Structuring the Review of Human Genetics Protocols Part II : Diagnostic and Screening Studies

Building on the authors' previous work, this article is intended to assist investigators and IRB members in their review of genetic diagnostic and screening protocols. The authors provide a general description of diagnostic and screening studies and identify five operational levels of genetic testing. They then set out a checklist identifying issues for IRB review and discuss in greater detail several points of controversy raised by this kind of research. These issues include the uncertainty of clinical prediction, research with communities, the confidentiality of test results, and the potential impact on insurance