The National Institute of Diabetes & Digestive & Kidney Diseases

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

• Required Education in the Protection of Human Research Participants, September 5, 2001
• Revised Policy for IRB Review of Human Subjects Protocols in Grant Applications (May 1, 2000), and
• NIH Policy on Reporting Race and Ethnicity Data: Subjects in Clinical Research, August 8, 2001
• Inclusion of Women and Minorities As Participants In Research Involving Human Subjects - Policy Implementation Page
• NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects

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