how to prevent institutional shutdowns: safeguarding your human subjects research program a workshop...

How to Prevent Institutional How to Prevent Institutional Shutdowns: Safeguarding Your Shutdowns: Safeguarding Your

Human Subjects Research ProgramHuman Subjects Research Program

A Workshop Sponsored by the Experimental Biology 2005

Societies, April 5, 2005

Chair: Mark E. Sobel, MD, [email protected]

Executive Officer, ASIPBoard of Directors, AAHRPP

Copyright © 2005 ASIP®

All rights reserved

How to Prevent Institutional Shutdowns: How to Prevent Institutional Shutdowns: Safeguarding Your Human Subjects Research Safeguarding Your Human Subjects Research

ProgramProgram

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 Suspensions of U.S. federally supported researchsupported research

1998 Rush-Presbyterian St Luke’s Medical Center

1999 Greater Los Angeles Health Care System, West Los Angeles VAMC

1999 Duke University Medical Center1999 University of Illinois, Chicago2000 Virginia Commonwealth University2001 University of Oklahoma Health Sciences

Center2001 Johns Hopkins Medical Institutions


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Media AttentionMedia Attention

•Newspapers

•Magazines

•Television

•Radio

•Trade Publications


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Legal ActionsLegal 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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ConsequencesConsequences

• 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 ResponsesCongressional Responses

•Increased Regulation

•Required Accreditation

•Enforced Financial Penalties


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DHHS Responses DHHS Responses

•FDA:Updated Information SheetsMinor revisions to regulationsAddition of Subpart D Minor revisions to regulationsAddition of Subpart D

•Office of Civil Rights: HIPAA

•OHRP: GuidancesCopyright © 2005 ASIP®

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Benefits of a private sector responseBenefits 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

•Copyright © 2005 ASIP®

•All rights reserved

Goals of AccreditationGoals of Accreditation

•Protection of research participants

•Promotion of research that is consistent with ethical principles and standards



Accreditation of human research Accreditation of human research protection programsprotection 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



Accreditation ModelsAccreditation 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 •Copyright © 2005 ASIP®


Accreditation ModelsAccreditation Models

• Voluntary• Peer-driven• Educationally based• Standards:

DHHS: 45CFR 46FDA: 21CFR 50, 56

• Assessment of performance-based outcomes



How does accreditation work?How does accreditation work?

AAHRPP



Council on Accreditation

Determines accreditation

category

On-site evaluationExpert site visitors

Tailored to organizational

setting

Self-assessmentSelf Evaluation

Program Description

Benefits of accreditation – Benefits of accreditation – sound ethics in researchsound ethics in research

• Improves human research protection programs

• Improves research quality

• Builds public trust



Benefits of accreditation – Benefits of accreditation – achieving regulatory complianceachieving regulatory compliance

• Assures regulatory compliance

• Reduces burden from government and industry inspection

• Leads to better risk management

programs

• Gauges over-interpretation of regulations



Benefits of accreditation – Benefits of accreditation – competitive advantagecompetitive 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®


In the end,In the end,

It’s the right thing to do



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