Scientific, Scholarly, and Other Expertise Review Policy

The UW-Madison ensures that research studies are evaluated by individuals with the appropriate regulatory, clinical (when applicable), scientific, and scholarly expertise through several mechanisms.

  1. Regulatory Review: UW-Madison IRBs use a variety of means to ensure the appropriate regulations, state and local laws, and institutional policies are applied to a research study.

    1. IRB staff and members use information in IRB applications (including a stand-alone protocol, which is required for most clinical studies), IRB guidance, checklists, and institutional policy to identify that the appropriate regulations, laws, and policies are applied to human subjects research.

    2. The IRBs or IRB offices consult with UW-Madison legal counsel as necessary, such as when determining which regulations apply to a research study.

    3. The IRBs or IRB offices consult with personnel at the Madison VA (e.g., within the Research Office or the Research Compliance Officer) regarding questions about VA regulations and requirements.

    4. Others are consulted as applicable, such as individuals with expertise in FDA IND or IDE regulations and representatives from the Radioactive Drug Research Committee.

  2. Scientific and Scholarly Review: UW-Madison IRBs use a variety of means to assess the scientific and scholarly merits of proposed non-exempt human subjects research to the extent necessary to determine whether (a) the study is designed so that the risks to subjects are minimized, and (b) the risks to participants are reasonable in relation to anticipated benefits, if any, to participants, and (c) the importance of the knowledge that may be expected to result.

    1. The level of review is commensurate with the level of risk of the study

    2. In the case of non-exempt human subjects research, assessment of scientific or scholarly merit may be completed by:

      1. The convened IRB

      2. An IRB member or members possessing sufficient expertise on the subject matter

      3. A consultant or ad-hoc committee with specific expertise

      4. A study’s sponsor

      5. A formal scientific review committee, such as the Institute for Clinical & Translational Research Scientific Review Committees (ICTR SRCs) or UW-Madison Carbone Cancer Center Protocol Review & Monitoring Committee (PRMC).

    3. In the case of most minimal risk human subjects research (and exempt human subjects research), assessment of scientific or scholarly merit is generally limited to feedback on components of study design that appear to raise ethical or regulatory concerns.

    4. All cancer-related research is required to undergo review by the UW-Madison Carbone Cancer Center PRMC, which assesses study design, feasibility, and the qualifications of the study team to conduct the research.

    5. The Health Sciences IRBs may require review by an ancillary scientific review committee (e.g., ICTR SRC) in the absence of prior adequate review of the scientific or scholarly merits of the research or if it determines additional review is necessary.

    6. The Health Sciences IRBs maintain guidance that describes the types of research which may require this ancillary scientific review.

    7. The review by an ancillary scientific review committee is communicated to the IRB as part of the process for review and approval.

  3. Research studies are assigned to the appropriate IRB or IRB office: The UW-Madison has established specialized IRBs with varied expertise in research areas and methodologies to accommodate the range of human participants research conducted by UW-Madison faculty, staff, and students.

    1. IRB members are selected who have expertise in the subject matter areas most frequently represented in the research studies directed to the IRB.

    2. Non-exempt research studies are assigned to at least one IRB member with the appropriate expertise as a primary reviewer who conducts an in-depth review of the research study.

    3. Exempt human subjects research is reviewed by IRB staff or IRB members who have sufficient expertise to assess the risks of the research and make appropriate regulatory determinations (e.g., the category(ies) under which the research qualifies for exemption).

    4. If an IRB thinks that additional expertise is needed to evaluate a research proposal, the IRB may request the assistance of an independent consultant or refer non-oncology studies for review by the ICTR SRC.

      1. The consultant may be a UW–Madison employee or an outside expert.

      2. The consultant’s review is communicated to the IRB as part of the process for review and approval.

      3. Any consultant used by an IRB to provide input on the review of a study must satisfy UW–Madison’s conflicts of interest policy applicable to IRB members and consultants. See, IRB Consultant Use and Conflict of Interest Policy.

Reviewed By Cross Campus HRPP Advisory Committee: November 7, 2019
Adopted By: UW-Madison Institutional Official
Adoption Date: November 7, 2019

Copyright © 2019 University of Wisconsin System Board of Regents

Keywords:scientific review regulatory expertise IRB SRC ICTR scholarly   Doc ID:95822
Owner:Travis D.Group:VCRGE and Graduate School
Created:2019-11-14 15:46 CDTUpdated:2019-11-14 15:46 CDT
Sites:VCRGE and Graduate School
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