Appendix JExamples of Ethics Oversight Groups
Genomics Collaborative, Inc., Bioethics Advisory Board
Genomics Collaborative, Inc. (GCI) is a commercial venture that provides consented DNA, RNA
sera, and snap-frozen tissues linked to clinical information from donors worldwide in its GCI
global repository. GCI empanelled a bioethics advisory board at the outset to develop solutions
to the ethical issues inherent in creating a repository of this nature. The board played a
significant role in creating a consent process for the repository, developing a proprietary system
for making collections anonymous while still collecting longitudinal clinical data without
compromising patient confidentiality.
Department of Veterans Affairs Cooperative Study DNA Bank Ethics Oversight
Committee
The Department of Veterans Affairs (VA), through the Cooperative Studies Program, supports a
genetic tissue bank (Study 478, “Genetic Tissue Banking in VA Clinical Research”) for the
collection of samples in ongoing clinical trials and the provision of samples for future study. The
bank is overseen by three appointed committees that guide the ethical use of materials and
provide scientific review of policies and procedures. The Ethics Oversight Committee (EOC),
the Scientific Advisory Committee, and the Veterans Advisory Committee are both appointed by
the VA Research and Development Office and serve overlapping terms. The EOC is made up of
experts in the legal and ethical implications of genetic research, and experts in relevant scientific
disciplines.
Ardais Bioethics Advisory Board
Ardais Corporation, a commercial clinical genomics company that maintains a sizable repository
of annotated tissue samples, created a bioethics advisory board to oversee its human subjects
activities. The board, comprised of legal, ethical, and technical experts, helps set policies for the
ethical distribution of tissues but is not involved in the day-to-day operational aspects of
decisionmaking or approval. The board also supports the evaluation of new opportunities for
providing new clinical genomics products and services to the research community, each of which
comes with unique sets of bioethical issues.
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