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4 The minutes of the 4th meeting were approved. There was one correction.

5 There was a great deal of information in the minutes and notes of the fact-finding meetings which could be easily incorporated into the chapters to strengthen them.

POSSIBLE CONCLUSIONS AND RECOMMENDATIONS

6 A list of possible conclusions and recommendations was tabled and it was agreed that it would be useful to consider these, and reach preliminary agreement on the conclusions the Working Party might draw, before turning to the individual chapters.

7 It would be necessary to define what was meant by ‘relevant’ research. If an intervention could never be afforded, was it relevant? This issue could be first mentioned in the introduction to the Report and would then be taken up in later chapters. It was important to distinguish between the question of what was locally relevant and the larger issue of what should happen after research is over.

8 Another important issue was whether or not the research was exploitative. A contrast could be drawn between research which was being conducted in a certain community for a scientific reason, such as a specific genetic propensity to a disease, and research which was being conducted in an area, simply because it was cheaper and some healthcare infrastructure already existed.

9 Forms of basic research, which involved taking a large number of samples over a period of time, often needed to be conducted all over the world. This could be contrasted to the potentially exploitative situation that could occur in clinical trials. When research ethics committees considered research being proposed in developing countries they had to take a number of issues into account, such as the possibility that the results of research may create a pressure on healthcare providers to implement a particular treatment.

10 In addition to research about the efficacy of an intervention, it was also necessary to conduct research into implementation, and this would cover issues such as compliance with treatment regimes. Such research needed to be conducted in the country in which the treatment was to be implemented.

11 Who should set the priorities within a developing country? Once an agenda had been set, external funding could be sought, rather than countries simply considering protocols proposed by pharmaceutical companies or external funders. It was important for developing countries and sponsors to meet on equal terms. It would be useful for the Working Party to consider the influence and agendas of funding agencies.

12 Different approaches could be taken to standards of care. It could be required that standards of care were:
a) The best locally available;
b) The best available in the world, with anything less than this being specifically justified;
c) What was locally available (with the assumption that those conducting research would improve the standard of care and local healthcare more generally).

13 The revised Declaration of Helsinki recognised the need to take economic and medical disadvantages into account. There were some conventions which were specific and went beyond this, being more in line with the position taken in (a) or (c) above, with the intention to eventually achieve (b).

14 There was some question of whether the concept of ‘standard of care’ should be expanded to include the infrastructure required to deliver that care. Standards of care could be defined in two ways:
1. The therapeutic component;
2. The infrastructure required to deliver that care including the ability to diagnose, define and follow-up participants.

15 The revised Helsinki Declaration stated that the use of placebo was acceptable if no treatment existed. What if a treatment was available in a country but not the region being studied simply because it was difficult for the remote region to have access to the intervention? Many drugs in countries’ national formularies were not available in remote communities. What obligations were there on researchers to make such treatments available locally?

16 It was important to consider what the research question was. If the question was whether the novel intervention was better than what was already available, then the novel intervention would need to be compared accordingly.

17 It was important for the Working Party to consider situations where someone may consent on behalf of an individual who was competent to consent on his or her own behalf: such as a husband consenting on behalf of his wife. Consent was predicated on the need to show respect for persons and was therefore crucial in research.

18 It was important to look at the intention behind the consent form, was it to protect participants or researchers? It might be difficult to unravel those two aspects, although long and legalistic forms were arguably primarily intended to protect researchers.

19 In the drafting on what happens after research is over there would need to be some recognition for the need for negotiation about what happened after research before the research was conducted. If nothing was to remain after the research had been conducted, would this be acceptable? Many countries would wish to implement the results of research but would not have the resources to do so.

20 Often there were levels of review of research which would not be conducted by an ethics committee but would still have a strong ethical component. In many developing countries, the only committee reviewing research was an ethics committee, there would be no scientific committee. A number of countries had joint scientific/ethical committees.

SECOND DRAFT OF THE REPORT

The majority of chapters had been substantially redrafted and would now be amended to include discussed conclusions and recommendations.

FACT-FINDING MEETINGS