New York Medical College

Research

ORA Clinical Research Proclamation

Clinical Research: A Reaffirmation of Trust Between Medical Science and the Public Proclamation and Pledge of Academic, Scientific, and Patient Health Organizations

Whereas the future of medicine and health depends on an enduring collaboration and trust between scientific researchers and patients, and

Whereas recent, widely reported problems in clinical research have shaken public trust, and

Whereas research integrity is paramount to achieving good science and valid results, and

Whereas the ethical and responsible conduct of research involving human beings is essential in order to develop tomorrow's therapies and cures, and

Whereas by volunteering to participate in clinical research, patients make an essential and irreplaceable contribution to science and society, agreeing to take part in procedures that often have no known direct benefit to them as individuals while at times putting themselves at some measure of risk, and

Whereas in return for this contribution and for the trust that they place in researchers, research volunteers have a right to expect that they be treated with beneficence, justice, and respect, and

Whereas the health and welfare of patients must always be placed above all other concerns,

BE IT THEREFORE RESOLVED that the undersigned medical schools, teaching hospitals, patient groups, health care associations, scientific societies, and other organizations reaffirm their commitment to the safe and ethical pursuit of the new knowledge necessary for the development of treatments and cures. We are committed to the protection and preservation of the right and welfare of all the individuals who volunteer to participate in human subjects research.

We pledge ourselves, our institutions, and our researchers to uphold and ensure:

  • The principles of beneficence, justice, and respect for individuals;

  • The rights of patients and the responsibilities of researchers;

  • The inviolable trust of informed consent, freely given by anyone who volunteers to participate in research. Informed consent means:
    • That patients are informed of any reasonably foreseeable risks and benefits of participating in the research activity; and
    • That patients understand that research procedures are not necessarily treatment and, in given instances, may not benefit themselves in any way and may possibly harm them.
  • That no coercion whatsoever, financial or otherwise, is used to induce patients to enter into or to remain in a research project; and that patients have complete freedom of choice as to whether to withdraw from a research activity;

  • The central importance of, and adherence to, the procedures mandated by federal human subjects regulations, which prescribe a process by which research protocols are reviewed with attention to safety, ethics, and the protection of human participants;

  • That the potential benefits to the individual and society exceed any known risks before studies involving human subjects research begin;

  • The provision of adequate resources, training, and oversight for, and the creation of, a climate of support and respect for Institutional Review Boards (IRBs), which play a critical role in ensuring the integrity of human subjects research and in the federally-mandated process for monitoring research protections; and

  • Respect for and adherence to other rules, laws, and recognized codes that guide the ethical conduct of research generally. Such rules include those pertaining to conflicts of interest, misconduct, privacy and confidentiality, genetics research, and others.

 

The undersigned institutions and organizations stand committed to these principles and take public responsibility for keeping the ethical conduct of research involving human beings high on the national agenda.

As of June 7, 2000, this proclamation has been endorsed by the following organizations and institutions:

