During the proprietary period, while a study is ongoing, how do approved ancillary studies gain access to samples?
Ancillary studies that are approved by the study’s Steering Committee, must apply to the NIDDK for access to stored samples using the regular procedures. However, if the ancillary study has been funded through the NIH peer-review process, NIDDK may waive review by the Sample Access Review Panel. In such cases, NIDDK staff will review the request administratively for availability of requested samples, consistency with the informed consent, and human subjects research issues.
