It is impossible to discuss almost any aspect of informed consent in the tribal context without first touching on the Havasupai case. Based simply on the number of articles that reference it, it is evident that the case has played a large part in shaping the way in which informed consent is discussed, is being conceived of and required by tribes in the U.S. Indeed, some of the conceptions and requirements of informed consent in the tribal context might be traced back to the inadequacies of the consent obtained by ASU researchers in their genomic research with the Havasupai tribe. Perhaps it is partially due to the influence of the Havasupai case that so much of the literature reviewed comes from the perspective of biomedical and genomic science though, this may also be a result of the types of databases our study targeted (specifically Web of Science and PubMed). The inadequacy of the “broad consent” obtained by the ASU researchers in this case, in addition to the insufficiency of the information Havasupai participants were given and on which they were expected to make a decision as to whether to give or withhold their consent to participate, seems to be a significant influence behind requirements of increased specificity in the informed consent process.
Conception of Informed Consent
Based on the scope of this study, there appears to be three main themes in the conception of informed consent in the tribal context: the conception of informed consent as a process, its operation at various levels, and its viability as a defense against unethical research (as opposed to other suggested solutions, such as property law).
Notable is the conception of informed consent as a process and ongoing dialogue, requiring time, attention, a trusting relationship, and cultural awareness, if not cultural competence. This is in contrast to the “mainstream” paradigm of informed consent, which is framed more as a one-time transaction, and potentially less genuine. Rao seems particularly critical of informed consent as it is currently applied, referring to the “venerable doctrine” as “a charade, a collective fiction which thinly masks the uncomfortable fact that the subjects of human research are not actually afforded full information regarding the types of research that may be contemplated, nor do they provide meaningful consent” . Rao, it might be remembered, concludes that the language of property rights may provide more substantial protections. Yet, most of the other authors (Sahota, Drabiak, Smith-Morris, and others) seem to be seeking not an alternative to informed consent, but an update of it, or as Sahota describes it, a “paradigm shift”: a version of informed consent that is more critical, interactive, negotiable, and sensitive to cultural norms .
The idea of including lists of options as a way to combat broad, all-or-nothing consent, in favor of specific and negotiable consent, is put forth by many authors. Angal et al. provide an example of its use in their study, when their collaboration with the Oglala Sioux Tribe Research Review Board led to the creation of consent forms that did, indeed, present the participant with options, allowing them to either accept or decline involvement in specific study components . The study from Hiratsuka et al. suggests that options are desirable not only for procedures and specimen uses, but also for disposal or destruction . This may provide even more flexibility in allowing tribal peoples to participate in research, by addressing concerns about the unending use and re-use of specimens. In this way, researchers are not forcing individuals to choose between giving up their agency or compromising on their beliefs and giving up any possible benefits that participation in research could provide. However, there is also the concern, as voiced by Rao, that providing so many options might, instead of creating understanding and providing more choices and room for negotiation, result in information overload, making it difficult for individuals to take advantage of any of the options being presented . Balancing the provision of specific information and a variety of options, and the need for an easily-comprehended, jargon-free informed consent process may be challenging, but both needs are highlighted in the literature. Harding et al. in particular note the increasingly complex nature of modern research (specifically genomic and biomedical research), which may be so complicated that “even a fully competent non-specialist might not understand the disclosed information enough to make a truly informed decision” . Extra time and attention dedicated to explanation, and ensuring that participants are truly informed, is needed. The authors add that trained tribal staff and projects that help build “skills, understanding, data, or equipment” within a tribe may also be helpful in achieving adequate informed consent in the long-term . This recalls the idea of a paradigm shift in informed consent, away from the long, complex, legalistic forms to be filled out and signed, and towards the dedication of time, care, and long-term relationship-building to the process. Although the idea of informed consent forms with a list of options seems to be popular, one must wonder which of these conceptions it really fits into.
