Views of Cohort Study Participants about Returning Research Results in the Context of Precision Medicine

Abstract

Background: The practice of biorepository-based genetics research raises questions related to what ethical obligations researchers have to their participants. It is important to explore and include the thoughts of current biorepository participants as we move forward with this type of research. Methods: Thirty participants (17 cancer patients, 7 cancer-free controls, and 6 relatives) were drawn from the Northwest Cancer Genetics Registry and participated in qualitative interviews lasting between 45 and 90 min. Topics explored in this study include which types of genetic test results participants of large biorepositories expect and would like to receive from research analyzing their samples, as well as thoughts on best practice for conducting this type of research. Results: Cancer cases, controls, and first-degree relatives have differing views on what results they would like to receive from biorepository-based research. Participants across all groups attempted to balance the costs and benefits of returning individual research results. Discussion: In the wake of precision medicine, it is important to describe the range of ways participants in large biorepositories both think and talk about the utilization of their specimens for genetics research.

Genetic counselors' research dissemination practices and attitudes

“…Previous studies have determined that the best time to set expectations for RRTP is during the initial consent process and have suggested the routine integration of this option into consent forms (Fernández-Peña et al, 2008;Hyams et al, 2016). This aligns with the opinions and practices of respondents in our study, indicating that genetic counselors also place importance on setting expectations for RRTP in the initial consent process.…”

“…However, many expressed that not all studies or findings require dissemination to study participants, specifically, chart reviews and qualitative research studies. A previous study reported that individuals who had participated in biorepositories desired the option to receive aggregate results from any studies which used their sample (Hyams et al, 2016) to be a common practice among researchers (Fernandez, Kodish, Taweel, et al, 2003;Hiratsuka et al, 2012;Long et al, 2016Long et al, , 2019.…”

“…Previous studies have shown that sharing summary research results (aggregate findings) with participants is an important practice that benefits both participants and researchers (Cook et al, 2022; Fernandez, Kodish, & Weijer, 2003; Hiratsuka et al, 2012; O'Daniel & Haga, 2011) with benefits including: building trust between communities and researchers, encouraging future research participation and understanding, and thanking participants for their contributions (Cook et al, 2022; Fernandez, Kodish, & Weijer, 2003; Hiratsuka et al, 2012; O'Daniel & Haga, 2011). Study participants largely desire to receive aggregate research findings and appreciate research teams who prioritize this practice (Aldinger et al, 2018; Dixon‐Woods et al, 2006; Hyams et al, 2016; Purvis et al, 2017). Barriers to returning aggregate research results include financial and resource constraints and concern for the potential to cause distress to participants (Fernandez, Kodish, & Weijer, 2003; Long et al, 2019).…”

Return of individual research results from genomic research: A systematic review of stakeholder perspectives

“…A study of 3630 adults, which included 464 biobank participants with a diagnosis of pancreatic cancer, indicated that 62.1% expect to receive SSR; high proportions of participants held expectations that they would be told about ‘bad’ stuff (e.g., health risks for conditions), rather than ‘good’ stuff (e.g., things that do not have associated health risks) [ 34 ]. Yet, interviews with 17 cancer patients, 6 first degree relatives and 7 cancer-free controls showed that while many felt researchers should return research reports to patients, over half said there was no moral obligation to do so [ 37 ].…”

Patients’ and professionals’ views related to ethical issues in precision medicine: a mixed research synthesis

“…Incidental findings [ 79 , 96 ], variants of unknown significance [ 79 ] or results that indicate a high risk for an incurable disease can affect the well-being of patients [ 51 ]. In some studies, patients explicitly state that they do not want to know certain results, e.g., about a genetic predisposition to a disease [ 95 ], especially if it cannot be cured [ 61 , 118 ]. Not knowing enables people to keep hope, a positive self-perception and remain optimistic [ 113 ].…”