by Wamia Siddiqui, BS and Richard R. Sharp, PhD
The following blog is an editorial found from the American Journal of Bioethics, Volume 1, Issue 10.
For decades, the Belmont Report—and the associated regulatory framework it inspired—has been a cornerstone in the ethical conduct of research involving human subjects. Despite its canonic status, there are many reasons to view the protections articulated in the Belmont Report as insufficient for managing the ethical challenges of biomedical research. For example, critics of the Belmont Report have suggested that its authors placed too much emphasis on individual choice, failed to consider research-related harms to nonparticipants, and built its regulatory framework around a model of participant interaction that does not apply in many types of biomedical research (Brothers et al. 2019). These and other critiques have sparked multiple calls to revise, adapt, or supplement the core principles of the Belmont Report to better protect research volunteers (Brothers et al. 2019; Cragoe 2019; Friesen et al. 2017).
By examining the potential value of reframing the Belmont Report’s guiding principles, which were designed to protect individual volunteers, as principles to protect tribal communities, Saunkeah and colleagues have made an important contribution to this literature (Saunkeah et al. 2021). Their thoughtful analysis acknowledges and highlights several limitations with such an approach. Many of those difficulties relate to adapting individual commitments to respecting autonomy and promoting justice to concepts that are more readily applicable to communities. Other challenges relate to blind spots within the Belmont Report itself, which says little about community needs or values. The authors conclude by calling for greater sensitivity to community interests, describing how concepts like tribal sovereignty and solidarity might inform frameworks for the ethical conduct of biomedical research.
We are in strong agreement with Saunkeah et al. that there is an urgent need to improve the oversight of research involving American Indian and Alaska Native (AI/AN) communities. Many indigenous communities have a long history of abuse and oppression, including forced relocation, broken treaties, and theft of cultural knowledge and property (Yuan, Bartgis, and Demers 2014). Members of the scientific community have contributed to these abuses, by conducting unethical research, disregarding the needs and values of AI/AN communities. The transgressions of researchers from Arizona State University against the Havasupai tribe, in which researchers analyzed samples that they had been collected for diabetes-related projects for unauthorized investigations, is a paramount example (Garrison 2013). As a result, research guidelines that fail to recognize the continued impact of this history are unlikely to resonate with the experiences of many AI/AN communities.
Building on the work of Saunkeah et al., we would like to propose a more radical departure from traditional critiques of the Belmont Report and its principles. The approach we propose begins by setting aside the ethical guidance found in statements like the Belmont Report and starting anew with respect to envisioning ethical research in tribal communities.
Historical Neglect and Prior Exploitation
To appreciate the limitations of the Belmont Report as a guide to the ethical conduct of research involving tribal communities, it is important to revisit its historical origins. The Belmont Report was authored by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (Carroll and Gutmann 2011; National Institutes of Health n.d.). The National Commission was established in 1974, in the aftermath of the Tuskegee Syphilis study. In that historical context, it is easy to understand the Commission’s call for greater transparency about the conduct of biomedical research and the importance that it assigned to individual rights—including the right to be informed about the terms of research participation and be given the option to decline participation (Brothers et al. 2019; Carroll and Gutmann 2011; Cragoe 2019; Quinn, Kass, and Thomas 2013). The Belmont Report was undoubtedly shaped by the worldviews of the eleven individuals on the National Commission, which included lawyers, physicians, researchers, bioethicists, and a civil rights advocate (Carroll and Gutmann 2011). Many of these individuals held academic positions at prominent research universities, which likely contributed to favorable attitudes about the importance of pursuing new knowledge through scientific research (Carroll and Gutmann 2011).
The Commission’s perspectives on the value of scientific research contrasts starkly with opinions held in many AI/AN communities, where the appropriation of cultural knowledge by outsiders can be a source of concern and the research may not be viewed as unambiguously positive. Many native peoples “believe that researchers do not inherently have a right to ‘discover’ knowledge in Indigenous communities” and that attempts to do so often fail to appreciate cultural constraints on the sharing of traditional knowledge with outsiders (Simonds and Christopher 2013). Additionally, the history of abuse and marginalization noted above reinforces a deep mistrust of nonindigenous persons who approach AI/AN communities seeking partnerships (Hayward et al. 2021; Morton et al. 2013; Simonds and Christopher 2013). Many of those individuals, including some biomedical researchers, are viewed by members of indigenous communities as pursuing financial gain or personal career advancement, even in situations where there may be reciprocal benefits to tribal partners (Hayward et al. 2021; Kuhn, Parker, and Lefthand-Begay 2020; Morton et al. 2013; Simonds and Christopher 2013; Yuan, Bartgis, and Demers 2014).
Despite the fact that this distrust of researchers has been pervasive for decades, ethical guidelines such as the Belmont Report rarely do more than point to a troublesome past. Given this silence, it is not surprising that indigenous groups have taken steps to prevent further harms to their communities from scientific research, as reflected in increasing use of independent tribal IRBs, and the recent work of nonprofit organizations such as the Native BioData Consortium (Cragoe 2019; Garrison 2013; Hayward et al. 2021; Hull and Wilson 2017; Morton et al. 2013; Native BioData Consortium 2021).