The conception of informed consent on different levels (individual, collective, and government-to-government) is a large part of how informed consent is being thought and written about in the tribal context. Perhaps this is because of the tension between the worldview that created informed consent as we know it, with its hyperfixation on individual rights, and a worldview that recognizes individuals within the context of a community, and how easily risk can be transferred from an individual to their community. This tension is representative of a fundamental cultural difference, as many authors point out, and perhaps, therefore, begs for a more culturally aware approach. Garrison, Hudson et al. and Tsosie et al. all note the particular risk in genetic and biomedical research, where data gleaned from one individual can be used to make inferences about the entire community, and possibly subjecting it, as a whole, to harm and stigmatization [5, 27]. Because of this, Tsosie et al. ask: If risk to the community is not communicated to individual participants, then is that participant giving truly informed consent ?
Many authors, including Smith-Morris and Tsosie et al. speak to the over-valuing of individual consent in research and the necessity of obtaining consent at both the individual and the collective level [20, 27]. Most come from the perspective, again, of biomedical and genomic research. Palosaari provides a helpful perspective from the social sciences/humanities: fields in which traditional, and culturally sensitive, knowledge may come up. It befits the researcher, in this context, to be aware and sensitive to the fact that individuals who hold certain knowledge or information may not have the authority to consent to sharing it . Where knowledge (language and sacred sites, for example) is regarded as a community resource rather than an individual’s competence, collective consent and cultural competence become incredibly important . There is the question, then, of who is authorized to give collective consent on the behalf of the community. Pensabene notes that the entity authorized to do so will vary, depending on the tribe and their elected form of governance, but tribal councils and other governing bodies, as well as community-guided or tribal IRBs, are referenced by a number of authors . Similarly, as a way to address both the individual and collective concerns related to the research being conducted, Harding et al. indicate that additional IRB approval from other organizations, like the IHS, may be required by tribes before giving their collective consent .
How tribes without federal or state recognition or Native peoples living outside of reservations can protect themselves is a question of great interest, since, as Champagne writes, the recognition of tribal sovereignty makes tribal IRB review and other means of tribal oversight of research possible . Since off-reservation Native communities and intertribal organizations do not have the legal status of tribal governments, researchers are not obliged to seek any kind of collective consent or to go through the tribal IRB process. This means that Native Americans living outside of reservations are protected only by whatever state and federal human subjects protocols are applicable . If these regulations do not address tribal needs and concerns, non-recognized tribes and other Native communities are left vulnerable. Despite Claw’s argument that researchers should extend recognition of sovereignty to all tribal groups, regardless of their legal status, they are not required to, and therefore, are unlikely to regard such advice . The study from Abadie & Heaney is interesting in this context, not only because they themselves exhibit the behavior of approaching off-reservation and urban Native individuals after having their research proposal rejected by a tribal government, but also because their results and arguments are a contrast to those presented by most other scholars reviewed here . The authors ask, as genomic research and biobanking become more routine in medical care, will Native Americans not living on reservations “be aware of their tribe[‘s] position regarding genomic research and, if so, would they cho[o]se to follow it or would they instead trust their medical providers and participate in the collection of genetic material?” . They report that their participants see the decision of whether or not to take part in research as an individual, not a tribal decision (or, as a matter of individual consent rather than collective, tribal consent) . The authors do acknowledge the controversy of the issue, stating that “other studies involving Native Americans living on reservations might lead to very different results” . Indeed, the emphasis placed on community consent and privacy by Alaska Native participants in Hiratsuka et al.’s study, and Native participants from the Southwest in Williams et al.’s study seem to indicate that this difference is present [21, 23].
