It is unclear whether the regulatory distinction between
non-identifiable and identifiable information?information used to
determine informed consent practices for the use of clinically derived
samples for genetic research?is meaningful to patients. The objective
of this study was to examine patients’ attitudes and preferences
regarding use of anonymous and identifiable clinical samples for
genetic research. Telephone interviews were conducted with 1,193
patients recruited from general medicine, thoracic surgery, or medical
oncology clinics at five United States academic medical centers.
Wanting to know about research being done was important to 72% of
patients when samples would be anonymous and to 81% of patients when
samples would be identifiable. Only 17% wanted to know about the
identifiable scenario but not the anonymous scenario (i.e., following
the regulatory distinction). Curiosity-based reasons were the most
common (37%) among patients who wanted to know about anonymous samples.
Of patients wanting to know about either scenario, approximately 57%
would require researchers to seek permission, whereas 43% would be
satisfied with notification only. Patients were more likely to support
permission (versus notification) in the anonymous scenario if they had
more education, were Black, less religious, in better health, more
private, and less trusting of researchers. The sample, although not
representative of the general population, does represent patients at
academic medical centers whose clinical samples may be used for genetic
research. Few patients expressed preferences consistent with the
regulatory distinction between non-identifiable and identifiable
information. Data from this study should cause policy-makers to
question whether this distinction is useful in relation to research
with previously collected clinically derived samples.
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