Criteria for the Approval of Research

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.

What Past Participants Are Saying

[The presentation was] well prepared and approachable with helpful solutions and guidance.

The entire presentation was helpful. It should be required for all IRB members.

Very applicable to current trends and issues regarding research.

The course provides a foundation and an understanding that I found hard to come to on my own.  I have read the regulations, but this really tied everything together with the historical background, origins of the principles, and the reiteration of the importance of the principles.