Research Ethics Regulations and Guidelines

International and Sri Lankan Malik Fernando M.B.,Ch.B. (Bristol) 1

Presentation Content

     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 2

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 3

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: 4

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 or scientific experimentation” to medical 5

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) 6

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 7

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 8

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 9

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 .” 10

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) 11

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 12

Operational Guidelines draw inspiration from

    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

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2.

3.

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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 14

Ethics Review Committee Guidelines –

FERCSL, 2007

A Guide for Developing Standard Operating Procedures for Committees that Review Biomedical Research Proposals 15

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 16

Contents

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5.

The Role of ERC Composition of ERC Ethics Review ERC Meetings Elements of the Review Process 6.

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9.

Decision Making and Communicating Follow-up Notification Documentation and Archiving 17

Contents

continued

Annexes A.

B.

Application for Ethics Review Information Sheet/Application Form C.

Ethics Review Evaluation Form D.

Participants/Contributors

URL: http://www.fercsl.net

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