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Phasing Out Voluntary Donation in Clinical Trials: The Ethics of Mandating Biospecimen Collection

Vasiliki Rahimzadeh

Biomarker studies are one of the primary research vehicles for gathering necessary genotypic evidence in the search for genetic etiologies of disease. Until recently, samples used for biomarker studies were almost exclusively collected from participants donating to bio-banks or dedicated genome-wide association studies. Based on observations while serving on a research ethics board in Canada, it has become commonplace for clinical trial sponsors to mandate that participants provide tissue and other DNA samples as a condition for their participation in the trial. This viewpoint argues that imposing such a condition runs counter to the premise of voluntariness upon which bio-bank donation specifically, and biomedical research generally has historically rested. Public apprehension regarding data protection and fear of genetic discrimination can accentuate the ethical dubiousness of mandating bio-specimen collection.