Discussion points to consider in research related to the human genome.

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.