into new and improved healthcare policy and practice
Funds research partnerships
Encourages commercial exploitation of its scientists’ discoveries, for the benefit of the UK’s health and economy
Provides leadership in the governance of medical research

Type of Authority
Funding and research Research and Development Directorate http://www.nihr.ac.uk/about/Pages/default_old.aspx http://www.dh.gov.uk/en/Aboutus/Researchanddevelopment/index.htm http://www.dh.gov.uk/en/index.htm Key People
Chief Medical Officer, Professor Dame Sally C. Davies

Better health and well-being for all: helping people stay healthy and well; empowering people to live independently; and tackling health inequalities
Better care for all: the best possible health and social care that offers safe and effective care, when and where people need it; and empowering people in their choices
Better value for all: delivering affordable, efficient and sustainable services; contributing to the wider economy and the nation

Expenditure in 2009-10 was £98,781 million Relation to Other Stakeholders
Works with a range of partners, principally the health and social care system (including the NHS, local government, the Medicines and Healthcare Products Regulatory Agency, special health authorities, and quasi-governmental bodies), but also with other partners in public services, the private sector, the third sector and international bodies
Regional public health groups (PHGs) are part of the DOH, and are linked to each of the nine regional government offices
One component of the DOH is the Research and Development Directorate

Areas of Responsibility
Is committed to improving the quality and convenience of care provided by the NHS and social services
Sets national standards, shapes the direction of health and social care services and promotes healthier living.
Provides strategic leadership to the NHS and social care organisations in England

Type of Authority
Policy Relation to Other Stakeholders
Consists of the Policy Research Programme (PRP) and the National Institute of Health Research (NIHR)
Part of the Department of Health
Provides information to the Secretary of State for Health and his Ministers

Areas of Responsibility
The PRP is dedicated to providing an effective evidence base for policy-making in the DOH
The NIHR provides the framework through which DOH maintains and manages the research, research staff and research infrastructure of the NHS in England

Type of Authority
Policy and Research Key People
Chief Medical Officer, Professor Dame Sally C Davies, Director General (DG) of Research and Development and Chief Medical Officer for the Department of Health and NHS
Head of research systems and governance in the Research and Development Directorate, Marc Taylor

Developing evidence to inform and underpin health and social care policy and commissioning research focused on the needs of patients and the public

Budget unknown, but funding sources include DOH; the Department for Business, Innovation and Skills; Health Departments in Scotland, Wales and Northern Ireland; Research Councils; Charities, including the Wellcome Trust; and the European Commission’s Research Framework Programme Relation to Other Stakeholders
Part of the UK Department of Health Research and Development Directorate
Funds research while other organizations, such as National Institute for Health and Clinical Excellence, provide guidance
Engages in strategic dialogue and working partnerships with industry to create the best possible research environment in the NHS and build an international reputation for excellence in translational and applied research

Areas of Responsibility
Develops the research evidence to support decision making, makes research evidence available- e.g., through a program called NHS Evidence
Improves the quality, relevance, and focus of research in the NHS and social care by distributing funds in a transparent way after open competition and peer review
Manages activities through four main work strands: 1) Faculty (supporting investigators), 2) Research (commissioning and funding), 3) Infrastructure (support and facilities), and 4) Systems (knowledge management and information systems)

Type of Authority
Funding and coordinating Key People
Director General of Research and Development at the Department of Health, Professor Dame Sally C. Davies

The goal of the NIHR is to create a health research system in which the NHS supports outstanding individuals, working in world class facilities, conducting leading edge research focused on the needs of patients and the public.

FY10/11 = £ 992 Million Relationship to Other Stakeholders
Since 1972, the US National Cancer Institute (NCI) has provided core support to EORTC Headquarters
Much of this success in new drug development has been facilitated by the close working relationship between the NCI, the EORTC, and the British Cancer Research United Kingdom (CRUK) in London
A close scientific collaboration has been maintained to promote transatlantic research through compound acquisitions, selection, screening, formulation, toxicology, and clinical evaluation

Areas of Responsibility
Develops, conducts, coordinates, and stimulates translational and clinical research in Europe to improve the management of cancer

Collaborating and coordinating www.ecrin.org Relationship to Other Stakeholders
Brings together stakeholders from all participating EU Member State governments, the EU government, the EMA, industry, patient associations, public research institutions, and international partners
Users of ECRIN consultancy and services are clinical research projects initiated by academic investigators or disease-oriented scientific networks, projects sponsored by public institutions, public-private partnerships, small and medium-sized enterprises (SMEs), medical devices or pharmaceutical companies

Areas of Responsibility
Its objective is to become its own legal entity to provide integrated support to multinational clinical research projects through information, consultancy, and a set of flexible services

Coordinating and Capacity Building Key People
ECRIN Coordinator, Jacques Demotes-Mainard (France)

