Markman advocates a revised informed consent strategy that balances the subject's right to know the results of the study and an individual patient's right to know how the data will specifically impact him or her. This strategy includes pre-study education about the meaning of trial data as statistical probabilities pertaining to general populations rather than a specific individual; the risk that trial data will have no benefit for the individual and may in fact demonstrate poor prognosis; the subjects' choice to receive trial data at the end of the study; and possibility that investigators may decide that trial data is of no relevance to the individual participant and not share the data.

This approach, Dr. Markman argues, "will preserve a research subject's right to be provided study findings, while at the same time responding to an individual's legitimate wish to specifically focus on data which is relevant to his/her future management."

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Contact: David Greenberg
dgreenbe@wiley.com
201-748-6484
John Wiley & Sons, Inc.
27-Feb-2006

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