The Underdeveloped “Gift”: Ethics in Implementing Precision Medicine Research

Lee (2021) emphasizes the need to better understand the moral relationship between researchers and participants connoted by precision medicine, with the framework of “the gift” offering bioethics an avenue to address systemic issues of justice and equity. Lee’s call for researchers to address failures of the medical and research community, drawing on Marcel Mauss’s (2002) concept of the “gift” relationship, is an important contribution to the conversation about reciprocity and responsibility in precision medicine, but it must be extended further. Specifically, the practical application of Lee’s call is complicated by differing understandings or expectations of the gift-giver/researcher relationship, participants’ and communities’ prior experiences with biomedical research, and research agendas that do not adequately account for the moral relationships between participants, researchers, and institutions. To illustrate these complexities, we will draw upon our own experiences with establishing a biobank (Barnes et al. 2012), participant-driven genomic research ethos (McGowan et al. 2017) and a return of genomic research results study (Myers et al. 2020).

Drawing from our past experiences, we are launching a precision medicine clinical trial this year to explore how youth ages 13–21 make choices about whether and which genomic testing results to receive. We will recruit a prospective cohort from the local, urban community, as well as a cohort from an existing pediatric hospital biobank. In preparing to launch this clinical trial, we have found complexities in two types of interactions for which Mauss’s framing of the gift is underdeveloped: balancing institutional and community members’ desires regarding establishing a biobank and addressing power dynamics between researchers and the underserved communities we hope to engage. We have argued elsewhere that it is ethically imperative for genomic researchers to attend to the values and goals of each population they are seeking to enroll and engage in research (McGowan et al. 2017). Specifically, we have found that collaborating with an institutional biobank and community-based research advisory committees require tailored approaches to not only research design, but also to negotiating the “gift” framework in both relationships.

Biobanking scholarship has often defined the “gift” as one directed to scientists, or a medical research center, that can commercialize that gift as they see fit (Busby 2006). While this viewpoint reflects the legal framework for biobanks, it may stand in sharp contrast to the attitudes of participants. Among the reasons participants offer to contribute to biobanks, the belief that they are helping future patients is consistently prominent (Condit et al. 2015). This has been confirmed in our own experience establishing an institutional pediatric biobank, where in consultation with multiple community groups, parents indicated that they and their children would be willing to contribute if samples could be used to help children in the future (Barnes et al. 2012). This was especially true for Black participants we consulted, which is consistent with findings from other biobanking initiatives (Streicher et al. 2011). Considering this prospective impact, the recipients of the gift to the biobank do not yet exist; they are future patients, and the organizations maintaining the samples are then stewards, holding and developing those gifts so knowledge gained from the biobank can be used to benefit future patients.

While not represented in legal and institutional discourses around biobanks, the idea that participant samples in biobanks and databases are given as a gift to future patients should be taken seriously by researchers and biobank managers. As Lee reminds us, Black, Indigenous, and People of Color (BIPOC) are increasingly being asked to participate in research in the name of improving population genomic databases to inform precision medicine. However, this participation can underscore the disjointed relationship between individual participants, their communities, institutional biobank leadership, and researchers seeking to draw from biobank collections to forward their own research. Any “gift,” especially one provided on behalf of racially minoritized or other marginalized communities, ought to be established in a way that attends to the complex, multifaceted nature of the giver-receiver relationship. This complicated dynamic is characterized by the need for researchers to pay attention to reciprocity and responsibility on behalf of research beneficiaries.

Bioethicists have also drawn attention to the increased call and response to include historically underrepresented groups in precision medicine research, arguing that the simple act of recruitment and data collection within these populations is insufficient to provide substantial, meaningful engagement (Goldenberg, McGowan, and Fullerton 2020; Lee 2021). Ethical obligations of the giver-receiver relationship demand a more thorough, purposeful commitment to bidirectional development and translation of an equitable participant-research relationship. As Lynch and Mitchell (2010) argue, “If a community will not or cannot use the health intervention or service because of a lack of infrastructure or a lack of trust in researchers and clinicians, then the research has provided no benefit.”

For example, our previous research found that not only did Black youth choose to learn fewer genomic testing results about themselves than their white counterparts, but they also chose to learn fewer results for themselves than their parents and legal guardians wanted to learn about them (Myers et al. 2020). However, Black-identifying participants made up only a small fraction of the total pool of participants for this study, so our upcoming clinical trial is designed to purposively recruit participants from communities that have been underrepresented in genomic research. To achieve our aims of enrolling a diverse cohort, we have been cultivating relationships with local communities where trust in the medical profession can be low. As we embark upon clinical research in local communities, we must confront tensions between the racial and generational differences in research engagement, with the potential knowledge benefits offered by enrolling in genomic research that will return individual results.

We must also account for potential conflicting agendas between participants and researchers. To promote equitable research outcomes and benefits for all stakeholders involved, we have developed ongoing rapport with community members and leaders, in collaboration with institutional and community-based research advisory committees, to inform the design of educational and interventional tools for use in our clinical trial. During our community engagement work with Cincinnati’s predominately Black neighborhoods, community members have expressly stated that the health impact of gene-environment interactions is the most compelling issue for community members interested in genomic research. Yet the aims of our precision medicine clinical trial, and funding for this study, center on returning hereditary variants included on the professional society recommendations for return of results in clinical settings. Attending to divergent agendas in both research design and results to be returned is key for cultivating and maintaining the moral relationship between participants and researchers. It will involve negotiation of research priorities and community/gift-giver expectations, both in our own study, and prospectively in future genomic research studies. Doing so will honor Lee’s call toward attending to the gift relationship by considering the unique values and goals of each entity entering the research relationship (McGowan et al. 2017).

Despite the focus on the “participant-researcher” relationship, we have often encountered stakeholders who do not fit neatly into the participant or researcher categories. Community-engaged researchers often collaborate with community-based research advocates who seek to create mutually beneficial outcomes for both participants and researchers. This collaboration can generate challenges of its own, particularly if researchers and advocates perceive different priorities for the community and the study. As such, the gift-giving relationship in precision medicine often involves more than simply a giver/recipient quid pro quo. There may be a variety of relationships, including, but not limited to, the future patient who is receiving the gift, researchers, stewards, and research advocates. The relationship between community leaders and researchers balances on a ledge of mutual trust: trust that the community advocates represent the study’s aims adequately and effectively, and trust from the community that the researchers seek to provide meaningful outcomes to individual participants and to their community. If that delicate balance is disrupted, both parties of the gift-giving relationship suffer. Our approach, thus far, has been to tailor engagement with different community-based partners in order to determine community needs in real time, and to assess how well-poised we are to address and act on said needs within the context of our study.

Lee proposes that the anthropological analysis of the gift ought to inform the moral relationship between participants and precision medicine researchers. We agree and contend that the implementation of national and local precision medicine research relationships may complicate that analysis. As stewards of a gift, the researcher’s moral obligation to the giver is amplified beyond what both Mauss and Lee describe. The practical implications that we describe here pose a challenge for all committed to realizing the potential of ethically engaged genomic research and precision medicine.