Multinational organization dedicated to improving the health of patients and citizens across the world through clinical research
Supports, services, coordinates, and manages high-quality, independent, and fully transparent multinational clinical research
Synergizes the capacities and capabilities of national clinical research
Strives for harmonisation of European clinical research
By facilitating clinical research across Europe, contributes to the achievement of the ‘European Research Area’ and the ‘society of knowledge’ and adds to European competitiveness

Has been funded by the EU
The current step (2008-2011) of developing a sustainable infrastructure is funded by FP7 Key People
Executive Director, Prof. Charles Mgone (Formerly Network Director African Malaria Network Trust)

EDCTP aims to accelerate the development of new or improved drugs, vaccines, and microbicides with a focus on phase II and III clinical trials in sub-Saharan Africa

Approximately €400 million over 7 years
European countries and the European Commission (through FP7) each contribute approximately €200M Relationship to Other Stakeholders
Creates partnerships among the 14 participating EU Member States plus Norway and Switzerland with sub-Saharan African countries

Areas of Responsibility
The partnership helps European countries to integrate and coordinate their own national research and development programmes and form partnerships with their African counterparts.
Clinical research and clinical trials for preventing and treating HIV/AIDS, tuberculosis and malaria diseases has been identified as a main priority.
Supports clinical trials by networking and capacity building

Collaborating and coordinating http://www.edctp.org/About-EDCTP.2.0.html EDCTP
European and Developing Countries Clinical Trials Partnership Relationship to Other Stakeholders
Has official relations with the many other international organisations including the United Nations bodies and non-member countries

Areas of Responsibility
Collects, monitors, and analyzes economic and social data
The OECD Secretariat collects and analyses data, after which committees discuss policy regarding this information, the Council makes decisions, and then governments implement recommendations
Works on Global issues in the following areas: Economy, Society, Development, Finance, Governance, Innovation, and Sustainability

Coordinating research and analysis in areas including health Key People
Secretary-General, Angel Gurría

OECD brings together the governments of countries committed to democracy and the market economy from around the world to: support sustainable economic growth, boost employment, raise living standards, maintain financial stability, assist other countries' economic development, and contribute to growth in world trade

FY 2010 = €328 million
Funded by member countries’ national contributions based on a formula which takes account of the size of each member's economy
The United States is the largest contributor, which provides nearly 24% of the budget, followed by Japan
Countries may also make voluntary contributions to financially support outputs in the OECD programme of work http://www.oecd.org/pages/0,3417,en_36734052_36734103_1_1_1_1_1,00.html DG Enterprise and Industry
Directorate General for Enterprise and Industry http://ec.europa.eu/enterprise/index_en.htm Key People
Director General, Heinz Zourek
Unit F2 Pharmaceuticals/Medicinal Products for Human Use, Stefan Fuehring

The mission of DG Enterprise and Industry is to promote the sustainable competitiveness of EU enterprises and industries

€ 1.5 billion Relationship to Other Stakeholders
Has close relationships with businesses and EU and Member State governments
Works with these stakeholders to help Europe become a more competitive, innovative, and resource-efficient economy.

Areas of Responsibility
Strengthens Europe’s industrial base and promotes the transition to a low-carbon economy
Promotes innovation as a means to generate new sources of growth and meet societal needs
Encourages the creation and growth of SMEs and promotes a new entrepreneurial culture
Ensures an open internal market for goods
Supports the European presence in space and the development of innovative technologies through space applications

Regulatory Relationship to Other Stakeholders
The Forum's principal customers are the government science policy officials who bring issues to the Forum for analysis, deliberation and resolution in an intergovernmental setting
The Forum’s working groups bring together government officials, scientific experts, and representatives of international organisations

Areas of Responsibility
Explores opportunities for new or enhanced international co-operation in selected scientific areas
Defines international frameworks for vital national or regional science policy decisions
Addresses the scientific dimensions of issues of global concern
Produces findings and recommendations for action at senior administrative or operational levels

Coordinating and advisory Key People
Directorate for Science, Technology and Industry/International Scientific Cooperation (Global Science Forum), Frédéric Sgard

Its goal is to identify and maximise opportunities for international co-operation in basic scientific research. The Forum establishes special-purpose working groups and workshops to perform technical analyses, and to develop findings and recommendations for actions by governments Global Science Forum http://www.oecd.org/department/0,3355,en_2649_34319_1_1_1_1_1,00.html Relationship to Other Stakeholders
WHO is the directing and coordinating authority for health within the United Nations system

Areas of Responsibility
Provides leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries, and monitoring and assessing health trends

