Tissue Research Issues
Convener: Eric Kodish
Collaborators: Eric Juengst, Mary Quinn-Griffin,
Chris Winkleman
Under the leadership of Eric Kodish, this research group
conducts empirical research to identify the research ethics challenges
posed by newer approaches to genome-wide analysis in human genetic
research. As a pilot project, the group worked with the ongoing
genome-wide scanning projects at CWRU to assess the adequacy
of current thinking about genetic research with stored human
tissue to accommodate new applications of genome-wide scanning
research and recommend policy options for addressing any deficiencies.
Specific Aims:
1) To learn about the key ethical challenges faced by investigators
pursuing a range of studies that conduct whole genome scans.
2) To assess the practical application and meaning of efforts
to obtain informed consent for research that involves whole
genome analysis.
3) To compare and contrast the ethical and regulatory framework
that has been developed for single gene testing of stored tissue
samples with anticipated concerns that accompany the potential
for whole genome scanning.
Rationale:
Informed consent for research involves a decision by a subject/participant
to volunteer in the name of advancing scientific discovery.
Traditionally, research ethics has dichotomized human subject
investigation into those studies that are non-therapeutic and
studies with the potential to benefit the subject. Research
that involves whole genome scanning would initially be considered
as the former, but with a rapid pace of scientific progress
may quickly become a new form of "therapeutic research."
This taxonomy has implications for how we should construct
a new theory of informed consent for whole genome scanning.
Models that work will require a more significant educational
effort than has been previously used in the consent process,
because of the profound identity implications of whole genome
scanning. A number of influential groups over the past decade
have put forth policy guidelines regarding research on stored
tissue samples. These have sought to balance the need for protection
against genetic discrimination with the potential scientific
benefits of research to study single gene abnormalities or polymorphisms.
The advent of whole genome scanning technology may alter the
balance between these two competing goals in a way that calls
for a reexamination of these questions. Previous guidelines
have relied heavily on distinctions such as anonymous, anonymized,
identifiable, and identified, and have suggested informed consent
"check-box" formats that allow subjects to control
future research use of tissue. At worst, these suggestions may
become antiquated and useless in an era where identity becomes
defined by an individual's genome scan. At best, these policy
guidelines will need significant modification to assure that
public policy remains prudent in the era of whole genome scanning.
For meaningful informed consent to approximate a truly "informed"
status, research to determine optimal methods of educating subjects
will be required. The study of actual informed consent discussions
will provide the basis for achieving this specific aim.
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