The debate over returning incidental findings has been a hot topic in medical and legal circles for many years and is described as “one of the thorniest current challenges.” Currently, no federal or state laws regulate the disclosure of these findings. Although many agree that ethical duties arise in returning certain individual results and incidental findings, the legal implications are much more opaque. This legal ambiguity raises concerns as ethical recommendations for researchers evolve and seem to establish a standard of care for the research enterprise. An established standard of care may lead to legal liability for researchers.
More recently, the cost and resource implications of a duty to return incidental findings have raised concerns that such a duty may severely inhibit the advancement of genetics and genomics research and threaten the societal benefit of continued research. Furthermore, as researchers continue to identify new genetic and genomic variants, researchers will discover more incidental findings and the costs of returning these results will likely increase. This Note analyzes the cost implications of a duty to return incidental findings and how these cost implications should shape future policy recommendations for genetics and genomics research. This Note takes previous recommendations one step further to provide an ethically, legally, and fiscally responsible default rule, proposing that researchers should default to offering to return incidental findings in genomics or genetics research to participants, unless the researchers weigh the costs and benefits of returning versus the costs and benefits of not returning and reasonably conclude that they should not return the incidental findings. The default rule places a minimal burden on researchers while providing much needed guidance in an area of continued and tumultuous debate.