Criteria for the Approval of Research (formerly IRB 201)
Criteria for the Approval of Research provides attendees with the tools and knowledge they need to be effective IRB chairs, members, or staff.
This didactic program reviews and analyzes each of the eight regulatory criteria that the IRB must consider during protocol review, examines the ethical principles that underlie these criteria, and discusses how the criteria are applied.
The specific criteria* covered are:
- Minimization of risks
- Risk-benefit relationship
- Equitable selection
- Consent process
- Consent documentations
- Data monitoring
- Privacy / confidentiality
- Vulnerable subjects
* From 45 CFR 46.111 and 21 CFR 56.111
This course has been designed for those who conduct reviews as part of a convened IRB or through the expedited procedure, and who understand the fundamentals of IRB operations.
Please note that this course does not cover administrative issues.