At the government-to-government level, the informed consent process is approximated by the process of consultation. Significantly, however, the process does not actually require that consent from tribal governments be obtained, only that federal agencies hear tribal concerns about proposed projects . Several authors reference the idea that consultation is simultaneously “too much” and “too little,” meaning that it requires a great deal of time and resources from tribal governments, with no guarantee that the tribe’s position will be respected. As Miller writes, many tribal governments “do not have sufficient numbers of employees, government officials, and/or the funding to effectively study, plan, travel, and fully engage in all of these requested consultations” . Meanwhile, the federal government does not provide any real mechanisms for tribes to oppose proposals, and, similarly to the “mainstream” conception of informed consent at the individual and collective levels, the process becomes just “another procedural step before a federal agency can commence their action” .
Frustration with informed consent at all these levels leads to the question of whether, even with adaptations, it is really the best way for U.S. tribes to protect themselves from unethical research. Rao, arguing for the use of property law, writes that, as autonomous individuals, participants should “not only possess the power to contribute their biological materials, but also the right to help control the course of research, and to share in the resulting benefits or profits” . Using the language of body property may be uncomfortable for many, Rao acknowledges, because it can bring to mind the idea of slavery and of human beings as property. However, he writes, this type of language “might enable research subjects to regain power and a measure of self-sovereignty,” if informed consent has proved inadequate in this regard . Winters, meanwhile, frames culturally competent informed consent as the better option to protect participants in biomedical research . Like Winters, Pensabene maintains that “informed consent remains a stronger alternative to protect Native American test subjects” . Property rights, the author writes, “fail to protect the genetic information contained in the genetic material,” and property interests can be silenced when an individual agrees to transfer this material to another person or institution . Informed consent, unlike property law, recognizes the self-determination and autonomy (and, at other levels, collective or tribal sovereignty) of participants when they, with all the information required for them to make a truly informed decision, consent to provide their genetic material to researchers . This debate also reminds one of the tension between providing consent forms with long lists of options and engaging in a culturally appropriate informed consent process, which may take more time and effort, but perhaps avoid the risk of information overload. Here, too, we might ask what kind of paradigm each solution fits into: Would the use of property law make an already complicated and legalistic transaction even more so? And does a more culturally competent approach to informed consent contribute to a more critical process, based in dialogue and the building of relationships?
Requirements of Informed Consent
The overarching theme within the discussion of what is actually being asked of informed consent is the inadequacy of the “broad consent” that has been obtained by many researchers, including the ASU researchers involved in the Havasupai case. Mello & Wolf, as well as Rao, ask: If broad consent is insufficient, then what actually constitutes informed consent, especially in the genomic and biomedical context [12, 18]? Because the Havasupai case was settled outside of court, it may leave a moral and ethical indication of what informed consent should involve, but not a legal precedent. Of particular interest here is Pensabene’s discussion of the Common Rule, and how the district court involved in the Havasupai case chose to focus on the broad consent that was given, instead of how informed that consent actually was . If they had considered the Common Rule, and accordingly judged the consent given based on whether the information provided to participants was sufficient, instead of whether consent (regardless of how informed it was) was given or not, Pensabene indicates that the result may have been quite different . The Common Rule’s requirement of specifics as to the risks and benefits of research, the procedures involved, confidentiality, informing participants of results and changes that may affect their willingness to continue involvement, etc. seems to indicate the inadequacy of “broad consent,” even according to “mainstream” standards. As we discuss the areas in which increased specificity is being asked for by U.S. tribes, it might be worth noting how many of these requirements are indeed expansions to the way informed consent is perceived according to the Common Rule and other standards, and how many of these requirements overlap.