Directing and coordinating Key People
Director-Genral, Margaret Chan, MPH

The attainment by all peoples of the highest possible level of health

2010-2011 = $822 million http://www.who.int/about/en/ http://www.efpia.org/Content/Default.asp Relationship to Other Stakeholders
Represents the pharmaceutical industry operating in Europe
Through its membership of national associations and leading pharmaceutical companies, EFPIA is the voice in the EU of 2,200 companies committed to researching, developing, and bringing to patients new medicines to improve health

Areas of Responsibility
AIMS Programme (Access, Innovation, Mobilization, Security)
Access by speeding up regulatory approval and reimbursement processes for new medicines
Innovation by creating a strong science base and making Europe an attractive location for researchers
Mobilization through joining forces with key stakeholders to address the challenges of an ageing population and deliver modern and sustainable healthcare
Security refers to the need to strengthen the integrity and transparency of the pharmaceutical supply chain

Coordinating and lobbying Mission
EFPIA's mission is to promote pharmaceutical research and development in Europe and to create a favourable economic, regulatory, and political environment, enabling the industry to meet the growing healthcare needs and expectations of patients http://www.g20.org/ Relationship to Other Stakeholders
Made up of the finance ministers and central bank governors of 19 countries and the President of the Council of the European Union
Brings together important industrial and emerging-market countries from all regions of the world
Member countries represent around 90% of global gross national product, 80% of world trade (including EU intra-trade), and 2/3 of the world's population

Areas of Responsibility
The G-20 is the premier forum for international economic development that promotes open and constructive discussion between industrial and emerging-market countries on key issues related to global economic stability
By contributing to the strengthening of the international financial architecture and providing opportunities for dialogue on national policies, international co-operation, and international financial institutions, the G-20 helps to support growth and development across the globe
The G-20's economic weight and broad membership gives it a high degree of legitimacy and influence over the management of the global economy and financial system

Coordinating and facilitating Key People
Unlike international institutions such as OECD, IMF, or World Bank, the G-20 (like the G-7) has no permanent staff of its own. The G-20 chair rotates between members, and is selected from a different regional grouping of countries each year. In 2010 the G-20 chair is the Republic of Korea, and in 2011 it will be France

The G-20 was established in 1999 to bring together systemically important industrialized and developing economies to discuss key issues in the global economy European Commission European Commission European Commission European Commission European Commission European Commission European Commission European Commission European Commission/DG SANCO European Commission/DG SANCO European Commission European Commission Council of the European Union Council of the European Union European Parliament European Parliament Policy Changes Committee Environment, Public Health and Food Safety Committee European Council European Council European Medicines Agency European Medicines Agency Committee for Medicinal Products for Human Use Clinical Trials Service Unit Clinical Trials Service Unit Department of Health Department of Health Research and Development Directorate Research and Development Directorate London Medical Research Council London Medical Research Council European and Developing Countries Clinical Trials Partnership European and Developing Countries Clinical Trials Partnership European Forum for Good Clinical Practice European Forum for Good Clinical Practice Impact on Clinical Research of European Legislation Impact on Clinical Research of European Legislation European Science Foundation European Science Foundation European Medical Research Councils European Medical Research Councils European Clinical Infrastructure Network European Clinical Infrastructure Network European Organisation for Reserach and Treatment of Cancer European Federation of Pharmaceutical Industries and Associations European Federation of Pharmaceutical Industries and Associations Organisation for Economic Co-Operation and Development Organisation for Economic Co-Operation and Development Global Science Forum Global Science Forum United Nations/World Health Organzation United Nations/World Health Organzation Group of Twenty Group of Twenty Key People
President, Jeans-Yves Blay
Director General, Francoise Meunier

The ultimate goal of the EORTC is to improve the standard of cancer treatment through the testing of more effective therapeutic strategies, the development of new drugs, and other innovative approaches
This is accomplished mainly by conducting large, multicentre, prospective, randomised, phase III clinical trials, which facilitate the passage of experimental discoveries into treatments

Budget unknown but funding sources include the EORTC Charitable Trust, Core grants from the Fonds Cancer, FOCA (BE), The Parthenon, BELSPO (the Belgian Federal Science Policy Office), the Belgian National Lottery, and the European Commission under the 7th Framework Programme (FP7) http://www.eortc.be/ EORTC
European Organisation for Research and Treatment of Cancer European Organisation for Reserach and Treatment of Cancer European Stakeholders International Collaborations Mission
The mission of ICTRP is to ensure that a complete view of research is accessible to all those involved in health care decision making. This will improve research transparency and will ultimately strengthen the validity and value of the scientific evidence base

Areas of Responsibility
WHO regards trial registration as the publication of an internationally-agreed upon set of information about the design, conduct, and administration of clinical trials. These details are published on a publicly-accessible website managed by a registry conforming to WHO standards http://www.who.int/ictrp/en/ ICTRP
International Clinical Trials Registry Platform International Clinical Trials Registry Platform IFPMA
International Federation of Pharmaceutical Manufacturers & Associations http://www.ifpma.org/aboutus/ Relationship to Other Stakeholders
Comprised of 25 leading international companies and 46 national and regional industry associations from both developed and developing countries
Has consultative status with the UN and international organizations such as WHO, the World Intellectual Property Organization (WIPO), WTO, the World Bank, the Council of Europe, and several UN organizations
Provides the secretariat for ICH

