IRB 201 Agenda

This program will provide attendees with the tools and knowledge they need to become effective IRB chairs, members, and staff. This didactic educational program will review and analyze each of the eight regulatory criteria that the IRB must consider during protocol review, examine the ethical principles that underlie these criteria, and discuss how the criteria are applied. 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 will not cover administrative issues.

Sonesta Philadelphia Downtown | Philadelphia, PA
April 15 ∙ 8:30 AM–4:30 PM
Please note this agenda is subject to change.
7:00–8:30 AM Registration
8:30–10:30 AM Brief Overview of Ethics and Regulations
What is Research?
Criteria for Review of Research Overview
Criterion 1: Risks to Participants are Minimized
10:30–10:45 AM Break
10:45 AM–12:00 PM Criterion 2: Risks are Reasonable in Relation to Anticipated Benefits
Criterion 3: Selection is Equitable
12:00–1:00 PM Lunch
1:00–2:30 PM Criterion 4: Informed Consent will be Sought in Accordance with and to the Extent Required by the Regulations
Criterion 5: Informed Consent will be Documented in Accordance with and to the Extent Required by the Regulations
2:30–2:45 PM Break
2:45–4:15 PM Criterion 6: Research Plan Makes Adequate Provisions for Monitoring Safety
Criterion 7: Adequate Provisions to Protect Privacy and Maintain Confidentiality
Criterion 8: Additional Safeguards for Participants Likely to be Vulnerable to Coercion or Undue Influence
4:15–4:30 PM What it Takes to be a Good IRB Member (Including Conflicts of Interest) 
4:30 PM Adjournment