1 Research Ethics Regulations and Guidelines International and Sri Lankan Malik Fernando M.B.,Ch.B. (Bristol)

2 Presentation Content  The Nuremberg Code  The Universal Declaration of Human Rights  The WMA Helsinki Declaration  The Belmont Report  The CIOMS Guidelines  Operational Guidelines of the Ethical Review Committee – FMC, 2005  Ethics Review Committee Guidelines – FERCSL, 2007

3 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

4 Universal Declaration of Human Rights  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:

5 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”

6 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,  Clarifications: Para 29 (2002); Para 30 (2004)

7 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

8 The Belmont Report 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

9 CIOMS Guidelines International ethical guidelines for biomedical research involving human subjects  Geneva, Council for International Organisations of Medical Sciences (CIOMS) in collaboration with WHO, 2002

10 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.” “… 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.”

11 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)

12 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

13 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 both by E. J. Emanuel et al

14 Structured Review Process 1.Social or Scientific value 2.Scientific validity 3.Fair subject selection 4.Favourable risk-benefit ratio 5.Independent review 6.Informed consent 7.Respect for potential and enrolled subjects

15 Ethics Review Committee Guidelines – FERCSL, 2007 A Guide for Developing Standard Operating Procedures for Committees that Review Biomedical Research Proposals

16 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

17 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

18 Contents continued Annexes A.Application for Ethics Review B.Information Sheet/Application Form C.Ethics Review Evaluation Form D.Participants/Contributors URL:

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