Bridging the gap between gene discovery and our ability to use genetic
information to benefit health requires population-based knowledge about the
contribution of common
variants and gene-environment interactions to
the risk of disease. The risks and benefits associated with population-based
research involving genetics, especially lower-penetrance gene variants, can
differ in nature from those associated with family-based research. In response
to the urgent need for appropriate guidelines, the Centers for Disease Control
and Prevention formed a multidisciplinary group to develop an informed consent
approach for integrating genetic variation into population-based research.
The group used expert opinion and federal regulations, the National Bioethics
Advisory Commission's report on research involving human biological materials,
existing consent forms, and literature on informed consent to create suggested
language for informed consent documents and a supplemental brochure. This
language reflects the premise that the probability and magnitude of harm,
as well as possible personal benefits, are directly related to the meaning
of the results for the health of the participant and that appropriate disclosures
and processes for obtaining consent should be based on an assessment at the
outset of the likelihood that the results will generate information that could
lead directly to an evidence-based intervention. This informed consent approach
is proposed to promote discussion about how best to enable potential participants
to make informed decisions about population-based research involving genetics
and to suggest issues for consideration by research sponsors, institutional
review boards, and investigators.
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