Human Research Protection Program: Policy
Retention of IRB Records
Adopted By: All Campus IRB
Adoption Date: November 10, 2005
Purpose:
This document describes the record retention practices of the UW-Madison IRBs.
Policy
I. The policy of UW-Madison is to keep protocol
records for 7 years after research ends.
II. If a study is canceled without
participant enrollment, IRB records are required to be maintained for seven
years after cancellation.
III. IRB records not related to a specific
protocol, including IRB meeting minutes and general correspondence, are kept
for a minimum of 7 years.
IV. All records are accessible for
inspection and copying by authorized representatives of federal agencies or
departments at reasonable times and in a reasonable manner.
Procedure
I. Social and Behavioral Science IRB (SBS
IRB) active files are kept in IRB Office. Inactive SBS IRB files are locked in
basement storage room for one year and then archived. Inactive files are
destroyed 7 years after archived.
II. Education Research IRB (ED IRB) files
are kept in IRB office until office requests that they be archived. Inactive files are destroyed 7 years after archived.
III. Health Sciences IRB (HS IRB) and Health
Sciences Minimal Risk IRB (MR IRB) active files are kept In the IRB Office.
Inactive 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.
IV. Records are stored safely.
V. Records are stored in a way that
maintains confidentiality.
VI. Requests by the public to see the
records must go through open records request.
VII. 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).
VIII. 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.
IX. Files and/or boxes of files are
numbered for ease in location (by year and sequential).
X. File movement is tracked through
outcards.
