Research Scientific Review Committee

Updated April 2008

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Scientific Review Committee

The Scientific Review Committee reviews all research proposals for studies that will be conducted in part or in whole at Carle Foundation Hospital (CFH).  The review can either be expedited or full review.   Protocols include, but are not limited to, research in the areas of translational, aging, oncology, cardiovascular, gastroenterology, genomics, and medical informatics.

The primary responsibilities of the Scientific Review Committee are:

1. Evaluate all new research proposal packages for its scientific quality and merit including, but not limited to, experimental design, statistical analysis, number of subjects, frequency of these subjects, and potential scientific impact.

2. Evaluate new research study proposals for the utilization of CFH resources and services.

3. Evaluate if the new research study proposals are within the priority research areas of CFH.

4. Evaluate the potential long-term beneficial impacts of new research study proposals on patient care at CFH.

5. Evaluate ongoing research studies annually, or more frequent if needed, to ensure continued scientific quality and feasibility of continuation of the study at CFH.

Composition of the Scientific Review Committee

The Scientific Review Committee (SRC) is composed of a broad range of scientific and clinical specialties as well as administrative areas to ensure a thorough review and proper use of resources and services for all research studies conducted at CFH.

The core of the SRC consists of:

Chair (the Director of Foundation Research Office [FRO])

Co-Chair (a FRO member)

Administrative Coordinator (FRO Office Coordinator)

Data and Safety Monitor(s)

            Biostatician(s)

            Nurse(s) in Research

            Basic Scientist(s)

Depending on the focus of the proposed research study, at least one expert member from one of the following clinical specialty areas will be required to review the proposed study and attend the Scientific Review Committee meeting when that proposed study is discussed:

            Oncology/ Hematology

Gastrointestinal

Genetics/Genomics

Stem cells

Cardiovascular

Imaging

Medical Informatics

Pathology

            Database

Other: as required

Members can be affiliated with CFH, Carle Clinic Association, the University of Illinois or other institutions as needed for the Scientific Review Committee to conduct a thorough review of proposed research studies.  Members will be appointed by the VP of Research at the CFH.  Before a member can serve on the Scientific Review Committee, he/she will need to go through basic training and sign a personal Accountability Agreement.  For each specified research area there will be at least one member but we are aiming to have two or more members in each area so that not all members have to attend each monthly meeting. At least five voting members must be present at each monthly meeting.

List of current Scientific Review Committee members:

Review Response Documents

Statistical Review Response

Feasibility Review Response

Scientific & Feasibility Review Response

Meetings

The Scientific Review Committee meets on the fourth Wednesday of the month.  Exceptions to the regular meeting schedule might occur.  A listing of Scientific Review Committee submission deadlines and meeting dates are circulated on an annual basis and are posted on the Research on CFH website under Deadlines section.  There are no full reviews of study proposals outside the scheduled meetings.  The submission deadline for review of new protocols and revisions is noon on the second Friday of the month.

Documents Needed for Scientific and Feasibility Review

The principal investigator must submit a complete study protocol package via IRBNet (with assistance by an assigned Research Coordinator from the Foundation Research Office), to the Scientific Review Committee for review of any new protocol. The following documents are needed before a scientific review can occur:

1.             Study Protocol (including final budget* and budget justification)

2.             Informed Consent Form*

3.             IRB Application

4.             IRB Registration Form

*All submitted protocols must be in final format.  No drafts or pre-finalized versions are accepted.  If a submission does NOT include a completed Study Protocol, Informed Consent Form and a Scientific and Feasibility Review Application, it will automatically be rejected.

The assigned Research Coordinator from the Foundation Research Office will provide the following to the Scientific Review Committee:

1.       Approval from Carle departments to participate in the proposed project

Each principal investigator is notified of the outcome of the study protocol review within 2-4 working days after the monthly meeting to facilitate response to specific criticisms or questions detailed in the written report.  If there are no changes needed, the Chair of the Scientific Review Committee automatically forwards the study package onto the Carle IRB.  If there are changes needed, the Principal Investigator will work with their Research Coordinator to get these changes completed and the package re-submitted to the Scientific Review Committee. For more detailed information about the Scientific Review Committee see CFH Research Policy 104.