Trend: Genetic Testing and Data Privacy Ownership

With the growth of direct-to-consumer genetic testing, the opportunity to draw insights from the data for clinical research into potential new treatments for numerous diseases is compelling. However, for sponsors and investigators who run clinical trials with genetic components, significant patient risks emerge.

Investigators often have a limited understanding of basic genetic and genomic concepts, which can complicate how genetic results are delivered, especially in a clinical trial setting. Unfortunately, many patients interpret their test results incorrectly, ultimately causing confusion and concern, and in some cases, disastrous results. At the same time, sponsors worry about the retention rates of their patient populations, and whether privacy concerns or a misunderstanding of results will cause their patients to drop out of the trial.

How then, should sponsors, investigators and patients think about data protection when it comes to genetic testing? Are there sophisticated mechanisms for how investigators should handle the interpretation and communication of results with patients?