Policies on Conducting Clinical Trials with Human Participants
NIH requires that all clinical trials be conducted in such a way as to ensure the safety of all participants and the validity and integrity of the resultant data. Please see the NIH Policy for Data and Safety Monitoring (June 10, 1998), Further Guidance on a Data and Safety Monitoring for Phase I and Phase II Trials (June 5, 2000) and the NIDDK Data and Safety Monitoring Guidelines for Clinical Trials Information regarding Department of Health and Human Services policies on research using human subjects can be found on the home page of the Office for Human Research Protections (formerly OPRR). The Office of Extramural Research Grants Home Page contains links to the most up to date information on NIH research grants.
Several recent policies should also be consulted, including
For more information, please contact NIDDK program staff:
Division of Diabetes, Endocrinology, and Metabolic Diseases
Barbara Linder, M.D., Ph.D.
Phone: (301) 594-0021
Division of Digestive Diseases and Nutrition
Mary Evans, Ph.D.
Phone: (301) 594-4578
Division of Kidney, Urologic, and Hematologic Diseases
John Kusek, Ph.D.
Phone: (301) 594-7735
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Page last updated: February 12, 2013