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. Author manuscript; available in PMC: 2022 Oct 1.
Published in final edited form as: Am J Bioeth. 2021 Jan 15;21(10):5–12. doi: 10.1080/15265161.2020.1865477

Extending Research Protections to Tribal Communities

BOBBY Saunkeah 1, Julie Beans 2, Michael Peercy 3, Vanessa Y Hiratsuka 4, Paul G Spicer 5
PMCID: PMC8280236  NIHMSID: NIHMS1687375  PMID: 33449863

Abstract

The history of research in American Indian/Alaska Native (AI/AN) communities has been marked by unethical practices, resulting in mistrust and reluctance to participate in research. Harms are not limited to individual persons – tribal communities experience harmful misrepresentation and generalizations disrespectful of AI/AN groups’ heritage, cultures, and beliefs. The Belmont Report’s research ethics principles are applied primarily to protect individual research participants. The principles of sovereignty and solidarity are argued to be important concepts in extending Belmont’s research protections to tribal communities. Sovereignty, an expression of respect for autonomy at a group level, is the basis for tribal self-determination. The principle of solidarity provides an ethical underpinning for tribes’ obligations to protect community interests and culture. Extension of Belmont through these principles should serve to minimize harms to AI/AN groups in research.

Keywords: American Indian, Alaska Native, Belmont Report, CBPR, sovereignty, solidarity

Introduction

In the 2010 United States (US) Census, 5.2 million people self-identified as American Indian/Alaska Native (AI/AN) (Norris, Vines, and Hoeffel 2012). There are 574 federally recognized tribes in the US, each with its own constitution or other mechanism for determining criteria for tribal membership and the right to exercise tribal sovereignty to self-govern and provide services to their citizens (Koenig and Steinberg 2008). This inherent authority has repeatedly been codified through treaties, executive orders, and public laws, and examples of such services include housing, education, and health care, as well as health research.

Many AI/AN tribes have experienced historical and recent abuses in research activities within their communities which have resulted in significant individual and community harms (Foulks 1989, Garrison 2013). This tumultuous relationship with research has led to mistrust of research investigators and, in some cases, an unwillingness of AI/AN groups to participate in research (Hodge 2012). Misrepresentations, stereotyping of tribes, inappropriate generalizations, lack of respect for culture and beliefs and failure to share in any benefits have contributed to this mistrust (Chadwick et al. 2014, Garrison et al. 2019).

As recently as 2010, a dispute was settled where Arizona State University researchers allegedly conducted research and published results without an Arizona tribe’s knowledge or informed consent (Pacheco et al. 2013). Tribal citizens contended that the tribe did not benefit from the unauthorized research; rather, they experienced stigma, emotional and mental anguish, and public disrespect for religious beliefs and origination history (Pacheco et al. 2013). Additionally, biospecimens were provided to various secondary researchers in other institutions to conduct unapproved studies and publish articles on schizophrenia, inbreeding and population migration (Drabiak-Syed, 2010; Pacheco et al., 2013). This case has served to emphasize the harms that tribes can experience in research, and the importance of considering group interests when contemplating research participation.

To provide oversight and protect AI/AN individuals and communities from research harms, the Indian Health Service Institutional Review Board (IRB) was established in 1991 (Morton et al. 2013). In addition, AI/AN groups proactively developed research models that are tribally initiated and driven (Around Him et al. 2019, Hiratsuka et al. 2017), and that account for the diversity and sovereign status of AI/AN tribes, and recognizes Indigenous knowledge (Simonds and Christopher 2013). Tribes are establishing respectful and reciprocal research partnerships that are equitable in sharing responsibility and benefits (Hiratsuka et al. 2019, Kelley et al. 2013) and tribal leaders and community members expect health science research to benefit their communities (Champagne and Goldberg 2005, Beans et al. 2018, Tsosie, Yracheta, and Dickenson 2019). Additionally, stronger AI/AN research infrastructure and improved protections for tribal research participants have been developed through the implementation of tribal IRBs (Chadwick et al. 2014, Morton et al. 2013); written research codes and policies (American Indian Law Center, 1999); increased number of AI/AN health researchers (Blue Bird Jernigan et al. 2015); professional and academic training in ethics (Morton et al. 2013, Pearson et al. 2019); and the emergence of national research resources such as the National Congress of American Indians’ Policy Research Center (Sahota, 2007).

