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Scientific Consultation and Assessment

Scientific Assessment of Proposals Submitted to the IRB

Since July 1, 2007, evidence of scientific review for medical research involving human subjects deemed by the Institutional Review Board (IRB) to be greater than minimal risk has been required at the time of submitting an application to the IRB.  A new scientific assessment option will be added to other available options effective July 1, 2013.

The purpose of scientific assessment  is to encourage the development of scientifically sound medical research.  To justify the inclusion of human subjects in research, and to assess the balance between any risks that may be imposed upon human subjects with the utility of the outcomes of the investigation, an assessment is required to evaluate the scientific question and appropriateness of the methods planned to answer the scientific question.  

After receiving documented acceptance of the protocol via an approved scientific assessment process, the IRB will continue to determine that the following requirements will be satisfied:

  • Risks to subjects are minimized
  • Risks to subjects are reasonable in relation to anticipated benefits
  • Selection of subjects is equitable
  • Informed consent will be sought from each subject or the subject’s legally authorized representative
  • Informed consent will be appropriately documented
     - Adequate provisions to protect privacy and maintain confidentiality are in place
Applicability

Scientific assessment is required for medical research that is not exempt under CFR 45 §46.101 (b) or does not qualify for expedited review under CFR 45 §46.110.

Acceptable Methods for Scientific Assessment

1. Nationally-based, federal funding organizations (NIH, NSF) 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.

2. Nationally based non-federal funding organizations (March of Dimes, American Academy of Pediatrics) employing peer review mechanisms for awarding of funding

  • 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.

3. Locally constituted mechanisms using peer review for awarding of funding, or for permission to use resources, including:

  • Cancer Protocol Review Committee (CPRC)
  • Clinical and Translational Science Institute (CTSI) pilot funding awards
  • Departmental peer review
4. All other applicable medical research not reviewed under one of the methods above: o HRPP scientific assessment – information, including a joib aid and link to the portal to request HRPP scientific assessment, may be found on the HRPP website.
Features of an Appropriate Review Committee
  • A minimum of two reviewers
  • 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).
Review Requirements for Method 3
  • 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?
Review Requirements for Method 4

Review by a biostatistician is required for all applicable research prior to scientific assessment under Method 4. This will permit an initial foundation that allows further assessment; reviewers know as they initiate assessment that the study is powered to yield results.  With that foundation, reviewers will consider two fundamental questions, considering the bulleted issues for each as they answer the questions:

Is the scientific question reasonable?

  • The question is precisely articulated
  • The research has the potential to provide new and/or useful knowledge
  • The potential to provide useful knowledge is supported by literature review

Will the methods described in the protocol answer the question?

  • Research tests and procedures are appropriate to answer the scientific question
  • Research measures are valid and reliable, or there are methods proposed to establish validity and reliability
  • The proposed subject population is appropriate
  • The principal investigator is qualified to conduct the research
Procedures to Satisfy Review
  1. Select one of the four scientific review methods
  2. Document fulfillment of the scientific review requirement and include with the IRB application submission.
    Note:  Medical applications requiring full committee IRB review will not be assigned to a meeting until documentation of scientific review is provided.
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