September 29, 2016
Indiana University and the Indiana CTSI are taking part in a nationwide demonstration project lead by Tufts University on the implementation and evaluation of a Scientific Review Committee (SRC) process for clinical research. This project aims to test a SRC process that positively affects the scientific quality and feasibility of a study without causing meaningful delays on a small number of trials that meet specific criteria.
For the purposes of this project, the SRC will serve in an advisory role to the IRB. At the time of submission to the IRB, the Human Subjects Office will identify studies that meet the criteria for SRC review. Studies that are new full Board investigator-initiated, non-peer reviewed studies that have not been reviewed by the IUSCC SRC or the CTSI Project Development Teams (PDTs) will undergo review by the CTSI SRC.
The 6-month SRC pilot runs from October 1, 2016, until April 1, 2017.
The SRC review will happen concurrently with the HSO pre-review process in order to minimize delays. Notification of any recommended revisions will be sent directly to PIs who must adequately address these prior to IRB review. The IRB will consider SRC recommendations and responses from the PI in its review.
Would you be interested in having your study reviewed by the SRC prior to IRB submission? If so, PIs are also welcome to submit protocols directly to the SRC for review. For more information, contact firstname.lastname@example.org.