CHIRON scholar Joon-Ho Yu explores how researchers might identify when they need to invoke the consent of a community, even in the context of biorepository-enabeled research by Joon-Ho Yu and Megan Doerr
Published on May 30, 2024. DOI 10.21428/4f83582b.995801e2
In this week’s blog, CHIRON scholar Joon-Ho Yu explores how researchers might identify when they need to invoke the consent of a community. Given that the CHIRON toolkit focuses on researchers and oversight boards involved in biorepository-enabled research, the vast majority of which involves secondary data use–in other words, using data that have already been collected by others–the need to invoke anyone’s consent may seem counterintuitive. We encourage you to read on.
Of note, in his writing, Joon uses the term visible communities as a “super group” encompassing previously described informal, invisible, and impacted communities, further highlighting the efforts of communities to be seen and valued across the research ecosystem.
In what situations is it necessary to invoke consent of a predefined community?
At a minimum, community consent and engagement should be invoked when a community, researcher or research governing body identifies risk of harms to a community. However, reflecting on our CHIRON academic workgroup’s discussions, writings, and general back-and-forth on this question, we would likely all agree that the opposite question might be more relevant, “In what situations is it NOT necessary to invoke consent of a predefined community?” Given constraints, such an expectation may be idealistic and untenable; yet the deeper we dig into questions like “what is community,” we unearth complexities that resist easy answers. Further, “invoking consent” devolves from a one-time instance to a process of engagement inclusive of community education and enablement so that communities can actually, if so desired, refuse to participate and even engage in the first place. Despite these complexities, we recommend that researchers and communities consider a range of situations and conditions in which to actively pursue community engagement and consent.
Legally recognized and other visible communities constitute “a predetermined community.”
At a minimum, community consent ought to be sought when a community has legally recognized status and rights (e.g., sovereignty) that require formal consultation and engagement. U.S. federally recognized American Indian tribes and their experiences with biomedical, and specifically genetics, research anchor this position and our analysis.
Beyond legally recognized sovereign nations, visible communities constitute another form of pre-determined status. These communities often self-organize around an identity or affiliation and or legally protected status (e.g., racial/ethnic groups), and benefit from a wide range of consultation and engagement. Thus, a predefined community is often comprised of members, some of whom, at least, are continuously involved with each other in an active community, often advocating as a community.
Notably, visible communities come into being and change. Communities form, reform, fracture, and segment over time. Horrifically, visible communities may be extinguished over time. Their formation may be in response to externally imposed labels and identities (e.g., Asian Americans) and may hold little-to-no meaning for their ascribed members. Biorepositories and derived research contribute to this complex ontology of communities in its own ways and may lead to the formation of visible communities. [Editor’s Note: the evolution and longevity of communities will be explored in more depth in our next CHIRON blog post.]
Collective interests necessitate community consent and engagement
Community consent of a predefined community ought to be invoked whenever the collective interests of the community or its members are at stake. Why you might ask?
The potential for collective benefit from biorepository research requires community engagement because perceptions of benefit differ between stakeholders and communities and often prevent recognition or even consideration of unintended consequences, especially collective or group harms. Group harms, defined as “damages or injury, tangibly experienced or perceived, that impact the welfare interests of a group and its people,” have received increasing attention in biorepository research and in part motivates CHIRON. Additionally, when group harms are argued too distant a consequence of research offense, distinguishing group harms connects experiences of reputational, dignitary and cultural offense to their tangible downstream harms to groups.
In addition to risk of present or future group harms, a community’s prior experience of group harms is a strong motive for eliciting community consent. Notably, most predetermined communities have had such experiences. Further, communities’ experiences of historical trauma, social injustices, and continued structural inequities again points to communities who ought to be regularly engaged. Community consent should be sought when biorepository research involves sensitive topics (e.g., behaviors perceived to have a moral quality) and when derived research might exacerbate within or between communities.
Communities define “the situation” in the context of the research lifecycle
A community should have final say on whether it has a stake or not at any given point in the research lifecycle. Similar to recommendations for community engagement in research with underrepresented populations (e.g., here & here), we propose that community consent ought to be solicited for all forms of data use over the entire data lifecycle. Community consent and engagement are crucial for decisions about sample or data use including both the purposes of that use and to whom access requests will be granted–with particular attention to requests made by for-profit or commercial entities (to assess for misalignment with community values and/or untrustworthy practices).
Community involvement must extend beyond data’s initial collection to all aspects of data curation and use, extending for the life of the dataset. To this end, communities need to be informed about, for example, the critical role of metadata in analysis, and be involved in what is included in metadata and how metadata are structured. Consent and engagement during analysis and interpretation is likely to benefit from revisiting research “purpose” so that additional analyses and reanalysis in perpetuity remain true to the biorepository’s stated purpose, even if broad. Community engagement on aggregating or linking external data with a biorepository's data can help ward against discrimination-prone data types (e.g., crime databases, other socially charged topics, etc.).
Adhering to these standards may be difficult, indeed unfeasible in practice but practicability will remain unknown until attempts are made to engage communities and strive toward an interactive model of community consent. Research infrastructure that supports this engagement is essential to strengthening the social contract between communities and research initiatives. Tools are needed both to support researchers and oversight boards as they look to engage communities (this is the CHIRON Toolkit's aim!), as well tools that scale community engagement within biorepositories themselves.
Researchers should support community learning in support of meaningful community consent and long-term engagement
In practice, unpacking this “invocation” of consent and engagement highlights the importance of a community recognizing its collective rights and considering the potential for group harm, both of which might benefit from opportunities for community learning. Researchers have an obligation to support communities’ process of learning and collective decision-making, analogous to that of ensuring individuals’ comprehension of their rights, assessment of benefits/risks, procedures/alternatives, and considerations of justice in support of autonomous decision-making.