Bernard A Schwetz, D'V'M', Ph'D'

1
Issues Before IRBs OHRP Views

• Presented by
• Bernard A Schwetz, D.V.M., Ph.D.
• Acting Director
• Office for Human Research Protections
• Washington, D.C.
• April 8, 2004

2
Topics

• what is research?
• burdens on IRBS
• greatest challenges to HSP
• challenge to the VA

3
What is Research?

• How do I avoid going to the IRB?
• surveys
• public health surveillance
• quality improvement programs
• self exemption is a problem
• differentiating criteria not agreed upon

4
Research or Not?

• a systematic investigation, including research
  development, testing, and evaluation, designed to
  develop or contribute to generalizable
  knowledge.
• involves living human subjects or their
  identifiable data

5
Criteria Research or Not?

• intent
• generalizable results
• publication
• source of funding
• legal authorization
• SACHRP asked to consider

6
Burdens on IRBs unnecessary ones?

• adverse event reports
• over-interpretation of regulations
• no expedited review
• excessive records
• excessive informed consent documents
• review of the scientific details?
• fear of litigation
• central vs. local IRBs
• lack of standard format for protocols
• protocol vs. grant application

7
Greatest Challenges to HSP

• recruitment of subjects
• therapeutic misconception
• divergence of IRBs
• institutional culture of indifference
• relocation of research AHC to community
• burden vs. protection

8
Greatest Challenges to HSP (cont)

• lack of detailed knowledge of the enterprise
• hard to detect problems
• cant follow trends
• research enterprise is fragile

9
Human Research Enterprise
SPONSORS Industry, Government agencies, others
RESEARCH INSTITUTIONS IRBs committees
protocol, COI, radiation, biosafety, etc.
PAYERS, INSURERS
CRO
SMO
EDUCATORS
RESEARCH TEAMS Investigators Collaborators Team
members
DSMB
REGULATORY OVERSIGHT FDA, Common Rule
Agencies state and local government

• RECIPIENTS
• the public
• products
• knowledge

STUDY SUBJECTS
ACCREDITING ORGANIZATIONS AAHRPP PHRP
Patient Representatives Advocacy Groups
10
Challenge to the VA Research Community

• How could the VA become the model for HSP?
• accreditation
• compliance
• consistent procedures
• best practices
• measured impact of accreditation

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Closing Thoughts

• public trust is the key
• credibility! credibility!
• need for a role model