Informed Consent and Cultural Dignity: Rethinking Research Ethics through the Havasupai Tribe Case – Toward Collective Consent Models

Carolina Ruiz

Law, History and Society, 19 May 2025

Abstract

This article examines the limitations of Western individualistic informed consent frameworks through a critical analysis of the Havasupai Tribe v. Arizona State University Board of Regents case and its broader implications. By exploring the tension between Western legal paradigms and Indigenous collectivist worldviews, this research demonstrates how prevailing consent models systematically fail to recognize cultural dignity and communal harm as fundamental rights. This article situates this failure within a historical pattern of research abuses against Indigenous populations while drawing parallels across multiple domains: Fourth Amendment jurisprudence, digital privacy regulation, and international approaches to Indigenous research ethics. Through these comparisons, the analysis reveals systemic deficiencies in how American legal frameworks conceptualize meaningful consent for vulnerable populations with collective identities. Based on comparative analysis of international models and examination in emerging challenges in genetic and digital research, the article proposes comprehensive reforms including cultural impact assessments, collective consent mechanisms, and ongoing consent processes that honor Indigenous sovereignty. This contribution advances a more nuanced ethical framework that protects cultural dignity while acknowledging the inherently communal nature of harm in Indigenous contexts and emerging technological landscapes.

Editor’s Note:
We recognize a growing literature which argues [in whole or in part] that norms requiring the individual, prior, free, express and informed consent of persons to be involved in research must accommodate notions which integrate terms such as ‘community-driven’, ‘decolonized’, or ‘culturally-appropriate’ and which insist that consent processes “prioritize local/indigenous values and protocols.” As an editorial policy, we have decided to group such literature together in this section of the digest.

More broadly, we recognize that this literature raises critically important issues around consent integrity. Our Center for Informed Consent Integrity is actively developing a position on this matter, mindful of core guidance in research involving human participants overall, and selected instruments such as the Universal Declaration on Bioethics and Human Rights [2005] which notes:

Article 12.  Respect for cultural diversity and pluralism
The importance of cultural diversity and pluralism should be given due regard. However, such considerations are not to be invoked to infringe upon human dignity, human rights and fundamental freedoms, nor upon the principles set out in this Declaration, nor to limit their scope.

We will keep readers advised of our progress. If you have an interest in participating in our working group, please contact Paige Fitzsimmons [paige.fitzsimmons@ge2p2global.org].

Informed consent in global outreach
Book Chapter
Meseret E. Kassa, Morris E. Hartstein
Global Oculoplastics: A Guide to the Care of Patients in Resource-Poor Environments, 2025; pp 93-95
Abstract
Informed consent in resource-poor settings is equally important as in Western settings. However, language and cultural barriers exist, making it much more challenging to obtain. This chapter will discuss the potential barriers, enhance understanding and respect of the culture, and discuss methods to modify the process in order to successfully obtain informed consent in resource-poor environments.

Editor’s note: The barriers discussed in this chapter include understanding and respecting community norms, cultural and religious variations, communities with strong social interdependence family structure, informed consent for women, deference to physician, rejection of medical interventions, confidentiality, justice, and patient anonymity, and language and illiteracy.

Women’s Decision-Making Autonomy and Free and Informed Consent in Accessing Reproductive Health Care in Community Settings: A Qualitative Study in the N’djili Health Zone (Kinshasa City, Democratic Republic of the Congo)
Bertine Mbongopasi Ekeni, Koto-Te-Nyiwa Ngbolua, Bernard Ntoto Nkunzi, Félicien Mukandu Basua Babintu
Mechanisms and Machine Science, 14 November 2024
Abstract
The aim of this study is to identify factors influencing the improvement of decision-making autonomy and free, informed consent among women in the N’djili Health Zone. A cross-sectional analytical study was conducted from September 25 to October 26, 2022. Results revealed that participants faced challenges in exercising autonomy over reproductive health decisions, impacting their capacity to give informed consent. Additionally, a lack of information and awareness about reproductive health rights and options perpetuates existing inequalities. Developing educational and awareness programs that inform women of their rights, while involving the community and health professionals, are crucial to fostering sustainable change.

