Prior to Institutional Review Board (IRB) review, the Indiana CTSI Scientific Review Committee (SRC) reviews new studies that meet the following criteria:
- greater than minimal risk
- investigator initiated
- require biomedical IRB review, and
- no previous peer review process.
Investigators should send protocols to the Scientific Review Committee directly at firstname.lastname@example.org prior to IRB submission. If Scientific Review Committee review is not completed prior to IRB submission, the Human Subjects Office (HSO) will notify the committee once the study is submitted in KC IRB. Further HSO and IRB review will not occur until Scientific Review Committee review is completed. Once received, the committee will review new studies within two weeks.
The Scientific Review Committee will review studies under the following review criteria:
- Objectives: Clearly stated specific aims aligned with well-defined endpoints and appropriate study design.
- Scientific Merit/Background and Rationale: Justification for conducting the study; results of similar or pilot data; current literature cited.
- Design: Cleary describes: how stated objectives will be achieved, methods to acquire data, and strategies to overcome anticipated barriers. Addresses randomization, minimization of bias, patient follow-up, and blinding (if applicable).
- Eligibility Criteria: Specific inclusion/exclusion requirements and stratification factors (if applicable).
- Outcome Characteristics and Endpoint Definitions: Clearly defined primary and secondary endpoints/outcomes.
- Statistical Analysis and Sample Size: Appropriate and adequate study design statistical analysis plan. Prospective analysis plan, including sample size justification to achieve study objectives and plans to minimize missing data.
- Data Management: Practices and procedures in order to manage data analysis, quality, cleaning, and storage.
- Principal Investigator and Study Site Qualifications and Resources: Has the necessary skills, experience, time, and resources to ensure that the study can be successfully completed, including identification of personnel to provide statistical computations and statistical expertise. A plan to register protocol with clinicaltrials.gov.
If the Scientific Review Committee has found that each criterion is Present/Acceptable, the committee will approve and forward to the IRB for consideration. If any criteria are absent or deemed not acceptable, the Scientific Review Committee will return comments to the Principal Investigator (PI) for revisions. The PI must address all Scientific Review Commitee comments by making recommended revisions or providing further justification for resubmission to the committee. When resubmitting to the Scientific Review Committee, respond point-by-point to comments and revise the protocol. Once the committee approves the revised protocol, it will notify the PI, at which time the study can be submitted to the IRB for review.