Ancillary Studies

TrialNet recognizes the importance of ancillary studies in the overall mission to better understand the natural history of type 1 diabetes, to devise means to prolong the honeymoon phase in subjects with new onset disease, and to prevent diabetes altogether. Ancillary studies that complement the objectives and thereby enhance the value of TrialNet studies are strongly encouraged.

Ancillary studies will be evaluated with careful consideration for their potential impact on the objectives and performance of TrialNet studies. Further, ancillary studies must not interfere with the continued interest and participation of the study subjects and investigators. To protect the interests of TrialNet, each ancillary study must be reviewed and approved by the Ancillary Studies Committee before its initiation. If an ancillary study is considered highly worthy by the Ancillary Studies Committee, but may cause deviation in the study protocol, or may interfere with the subjects’ interest or participation in TrialNet, then the study must be additionally reviewed and approved by the TrialNet Steering Committee before formal approval is granted. All approved ancillary studies will be reviewed yearly to evaluate their progress, and impact on TrialNet as a whole.

TrialNet welcomes the submission of ancillary studies as an adjunct to ongoing protocols.

Type 1 Diabetes TrialNet Sub-Study and Ancillary Studies Policies [.pdf]

Application Form [.doc]