Nuffield Council on Bioethics / Home

PRESENT
Professor Sir Kenneth Calman (Chairman)
Fred Binka
David Parkin
Povl Riis
V I Mathan
Shahwar Sadeque
Keith McAdam
Peter Smith
Anne McLaren
Nelson Sewankambo
Fabio Zicker
Michael Elves
Bhikhu Parekh
Catherine Peckham

SECRETARIAT
Sandy Thomas
Susan Bull
Yvonne Melia

APOLOGIES

CHAIRMAN’S INTRODUCTION

1 The fact finding meeting yesterday had been very useful. It had provided an excellent opportunity to discuss a range of issues with a group of experts who had direct involvement in healthcare-related research.

MATTERS ARISING FROM THE MINUTES OF (00) 3rd MEETING

International meetings

2 It was agreed at the 2nd Working Party HRRDC (00) 2nd meeting that a sub-group of members would meet with researchers in Africa and Asia. Members of the Working Party from the relevant regions would liaise to discuss appropriate dates and venues.

3 In October the International Conference on Health Research for Development and the Global Forum for Bioethics in Research Year 2000 would be held in Bangkok. Fabio Zicker and Nelson Sewankambo were attending both of these meetings and Professor Mathan was attending the Global Forum. Susan Bull would also attend these meetings and meeting reports would be circulated to the Working Party. In 2001, the Global Forum on Bioethics in Research would meet in The Gambia. It was being organised by the UK MRC and the Working Party’s report would be presented at that meeting.

FIRST DRAFT OF THE REPORT

4 Although the first draft report had now been prepared, a great deal of work remained to be done. Working Party members need to provide feedback and information to chapter authors to assist with the re-drafting over the next three to five weeks.

5 Povl Riis and Bhikhu Parekh had met in August to discuss the text on ethical issues. It was agreed that it was important to keep it concise. It was also important for the drafting to set out basic principles because such principles would provide a framework for consideration of ethical issues in the report. The chapter would then go on to discuss what would happen when the principles were applied in practice. Some of this material would be picked up in later chapters, such as the chapter on social and cultural issues. Much of the writing on the ethical issues raised by healthcare-related research in developing countries had not really taken into account the effect that economics had on the decision-making process.

6 It would also be important for the report to consider the legal implications of research, such as who was liable for rectifying problems arising out of research activities. Such considerations had had an impact on consent forms, many of which were still balanced towards legal considerations rather than the protection of research participants. Some ethics committees required that consent forms be no longer than one page and should be translated into, and back translated from, the local language. In addition, witnesses might be requested to watch translators giving information to prospective participants.

7 It was noted that many people who received training as part of a research protocol did not necessarily stay within the developing country where they received it. Would it be possible to formulate a policy to address ‘brain drain’ which did not limit the freedom of individual researchers? It was suggested that an appropriate answer would be to build opportunities for conducting good research within developing countries so there was a motivation for researchers to stay within their own country. It was noted that capacity-building did not just involve people, it was also a question of infrastructure and equipment.

8 The chapter on social and cultural issues noted that in most parts of the world there were dual systems of medical treatment. Issues raised in relation to consent included the purpose of consent, the level of consent, who profited by consent, the motivation for consenting to research and shared consent. It might be useful to increase the emphasis on information provision in this chapter. Concerns were raised about the idea of community consent, particularly because in some circumstances there was concern that the will of the community would override that of the individual. It would also be important to protect the confidentiality of participants who are excluded from taking part in research for medical reasons, such as having an HIV-positive status. It was suggested that 99% of those tested for HIV in some areas did not want to know the result of their test and would not come back for it. Was there a right not to know? Some researchers had been criticised for not giving information to participants who did not want to know the results of tests.

9 The drafting on healthcare economics and access to resources had been substantially amended. Important issues raised included the need for long-term follow up of populations and monitoring of side effects. The text about developing a new intervention was intended to show what was involved, and in particular the costs incurred and the time taken to develop a new intervention.

10 Although life expectancy was increasing on a global basis, it might be useful to break such figures down into smaller groups. For example, in parts of Eastern Europe, life expectancy was falling, as was the life expectancy in parts of Africa where the adult mortality due to AIDS was significant. In areas such as the Congo, Zaire and Sierra Leone, the effects of war would also affect adult mortality rates. In the European context, WHO regional offices could give good data about infant and adult mortality rates and life expectancy.

11 Questions were also raised about whether forms of non-healthcare research should be covered, such as research into ‘water sanitation’ or ‘poverty and public health’. It was also important to cover epidemiological research. Ethical issues were raised when research was conducted which was non-therapeutic on an individual basis but would offer benefit to the population as a whole.

12 The drafting describing forms of healthcare-related research would be significantly revised in light of the discussions over the previous two days. Much of the debate about current research had been driven by consideration of perinatal HIV transmission trials and the debate arising out of the Marcia Angell editorials needed to be included. The purpose of this chapter was to provide a flavour of the heterogeneity with which research was conducted and health care was delivered.

