1. Promoting a Rights Based Approach in Research Ethics Pathmeswaran A & Perera WN Ethics Review Committee Faculty of Medicine University of Kelaniya, Sri Lanka

2. Outline Development of research ethics Role of the ERCs Some problems in promoting research ethics Human rights and research ethics Way forward

3. Landmarks Hipocratic oath Nuremburg code1947 Declaration of Helsinki1964 Belmont report1979 Universal declaration of Human Rights

4. Historical Developments Hippocratic Oath (~400 BC) Behavior of practitioners not researchers Physicians relationship with –Teachers –Fellow physicians –Patients Physician’s main concern individual patients Researcher’s main concern finding the truth

5. Historical Developments Nuremberg Code (1947) Comprehensive document dealing with medical research Main feature – protecting research subjects Objective – to bring about successful conviction of German physicians Negative focus Ex post facto

6. Historical Developments Declaration of Helsinki (1964) One page document Guidance on clinical research Conflicts of physician researcher –Paternalistic physician –Patients best interest –Truth seeking researcher –Autonomy of research subjects

7. Historical Developments Belmont Report (1979) National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974) Belmont Report - ethical principles and guidelines for the protection of human subjects of biomedical research

8. Belmont Report 1.Boundaries between practice and research 2.Basic ethical principles a.Respect for persons b.Beneficence c.Justice 3.Applications of these principles a.Informed consent b.Assessment of risks and benefits c.Selection of subjects

9. Research Ethics BeneficenceJustice Autonomy

10. Informed consent – Helsinki declaration Research subjects informed about –aims & methods –sources of funding –any possible conflicts of interest –institutional affiliations of the researcher –the anticipated benefits and potential risks –the discomfort it may entail –post-study provisions –any other relevant aspects of the study

11. Problems 1.Research is not always experimental 2.Need for continued monitoring to ensure compliance 3.Conflict between researchers and ERCs 4.Cost of compliance

12. Observational studies (Non-experimental studies) All codes mainly focus on medical experiments Majority of biomedical research involve observational design where degree of possible harm to participants is lower Codes considered too restrictive

13. Need for continued monitoring to ensure compliance Unequal relationship between the research subjects and researchers Possibility for violations / non compliance Stricter codes Responsibility transferred to ERCs Accreditation of ERCs

14. Conflict between researchers and ERCs Bureaucratic ERCs Ethics = ERC approval Mismatch between protocol & actual conduct of research

15. Cost of compliance Challenge to new researchers & small research groups Paper work Comprehensibility of very long participant information sheets and consent forms

16. Rights based approach to research ethics Empower people Raise awareness regarding universal declaration of human rights

17. Informed consent information to be provided assessment of comprehension voluntariness

18. Universal declaration of Human Rights & Informed consent Article 1 – endowed with reason and conscience Article 12 –protection against interference with privacy Article 19 –Freedom to access information Article 25 –Right to medical care

19. Universal declaration of Human Rights & Assessment of risk & benefit Article 3 – right to life, liberty and security of person Article 5 – freedom from torture or cruel, inhuman or degrading treatment or punishment

20. Universal declaration of Human Rights & Selection of subjects Article 2 –No discrimination based on race, color, sex, language, religion, political or other opinion, nationality or social class Article 29 –Everyone has duties or obligations towards their communities

21. Way forward Consider research participants as partners and not as ‘subjects’ Educate the public regarding the universal declaration of human rights Empower the patients Do not leave the promotion of research ethics entirely in the hands of ERCs