The past few decades have been dominated by a targeted genetic research paradigm; the ethical, legal and social implications (ELSI) associated with this “first phase” genetic research were focused primarily on concerns about informed consent, stigma (i.e., being judged or labeled as a result of genetic test results), privacy (both individual and group), and genetic discrimination. The past couple of years, however, have been marked by a transition into a new phase of research that focuses on the genome as a whole. The increasing availability of affordable next generation sequencing makes it easier for laboratories to engage in genomic research. The ELSI concerns previously associated with targeted genetic research are amplified by the magnitude and types of information generated by large-scale genomic sequencing. Concerns that had been rare now are becoming more prevalent and more complex, and institutional review boards (IRBs) are being called upon to review the ethics of research involving the use of these emergent, cutting edge technologies in research with human subjects prior to the development of ethical consensus and regulatory guidance about the use of these technologies. For example, genomic research with human subjects raises complicated questions about the management of incidental or secondary findings. Incidental findings are research results concerning an individual research participant that have potential health or reproductive importance and are discovered in the course of conducting research but are beyond the aims of the study. There are controversial questions about how, to whom, and under what circumstances to return incidental results. Genomic research also raises questions about the nature and magnitude of individual and group risks associated with genetic and genomic information.
The goal of this workshop is to examine these and other ethical, legal, and social issues and to develop a regulatory framework for genomic research. The workshop will include weekly seminar sessions, meetings at the National Institutes of Health (NIH) in Bethesda, and field work with IRBs in Maryland. Under the supervision of Professor Karen Rothenberg and Ben Berkman, a faculty member with the Department of Bioethics at NIH, students will work with bioethicists and policy-makers from the National Human Genome Research Institute (NHGRI) to identify the regulatory questions that are emerging in this evolving field. Students will produce individual papers that analyze a specific ethical, regulatory and/or policy issue, with the goal of presenting a concrete proposal that provides guidance as to how NIH may proceed on that issue. Topics will be sub-divided to include at least three broad areas of research ethics: management of individual research results, privacy, and the informed consent process. Students will also work in collaboration to produce a workshop consensus document that synthesizes their individual research to be presented to NHGRI and policy-makers at NIH. Additionally, the class will observe and critique IRB deliberations and as part of their field work, participate in a qualitative study of IRB member attitudes relating to the return of incidental genetic research findings.
Current & Previous Instructors:
|This course is not currently scheduled.|