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Dianne Gove attends forum for good clinical practice

Wednesday 25 January 2012

On 24-25 January, Dianne Gove (Information Officer, Alzheimer Europe) attended the Annual Conference of the European Forum for Good Clinical Practice (EFGCP) entitled “Informed consent – How less could be more: effecting a paradigm shift so we do inform participants.”

A recurring theme at the conference was the inappropriateness and inadequacy of the informed consent procedure for research. Delegates clearly felt that this procedure responded more to the needs of lawyers than research participants. The need to consider informed consent as a process rather merely a signed document was emphasised.

The conference included a workshop on adopting a risk-based strategy for consent to participation in clinical trials of new drugs. Participants settled on the following priorities for such a document:

  • organise the information into different levels of detail, giving participants the freedom to choose how much information they want
  • ensuring that they have a copy for future reference
  • structuring the information in such as way as to ensure that people easily find the exact information they need.

The participants also agreed that informed consent documentation should not be unnecessarily long; current participant information sheets can be up to 30 pages long.

Another conference issue which provoked lively debate was that of consent to research in emergency situations when the patient is unable to give consent or is unconscious.