Areas of Responsibility
IFPMA’s Clinical Trials Portal, Ethical Promotion online resource, and Developing World Health Partnerships Directory help make the industry’s activities more transparent
Strengthens patient safety by improving risk assessment of medicines and combating the counterfeiting of medicines

Coordinating and collaborating Key People
President, Haruo Naito, President and Chief Executive Officer, Eisai Co., Ltd.
Director General, Eduardo Pisani

Encourage a global policy environment that is conducive to innovation in medicine, both therapeutic and preventative, for the benefit of patients around the world
Contribute industry expertise and foster collaborative relationships and partnerships with international organizations, national institutions, governments and non-governmental organizations that are dedicated to the improvement of public health, especially in developing and emerging countries
Assure regular contact, experience-sharing, and coordinated efforts among members towards the realisation of the above objectives International Federation of Pharmaceutical Manufacturers & Associations International Federation of Pharmaceutical Manufacturers & Associations Relevant 2010 Topics
Plenary 3: Improving the role of regulation as part of health systems
Plenary 4: Collaboration and cooperation among regulatory agencies
Workshop H: Good regulatory practices: developing business practices
Workshop J: Clinical trials and globalization Accountable to Drafts and Redrafts Proposals Drafts and Redrafts Proposals DG MARKT
Directorate General for Interntal Market and Services http://ec.europa.eu/dgs/internal_market/index_en.htm Key People
Director General, Jonathan Faull (appointed in July 2010)

The DG's mission is to develop and maintain a dynamic and open European single market that enables citizens to meet the challenges of globalisation. We aim to provide a regulatory environment that enhances competitiveness, stimulates innovation, and promotes financial stability. We also aim to improve the range and quality of products and services available at competitive prices throughout the Single Market in order to deliver higher living standards, better job opportunities, and a prosperous economic future for all citizens. Relationship to Other Stakeholders
One of the DG’s within the EU Commission

Areas of Responsibility
Once laws are adopted by the European Parliament and Council, it proposes and controls implementation of a European legal framework in several areas
Brings forward proposals for legislation aiming to remove barriers, thus simplifying life for consumers and for businesses, stimulating competition, reducing prices and widening choice
Ensures that the opportunities offered by the Single Market are fully exploited by controlling the full and timely respect of Community law in co-operation with the Member States
Informs citizens and businesses about the rights they have within the Single Market and of the benefits available to them.

Regulatory Relevant 2008 Topics
1. Regulatory systems in a changing environment (moderated by Thomas Lönngren, Executive Director of the European Medicines Agency (EMA))
Description: Regulators are facing a rapidly changing environment including demographics and burden of disease, scientific progress, globalization of manufacturing and clinical research, difficulties in availability of new and old drugs, and difficulties for individual agencies to meet challenges on their own. Role of regulators in clinical trial approval
Resulting Recommendations: ICDRA
WHO/International Conference of Drug Regulatory Authorities Key People:
Director, FDA International Harmonization and Multilateral Affairs Office, Michelle Limoli http://www.icdra2010.sg/ 1) Member States should:
Facilitate and speed up global regulatory cooperation
Support and stimulate their regulatory authorities to work with regional and global partners.
2) WHO should continue to support and create new activities that stimulate cooperation and build trust among regulatory agencies. Mission:
To promote collaboration between national drug regulatory authorities, to forge a consensus on matters of mutual interest, to facilitate timely and adequate exchange of technical information, and to discuss contemporaneous issues of international relevance. Relationship to Other Stakeholders
Convenes the regulatory agencies of World Health Organization member states Areas of Responsibility
Convenes the regulatory agencies of World Health Organization member states
Provides opportunities for drug regulators and interested stakeholders to share and discuss current and topical issues of global concern, for example, the H1N1 influenza situation, counterfeit medicines and access to quality drugs Authority
Advisory, but the participating regulatory agencies all presumably have authority in their respective countries 2. Role of regulators in clinical trial approval (moderated by Rohan Hammett, National Manager of Therapeutic Goods Administration (TGA), Australia)
Resulting Recommendations: 1) Member States should:
Promote national mechanisms for communication and collaboration between ethics committees and regulatory agencies regarding the oversight of clinical trials
Provide mechanisms that allow experts from well resourced regulatory agencies to assist in capacity building of regulation of clinical trials in less resourced regulatory authorities. This may include expert support from regulators of the manufacturing country to regulators of the trial host country
Promote a risk-based approach to regulatory oversight of clinical trials
2) WHO should:
Promote regulation of clinical trials by supporting countries to establish robust legal and regulatory frameworks and systems to register and publish ongoing trials to achieve transparency
Facilitate the establishment of confidentiality provisions that will allow communications and cooperation between regulatory agencies from manufacturing and trial host countries WHO/International Conference of Drug Regulatory Authorities WHO/International Conference of Drug Regulatory Authorities 1) Health-related human rights - promoting and defending the basic rights of patients and physicians;
2) Medical education - helping physicians to continuously improve their knowledge and skills
3) Human resources planning for health care services
4) Patient safety
5) Public health policy and projects such as tobacco control, immunization
6) Democracy building for new medical associations, especially in new or developing democracies
7) Leadership and career development
8) Advocacy for physicians' and patients' rights
9) Occupational health and safety WMA
World Medical Association http://www.wma.net/en/10home/index.html Organizational Structure

