en

Scientists from North and South grapple with informed consent in Brussels

Finding consensus is the way forward, a collection of scientists and ethicists from developing and developed countries agreed, following discussions on the complex issues of

Finding consensus is the way forward, a collection of scientists and ethicists from developing and developed countries agreed, following discussions on the complex issues of informed consent and double standards in science at a conference on ethics, research and globalisation on 14 May.

All conference delegates agreed that using clinical trials to gain knowledge without taking care of the trial participants would be unethical. But speakers had different views on how to ensure that research is strictly ethical, and how to judge when the correct standards have been met.

A 2003 opinion from the European Group on Ethics in Science and New Technologies stated that the ethical rules applied to clinical trials in industrial countries should also be used for clinical trials elsewhere (although there was no consensus on the use of a placebo).

In practice, the environment in which trials are conducted means that processes from northern countries cannot simply be transferred to southern countries, and informed consent guaranteed. Two major problems with this approach are levels of education, and the alternative to participating in research.

In many cases, asking a potential participant to read through a consent form and then sign is not practical, and not sufficient. Communicating what the research is about may require visual aids, and must always be explained by an independent third party who understands local values. On the other hand, using field workers to explain the research and collect signatures introduces new problems – field workers will inevitably be working towards a promotion, and may assume that collecting the highest number of signatures possible is the best way to do this. Ad hoc checks are one way of ensuring that field workers are doing their job properly.

A to już wiesz?  Co to są "infekcje oportunistyczne"?

Even if the research can be explained to potential participants in a fully comprehensible way, potential participants are not necessarily free to make an objective decision on whether or not to take part, as several speakers at the Brussels conference emphasised. Even if researchers are not consciously seeking to gain consent with the use of incentives, the alternative to participating in a trial – missing out on healthcare – is an indirect incentive, and removes the freedom of choice.

‘What would we do in Brussels if access to hospitals depended on your consent for participation in research?’ asked Jean-Claude Ameisen from the French National Consultative Committee on Ethics and INSERM, the National Institute for Health and Medical Research.

His solution to the incentive question in developing countries is to only carry out clinical trials in those places where the minimal standard of healthcare is already provided. ‘Countries should know that the first priority is to provide care, the second priority is to further knowledge,’ he said.

Clement Adebamowo, Director of the West African Centre of Ethics, pointed to a further problem with gaining informed consent. His experience suggests that many people in Africa prefer a communitarian approach, rather having the autonomy to decide for themselves whether or not to participate in research. He believes that this preference has been shaped by historical and cultural circumstances, but said that more research is needed in order to understand it.

In response to questions on double standards, speakers suggested that while they do exist, they not only create a division between Europe and Africa, but within Europe and within Africa.

A to już wiesz?  Forscher finden molekularen Zusammenhang zwischen Virusinfektion und Krebsanfälligkeit

In Europe there is a unified informed consent procedure, but it is not necessarily appropriate for all. Europe also has people with low levels of education, as well as many migrants. European consent forms were also criticised for serving hospital legal departments before patients.

John Williams of the World Medical Association closed his presentation with a concise synopsis of exactly why finding a consensus on research ethics is problematic. Different stakeholders are driven by disparate views and interests, but the division exists not only between industry and societal groups. Even those that develop guidelines are sometimes unable to agree – some are simply more principled, while others are more pragmatic.

While difficult to obtain, consensus must nonetheless be the way forward, conference participants agreed.

There is a role for the European Commission to play in opposing double standards and supporting consensus-building efforts, said Mr Williams. The support could take the form of funding fora for stakeholders to come together in an attempt to find a consensus. The Commission could also identify and publicise best practices, Mr Williams suggested.

The recommendations coming out of the conference will of course be presented to the European Commission. DG Research will then identify capacity-building actions aimed at remedying specific problems and responding to needs in partner countries.

Such actions will be financed under the ‘Science in Society’ programme of the Seventh Framework Programme (FP7), which has a budget of €330 million for 2007 until 2013.

Category: Miscellaneous
Data Source Provider: CORDIS News attendance at ‘Ethics, Research and Globalisation’ conference
Document Reference: Based on CORDIS News attendance at ‘Ethics, Research and Globalisation’ conference
Subject Index: Scientific Research; Social Aspects

A to już wiesz?  Potocnik destaca el papel crucial de la ciencia en la lucha contra el SIDA

RCN: 27677

http://cordis.europa.eu/fetch?CALLER=EN_NEWS&ACTION=D&DOC=38&CAT=NEWS&QUERY=0123f1cfd725:aaa8:247d0338&RCN=27677

Artykuly o tym samym temacie, podobne tematy