Research involving and impacting Indigenous Peoples is often of little or no benefit to the communities involved and, in many cases, causes harm. Ensuring that Indigenous research is not only ethical but also of benefit to the communities involved is a long-standing problem that requires fundamental changes in higher education. To address this necessity for change, the authors of this paper, with the help of graduate and Indigenous community research assistants, undertook community consultation across (...) their university to identify the local and national ethical needs of Indigenous researchers, communities, and Elders. This paper provides an overview of the consultation process, the themes that emerged from the consultations, and a model of the Wholistic Indigenous Research Framework that emerged. (shrink)

The introduction of the National Health and Medical Research Council guidelines for the ethical conduct of Indigenous health research: Values and Ethics: guidelines for ethical conduct in Aboriginal and Torres Strait Islander health research (NHMRC, 2003), has prompted renewed debate about the ethical assessment of Indigenous health research in Australia. Concern has been expressed that these guidelines provide inadequate protection of Indigenous interests and that their introduction will result in a rolling back (...) of important Indigenous research reform gains of the past three decades. Another view is that the participatory focus of the Guidelines will help ensure that key Indigenous values are positioned as central to the development of research involving Indigenous interests. In this article we provide an overview of recent commentary on the Guidelines, and canvass practical proposals for their implementation into practice. In particular, we present a case for applying the Values and Ethics Guidelines as a foundation for establishing negotiated research agreements between Indigenous peoples and professional researchers at the local community level. The intention of this proposal is to give voice to the concerns and perspectives of Indigenous peoples through research, and to provide a framework for monitoring research after ethics approval has been granted. (shrink)

Research ethics guidelines grew out of several infamous episodes where research subjects were exploited. There is significant international synchronization of guidelines. However, indigenous groups in New Zealand, Canada and Australia have criticized these guidelines as being inadequate for research involving indigenous people and have developed guidelines from their own cultural perspectives. Whilst traditional research ethics guidelines place a lot of emphasis on informed consent, these indigenous guidelines put much greater emphasis on (...) interdependence and trust. This article argues that traditional guidelines are premised on relationships of equal power, and that often the researcher has more power that is not fully equalized by providing information. Where there is a relationship of unequal power, then focusing on interdependence and trust is more likely to achieve ethical safety. We illustrate this thesis by describing the detail of a research project looking at the use of interpreters, where we video-recorded live consultations and then interviewed the patient, interpreter and doctor. We conclude by suggesting that mainstream research ethics guidelines should pay more attention to the development of a trustworthy relationship between subject and researcher, and that, following the lead from clinical medicine, we should develop a culturally competent ethical framework for research on human subjects. (shrink)

Institutional ethical oversight of research involving humans conducted at Canadian universities is guided by the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2). Beginning in 2010, the TCPS2 included a chapter specific to research involving First Nations, Inuit, and Metis Peoples of Canada, which is intended to provide a framework for the ethical conduct of research with Indigenous communities. These institutional guidelines reflect progress in the way research is done with (...) class='Hi'>Indigenous communities. However, concerns remain about the ways in which these guidelines are taken up, interpreted, and operationalized by institutional research ethics boards, which include creating tensions and challenges for Indigenous scholars conducting research together with their own communities. The purpose of this paper is to describe some of the challenges and conflicting expectations we faced as an Indigenous doctoral student and non-Indigenous academic supervisor, navigating the axiological differences between institutional ethical oversight and community relational ethics with the aim of supporting other Indigenous scholars who may experience similar challenges and influencing policy change and relational engagement in ethical review processes in university settings. We outline the various critiques of institutional oversight of Indigenous research, share several examples of how we experienced the tensions and potential/actual harm that institutional power interference caused in the review process and how we worked through them, and demonstrate how, in our experience, it was not bureaucratic institutional procedures that protected community participants from risk, it was community relationships. We conclude by discussing implications and offering our suggestions for change. (shrink)

