NIDDK Central Repository Non-renewable Sample Access (X01 Clinical Trial Not Allowed)

Funding Opportunity Description NIDDK supports research on topics that encompass some of the most common, severe, and disabling conditions affecting Americans today: endocrine and metabolic diseases such as diabetes and obesity, digestive diseases such as hepatitis and inflammatory bowel disease, kidney and urologic diseases such as kidney failure and prostate enlargement, and blood diseases such as the anemias. Many of the large clinical studies funded by the NIDDK collect biospecimens from participants for analysis and future study. The collection of these samples from many different studies in the NIDDK Central Repository has created a valuable resource with which researchers can rapidly validate clinical hypotheses and algorithms for clinical decision-making. The collection is also advancing the development of prognostic variables, biomarkers, and therapeutics for diseases related to the mission of the NIDDK. The Repository facilitates sharing of NIDDK-supported resources, thus encouraging work by junior investigators, investigators with novel approaches, and others not included in current collaborations, without excluding those who are established in their fields. They help to ensure that research participants make a maximal contribution and decrease duplicative sampling efforts. Non-renewable samples, such as tissue, cells, serum, plasma and urine, and associated data are available from many studies, including the Chronic Renal Insufficiency Cohort study (CRIC), the Drug-Induced Liver Injury Network (DILIN) study as well as several diabetes studies such as the Diabetes Prevention Program Type 2 Diabetes (DPP), and Diabetes Control and Complications Trial / Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC). A complete list of studies and resources available for request can be found here: https://repository.niddk.nih.gov/search/study. Applicants are required to contact the NIDDK Central Repository at least 6 weeks prior to the due date to obtain an availability report that estimates quantity of samples available for the proposed study. In addition, applicants must consult with the Repository to determine whether the proposed use of samples is consistent with the limitations of the participants informed consents. If requests are of modest impact to the sample collection (<10% depletion), or the proposed use has been previously peer-reviewed, it may be possible to obtain access after an administrative review rather than the full X01 application. Administrative review is generally streamlined although may require the applicant to provide additional documentation related to prior peer review if applicable. This FOA is intended to facilitate equitable and appropriate distribution of samples from the NIDDK Central Repository. Investigators interested in taking advantage of Repository resources must submit an application requesting samples. See Content and Form of Application Submission below for detailed application instructions specific to this FOA. Applications NOT Responsive to this FOA: Applications that do not include a volume and impact assessment report from the NIDDK Central Repository to document sample availability will not be considered responsive to this FOA. Non-responsive applications will be administratively withdrawn and will be returned without review. See Section VIII. Other Information for award authorities and regulations.