First study on legal status of consent forms for research

Posted by hct16 at Dec 19, 2012 03:55 PM |
Researchers at the universities of Leicester and Edinburgh have conducted the first study on the legal status of research consent forms.
First study on legal status of consent forms for research

Professor Mary Dixon-Woods

A new study finds that consent forms for research have a valuable role, but on their own cannot fully protect all of the rights of research participants,

Part of a Wellcome Trust project to examine views of participants in long-term research that may be conducted over many decades, the study shows that research participants now enjoy stronger rights than ever before when they take part in research. While it identifies the key role of the consent process in securing those rights, it also points out the dangers of excessive focus on up-front, one-off signatures on consent forms.

“There can be little doubt that consent, and the signed forms that document it, now occupy talismanic status in a research culture,” said Graeme Laurie, Professor of Jurisprudence at University of Edinburgh, who led the research.  “But there is a real danger that we are beginning to drift towards valuing form over function. Signing the consent form is just one moment in a long term relationship of equals. The consent form should be seen as a starting point to capture participant expectations, not the end.”

The study recognises the importance of the law’s involvement in research. But it warns of the dangers of too legalistic an approach to the research relationship, instead emphasising the need for mutual trust and respect.

“Researchers need to make sure partnership is a reality for research participants”  said Professor Mary Dixon-Woods from our Department of Health Sciences.  “That means providing better and clearer communication throughout the life of a project, including changes to research design.”