In addition to protecting individual research participants, tribal research review bodies are often charged with protecting the tribal community where the research occurs to prevent negative impacts on tribal identity that may reduce potential community or individual benefits that might otherwise have been reaped (Morton et al. 2013, Around Him et al. 2019, Oetzel et al. 2015, Hiratsuka et al. 2017). To protect the culture and heritage of tribal nations it has been suggested that the Belmont Report’s biomedical research principles of respect for persons, beneficence and justice should be applied equally to the entire tribal community (Champagne and Goldberg 2005, Hull and Wilson 2017, Freeman 2005, Sahota 2007). Despite the scarcity of research on this expanded application of the Belmont principles from individuals to tribal communities, and the observation that Western principles of ethics are not universally applicable in different cultural contexts (Pearson et al. 2014), this approach is already being adopted in tribal research programs (Buffalo et al. 2019). The purpose of this article is to examine the appropriateness of extending the Belmont Report’s research ethics principles, which were primarily intended to protect individual human research subjects, to protect tribal communities as a whole.

Community Based Participatory Research

Community based participatory research (CBPR) has been proposed to be an appropriate and ethically-grounded framework for research conducted with AI/AN communities (Pacheco et al. 2013, Simonds and Christopher 2013, Sahota 2010, Blue Bird Jernigan et al. 2015). CBPR’s principles of the community as the “unit of identity”, utilizing local resources and strengths, creating collaborative partnerships that share power and trust equitably, and ensuring a balance between research and beneficial action, all contribute value to this approach from a tribal perspective (Burdine et al. 2010). A distinguishing characteristic of CBPR is community involvement in every step of the research process, beginning with the development of the research question, an equitable and expected approach for many AI/AN groups and people (Beans et al. 2018, Hiratsuka, Brown, and Dillard 2012, Hiratsuka et al. 2012). When CBPR is applied faithfully, the researcher and the community develop a relationship, and the concepts of cultural humility and cultural safety are incorporated into the research process methods and procedures to establish and maintain the research partnership (Israel 2013). Although the CBPR framework provides a guide for the conduct of inclusive research, additional ethical guidelines and principles may be needed to sufficiently protect previously exploited communities (Mikesell, Bromley, and Khodyakov 2013, Oetzel et al. 2015, Tsosie, Yracheta, and Dickenson 2019, Bentley, Callier, and Rotimi 2020).

The Belmont Principles

The basic research ethics principles outlined in the Belmont Report are generally interpreted and applied to the protection of individual research participants. However, the Report also makes note of respecting prisoners as a vulnerable group that should neither be deprived of the opportunity nor coerced to engage in research (Bankert & Amdur, 2006, p. 482). Similarly the Report also notes that the principle of justice in research participant selection requires application at two levels, the individual and the social, where social refers to classes of potentially vulnerable persons such as children and the institutionalized infirm (Bankert & Amdur, 2006, 2006, p. 485). The call to extend the Belmont Report’s (Emanuel 2011, Hull and Wilson 2017) research principles to protect tribal community, culture and heritage is an understandable and reasonable response to abuses in research conducted in AI/AN communities (Freeman 2005, Sahota 2007). The Belmont Report established the standard for biomedical research ethics in the US, grounding protections for individual research subjects in three basic principles: respect for persons, beneficence and justice (Emanuel 2011).

