SOP 039: IRB Records and Data Information Management

1. Purpose

This SOP describes the policies and procedures for WVU OHRP and IRB record keeping.

2. Overview

WVU OHRP and IRB maintain files in a manner that contains a complete history of all IRB actions related to review and approval of a protocol, including continuing reviews, amendments, and other reporting documents. All records regarding a submitted proposal are retained as required by regulatory requirements and institutional policy. Records are kept regardless of whether the submitted proposal is approved. These records indicate clearly the documents that the IRB has approved.

Records are accessible for inspection and copying by authorized WVU OHRP and IRB representatives, Vice President for Research, officials of federal and state regulatory agencies, HHS Office for Human Research Protections (OHRP), the Food and Drug Administration (FDA), and accrediting bodies.

This policy applies to both paper and electronic files.

3. Storage of and Access to Records

3.1 WVU OHRP staff may grant access to individuals outside of those listed above on an as- needed basis for official WVU business. Investigators or their authorized project personnel have reasonable access to files related to their research activities. WVU OHRP staff limit all other access to IRB records to those who have a legitimate need for them, as determined by the OHRP Director (or designee), and/or WVU legal counsel when submitted through state open records statutes.

3.2 Administrative requests for access must be submitted through WVU OHRP’s electronic Information Access Request Form. This form requires the requestor's name, job title, department, and department head. Additionally, this form requires the requestor to justify the need to access the requested information, requirements for sharing the data, data fields or access requested, requested start date, and requested end date (which cannot exceed 90 days).

3.3 Once submitted electronically, the request is sent to the WVU OHRP Director (or designee) for a determination as to whether the request to access can be granted. The requestor receives the access request determination via e-mail after the determination is made.

3.4 In addition to protocol files, WVU OHRP maintains the following information and records. WVU OHRP staff organize and store records in files, binders, or electronically, as appropriate. Such records include but are not limited to:

• Standard operating procedures
• IRB membership rosters
• Meeting minutes, which include documentation of convened IRB meetings
• Federal Wide Assurance (FWA)
• Computerized research protocol tracking system
• Other IRB correspondence (as necessary)
• Agendas for IRB meetings, which include items to be reviewed and documentation of expedited and exempt/flex reviews
• Alleged non-compliance case records
• Mandated reports
• Resumes of currently active IRB members
• Electronic records documenting completion of mandatory training for project personnel, IRB members, and WVU OHRP staff

3.5 IRB membership rosters (see above) should include (but are not limited to) the following:

• Name
• Earned degrees
• Representative capacity
• Indications of experience such as board certifications or licenses sufficient to describe each member’s chief anticipated contributions to IRB deliberations
• Any employment or other relationship between each member and the institution (e.g., part-time employee, governing panel or board member, paid or unpaid consultant, etc.)

3.6 WVU OHRP staff maintain records that are not part of specific protocol files such as meeting minutes, agendas, standard operating procedures, and membership rosters, and periodically destroy them as appropriate and determined by the WVU OHRP Director (or designee).

3.7 WVU OHRP also maintains communications to and from the IRB in the office and keep any relevant communication to a specific research protocol in the protocol record/file.

4. Protocol Related Documentation and Record Retention

4.1 WVU OHRP maintains protocol records for a minimum of 7 years (as determined by the WVU OHRP Director or designee) after a research protocol is closed. This storage requirement applies even if the project never enrolled a participant. These protocol records may be stored indefinitely, at the discretion of the WVU OHRP Director and/or WVU Institutional Official.

4.2 Adequate documentation of each IRB’s activities will be prepared, maintained, and retained in a secure location. Retained documents include but are not limited to:

• Copies or electronic files of all original research protocols reviewed, scientific evaluations, if any, that accompany the proposals, approved consent documents, progress reports submitted by PIs, and other reporting documents submitted by PIs
• Copies or electronic files of all submitted monitoring reports, site visit reports, progress reports, and other continuing review activities
• Copies or electronic files of all protocol review-related correspondence between the IRB and the PIs

5. References

Federal Regulations:
45 CFR 46.115
21 CFR 56.115