University of Minnesota
Institutional Review Board
http://www.research.umn.edu/irb
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Scientific assessment

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.

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.

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. Scientific assessment applies to the actual clinical research protocol which describes in detail the involvement of human subjects. Download a model template for clinical trial protocols.

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

4. All other applicable medical research not reviewed under one of the methods above:

  • HRPP scientific assessment – information, including a job aid and link to the portal to request HRPP scientific assessment, may be found on the HRPP website.

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 useful knowledge
  • The rationale for the proposed research is supported by the literature/background provided in the protocol

Will the methods described in the protocol answer the question?

  • Research tests and procedures are appropriate to answer the scientific question
  • The proposed research measures are valid and reliable or there are methods proposed to establish validity and reliability
  • The proposed subject population is appropriate
  • The sample size calculation appears valid and will answer the research question
  • 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.

Need help?

Email or call the IRB:
irb@umn.edu
(612) 626-5654

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