The ethics of research related to healthcare in developing countries

1. The ethics of research related to healthcare in developing countries Santiago, October 16th,2003 Keith McAdam Member of the Nuffield Council Working Party Professor of Clinical Tropical Medicine London School of Hygiene and Tropical Medicine and 1995 – 2003 Director, Medical Research Council (UK) Laboratories The Gambia, West Africa The ethics of research related to healthcare in developing countries

2. Nuffield Council on Bioethics • Independent body that examines ethical questions raised by advances in biology and medicine • Contributes to policy making and stimulates debate • Established in 1991 The ethics of research related to healthcare in developing countries

3. The ethics of research related to healthcare in developing countries

4. Method of working • International Working Party • 9 meetings over 21 months • Fact-finding meetings including: • International meeting in Oxford • India (Chennai) • USA (Boston and Washington) • Public consultation • Responses from over 20 countries The ethics of research related to healthcare in developing countries

5. Need for research • Disease burden in developing countries • 10/90 gap in research • Externally-sponsored research is vital • Developing countries should set their own priorities for research into healthcare. The ethics of research related to healthcare in developing countries

6. The role of the report • Suggests appropriate safeguards for externally-sponsored research. • Sets out framework for assessing the duties and responsibilities of those designing and conducting research. • Identifies the minimum requirements which must be met in all circumstances. The ethics of research related to healthcare in developing countries

7. Ethical framework • Based on four principles: • duty to alleviate suffering • duty to show respect for persons • duty to be sensitive to cultural differences • duty not to exploit the vulnerable • Local social, cultural and economic contexts must be taken into account The ethics of research related to healthcare in developing countries

8. Key issues • Genuine Consent • Standards of care • Ethical review of research • What happens once research is over? The ethics of research related to healthcare in developing countries

9. Consent • We recommend that genuine consent to participate in research must be obtained from each participant BUT: • In some cultural contexts it may also be appropriate to obtain agreement from the community or a senior family member The ethics of research related to healthcare in developing countries

10. Consent • The ethically significant requirement is that consent must be genuine. This requires that it be: • Appropriately informed • Voluntary • Will sometimes need to get verbal consent The ethics of research related to healthcare in developing countries

11. Standards of care • International debate about standard of care that should be provided to control group in research: • Universal (the best treatment available anywhere in the world) • Non-universal (the treatment available in a defined region) The ethics of research related to healthcare in developing countries

12. Standards of care We recommend: • Wherever appropriate, a universal standard of care should be offered to the control group • Where this is not appropriate, the minimum is the best treatment provided by the national public health system The ethics of research related to healthcare in developing countries

13. CIOMS Guideline 11 • Requires an ‘established effective intervention’ for the control arm of the trial • Includes the best, and various alternatives to the best, interventions • This revision is closer to Nuffield position The ethics of research related to healthcare in developing countries

14. Ethical review of research • Effective ethical review of research provides a crucial safeguard • Externally-sponsored research should receive 3 levels of assessment: • relevance to healthcare priorities • scientific validity • ethical acceptability • Should be carried out in both host and sponsor countries The ethics of research related to healthcare in developing countries

15. What happens once research is over? • Is research acceptable if benefits will not be made available to the community where it was undertaken? • Complex issue because: • the price of treatments may decrease • differential pricing agreement The ethics of research related to healthcare in developing countries

16. What happens once research is over? • What should be provided once research is over to: • the control group? • all participants in research? • the wider community? The ethics of research related to healthcare in developing countries

17. Provision to control group • Control group should be provided with effective intervention • Decision must be made before study begins • Information should be given as part of consent process The ethics of research related to healthcare in developing countries

18. Provision to all participants Helsinki: • At the end of a study, ‘every patient in the study should be assured of access to the best proven prophylactic, diagnostic and therapeutic methods identified in the study’ • New working group set up to consider conflicting views EGE: • requires provision of successful treatments to trial participants upon completion of the trial, even if provision would need to be life-long The ethics of research related to healthcare in developing countries

19. Provision to all participants • Address issue before research begins • Try to secure post-trial access to effective interventions for all participants in the trialwho could benefit • Questions about on-going interventions for chronic conditions • Whose responsibility? The ethics of research related to healthcare in developing countries

20. Provision to wider community • Should an effective treatment be provided to the wider community after research? • How effective must an intervention be shown to be to merit provision? • Should the whole country receive the intervention (if appropriate)? For how long? • Who should provide it? The ethics of research related to healthcare in developing countries

21. Role of researchers • What is responsibility of researchers to ensure provision of treatment after a trial? • Difficult for researchers to translate results into action • Researchers can draw attention to problems and demonstrate feasible solutions The ethics of research related to healthcare in developing countries

22. Role of sponsors and governments • If sponsors were required to fund future provision, many would stop supporting research • Primary responsibility lies with governments • Pharmaceutical industry may contribute The ethics of research related to healthcare in developing countries

23. Provision to wider community • Issue should be considered before trial is begun • If it is unlikely that new intervention will be accessible to the wider community, should justify to research ethics committee why research should be carried out. The ethics of research related to healthcare in developing countries

24. Adverse Effects • Responsibility to care for people who suffer adverse effects:- as a result of the trial- after the trial is over- chronic effects • Compensation? • Long-term surveillance? The ethics of research related to healthcare in developing countries

25. Continued provision of improved healthcare • Community may benefit from general improvements in healthcare and facilities as a result of research • Should these be sustained after trial? • Sponsors rarely able to make open-ended commitments • But can assist in capacity-building, giving potential for a sustained improvement The ethics of research related to healthcare in developing countries

26. Building expertise • Expertise to undertake research at local level is severely limited • Not enough training, too few researchers • Promote genuine partnerships to strengthen expertise in research and to develop institutions • Opportunities for transfer of skills and knowledge The ethics of research related to healthcare in developing countries

27. Building expertise We recommend: • Development of expertise in healthcare and research should be an integral component of all research in developing countries. • Sponsors should ensure provision for education and training in ethics of all professionals involved in research. The ethics of research related to healthcare in developing countries

28. Post launch • Wide distribution of Report • Use as teaching material • Raise awareness of stakeholders • Follow up Workshop, Cape Town 2004 The ethics of research related to healthcare in developing countries