This document describes the record maintenance practices of the UW-Madison IRBs.
- UW-Madison IRBs maintain a complete set of materials relevant to review of a research study in each study file.
- IRBs maintain both paper files and electronic files.
- All UW-Madison IRBs use an electronic study management system to track and store information about research studies.
- IRBs maintain records of the following items as applicable:
- All research proposals reviewed.
- Investigator brochure.
- Scientific evaluations.
- Consent documents.
- Recruitment materials.
- DHHS-approved sample consent documents.
- Progress reports submitted by investigators.
- Reports of injuries to participants.
- Minutes of IRB meetings.
- Records of continuing review activities.
- Data and safety monitoring reports.
- Modifications to previously approved research.
- Unanticipated problems involving risks to participants or others.
- Documentation of non-compliance.
- All correspondence between the IRB and the investigators.
- Procedures for the IRB.
- Statements of significant new findings provided to participants.
- Approval of waiver or alteration of HIPAA authorization.
- Veterans Administration Research and Development Committee approval of study.
- IRB records for initial reviews and continuing reviews by an expedited procedure include:
- The specific permissible category.
- A description of the review.
- A description of action taken by the reviewer
- Any determinations and study specific findings required under federal regulations.
- The IRB records for each study’s initial and continuing review note the frequency (not to exceed one year) for the next continuing review in either months or other conditions, such as after a particular number of participants are enrolled.
- IRB records for all exemption determinations include a citation to the specific regulatory category justifying the exemption.
- IRB records document study specific findings required by applicable regulations for:
- Waiver or alteration of informed consent.
- Waiver of consent documentation.
- Research involving pregnant women, human fetuses and neonates.
- Research involving prisoners.
- Research involving children.
- IRB records for a study are organized to allow a reconstruction of a complete history of all IRB actions related to the review and approval of the study.
- IRB records clearly indicate what the IRB actually approved.
- IRB records are accessible for inspection and copying at reasonable times and in a reasonable manner.
Adoption By: All Campus IRB
Adoption Date: November 10, 2005
Revised By: Cross-Campus Human Research Protection Program Committee
Revision Date: November 11, 2015
Copyright © 2015 University of Wisconsin System Board of Regents