Twenty-first century medicine is likely to be dominated by genetics. With the extraordinary accomplishments of the Human Genome Project and the rapid evolution of pharmacogenomics, genetic knowledge and its applications are increasing at a remarkable pace. As the technology develops, society will continue to be challenged by a host of ethical, legal and social issues.
The University of Miami Bioethics Program is contributing to the “genomic revolution” in a number of ways:
- Developing consent tools for genetics research. UM was one of the first sites in the world to develop a suite of consent tools to permit tissue banking for genetic research. (The three documents are available at UM’s IRB web site.) Versions of these tools have been adapted or used by a variety of academic research centers, pharmaceutical firms and the federal government.
- Studying ways genetic research will be affected and governed by the privacy provisions of the Health Insurance Portability and Accountability Act. HIPAA poses a variety of interesting and important challenges to the collection, storage and study of biological materials and the genetic information they contain.
- Developing policies for the production and use of transgenic creatures. The biomedical sciences rely on animal models for a vast array of tests, studies and experiments – but comparatively little is known about how best to apply animal care and use guidelines in the case of transgenic research. The Bioethics Program has contributed to an institutional resource on use of transgenic animals and the plan is to develop this guidance into a more fully useful document.