1. AAHRPP ACCREDITATION (Association for the Accreditation of Human Protection Programs)

2. AAHRPP Founders AAHRPP Founders 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

3. Advantages of Accreditation Builds public trust Self regulation Attracts research and researchers Fosters alliances with accredited organizations Improves the Research Program

4. Academic Institutions That Have Been Accredited University of Iowa Full accreditation University of Minnesota Qualified accreditation Vanderbilt University Full accreditation Washington University at St. Louis Full accreditation www.aahrpp.org

5. The Review Process The Review Process Self assessment – Evaluation Instrument Pre Review Site Visit Consideration and Decision by the Council

6. Potential Outcomes Full AAHRPP Accreditation Qualified AAHRPP Accreditation Accreditation Pending Accreditation Withheld

7. Accreditation Principles The Institution is the unit being accredited Emphasis on education and communication, not penalties Applicable across the range of human subjects’ research Promotes development of outcome measures

8. Accreditation Domains The Institution The IRB The investigators The sponsors The participants

9. The Institution Commitment to protecting human subjects Appropriate leadership Adequate resources Standardizing policies across the “Research Unit” Monitoring approved research Managing conflict of interest Training Integration of all units that affect human subjects

10. Units Within The Institution Senior Leadership The IRB Clinical Trials Contracting Office Office of Sponsored Programs Conflict of Interest Committee Biosafety and Radiation Safety Pharmacy

11. The IRB The IRB Evaluating risks to participants Scientific Merit Protection of confidentiality Informed consent Conflict of Interest Oversight of sites outside the institution

12. The Investigator Employs ethical and regulatory principles in research Demonstrated Competency Standardized policies Designs studies to protect participants Adequate resources/facilities Minimizes risk Scientifically sound Data safety monitoring Responds to concerns of participants

13. The Sponsor The Institution negotiates ethical research with sponsors Monitors conflicts of interest Accurately reports results

14. The Participant Educate the public about research Provide a mechanism for feedback from participants Respond to their concerns

15. UC’s Human Subject Research Clinical – Approved by IRB’s 1 and 2 Social and Behavioral IRB, Margaret Miller, Chair Federally sponsored Non federally sponsored, including pharmaceutical companies and foundations University sponsored

16. Major Tasks Commitment of the University to protection of human research subjects University Rule Compliance Plan HRP Website www.medcenter.uc.edu/hrp

17. Major Tasks (cont.) Identifying the appropriate “Research Units.” Written policies for each “Research Unit.” Administering standard policies across “Research Units.”

18. Major Tasks (cont.) Communicating policies to researchers Monitoring approved research Commitment to training researchers and research staff Communicating to potential participants in research

19. Involvement of Researchers Review draft policies Assist AAHRPP Oversight Committee Participate in the site visit

20. Definitions Research: a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Human subject: a living individual about whom an investigator conducting research obtains: Data through intervention or interaction with the individual, or Identifiable private information

21. Policies IRB Review of Research All research at the university involving human subjects shall be submitted to the IRB for review. See: http://www.uc.edu/trustees/rules/RuleDetail.asp?ID=222 Categories of Review – Research Which is Exempt From Continuing Review – Research Which is Expedited: – Review at a Convened Meeting.

22. AAHRPP Initiatives Written policies in the Office of the Vice President for Research HRP website for review and comment of new policies Competency Testing for Researchers Training Programs QA/QI for approved research and the IRB