Discussion Points to Consider in Research Related to the Human Genome

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Abstract
The advances in DNA technology and molecular genetics, spurred by the Human Genome Project, have created new challenges for human subjects research and the system of institutional review board (IRB) review. The populations to be studied are vulnerable because of genetic diseases or risk for them; until now, IRB review has concentrated on overt physical and medical hazards. Attention to the interests of individuals and families participating in, or affected by, research on the human genome frames the agenda for IRB deliberations and suggests the information to be conveyed to prospective participants. By a series of questions, this article explores how human genome research involves a distinct paradigm in human subjects research with its own imperatives for researchers and IRBs. The immediate impact of the human genome project will be felt by those already affected by genetic diseases. Although the IRB system, in principle, ensures adequate protection for research participants, responding to the approaches and implications of human genome research calls for reexamination of IRB deliberations in the light of factors specific to the procedures used in this research. IRBs and researchers will find a challenge to some traditional modes of deliberations in the perspective of individuals whose participation is integral to the success of this new direction in research. Questions critical to decisions to take part in human genome research are delineated to provide guidance in accomplishing the necessary reexamination.