Ethical committee members have different views on how to evaluate clinical trials

Members of ethical committees, which decide whether or not to grant approval for phase two clinical trials, infrequently use systematic methods when weighing up the risks and benefits of a study, according to research published today (Thursday 1 August) in the Annals of Oncology, the journal of the European Society for Medical Oncology.*

A team of researchers from The Netherlands report that members of Institutional Review Boards (or ethical committees) use a variety of ways to identify, estimate and evaluate the risks and benefits associated with phase two clinical cancer trials, and their approach often depends on their own professional background.

However, Professor Neil Aaronson, Head of the Division of Psychosocial Research and Epidemiology at The Netherlands Cancer Institute in Amsterdam and senior author of the paper, says this is not necessarily a problem because the ethical committees reach collective decisions on whether or not to grant approval to clinical trials, and the different experiences of the individual members may actually strengthen the decision-making process. "Undoubtedly the whole is more than the sum of its parts," he said.

The study, carried out by Dr Heleen van Luijn of the Institute for Ethics at the Vrije University in Amsterdam, involved interviews with 53 members of Institutional Review Boards (IRBs) from six research hospitals and specialist cancer centres in The Netherlands. The IRB members were asked about their attitudes, beliefs and experiences in evaluating the risk/benefit ratios of phase two clinical trials. In particular, they focused on: how members identified the risks and benefits of trials; how much information they needed to make a risk/benefit assessment and whether such information is usually available in phase two clinical trial protocols; how they perceive their own competence in making risk/benefit assessments; and how they evaluate specific risks and benefits of the trials to participating

Contact: Emma Mason
European Society for Medical Oncology

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