Notice of Correction Regarding Research Using Control Subjects for NIDDK PAR-13-028 "Research Using Subjects From Selected Type 1 Diabetes Clinical Studies (Living Biobank) (DP3)"
Release Date: February 11, 2013
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
This Notice clarifies that PAR-13-028 "Research Using Subjects from Selected Type 1 Diabetes Clinical Studies (Living Biobank) (DP3)" can fund studies that require the recruitment of control subjects (including healthy controls, for example) as part of a larger study of subjects enrolled and followed in Diabetes Control and Complications Trial (DCCT)/Epidemiology of Diabetes Interventions and Complications (EDIC). Healthy controls are also allowed in TrialNet, since the Pathway to Prevention already recruits and follows healthy control subjects. The following sections of the FOA are amended, with amendments shown in bold:
Section I. Funding Opportunity Description
This opportunity is intended to fund projects using subjects who have been phenotypically and genetically characterized for risk of developing type 1 diabetes through the Type 1 Diabetes TrialNet Pathway To Prevention clinical research network, and projects using subjects currently enrolled and followed for diabetic complications in the Diabetes Control and Complications Trial (DCCT)/Epidemiology of Diabetes Interventions and Complications (EDIC). A small number of additional controls (for example, healthy controls) may be recruited if well justified.
This FOA provides a means of accessing this unique population being followed in DCCT/EDIC, and a small number of newly-recruited controls (if required).
Applicants may propose to perform tests on subjects and/or collect samples "on demand" at regularly scheduled EDIC study visits, or scheduled as needed in the case of required newly recruited controls.
Section IV. Application and Submission Information
2. Content and Form of Application Submission
Research Strategy
All other aspects of the FOA remain unchanged.
For TrialNet:
Lisa M. Spain, Ph. D.
Program Director for Immunobiology of Autoimmune Endocrine Diseases
Division of Diabetes, Endocrinology, and Metabolism
National Institute of Diabetes Digestive & Kidney Diseases (NIDDK)
Telephone: 301-451-9871
Email:[email protected]
For DCCT/EDIC:
Catherine C. Cowie, PhD, MPH
Senior Advisor & Director for Diabetes Epidemiology
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8804
Email: [email protected]