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Ethics and research

Leading researchers debate the latest challenges

The second day of the 11th Egozcue Lectures was dedicated to the subject of ethics in research. Such activity aims to improve human health, and the participants in any study are a means to achieving this goal. However, if people are used to this end and no significant benefits are obtained, then the result is exploitation. The role of ethics is to minimize such risks.

 

According to Ezekiel Emanuel, Chair of Medical Ethics at the University of Pennsylvania, ethics in research needs to be given far higher priority, instead of its current limited role, and it needs to be more rigorous. Ethics committees have many guidelines to help them analyze whether research is ethical – the Nuremberg Code, the Helsinki Declaration, the Belmont Report, CIOs, Common Rule, etc. – but these agreements are often contradictory and, having been created to address specific situations, frequently lack a general perspective.

 

Ezekiel Emanuel's team has worked over recent years to develop a series of ethical principles that should be considered before undertaking any research procedure: studies should contribute value to society; their results should have significant scientific value; the fair selection of trial participants is essential; the risk–benefit ratio must clearly favour the benefits; the informed consent of patients is essential; and participants must be respected. Emanuel argues that only if all of these principles are satisfied should the research go ahead.

 

The most important principle is the one that refers to the risk–benefit ratio. He argues that it is essential not to base the risk analysis for any study on intuition, and that it should instead be subject to systematic evaluation. To achieve this, he proposes a detailed data analysis from which to extract risk–benefit conclusions for any research project. To analyze these variables, the group has established a set of guidelines which stipulate that an investigation project with minimum risks is one in which the difficulty or harm it may pose for participants is no greater than what might be encountered in daily living. Risk is a part of daily life (domestic accidents, traffic accidents, sporting injuries etc.). This statistical analysis should then be used to determine the percentage of daily risk in the specific environment, and to compare it with the objective risks of the research. If the risk this entails is equal to or lower than the minimum daily risk of the environment in which the study is to be performed, the research can be conducted; otherwise, it should be ruled out.

 

Biomedical research in Spain

 

The final event was a penal discussion with leading researchers Manel Esteller (researcher at Bellvitge Institute of Biomedical Research), Bonaventura Clotet (director of IrsiCaixa), Mercè Boada (medical director at Fundació Ace) and Joan MV Pons (scientific coordinator at Aquas health evaluation and quality agency). They all agreed on the importance of research as a generator of knowledge, wealth and health. In general, the outlook is positive, with Spain boasting plenty of world-class research talent. However, researchers emphasize the need for public bodies to back research and not to reduce budgets in the face of crises such as that seen in recent years. They also argue for continued support for projects such as ICREA, which attracts talent from across the globe but in recent years has suffered budget cuts.

 

Participants in the panel discussion advocated the need to promote a culture of research, which should start by teaching people about the benefits of such activity for the territory where it is located. We also need to promote fundraising at the individual and corporate level, explaining the economic benefits that may derive from the research. These practices are commonplace in some countries, but there is little tradition of them in Spain. Finally, researchers noted the need to take a more balanced approach to the issue of publication, as recent years have seen the withdrawal of numerous publications as a result of failure to satisfy scientific research standards. It is important to find other ways of recognizing the work of doctors and scientists, ensuring that such recognition does not take the exclusive form of the number of publications in prestigious journals and mentions in the literature.

 

 

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