Minutes of the meeting held on 7 June 2000
Wed, 17 August 2005
3rd Meeting
NUFFIELD COUNCIL ON BIOETHICS
WORKING PARTY ON HEALTHCARE-RELATED RESEARCH IN DEVELOPING COUNTRIES
Minutes of the Meeting held at the Nuffield Council on Bioethics 28 Bedford Square London WC1B 3JS on Wednesday 7 June 2000
PRESENT
Professor Sir Kenneth Calman (Chairman)
Fred Binka
Shahwar Sadeque
Michael Elves
Nelson Sewankambo
V I Mathan
Peter Smith
Anne McLaren
Fabio Zicker
Bhiku Parekh
SECRETARIAT
Sandy Thomas, Susan Bull
APOLOGIES
Professor Keith McAdam, Professor David Parkin,
Professor Povl Riis
CHAIRMAN’S INTRODUCTION
1 The Chairman welcomed Dr Fred Binka, Professor Bhiku Parekh and Dr Fabio Zicker to their first Working Party meeting. Discussion about the fact-finding meeting with Professor Dan Wikler from the World Health Organization (WHO) on the previous evening then opened.
MINUTES OF (00) 2nd MEETING
2 Subject to one amendment, the minutes were agreed to be a correct record.
MATTERS ARISING
Fact-finding meeting in Africa
3 It was agreed at the second Working Party meeting (HRRDC (00) 2nd meeting) that a sub-group of the Working Party would go to Africa to meet with researchers in the region. It was agreed that it would also be appropriate to hold such a subgroup meeting in Southern Asia.
WORKING PARTY MEETING IN OXFORD
4 The fourth Working Party meeting, which was originally to be held in October 2000, had been rescheduled to 17-19 September 2000. A fact-finding meeting would be held on 17 September, and 15-20 attendees of the Oxford 2000 conference on New Challenges in Tropical Medicine and Parasitology would be invited to attend.
CHAPTER OUTLINES
Chapter on healthcare-related research: past present and future
5 It was agreed that for this chapter pieces would be commissioned which looked at the history of healthcare-related research and the evolution of research ethics in developing countries. Following the discussion at the last meeting this chapter had been redrafted around two case studies and focused on the issues they raised. Important issues raised included questions about who makes decisions about the appropriate standard of care and how research benefited the country in which it was conducted. It was important to classify the forms of healthcare-related research which could be conducted and to look at the distinctive ethical issues raised by each. Questions arose following attempts to make regulation which was universally applicable to all forms of research. It was important to analyse two components of research: the motivation for it and the legacy left behind.
Chapter on healthcare economics and access to resources
6 It would be useful to begin incorporating data in this chapter, such as average life expectancy in various countries and the costs of bringing drugs to the market. Questions arose if the intervention being tested was unlikely ever to be affordable in the country in which it was being tested. It was important to look at variation between and within developing and developed countries.
Chapter on social and cultural issues
7 The importance of local research ethics review was discussed and it was noted that some countries did not have developed systems of medical ethics. Some consideration needed to be given to the boundary between care and research. A general issue was the healer-client relationship which varied over time and geographically. This relationship affected other matters such as informed consent. Some developing countries were moving towards the concept of individual informed consent. The perception of informed consent was also changing in developed countries. Issues were raised when consent was sought for tissue collection, as some of the research might be on samples stored for many years. Would researchers be obliged to go back to the ethics committee in the developing country to request consent to the research?
Chapter on ethical issues
8 Issues discussed in this chapter included:
• The costs of conducting trials in developing countries
• The need to monitor published research if research was to be conducted responsibly
• Informed consent
• The personal ethics of scientists
• Publication ethics
• The relevance of projects to developing countries
• Capacity building.
Chapter on ethical guidance and regulation
9 A discussion of the guidance from the Council of Europe would be included in this chapter. International guidance currently under revision, such as the Declaration of Helsinki and CIOMS guidance would be monitored and incorporated. National guidance had been requested from a number of developing and developed countries and this would be included where relevant. This chapter would be redrafted to become 'issue-led' as examples of national and international guidance were received.
Chapter on ethical review of research protocols
10 This chapter would focus on three topics: the need for ethical review, varied templates for ethical review, and who would have the final decision. Who should judge the efficacy of ethics committees? It was important to discuss the structure and function of committees - different types of committees might be relevant to different countries. Questions were raised about the role of the committee once the research had been approved. When research ethics committees did not function well, this was not just a question of training, but also of resources. Would accepting fees for review compromise the independence of the committee? If ethics committees charged for review, such charges might be affordable for institutions but not individuals. Issues arose when there was a conflict between the ethical review undertaken by the funding body and that undertaken by the local ethical review committee.
11 The Chairman thanked the Working Party for redrafting their chapters. The Working Party were asked to develop their chapters further along the lines discussed at the meeting.The redrafted chapters would be due at the Secretariat at the beginning of August. The Secretariat would bring the chapters together before the September meeting to form the first draft of the report.
PUBLIC CONSULTATION
12 Working Party members were asked to provide specific feedback on the consultation document to the Secretariat within the next two weeks. The consultation would be launched in June. As consultation responses were received, these would be forwarded to Working Party members in batches, with a summary.
FACT-FINDING MEETINGS
13 Working Party members were requested to return the pro-formas to the Secretariat indicating which fact-finding meetings they would be interested in attending. If Working Party members wished to suggest any other names they were asked to let the Secretariat know directly.
ANY OTHER BUSINESS
14 There was no other business.
Last Updated Wed, 17 August 2005