Precision medicine research — which involves the consolidation of massive amounts of complex data and the widespread sharing of those data for a variety of research studies — offers the prospect of both benefit and harm.
To help illuminate these, investigators with Vanderbilt’s Center for Biomedical Ethics and Society gathered the perspectives of a diverse group of thought leaders in a range of relevant fields.
Results of the study, published Nov. 26 in PLOS One, suggest the prospect of an array of individual and societal benefits, as well as physical, dignitary, group, economic, psychological and legal harms, many of which may have been over-emphasized or overlooked in the literature.
The findings highlight specific challenges that warrant concentrated care during the design, conduct, dissemination and translation of precision medicine research and in the development of consent materials and processes, said lead author Dr. Laura Beskow, Ann Geddes Stahlman Professor of Medical Ethics.
For the study, Dr. Beskow and colleagues Ms. Catherine Hammack, associate in health policy, and Dr. Kathleen Brelsford, research assistant professor of health policy, interviewed 60 primarily U.S.-based experts and scholars in the areas of ethics, genome research, health law, historically disadvantaged populations, informatics and participant-centric perspectives as well as government officials and human subjects protections leaders.
While interviewees acknowledged the potential for precision medicine research to identify targeted approaches to improving health and preventing disease, they also raised privacy and confidentiality concerns.
Several notable themes emerged, including:
“It will be important to develop informed consent materials processes that accurately reflect the rapidly evolving landscape of precision medicine research,” Dr. Beskow said. “Our study highlighted several considerations that are hard to quantify, and we need to assist people in evaluating decisions about participation in light of their own circumstances and values.”