Clinicians’ experiences of obtaining informed consent for research and treatment: a nested qualitative study from Pakistan
Research
Rakhshi Memon, Muqaddas Asif, Bushra Ali Shah, Tayyeba Kiran, Ameer B Khoso, Sehrish Tofique, Jahanara Miah, Ayesha Ahmad, Imran Chaudhry, Nasim Chaudhry, Nusrat Husain, Sarah J L Edwards
BMC Medical Ethics, 15 November 2024
Open access
Abstract
Background
Informed consent is considered to be the standard method for respecting the autonomy of individual participants in research and practices and is thought to be based on several conditions: (1) providing information on the purpose of the research or a specific treatment, what it will entail, (2) the participants being mentally competent to understand the information and weigh it in the balance, and (3) the participants to be free from coercion. While there are studies of informed consent in other countries, especially Low and Middle Income Countries (LMICs), this study explored the experiences of clinicians regarding the process of obtaining informed consent to participate in a Randomised Controlled Trial (RCT) in particular and treatment in general in healthcare settings, both general and mental health, specifically focusing on the tension between individualistic concept of autonomy and collectivist values in cultures such as Pakistan.
Methods
Qualitative interviews with 20 clinicians from healthcare settings in Pakistan who also served as recruiters in a suicide prevention RCT in Pakistan. The interviews were guided by semi-structured topic guide. All interviews were audio-recorded and transcribed verbatim.
Results
The interviews revealed that shared decision making was more morally important than individual autonomy, the role of the family played a dominant part in the consent-taking procedure, the decision of the elder and/or family patriarch took prominence, and that clinician-researchers encountered significant challenges in consent process in Pakistan, while recruiting patients into the trial as well as during routine treatment processes in healthcare settings. Four distinct themes emerged which were (1) Family deciding for patients, (2) Benefits of involving family in consent process, (3) Gender disparity in consent process, (4) Challenges experienced by clinician-researchers during consent process in Pakistan.
Conclusions
The concept of consent is generally considered important in many cultures, however, there are two strands of understanding. There seems to be consensus that participant agreement is necessary to protect the participant but with regards to autonomy there are significant cultural differences whether it is the right for autonomy of the individual (individualistic concept) or family, community, or expert authority in other cultures. In Pakistan clinician-researchers sometimes preferred one approach and sometimes the other as they appreciated the interests of the patient to be.

The Ubuntu Way: Ensuring Ethical AI Integration in Health Research
Review
Brenda Odero, David Nderitu, Gabrielle Samuel
Wellcome Open Research, 28 October 2024
Open Access
Abstract
   The integration of artificial intelligence (AI) in health research has grown rapidly, particularly in African nations, which have also been developing data protection laws and AI strategies. However, the ethical frameworks governing AI use in health research are often based on Western philosophies, focusing on individualism, and may not fully address the unique challenges and cultural contexts of African communities. This paper advocates for the incorporation of African philosophies, specifically Ubuntu, into AI health research ethics frameworks to better align with African values and contexts.

This study explores the concept of Ubuntu, a philosophy that emphasises communalism, interconnectedness, and collective well-being, and its application to AI health research ethics. By analysing existing global AI ethics frameworks and contrasting them with the Ubuntu philosophy, a new ethics framework is proposed that integrates these perspectives. The framework is designed to address ethical challenges at individual, community, national, and environmental levels, with a particular focus on the African context.

The proposed framework highlights four key principles derived from Ubuntu: communalism and openness, harmony and support, research prioritisation and community empowerment, and community-oriented decision-making. These principles are aligned with global ethical standards such as justice, beneficence, transparency, and accountability but are adapted to reflect the communal and relational values inherent in Ubuntu. The framework aims to ensure that AI-driven health research benefits communities equitably, respects local contexts and promotes long-term sustainability.

Integrating Ubuntu into AI health research ethics can address the limitations of current frameworks that emphasise individualism. This approach not only aligns with African values but also offers a model that could be applied more broadly to enhance the ethical governance of AI in health research worldwide. By prioritising communal well-being, inclusivity, and environmental stewardship, the proposed framework has the potential to foster more responsible and contextually relevant AI health research practices in Africa.

