HRPP Policy - IRB records and retention

1.0 - Scope

This policy applies to human subjects research under the oversight of the Indiana University Institutional Review Boards (IRBs).

2.0 - Policy Statement

HRPP Policies and IRB membership rosters, resume for each IRB member, agendas, and minutes are retained indefinitely or until the Associate Vice President, Research Compliance, gives the authority to dispose of such records.

The IRB study file includes all documents reviewed by the IRB in connection with the research, including where applicable:

• IRB application
• Protocol or research plan
• Investigator brochures, package inserts, or instructions-for-use documents for medical devices
• Data collection instruments, including surveys, questionnaires, interview questions, etc.
• Recruitment materials
• Informed consent documents
• HIPAA authorization forms
• Documentation of scientific review, when provided by an external committee
• When NIH has granted an exception to the NIH Single IRB Policy, a copy of the exception request and NIH’s granting of the exception
• Modifications to previously approved research
• Significant new findings
• Records of renewal activities, including progress reports and data safety monitoring reports
• Reports of reportable events, including unanticipated problems involving risks to subjects or others and noncompliance
• Reports of injuries to subjects
• All correspondence between the IRB and researchers
• Documentation of the permissible category of exemption or expedited review category
• Description of the action taken by the reviewer
• For research subject to VA regulations, correspondence between the IRB and the Research and Development Committee
• IRB determinations required by federal laws and regulations, state and local laws and regulations, and institutional or agency policy or procedure

The IRB study file is retained while the study is active and for a period of three (3) years following closure, termination, or expiration of IRB approval, and may be destroyed after that time.  For research with waivers of authorization, the IRB study file is retained for a period of six (6) years following closure, termination, or expiration of IRB approval.

Until destruction of IRB records has occurred, they are accessible for inspection and copying by interested parties, including but not limited to representatives of federal agencies and departments, sponsors, and institutional officials, at reasonable times and in a reasonable manner.

The IRB will not accept or retain data in its records which is classified as Critical Data per the IU Policy on Management of Institutional Data.

3.0 - Procedures

No applicable procedures

4.0 - Sanctions

Individuals found to be in violation of this policy may be subject to sanctions relating to their participation in review of research with human subjects.

5.0 - History

Section 2.0 revised to specify for research with waivers of authorization, the IRB study file is retained for six years. Removed differentiation of specific files being maintained electronically.

6.0 - Related Information