ETHICAL ISSUES IN CLINICAL RESEARCH

1. ETHICAL ISSUES IN CLINICAL RESEARCH CHALLENGES TO ETHICS OVERSIGHT IN INTERNATIONAL RESEARCH Rio de Janeiro, Brasil 2008 Prof. Enrique Guntsche

2. GLOBAL SCENERY IN INTERNATIONAL RESEARCH INVOLVING HUMAN SUBJECTS NOWADAYS FACTS • Increasing number of collaboratives and multicenter studies • Study design, laboratory and animal experimentation and ethic evaluation done mostly in developed countries

3. GLOBAL SCENERY IN INTERNATIONAL RESEARCH INVOLVING HUMAN SUBJECTS NOWADAYS FACTS • Important switch of research from public to private incumbency • From altruism in science development research to investment for profit purposes • Research in developing countries: from poverty related diseases to less frequent but more profitable ones

4. GLOBAL SCENERY IN INTERNATIONAL RESEARCH INVOLVING HUMAN SUBJECTS NOWADAYS FACTS • 90% of global research funding invested to solve problems affecting 10% of world population • Insufficient funding assignment for research generally in developing countries • Known differences in social, cultural and economic contexts between developed and developing countries

5. GLOBAL SCENERY IN INTERNATIONAL RESEARCH INVOLVING HUMAN SUBJECTS NOWADAYS FACTS • Lesser bioethical development at national, regional and local levels in developing countries

6. GLOBAL SCENERY IN INTERNATIONAL RESEARCH INVOLVING HUMAN SUBJECTS CONTROVERSIES • Placebo: when is it ethically allowed its use? • Standard of medical care: is there room for distributive and commutative justice? • Treatment resultant from research: whom should it be provided to? For how long?

7. GLOBAL SCENERY IN INTERNATIONAL RESEARCH INVOLVING HUMAN SUBJECTS LANDMARKS IN BIOETHICS CONTRIBUTIONS • Nüremberg Code • Helsinki Declaration • Belmont Report • CIOMS guidelines • Nuffield Council on Bioethics • UNESCO Universal Declaration on Bioethics and Human Rights

8. GLOBAL SCENERY IN INTERNATIONAL RESEARCH INVOLVING HUMAN SUBJECTS QUESTION • Can Unethical Clinical Research be prevented?

9. HISTORY OF INTERNATIONAL RESEARCH ETHICS REVIEW

10. RELEVANT EVENTS AND ORIGIN OF NORMS AND CODES

12. Subject autonomy • Researcher freedom • No legislate • Moral autoregulation NUREMBERG CODE • Physician duty is always to promote and protect people health. His/her knowledge and conciousness are subordinated to fulfil this duty. • In medical research with human beings, concern for their welfare must always have primacy over science and society interests HELSINKI DECLARATION OF WMA

13. 1964: HELSINKI DECLARATION 1975: TOKYO 1983: VENICE 1989: HONG KONG 1996: SOUTH AFRICA 2000: EDIMBURGH

14. 1979: BELMONT REPORT Respect for Persons Informed Consent Justice Subjects selection Beneficense Risk/Benefit

15. GREAT CONTRIBUTIONS NORMS - GUIDELINES- DECLARATIONS • Respect for person subject of research: • AUTONOMY FREEDOM DIGNITY • Do not harm • Always look for subject benefit • Act with justice

16. How to move towards an ethical conduct in international research?

17. THE CULTURE OF ETHICAL CONDUCT Values and Practice Human environment Political environment Development context: Degree of delivery and protection of fundamental freedoms by society and how they contribute to political and human environment development J.V. Lavery “A culture of ethical conductt in research: The proper goal of capacity building in International Research Ethics” 2002

18. INTERRELATION SCHEME Transparence guarantee Political freedom ETHICAL BEHAVIOR IN RESEARCH PRINCIPLES-PRACTICES Protection and security Economic facilities Social Opportunities

19. MULTICENTRIC RESEARCH Results comparison Consent request To guarant respect of bioethics principles and norms DIFFICULTIES Equity in sample selection Standards of care application Harm reimbursement Monitoring

20. SPECIAL POPULATIONS IN MEDICAL RESEARCH • Vulnerability • Dependency level • Competence and capacity • Risk/benefit ratio • Children • Women • Elderly persons

21. SPECIAL POPULATIONS IN MEDICAL RESEARCH • Persons with congnitive disability • Subordinated personnel • Coma or critically ill patients • Terminal diseases • HIV/AIDS • Healthy volunteers • Minorities

22. SCIENTIFIC AND ETHICAL MISCONDUCT DEFINITION: Scientific error: unintended and unintentional Misconduct: purposeful, knowing and reckless DEGREE OF MISCONDUCT: - fabrication, - falsification, - plagiarism RESPONSES TO MISCONDUCT: - External sanctions: criminalizing misconduct - Due process protection for the accused - Informant protection

23. ETHICAL CHALLENGES IN INTERNATIONAL RESEARCH

24. ETHICAL CHALLENGES IN INTERNATIONAL RESEARCH • TO STIMULATE DIALOGUE • TO PROPOSE AND PROMOTE NEW PATHWAYS FOR INSTITUTIONAL IMPROVEMENT • TO AVOID IMPROVISATION

25. AGENTS FOR THE CHALLENGES: BUILDING CAPACITY • LATINAMERICAN RESEARCHERS • GRADE STUDENTS • ACADEMIC INSTITUTIONS AUTHORITIES • ETHICS COMMITTEE MEMBERS • CONGRESS MEMBERS • POLITICIANS • CITIZENS

26. CHALLENGE GOALS • ETHICAL • ECONOMICAL • CULTURAL • TO REACH: • ALL INHABITANTS OF NATIONS RICH DEVELOPED POOR DEVELOPING

27. “All written norms will not have a lasting value as long as some interests, at times not identified non concientious (scientific promotion, economic incentives, competing for rewards), continue influencing researchers education. The conclusion to be imposed is that the ethical structure of the scientific work, has to be part of science body and neither a foreign nor extemporary addendum” Lolas, F. Quesada, A. “Pautas éticas de investigación en sujetos humanos: nuevas perspectivas” 2003

28. “There is nothing more difficult to carry out, nor more doubtful of success, nor more dangerous to handle, than to initiate a new order of things. For the reformer has enemies in all who profit by the older, and only lukewarm defenders in all those who would profit by the new order.” Nicolo Machiavelli (In Shamoo and Dunigan 2000)

29. MENDOZA, ARGENTINA