  • Respect for Persons: The principle of respect for persons is expressed in voluntary informed consent, the protection of privacy and confidentiality, and the right to withdraw from research (Amdur 2011).

  • Beneficence: Beneficence requires careful consideration of potential risks and benefits to research participants, so that benefits are maximized while risks are justified and minimized (Amdur 2011).

  • Justice: Justice as a response to past research abuses on vulnerable populations finds expression in equitable opportunity to participate in research, sharing in potential risks and benefits without systematically excluding or exploiting any individuals or groups (Amdur 2011).

Research conducted with fidelity to CBPR principles is consistent with Belmont’s protections. In their extensive literature review on CBPR’s ethics, Mikesell et al. (2013) found that a majority of the articles (30/57) reviewed contend that community autonomy is an expectation of CBPR, expressed as respect for community needs, values, interests, culture, strengths and worth, as well as the requirement for voluntary informed community consent. However, concerns for social and community justice in CBPR was of noted concern, as well as the need for community risk-benefit analysis (beneficence) (Mikesell, Bromley, and Khodyakov 2013). For many AI/AN tribes, how the proposed research will directly benefit the community is the decisive consideration, although in some situations potential benefits to AI/AN people in general or even to other populations may also be taken into account (Hiratsuka et al. 2017).

From individuals to tribal communities

Extending Belmont’s protections from individuals to tribal communities is complicated and requires a balance between tribal individuals and community as a whole (Tsosie, Yracheta, and Dickenson 2019). Freeman (2005) proposed applying the Belmont’s principles to tribal communities to protect AI/AN interests in research. His early work discussed why and how these bodies could apply the Belmont principles to tribal communities: by respecting tribes as being autonomous, obtaining tribal consent and recognizing their special concerns; maximizing tribal benefits and reducing risks by planning together, protecting privacy and reporting results back; and by giving tribes the opportunity to participate in research of potential benefit without subjecting them to unnecessarily high-risk research with little benefit potential (Freeman 2005).

However, within the context of sovereignty, tribes may charge their research review committees with approving any or all research conducted within their jurisdiction (Hiratsuka et al. 2017, Code 2014). If a research proposal is not approved, all tribal members residing within the tribe’s boundaries are effectively denied the opportunity to participate in that particular research project. This approach may appear to give greater weight to tribal autonomy over respect for individual autonomy, which we discuss below. Further, in research, justice requires that risks and benefits be shared equally to ensure that vulnerable populations are provided the opportunity to be included in research activities and protected from exploitation (Amdur 2011). The historical preeminence of the common good, the collective solidarity of the tribe having precedence over the rights of individuals, bears further exploration in today’s modern tribal societies.

Extending individual protection principles to communities may pose other important ethical dilemmas that should be considered. Overly cautious or inexperienced tribal research review committees may overestimate possible risks to the tribal community. Some tribes have research contracts that stipulate all research data collected within tribal boundaries is solely owned by the tribe, not the researcher or the individual donor (Chadwick et al. 2014, Kelley et al. 2013, Around Him et al. 2019, Hiratsuka et al. 2017, Garrison et al. 2019). Many tribes require tribal approval prior to any public presentation or publication of research data (Chadwick et al. 2014, Kelley et al. 2013, Garrison et al. 2019). Constraints such as these imposed on the disposition of research data and findings raise issues of academic freedom, censorship and ownership of intellectual property (Manson et al. 2004).

Finally, many tribal health facilities serve members of different tribes (Warne and Frizzell 2014). Research conducted at these facilities often includes individuals who are not citizens of the tribe operating the health facility. Tribal research review committees have a responsibility to protect tribal citizens who participate in research and tribal interests. It is not clear how, and to what extent the tribal research review committee is also responsible for determining how other tribes represented in research protect their members and tribal interests in research activities. Some tribal research review committees have developed policies that prohibit individual research subjects from being identified by tribal affiliation (Code 2014). And in Oklahoma, for example, there is frequent collaboration and consultation between the Oklahoma City Area Indian Health Service IRB and the Cherokee Nation, Chickasaw Nation and Choctaw Nation tribal IRBs to resolve potential jurisdictional concerns early, and in a collegial manner (Chadwick et al. 2014, Kelley et al. 2013).