http://www.wma.net/en/60about/30structure/index.html Key People
President, Dr. Wonchat Subhachaturas (Thailand)
Secretary-General, Dr. Otmar Kloiber (Germany)
Dr. Cecil B. Wilson, Member of Council (USA – Current President of AMA through June 2011)
Dr. Peter W. Carmel, Member of Council (USA – President-Elect of AMA for June 2011)

Main decision-making body is the General Assembly (meets annually), comprised of delegations from National Member Associations, the officers and members of the Council of the WMA, and representatives of the Associate Members (individual physicians who join the WMA)
The Assembly elects the WMA Council every two years with representatives drawn from each of the six WMA regions: Africa, Asia, Europe, Latin America, North America and the Pacific.
The Chairperson of Council, elected by the WMA Council every two years, is the political head of the organization. The Ceremonial Head of the WMA is the President, elected annually by the Assembly. As Chief Executive of the operational units of the WMA, the Secretary-General is in full-time employment at the Secretariat, appointed by the WMA Council.
WMA Secretariat is situated in Ferney-Voltaire, France (adjacent to Geneva)

The purpose of the WMA is to serve humanity by endeavoring to achieve the highest international standards in Medical Education, Medical Science, Medical Art and Medical Ethics, and Health Care for all people in the world Relationship to Other Stakeholders

The WMA has two levels of membership:
Constituent Membership (97 countries) - typically represented by National Associations of Physicians from different countries in the world. Such associations are broadly representative of the physicians of their country by virtue of their membership, with their voting membership being limited to physicians and medical students. They are not subject to, or controlled by, any office or agency of government.
Associate Membership: Individual physicians can join as Associate Members, with voting rights at the Annual Associate Members Meeting and the right to participate in the General Assembly through the chosen representatives of the Associate Members
The WMA also has official advisors, individuals from various national medical associations, that advise in areas of medical ethics, finance and planning, and socio-medical affairs
WMA has official relationships with the WHO and also cooperated with other factions of the UN, including UNESCO, UNICEF, and UNAIDS. The Official Relations designation means that the WMA commits to supporting the policy and work of the WHO. In addition, WMA seeks to advise and influence the work of the WHO in nearly all areas of medicine. There is currently a strong focus on health systems development and strengthening and public health programs, such as tobacco control.
WMA has partnering relationships with several types of organizations, including academic centers, corporations, multinational organizations (e.g. Amnesty International, International Society for Health and Human Rights, etc.), medical student organizations, patient organizations, regional medical organizations, professional organizations (e.g. International Pharmaceutical Federation, World Health Professions Alliance, World Psychiatric Association, etc.), and nonprofits (the Red Cross and Red Crescent). World Medical Association World Medical Association World Medical Association UNESCO
United Nations Educational, Scientific and Cultural Organization http://www.unesco.org/new/en/unesco/ Key People
President of the General Conference, Davidson L. Hepburn
Director-General of UNESCO, Koïchiro Matsuura of Japan. Was appointed in 1999, Eight Directors-General have served the Organization since 1946.
US Ambassador and Permanent Delegate, His Excellency (H.E.) Mr. David Killion

UNESCO’s mission is to contribute to the building of peace, the eradication of poverty, sustainable development and intercultural dialogue through education, the sciences, culture, communication and information.

