copyright © 2013 aahrpp ® all rights reserved elyse i. summers, j.d. president and ceo careb 2015...
TRANSCRIPT
Copyright © 2013 AAHRPP® All rights reserved
Elyse I. Summers, J.D.President and CEO
CAREB 2015 National ConferenceVancouver, British ColumbiaMay 1-2, 2015
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
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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
Why Accreditation? Deux
“[to] reduce the overall administrative burden for REBs and enhance efficiency, while supporting high quality ethical reviews.” 4
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
Why AAHRPP Accreditation? Deux
AAHRPP accreditation demonstrates that your organization follows rigorous standards for ethics, quality and protections.
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Perhaps most importantly…
AAHRP Accreditation is complementary and congruent with all Canadian initiatives currently under consideration or operational.
In short,
AAHRPP
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AAHRPPGlobal 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)
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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
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The focus of AAHRPP accreditation
Organization REB or IRB Researchers and
Research staff
Protecting research participants is a shared responsibility
Human ResearchProtectionProgram
}
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Human Research Protection Program
Organizational Plan
EducationPrograms
Conflictof Interest
Researcher and Research Staff
ComplianceOversight
CommunicationsSystem
IRB or REB
Pharmacy Services
Contracts and Grants
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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)
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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.
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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
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Add Burden? NoBenefits? 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 landscape16
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
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Oh, Canada:
The time is right
Le moment est venu
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Contact AAHRPP
Elyse I. Summers, J.D.
President and CEO
Michelle Feige, MSW
Executive Vice President
Sandra Jackson, MBA
Chief Operating Officer
Sarah Kiskaddon, J.D.
Director of Global Business Development and Public Affairs
202.783.111219