AAHRPP - CAREB

Report
Elyse I. Summers, J.D.
President and CEO
CAREB 2014 National Conference
Montreal, Quebec
April 23 – 26, 2014
Copyright © 2013 AAHRPP® All rights reserved
Outline
 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
We are AAHRPP!!
AAHRPP
Global non-profit organization founded in 2001
– Contract research organizations, hospitals, independent
REBs/IRBs, research institutes, sponsors, universities and
government agencies
– Small (fewer than 20 protocols) and large (greater than 6,000
protocols) institutions
– Clinical and non-clinical research programs
– The world’s largest research-based pharmaceutical company
AAHRPP-Accredited organizations
 As of March 2014, 196 organizations
representing over 600 entities
 Truly global – AAHRPP-accredited organizations
in Canada, China, India, Korea, Mexico, Saudi
Arabia, Singapore, Taiwan, United States
 Other countries with organizations in the
application process, include: Brazil, Belgium,
Lebanon, Spain, Thailand
The focus of AAHRPP accreditation
 Organization
 REB or IRB
 Researchers and
Research staff
}
Human
Research
Protection
Program
Protecting research participants is a shared
responsibility
Human Research Protection Program
Education
Programs
Conflict
of Interest
Researcher and
Research Staff
Compliance
Oversight
Organizational
Plan
Pharmacy
Services
Contracts
and Grants
Communications
System
IRB or REB
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)
AAHRPP Accreditation standards
 Human Research Protection Program
Domain 1: Organization
Domain 2: REB or IRB
Domain 3: Researchers and Research Staff
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.
What is accreditation of a human research
protection program?
 Accreditation of an Organization:
– is voluntary
– is flexible
– is based on outcome-based standards
• consistent regulatory, legal, and ethical requirements
• allows a proportionate risk management approach
–
–
–
–
evaluates structures, processes, and outcomes
is not an audit of ethics decisions
is not an audit of individual studies
focuses on quality
Benefits of Accreditation
 Assures highest level of protection afforded
to participants
 Increases public trust and participation in
research
 Meet uniform worldwide standards
 Signals high standards of performance to
sponsors
 Facilitates collaborations across institutions
Benefits of Accreditation, cont’d.
 Attract and retain high level researchers
 Improves science – facilitates acceptance to
prestigious journals
 Fewer findings on FDA inspections
 Fewer findings in OHRP compliance cases
AAHRPP’s Goals
 One set of Standards Worldwide
 Promote Organization-wide commitment to
protecting participants in clinical research
 Reinforce high standards and continuous
quality improvement of HRPPs
 Explore ways to improve efficiency
15
The AAHRPP Advantage:
Rigorous and Accessible
HRPP Accreditation
Rigoureuse et accessible
HRPP Accréditation
Oh, Canada:
Le moment est venu
The time is right
Contact AAHRPP
Elyse I. Summers, J.D.
President and CEO
[email protected]
Sarah Giannakopoulos
Director of Operations
[email protected]
Sarah Kiskaddon, J.D.
Director of Global Business Development and Public Affairs
[email protected]
202.783.1112

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