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

2. 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)

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. Partnership for Human Research Protection, Inc. The Accreditation Process –bird’s eye view Introductory surveys offer first-time organizations low risk options Appeal available

13. 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)

14. Partnership for Human Research Protection, Inc. Standards Take Three Views Written process (intentions, SOPs) Performance (actions taken) Measurement, evaluation and improvement of performance

15. Partnership for Human Research Protection, Inc.

17. Must-Pass Elements ONR1A (HRP, IRB) Organizational Leadership Accountability IRB1A IRB Membership IRB2A Materials for IRB Review ICS1C Approved Consent Forms: Basic Elements

18. 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

19. 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

20. 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

21. Partnership for Human Research Protection, Inc. Getting the Most out of PHRP Accreditation Get policy guidance during the readiness evaluation: Email questions to policysupport@phrp.org policysupport@phrp.org 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

22. 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

23. 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 1-888-503-4438www.phrp.org For general inquiries, call 1-866-787-7477 or email customersupport@phrp.orgcustomersupport@phrp.org For questions about the standards, email policysupport@phrp.org policysupport@phrp.org

24. Partnership for Human Research Protection, Inc. 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