Health Services Research

1
Health Services Research Human Subjects
Protection

• K. Lynn Cates, MD
• Assistant Chief Research Development Officer
• Director, PRIDE
• Office of Research Development
• Department of Veterans Affairs
• February 23, 2007

2
Human Research Has Changed

• New opportunities
• Electronic age
• Larger, more complex studies
• Faster translation to clinical care
• New risks
• How can we meet your needs?

3
Health Services Research Human Subjects
Protection - Perceptions

• What we hear from HSRD investigators about IRBs
• Reviews are inconsistent
• Too slow inefficient unnecessary delays
• Too demanding
• Requirements are not realistic
• Demands compromise study design
• Over-estimate risks

4
Health Services Research Human Subjects
Protection - Perceptions

• What we hear from IRBs about HSRD investigators
• Dont understand when they need IRB approval or
  informed consent
• Protocols dont provide adequate information to
  assess human subjects issues
• Under-estimate risk

5
Ultimate Goals

• Teamwork (e.g., PIs, ORD, ORO, ISOs, Privacy,
  Police/Security, unions, etc.)
• Define the issues (not just perceptions)
• Develop informed guidance for investigators, IRBs
  and others responsible for protecting subjects

6
Meeting Challenges to HSRD Investigators for
Human Subjects Protection

• VA Central IRB
• Key issues
• Defining risks (e.g., to privacy
  de-identification)
• When is it research vs. QI or program evaluation
• Dealing with large, complex studies
• Engagement - Which IRBs need to approve a
  multi-site study?
• Data security confidentiality
• HSRD investigators perspective

7
VA Central IRBPurpose

• Improve human research protection
• in VA-funded multi-site studies by ensuring
• Appropriate ethical scientific review
• Local issues are addressed
• Enhance efficiency of reviews

8
VA Central IRBExamples of Research Projects

• Health Services Research
• Quality Improvement
• Database Research
• Nursing Research
• Cooperative Studies
• Genomics Research

9
VA Central IRB Roll-out

• VA-funded research only
• First - Multi-site VA Health Services Research
  Cooperative Studies
• Later - Will consider the possibility of serving
  as IRB of record for small research programs

10
VA Central IRBLogistics

• No charge to VA facilities
• Staffed by PRIDE in ORD
• IRB members from all over the country
• Monthly meetings
• Evaluate performance

11
VA Central IRBProcess

• PI enlists sites
• PI submits protocol to VA Central IRB including
  list of participating VA facilities
• VA Central IRB performs review
• Local VA facilities provide comments
• (e.g., local issues, state local language)
• VA Central IRB is final arbiter
• Local VA facilities opt in

12
VA Central IRBAdvantages

• More consistent expert ethical scientific
  review
• Earlier identification of trends in adverse
  events
• Improved veterans access to multi-center trials
• Improved efficiency
• Transparent, consistent process
• Model for local IRBs

13
Challenges for VA Central IRBLocal Accountability

• Concept of IRB vs. Human Research Protection
  Program (HRPP)
• Every facility that performs human research has
  ultimate responsibility for its HRPP, even if it
  uses another facilitys IRB or the VA Central IRB
  
• Medical Center Director must designate someone
  (e.g., IRB, RD Committee or an individual) to
  ensure accountability

14
Local AccountabilityLocal Responsibilities

• Providing local knowledge of
• Research culture
• Community culture attitudes
• State local laws
• Investigator oversight
• Research misconduct/impropriety
• Training credentialing
• Monitoring auditing
• Handling of adverse events

15
Memorandum of Understanding (MOU) Between Local
Facility VA Central IRB

• Crisp agreements with clear delineation of
  respective
• Roles
• Responsibilities
• Authorities

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Challenges for VA Central IRBIt Will Not Solve
Everyones Problems

• Other approvals - RD Committee, IACUC,
  biosafety, unions, OMB
• Many current delays are caused by investigators
  not promptly providing all information needed for
  IRB review

17
Preparing for the VA Central IRB

• Site visits to NCI CIRB independent IRBs
• National IRB workshops on alternatives to current
  IRBs
• Communications
• NLB Health Systems Committee, ORO, Ethics,
  Nursing, Patient Care Services, Public Health,
  etc.
• Field focus group
• 4 regional Local Accountability meetings
• VA IRB Chairs meeting
• New staff IRB Administrator IRB Coordinator
• Identify train IRB members

18
Contact Information

• lynn.cates_at_va.gov