This book contains an overview of the existing regulatory landscape for
biobank research in the Western world and some critical chapters to show
how regulations and ethical frameworks are developed and work. How
should international sharing work? How do we design an ethically
informed consent?
Biobank research and genomic information are changing the way we look at
health and medicine. Genomics challenge our values and have always been
controversial and difficult to regulate. In the future lies the promise
of tailored medical treatments and pharmacogenomics but the borders
between medical research and clinical practice are becoming blurred. We
see sequencing platforms for research that can have diagnostic value for
patients. Clinical applications and research have been kept separate,
but the blurring lines challenge existing regulations and ethical
frameworks. Then how do we regulate it?
An underlying critique: the regulatory systems are becoming increasingly
complex and opaque. The international community is building systems that
should respond to that. The authors argue that it is time to turn the
ship around. Biobank researchers have a moral responsibility to look at
and assess their work in relation to the bigger picture: the shared
norms and values of current society. Research ethics shouldn't only be a
matter of bioethicists writing guidelines that professionals have to
follow. Ethics should be practiced through discourse and regulatory
frameworks need to be part of that public discourse. Ethics review
should therefore not merely be an application of bureaucracy and a
burden for researchers but an arena where researchers discuss their
projects, receive advice and practice their ethics skills.
