Informed Consent on Trial

BRUSSELS- Informing clinical-trial participants of the risks they face is a cornerstone of modern medical research, and it is enshrined as a human right in international codes of ethics. But an influential group of ethicists and medical researchers warned at a meeting in Brussels last week that the process has become a box-ticking exercise focused more on offering legal protection to a trial’s organizer than actually protecting patients.

“We clearly identified there is an urgent need to do informed consent better,” says Ingrid Klingmann, chairman of the European Forum for Good Clinical Practice, a think tank based in Brussels and the organizer of the meeting. “The pressure is really huge on all those involved to better enable patients to understand the implications of their study participation, their benefits, risks and obligations.”

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. Yet delegates at the meeting detailed a host of ways in...