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Not So 'Informed'

A group of ethicists and medical researchers says informed consent has become more about protecting the researcher than protecting the patient, reports Nature News' Daniel Cressey. At the European Forum for Good Clinical Practice conference in Brussels last week, a Belgian think tank warned that the process of informed consent has become an exercise in legal obligation rather than an effort to help trial participants understand the risks and benefits of participation. "The European Clinical Trials Directive, which sets minimum standards for clinical trials conducted in the European Union's member states, says that trial participants must be duly informed of the 'nature, significance, implications and risks' of the clinical trial," Cressey says. "Yet delegates at the meeting detailed a host of ways in which the system fails to meet those criteria." For example, he adds, the median length of consent forms tripled between 1995 and 2009, but language explaining issues like possible side effects are "often vague, and jumble potentially serious problems among minor concerns."

One solution, Cressey says, is to include a short summary of pertinent information before the more detailed information on a consent form. Another possibility is the use of a digital consent form wherein participants are interactively led through the salient points.

This problem, he adds, is worldwide. "The US Department of Health and Human Services is currently consulting about revising clinical-trial regulations, and looks likely to demand shorter, more understandable consent forms, although there is no specific deadline for a decision," Cressey says. Whatever the solution, experts says researchers should shoulder some of the responsibility to help improve the system.

The Scan

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From FDA to Venture Capital

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Consent Questions

Nature News writes that there are questions whether informed consent was obtained for some submissions to a database of Y-chromosome profiles.

Cell Studies on Multimodal Single-Cell Analysis, Coronaviruses in Bats, Urban Microbiomes

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