$653,000,000 for 2010/11. The Programme and Budget of the Organisation is approved every two years by the General Conference . United Nations Educational,
Scientific and Cultural Organization Relationship to Other Stakeholders
UNESCO has 193 Member States and seven Associate Member States. It is governed by the General Conference and the Executive Board. The Secretariat, headed by the Director-General, implements the decisions of these two bodies.
Most Member States, including the US, have established Permanent Delegations to UNESCO which, headed by Ambassadors, undertake liaison between the Organization and their governments.
All Member States have established a National Commission for UNESCO, national cooperating bodies set up by the Member States for the purpose of associating their governmental and non-governmental bodies with the work of the Organization.
Member States and Associate Members designate one or several Ministries responsible for relations with UNESCO and/or Ministries in UNESCO's fields of competence. Several US departments interact with UNESCO but no one department is responsible for maintaining relationships.
UNESCO emphasizes its efforts to involve nationally and locally elected representatives in its action. Areas of Responsibility:
Every six years, UNESCO adopts a medium-term strategy, which sets out the strategic objectives and expected outcomes for the Organization’s work.
In fulfilling its mission, UNESCO will carry out for the international community five established functions: i)laboratory of ideas, including foresight; ii) standard-setter; iii) clearing house; iv) capacity-builder in Member States in UNESCO’s fields of competence; v) catalyst for international cooperation.
UNESCO places high priority on Africa and gender equality. Moreover, specific targeted action is envisaged for youth, the least developed countries (LDCs), and small island developing states (SIDS).
The Medium-Term Strategy (2008-2013) is structured around five programme-driven overarching objectives for the entire Organization, defining areas where UNESCO has a unique profile and comparative advantage in the multilateral field: Attaining quality Education for All;
Mobilizing scientific knowledge and science policy for sustainable development;
Addressing emerging ethical challenges;
Promoting cultural diversity and intercultural dialogue;
Building inclusive knowledge societies through information and communication Authority:
Advisory The Universal Declaration on Bioethics and Human Rights Aims of the Declaration:
To provide a universal framework of principles and procedures to guide States in the formulation of their legislation, policies or other instruments in the field of bioethics
To guide the actions of individuals, groups, communities, institutions and corporations, public and private
To promote respect for human dignity and protect human rights, by ensuring respect for the life of human beings, and fundamental freedoms, consistent with international human rights law
To recognize the importance of freedom of scientific research and the benefits derived from scientific and technological developments, while stressing the need for such research and developments to occur within the framework of ethical principles set out in this Declaration and to respect human dignity, human rights and fundamental freedoms
To foster multidisciplinary and pluralistic dialogue about bioethical issues between all stakeholders and within society as a whole
To promote equitable access to medical, scientific and technological developments as well as the greatest possible flow and the rapid sharing of knowledge concerning those developments and the sharing of benefits, with particular attention to the needs of developing countries
To safeguard and promote the interests of the present and future generations
To underline the importance of biodiversity and its conservation as a common concern of humankind Background:
The Universal Declaration on Bioethics and Human Rights is the latest standard-setting instrument on bioethics.
Adopted by UNESCO’s General Conference in 2005, it follows the Universal Declaration on the Human Genome and Human Rights, developed by UNESCO’s International Bioethics Committee and adopted in 1997.
This Declaration serves as a legal reference and a basis for reflection on such critical issues as human cloning. United Nations Educational,
Scientific and Cultural Organization United Nations Educational,
Scientific and Cultural Organization Areas of Responsibility:
Promotes the highest possible standards of medical ethics and provides ethical guidance to physicians through its Declarations (including Declaration of Helsinki), Resolutions and Statements. These also help to guide National Medical Associations, governments and international organizations throughout the world. The Declarations, Resolutions and Statements cover a wide range of subjects, including an International Code of Medical Ethics, the rights of patients, research on human subjects, care of the sick and wounded in times of armed conflict, torture of prisoners, the use and abuse of drugs, family planning and pollution.
Other areas of service include: World Medical Association Authority:
Advisory CIOMS
Council for International Organizations of Medical Sciences http://www.cioms.ch/ Key People
Secretary-General, Dr.Gunilla Sjölin-Forsberg, MD, PhD
President, Dr M.B. Vallotto

Relationship to Other Stakeholders
CIOMS is an international, non-governmental, non-profit organization established jointly by WHO and UNESCO in 1949.
Affiliated with IFPMA and ICH
Membership in 2010 includes over 55 international, national and associate member organizations, representing many of the biomedical disciplines, national academies of sciences and medical research councils.
Has collaborated with both the WMA on reviewing the Declaration of Helsinki in 2000 (CIOMS/WMA Collaboration) and the EMA on clinical trials and ethics (CIOMS/EMA Collaboration)
More information on membership: http://www.cioms.ch/about/membership/frame_membership.htm Areas of Responsibility:
Facilitates and promotes international activities in the field of biomedical sciences
Maintains collaborative relations with the United Nations and its specialized agencies, in particular with WHO and UNESCO
Initiates and coordinates the following main long-term programmes: Council for International
Organizations of Medical Sciences Council for International
Organizations of Medical Sciences 4)Drug Development and Use
Initiated in the early 1980s as an effort to minimize drug-induced injury.
Eight CIOMS working groups have proposed recommendations within areas, including: International reporting of adverse drug reactions -including the introduction of the standardized CIOMS I reporting form (CIOMS I Reporting Form)
International reporting of periodic drug-safety updates,
Core clinical safety information on drugs,
Evaluation of benefit/risk balance,
Current challenges of pharmacovigilance
Management of safety information from clinical trials and development safety update report (DSUR), and
Signal detection in pharmacovigilance.
Seven of these are previously published and the outcome of Working Group VIII on signal detection is presently being published. There are also Working Groups dedicated to reporting and terminology of adverse drug reactions, vaccine pharmacovigilance, drug development research and pharmacovigilance in resource-poor countries 1) Bioethics
Issuance of international guidelines for the application of ethical principles in various key areas. One example is the International Ethical Guidelines for Biomedical Research Involving Human Subjects originally published in 1993 and revised in 2002.
Issued the International Guidelines for Ethical Review of Epidemiological Studies in 1991. In 2009 they published an updated text that was informed by a multidisciplinary Core Group.
For more information on the Bioethics programme, visit: http://www.cioms.ch/about/frame_bioethics.htm