While the lack of attention paid to tribal sovereignty or the oppression of indigenous persons in the Belmont Report may not be surprising given its historical context, it is the document’s focus on Western moral traditions and commitments to the preservation of individual rights that is perhaps most at odds with indigenous perspectives on biomedical research. By affirming the importance of scientific knowledge and individual choice, the Belmont Report implicitly rejects non-Western moral traditions that celebrate communitarian values tied to solidarity, fraternity, and community benefit (Pearson et al. 2019; Simonds and Christopher 2013; Tilburt 2021: Tsosie, Claw, and Garrison 2021). Additionally, by placing the rights of the research volunteer at the center of its protectionist approach, the Belmont Report narrows the scope of “protections vulnerable populations are entitled to … and to whom the researcher should be accountable” (Cragoe 2019). While there have been proposals to expand the scope of the Belmont Report to recognize these community-level considerations, including proposals to integrate community-consultation requirements or community-based participatory research methods into the conduct of biomedical research, such proposals cannot overcome the Belmont Report’s reliance on moral frameworks that are not in close alignment with many indigenous worldviews (Cragoe 2019; Hull and Wilson 2017).
An Alternative Path Forward
In response to this inherent limitation, we propose a different process for establishing an alternative ethical framework for the conduct of biomedical research in AI/AN communities. We propose that tribal leaders eschew existing Western guidelines like the Belmont Report and the Common Rule, and rather, establish a consensus-development process that produces an entirely new set of ethical guidelines. Driven by indigenous communities, and with input from a diverse coalition of AI/AN stakeholders, such a guideline would not seek to adapt Western guidelines to research involving AI/AN communities but would instead build upon the moral traditions and governance structures that have existed within those communities for generations.
While it is difficult to anticipate the outcomes of such a tribal-lead approach to the development of ethical standards for the conduct of biomedical research, we believe the guidelines produced through such a process would likely reflect several core commitments. For example, it is likely that these guidelines would likely affirm the importance of tribal sovereignty and the preservation of cultural traditions, property, and knowledge. Additionally, these guidelines would reject “subtle forms of epistemological imbalances that give precedence to academic or ‘Western’ forms of knowledge over other worldviews” (Hayward et al. 2021). We also expect that such guidelines would place indigenous voices and concerns at the center of the research process, including not only the review of volunteer protections but also decisions regarding the release or sharing of research data with others (Hayward et al. 2021; Hull and Wilson 2017; Kuhn, Parker and Lefthand-Begay 2020; Simonds and Christopher 2013). Lastly, we expect that these guidelines would emphasize the importance of addressing community needs, respecting internal tribal values and traditions, and attending to the environment in all aspects of research (Kuhn, Parker, and Lefthand-Begay 2020).
Our proposal, while simple in concept, poses enormous logistical challenges. There are more than 5.2 million people who identify as AI/AN, and 574 federally recognized tribes in the United States. Given the heterogeneity of these communities, it is inevitable that substantive disagreements will arise. Additionally, tribal leaders may not fully represent the perspectives of all of their members, making it important to have mechanisms in place that allow for indigenous stakeholders outside of leadership roles to shape this process (Brothers et al. 2019; Cragoe 2019; Scheinerman 2021). The involvement of urban AI/AN communities is especially noteworthy as it is estimated that approximately 71% of AI/AN persons live in urban settings and may not be represented by sovereign tribal nations (Tsosie, Claw, and Garrison 2021; Tsosie, Yracheta, and Dickenson 2019; Yuan, Bartgis, and Demers 2014). Additionally, given the sovereign authority of individual tribes, any consensus framework produced would need to be understood as an ethical guide, not a legal requirement.
While we recognize that there would be considerable limitations to the approach we propose, we feel the value of articulating a novel ethical framework that is more deeply rooted in indigenous worldviews and reflective of the unique histories of AI/AN communities warrants the effort. It is only through an entirely new approach that the residue of Western moral traditions and scientific epistemologies can be washed from the bioethical guidance and regulations that currently shape researcher engagement with tribal communities.
In our opinion, any effort to transpose the bioethical principles of justice, beneficence, and respect for persons articulated in the Belmont Report into an analogous set of community-centered standards applied to tribal communities, will suffer from the limitations described by Saunkeah and colleagues. Worse still, such an initiative implicitly perpetuates a Western-centric approach to engagement with indigenous communities, one that ties research oversight responsibilities to academic structures that are unlikely to align with traditional tribal governance and epistemologies, thereby contributing to the erosion of indigenous leadership and knowledge (Cragoe 2019; Friesen et al. 2017; Hull and Wilson 2017; Simonds and Christopher 2013). It is our hope that by encouraging tribal communities to revisit the ethical standards that should guide the conduct of biomedical research anew, with indigenous leadership informing both the aims and outcomes of such an oversight system, a more useful and culturally appropriate set of ethical guidelines regarding the conduct of biomedical research involving AI/AN communities can be developed.