Page 91 - ASHG 2013 Program Guide

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Wednesday, October 23
Concurrent Invited Session I (3-9)
SESSION 5 – Does the Increasingly Blurry Distinction
between Research and Clinical Care Create an
Obligation to Actively Search for Secondary Findings
in Genomic Research or Otherwise Change the
Relationship between Researchers and Participants?
Grand Ballroom East, Level 3, Convention Center
Benjamin E. Berkman, NHGRI/NIH;
Stacy Gray, Dana Farber Cancer Inst.
The rise of next-gen sequencing has raised questions
about how best to negotiate the management of
large quantities of uncertain human DNA sequence
information in ways that reconcile the demands and
expectations of researchers, clinicians, regulators and
patients/participants. Particularly acute is the debate
about what responsibilities, if any, researchers have
to disclose secondary findings. Assuming there is
some obligation to disclose certain incidental findings
that are inadvertently discovered in the course of
research, is there a positive obligation to search for
these findings? And if so does this obligation extend
beyond identifying risks for “actionable” severe or
life-threatening diseases? The standard view has been
that researchers are not obligated to fulfill a clinical
role of actively searching for incidental findings, but
this assumption seems to be relatively unexamined.
An argument for a duty to look finds support in the
fact that genomic researchers are often in a unique
position to help their participants through application
of the knowledge, abilities and resources they hold
as scientists and/or physicians. On the other hand,
with finite resources and legal constraints, there
is often a tension between the research agenda
and provision of ancillary care to participants. The
duty to look” question is arguably synecdochic:
given the potential of whole-genome/whole-exome
sequencing to uncover clinically relevant variants, is
the research-clinical distinction still viable in a human
genomic context? And should the heterogeneous
wishes of research participants and patients be
taken into consideration? This session will explore
both the narrow issue of whether there is a duty to
look for secondary genomic findings as well as the
broader questions of how large-scale sequencing
results should be governed, the a priori obligations
researchers have (and don’t have) to participants,
and the epistemology of research versus medicine
in a genomic age that is both blurrier and more
Why researchers do not have a duty to
look for incidental findings.
E. W. Clayton. Vanderbilt
Law Sch.
Appropriately - but narrowly - defining
a researcher’s obligations to look for incidental
J. P. Evans. Univ. of North Carolina at
Chapel Hill.
Neither duty nor prohibition: Using
private ordering to transcend ‘one-size-fits-all’
in large-scale sequencing of human beings.
M. N. Meyer. Harvard Law Sch.
What we’ve got here is failure to
communicate: The growing disconnect between
th-century research protections and individual
agency in an age of whole-genome sequencing.
M. Angrist. Duke Inst. for Genome Sciences & Policy.