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22nd Nov 2011, 04:55 PM
#1
Pharmacogenetic consent and provision of results
We are aware of differences between countries with regards to a clinical trial subjects rights to obtain information from pharmacogenetic testing results in clinical trials (i.e., that it is permitted, if specifically requested by the subject, in some countries for the sponsor to provide the results of the analysis, but not in others).
I am looking for a list or guidance as to where it is permitted, and what information is required to be provided to a subject in the patient information sheet and consent form with regards to their rights to obtain this information.
If anyone has any specific guidance for the UK, this would be greatly appreciated.
Many thanks in advance for any advice on this matter.
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