Review Process by the Scientific Review Committee -Flow chart attached

• The investigator submits the documents (Protocol, Informed Consent, IRB application and Budget) electronically to SRC contact person along with the submission form available on the website.
• The study will be forwarded to the reviewer specialized in the area of the proposed research study.
• The principal investigator or the study coordinator may be contacted by the reviewer to give an overview of the study and answer any questions reviewer may have.
• The SRC designated reviewer for the protocol will then summarize and present the study to the SRC, suggest changes, if needed, as well as make a recommendation for consideration by the SRC. The investigator can attend the scheduled SRC meeting to discuss any issues reviewers may have.
• The protocol will be discussed in the weekly committee meetings depending upon the volume of the submitted studies and concludes with a vote to
  - Approval - the study is approved as submitted to the SRC
  - Approval with Clarifications - the protocol and/or consent form will be approved provided that clarification(s) are submitted in writing to the satisfaction of the SRC chair and/or Committee. The SRC chair may approve the study upon receipt of the clarification(s) without going before the SRC.
  - Disapproval – study issues stated by the Committee outweigh the merit of conducting the study at USF
  - Deferral – issues with the protocol, study design and/or consent form would negatively impact the conduct of the study at USF and must be addressed by the investigator. The investigator's written response will be brought before the SRC to re-assess the study.
• The SRC chair will notify the investigator in writing of the Committee’s decision.  If the investigator has questions or needs additional assistance, a member of the office of research or scientific review committee will meet in person with him/her.
• For high-risk, investigator-initiated trials that have not undergone review and approval by the department, the turnaround time should generally not exceed two weeks. For minimal risk studies the turnaround time will not exceed one week.
• The turnaround time for submissions to the SRC depends largely on the nature of the submission.  For instance, large, multi-center clinical trials that have received approval from the other IRBs and FDA will often be eligible for a facilitated review by the SRC Chair, the turn-around time for which will generally not exceed one week.
• SRC approval, disapproval and requests for revision or clarification will be communicated through formal correspondence via e-mail, and a hard-copy via mail.  The SRC will maintain weekly record of the meetings.