One of these areas where increased specificity is being required is the ownership of data and samples given by tribal participants for the purposes of research. It has already been noted that Caplan & Moreno’s proposed solution to the complexities that present themselves here, of considering research participants “donors” who give up their rights to their specimens and not “subjects” who have a stake in what happens to their bodily tissues and genetic material, might be seen as a way of avoiding tribal concerns altogether . This attitude may already be part of the mainstream: As Garrison explains, consent forms that don’t specifically address ownership almost automatically “[make] samples the property of the research institution, leaving participants with little control over research uses” . This approach, which “emphasizes the split of the biological material from the person as soon as it is removed and therefore gives the person no rights in the now separate material”, is antithetical to the worldview of many Indigenous peoples . Of particular interest here is Sahota’s study of Native American perspectives on specimen disposition. Specifically, the author’s exploration of Native American perceptions of who is considered to be the owner of specimens once they are taken. It is reported that 50% of the participants believed the provider of the specimen to be the owner, and 44% believed the researcher to be . Participants also had a variety of views about how informed consent affects ownership, some viewing the informed consent form as a transfer of property rights, and others viewing it as a written agreement on the limitations of how a specimen may be used . This variety of perspectives may indicate that, regardless of the actual position taken, consent documents need to specifically state what expectations there are with regard to ownership. Without making those expectations explicit, neither researchers nor Indigenous participants (or their tribal representatives) can negotiate for the kind of ownership that is needed, and confusion and misunderstanding may cause a multitude of problems.
Palosaari , once again providing a perspective from outside the context of biomedical science, draws a close relationship between informed consent and intellectual property rights . The author argues that researchers, in order to ensure that the consent process has indeed been informed, must “inform participants of their rights regarding data” . Palosaari cites the Navajo Nation Code, which “explicitly claims ownership over cultural intellectual property,” as an example of the way in which tribes are already giving attention to the issues that might arise if ownership is not addressed in the consent process . Palosaari also looks at the professional and ethical standards that are already expected of researchers from the social science and humanities fields. Oral historians, for example, have a set of professional standards that expressly give ownership and copyright of interviews to the interviewee, unless they transfer those rights to another individual or institution . However, in many fields, existing protocols are insufficient for ethical research involving Indigenous communities.
In biomedicine and genomics as well, it may not be sufficient for researchers to only inform individuals and tribal communities of what ownership and rights they have to the data and samples they provide. It may be a responsibility of researchers that they assert tribal communities as the owners, or at least shared-owners, of data and specimens collected. This is part of respecting tribal sovereignty and of being culturally aware enough to recognize that tribal individuals and communities are the only ones who can make decisions about what happens to their data and their specimens. For example, Harding et al. describe a model material data-sharing agreement (MDSA) for the use of researchers and tribes. The MDSA is meant to assure that the materials and data collected by researchers “are and remain tribal property” and to assert that they “are not to be shared with third parties without the written permission of tribal authorities” . Such an agreement between researchers and those authorized to give collective consent for their community, by making clear statements about ownership and by deliberately affirming the property rights of the tribe, may go a long way in avoiding misunderstandings. Chadwick, Copeland et al. report that many tribal IRBs and health boards in Oklahoma (where the authors conducted their research) already proactively and specifically address ownership, by including it in their contracts with researchers . Again, by directly asserting and affirming the rights to and ownership of data and specimens by tribes, these documents can disrupt the common assumption that researchers and institutions become the owners of data and specimens once a tribal community or individual has consented to participate in research.
The methods by which researchers plan to procure samples and/or data (drawing blood samples, distributing questionnaires, conducting interviews or focus groups, etc.) is also mentioned by a few authors, including Palosaari and Harding et al. [22, 13]. This may seem like the most obvious area in which researchers should be specific: How can anyone consent to involvement in a study without being aware of the procedures they are being asked to undergo? Perhaps this is self-evident, because it is less-often a subject of discussion in the articles selected. Palosaari writes that researchers “should inform participants of the purposes of the research, provide the expected duration of participation, and describe the procedures” ). The American Anthropological Association, for example, notes that the lack of transparency about research goals and methodology impacts whether consent is fully informed . Harding et al., in their MDSA model, include a section on the types of material and data that will be collected by researchers. This can include data of many kinds, including sampling results, demographic attributes, organic material, transcriptions of interviews and focus group discussions, questionnaires, etc. . The provision of this information, perhaps especially the expected duration of the study, is incredibly important.
