Informed consent: subjects as research collaborators?

A point of particular interest in the Fisher article concerns the model of informed consent whereby human clinical subjects become collaborators in the clinical research process. According to this model of informed consent, human clinical subjects not only seek information about the potential risks of participation in a clinical trial, but also seek information that is not relevant to such potential risks, such as information concerning the purposes of the trial or the theory behind the subject of the trial. Fisher notes that this model of informed consent may be feasible in clinical studies directed by the actual researchers or investigators of the subjects of the studies, but may prove to be less practicable in drug trials where the directors of the studies are seldom the primary researchers of the drugs being tested (as might be the case in CRO-directed drug trials). The success of this model of informed consent would also be predicated on the actual active participation of clinical subjects in the research process, which might rarely occur in practice. Now, as remarked, Fisher characterizes such a model of informed consent as one wherein human subjects ‘engage actively in the research enterprise’ and become ‘collaborators in the research process’. But such a description seems rather inappropriate and overreaching, given the actual description of this model. If, within this model of informed consent, human clinical subjects are merely seeking out more information concerning clinical trials than that which relates to the potential patient risks of such trials, then such subjects can hardly be said to be actively engaging in the research enterprise of clinical trials or becoming collaborators in the clinical research process. Within this model of informed consent, human subjects would still remain outsiders to the clinical research process, albeit potentially more informed outsiders.

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