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Scientific Review

Purpose

Ensuring scientific merit is a key component in protecting the rights and welfare of human research subjects. The regulations for the protection of human subjects require that all of the Criteria for IRB Approval of Research are satisfied (45 CFR 46.111 & 21 CFR 56.111) including the two criteria that address scientific review:

  1. Risks to participants are minimized by using procedures consistent with sound research design and which do not unnecessarily expose participants to risk.
  2. Risks to participants are reasonable in relation to anticipated benefits, if any, to participants, and the importance of the knowledge that may reasonably be expected to result.

Scientific Review at UCI

There are several options for scientific review at UCI:

  1. For research previously subjected to full peer review (e.g., reviewed by a study section, grant committee or grant agency): No additional internal scientific review is required. This assumes that the actual research study submitted to the IRB was peer reviewed in its current form. Peer review of a grant describing research in general terms does not satisfy this criterion. In addition, a UCI investigator-authored, industry-sponsored clinical trial does not satisfy this criterion for independent peer-review. The IRB may request a copy of the peer review comments to confirm prior peer review.
  2. For research involving cancer: Including individuals with cancer, individuals at risk for cancer, or individuals in a study involving a specific cancer focus (e.g., program evaluations, quality of life, and health education), scientific review is conducted by the Chao Family Comprehensive Clinical Trials Protocol Review and Monitoring Committee (PRMC). No additional scientific review is required. Go to the PRMC web page for more information.
  3. For non-cancer research that is investigator-authored and has not been subject to full peer review:
    1. Biomedical/clinical research involving greater than minimal risk (full board review): Scientific review clearance is required before IRB review.  The IRB will conduct the scientific review utilizing the expertise of the biostatisticians in the Biostatistics, Epidemiology, & Research Design (BERD) unit of the ICTS as consultants. The UCI Human Research Protections (HRP) staff will coordinate the scientific review with the BERD unit. Lead Researchers must complete and submit the most current version of the Protocol Narrative for Expedited and Full Committee Review (available for download on the Applications and Forms web page under the “IRB Forms” heading) with the IRB application.  If the methodological or statistical information provided in the narrative is incomplete or unclear, the researcher will be required to revise the narrative.  IRB review may be delayed. 
      IMPORTANT NOTE: Lead Researchers proposing investigator-authored studies are strongly encouraged to seek the consultation of a biostatistician prior to submission of an IRB application.  This review will help assure the quality of the IRB submission and reduce the turnaround time for IRB review and approval.
    2. For biomedical/clinical research involving minimal risk (Exempt and Expedited level of review):  Scientific review remains the responsibility of the school or department. The Department Chair or Institute Director signature on the IRB application serves as the verification that the research is appropriate in design (i.e., the research uses procedures consistent with sound research design, the study design can be reasonably expected to answer the proposed question, and the importance of the knowledge expected to result from the research is known).  However, the IRB reserves the right to require scientific review on a study-by study basis.
    3. For social, behavioral and educational research (all levels of review):  Scientific review remains the responsibility of the school or department. The Department Chair or Institute Director signature on the IRB application serves as the verification that the research is appropriate in design (i.e., the research uses procedures consistent with sound research design, the study design can be reasonably expected to answer the proposed question, and the importance of the knowledge expected to result from the research is known). However, the IRB reserves the right to require scientific review on a study-by study basis.

Scope of Scientific Review

The following items are assessed as part of the UCI IRB’s scientific review of the proposed research:

  • Purpose and Background: The background discussion must provide a brief review of the proposed research study, as well as the previous research and related studies which generated the rationale and the specific aims and objectives of the proposed study. Supporting citations should be referenced at the end of Section 1.
  • Hypothesis/es: The proposed research described in the Background section must include a research question which requires evaluation; thus the research must include a primary hypothesis and possibly one or two secondary hypotheses.
  • Methodology: For the methodology of the proposed research to validate the hypothesis/es and specific aim(s) of the study objective(s), the proposed research must be consistent with sound scientific study design including sample size, proposed subject population, inclusion/exclusion criteria, screening process, interaction/intervention and data collection procedures.  A description of any stratification, randomization, and blinding schemes must be included.
  • 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 biochemical parameter as a result of a drug or procedure). An assessment will be made whether the proposed measures and outcomes can reasonably be expected to answer the proposed research question(s).
  • Study endpoints: Precise definitions of the study endpoints and criteria for evaluation are required. If the primary outcomes are derived from several measurements (i.e., composite variables) or if the endpoints are based on composite variables, a description of how the composite variables are derived must be included.
  • Risk/Benefit Assessment:  A description of the risks and potential discomforts to subjects must be included.  In addition, a discussion of the potential direct benefits to subjects and/or the potential societal/scientific benefit(s) must be provided.
  • Clinical Relevance: For clinical research, the potential value of the proposed study in the understanding, diagnosis, and management of a clinical condition or pathologic state must be clearly defined.
  • Statistical Analysis Plan: A description of the statistical methods planned for the specific aim(s) and hypothesis/es must be included (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).
  • 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.  Alternatively the analysis could be a projection of the number of subjects needed to achieve an important difference in what is being examined in the hypothesis/es and the specific aims.
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