11

Research Ethics Research Ethics Regulations and Regulations and Guidelines Guidelines

International and Sri LankanInternational and Sri Lankan

Malik Fernando Malik Fernando M.B.,Ch.B. (Bristol)M.B.,Ch.B. (Bristol)

22

Presentation ContentPresentation Content

The Nuremberg Code - 1947The Nuremberg Code - 1947 The Universal Declaration of Human Rights - 1948The Universal Declaration of Human Rights - 1948 The WMA Helsinki Declaration - 1964The WMA Helsinki Declaration - 1964 The Belmont Report - 1979 The Belmont Report - 1979 The CIOMS Guidelines - 1982The CIOMS Guidelines - 1982

Operational Guidelines of the Ethical Review Operational Guidelines of the Ethical Review Committee – FMC, 2005Committee – FMC, 2005

Ethics Review Committee Guidelines – FERCSL, 2007Ethics Review Committee Guidelines – FERCSL, 2007

33

The Nuremberg Code The Nuremberg Code 19471947

The first international instrument on the The first international instrument on the ethics of medical research on human ethics of medical research on human subjectssubjects

Designed to protect the integrity of the Designed to protect the integrity of the research subjectsresearch subjects

Set out conditions for the conduct of Set out conditions for the conduct of ethical research on human subjectsethical research on human subjects

Emphasized the need for voluntary Emphasized the need for voluntary consent for researchconsent for research

44

Universal Declaration of Universal Declaration of Human Rights - 1948Human Rights - 1948

Adopted by the General Assembly of the Adopted by the General Assembly of the UN in 1948UN in 1948 Article 1: all human beings are born free and Article 1: all human beings are born free and

equal in dignity and rights…equal in dignity and rights…

International Covenant on Civil and International Covenant on Civil and Political Rights – 1966Political Rights – 1966 Article 7: Article 7:

55

International Covenant on Civil and Political International Covenant on Civil and Political Rights – 1966Rights – 1966

Article 7: “No one shall be subjected to torture Article 7: “No one shall be subjected to torture or to cruel, inhuman or degrading treatment or or to cruel, inhuman or degrading treatment or punishment. In particular, no one shall be punishment. In particular, no one shall be subjected subjected without his free consentwithout his free consent to medical to medical or scientific experimentation”or scientific experimentation”

66

World Medical AssociationWorld Medical Association

Declaration of Helsinki Declaration of Helsinki 19641964

Ethical Principles for Medical Research Ethical Principles for Medical Research Involving Human SubjectsInvolving Human Subjects

Adopted by the World Medical Assembly Adopted by the World Medical Assembly Helsinki, 1964Helsinki, 1964

Amended Tokyo, 1975; Venice, 1983; Hong Amended Tokyo, 1975; Venice, 1983; Hong Kong, 1989; South Africa, 1996; Edinburgh, Kong, 1989; South Africa, 1996; Edinburgh, 2000.2000.

Clarifications: Para 29 (2002); Para 30 (2004)Clarifications: Para 29 (2002); Para 30 (2004)

77

Declaration of HelsinkiDeclaration of Helsinki

Is the fundamental document in the field Is the fundamental document in the field of ethics in biomedical researchof ethics in biomedical research

Has influenced the formulation of many Has influenced the formulation of many codes and guidescodes and guides

Contains ethical guidelines for both Contains ethical guidelines for both clinical and non-clinical researchclinical and non-clinical research

88

The Belmont Report - The Belmont Report - 19791979

National Commission for the Protection of National Commission for the Protection of Human Subjects of Biomedical and Human Subjects of Biomedical and

Behavioural ResearchBehavioural Research Focuses on informed consent Focuses on informed consent Favourable risk-benefit ratioFavourable risk-benefit ratio Need to ensure that vulnerable Need to ensure that vulnerable

populations are not targeted for risky populations are not targeted for risky researchresearch

99

CIOMS Guidelines - 1982CIOMS Guidelines - 1982

International ethical guidelines for International ethical guidelines for biomedical research involving biomedical research involving

human subjectshuman subjects

Geneva, Council for International Geneva, Council for International Organisations of Medical Sciences Organisations of Medical Sciences (CIOMS) in collaboration with WHO, (CIOMS) in collaboration with WHO, 20022002

1010

CIOMS GuidelinesCIOMS Guidelines

“… “… the Guidelines are designed to be of the Guidelines are designed to be of use to countries in defining national use to countries in defining national policies on the ethics of biomedical policies on the ethics of biomedical research involving human subjects, research involving human subjects, applying ethical standards in local applying ethical standards in local circumstancescircumstances, and establishing or , and establishing or improving ethical review mechanismsimproving ethical review mechanisms.”.”

