Transcript Accreditation: Panacea or Pain?

How to Prevent Institutional
Shutdowns: Safeguarding Your
Human Subjects Research Program
A Workshop Sponsored by the
Experimental Biology 2005
Societies, April 5, 2005
Chair: Mark E. Sobel, MD, PhD
[email protected]
Executive Officer, ASIP
Board of Directors, AAHRPP
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How to Prevent Institutional Shutdowns:
Safeguarding Your Human Subjects Research
Program
12:00 Introduction: How accreditation can
safeguard and improve the research
enterprise: Mark E. Sobel, ASIP
12:20 Perspective of a Human Research
Protections Officer on Institutional
Shutdowns: Moira Keane, U. Minnesota
12:40 Perspective of a Researcher: Richard W.
Bianco, U. Minnesota
1:00 Panel Discussion
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Suspensions of U.S. federally
supported research
1998 Rush-Presbyterian St Luke’s Medical Center
1999 Greater Los Angeles Health Care System,
West Los Angeles VAMC
1999 Duke University Medical Center
1999 University of Illinois, Chicago
2000 Virginia Commonwealth University
2001 University of Oklahoma Health Sciences
Center
2001 Johns Hopkins Medical Institutions
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Media Attention
•Newspapers
•Magazines
•Television
•Radio
•Trade Publications
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Legal Actions
•Scheer v. Burke, et al
•Hamlet v. Fradin, et al
•Steubing v. Kornak, et al
•Quinn v. Abiomed, et al
•Gelsinger v. University of Pennsylvania
•Robertson, et al v. McGee et al
•Wright v. Fred Hutchinson Cancer Research Center, et al
•Berman v. Fred Hutchinson Cancer Research Center, et al
•Pamel H. Lett and Jim Lett v. The Ohio State University, et al
•Aderman v. Trustees of the University of Pennsylvania
•Beth Wade v. Oregon Health and Science University
•Guckin v. Nagle, et al
•D’gosto, Marion v. FHCRC
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Consequences
• Protections are questioned
• Governmental response
• Private sector response
• Public’s trust in research is diminished
• Enrollments in clinical trials decrease
• Fewer patients consent to use of specimens
• Fear of loss of privacy and stigmatization
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Congressional Responses
•Increased Regulation
•Required Accreditation
•Enforced Financial Penalties
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DHHS Responses
•FDA:
Updated Information Sheets
Minor revisions to regulations
Addition of Subpart D
Minor revisions to regulations
Addition of Subpart D
•Office of Civil Rights: HIPAA
•OHRP: Guidances
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Benefits of a private sector response
•Deeper penetration and consistent
implementation of regulatory
compliance
•Change to a “culture of concern”
•Response is faster, flexible, and
meaningful
•Builds public trust
•Instills confidence in sponsors
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Goals of Accreditation
•Protection of research participants
•Promotion of research that is
consistent with ethical principles
and standards
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Accreditation of human research
protection programs
•Created in an environment of concern
•An integral component of a sound and
quality-driven research policy
•Broad focus of responsibility beyond
that of IRBs
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Accreditation Models
• AAHRPP: Association for the Accreditation of
Human Research Protection Programs:
Association of American Medical Colleges
Association of American Universities
Consortium of Social Science Associations
Federation of American Societies for Experimental
Biology
National Association of State Universities and Land
Grant Colleges
National Health Council
Public Responsibility in Medicine and Research
• PHRP: Partnership for Human Research
Protections: NCQA and JACHO
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Accreditation Models
•
•
•
•
Voluntary
Peer-driven
Educationally based
Standards:
DHHS: 45CFR 46
FDA: 21CFR 50, 56
• Assessment of performance-based
outcomes
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How does accreditation work?
AAHRPP
Self-assessment
Self Evaluation
Program Description
Expert site visitors
On-site evaluation
Tailored to
organizational
setting
Council on
Accreditation
Determines
accreditation
category
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Benefits of accreditation –
sound ethics in research
• Improves human research
protection programs
• Improves research quality
• Builds public trust
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Benefits of accreditation –
achieving regulatory compliance
• Assures regulatory compliance
• Reduces burden from government and
industry inspection
• Leads to better risk management
programs
• Gauges over-interpretation of regulations
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Benefits of accreditation –
competitive advantage
• Instills confidence in sponsors
• Helps in recruiting participants
• Attracts high-quality investigators
• Increases efficiency and reduces costs
• Fosters alliances with accredited
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organizations
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®
In the end,
It’s the right thing to do
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