partnership for human research protection, inc. jessica briefer french, mhsa assistant vice...
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Partnership for Human Research Protection, Inc.
Jessica Briefer French, MHSAAssistant Vice President
Partnership for Human Research Protection, Inc.
PHRP Principles and Goals
• Generate environment in which HRPP receives sufficient focus and attention to carry out functions
• Guide provision of essential protections and complete disclosure of potential risks
• Provide information useful for quality improvement
• Set achievable requirements, and encourage excellence
• Publicly report results (after phase-in period)
Partnership for Human Research Protection, Inc.
Benefits of Participation
• Improve systems and processes designed to protect research subjects
• Build trust among public, study candidates• Help prevent failures, negative media
coverage• Reassure funders of institutional integrity• Dissuade unnecessary regulation and/or
facilitate compliance
Partnership for Human Research Protection, Inc.
PHRP’s Long Range Objectives for Accreditation
• Increase the confidence of the public in the research enterprise
• Establish public accountability for human research protections through disclosure of accreditation results
• Support the research community in embracing a culture of ethics and continuous improvement
Partnership for Human Research Protection, Inc.
PHRP Approaches to Ensuring Integrity of Accreditation
• Outside Board of Directors comprised of experts
• Standards Committee made up of experts representing a variety of stakeholders
• Open, public process for development, refinement of accreditation standards
• Federal regulations as “floor,” or starting point, for standards
Partnership for Human Research Protection, Inc.
PHRP Approaches to Ensuring Integrity of Accreditation
• Precisely defined requirements, clear scoring guidelines
• Continuous quality improvement applied to the accreditation process itself
Partnership for Human Research Protection, Inc.
Members of the Board of Directors
• Mark Barnes, J.D., LL.M., Ropes & Gray
• Norman Fost, M.D., MPH, University of Wisconsin Hospital
• Paul Gelsinger, Citizens for Responsible Care & Research
• Dale Hammerschmidt, M.D., University of Minnesota
• Melinda Hurst, M.S., LAC/USC Medical Center
• Mary Faith Marshall, Ph.D. (Chair), University of Kansas Medical Center
• Margaret E. O’Kane, NCQA
• Dennis S. O’Leary, M.D., JCAHO
• Thomas R. Reardon, M.D.
• Richard B. Tompkins, M.D., Mayo Clinic
Partnership for Human Research Protection, Inc.
Accreditation Committee
• IRB chairs • Investigators• Clinical research
coordinators• Ethicists• Research directors• Research compliance
officers• HRP educators
• Academic institutions• Independent IRBs• Community health
care systems
Partnership for Human Research Protection, Inc.
Program Features
• Web-based Interactive Survey System features an easy-to-use Survey Tool
• Decisions include detailed reports on performance with improvement recommendations
• Carefully selected and trained expert surveyors• Zealous guarding against conflict of interest• Introductory Option for first timers
Partnership for Human Research Protection, Inc.
The Accreditation Process–bird’s eye view
• Organizations first use the web-based Survey Tool to conduct a readiness evaluation
• Survey begins when the organization submits the Survey Tool and includes dialogue between surveyors and the organization
• Trained, expert peer surveyors perform survey both off-site and on-site
• Off-site survey involves document review, conference calls
Partnership for Human Research Protection, Inc.
The Accreditation Process–bird’s eye view
• On-site survey includes interviews, document review, informal and formal feedback
• Preliminary results presented for review and comment
• Accreditation decisions rendered by peer committee, appointed by PHRP Board
• Final results include accreditation status, scores, detailed findings and recommendations for quality improvement
Partnership for Human Research Protection, Inc.
The Accreditation Process–bird’s eye view
• Introductory surveys offer first-time organizations low risk options
• Appeal available
Partnership for Human Research Protection, Inc.
Four Standards Categories
• Organizational Responsibilities (ONR)
• IRB Structure and Operation (IRB)
• Consideration of Risks and Benefits (CRB)
• Informed Consent (ICS)
Partnership for Human Research Protection, Inc.
Standards Take Three Views
• Written process (intentions, SOPs)
• Performance (actions taken)
• Measurement, evaluation and improvement of performance
Partnership for Human Research Protection, Inc.
Must-Pass Elements
• ONR1A (HRP, IRB)Organizational Leadership Accountability
• IRB1AIRB Membership
• IRB2AMaterials for IRB Review
• ICS1CApproved Consent Forms: Basic Elements
Partnership for Human Research Protection, Inc.
Accreditation Committee Role
• Finalize and validate accreditation outcome
• Use expert judgment to apply decision rules
• Ensure each decision is fair and process is reliable
• Provide advice to Standards Committee and Board of Directors
Partnership for Human Research Protection, Inc.
After the Survey
• Possible outcomes:– Accredited – Not Accredited
• Decisions will be publicly reported• Organizations receive detailed results,
recommendations• Accredited organizations receive PHRP seal• Maintain a state of continuous readiness and
improvement using the web-based tool and its document library feature
Partnership for Human Research Protection, Inc.
Getting the Most out of PHRP Accreditation
• Use the Readiness Evaluation– Do an honest evaluation of performance– Improve performance , where warranted– Organize documentation
Partnership for Human Research Protection, Inc.
Getting the Most out of PHRP Accreditation
• Get policy guidance during the readiness evaluation: Email questions to [email protected]
• Engage with the survey team– Ask questions– If surveyors can’t find evidence of compliance,
they will ask you to locate it
• Welcome the feedback
Partnership for Human Research Protection, Inc.
Getting the Most out of PHRP Accreditation
• Use the recommendations to guide improvements
• Continue to use the Survey Tool to maintain ongoing readiness and to track improvements
Partnership for Human Research Protection, Inc.
Contact PHRP for More Information
• To purchase publications, sign up for audio conferences, obtain an application for accreditation, visit www.phrp.org or call 1-888-503-4438
• For general inquiries, call 1-866-787-7477 or email [email protected]
• For questions about the standards, email [email protected]