Partnership for Human Research Protection, Inc. Jessica Briefer French, MHSA Assistant Vice President

Partnership for Human Research Protection, Inc.

Jessica Briefer French, MHSAAssistant Vice President


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)


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


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


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


PHRP Approaches to Ensuring Integrity of Accreditation

• Precisely defined requirements, clear scoring guidelines

• Continuous quality improvement applied to the accreditation process itself


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


Accreditation Committee

• IRB chairs • Investigators• Clinical research

coordinators• Ethicists• Research directors• Research compliance

officers• HRP educators

• Academic institutions• Independent IRBs• Community health

care systems


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


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



• 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



• Introductory surveys offer first-time organizations low risk options

• Appeal available


Four Standards Categories

• Organizational Responsibilities (ONR)

• IRB Structure and Operation (IRB)

• Consideration of Risks and Benefits (CRB)

• Informed Consent (ICS)


Standards Take Three Views

• Written process (intentions, SOPs)

• Performance (actions taken)

• Measurement, evaluation and improvement of performance




Must-Pass Elements

• ONR1A (HRP, IRB)Organizational Leadership Accountability

• IRB1AIRB Membership

• IRB2AMaterials for IRB Review

• ICS1CApproved Consent Forms: Basic Elements


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


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


Getting the Most out of PHRP Accreditation

• Use the Readiness Evaluation– Do an honest evaluation of performance– Improve performance , where warranted– Organize documentation



• 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



• Use the recommendations to guide improvements

• Continue to use the Survey Tool to maintain ongoing readiness and to track improvements


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]


Summary

Accreditation will:

• Drive continuous quality improvement

• Align with regulation, facilitate compliance

• Help restore public trust in research involving human subjects

• Recognize and facilitate best practices in human research protections

Documents

Partnership for Human Research Protection, Inc. Jessica Briefer French, MHSA Assistant Vice President