Executive Summary
Management of Ethical and Legal Issues
The relationship between the patient and the NBN is critical, since the patient is the potential
donor of specimens and, as such, is the mainstay of the NBN. The NBN should promote a
conceptual “chain of trust,” with links in the chain that begin with the patient and include the
institutional review boards, those responsible for the collection and storage of tissues and data,
and researchers who use the resource. Each link will be entrusted with the responsibility to
ensure privacy, safety, and compliance not only with applicable rules and regulations, but also
with the wishes of donors. The strength of the entire chain is the assurance that the NBN can
give to potential donors that responsible use will be made of their biospecimens and associated
data.
The NBN informed consent process must ensure that potential participants understand how their
specimens may be used, and should use tiered consent procedures that provide individuals with
options for levels of participation. In general, donors will not be apprised of specific research
results derived from their particular specimens, but information about general scientific
discoveries made through the use of biospecimens will be publicly available.
Specimen allocation should be equitable and ensure appropriate use by qualified researchers. The
NBN should create a system whereby the NBN has permission to use, and in turn gives
permission to use, all biospecimens and associated data. The NBN should avoid asserting any
reach-through rights to intellectual property developed through researcher use of tissues and
associated data, as attaching such rights may hinder access by certain users and slow research
progress.
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