SRC Application - Protocol Review

The purpose of the Scientific Review Committees is to assure the research studies conducted in the ICTS have scientific validity, feasibility, statistical relevance, and potential benefit to the participant and/or to the society, and are conducted by qualified investigators.

Steps in the review process:

• Application is submitted to the SRC and pre-reviewed to determine the type of study, the services requested from ICTS, and the presence of all the elements to be reviewed.

• Two categories for protocols: “fast track review” or “full committee review.”

  For fast track review:

  • Protocols that appropriately qualify for “exempt” or “expedited” review through the IRB review process will be considered by the SRC for fast track review process, unless services are being requested from the ICTS.
  • If the protocol has all the required elements satisfactorily included and there are no concerns about the scientific value of the study, the chair shall write the approving comments on behalf of the ICTS-SRC and send them to the IRB. The scientific review shall be considered completed at that time.
  • If the protocol requires additional data, the comments will be sent to the IRB. The comments shall be attached to the IRB comments addressed to the investigator who shall respond to both sets of comments. The investigator’s reply shall be referred by the IRB to the SRC chair for review.
  • If full committee review will be necessary, the protocol will be added to the first available SRC meeting agenda for review by the convened committee.

  Full Committee Review Process:

  • The SRC’s shall undertake a detailed examination of the protocol for scientific merit and all supporting documentation, including any questionnaires or survey instruments shall be examined. Consideration, discussion, and a vote regarding the proposed research shall occur.
  • Administrator sends a letter to investigator informing of the committee’s decision, and including any relevant comments.
  • Possible Outcomes of the Committee:
    • Approved as presented, procedures are consistent with sound scientific study design. (Protocol is complete as submitted with no revisions, restrictions or contingencies required by the Committee)
    • Modification(s) Required (Protocol requires minor modifications that, when resubmitted, may be approved by an expedited review by the Chair and/or designated Committee members)
    • Tabled (Protocol requires significant modifications or has major deficiencies that, when resubmitted, requires re-review by the convened committee)

   

• Elements of the Scientific Review
  These should be clearly shown in your protocol:

• Background: A brief review of the problem to be studied and of related studies that generated the rationale and the central idea of the proposed study. Pertinent references should be provided.

• Hypothesis/es: The problem/s stated in the Background may generate a primary hypothesis and possibly one or two secondary hypotheses. A hypothesis is often stated in the null, e.g.,"No difference between treatments A and B is anticipated”, or "No association between X and Y exists." Alternatively, it can be stated according to what one expects, e.g.,“A will be more effective than B in reducing levels or symptoms of C," or “X will be associated with Y.”

• Clinical Relevance: In case of clini cal studies, the potential value in the understanding, diagnosis, and management of a clinical condition or pathologic state should be formulated.

• Specific Aims or Objectives: These are the endpoints of the research intended. There may be several specific aims in a given study.

• Methodology: Should validate the hypothesis and specific aim/s using procedures consistent with sound scientific study design including nature and size of the subjects studied, recruitment, screening, and enrollment procedures, inclusion and exclusion criteria, treatment schedules, and follow-up procedures, if applicable. A chart of the examinations or studies to be performed at each visit and the time of each visit and test is needed.

• Measures and Outcomes: Measures include both independent (predictor) and dependent (outcome) variables. Outcomes include what the investigator is trying to predict, e.g., new or recurrent onset of a disease state, survival, or lowering of a biochemi cal parameter as a result of a drug or procedure. The measures and outcomes are reasonably expected to answer the proposed question/s and the importance of the knowledge expected to result from the research.

• Power/Sample Size: A power/sample size analysis should include an estimate of minimum effect or difference expected at a given level of power when the sample size is fixed or a projection of the number of subjects needed to achieve an important difference in what is being examined in the hypotheses and the specific aims. Power analysis is not required for pilot studies.

• Data Management: Data management includes how data will be captured for analysis and the tools that will be utilized while capturing the data.

• StatisticalMethods of Analysis: Statisti cal analysis includes the statisti cal tests planned to perform to examine the results obtained; e.g., Student’s t-test will be used to compare levels of A and B between treatment and placebo groups. Multiple logistic regression analysis will be used to examine an independent treatment effect on the likelihood of recurrent disease.

Once a study is fully approved an approval letter from the ICTS director will be forwarded to the principal investigator. To check on study approval status, contact Lisa Twachtmann, Administrator, Scientific Review Committee, ltwachtm@uci.edu.