A qualitative study on informed consent decision-making at two tertiary hospitals in Uganda: Experiences of patients undergoing emergency surgery and their next of kin
Research Article
Olivia Kituuka, Erisa Sabakaki Mwaka, Ian Guyton Munabi, Moses Galukande, Nelson Sewankambo
SAGE Open Medicine, 22 June 2024
Open Access
Abstract
Background
In emergency situations, patients and their next of kin must make complex medical and ethical decisions in a quick and timely way.
Objectives
To describe the decision-making process during informed consent for emergency surgery among patients and the next of kin of patients who have undergone emergency surgery.
Methods
Consecutive sampling of 39 participants and in-depth semi-structured interviews were conducted at two tertiary teaching hospitals in Uganda. There were 22 patients and 17 next of kin of patients who had undergone emergency surgery within 24–72 h. Responses about decision-making were coded into themes using the social constructivist theory and phenomenological approach.
Results
There were four emergent themes; decision-makers, people consulted, documentation of the consent and factors influencing decision-making. Most patients and next of kin made decisions on their own and documented the consent for themselves. Other family members and doctors were consulted during the decision-making process. Decision-making was influenced by reassurance of good outcomes of surgery and disclosure by the doctors.
Conclusion
Decisions were made collaboratively with the patient at the center but with input of health personnel, the next of kin
and other family members. A communitarian approach combined with shared decision-making between the doctor and the patient and next of kin with adequate discussion and disclosure of information in simple language would improve decision-making for patients and their next of kin.

Communities and Informed Consent in Medical Research in Africa
Book Chapter
Yaw A. Frimpong-Mansoh
An African Research Ethics Reader, 2024 [Brill]
Abstract
This chapter seeks to clarify the imperative role of community in the complex process of obtaining informed consent in clinical research in African societies. Although the communal character of African ethics and cultures have been much discussed in recent research ethics scholarship, there is still a lack of clarity on the role and justification of community members in the complex process of obtaining informed consent in medical research. The Western liberal individualistic system of ethics is seen as antithetical to the African communal system. The Western system seems concerned that the communal system encourages intrusive paternalism and infringement upon the autonomous rights of the individual. It is argued here however that community involvement in clinical research in Africa is nothing but another justified level of institutional protection comparable to the roles of REC s in efforts to safeguard against exploitative and abusive unethical practices.

Exploring the consent process among pregnant and breastfeeding women taking part in a maternal vaccine clinical trial in Kampala, Uganda: a qualitative study
Research
Agnes Ssali, Rita Namugumya, Phiona Nalubega, Mary Kyohere, Janet Seeley, Kirsty Le Doare
BMC Medical Ethics, 16 May 2024
Open access
Abstract
Background
The involvement of pregnant women in vaccine clinical trials presents unique challenges for the informed consent process. We explored the expectations and experiences of the pregnant women, spouses/partners, health workers and stakeholders of the consent process during a Group B Streptococcus maternal vaccine trial.
Methods
We interviewed 56 participants including pregnant women taking part in the trial, women not in the trial, health workers handling the trial procedures, spouses, and community stakeholders. We conducted 13 in-depth interviews and focus group discussions with 23 women in the trial, in-depth interviews with 5 spouses, and 5 women not in the trial, key informant interviews with 5 health workers and 5 other stakeholders were undertaken.
Results
Decision-making by a pregnant woman to join a trial was done in consultation with spouse, parents, siblings, or trusted health workers. Written study information was appreciated by all but they suggested the use of audio and visual presentation to enhance understanding. Women stressed the need to ensure that their male partners received study information before their pregnant partners joined a clinical trial. Confidentiality in research was emphasised differently by individual participants; while some emphasised it for self, others were keen to protect their family members from being exposed, for allowing them to be involved in research. However, others wanted their community participation to be acknowledged.
Conclusion
We found that pregnant women make decisions to join a clinical trial after consulting with close family. Our findings suggest the need for an information strategy which informs not only the pregnant woman, but also her family about the research she is invited to engage in.

Please refer to the editor’s note regarding ‘Relational, Culturally-Conditioned, Decolonized Consent’ here.

The ethics of research informed consent from the Kyrgyz perspective: A qualitative study
Tamara Kudaibergenova
Developing World Bioethics, 14 May 2024
Abstract
To ensure informed consent is tailored to ethnic Asian communities, it is necessary to establish an ethical foundation that is relevant to the specific populations. We hypothesized that certain communitarian factors unique to traditional Kyrgyz culture may influence an individual’s decision to participate in research. Guided by Seedhouse’s (2005) Rational Field Theory, we conducted qualitative, in-depth interviews with cultural experts in Kyrgyzstan to identify the ethical foundations of decision-making for informed consent in Kyrgyz culture. The results indicate that Kyrgyz people have a distinctive decision-making style influenced by their nomadic culture and history, which values and prioritizes family integrity and reputation. These findings indicate that a multidimensional approach based on socio-cultural sensitivities is necessary to assess the appropriateness of consent procedures. We believe our results may have implications for revising the guidelines of local and regional research ethics committees in Kyrgyzstan and other Central Asian countries.

Please refer to the editors note regarding ‘Relational, Culturally-Conditioned, Decolonized Consent’ here.