overcoming challenges faced by international irbs sharing ... · overcoming challenges build an...
TRANSCRIPT
Copyright © 2018 AAHRPP® All rights reserved.
Elyse I. Summers, J.D.
President and CEO
Overcoming Challenges Faced by International
IRBs
Sharing of Best Practices Among IRBs: Breakout 6
Inaugural Singapore Research Ethics Conference
March 1-2, 2018
Singapore
Outline
Background -- what is AAHRPP?
Overcoming challenges:
-- Build an HRPP
-- Embrace flexibility
-- Protect participants
Questions
What is the
Association for the Accreditation of Human Research
Protection Programs, Inc. (AAHRPP)?
Nonprofit NGO
Offers accreditation to organizations that
conduct, review, or manage research
involving human participants
Seeks to identify quality programs;
promote innovative practices; and, ensure
regulatory compliance
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)
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AAHRPP-Accredited organizations
As of December 2017, almost 250 organizations
representing over 600 entities
Truly global – AAHRPP-accredited organizations
in Belgium, Brazil, Canada, China, India, Korea,
Mexico, Saudi Arabia, Singapore, South
Africa, Taiwan, Thailand, United States
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Why This Is Important
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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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Overcoming Challenges
Build an HRPP - One Model: AAHRPP
Accreditation
AAHRPP Accreditation = Logical, robust, and
elegant manifestation of an organization’s
commitment to and ownership of the
responsibility to protect the volunteers who make
the human research enterprise possible
Establishes and demonstrates a worldwide
standard against which to gauge the quality of a
human research protection program
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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 Research Protection Program
}
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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
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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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Overcoming Challenges
Embrace Flexibility: 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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Overcoming Challenges
Embrace Flexibility: Examples
What laws does AAHRPP require we follow?
How to implement quality improvement?
Do we have to reporting to US agencies?
What is “community-based research”?
What are organizational conflicts of interest?
What regulations does AAHRPP require we
follow for drugs and devices?
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Challenge: What laws do we have to follow? US regulations?
Standard I-1
Define which rules apply
– AAHRPP accredits to country law and funding agency
requirements
– If no US DHHS funding (NIH), then no need to follow US
regulations
– ICH-GCP (E6) – comprehensive protections for vulnerable
populations, including adults unable to consent (more extensive
than US regulations)
– If follow ICH-GCP (E6) or country-specific GCP – meets US FDA
requirements
Define ethical standards
– Declaration of Helsinki or Singapore Medical Council Ethical
Code and Ethical Guidelines; alternately Belmont Report
Challenge: What is “community-based research”?
Standard I-4
May not apply, if organization does not conduct this type
of research
Community-based research:
– Community members involved in design, recruitment,
evaluation of results
– More common in public health, social science
– Unusual in clinical studies of new drugs and devices
Organization can provide education about research, how
to get involved (website, handouts, education events),
when appropriate
Challenge: Implementing Quality Improvement Programs
Standard I-5 Quality Improvement
Define a goal, define a measure, review periodically
Start with just one goal – learn how the process works
Examples – quality, efficiency, effectiveness (I.5.A.):
– 80% of studies will be approved (submission to approval) within 2
months
– 50% of minimal risk studies use waivers of signed consent and provide
an information sheet instead of using a signature (example of greater
flexibility, reduced burden)
Examples – quality of the compliance program (I.5.B.):
– 100% of minutes document the IRB’s or EC’s protocol-specific
determinations that the study includes additional protections when
research involves vulnerable participants (children, pregnant women,
prisoners, adults unable to consent), when applicable
– 100% of minutes differentiate between substantive and minor changes • Substantive changes – return to the convened IRB, information needed to determine if
criteria for approval are met
Challenge: Reporting requirements?
Implementing Standard I.5.D. – review of non-compliance
Report to Singapore regulatory agencies as required
– Generally do not need to report to US FDA
When research is not funded by a US DHHS-agency (NIH)
– Do not need to report non-compliance to US regulatory agencies
– Also, do not need to report unanticipated problems involving risks to
participants or others to US regulatory agencies (See Element II.2.G.)
Challenge: Organizational Conflicts of Interest
Standard I-6 Conflicts of Interest
Does organization:
– Own patents or other intellectual property related to research?
– Own start up companies to commercialize research?
– Conduct investigator-initiated research involving new drugs /
devices developed by a researcher at the organization?
If not, then organizational conflict of interest may be
limited to interests of leadership
– Address investments of senior leadership (e.g., President’s
investment in specific drug company – general funds or mutual
funds do not involve conflicts)
Potential conflicts do not necessarily have to be reviewed by
the IRB or EC
Challenge: AAHRPP’s requirements for drugs / devices
Standard I-7 Oversight of Drugs and Devices
Approval is required from the relevant authority in the
jurisdiction
– This means Singapore regulatory authorities
– Not US FDA
Policies should describe approval process for Singapore
regulatory agencies
An “IND” or “IDE” from the US FDA is not required
Summary – Keys to Overcoming
Challenges
Promote the development of an HRPP
through an Organization-wide commitment to
quality in which everyone understands his or
her role in the endeavor and its importance
Embrace flexibility wherever possible
All of which leads to: protecting human
research participants – the ultimate goal
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Contact AAHRPP
202.783.1112
Elyse I. Summers, J.D.
President and CEO
Michelle Feige, MSW, LCSW-C
Executive Vice President
Harry Frazier
Controller
Robert Hood, Ph.D.
Director of Accreditation
Rob Withrow
Director of Operations
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Thank You!
Questions?
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