ACCREDITATION

1. ACCREDITATION Dr. Sarah

2. AAHRPP • The Association for the Accreditation of Human Research Protection Programs, Inc.,

3. AAHRPP • non-profit organization in Maryland in 2001, the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) offers accreditation to organizations that conduct or review research with humans. </P • Responding to increased public concern for protecting research participants, AAHRPP seeks not only to ensure compliance with federal regulations, but to raise the bar in human research protection by helping organizations reach performance standards that surpass the threshold of state and federal requirements.

4. Why accreditation? • Human subject protection: • Stakeholder compliance to standards • Public Assurance • Clinical research enterprise

5. AAHRPP • The Association for the Accreditation of Human Research Protection Programs, Inc., (AAHRPP) works to protect the rights and welfare of research participants and promote scientifically meritorious and ethically sound research by fostering and advancing the ethical and professional conduct of persons and organizations that engage in research with human participants. AAHRPP achieves its mission by using an accreditation process based on self-assessment, peer review, and education.

6. How to make sure that principles are applied to your EC? • Do you have the components (committees, space, written policies and procedures): • Required by the regulations described in the Regulatory and Guidance Requirements? • Recommended by guidance described in the Regulatory and Guidance Requirements? • Recommended in the Additional Structural and Procedural Criteria? • Do your activities: • Comply with the regulations describedin the Regulatory and Guidance Requirements?

7. AAHRPP • Meet the guidance described in the Regulatory and Guidance Requirements? • Meet the Additional Structural and Procedural Criteria? • Do you define and communicate these practices? • Do your policies and procedures describe the operational steps that are followed? • Do your activities meet the Outcome Criteria?

8. Accreditation principles • Principles for Accreditation of Human Research Protection Programs

9. What AAHRPP expects from organizations • Protecting the rights and welfare of research participants must be an organization's first priority. An organization should promote a research environment where ethical, productive investigation is valued.

10. What AAHRPP expects from organizations 2. Protecting research participants is the responsibility of everyone within an organization and is not limited to the Institutional Review Board (IRB). Accreditation examines whether the policies and procedures of the organization as a whole result in a coherent, effective system to protect research participants and that all individuals know their roles and responsibilities.

11. What AAHRPP expects from organizations 3. Striving to exceed the federal requirements and continually seeking new safeguards for protecting research participants while advancing scientific progress must be integrated into an organization’s mission.

12. What organizations can expect from AAHRPP • The standards for protecting participants in human research will be clear, specific, and applicable to research across the full range of settings (e.g., university-based biomedical, behavioral and social science research, independent review boards, hospitals, government agencies, and others). Standards will address any special concerns (e.g., the use of vulnerable populations or heightened risk to privacy and confidentiality) that may arise in each setting.

13. What organizations can expect from AAHRPP 2. The standards will identify outcome measures that organizations can use to assess and demonstrate quality improvement over time.

14. What organizations can expect from AAHRPP 3.The standards will be performance-based using objective criteria and measurable outcomes to evaluate whether a Human Research Protection Program effectively implements the standards. The evaluation will result in a grade of pass or fail for each standard and, where appropriate, will also include commendations or recommendations for meeting the standards.

15. What organizations can expect from AAHRPP 4. The accreditation process will provide a clear, understandable pathway to accreditation, along with equally clear pathways for appeal and the remediation of identified shortcomings

16. What organizations can expect from AAHRPP 5. The accreditation process will be educational involving collegial discussion and constructive feedback. The accreditation process will identify areas in which the Human Research Protection Program does not yet meet the standards and give organizations the opportunity to discuss potential program improvements

17. What organizations can expect from AAHRPP 6. The accreditation process will be responsive to changes in federal regulations and to standards that will evolve based on what AAHRPP learns from accrediting organizations from research settings.

18. The five domains of standards • AAHRPP allocates the criteria for accrediting Human Research Protection Programs into the following five domains: • Organization • Research Review Unit,including IRBs • Investigator • Sponsored Research • Participant Outreach

19. DOMAINS(DETAILS) • ORGANIZATION: • HRPP • RESOURCES • TRAINING • EVALUATION • INTERVENTION

20. DOMAINS(DETAILS) • RESEARCH REVIEW UNIT • FINANCING, STRUCTURE AND COMPOSITION • EVALUTION OF HRPP • DOCUMENTATION • INITIAL/ ONGOING REVIEW • SELECTION PROCESS • INFORMED CONSENT • CONFIDENTIALITY • MULTISITES

21. DOMAINS(DETAILS) • INVESTIGATOR: Policies, compliance. • PARTICIPANT : Need of Participation, Education • SPONSOR: scope, communication, benefits from research conflicts of interest.

22. Independent EC • Wirb.

23. OHRP. • IRB REGISTERATION: FWA