13 It was important to consider the notion of global health and the question of the emerging and re-emerging diseases which were no longer specific to developing countries. In addition, genomics would accelerate the process of developing new drugs and interventions.

14 New sections had been added to the chapter on ethical guidance and regulation. They covered areas such as the revisions of the Declaration of Helsinki, the use of human tissue and data banks, and genomics. This chapter would be substantially redrafted before the December meeting, so that it would move from being code led to issue-led. The application of the guidance to new areas of research such as genomic research would be considered, as would gaps in the current codes. It would be useful to consider which declarations and conventions were applicable to specific fields of research such as epidemiological research. A number of relevant codes were currently under revision. As national guidance was received by the Secretariat this would be forwarded to the authors of the chapter and incorporated.

15 It was discussed whether the section on the regulatory framework should come earlier in the report, so that a critical analysis of the current codes could provide a reason for why this Working Party had been set up and outline any gaps to be considered in further detail. An alternative would be to summarise the issues raised in this chapter in the introduction to the report.

16 Much of the material in the fact-finding meeting yesterday was very useful for the drafting on the ethical review of research and would be incorporated by the authors of the chapter. An in-depth discussion on consent forms could be included either in the chapter on social and ethical issues, the chapter on ethical regulation or in this chapter. A number of issues had been raised with regard to funding ethics committees that would be important to consider in this drafting. One obvious problem was that in many developing countries there would be no central pool available for levies on the review of research to be paid into.

17 Yesterday the question of how to make ethics committees efficient was considered. There was some discussion in previous Working Party meetings about whether scientific review committees and ethical review committees should be separated. Some forms of guidance contained a checklist for ethical review and it was discussed whether the report should go into that amount of detail. Different forms of research might require different checklists, for example, social sciences research, biological research and epidemiological research all raised slightly different issues. Researchers might find it useful to have checklists as an annex to the report.

18 Gaps in the current draft of the report were considered and it was important for the report to cover the spectrum of research ranging from that conducted on healthy volunteers through to interventional research. The ethics of not doing research should be discussed as well as the extent to which it was necessary to duplicate research.

19 It was important to discuss whether developing countries had more than the ability to veto research, for example, how could they be involved in the design of the research protocol or even in setting research priorities for a specific region?

20 It would be important to consider the need for long-term monitoring of research participants. At present there was virtually no long term follow-up (more than ten years) of research anywhere in the world. In the UK there was a mechanism for serious incidents to be flagged some years after research had been completed, but this mechanism was not available in many developing countries. One example of research which had caused delayed morbidity was the high dose measles vaccine which caused death in children some time after research. Such deaths were picked up as part of demographic surveillance.

21 Specific issues were raised by the uptake of HIV testing. This was a complex area: when a pregnant woman was tested, researchers had herself, her husband and her child to think of. Issues also arose when drugs were used during pregnancy, in some cultures the father or mother-in-law of a pregnant woman would make decisions about her testing and treatment. Issues also arose about operational research, for example, HIV implementation projects raised important issues about breast feeding. In some situations artificial breast milk was provided free of charge. It was not helpful to tell mothers that it was not appropriate to breast feed their children if there was no alternative available. Further issues were raised when there was not sufficient clean water to mix with the breast milk powder, or where women did not give their babies adequate nutrition because they wanted a packet of breast milk to last longer.

22 Important issues were also raised by health service research. In the area of malaria there were various issues raised by multiple-drug-resistant malaria and the use of ineffective drugs to treat those affected. There was no system to monitor this practice and this issue would be discussed in the chapter on healthcare economics. Similar issues arose with the treatment of multiple-drug-resistant sexually transmitted diseases. If drugs were being deployed in practice their efficacy needed to be assessed and monitored. This issue was related to the question of the ethics of not doing research and the ethics of not publishing the results of research.

23 The redrafted chapters were due back in the Secretariat in the week beginning 23 October 2000. This would allow the Secretariat two weeks for editing the draft report before it was circulated prior to the December meeting.

KEY ETHICAL ISSUES

24 Many of the issues raised in paper HRRDC (00) 15 were discussed during previous conversations about the draft report.

PUBLIC CONSULTATION

25 The public consultation document had been widely distributed and the consultation would close on 30 November. Working Party members were requested to continue circulating the public consultation to interested parties. The Secretariat would collate public consultation responses and highlight those responses of particular relevance to individual chapters.

FACT-FINDING MEETINGS

26 It was agreed that it was important for the Working Party to consult with US representatives. It would be useful if the whole Working Party could be present at such a meeting. The Chairman and Director would be at a meeting with American representatives over the next two days and would discuss the possibility of a fact-finding meeting with them.

Last Updated Wed, 17 August 2005