Association of American Medical Colleges
National Health Council
Association of American Universities
Association of Academic Health Centers
Research!America
Federation of American Societies of Experimental Biology
Academy of Clinical Laboratory Physicians & Scientists
Academic Orthopaedic Society
Advocate Health Care
Albany Medical Center
Albert Einstein College of Medicine
Allegheny General Hospital, Pittsburgh, PA
Allegheny-Singer Research Institute, Pittsburgh, PA
Alton Ochsner Medical Foundation
Alvin C. York Veterans Affairs Medical Center, Nashville, TN
Ambulatory Pediatric Association
American Academy of Allergy, Asthma & Immunology
American Academy of Otolaryngology-Head & Neck Surgery
American Association of Anatomists
American Association of Cancer Research
American Association of Chairs of Emergency Medicine
American Association of Colleges of Nursing
American Association of Colleges of Osteopathic Medicine
American Association of Colleges of Pharmacy
American Association of Immunologists
American Association of Neurological Surgery
American Association of the Surgery of Trauma
American Board of Pediatrics
American College of Clinical Pharmacology
American College of Neuropsychopharmacology
American College of Radiology
American Dental Education Association
American Federation for Medical Research
American Gastroenterological Association
American Heart Association
American Medical Association
American Optometric Association
American Orthopaedic Association
American Osteopathic Association
American Pediatric Society
American Physiological Society
American Podiatric Medical Association
American Preventive Medical Association
American Psychological Association
American Society for Bone & Mineral Research
American Society for Nutritional Sciences
American Society for Reproductive Medicine
American Society of Clinical Nutrition American Society of Clinical Pharmacology & Therapeutics American Society of Hematology
American Society of Human Genetics
American Society of Investigative Pathology
American Society of Nephrology
American Society of Pediatric Nephrology
Americans for Medical Progress
American Thoracic Society
Association for the Cure of Cancer of the Prostate
Association for Molecular Pathology
Association for Research in Vision and Ophthalmology
Association of Academic Departments of Otolaryngology
Association of Academic Surgery
Association of American Cancer Institutes
Association of Anesthesiology Program Directors
Association of Departments of Family Medicine
Association of Medical School Microbiology & Immunology Chairs
Association of Medical School Pediatric Department Chairs
Association of Pathology Chairs
Association of Professors of Dermatology
Association of Professors of Medicine
Association of Program Directors in Internal Medicine
Association of Subspecialty Professors
Association of Teachers of Preventive Medicine
Association of University Professors of Ophthalmology
Association of University Radiologists
Atlanta Veterans Affairs Medical Center
Barnes-Jewish Hospital of St. Louis
Baylor College of Medicine
Berkshire Health System
Beth Israel Deaconess Medical Center
Boston University School of Medicine
Boys Town National Research Hospital, Omaha, NE
Bridgeport Hospital, CT Brigham & Women's Hospital of Boston
Brody School of Medicine at East Carolina University
Bronx Veterans Affairs Medical Center
Brooklyn Hospital Center
Brown University Camcare Health Education & Research Institute, Charleston, WV
Cancer Research Foundation of America
Cancer Treatment Research Foundation
Candlelighters Childhood Cancer Foundation
Carolinas Medicine Center
Carraway Family Medicine
Case Western Reserve University
Cedar-Sinai Health System
Charles R. Drew University of Medicine & Science
Children's Hospital Medical Center of Akron, OH
Children's Memorial Hospital, Chicago, IL
Christiana Care Coalition for American Trauma Care
Coalition for Heritable Disorders of Connective Tissue
Coalition of National Cancer Cooperatives Groups
College on Problems of Drug Dependence
Columbia University
Continuum Health Partners
Cook County Hospital
Creighton University School of Medicine
Cure for Lymphoma Foundation
Cystic Fibrosis Foundation
Dana-Farber Cancer Institute
Dartmouth Medical School
Dartmouth-Hitchcock Medical Center
Duke University
Eastern Virginia Medical School
East Tennessee State University
ENH Research Institute
Evanston Northwestern Healthcare
Fairview-University Medical Center, Minneapolis, MN
Faulkner Hospital, Boston, MA
Finch University of Health Sciences/Chicago Medical School
Fox Chase Cancer Center, Philadelphia, PA
Genetics Society of America Glaucoma Research Foundation
Good Samaritan Regional Medical Center, Phoenix, AZ
Greenville Hospital System, Greenville, SC
Gundersen Lutheran Medical Center, La Crosse, WI
Hartford Hospital
Harvard Medical School
Health Alliance Plan, Detroit, MI
Henry Ford Health System, Ann Arbor, MI
H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL
Howard University
Inova Health System, Fairfax, VA
International Foundation for Anticancer Drug Discovery
International Pediatric Nephrology Association
Institute for the Medical Humanities
James A. Haley Veteran's Hospital, Tampa, FL
Joan C. Edwards School of Medicine at Marshall University
Joint Council of Allergy, Asthma, & Immunology
Jefferson Medical College of Thomas Jefferson University
Johnson City Medical Center, Johnson City, TN
Johns Hopkins Medicine
Johns Hopkins Bayview Medical Center
Johns Hopkins Hospital
Juvenile Diabetes Foundation International
Kansas University Medical Center
Kessler Medical Rehabilitation Research & Education Corp., West Orange, NJ
Lehigh Valley Hospital, Allentown, PA
Lenox Hill Hospital, New York, NY
Loma Linda University School of Medicine
Long Beach Research Foundation
Long Island College Hospital
Louisiana State University Health Sciences Center
Louisiana State University Health Sciences Center-Shreveport
Loyola University of Chicago Stritch School of Medicine
Lustgarten Foundation for Pancreatic Cancer Research
Lutheran General Hospital, Park Ridge, IL MacNeal Hospital, Berwyn, IL Magee-Women's Hospital, Pittsburgh, PA
MCP-Hahnemann University School of Medicine
Medical Center of Louisiana at New Orleans
Medical College of Georgia
Medical College of Ohio
Medical College of Wisconsin
