Regulatory/Legal Core
Under the leadership of Jessica Berg, this core will provide
CGREAL investigators with expert advice on the implications
of current institutional policies, federal research regulations,
and the HIPAA legislation for our own empirical studies of the
genetic research process. Investigations of participation in
genetic research are often more legally and ethically complicated
than the genetic research itself, as many social scientists
interested in studying biomedical research participation have
discovered . Issues of privacy, consent, deception, and disclosure
challenge the design of the research the CGREAL seeks to pursue.
The regulatory/legal team will be available to advise CGREAL
investigators on their research designs prior to submission
to the CWRU Institutional Review Board and on an ongoing basis
throughout the research trial. The other members of this core
include Eric Cottington, Director of the CWRU Office of Research,
Anne Matthews, who chairs the Genetics Subcommittee of the University
Hospitals of Cleveland, and Sharona Hoffman, who is expert on
federal research regulations and the HIPAA law.
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