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Mayo Clinic’s biomedical ethics team reaches milestone in patient-centered research
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As scientists at the Mayo Clinic Center for Individualized Medicine discover new ways to use genomic information in the diagnosis, treatment and prevention of disease, their progress will touch the lives of many Mayo Clinic patients.
Since its inception, the center has recognized the importance of understanding the experiences of people who undergo genomic evaluation. In line with this commitment, the center formed a Bioethics Program as part of its infrastructure, which has enabled consistent focus by bioethicists on its clinical and research projects.
This embedded approach helps ensure that patients have a voice in the center’s work and identifies ways to best support them in their healthcare journey.
Over the past decade, Richard Sharp, Ph.D., director of Mayo Clinic's Biomedical Ethics Research Program, as well as CIM’s Bioethics infrastructure program, has led many research studies centered on patients’ experiences with personalized medicine. Dr. Sharp’s team has focused on how the growth and scale of genomic services may require new approaches to effectively support people who receive multigene, multi-disease risk genetic evaluations.
Recently, the biomedical ethics team surpassed a major milestone of enrolling 100,000 national and international research participants in these bioethics studies.
"This is an accomplishment that is uncommon – if not unique – among bioethics programs around the world," Dr. Sharp says. "And this success can be attributed to the longstanding integration of the Biomedical Ethics Research Program into center initiatives.”
Bioethics in patient research participation
Dr. Sharp says his team has proactively addressed the issue head-on of how best to support people who participate in genomic research.
"As genomic medicine has shifted to affect more and more patients, the bioethics research that we've done has also shifted to reach more patients and to characterize the diversity of patient experiences with individualized medicine," Dr. Sharp says.
In one recent study, researchers explored the level of demand for pretest genetic counseling when people are offered genomic screening. In another study, the team evaluated the quality of patients’ choices for genetic screening in the absence of a traditional pretest genetic counseling session.
Another, similar study assessed patients’ experiences receiving neutral genomic screening results when no pretest counseling has occurred.
"Our findings from these studies suggest that large-scale genomic screening is both feasible and acceptable and that patients may be adequately supported even when the volume of patients tested is scaled up considerably," Dr. Sharp explains.
Tracking the bioethics of biobank participation
The bioethics team also conducted several studies focused on the experiences of biobank participants. For example, they looked at how people's preferences for management of their biological samples may change over time, and how people may experience receiving clinically significant results from studies that use their biobank sample.
Additionally, the team explored how people view the scope and limits of giving their broad consent to biobank participation.
"Each of these studies informs our understanding of how best to steward a large biobank population over time, including a biobank where clinically significant information may need to be returned to patients in the course of conducting genomic research," Dr. Sharp explains.
Examining patient recruitment in low-resource settings
Furthermore, the team has taken an in-depth look at recruitment efforts directed to people receiving care in lower resource settings.
"While minority recruitment is increasing in large academic medical centers, almost no data exists on the implications of moving genomic evaluation to low-resource settings, like Federally Qualified Health Centers that serve a large proportion of minority and historically underserved populations," Dr. Sharp says.
The Bioethics program, in collaboration with the Mayo Clinic Kullo Laboratory and Mountain Park Health Center in Phoenix, Arizona, explored the effect of extending genomic evaluation into a low-resource setting. Its researchers found that many of the bioethics issues thoroughly studied in high-resource settings will need to be reevaluated in low-resource settings.
Researchers also explored ways in which genomic results may establish whether doctors in already-strapped clinics and other low-resource settings will be able to handle the additional work of genomic screening at those locations.
Dr. Sharp says the findings may help advance the understanding of how expanded access to genomic medicine may affect not only patients but also the low-resource institutions that serve them.
Speaking for the Biomedical Ethics Research Program, Dr. Sharp says, "We are grateful to the Center for Individualized Medicine for its long-standing partnership. Without the support of the center’s scientists, leadership and staff, we could not conduct the critical research needed to advance genomic medicine in a way that respects patients' values and goals."
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