Quality Assurance and the IRB

1
Quality Assurance and the IRB

• Deborah Barnard, MS, CIP
• Director
• Office for the Protection of Research Subjects
  
• Dana Farber Cancer Institute
• Boston, MA

2
IRB?

• The IRB is not the NIH, NCI, NSF, FDA
• The lack of IRB approval can lead to problems
  with all those
• The IRB is an integral part of a human research
  protections program

3
What do the Regulations Say

• The regulations do not allow federal funds to be
  dispensed for human subjects research without IRB
  approval
• The FDA does not allow a study to go forward
  without IRB approval
• 16 federal institutions have signed on to this
  idea

4
But its not JUST the IRB

• The IRB may be the hub
• Grants and Contracts
• Radiation Safety Review
• Conflict of Interest
• Biosafety
• Data Safety Monitoring Boards

5
Systemic Issues?

• 1998, Rush Presbyterian St. Lukes Medical Center
• University of Colorado
• Duke University
• Johns Hopkins

6
Prevention

• Review the entire program
• Institutional Responsibilities
• IRB Structure and Operations
• Sponsorship
• Researchers and their staff
• Study Participants
• Any other group thats part of your system

7
Accreditation

• May be the prevention we need
• They focus on the entire system
• Forces the institution to look at the system
• Address any gaps
• The feds are excited about accreditation

8
You can build your own program

• DFCIs Audit Program
• Found Tools
• OHRPs most common problems letter
• OHRPs Guidance by Topic
• Monitor the rest of the country

9
In A Perfect World...

• The Federal Government would fund (at least in
  part) for IRB programs
• IRB service would be considered a 50 - 100
  position that all faculty and staff would rotate
  through