Informed Consent on Trial
By Daniel Cressey,
Nature News
| 01. 30. 2012
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...
Related Articles
By Annika Inampudi, Science | 08.01.2025
In June, Sara* received a message asking whether she wanted to continue to participate in a massive, multicenter research project led by scientists at Aarhus University in Denmark. The iPsych study, the message said, had sequenced her genetic data from...
The Center for Genetics and Society is delighted to recommend the current edition of GMWatch Review – Number 589. UK-based GMWatch, a long-standing ally, was founded in 1998 by Jonathan Matthews as an independent organization seeking to counter the enormous corporate political power and propaganda of the GMO industry and its supporters. Matthews and Claire Robinson are its directors and managing editors.
CGS works to ensure that social justice, equity, human rights, and democratic governance are front...
By Harry Hunter, PET BioNews | 08.11.2025
The Parliamentary Office of Science and Technology has announced plans to publish a POSTnote and called for submissions on surrogacy law in the UK and internationally.
The current UK surrogacy laws, largely based on legislation from the 1980s, have been...
By Molly Gray, Nuffield Council on Bioethics | 08.13.2025
Human embryo at about 8 weeks
by Anatomist90, CC3.0
With debate growing around whether the “14-day rule” on human embryo research remains fit for purpose, the need for inclusive public dialogue is more important than ever. Decisions about whether...