IRB members play an essential role in this review process and bring diverse backgrounds and experience to the review of research applications. The board discussion is focused on making sure the study design and procedures meet a set of regulatory criteria required for IRB approval. In brief, those are:
- Research design is sound and study hypothesis is reasonable
- Risks to subjects are minimized
- Risks to subjects are reasonable in relation to anticipated benefits
- Selection of subjects is equitable.
- Informed consent is obtained or appropriately waived from all prospective subjects and documented
- The research protocol includes a plan for data and safety monitoring
- Subject’s privacy and confidentiality are protected
- Appropriate additional safeguards are incorporated for any vulnerable subjects
- IEP IRB Member: Upcoming Changes and Training Materials
This FAQ covers questions about: the HRPP Toolkit; training resources, support, and materials available to IRB members; and changes in staff pre-review and the IRB member review process.
These resources are available to prepare members in conducting thorough, high quality reviews of all human subjects research under the purview of the UW IRBs.
- IRB Member Training Session 1: Project Overview, HRPP Toolkit Intro and Crosswalk – 3.11.21
- IRB Member Training Session 2: Refresher Training on the Regulatory Criteria for Approval – 3.18.21
- IRB Member Review Walk-Through: How to transition to reviewing agenda items using the Toolkit – 3.29.21
- New IRBM Walk-Through: How to navigate ARROW and complete agenda item reviews – 4.29.21
Contact the IRB Member Point of Contact, Jackie Lee at (608) 261-1157 or Jessie Johnson at (608) 263-0835