USF Health Scientific Review Committee for Research Involving Human Subjects

The USF Health Scientific Review Committee (SRC) housed in the Clinical and Translational Sciences Institute (CTSI) provides scientific review of research studies conducted at USF and its affiliate partners. The SRC will ensure that the studies being conducted at USF meet the scientific merit. The SRC will provide experienced and skilled reviewers from different departments across campus. This committee will not delay the submission process in anyway but will facilitate its approval by the IRB. IRB policy states that a departmental scientific review is required before it is submitted to the IRB. Please refer to the IRB policy at:

http://www.research.usf.edu/cs/irb_policies/209.pdf

The CTSI –SRC will service those centers and Institutes where departmental review is not available to the investigator for a scientific review.

Purpose:

The main purpose of this Scientific Review Committee (SRC) is to establish guidelines for the conduct of scientific and scholarly review and to ensure that the design of the submitted protocol is appropriate to answer the research question.

Departments, Institutes and Centers:

The clinical research proposals involving human research subjects requiring a scientific review will be submitted for review for their scientific merit and should be approved by the SRC prior to submission to the Institutional Review Board (IRB). This service is provided to:

1. All centers and institutes reporting directly to CTSI

2. All protocols referred by the departments outside CTSI for an additional review

3. Investigator initiated protocols requiring an additional review
   

The SRC will primarily focus on the research protocol for the following elements:

1. Study design

2. Scientific rationale and study background

3. Specific Aims

4. Study outcomes

5. Validity of bio-statistical analysis plan

6. Sample size adequacy and relevance of controls

7. Feasibility of methods

The oversight provided by the SRC will also ensure that the study is conducted in accordance with the scientific principles and integrity maintained by the USF Health Office of Clinical Research, Office of Research Integrity and Compliance and the IRB. This committee will also ensure that the University’s resources to support clinical research are appropriately used.

The SRC chair will provide an overview / summary of the clinical research activity at USF and its affiliate partners on quarterly basis to the CTSI board and VP for research.

Study protocol proposed for the Scientific Review must be submitted at least two weeks prior to the desired review date to guarantee a timely response. Principal Investigators can also attend the SRC meeting to present their protocol and for any questions or clarifications.

Scientific Review Committee Members 

Members of the Scientific Review Committee are appointed by the CTSI Executive Committee. Each member will have a term for one year and will have a choice for re-appointment for the next term. In addition to the voting members, other  investigators from USF affiliate partners and representatives from other research areas may be invited to attend the meetings and provide their input in a productive manner as non-voting (ex-officio) members.

For Investigators: Applying for Initial Scientific Review in Human Subjects Research The following information is required by the Scientific Review Committee for consideration of a study to be conducted at USF and its affiliate partners. The following documents should be submitted to the Office of Clinical Research at USF Health along with the submission form.