Research Ethics Regulations and Guidelines

Report
Research Ethics
Regulations and
Guidelines
International and Sri Lankan
Malik Fernando M.B.,Ch.B. (Bristol)
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Presentation Content
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The Nuremberg Code - 1947
The Universal Declaration of Human Rights - 1948
The WMA Helsinki Declaration - 1964
The Belmont Report - 1979
The CIOMS Guidelines - 1982
 Operational Guidelines of the Ethical Review
Committee – FMC, 2005
 Ethics Review Committee Guidelines – FERCSL, 2007
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The Nuremberg Code
1947
 The first international instrument on the
ethics of medical research on human
subjects
 Designed to protect the integrity of the
research subjects
 Set out conditions for the conduct of
ethical research on human subjects
 Emphasized the need for voluntary
consent for research
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Universal Declaration of
Human Rights - 1948
 Adopted by the General Assembly of the
UN in 1948
 Article 1: all human beings are born free and
equal in dignity and rights…
 International Covenant on Civil and
Political Rights – 1966
 Article 7:
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International Covenant on Civil and Political
Rights – 1966
 Article 7: “No one shall be subjected to torture
or to cruel, inhuman or degrading treatment or
punishment. In particular, no one shall be
subjected without his free consent to medical
or scientific experimentation”
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World Medical Association
Declaration of Helsinki
1964
Ethical Principles for Medical Research
Involving Human Subjects
 Adopted by the World Medical Assembly
Helsinki, 1964
 Amended Tokyo, 1975; Venice, 1983; Hong
Kong, 1989; South Africa, 1996; Edinburgh,
2000.
 Clarifications: Para 29 (2002); Para 30 (2004)
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Declaration of Helsinki
 Is the fundamental document in the field
of ethics in biomedical research
 Has influenced the formulation of many
codes and guides
 Contains ethical guidelines for both
clinical and non-clinical research
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The Belmont Report - 1979
National Commission for the Protection of
Human Subjects of Biomedical and
Behavioural Research
 Focuses on informed consent
 Favourable risk-benefit ratio
 Need to ensure that vulnerable
populations are not targeted for risky
research
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CIOMS Guidelines - 1982
International ethical guidelines for
biomedical research involving
human subjects
 Geneva, Council for International
Organisations of Medical Sciences
(CIOMS) in collaboration with WHO,
2002
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CIOMS Guidelines
“… the Guidelines are designed to be of
use to countries in defining national
policies on the ethics of biomedical
research involving human subjects,
applying ethical standards in local
circumstances, and establishing or
improving ethical review mechanisms.”
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Sri Lanka Guidelines:
Introduction
 Draft Act to provide for the Establishment
and Development of a National Center for
Ethics in Research involving Human
Subjects (NCERHS) – ad hoc Committee of
the Ministry of Health (1995) (unpublished)
 SLMA Ethical Review Committee Guidelines
(1998)
 A Guidebook on Research Ethics –
NASTEC (2004)
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Operational Guidelines of the
Ethical Review Committee
Faculty of Medicine, Colombo – 2005
 Ethical review first started in 1981
 Program to formalise ethics review
commenced in 2003
 The Operational Guidelines published in
2005
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Operational Guidelines
draw inspiration from
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Nuremberg Code
CIOMS Guidelines
ICMR Guidelines
Declaration of Helsinki
 What makes clinical research ethical?
 What makes clinical research in developing
countries ethical? The benchmarks of ethical
research
both by E. J. Emanuel et al
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Structured Review Process
1.
2.
3.
4.
5.
6.
7.
Social or Scientific value
Scientific validity
Fair subject selection
Favourable risk-benefit ratio
Independent review
Informed consent
Respect for potential and enrolled
subjects
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Ethics Review Committee
Guidelines – FERCSL, 2007
A Guide for Developing Standard
Operating Procedures for
Committees that Review Biomedical
Research Proposals
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Genesis
 Based on the FMC operational guidelines
 Draft reviewed at National Conference
“Responding to emerging ethical
issues…” Nov-Dec 2006
 Circulated to Colleges, Associations and
Editors of medical journals
 Two FERCSL workshops June 2007
 Feedback incorporated in the final draft
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Contents
1. The Role of ERC
2. Composition of
ERC
3. Ethics Review
4. ERC Meetings
5. Elements of the
Review Process
6. Decision Making
and Communicating
7. Follow-up
8. Notification
9. Documentation and
Archiving
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Contents
continued
Annexes
A.
B.
C.
D.
Application for Ethics Review
Information Sheet/Application Form
Ethics Review Evaluation Form
Participants/Contributors
URL: http://www.fercsl.net
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