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 mesobel@asip.org
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 RushPresbyterian 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
On-site evaluation
Council on
Accreditation
Expert site visitors
Tailored to organizational setting
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 organizations •Copyright © 2005 ASIP ®
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It’s the right thing to do
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