1111

Sri Lanka Guidelines: Sri Lanka Guidelines: IntroductionIntroduction

Draft Act to provide for the Establishment Draft Act to provide for the Establishment and Development of a National Center for and Development of a National Center for Ethics in Research involving Human Ethics in Research involving Human Subjects (NCERHS) – Subjects (NCERHS) – ad hocad hoc Committee of Committee of the Ministry of Health (1995) the Ministry of Health (1995) (unpublished)(unpublished)

SLMA Ethical Review Committee Guidelines SLMA Ethical Review Committee Guidelines (1998)(1998)

A Guidebook on Research Ethics – A Guidebook on Research Ethics – NASTEC (2004)NASTEC (2004)

1212

Operational Guidelines of Operational Guidelines of the Ethical Review the Ethical Review Committee Committee

Faculty of Medicine, Colombo – 2005Faculty of Medicine, Colombo – 2005

Ethical review first started in 1981Ethical review first started in 1981 Program to formalise ethics review Program to formalise ethics review

commenced in 2003commenced in 2003 The Operational Guidelines published in The Operational Guidelines published in

20052005

1313

Operational Guidelines Operational Guidelines draw inspiration from draw inspiration from

Nuremberg CodeNuremberg Code CIOMS GuidelinesCIOMS Guidelines ICMR GuidelinesICMR Guidelines Declaration of HelsinkiDeclaration of Helsinki

What makes clinical research ethicalWhat makes clinical research ethical? ? What makes clinical research in developing What makes clinical research in developing

countries ethicalcountries ethical? ? The benchmarks of ethical The benchmarks of ethical researchresearch

both by E. J. Emanuel both by E. J. Emanuel et alet al

1414

Structured Review Structured Review ProcessProcess1.1. Social or Scientific valueSocial or Scientific value2.2. Scientific validityScientific validity3.3. Fair subject selectionFair subject selection4.4. Favourable risk-benefit ratioFavourable risk-benefit ratio5.5. Independent reviewIndependent review6.6. Informed consentInformed consent7.7. Respect for potential and enrolled Respect for potential and enrolled

subjectssubjects

1515

Ethics Review Committee Ethics Review Committee Guidelines – Guidelines – FERCSL, FERCSL, 20072007

A Guide for Developing Standard A Guide for Developing Standard Operating Procedures for Operating Procedures for

Committees that Review Biomedical Committees that Review Biomedical Research ProposalsResearch Proposals

1616

GenesisGenesis

Based on the FMC operational guidelinesBased on the FMC operational guidelines Draft reviewed at National Conference Draft reviewed at National Conference

“Responding to emerging ethical “Responding to emerging ethical issues…” Nov-Dec 2006issues…” Nov-Dec 2006

Circulated to Colleges, Associations and Circulated to Colleges, Associations and Editors of medical journalsEditors of medical journals

Two FERCSL workshops June 2007Two FERCSL workshops June 2007 Feedback incorporated in the final draftFeedback incorporated in the final draft

1717

ContentsContents

1.1. The Role of ERC The Role of ERC

2.2. Composition of Composition of ERCERC

3.3. Ethics ReviewEthics Review

4.4. ERC MeetingsERC Meetings

5.5. Elements of the Elements of the Review ProcessReview Process

6.6. Decision Making Decision Making and Communicatingand Communicating

7.7. Follow-upFollow-up

8.8. NotificationNotification

9.9. Documentation and Documentation and ArchivingArchiving

1818

Contents Contents continuedcontinued

AnnexesAnnexes

A.A. Application for Ethics ReviewApplication for Ethics Review

B.B. Information Sheet/Application FormInformation Sheet/Application Form

C.C. Ethics Review Evaluation FormEthics Review Evaluation Form

D.D. Participants/ContributorsParticipants/Contributors

URL: http://www.fercsl.net

1919