Governance of biomedical research in the United States has been characterized by ethical individualism, a mode of reasoning that treats the individual person as the center of moral concern and analysis. However, genomics research raises ethics issues that uniquely affect certain genetically related communities as collectives, not merely as aggregates of individuals. This is especially true of identifiable populations—including Indigenous Peoples—that are often minoritized, socially marginalized, or geographically isolated. We propose an alternative, complementary framework based (...) on the United Nations Declaration on the Rights of Indigenous Peoples (UNDRIP) (2007), which explicitly recognizes both individual and collective rights. We use the CARE Principles for Indigenous Data Governance as a case study to show how this UNDRIP‐based framework can complement the individual‐focused national standard for research oversight represented by the Belmont principles, thereby better protecting Indigenous Peoples’ rights and interests in genomic data. (shrink)

This forward-looking resource offers readers a modern contextual framework for conducting social science research with indigenous peoples. Foundational chapters summarize current UN-based standards for indigenous rights and autonomy, with their implications for research practice. Coverage goes on to detail minimally-invasive data-gathering methods, survey current training and competency issues, and consider the scientist’s role in research, particularly as a product of his/her own cultural background. From these guidelines and findings, students and professionals have a robust (...) base for carrying out indigenous research that is valid and reliable as well as respectful and ethical. Among the topics covered: -/- · Cultural theories and cultural dominance. -/- · The legal framework of research in indigenous contexts. -/- · The role of language within indigenous peoples’ cultural rights. -/- · Methodology: how to optimally collect data in the field. · Researchers’ influence and philosophy of science. -/- · Learning how to prepare research in indigenous contexts. -/- Research Methods in Indigenous Contexts is an important reference benefitting a wide audience, including students and researchers in the social sciences, humanities, and psychology; decision-makers of NGOs and GOs that act with regard to humanitarian aid, for tourism projects, or any other contingency with indigenous contexts; and policymakers interested in the aspects of human activity upon which indigenous cultural concerns are based. (shrink)

How does one decolonize and reclaim the meanings of research and researcher, particularly in the context of Western research? Indigenous communities have long experienced oppression by Western researchers. Is it possible to build a collaborative research knowledge that is culturally appropriate, respectful, honoring, and careful of the Indigenous community? What are the challenges in Western research, researchers, and Western university methodology research training? How have ‘studies’ – critical anti-racist theory and practice, cross-cultural (...) class='Hi'>research methodology, critical perspectives on environmental justice, and land-based education – been incorporated into the university to disallow dissent? What can be done against this disallowance? According to Eve Tuck and K Wayne Yang’s suggestion, this article did not use the concept of decolonization as a substitute for ‘human rights’ or ‘social justice’, but as a demand of an Indigenous framework and a centering of Indigenous land, Indigenous sovereign... (shrink)

Background Many indigenous people have died or been harmed because of inadequately monitored research. Strong regulations in Human Research Ethics (HRE) are required to address these injustices and to ensure that peoples’ participation in health research is safe. Indigenous peoples advocate that research that respects indigenous principles can contribute to addressing their health inequities. This scoping literature review aims to analyze existing peer reviewed and grey literature to explore how indigenous values (...) and principles from countries of Oceania are incorporated into HRE and the governance of research involving human participants. Methods A scoping literature review framework was used for this study. A search for peer reviewed and grey literature from Google, bibliographies, and electronic databases such as SCOPUS, SPRINGER, Medline (Ovid) and JBI Database of Systematic Reviews was conducted, limited to the years 2002–2020. Sixty (60) documents that focused on indigenous knowledge from Oceania region and HRE were included, from which key findings and themes were synthesized. Results Charting the data showed that more than half the eligible documents were peer-reviewed journal articles (54%). Other sources included: International Declarations on Human Research (8%); book chapters (8%); government documents (8%); HRE Guidelines or protocols (13%); news articles (7%) and PhD thesis (2%). The literature was from Australia, Cook Islands, Guam, New Zealand, Fiji, Samoa, Tonga and Vanuatu, some of which focused specifically on HREs in the Pacific Region. Issues emerging from the literature were grouped into five themes (i) indigenous and cultural principles of HRE; (ii) informed consent in indigenous settings in Oceania; (iii) vulnerability and minority status of indigenous populations exploited for research; (iv) research ethics governance for Oceania indigenous peoples; and (v) research ethics committees in Oceania. Respect, relationship building, and trust were priority indigenous HRE principles that encompass the principles of partnership, capacity building, reciprocity, and equality. Relationship building and trust imply the equal distribution of benefits for indigenous population and researchers. Conclusion Indigenous principles of HRE identified were interconnected and interdependent. Recommendations were to incorporate indigenous principles of research in HRE regulations and processes of all countries with indigenous populations. This is especially pertinent for emerging national research committees in LMIC countries, including Fiji and Tonga. Relationship building among researchers and indigenous populations is key to successful research with indigenous populations. HRE principles important for relationship building include respect that is reciprocal among researchers and indigenous people. Elements of the principle of respect highlighted are empathy, collaboration, sharing of benefits, reciprocity, appreciation, empowerment, protection, safety and awareness of culture and languages. Indigenous ontology from the Oceania region involves spirituality, connectedness to land, religious beliefs and a participatory approach to HRE and should be respected in research. An ethical governance mechanism of HRE is one that incorporates indigenous principles and applications for the purpose of maximizing the protection of the dignity and rights of indigenous peoples of Oceania. (shrink)

