Office for the Protection of Research Subjects
Institutional Review Board
310 AOB (MC 672)
IRB Record Retention 1737 West Polk Street
Chicago, IL 60612-7227
Phone: 312 996-4995 Fax: 312 413-0238
Version: 1.1 www.research.uic.edu/protocolreview/irb
Approved by: Interim Vice Chancellor for Research
AAHRPP REF#: 136
AAHRPP Elements: II.3.B
I. Currently, UIC requires that all IRB research file documents be uniformly held
indefinitely after the closure of a research file, regardless of enrollment status, until
the forthcoming UIC OVCR Records Retention Schedule is active.
II. IRB Records must include the following materials, as applicable, in each study file:
A. Scientific evaluations;
C. Protocol violations submitted to the IRB;
D. DHHS-approved sample consent documents;
E. Progress reports submitted by investigators;
F. Reports of injuries to participants;
G. Records of continuing review activities;
H. Correspondence between the IRBs and investigators;
I. Statements of significant new findings provided to participants;
J. For exemption determinations: cite the specific category of exemption;
K. Determinations required by the regulations and protocol-specific findings
supporting those determinations for waiver or alteration of the consent
L. For each protocol’s initial and continuing review, the frequency for the next
M. The credentials and conflict of interest form of ad hoc consultants;
N. FDA IND and IDE approval letters;
O. Correspondence between the IRBs and the JBVAMC R&D Committee;
P. Unexpected adverse events submitted to the IRBs; and/or
Q. For initial and continuing review of research by the expedited procedure:
1. The specific permissible category;
2. Description of action taken by the reviewer;
3. Any findings required under the regulations.
III. OPRS ADs will maintain IRB roster files that contain each IRB member’s resume.
IV. Once the UIC OVCR Records Retention Schedule is in effect, after the closure of a
research file, all related documents are archived for a minimum of seven years or as
required by the Illinois State Record Act (5 ILCS 160), other applicable state
requirements and regulations, federal regulations, VA regulations and/or directives,
and in accordance with the forthcoming UIC Records Retention Schedule.
Page 1 of 2 OVCR Document #0286
IRB Record Retention, Version 1.1
V. IRB records are accessible for inspection and copying by authorized representatives
of federal agencies or departments at reasonable times and in a reasonable manner
in accordance with UIC HSPP policy Inspections by Regulatory Agencies.
VI. To maintain confidentiality, IRB records are housed initially within the OPRS office
space where only OPRS staff, IRB members, and designated OVCR staff have
access to the documents. After the closure of a research file, the IRB records are
then moved to a secure records depot where the records are maintained in a locked
space either on the UIC campus or on the site of an external storage company. Only
designated OPRS or OVCR staff are permitted to have access to IRB records in
either storage method to retrieve documents or files.
PROCEDURE FOR VA RESEARCH:
I. The UIC OPRS maintains copies of Collaborative IRB records on behalf of the
JBVAMC and NU.
II. The JBVAMC R&D Committee has access to all relevant Collaborative IRB records
at reasonable times and in a reasonable manner.
III. The JBVAMC R&D Office and NU OPRS may keep copies of any research-related
materials it deems necessary for oversight of research to be conducted at the
IV. If the JBVAMC’s affiliation with UIC is terminated, copies of all research protocol files
related to JBVAMC research will be provided to the JBVAMC R&D Office. Prior to
document destruction, the UIC OPRS will notify the JBVAMC R&D Office.
21 CFR 56.115(b)
38 CFR 16.115(b)
45 CFR 46.115(b)
FDA Information Sheets: Frequently Asked Questions: IRB Records
Version (#, date) Replaces (#, date) Summary of changes
1.1, 06/18/09 1.0, 10/15/08 Added credentials and FDA IND and IDE
letters to documentation required by policy.
Page 2 of 2 OVCR Document #0286