Toward The Ethical Treatment Of Whole Genome Research Participants

Recent technological developments have made it possible for scientists to sequence an entire human genome, but these advances may be a mixed blessing.
While much has been made of the benefits of whole-genome sequencing, from improved disease diagnosis to rational drug design, the impacts on the
privacy and autonomy of individual participants has received much less scrutiny. In a new essay published in the open-access journal PLoS Biology,
Timothy Caulfield and his colleagues argue that the ability to sequence a person’s entire genome has created a whole new set of moral challenges
that standard research ethics guidelines were not designed to solve.

Several aspects of whole-genome sequencing challenge existing research ethics norms. Some of the most pressing ethical issues arising from whole
genome research include the vast amount of data produced, the uncertainly regarding future research uses of the data, implications of the data for
family members, and the technological ability (and expectations) to publicly release the data. To date, very little effort has been put into providing
new ethical standards to address these unique challenges.

With an eye toward remedying this oversight, Caulfield et al. offer a consensus statement aimed at providing “ethically rigorous and practical
guidance for investigators and research ethics boards.” The consensus statement, a product of a workshop involving an interdisciplinary panel of
eminent bioethicists, lawyers, and researchers, tackles the central issues facing whole-genome research: informed consent, the right to withdraw from
research, the return of results, and the public release of data. In each case, the authors argue, the public dissemination of collected data presents
challenges to the standard methods researchers use to protect participants’ privacy and autonomy. In whole-genome research, participants quickly
lose control over access to their personal information, and they run the risk of “genetic profiling.” Protecting participants in whole genome
research studies requires updating informed consent to include information about future use, the limited ability to withdraw information, disclosure
of research results, and the potentially wide distribution of personal data.

Central to Caulfield et al.’s recommendations is the use of “robust governance and oversight mechanisms.” Review boards must play a much larger
role in genomic research than it has in other areas, the authors argue, “in part because the unique challenges associated with the research make it
impractical to satisfy the norms, tools, and processes usually utilized to respect autonomy.” Even if controversial events are rare, responding to
these concerns is essential, they maintain, because “history has told us that they do occur and can have a devastating impact on public trust and
the research environment.”

Fully acknowledging that many related policy issues also warrant attention-including commercialization and patenting, for example-Caulfield et al.
urge immediate action on whole genome research ethics guidance, while the ethical, legal, and social implications of this rapidly evolving field
continue.

Research ethics recommendations for whole-genome research: Consensus statement.
Caulfield T, McGuire AL, Cho M, Buchanan JA, Burgess MM, et al. (2008)
PLoS Biol 6(3): e73. doi:10.1371/journal.pbio.0060073
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