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
Sanford Garfield, Ph.D.
Phone: (301) 594-8803
Email: GarfieldS@extra.niddk.nih.gov
Division of Digestive Diseases and Nutrition
Patricia Robuck, Ph.D.
Phone: (301) 594-8878
Email: RobuckP@extra.niddk.nih.gov
Division of Kidney, Urologic, and Hematologic Diseases
John Kusek, Ph.D.
Phone: (301) 594-7735
Email: KusekJ@extra.niddk.nih.gov
Page last updated: November 25, 2008