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 - Awardees are required to develop data and safety monitoring plans (DSMPs). Some awardees are also required to have a Data and Safety Monitoring Board (DSMB).
• Clinical Research Milestones (PDF, 123.58 KB) – Prior to award, investigators conducting clinical studies or clinical trials will be required to provide detailed interim performance measures and timelines for completing key objectives and administrative functions for the proposed clinical study or trial.
• Financial Disclosure Guidelines for Multicenter Clinical Trials - Multicenter study groups must follow financial disclosure guidelines to 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.
• NIDDK Central Repository Resource Archival and Sharing Policy (PDF, 243.66 KB) – Some awardees may be required to provide project generated resources and associated materials to the NIDDK Central Repository (NIDDK-CR). Projects that are eligible and are required or intend to submit resources to NIDDK-CR must adhere to established NIH/NIDDK policies, practices and procedures, and are encouraged to review the documents on the NIDDK Central Repository website.
• Regulatory Policies and Guidance (PDF, 111.95 KB) – Awardees with clinical cooperative agreements and Data Coordinating Centers (DCCs) must follow policies that ensure consistent management of regulatory obligations across studies. Further guidance is provided regarding clinical trial management responsibilities delegated to a DCC.