Policies for Clinical Researchers

NIDDK follows all NIH policies related to clinical and human subjects research. In addition, the following policies apply to all grantees conducting human subjects research through NIDDK-funded studies.

• Data and Safety Monitoring Plans - Guidance and information on the development of data and safety monitoring plans (DSMPs), as well as on NIH and NIDDK policy regarding which clinical studies require a Data and Safety Monitoring Board (DSMB)
• Financial Disclosure Guidelines for Multicenter Clinical Trials - Financial disclosure guidelines to help multicenter study groups ensure that the scientific design, conduct, and reporting of the study are not biased by financial influences
• NIDDK Intellectual Property and Patents Policy for U01 Grantees - When NIDDK partners with industry to conduct clinical trials through its extramural U01 grantee network, and the industry partner is donating a drug, they may request certain rights to intellectual property. This policy, along with the NIH Intellectual Property, may be applicable. Network grantees are encouraged to contact the NIDDK Technology Advancement Office for any questions they may have regarding the application of this policy.
• Data Sharing Policy for the NIDDK Central Repository (PDF, 27 KB) – Some grantees may be required to provide protocols, data, or samples to the NIDDK Central Repository. If you are required to provide materials you are encouraged to review the documents on the NIDDK Central Repository website.
• Regulatory Policies and Guidance (PDF, 177.57 KB) – Policies to guide the management of extramural clinical cooperative agreements and Data Coordinating Centers (DCCs) to ensure consistency across studies in the area of regulatory obligations.  Further guidance is provided in the area of clinical trial management for the delegated responsibilities to a DCC.