1. Copyright © 2013 AAHRPP ® All rights reserved Elyse I. Summers, J.D. President and CEO CAREB 2015 National Conference Vancouver, British Columbia May 1-2, 2015

2. Outline  Why accreditation? Pourquoi accreditation?  Who is AAHRPP? Que est AAHRPP?  What is AAHRPP’s role? Quel est le rôle de AAHRPP?  What we do/Ce que nous faisons  Questions/Questions 2

3. Why Accreditation? “to provide research ethics boards (REBs) in Canada with a common platform for governance, membership, operations, ethics review processes, and quality management.” 3

4. Why Accreditation? Deux “[to] reduce the overall administrative burden for REBs and enhance efficiency, while supporting high quality ethical reviews.” 4

5. Why AAHRPP Accreditation? AAHRPP accreditation is a public affirmation of your commitment to protect research participants, which resonates with participants, researchers, sponsors, government agencies and the general public. 5

6. Why AAHRPP Accreditation? Deux AAHRPP accreditation demonstrates that your organization follows rigorous standards for ethics, quality and protections. 6

7. Perhaps most importantly…  AAHRP Accreditation is complementary and congruent with all Canadian initiatives currently under consideration or operational.  In short,  AAHRPP 7

8. AAHRPP Global non-profit organization founded in 2001 –Contract research organizations, hospitals, independent ECs/IRBs, research institutes, sponsors, universities and government agencies (e.g., NIH, NCI, VA, State Departments of Health) –Small (fewer than 20 protocols) and large (greater than 6,000 protocols) institutions –Clinical and non-clinical research programs –The world’s premier research organization (NIH) –The world’s largest research-based pharmaceutical company (Pfizer) 8

9. AAHRPP-Accredited organizations  As of March 2015, more than 200 organizations representing over 600 entities  Truly global – AAHRPP-accredited organizations in Canada, China, India, Korea, Mexico, Saudi Arabia, Singapore, Taiwan, Thailand, United States  Other countries with organizations in the application process, include: Brazil, Belgium 9

10. The focus of AAHRPP accreditation  Organization  REB or IRB  Researchers and Research staff Protecting research participants is a shared responsibility Human Research Protection Program } 10

11. Human Research Protection Program Organizational Plan Education Programs Conflict of Interest Researcher and Research Staff Compliance Oversight Communications System IRB or REB Pharmacy Services Contracts and Grants 11

12. AAHRPP Accreditation standards  Relevant Country laws, codes and guidelines  Based on ICH-GCP Guideline (E6)  If organization conducts research under U.S. federal regulations for conducting human research: U.S. Department of Health and Human Services (45 CFR part 46); U.S. Food and Drug Administration (21 CFR parts 50, 56) 12

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14. AAHRPP Accreditation Standards AAHRPP process is outcomes-based approach  many possible avenues to achieve shared goal: Protection of the health and welfare of research volunteers, whose participation makes the whole enterprise possible. 14

15. AAHRPP Standards and Philosophy  A collegial and transparent process  Peer-to-Peer review (not an audit)  Goal to assist organizations in accreditation –Agreed upon standards –Fill in gaps –Collaborate –Be efficient and effective  Share responsibility throughout the organization 15

16. Add Burden? No Benefits? Yes  Self-assessment and peer review  Raises participant protection to an organizational priority  More visible role of IRB/EC  Better efficiency and streamlining  Improved communication/operational transparency  Attract and retain high level researchers  Increases ability to act nimbly and responsively to ever-changing research landscape 16

17. Moving Toward a Global Standard  Globalization of clinical research  Encourage trust and collaboration among research partners  Sponsors seek to reduce compliance risk and increase data quality  Building a strong infrastructure to protect research participants based on agreed upon standards promotes public trust and enhances the research enterprise as a whole 17

18. Oh, Canada Oh, Canada: The time is right Le moment est venu 18

19. Contact AAHRPP Elyse I. Summers, J.D. President and CEO esummers@aahrpp.org Michelle Feige, MSW Executive Vice President mfeige@aahrpp.org Sandra Jackson, MBA Chief Operating Officer sjackson@aahrpp.org Sarah Kiskaddon, J.D. Director of Global Business Development and Public Affairs skiskaddon@aahrpp.org 202.783.1112 19