2) International Nomenclature of Diseases

3)Health Policy, Ethics and Human Values
Originated in 1984 in cooperation with WHO. This program has brought together health policy-makers, ethicists and philosophers from many of the world's major cultural and religious groups, as well as "securalists". The topics covered have included equity, social justice, community participation, and the dignity of individuals in sickness and health in the context of health policy-making. Authority:
Advisory International Ethical Guidelines for Biomedical Research Involving Human Subjects Background
In cooperation with WHO, CIOMS set out to prepare guidelines to "indicate how the ethical principles that should guide the conduct of biomedical research involving human subjects, as set forth in the Declaration of Helsinki, could be effectively applied, particularly in developing countries, given their socioeconomic circumstances, laws and regulations, and executive and administrative arrangements."
This document is the third in the series of international ethical guidelines for biomedical research involving human subjects issued by CIOMS since 1982. CIOMS Guidelines: http://www.cioms.ch/publications/frame_available_publications.htm Other Relevant Documents
International Guidelines for Ethical Review of Epidemiological Studies, 1991
International Ethical Guidelines for Biomedical Research Involving Human Subjects, 1993 Council for International
Organizations of Medical Sciences WHO/International Conference of Drug Regulatory Authorities Board on Health Sciences Policy http://www.iom.edu/About-IOM/Leadership-Staff/Boards/Board-on-Health-Sciences-Policy.aspx Mission
The Board on Health Sciences Policy works to ensure that adequate attention is paid to the science base underlying health and health care. In particular, the Board is concerned with both public and private policies and with institutional affairs that shape health sciences research and facilitate the application of new knowledge. In conducting these activities, consideration is given to the ethical, legal, and social contexts of scientific and technologic advances, and to the balance between scientific opportunities and public needs. Relationship to Other Stakeholders
The Board on Health Sciences Policy is part of the Institute of Medicine Areas of Responsibility
The Board on Health Sciences Policy provides findings and recommendations that are used by government agencies and public organizations
Helps guide medical and scientific research and helps to identify priorities for the nation
Emphasizes biomedical and clinical research, human subject protections, medical and public health preparedness, neuroscience, genomics, and drug discovery, development, and translation Authority
Advisory Activity of Interest: 1946-1948 United States Public Health Service STD Inoculation Study Consensus Study http://www.iom.edu/Activities/PublicHealth/GuatemalaReview.aspx Background
In October 2010, HHS disclosed that the U.S. Public Health Service conducted studies in Guatemala in the late 1940s that intentionally infected institutionalized individuals with syphilis. At the same time, HHS asked IOM to undertake a review of the history of the Guatemala study Current Status
Since receiving the request from HHS, the Board of Health Science Policy learned that at the time of the Guatemala study at least five individuals served simultaneously on the National Institutes of Health Study Section on Syphilis and the National Research Council’s Subcommittee on Venereal Diseases. The same individual served as chair of both groups. Because of these overlapping appointments between our institution and a body involved in the federal government’s syphilis research program, the National Academies should not conduct this historical review. The IOM has informed HHS that it is withdrawing from the assignment. Institute of Medicine
Board on Health Sciences Policy Institute of Medicine
Board on Health Sciences Policy Institute of Medicine
Board on Health Sciences Policy Presidential Commission for the Study of Bioethical Issues http://www.bioethics.gov Key People
Chair and President of University of Pennsylvania, Amy Gutmann, PhD
Acting Chief of the Department of Bioethics at the NIH Clinical Center, Christine Grady, RN, PhD
Assistant Secretary for Health Affairs and Chief Medical Officer for the Department of Homeland Security, Alexander Garza, MD, MPH
Director of the Division of Retrovirology at the Walter Reed Army Institute of Research and the Director, U.S. Military HIV Research program (MHRP), Nelson Michael, MD, PhD
Executive Director, Valerie H. Bonham, JD Mission
The Commission shall advise the President on bioethical issues that may emerge as a consequence of advances in biomedicine and related areas of science and technology. The Commission shall pursue its work with the goal of identifying and promoting policies and practices that ensure scientific research, healthcare delivery, and technological innovation are conducted in an ethically responsible manner Presidential Commission for the Study of Bioethics Areas of Responsibility:
Identifies and examines specific bioethical, legal, and social issues related to the potential impacts of advances in biomedical and behavioral research, healthcare delivery, or other areas of science and technology
Recommends legal, regulatory, or policy actions it deems appropriate to address these issues
Critically examines diverse perspectives and explores possibilities for useful international collaboration on these issues
Examines issues linked to specific technologies and issues not linked to specific technologies, including but not limited to the protection of human research participants; scientific integrity and conflicts of interest in research; and the intersection of science and human rights
Conducts original empirical and conceptual research, commissions papers and studies, holds hearings, and establishes committees and subcommittees, as necessary Relationship to Other Stakeholders
Provides a forum for panels of experts and stakeholders in fields such as education, philosophy, bioethics, technology, etc. to present their perspectives and considerations on relevant topics.
Members of the public are also invited to share their opinion Authority:
Advisory Budget
Unknown, but funded by HHS Activity of Interest:
Following the recent discovery that the United States Public Health Service conducted research on sexually transmitted diseases in Guatemala from 1946 to 1948 involving the intentional infection of vulnerable human populations, the President tasked the Commission to convene a panel to conduct a thorough review of human subjects protection to determine if Federal regulations and international standards adequately guard the health and well-being of participants in scientific studies supported by the Federal Government.
The panel convened by the Commission will also review and report on the most effective methods to ensure that all human medical research conducted worldwide today meets rigorous ethical standards and how training of researchers will ensure such abuses do not occur
The President also requested the Commission oversee a thorough fact-finding investigation into the specifics of the U.S. Public Health Service Sexually Transmitted Diseases Inoculation Study
Work on these tasks will begin in January 2011 and is set to be complete within 9 months
The Commission's 2011 meeting schedule is as follows: February 28-March 1 in Washington, D.C.; May 18-19 (location TBD); August 29-30 (location TBD); and November 16-17 (location TBD) Presidential Commission for the Study of Bioethics Presidential Commission for the Study of Bioethics American Medical Association http://www.ama-assn.org Key People
President, Cecil B. Wilson, MD (through June 2011)
President-Elect, Peter W. Carmel

