Ethics study explores precision medicine’s risks, rewardsNov. 29, 2018, 10:11 AM
by Doug Campbell
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 Laura Beskow, PhD, MPH, Ann Geddes Stahlman Professor of Medical Ethics.
For the study, Beskow and colleagues Catherine Hammack, MA, JD, associate in Health Policy, and Kathleen Brelsford, PhD, MPH, 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:
- Return of results to research subjects — Thought leaders pointed to the importance of setting realistic expectations among research participants concerning benefits and harms, careful decisions about which results will be offered and allocating resources to support an ethical process of return.
- Group harm — Many thought leaders raised issues of dignitary and group harm, while others commented on follow-up questions about risks to families and/or communities. The current system of human subjects protections is focused on individual participants and not long-range effects on groups of applying knowledge gained in research.
- Risks to the research enterprise itself — Thought leaders expressed concern about harm to the public’s willingness to participate in and support biomedical research given occurrences such as high-profile data breaches, use of data for objectionable purposes and failure to meet oversold expectations about possible benefits. They said it’s crucial not only to build and maintain trust, but to ensure that the people, organizations, policies and processes associated with the research are, in fact, trustworthy.
“It will be important to develop informed consent materials processes that accurately reflect the rapidly evolving landscape of precision medicine research,” 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.”