The procedure for departmental review and routing for human subjects research proposals at the medical school has changed, effective Jan. 1, 2013. These modifications reflect re-engineering of the Committee for the Protection of Human Subjects (CPHS) workflow to reduce unnecessary regulatory burdens and focus on meaningful subject protections.
The current procedure required routing of all protocols for initial review in iRIS through the department chair for approval. As of Jan. 1, human subjects research proposals will no longer require routing through the department chair for routine attestation. Protocols requiring full board review and approval, however, will be expected to undergo a more robust peer review for scientific merit and feasibility at the departmental level prior to iRIS submission. Proposals meeting the criteria for exempt, or expedited, CPHS approval will be excepted from this step.
A wizard within the electronic iRIS application now offers investigators a prompt determination of exempt status. CPHS staff also will provide a prompt determination to investigators as to whether or not a particular protocol qualifies for expedited IRB review. Departmental research review will be waived for both exempt and expedited protocols.
The fillable PDF form will be completed by the departmental research review faculty and submitted as an attachment with each protocol with a recommendation. Although investigators will have the option of protocol submission with an unfavorable departmental pre-review, CPHS will consider departmental comments and recommendations with due respect. For studies that have previously undergone rigorous outside peer review for scientific merit, such as those already funded by NIH, the external peer review comments or award notice may be submitted in lieu of the departmental form. The structure of the pre- review process will vary from department to department, depending upon the nature and volume of clinical research, as well as availability of expertise. Most departments will delegate this responsibility to internal committees. This form should be uploaded with your iRIS application.
The purpose of departmental review is to improve the completeness of applications and to reflect frankly on the importance of the study question and appropriateness of the methodology as well as feasibility at this site. Armed with robust peer review, the CPHS is better equipped to render decisive determinations more promptly.
Please refer to the FAQ for instructions on implementation of scientific pre-review in your department. You also may call 713.500.7943, if you have additional questions, or find more information at the CPHS website.