The risks and benefits participants can expect as part of their participation in research, and how these will be communicated to participants, is another area in which increased specificity is being requested. Part of addressing this issue may be in dismantling the false binary often presented of either agreeing to any and all components of research, or opting out and being excluded from research, and from its possible benefits. As previously mentioned, consent forms that provide lists of options, or a consent process that includes and welcomes negotiation, may go some way in ensuring that participants can receive the benefits of research, without being coerced into procedures they might otherwise be reluctant to consent to. Another part of this is simply communicating to potential participants what the risks, and benefits, of participation might be. This is already required by the Common Rule, but as we have already seen, these standards might not be sufficient in the U.S. tribal context. The Common Rule, once again, concentrates in the potential risks and benefits to the individual. Indeed, Chadwick, Copeland, et al. (2019), writing about the reasons that their tribal partners withheld their consent to participate in genomic research, report that the proposed consent form “stated that if a genetic abnormality were to be discovered, individuals would not be notified of the results, nor would any genetic education or counseling be provided.” . Some tribal IRBs objected to this, on the basis that participants in research should be notified of abnormalities and that researchers should share potentially beneficial information, if discovered . Although potential risks and benefits to the individual are important, the Common Rule does not address possible cultural harms, or the risks and benefits that research might present to the community as a whole. Harding et al. (2012), for example, include in their MDSA model a section about the “risks and benefits of research to the tribal community,” in which the risks and benefits expected from research should be summarized, covering risks and benefits for both individuals and for the community . Likewise, researchers should consider benefits not just to the individual, but to the community as a whole.
Finally, there is the necessity of reporting results back to the tribal community, and ensuring that the benefits of the research and knowledge gained are made accessible. As Winters argues, the informed consent process should include processes for reporting findings to the participants . In practice, this is not always done: Palosaari notes, for example, that linguists have a professional obligation to make their research available to the public, but do not have a standard that addresses the dissemination of research to the participants themselves, or consideration of research benefits to participants . Yet, this is an elementary part of ensuring that participants see the benefits of research, and one that researchers must consider and plan for since the “mainstream” methods of publishing research (in academic journals, conferences, etc.) may not be accessible for many Native communities and individuals. This is, in some ways, related to the ownership of data and specimens already discussed, in that both involve giving the results of the research (and the decision of what to do with those results) back to the community, whether that is done by returning specimens, specifying tribal ownership of data, or simply by ensuring that results are published and shared with the community in an accessible way.
The storage, security, and treatment of specimens and/or data is a well examined area in which greater specificity is required for informed consent. This may include who will have access to specimens and data, plans for the disposal or return of specimens and data, whether tribes and participants will be contacted when and if researchers wish to use their samples for different research directions, etc. Once again, the actions of the ASU researchers involved in the Havasupai case seem to have played a large role in bringing this issue to the forefront. The researchers’ description of the study as relating to diabetes, and the broad consent forms obtained, allowed the researchers perhaps technical (but not ethical) permission to use the samples for a variety of other secondary uses that the Havasupai, if they had been provided with the specifics, would not have agreed to . According to Drabiak , a breach of confidentiality happened when the original ASU researchers allowed others, including those from other institutions, to access the Havasupai samples and the codebooks that allowed for identification of the samples . These breaches are particularly egregious, because the informed consent document signed by the participants asserted that research would be carried out at ASU and that all information would be kept private: This seems to have been not simply a case of the informed consent document not being specific enough, but of researchers violating even the general protections the document did provide .
