Effective May 1, 2013, the Institute for Clinical and Translational Science (ICTS) Scientific Review Committee will no longer be responsible for the scientific review of research.
The purpose of scientific review is to ensure that research studies conducted at UCI have scientific validity, feasibility, statistical relevance, potential benefit to participants and/or to society.
For all research proposals submitted as of May 1, UCI’s Institutional Review Board (IRB) will assume responsibility for the scientific review of research, in conjunction with the Biostatistics, Epidemiology, & Research Design (BERD) unit in the ICTS.
Please note: All applications currently under scientific review by the ICTS Scientific Review Committee will remain under review with the ICTS Scientific Review Committee.
Studies meeting the following criteria will require scientific review as part of the review for IRB approval:
- UCI investigator-authored
- Biomedical or clinical research
- Does not involve the indication of cancer*
- Involves greater than minimal risk to subjects (i.e., full board review)
- Research described in the IRB protocol has not been previously peer reviewed or
- The IRB requires scientific review as part of its review (study-by-study basis)
* For research involving cancer, scientific review will continue to be performed by the Chao Family Comprehensive Clinical Trials Protocol Review and Monitoring Committee (CTPRMC).
Effective May 1, Lead Researchers requiring scientific review must complete and submit the most recent version (April 2013) of the Protocol Narrative for Expedited and Full Committee Review (available for download on the Applications and Forms web page under the “IRB Forms” heading) as part of the IRB submission process. The BERD consultant’s scientific review will be performed concurrent with the HRP administrative pre-review. However, if the methodological or statistical information provided in the narrative is incomplete or unclear, the researcher will be required to revise the narrative, and IRB review may be delayed.
In order to ensure a timely review of research that requires scientific review, Lead Researchers proposing investigator-authored research are strongly encouraged to seek the consultation of a biostatistician prior to the submission of an IRB application. Seeking expert consultation will help assure the quality of the IRB submission, and reduce the turnaround time for IRB review and approval.
For more information about the scientific review process, please see the Frequently Asked Questions (attached) or contact the HRP Staff.
IRB Scientific Review FAQs.pdf