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IRB Review of Study Resources

This document describes how UW-Madison IRBs assess whether study resources are adequate to protect research participants.

  1. As part of their initial and ongoing assessment and oversight responsibilities, the IRBs assess whether study resources are adequate for the protection of participants in research.
  2. IRBs take into consideration the level and type of risks the research presents as well as the specific procedures the study involves. The exact resources considered adequate for human subjects protection are study specific.
  3. IRBs collect the following information to assist them in assessing the adequacy of study resources:
    1. The qualifications and training of the Principal Investigator and study team members to perform the study and specific roles within the study
    2. Whether a sufficient number of study personnel have been identified to carry out study procedures
    3. The specific study procedures proposed
    4. The risks study procedures present to subjects and whether study design and monitoring adequately minimize these risks
    5. Where study procedures will occur and whether the location promotes the minimization of risks, both physical and psychosocial (e.g., privacy risks)
    6. Adequacy and source of funding
    7. Whether study support services are adequate (e.g., translation services), when applicable
    8. Whether any resources required for any follow-up triggered by the study are adequate (e.g., referrals to other services, such as genetic counseling or to address incidental findings)
    9. Procedures in place to handle emergencies, as applicable
    10. Adequacy of other resources may be evaluated as deemed necessary by the reviewing IRB
  4. In performing the evaluation of study resources, the IRBs may call upon the expertise of other independent University committees to conduct resource and safety reviews of particular study.

Adopted By: All Campus IRB
Adoption Date: January 5, 2006
Revised By: Cross-Campus HRPP Committee
Effective Date of Revisions: August 28, 2015

Copyright © 2015 University of Wisconsin System Board of Regents

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Keywords:adequate study resources IRB review human research participants subjects protection   Doc ID:29167
Owner:Travis D.Group:VCRGE and Graduate School
Created:2013-03-19 13:24 CDTUpdated:2017-10-03 12:07 CDT
Sites:VCRGE and Graduate School
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