The commentary recently published in the American Journal of Bioethics (AJOB urges revisions to the Common Rule, advocating for the incorporation of CARE Principles to address collective harms and enhance the ethical engagement of Indigenous Peoples in the use of AI and machine learning (ML) in health research.
Titled “Common Rule Revisions to Govern Machine Learning on Indigenous Data: Implementing the Expectations,” the paper calls for critical revisions to the Common Rule regarding the use of artificial intelligence and machine learning in health research involving Indigenous Peoples. The commentary recommends incorporating the CARE Principles for Indigenous Data Governance into research designs. This approach aims to address collective harms and ensure proper engagement with Indigenous communities.
The Common Rule, established in 1991, is a set of federal regulations in the United States that govern the ethical conduct of research involving human subjects. Based on the ethical principles outlined in the Belmont Report for biomedical and behavioral research involving humans, the Common Rule provides guidelines for institutional review boards (IRBs), informed consent, and other essential aspects of research ethics to protect the rights and welfare of participants.
Highlighting notable gaps concerning Indigenous Peoples’ rights and protections, particularly in light of emerging technologies like AI and ML that utilize data-centric approaches, the commentary argues that the Common Rule is deficient in its provisions for ensuring Indigenous authority, robust ethical oversight, and appropriate engagement of Indigenous Peoples in research.
Concerns raised about the use of AI and ML in health research involving Indigenous communities include issues of data permanence and the potential for misuse, which the paper argues can significantly exacerbate group harms. The commentary argues that such harms “threaten trustworthy, transparent and equitable research…resulting in lasting effects on trust, leading to limited participation and representation in future research, which exacerbates disparities for marginalized communities.”
Nicole Halmai, a co-author of the open peer commentary, highlights the importance of researchers taking into account the historical context and the existing mistrust between Indigenous communities and the biomedical research field. She is a postdoctoral researcher at UC Davis, affiliated with both the Genome Center and the Comprehensive Cancer Center; and a member of the Navajo Nation.
“I think we have to take into account our communities’ histories with the biomedical community,” Halmai explains. “Unfortunately, the results of many biomedical studies have been utilized to isolate our communities and have tried to define us in ways that our community values don’t align with.” She adds that historically, Indigenous communities have often participated in research in which they or their communities have not received any direct benefit.
Halmai continues that the Common Rule assumes that the individual participants will bear the most potential harms from the research. “The Common Rule has excellent policies in place for protecting the individual participants, but I think there is a critical gap when thinking about how the communities that are represented by the participants in a research study might also experience harm,” she states, highlighting the lack of regulations that allow Institutional Review Boards (IRBs) to assess whether or not a research study provides sufficient collective protections.
“The people who participate are individuals themselves, but we know that they come in with different identities that represent different communities…so when it comes to group harms, it’s important to think about how research results communicated back to society are going to affect those communities who are represented by the participant and about the biases that can come out of research design,” explains Halmai.
The commentary emphasizes that failing to consider the collective harms associated with emerging technologies may undermine the right of Indigenous Peoples to self-determination, a right affirmed by the United Nations Declaration on the Rights of Indigenous Peoples (UNDRIP) and the CARE principles for Indigenous Data Governance.
It asserts that it is the responsibility of the researchers to anticipate and avoid group harms in research, a responsibility that it argues can be upheld through several ways by implementing CARE.
Proposed Framework for Revision: CARE Principles
The CARE Principles for Indigenous Data Governance (Collective Benefit, Authority to Control, Responsibility, Ethics), published by the Global Indigenous Data Alliance (GIDA) in 2019, offer a framework for evaluating and preventing group harms associated with interactions involving Indigenous peoples. These principles aim to provide minimum standards to guide ethical research practices and ensure respect for Indigenous rights and sovereignty.
The paper advocates for a systematic approach to revising the Common Rule, highlighting the need to adjust Institutional Review Board (IRB) review processes to require the integration of CARE Principles into research design to address collective harms. It provides recommendations to researchers and research institutions to guide the integration of CARE into their practices.
As Halmai mentions, “Now moving forward, considering group harms and addressing that gap in the Common Rule is essential for ensuring that the benefits come back to those communities.” She adds, “Ultimately, we want our communities to benefit from the research in which we participate…For me, the CARE principles represent a tangible way to achieve that, ensuring that Indigenous values and community-centered research are placed at the forefront of how we design research.”
She hopes that following this publication, institutions that conduct research with Indigenous populations will prioritize protecting against group harms, starting by incorporating the CARE principles into their IRB review.
Read the full open peer commentary here.