Nuffield Council on Bioethics / Home

PRESENT
Professor Sir Kenneth Calman (Chairman)
Fred Binka,
David Parkin
V I Mathan
Catherine Peckham
Keith McAdam
Povl Riis
Anne McLaren
Peter Smith

SECRETARIAT
Sandy Thomas, Susan Bull, Tor Lezemore

APOLOGIES
Michael Elves, Bhikhu Parekh, Shahwar Sadeque,
Nelson Sewankambo, Fabio Zicker

CHAIRMAN’S INTRODUCTION

1 The Working Party agreed that the previous evening's discussions about Council's comments on the third draft of the Report (HRRDC (01) 02) and the fact-finding meeting in Chennai (HRRDCInfo (01) 01) had been very useful. The Chairman thanked Professor Mathan for organising the fact-finding meeting.

2 It was important to set out in the introduction what would not be covered in the Report: for example, issues about intellectual property rights were important, but not a primary focus. In addition to questions about DNA banks and tissue banks, there were concerns about biobanks, such as those in Iceland. It was agreed that discussions about tissue banks and biobanks be the subject of a separate inquiry. The focus of the report was on externally sponsored research in developing countries. The adjacent area of health inequalities within countries would be noted, but not covered in the Report.

3 Members of the Working Party from developing countries noted that the term 'developing countries' was acceptable to them, and was useful because it was widely used and widely understood.

4 At present there were six primary areas in which the Working Party were likely to reach conclusions and recommendations:
(1) who sets the research agenda (and how)
(2) standards of care
(3) consent
(4) committees
(5) what happens after research
(6) regulation

5 Before a research agenda could be set there needed to be an assessment of the health needs of a country. In practice, there were three main ways that research priorities could be set:
(1) by a healthcare worker on the ground who had a particular problem to solve and identified researchers to assist.
(2) academia and the pharmaceutical industry who wanted to conduct research, which was cost effective in a specific country. In such circumstances collaboration with partners in developing countries was actively sought.
(3) Government agencies in developed and developing countries had important agendas and attempted to build capacity in a certain field.

6 It could be concluded that all three of the forms of research priority above were acceptable, as long as they did not involve exploitation. Was research on healthcare issues which were not a priority in a country ever acceptable? Who decided which research should be conducted in a country? Would the requirement that research be relevant to the health needs of a country be imposing a standard which developed countries could not meet?

7 Many of the issues that the Working Party was considering under the heading of 'Who sets the agenda?' were also relevant to 'What happens after research is over?' One problem was that after a trial there was a long process of negotiation about the provision of interventions and it was unrealistic to expect discussions of these issues to be completed before a trial started.

8 What should be provided for the trial population after research? The question of who paid for treatment after research was over was different in the UK and developing countries because treatment was provided by the NHS in the UK. What if an intervention proved to be extremely effective and a country could not afford it? There was a difference between providing a ‘one-off’ treatment to cure a disease and providing on-going treatment. Examples of conditions that required ongoing treatment were hypertension, type II diabetes, arthritis and HIV. If there was a duty on a company to continue to provide an anti-hypertensive drug for 40 years, what would happen if the company became bankrupt, or merged with another company? If there was a diagnostic test developed for a disease which was common in developing countries, which had very limited use in the developed world, to whom should this test be made available, at what cost, and for how long?

9 The Working Party might wish to consider the value of the gold standard randomised clinical trial. Qualitative research was also important. In early chemotherapy trials, phase I and II trials had no control, but phase III trials did. An alternative would be an uncontrolled phase III trial, using a comparator such as medical records. The Working Party would have to consider how much they would want to discuss issues of trial design. The NBAC Report had devoted a chapter to this topic. There was a great deal of literature on the appropriate design of trials.

10 One difficulty with requiring that a third party witness verbal consent was finding and paying a literate person to act as a third party. With some vaccine trials, research was being carried out in 14 different areas, which would require a number of witnesses.

11 Drafting on ethical guidance and regulation would be considered at the next Working Party meeting.

12 It would be important for the Working Party to consider the question of costs of running ethics committees. Should committees charge for reviewing proposals? Who should pay the costs of running a committee and training members?

THIRD DRAFT OF THE REPORT

13 The Working Party agreed to revise the structure of the report.

The process of revision

14 The Secretariat would edit the Report for two weeks, moving the text as agreed. Comments from Council, the minutes of previous meetings, and the public consultation would be incorporated. The references would be standardised. The Report would be sent to the Working Party on 16 February and would need to be returned to the Secretariat by 16 March for circulation prior to the next meeting.

FACT-FINDING MEETINGS

15 The fact-finding meeting in Chennai had been extremely useful and the Chairman thanked Professor Mathan again for organising this.

16 It was agreed that the Working Party would hold meetings over two days in the US. Meetings would be held in Boston on 22 March and in Washington on 23 March. Working Party members would meet with individuals and small groups during the two days.

17 As the Working Party were unable to hold a fact-finding meeting in Lusaka, an alternative meeting with malaria researchers in Harare was proposed. Suggested dates for the fact-finding meeting were 11-12 March or 16-17 March.

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