Scientific Review Committee for Research Involving Human Subjects

The USF Health Clinical and Translational Sciences Institute (CTSI) has established a centralized Scientific Review Committee (SRC).  SRC review of protocols can be used instead of the departmental scientific review that is currently required by the USF IRB.  The SRC reviews investigator-initiated research studies that involve human subjects and that are conducted at USF and its affiliate partners.   SRC review has significant  advantages:  it can expedite the IRB approval process since it ensures that studies meet the requirements for scientific merit, and participation in the scientific review process provides investigators with valuable opportunities to enhance their study design skills.  

Purpose

The main purpose of the SRC is to strengthen the rigor of the scientific research process and to enhance scholarly activities at USF Health by providing content and methodology expertise to investigators. SRC review ensures that studies are scientifically valid, are designed appropriately, and have sufficient methodological rigor to answer the research question. SRC review does not delay the IRB submission process – in fact, it facilitates IRB approval.

The SRC focuses on the following aspects of protocols:

1.      Scientific rationale and study background

2.      Matching the study design to the research/scientific question

3.      Formulating specific aims to address the problem

4.       Adequacy of the sample size and statistical analysis plan (biostatistical support is available from the CTSI; click here for more information)  

5.      Overall methodological rigor

SRC review ensures that the study is conducted in accordance with the scientific and ethical principles required by the USF Health Office of Clinical Research, Office of Research Integrity and Compliance and the IRB.  SRC review also ensures that the University’s resources that support clinical research are used appropriately.

Studies that are Eligible for Review by the SRC:

Any investigator-initiated protocol that requires IRB review is eligible for review by the SRC, regardless of whether the protocol is internally or externally funded.  SRC review is usually not conducted for multi-center clinical trials for which the USF investigator is not the PI, and for industry sponsored clinical trials.

Scientific Review Committee Members 

The SRC is composed of content and study design experts, and includes representatives from various departments across USF Health and members of the CTSI Evidence-Based Medicine and Health Outcomes Research Team.  If none of the SRC content experts has sufficient expertise in the area of a proposed study, the SRC Chair will identify a non-SRC member to provide content review for the study.  Click here for a list of the current SRC members.  

SRC members are recused from participating in scientific review if there is potential bias or conflict of interest related to a research project. 

The SRC Review Process

The SRC process involves review of completed protocols by content and methodology experts.  If investigators need assistance developing their protocol and statistical analyses, they can contact the Center for Evidence-Based Medicine.  Protocols that are in the development phase may be referred to the appropriate USF Health departments for an assessment of resource utilization.

There are two levels of SRC review:  

SRC Chair and Co-chair Review: Retrospective studies, chart reviews, studies on existing specimens, humanitarian device exemption protocols, case studies, repository and registry studies, and  quality assessment and improvement studies are reviewed by the SRC Chair or Co-chair.

Full-Committee Review:  Prospective studies that include minimal risk or greater than minimal risk are reviewed by the full committee.

The steps for SRC review are as follows:

• The investigator submits an electronic copy of all documents related to the research project including the protocol, informed consent (if applicable), and any documents related to study conduct and analysis to the SRC contact person.  Click here for the protocol submission form.  
• The study is referred to reviewers who have expertise in the  area of the proposed study.  The reviewers send written comments to the SRC contact person.
• A SRC meeting is scheduled for 2 weeks after the review request was received by the SRC.  All SRC committee members and the principal investigator are invited to attend the meeting.  It is highly recommended that investigators attend the SRC meeting.  Investigator attendance at the SRC meeting facilitates and expedites the review process, and interaction with the SRC members provides investigators a valuable opportunity to enhance their study design and analysis skills.
• After discussion of the protocol, the SRC makes the following recommendations:

o   Approve: the protocol is approved as submitted.

o    Pending Approval: the protocol is approved if the investigator satisfactorily addresses the SRC's queries, and revises the protocol according to the SRC's suggestions.  The responses and revised protocol are reviewed by the SRC Chair and do not need to be re-reviewed by the study design team. 

o    Deferred:  the protocol must be revised according to the study design team’s recommendations, and submitted for re-review by the study design team.

The review process takes 1 to 3 weeks, depending upon the complexity of the protocol and the degree of risk to subjects.