To promote the art and science of medicine and the betterment of public health
AMA Vision Statement: to be an essential part of the professional life of every physician

In 2009, AMA brought in $286 million in revenue in 2009 with $16.5 million in profit.
Total assets equal $316.3 million. American Medical
Association Relationship to Other Stakeholders
The AMA’s members are either physicians who possess a US MD or DO (doctor of osteopathic medicine) or a recognized international equivalent, resident physicians enrolled in accredited programs, or medical students enrolled in accredited institutions. State, county, and specialized medical societies are also welcome in the AMA House of Delegates.
The AMA interacts with and lobbies to the US government frequently on behalf of physicians on health issues
The AMA is a member of the World Medical Association

The Board of Trustees guides AMA in setting standards and policy
The AMA House of Delegates is the primary policy-setting body
AMA Council members (who are either elected or appointed) develop expert understandings of specific issues in order to make policy recommendations Areas of Responsibility:
The AMA’s 2010 Strategic Issues are: 1) Access to care- working to facilitate expanded coverage, improve access to care, and address potential physician workforce shortages
Specific strategies include: 1) advocating for the inclusion of AMA policy in regulations, 2) working with state and local medical societies to develop and implement national, regional and state-based pilot projects and demonstrations; and 3) incorporating AMA positions into any national work force strategy.
2) Quality of care- convenes and supports the physician-led Physician Consortium for Performance Improvement and its efforts to develop clinically relevant quality measures, to test measures in clinical practice, and to integrate measures in health information technology to improve the efficiency and quality of patient care.
3) Prevention and wellness- Influencing patient healthy lifestyle behaviors, encouraging preventive interventions, enabling the effective treatment of chronic conditions, advocating for appropriate legislative support
4) Payment models- aligning payment incentives to promote high-quality, patient-centered care, as well as fair compensation.
5) Cost of health care- seeks to protect the vital relationship between patients and their physicians from interference by insurance companies and the government.
Specific strategies include: 1) developing educational policy documents for physicians and policymakers about the drivers of cost in the health care system, 2) publicizing relevant AMA policy, and 3) continuing advocacy. AMA also has Centers of Expertise that focus on several areas, including: health policy, government affairs/lobbying, AMA political action committee, ethics resource center and ethics institute Authority
Lobbying American Medical
Association American Medical
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