It is not surprising, then, to see calls for increased specificity on the subjects of storage, security, re-consenting for secondary research, etc. Caplan & Moreno report, as of 2010, that, according to federal regulations, samples that are de-identified and cannot be traced back to an individual are within the rights of researchers to be re-used in studies not related to the original informed consent document . Indeed, if a sample is anonymized, it may not be possible to seek informed consent again. This bypasses the participant’s right to make those decisions for themselves but also ignores the role of tribal authorities and IRBs in determining whether the proposed research poses a risk to the community. It also highlights, once again, the basis of “mainstream” informed consent on individual rights and risks, not acknowledging collective or cultural harms that may occur as a result of research. This is also relevant in fields where research may involve traditional or culturally sensitive information. Consent, Palosaari writes, cannot really be considered voluntary “without a complete understanding of who will access the data [provided by the participant] and how the data will be used” . And, as in biomedical research, there are issues with contacting participants for obtaining informed consent for new research directions: As new technologies make new research possible, researchers may have difficulty obtaining new consent if they cannot contact the participant or if the research environment is difficult to get to . And again, it may be difficult to re-consent individual participants if samples are completely anonymized.
A few solutions to concerns about the misuse of specimens include a “destroy by” date, the option to have a sample destroyed after the participant’s death, or options for specimen re-use and storage on informed consent forms . In fact, Chadwick, Copeland et al. report that most tribal boards in Oklahoma now require that consent forms include an expiration date, after which researchers must obtain new consent, or otherwise return or dispose of the sample provided . Additionally, researchers must seek IRB re-approval for continued or secondary use. Proposal and consent forms must also state specifically the disease being studied, how samples will be used, as well as any secondary uses of specimens and how they will be stored and secured. Most of these tribal boards also require that third parties, or other researchers interested in utilizing the specimens, must seek a new research agreement and IRB approval. The expiration date, or the date after which samples will be destroyed or returned to the tribe, not only guards against unauthorized uses of the specimens, but also gives the tribe a timeframe during which their oversight will be needed, and a date by which they can expect research data to be analyzed and reported .
Also, significant, and closely related to the storage and possibilities for future uses of specimens and data, is the clear and specific communication of protocols affirming the right of participants to withdraw from research at any time. Once again, this seems to be complicated by the de-identifying of specimens and data, which can prevent participants from having their samples returned or destroyed if they decide to withdraw their consent and researchers from being able to contact participants to seek new informed consent for new research. Deeply concerning are reports that many researchers’ protocols may not sufficiently address this: Drabiak cites Leslie E. Wolf et al., relating that some research protocols clarified that researchers would remove identifiers from a sample if a subject requested to withdraw, but that they would not actually withdraw the sample [12, 19]. Others put restrictions on withdrawal and state that de-identified samples would not be withdrawn, or that samples would not be withdrawn if the researchers deemed them “necessary for the integrity of the project” . Winters refers to the Havasupai case, where the participants requested to withdraw from research when they learned about the ways in which their specimens were being used and shared. This request was denied .
Palosaari, speaking specifically about the field of linguistics, writes about the necessity for researchers to consider how withdrawal requests may affect their methodology to plan for how these requests will be handled before research begins and to know how to explain their withdrawal protocols to participants . This is particularly important because of the tension between individual and collective rights in this context that can create a great deal of complexity. On the one hand, a participant may be requesting to withdraw because they do not wish to reveal communally-held traditional or culturally sensitive knowledge . On the other hand, if the goal of the research is language documentation for the benefit of the community, withdrawal and destruction of data may be antithetical to the goals of both the researcher and the community they are working with . The same attention might be applied in biomedical and genomic science to help ensure that participants are, in fact, able to exercise their right to withdraw from research. Clashing worldviews and conceptions of ownership may be contributing to the manner in which this issue has been handled in biomedicine and genomic research in the past: If researchers are working from a paradigm in which specimens are no longer connected to their providers, and therefore the use of their specimens has no ability to harm them, then of course simply de-identifying them might seem like a sufficient response to a request to withdraw from research. However, if one is working from a paradigm in which bodily tissues, blood, and other materials are still considered part of the individual who provided them, and in which community and cultural harms are acknowledged in addition to individual risks and harms, such a response is inappropriate.
 In fact, the authors entitle their article “Overvaluing individual consent ignores risks to tribal participants.”