Your Biobank, Your Doctor?: The right to full disclosure of population biobank findings

Abstract

The advent of personal genomics companies offering direct translation of scientific data into personal health information, calls into question traditional policies to refuse disclosure of such scientific data to research participants. This seems especially true for population biobanks, as they collect not only genotype information but also associated phenotype information, and thus may be in a unique position to translate their scientific findings into personal health information for their participants. Disclosure of such information seems mandated by the expectations raised by biobanks ('to help bring about the era of personalized medicine') and their participants' rights to know health information, to know clinical research results, to life and health and particularly their right to benefit. Refusals to disclose such information can be grounded in the lack of analytical validity and/or clinical utility of most findings, the need to avoid the therapeutic misconception, the complexity and costs involved in translation and disclosure and the disproportionate burden resulting from the obligation to respect participants' right not to know before any disclosure can be made. Currently, any demands by participants in population biobanks for full disclosure of all pertinent personal health information potentially resulting from the biobank's scientific findings are unlikely to be granted by a Dutch court under Dutch and international law. As the law stands now, a population biobank is neither a doctor nor a personal genomics company. However, in view of the rapid scientific, medical, technological, commercial and social developments, population biobanks must prepare to take more care of their participants' legitimate interest in receiving as much validated personal health information as reasonably possible, in a timely fashion, by developing appropriate translation and disclosure mechanisms. This paper examines whether population biobank participants have the right, under Dutch civil law and international law, to full disclosure, i.e. to all information generated by the biobank that is pertinent to their present and future health. It pioneers the format of a hypothetical court case to elucidate the legal and policy arguments" for and against full disclosure.