Contemporary business trends in Africa portray a spate of paradoxes in her socio-economic development. For instance, there is a rapid increase of international interventions and establishment of multinational corporations as a result of globalization; yet not much of this has been domesticated. Industrial and infrastructural developments are sprawled around us; yet unemployment is on the increase. While financial institutions and government agencies take capricious interests and levies in businesses; the human community and environment are left out in tatters. The media (...) advertises business via any means possible, ignoring questions about moral values of individual persons in the society as well as companies that drive the economy. These happenings, no doubt, raise genuine cause for concern as it threatens African indigenous morality. This is a pointer to the fact that there is something lacking. That desideratum is a unifying business ethic. This paper is a research that attempts to fill that ethical gap. It is considered that the philosophical concept of Ubuntu – an African traditional philosophy of social existence is essential. It supports and encourages integral human development, and as such can serve as an ethical ideal in an ever-dynamic business operation in Africa. (shrink)

Researchers seeking to engage in projects related to Tribal communities and their citizens, lands, and non-human relatives are responsible for understanding and abiding by each Tribal nation’s research laws and review processes. Few studies, however, have described the many diverse forms of Tribal research review systems across the United States (US). This study provides one of the most comprehensive examinations of research review processes administered by Tribal Research Review Boards (TRRBs) in the US. Through a systematic (...) analysis, we consider TRRBs’ online presence, online documentation, and themes across documents, for five entity types: Tribal nations and Tribal consortiums, Tribal colleges and universities, Tribal health organizations, Indian Health Services, and other Tribal organizations. Results include an assessment of online presence for 98 potential TRRBs, identification of 118 publicly available online documents, and analysis of 41 themes across four document types: Tribal research codes and TRRBs’ guidelines, applications, and post-approval documents. Altogether, this research provides a macro-level analysis of the most common types of TRRBs in the US in an effort to increase researchers’ understanding of these important processes as they prepare to ethically engage Tribal communities in research. These results aim to empower Tribal decision makers as they align their TRRBs’ online visibility and documentation with community priorities and strengthen their protections for the rights and wellbeing of their citizens and community. Ultimately, by expanding our knowledge of TRRBs across the US, this contribution seeks to uphold Tribal sovereignty in research and promote ethical approaches to research with Indigenous communities. (shrink)

Community engagement (CE) contributes to successful research. There is, however, a lack of literature on the effectiveness of different models of CE and, specifically, on CE strategies for the conduct of genomic research in sub-Saharan Africa. There is also a need for models of CE that transcend the recruitment stage of engaging prospective individuals and communities and embed CE throughout the research process and after the research has concluded. The qualitative study reported here was designed to (...) address these knowledge gaps and comprised of 36 key informant semi-structured interviews and fifteen focus groups with 50 participants. We interviewed selected stakeholders in genomic research in Nigeria: biomedical researchers, community rulers, opinion leaders, community health workers, and prospective research participants. We explored these stakeholders’ views on their understanding of community engagement, their expectations, experiences, and their opinions on acceptable processes of community consultation in genomic research. The methodological design, adapted from grounded theory, used the constant comparative method of data analysis; while normative conclusions were made using the symbiotic empirical ethics approach. Data analysis revealed five main themes important for successfully engaging communities in genomic research: effective communication, diversity of community gatekeeping, trust, cultural integration of research, and conservation of the research setting. From these themes, we have developed a four-stage model of community engagement that covers all stages of the research process; namely, the Community Approach, Intermediate phase, Collaboration and Post-research Cordiality model (CICP). This model could be used to improve the integration of CE in genomic research among local communities. (shrink)