Medical Device Manufacturers Association
Medical University of South Carolina
Meharry Medical College
Memorial Health, Savannah, GA
Memorial Sloan-Kettering Cancer Center, New York, NY
Mercy Hospital of Pittsburgh
Mercer University Methodist Health Care System, Houston, TX
Michigan State University College of Human Medicine
Morehouse School of Medicine
Moses Cone Health System, Greensboro, NC
Morton Plant Mease Health Care, Dunedin, Florida
Mount Auburn Hospital, Cambridge, MA
Mount Sinai Hospital Medical Center, Chicago, IL
Mount Sinai Medical Center of Florida
Mount Sinai School of Medicine
National Alliance for the Eye and Vision Research
National Alliance for the Mentally Ill
National Association for Biomedical Research
National Caucus of Basic Biomedical Sciences Chairs
National Childhood Cancer Foundation
National Foundation for Ectodermal Dysplasias
National Jewish Medical & Research Center
National Marfan Foundation
New York Medical College
New York-Presbyterian Hospital
New York University School of Medicine
Northeastern Ohio Universities College of Medicine
Northwestern Memorial Hospital, Chicago, IL
Northwestern University Medical School
Oklahoma City Veterans Affairs Hospital
Oncology Nursing Society
Oregon Health Sciences University
Osteogenesis Imperfecta Foundation
Palmetto Health Alliance, Columbia, SC
Paralyzed Veterans of America
Parkland Health & Hospital System of Dallas
Pennsylvania State University College of Medicine
Plastic Surgery Research Council
Ponce School of Medicine
Providence Portland Medical Center
Research to Prevent Blindness
Resolve: the National Infertility Association
Riverside County Regional Medical Center, Moreno Valley, CA
Roswell Park Cancer Institute
Rush Presbyterian-St. Luke's Medical Center, Chicago, IL
Rush University
St. John's Hospital, Springfield, IL
Saint Joseph's Hospital & Medical Center, Patterson, NJ
St. Joseph Mercy Health System, Ann Arbor, MI
Saint Louis University
Santa Clara Valley Medical Center
Scleroderma Foundation
Scott & White Memorial Hospital, Temple, TX
Shands Health Care, Gainesville, FL
Sinai Hospital of Baltimore
Society for Gynecologic Investigation
Society for Neuroscience
Society for Pediatric Research
Society of Gynecologic Oncologists
Society of University Otolaryngologists
Society of University Surgeons
Southern Illinois University School of Medicine
Stanford University School of Medicine
St. Peter's University Hospital, New Brunswick, NJ
Stratton VA Medical Center, Albany, NY
SUNY at Buffalo SUNY School of Medicine Stony Brook
SUNY Upstate Medical University
Texas A&M University System Health Science Center
Texas A&M University Health Science Center College of Medicine
Texas Tech University Health Sciences Center School of Medicine
Tourette Syndrome Association
Tufts University School of Medicine
Tulane University
UMDNJ-New Jersey Medical School
United States & Canadian Academy of Pathology
University of Alabama at Birmingham
University of Alabama Health Services Foundation
University of Alabama School of Medicine
University of Arizona Health Science Center
University of Arizona College of Medicine
University of Arkansas College of Medicine
University of Buffalo
University of California, Office of the President
University of California, Davis
University of California, Irvine
University of California, Los Angeles
University of California, San Francisco
University of California, San Diego
University of Chicago
University of Cincinnati Medical Center
University of Cincinnati College of Medicine
University Central Del Caribe School of Medicine
University of Colorado School of Medicine
University of Colorado Hospital
University of Connecticut Health Center
University of Florida
University of Hawaii at Manoa John A. Burns School of Medicine
University Hospitals of Cleveland
University Hospital, San Antonio, TX
University of Illinois at Chicago
University of Iowa College of Medicine
University of Kansas Medical Center
University of Kentucky
University of Louisville
University of Louisville School of Medicine
University of Maryland, Baltimore
University of Maryland School of Medicine
University of Maryland Medical System
University of Massachusetts Medical School
University of Miami University of Michigan
University of Minnesota
University of Minnesota Academic Health Center
University of Minnesota Medical School
University of Mississippi Medical Center
University of Missouri
University of Missouri Health Sciences Center
University of Missouri Columbia School of Medicine
University of Nebraska Medical Center
University of Nevada School of Medicine
University of New Mexico School of Medicine
University of North Carolina at Chapel Hill School of Medicine
University of North Carolina Healthcare System
University of North Dakota School of Medicine and Health Sciences
University of Oklahoma College of Medicine
University of Pennsylvania
University of Pittsburgh
University of Puerto Rico School of Medicine
University of Rochester School of Medicine and Dentistry
University of Southern California
University of Southern California Keck School of Medicine
University of South Carolina
University of South Dakota School of Medicine
University of South Florida College of Medicine
University of Tennessee Health Sciences Center College of Medicine
University of Texas Health Science Center at San Antonio
University of Texas-Houston Health Science Center
University of Texas Medical Branch at Galveston
University of Texas M.D. Anderson Cancer Center
University of Texas Southwestern Medical Center at Dallas
University of Utah
University of Vermont College of Medicine
University of Virginia
University of Washington
University of Wisconsin
University of Wisconsin Hospital
University of Wyoming College of Health Sciences
Vanderbilt University
Vanderbilt University Medical Center
Veterans Affairs Ann Arbor Healthcare System
Veterans Affairs Medical Center, Memphis, TN
Veterans Affairs New Jersey Health Care System
Virginia Commonwealth University School of Medicine
Wake Forest University School of Medicine
Washington University
Wayne State University School of Medicine
Weill Medical College of Cornell University
Western University Health Sciences
Winthrop-University Hospital, Mineola, NY
Wishard Health Services, Indianapolis, IN
Wright State University School of Medicine
Yale University York Hospital, York, PA