The dual responsibility to provide protections to individual research participants with those of the greater community requires a balance to operate within federal codes that require protection of individuals, while at the same time meeting tribal mandates to guard the heritage and culture of the tribe. To extend individual protections to protect the interest of tribal communities, additional ethical dimensions should be considered.

Additional ethical dimensions

Additional ethical dimensions may be required to extend research protections to tribal communities. Quigley (2012) states that existing bioethical research principles can be extended to protect groups, particularly “place-based communities and cultural groups who may share a common harm or burden” (Quigley 2012), which would apply to AI/AN tribes. Three alternative ethical frameworks are presented for extending individual protections to groups: principle based; community-based clinical ethics; and an activist framework termed ‘citizen science-data judo” (Quigley 2012). The principle- based and community-based clinical ethics frameworks extend protections to communities within the context of groups as aggregates of individuals. The activist framework, however, considers the value and interests of the community as an entity unto itself. Within this ethical framework researchers must address the “duty to respect the community…to ensure that the community is not left worse off (particularly from the risks of stigma and exploitation)” (Quigley 2012). Again, this is a particularly appropriate approach to tribes, who have experienced a history of stigma and exploitation from unethical research practices.

Similarly, Wallwork (2008) supports and justifies extending protections to groups. This analysis of research partnerships with communities suggests a new phase in the development of ethical research guidelines: adding ethical treatment of groups to the “moral individualism” of the Belmont Report principles (2008, p. 61). Further, Wallwork (2008) contends that taking community views and interests into account and protecting vulnerable communities from harm are researchers’ ethical obligations, because these actions demonstrate respect for community integrity (p. 61). Responding to the call (Mikesell, Bromley, and Khodyakov 2013, Quigley 2012) for additional perspectives and approaches to group protections, Wallwork (2008) describes three models of ethical approaches to community-partnered research: application and specification of individualistic research principles in which group concerns are relevant only as they affect individual subjects; true extension of research ethics principles beyond the individual to group interests and values; and introduction of new or novel moral standards that are drawn from the researched community itself. This last approach recognizes the inherent dignity of the beliefs and practices that define a community as a unique and valued entity.

To extend the Belmont’s research protections to communities seem to require additional principles and new guidelines (Quigley 2012, Wallwork 2008a). In addition, tribal communities increasingly require unique community protections (Hull and Wilson 2017, Garrison et al. 2019). CBPR is seen as an appropriate mechanism to provide research protections to communities but may be better grounded in two concepts fundamental to AI/AN identity and values: sovereignty and solidarity.

Sovereignty

AI/AN tribal nations exist today as sovereign entities within the US (Harding et al. 2012, Chadwick et al. 2014). Like any sovereign nation, tribal governments have the responsibility to protect the overall interests and well-being of their citizens (Harding et al. 2012); this charge includes the conduct of research within tribal jurisdiction. Tribal sovereignty and self-determination have been described as a fundamental reason that CBPR is such an appropriate fit for research with AI/AN communities (Pacheco et al. 2013, Sahota 2010, Claw et al. 2018, Garrison et al. 2019).

Even when Belmont’s protections are extended to the community, the principle of respect for persons (autonomy) has an inordinately prominent place ahead of the other two research principles: beneficence and justice. For example, in their review of community research ethics literature, Mikesell et al. (2013) found that, while community autonomy was discussed in 53% of articles analyzed, only 32% discussed community justice, and 30% community beneficence. Since the term ‘community’ is never mentioned in the Belmont Report some have called for a “new ethical principle of respect for communities” (Weijer, Goldsand, and Emanuel 1999). A similar call has not been made for beneficence and justice.