As part of a (bio)colonial project, the biological information of Indigenous Peoples has historically been under scientific scrutiny, with very limited benefits for communities and donors. Negative past experiences have contributed to further exclude Indigenous communities from novel developments in the field of omics research. Over the past decade, new guidelines, reflections, and projects of genetic research with Indigenous Peoples have flourished in Australia, providing opportunities to move the field into a place of respect and (...) ethical relationships. This review explores the ethical and cultural implications of the use of biological samples from Indigenous communities in biomedical research. A structured framework outlining emerging topics of interest for the development of respectful omics research partnerships with Indigenous Australians is presented. This paper highlights aspects related to Indigenous governance, community and individual consent, respectful handling of biological samples, data management, and communication in order to protect Indigenous interests and rights and to promote communities’ autonomy. (shrink)

The goal of the Human Genome Diversity Project (HGDP) was to reconstruct the history of human evolution and the historical and geographical distribution of populations with the help of scientific research. Through this kind of research, the entire spectrum of genetic diversity to be found in the human species was to be explored with the hope of generating a better understanding of the history of humankind. An important part of this genome diversity research consists in taking blood (...) and tissue samples from indigenous populations. For various reasons, it has not been possible to execute this project in the planned scope and form to date. Nevertheless, genomic diversity research addresses complex issues which prove to be highly relevant from the perspective of research ethics, transcultural medical ethics, and cultural philosophy. In the article at hand, we discuss these ethical issues as illustrated by the HGDP. This investigation focuses on the confrontation of culturally diverse images of humans and their cosmologies within the framework of genome diversity research and the ethical questions it raises. We argue that in addition to complex questions pertaining to research ethics such as informed consent and autonomy of probands, genome diversity research also has a cultural–philosophical, meta-ethical, and phenomenological dimension which must be taken into account in ethical discourses. Acknowledging this fact, we attempt to show the limits of current guidelines used in international genome diversity studies, following this up by a formulation of theses designed to facilitate an appropriate inquiry and ethical evaluation of intercultural dimensions of genome research. (shrink)

The research ethics framework put forward by McCradden et al. to support systematic inquiry in the development of artificial intelligence and machine learning technologies in healt...

The application of artificial intelligence and machine learning technologies in healthcare have immense potential to improve the care of patients. While there are some emerging practices surro...

The history of the National Health Service research ethics system in the UK and some of the key drivers for its change into the present system are described. It is suggested that the key drivers were the unnecessary delay of research, the complexity of the array of processes and contradictions between research ethics committee (REC) decisions. It is then argued that the primary drivers for this change are and will be replicated by the systems of (...) research ethics review being put in place at UK universities in response to the Economic and Social Research Council research ethics framework. It is argued that this is particularly problematic for multi-centre review and for researchers who switch institutions. Finally, some potential solutions to this problem and their feasibility are discussed. (shrink)

_This paper will explore two strands of Vilhjálmur Árnason’s extensive body of work: his analysis of dialogue ethics within medical ethics and his analysis of ethics in the Icelandic sagas. The central thesis is that combining these two strands, bioethics and literary analysis, can provide valuable insights to further the discussion of ethics among citizens in multicultural communities. _ _Vilhjálmur’s 1 analysis of the Icelandic sagas shows that the sagas have a specific value foundation, specific virtues (...) as well as narrative in how to present the ethical aspects. In the field of bioethics, he has developed the study of dialogue ethics in several aspects, such as between patient and professional, in interdisciplinary research, and in public deliberation. By integrating insights from historic literary studies with contemporary bioethical research we gain an interesting platform for a discussion on Western assumptions of what constitutes a good dialogue. One of the core aspects in dialogue ethics is how to develop the procedure for a fair, open-minded, and oppression-free discussion in ethical issues. Vilhjálmur’s contributions are summarized here, but could they also be extended beyond the Icelandic and Western horizon?_ _I will compare his ethical framework to a recent parallel discussion on the claims of indigenous peoples for a fair dialogue. That is, a dialogue that must be inclusive with a carefulness about deciding the foundation of inherent values and the procedure of how to perform the dialogue. Finally, I draw conclusions on what dialogue ethics will gain from this explorative work._ _Keywords: _dialogue ethics, one health approaches, Indigenous peoples, bioethics, interdisciplinarity, ethics in the Icelandic sagas, medical ethics, literary analysis, multicultural communities. (shrink)

