2015 Articles

Consenting for Molecular Diagnostics

Klitzman, Robert L.

The growing use of molecular diagnostics poses a wide range of issues and questions concerning informed consent that researchers, health care providers, and others will increasingly need to address. Molecular diagnostics are advancing more rapidly than our ability to decide how best to respond to their complex medical, ethical, legal, psychological, and social implications. Although some of these issues resemble those posed by prior tests, the newness and ever-faster spread of these tests, the advent of large-scale electronic databases, and the many inherent uncertainties involved present new challenges and dilemmas that require careful attention to determine how best to proceed. Obtaining appropriate informed consent will require considerable resources, which many researchers and providers may not fully appreciate. For example, for whole genome sequencing (WGS)2 and whole exome sequencing (WES), most researchers have indicated that they were willing to spend 30 minutes or less on obtaining informed consent (1). Yet the complexity of the information involved will probably often require significantly longer interactions.