What documents related to IRB review should be maintained by the study team as part of the research record?
Part of the responsibility of study teams is to maintain a record of regulatory documents, in addition to other study related documents. One of the benefits of the transition to the ARROW system for IRB review is a better means for tracking which documents the IRB has approved and any changes made to documents. Study teams should use ARROW to ensure they are working with the most current versions of IRB-approved documents, including protocols, recruitment materials, study instruments, and consent and HIPAA documents. Study teams are expected to be able to easily ascertain the correct (approved) version of documents that have been reviewed by the IRB. Failure to use the approved version of documents that have been reviewed by the IRB can result in non-compliance, and require reporting to the IRB.
Frequently Asked Question
Minimum documentation study teams are responsible for keeping related to IRB review of human subjects research includes the following:
- All versions of approved submissions (initial approved application, approved change of protocol forms and modified applications, approved continuing reviews, and approved/acknowledged reportable events)
- All versions of formal protocols submitted to and approved by the IRB, including tracked change versions to assist in determining what has changed
- All official correspondence to and from the IRB, including approval letters, requests for modifications, and other board determinations
- Funding documentation, including grant applications and award letters
- Stamped/approved consent documents, including consent forms, assent forms, information sheets, and other documents regarding the informed consent process
- Recruitment materials
- Study instruments
- HIPAA authorization forms reviewed and accepted by the IRB
- HIPAA waivers granted by the IRB
- Closure reports
Study teams are required to keep other documentation related to the conduct of human subjects research beyond those related to the IRB review and approval process. The UW Institute for Clinical and Translational Research (ICTR) has developed a Clinical Research Toolkit to assist study teams throughout the study process; including a “Regulatory Binder Guidance” that provides additional information on what materials should be kept.