IRB Management: Models, Styles, and Issues

1
IRB Management Models, Styles, and Issues

• Paula A. Bistak, RN, MS, CIP
• Human Subject Protection Manager
• Atlantic Health System

2
AHS Structure

• 3 Hospital System Central Unified IRB
• 300 protocols
• Cooperative Groups
• CIRB
• Pharmaceutical
• Investigator Initiated

3
Organizational Chart
4
IRB vs. HSP

• Broader Scope
• Supports a culture of HSP
• Responsibility rests on more than the IRB
  committee

5
Human Subject Protection

• IRB committee
• Compliance/Auditing
• Education
• BioSafety Committee

6
IRB Committee

• Committee of the Board of Trustees of AHS
• Representation from all three sites
• Teleconference
• Full committee meets twice a month
• Expedited review weekly

7
Auditing/Compliance

• IRB Self Audit policy
• Compliance Department

8
Education

• IRB Committee members
• Initial training requirements
• Pre-meeting education
• Yearly event
• Research Community
• Quarterly Coordinator meetings
• Audioconferences
• Guest Speakers
• Website

9
Education (continued)

• General Public
• Health Fairs
• Website (under construction)
• IRB staff
• Books
• Conferences
• Listserves
• Publications

10
BioSafety

• Ad hoc Committee
• OBA guidance

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Challenges

• Meeting requirements with smaller staff
• More falls within your domain
• Creative
• Importance of research varies
• Limited exposure to research types
• Limited funding
• NIH educational grant

12
Advantages

• Close Relationships with Researchers
• Flexibility
• Changes can be implemented more quickly
• Innovative

13
Strategies

• Consistency
• IRB Administrative meetings
• SOPs
• Both Administrative and Procedural
• Objectify response/cite regulations
• Relationships with larger institutions
• Professional organizations
• Stay current