Retention of IRB Records

This document describes the record retention practices of the UW-Madison IRBs.

Adopted By: All Campus IRB
Adoption Date: November 10, 2005
Revised: March 1, 2012 by HRPP Advisory Committee

Policy

  1. The policy of UW-Madison is to keep protocol records for 7 years after research ends.

  2. If a study is canceled without participant enrollment, IRB records are required to be maintained for seven years after cancellation.

  3. IRB records not related to a specific protocol, including IRB meeting minutes and general correspondence, are kept for a minimum of 7 years.

  4. All records are accessible for inspection and copying by authorized representatives of federal agencies or departments at reasonable times and in a reasonable manner.

  5. Requests by the public to see IRB records must go through open records request.
  6. Procedure

  7. Social and Behavioral Science IRB (SBS IRB) active files are kept in IRB Office.  Inactive SBS IRB files are kept in locked files cabinets in the IRB offices for one year and then archived.  Inactive files are destroyed 7 years after archived.

  8. Education Research IRB (ED IRB) files are kept in IRB office. Inactive Education Research files are kept in locked files cabinets in the IRB offices for one year and then archived. Inactive files are destroyed 7 years after archived.

  9. Health Sciences IRB (HS IRB) and Health Sciences Minimal Risk IRB (MR IRB) active files are kept In the IRB Office or within the ARROW, the online tracking and submission system. Inactive paper files are sent to State Archives and retained for at least 10 years and then a decision is made regarding whether the material is historically significant. If considered historically significant, the records are then retained by the University of Wisconsin-Madison indefinitely.

  10. Paper files

    1. Records are stored safely.

    2. Records are stored in a way that maintains confidentiality.

    3. Researchers and research staff permitted to view selected portions of the file upon request and may receive redacted documents (e.g., removing internal comments or IRB reviewer names).

    4. Others who are not listed as key personnel on an IRB file may only have access to file documents with explicit permission of the investigator.

    5. Files and/or boxes of files are numbered for ease in location.

    6. File movement is tracked through outcards.

  11. Electronic Files

    1. All IRBs have electronic protocol submission and tracking systems.

      1. HS IRBs Electronic Files

        1. HS IRB protocols approved prior to the implementation of its electronic system (ARROW) are migrated into the electronic system at the time of the study's continuing review through the use of a legacy application, which reflects the protocol as it was approved prior to the migration into ARROW.

        2. Applications to the IRB that have been granted exempt status or determined to not represent research or research involving human subjects are not migrated into ARROW and are maintained as scanned PDFs on a secure network.

        3. For HS IRBs studies approved prior to the implementation of ARROW, the paper file along with the ARROW files are considered the complete record.

        4. For any studies that were submitted for initial review to the IRB via ARROW, the ARROW file is considered to be the complete IRB record.

        5. Currently, ARROW records are maintained indefinitely. When studies are closed by the IRB or research team they are held electronically in an archived state but the complete file is still accessible.

  12. Files for VA Studies

    1. IRB records must be retained until disposition instructions are approved by the National Archives and Records Administration and are published in VHA's Records Control Schedule (RCS 10-1).

  13. All records are accessible for inspection and copying by authorized representatives of VA, OHRP, FDA, and other authorized entities at reasonable times and in a reasonable manner in accordance with 38 CFR 16.115(b).





Keywords:IRB records retention meeting minutes correspondence access public active inactive electronic paper VA research   Doc ID:29477
Owner:Ryan M.Group:VCRGE and Graduate School
Created:2013-04-16 10:04 CDTUpdated:2015-12-07 16:49 CDT
Sites:VCRGE and Graduate School
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