CRC Scientific Advisory Committee (SAC) Responsibilities

SAC members are appointed by the Dean of the College of Medicine.  The Committee is responsible to the Dean. Nonvoting members include the CRC support staff.

The SAC reviews and supervises study protocols and CRC operations, including oversight of the CRC budget and utilization of resources.  The SAC prioritizes protocols for CRC use so the Program Director can properly allocate resources.  NIH-supported investigations are given the highest priority.  The SAC periodically reviews CRC operations to ensure that the CRC resources are used for the most scientifically justified and relevant projects. 

In evaluating protocols for CRC use, the SAC also establishes policies for approval and continued support of protocols, addresses investigator resource needs, encourages CRC use by investigators not currently using the center, and assures that protocols meet the NIH requirements for subject safety and inclusion. 

SAC Review of Protocols

CRC Scientific Advisory Committee (SAC) meetings are typically held the first Monday morning of every month.  The principal investigator for the new protocol is invited to attend the SAC meeting in which the protocol will be reviewed.  The PI can present an overview of the protocol and then answer questions from SAC members. 

At times, this review may be conducted by the SAC members. If a more in-depth review is required, a member of the SAC Scientific Reviewers Reserve Group is utilized. This group is made up of all Pathfinders, Rainmakers, and CRC users. Utilizing this group assures that the CRC has a robust supply of reviewers from which to choose and that each proposal is reviewed appropriately.  

Usually primary and secondary reviewers are chosen for each new protocol to be reviewed.  At times, a funded grant from an experienced investigator or a well-vetted multicenter trial will not require two reviewers since the protocol has already been well vetted. The number of reviewers is decided by the SAC Director or another member in his absence.  Reviewers provide a written review of the protocol in electronic format following the meeting to the Administrative Director for inclusion as an addendum to the SAC minutes.  The primary reviewer will present a summary of the protocol to the SAC members with brief background, specific aims, and study design, as well as questions and concerns.  The secondary reviewer, if needed, will prepare a succinct set of comments and questions. 

The SAC makes the genuine effort to improve the scientific merit of protocols by reviewing statistical design, addressing ethical and subject safety concerns, and evaluating for proper inclusion of study subjects by gender, minority group, and children.

Having already reviewed the protocol prior to the SAC meeting, members of the CRC staff will discuss questions or concerns, including human subjects' issues, statistical issues, and the ability of the CRC to support the protocol as written.

When there are no further questions, the SAC scores the protocol.  The SAC method of scoring is similar to that used by NIH study section.  The SAC will reach a majority vote of one of three options:

Tabled:  The Committee feels the study should be returned to the PI for significant changes.  Once the PI has made the required changes, the protocol is reviewed by the full SAC.  The PI can move forward with the protocol only after the full SAC has approved the revised protocol.

Approved with contingencies:  The Committee has minor questions or concerns that must be addressed by the PI.  Once the PI had made the required changes, the protocol can be approved administratively (rather than by the full SAC review) and the implementation meeting can be scheduled.

Approved as submitted:  The SAC has approved the protocol as written.  The PI may move forward by scheduling the implementation meeting with the CRC Staff.

To assess scientific progress, all protocols supported through the CCTR are required to submit brief progress reports every year. To streamline this process, the progress report is the same as that built into the ARIA Web-based interface for IRB Continuing Reviews. The IRB Continuing Review requests a brief description of scientific progress and information on publications.