Proposals for ancillary studies that will seek to be funded from sources other than the National Institutes of Health (NIH) (e.g., industry, foundations, other governmental agencies) will be evaluated in accordance with the procedures described in the ancillary study review process. In addition, it is the responsibility of the PI to obtain agreement from the sponsor through an appropriate contractual mechanism that all data relevant to the Teen-LABS ancillary study will be shared with the DCC and the Steering Committee. Conduct of sponsored ancillary studies also must comply with all existing Teen-LABS, individual institutions within Teen-LABS, and NIH policies and guidelines. Specifically, the sponsor may not interfere with analysis or publication of any data obtained during the course of an ancillary study to Teen-LABS. If the ancillary study will involve industry support, the investigator should contact the NIDDK project scientist before beginning substantive discussions with any potential industry sponsor. Involvement of a study with industry may require a cooperative research and development agreement (CRADA) with NIDDK.
All investigators who are preparing proposals for a non-NIH sponsor should send completed proposals to the Ancillary Studies Committee (through Teen-LABS DCC) for scientific review no less than eight weeks before the sponsor’s deadline.