Weijer, Goldsand and Emanuel (1999) offer 23 guidelines for the protection of aboriginal communities in research, grouped together in five themes which, while not excluding justice and beneficence, are heavily weighed to respect for autonomy: consultation in protocol development (respecting the value of community priorities); clear informed consent process (respect for individual participants and the community); involvement in research conduct (respecting community knowledge and ensuring meaningful community input); access to data and samples (respecting the history of exploitation in use and disposition of data and biological samples, and respect for spiritual beliefs regarding human tissues); and dissemination and publication of study results (respecting tribes’ concerns for protecting their identities and portrayal in public venues).

Acknowledgement of sovereignty is an extension of respect for persons to additionally include respect for the tribal community. Respect for group autonomy is the primary justification for extending Belmont’s research principles to AI/AN communities, with respect for sovereign rights as its main expression (Chadwick et al. 2014, Morton et al. 2013, Simonds and Christopher 2013, Sahota 2010, Garrison et al. 2019). Although not an ethical principle, sovereignty - a political and legal institution that defines a state’s internal and external relations (O’Riordan & Jordan, 1997) - has significant ethical implications. Additionally, Belmont’s Western-based principle of respect for persons, and its biomedical ethics counterpart respect for autonomy, has been criticized for its lack of universal cultural applicability, particularly in Indigenous cultural contexts (Kelley et al. 2013). Sovereignty is therefore necessary but not sufficient for defining CBPR as a fitting research approach with tribes, and additional considerations are also relevant.

Justice relates to how the risks of research are distributed within the context of society, particularly regarding the potential for exploitation of vulnerable groups (Amdur 2011). Wallwork (2008) says that justice as reciprocity is extended to groups when a group receives reasonably fair compensation in return for what its individual members contribute to a research activity. Rencher and Wolf (2013) claim that additional protections are warranted for vulnerable groups such as African Americans (and by extension AI/AN), not because their individual capacities or particular group characteristics define them as vulnerable; rather because their vulnerability is created and reinforced by the experience of past exploitation and abuse.

Solidarity

Solidarity as a dimension of distributive justice is rarely discussed in the research context but warrants description as an ethical justification to extend Belmont’s protections to AI/AN communities. Solidarity implies a commitment to prioritize the needs, such as health care, housing and education, of society’s most vulnerable (Hoedemaekers and Dekkers 2003). The primary idea of solidarity is “that of a link, of being interconnected to others with reference to some action to be accomplished” (Reichlin 2011). Acknowledgement of solidarity in the tribal context is an extension of justice and beneficence as they apply to the tribal community.

Solidarity involves two key aspects: the collective responsibility to defend and promote the conditions and interests needed for the group to flourish; and the collective responsibility to care for the particular needs of the most vulnerable members of the group (Reichlin 2011). It is arguably the most appropriate ethical justification from the perspective of tribal self-determination because it acknowledges tribes’ inherent, collective responsibility for their continued existence and flourishing (Reichlin 2011, Whyte 2014). As previously mentioned, respect for tribes’ sovereignty is the concept most commonly invoked to justify broader community protections under Belmont’s biomedical research ethics, for example, through CBPR. Within the group context of the extension model, the duty to minimize harm to individual research subjects “gives rise to the obligation of investigators to try to protect the entire community from harms” (2008, p. 66) (Wallwork 2008b). This duty, as an expression of sovereignty, demands obligations from the tribe (to exert their sovereignty) and researchers (to respect tribal sovereignty) to ensure that group interests are protected (Claw et al. 2018, Garrison et al. 2019).

The principle of solidarity, however, gives tribal governments unique, exclusive obligations to protect their own people, which are independent from the values or actions of others, including “outside” researchers. This inherent collective responsibility, which is a reflection of tribes’ historical struggles for survival, provides the moral legitimacy to their efforts to protect the whole tribe by controlling research activities conducted in their communities.

