overcoming challenges faced by international irbs sharing ... · overcoming challenges build an...

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

esummers@aahrpp.org

Michelle Feige, MSW, LCSW-C

Executive Vice President

mfeige@aahrpp.org

Harry Frazier

Controller

hfrazier@aahrpp.org

Robert Hood, Ph.D.

Director of Accreditation

rhood@aahrpp.org

Rob Withrow

Director of Operations

rwithrow@aahrpp.org

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Thank You!

Questions?

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