Changes in Scientific Review of Proposals Submitted to the IRB
In order to approve research, the Institutional Review Board (IRB) must determine that risks to subjects are minimized by using procedures which are consistent with sound research design. The IRB previously performed this scientific review in conjunction with their regulatory and ethical review.
The IRB is changing its practice to ensure that the scientific review is based on expert peer review. Research involving human subjects is to be reviewed for scientific validity and appropriateness prior to IRB review. The procedure described here applies to all applications submitted to the medical IRB committee and does not apply to exempt studies.
What is Scientific Review?
Scientific review applies to the actual clinical research protocol which describes in detail the involvement of human subjects. For a model template for clinical trial protocols:
The review must be performed by independent reviewers; therefore, members of the research team cannot participate in this review. Only one method of scientific review (see below) is required prior to review by the IRB.
Acceptable Methods for Independent, Peer Review
- Funding organizations (NIH, NSF, foundations), when research projects have been subjected to full peer review (e.g., review by a study section or grant committee).
- The actual protocol being submitted to the IRB must have been reviewed in its current form. Peer review of a grant that describes a clinical trial in general terms does not satisfy this criterion.
- Industry-sponsored clinical trials designed by the sponsor with or without external consultants do not satisfy this criterion for independent peer-review.
- University of Minnesota scientific review committees, such as the:
- Cancer Protocol Review Committee (CPRC)
- General Clinical Research Center (CGRC) Scientific Advisory Committee
- Protocol Review and Data Use (PRDU) Committee (for solid organ transplantation)
- Any appropriately constituted departmental or collegiate peer review committee
Features of an Appropriate Review Committee
- A minimum of two reviewers (three or more is preferred)
- Consensus regarding the scientific acceptability of the project (if there is not initial consensus, some group discussion regarding the project must take place)
- Documentation of the review process (dates, participants, method of review and discussion, decision). Documents must be filed with the associate dean for research of the appropriate college (or assistant vice president for research for AHC-level reviews).
- Student research projects may have students included on the review committee, if desired. Evaluations of student research projects can be done by the advisor and at least one other faculty member. The review may also be done within the context of a course, provided that all the criteria below are considered.
Review Requirements
- Is the rationale for the study clearly stated and is the rationale scientifically sound?
- Are the aims and corresponding hypothesis clearly stated?
- Is the primary outcome (and secondary outcomes, as appropriate) clearly defined?
- Are there adequate preliminary data in the literature (or from the investigator) to justify the proposed research? Has an adequate literature review been done to support this study?
- Is the question or hypothesis being tested providing important knowledge to the field?
- Is the design of the study appropriate for the questions that are posed?
- Have the validity and reliability of measures been established or are there methods proposed for establishing validity and reliability?
- Is the proposed subject population appropriate?
- Are statistical considerations, including sample size and justification, estimated accrual and duration, and statistical analysis clearly described and adequate to meet the study objectives?
- Are all the proposed tests or measurements requested necessary to answer the scientific question?
- Are the investigators well qualified to conduct this study?
Procedures to Satisfy Review
- Select one of the three scientific review methods
- Complete the IRB form to document fulfillment of the scientific review requirement and include with the IRB application and send to Research Subjects’ Protection Programs office.
Implementation of Scientific Review Policy
The policy is effective immediately where existing scientific review committees (option two listed above) are already in place and are reviewing projects at this time.
For options one and three, where documentation or structure will need time to develop, the policy will be effective July 1, 2007.
For More on Scientific Review
As with any IRB related matters, for more information you may contact Moira Keane at irb@umn.edu or 612-626-4851.
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