The political-legal concept of sovereignty provides tribes with the right to self-determination. The justice principle of solidarity obligates tribes to fulfill their ethical duties to promote and protect community interests. It is this collective responsibility that provides the moral legitimacy for extending the Belmont principles to tribal communities. It is not solely the researchers’ responsibility to extend ethical protections to communities when the situation warrants. In the conduct of research in AI/AN communities, it is the tribe itself that has the obligation, through its dual expressions of solidarity and sovereignty, to ensure that respect for autonomy, beneficence and justice are provided to individual tribal citizens taking part in research and to the tribal community as a whole. Protecting tribal communities from research harms is a recognized priority (Parker et al. 2019). Moreover, consistent with values underpinning the ethical dimension of solidarity, tribal community members weigh the individual benefit of participating in health research with the potential for harm to their community when considering participation in health research. For example, individual tribal members described interest in participating in health research with the caveat that the research will have measurable, positive impacts on AI/AN health outcomes, that it contributes to increased knowledge of AI/AN health and disease while avoiding stigmatization of AI/AN people (Hiratsuka et al. 2020, Reedy et al. 2020). Accordingly, the principle of solidarity provides a vital complement to sovereignty, underscoring a foundational ethical principle that is relevant to the moral authority of tribal governments.

Discussion

The question addressed in this paper is whether it is appropriate to extend the Belmont Report’s individualistic research ethics principles to include tribal communities as a whole. The Belmont Report’s framework of basic moral principles (respect for persons, beneficence and justice) can be, and indeed have been an appropriate and ethical approach to protect AI/AN tribal communities from undue research harms. However, to extend the Belmont Principles of Respect for Persons, Justice and Beneficence to tribal communities, these principles must be considered within the context of tribal sovereignty and solidarity, which form an important set of additional considerations that arise prior to the engagement of individual research participants within tribal jurisdictions.

Some AI/AN groups have adopted this approach by requiring researchers to utilize community-engaged research strategies such as CBPR, despite the relative scarcity of literature on the ethical validity of this approach in AI/AN communities. While careful and considerate application of CBPR principles can promote ethical conduct of community research, CBPR itself is not an explicit ethical conceptual framework; it is a collaborative approach to conducting research (Woodbury et al. 2019). To ensure ethical tribal community research, CBPR’s principles must be applied within the context of the Belmont principles, as extended here, for example, by obtaining ongoing tribal input and consent at each stage of the project; by acknowledging tribes’ right to assess potential community risks and benefits; and by recognizing the role that tribes should play in deciding what constitutes equitable opportunity, harm and exploitation in their communities (Claw et al. 2018, Garrison et al. 2019).

Although not a true ethics theory, sovereignty is a concept that is frequently invoked as justification for extending research protections to tribal communities via strategies such as CBPR. The distributive justice theory of solidarity is rarely discussed in the research context. Yet, with its emphasis on social groups’ collective responsibilities for the defense, flourishing and survival of the group, it is a significant, and for tribes a more relevant and appropriate, ethical justification deserving of further exploration. Even beyond the research context, the interrelatedness between the dimensions of sovereignty and solidarity, how they are perceived and used to support tribal self-determination and ethics, is an area that could benefit from more scholarly work.

Footnotes

Declaration of interest statement

The authors report no conflict of interest.

Contributor Information

Mr BOBBY Saunkeah, Chickasaw Nation, Department of Health, Ada, 74820-2204 United States.

Ms Julie Beans, Southcentral Foundation, Anchorage, 99508-5919 United States.

Mr Michael Peercy, Chickasaw Nation, Department of Health, Ada, 74820-2204 United States.

Dr Vanessa Y Hiratsuka, Southcentral Foundation, Anchorage, 99508-5919 United States.

Dr Paul G Spicer, University of Oklahoma, Department of Anthropology, Norman, 73019-0390 United States.

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