Achieving equity in international research is one of the pressing concerns of the twenty-first century. In this era of progressive globalization, there are many opportunities for the deliberate or accidental export of unethical research practices from high-income regions to low- and middle-income countries and emerging economies. The export of unethical practices, termed “ethics dumping,” may occur through all forms of research and can affect individuals, communities, countries, animals, and the environment. Ethics dumping may be the (...) result of purposeful exploitation but often arises from lack of awareness of good ethical and governance practice. This chapter describes the work of the TRUST project toward counteracting the practice of ethics dumping through the development of tools for the improvement of research governance structures. Multi-stakeholder consultation informs all of TRUST’s developments. Most importantly, this gives voice to marginalized vulnerable groups and indigenous people, who have been equal and active partners throughout the project. At the heart of the TRUST project is an ambitious aim to develop a Global Code of Conduct for Research in Resource-Poor Settings. Uniquely, the Code provides guidance across all research disciplines in clear, short statements, focusing on research collaborations that entail considerable imbalances of power, resources and knowledge and using a new framework based on the values of fairness, respect, care, and honesty. The code was recently adopted by the European Commission as a reference document for Horizon 2020 and Horizon Europe. (shrink)

Rooted in a desire to conduct ethical research with Indigenous People rather than on them, this autoethnographic document-based case study relies on anti-colonial praxis and places the Navajo and non-Navajo perspectives of two researchers navigating the Navajo Nation Human Research Review Board’s (NNHRRB) processes for conducting human subjects research within Kirkness and Barnhardt’s (1991) “Four Rs” framework of respect, relevance, reciprocity, and responsibility. This case analyzes and presents thematic assertions drawn from entries of both authors’ (...) reflective journals they kept while working through the NNHRRB’s process for conducting research. Research findings promise to help other researchers develop research ethics and promote sovereignty for Tribes and Indigenous communities. (shrink)

We examined Confucian moral philosophy, primarily the Analects, to determine how Confucian ethics could help managers regulate their own behavior (self-regulation) to maintain an ethical standard of practice. We found that some Confucian virtues relevant to self-regulation are common to Western concepts of management ethics such as benevolence, righteousness, wisdom, and trustworthiness. Some are relatively unique, such as ritual propriety and filial piety. We identify seven Confucian principles and discuss how they apply to achieving ethical self-regulation in management. (...) In addition, we examined some of the unique Confucian practices to achieve self-regulation including ritual and music. We balanced the framework by exploring the potential problems in applying Confucian principles to develop ethical self-regulation including whistle blowing. Confucian moral philosophy offers an indigenous Chinese theoretical framework for developing ethical self-regulation in managers. This is relevant for managers and those who relate to managers in Confucian-oriented societies, such as China, Korea, Japan, and Singapore. We recommend further research to examine if the application of the Confucian practices outlined here actually work in regulating the ethical behavior of managers in modern organizations. (shrink)

In the past decade, there has been an increase in genomic research and biobanking activities in Africa. Research initiatives such as the Human Heredity and Health in Africa Consortium are contributing to the development of scientific capacity and infrastructure to support these studies on the continent. Despite this growth, genomic research and biobanking have raised important ethical challenges for key research stakeholders, including members of research ethics committees. One of these is the limited ethical (...) and regulatory frameworks to guide the review and conduct of genomic studies, particularly in Africa. This paper is a reflection on a series of consultative activities with research ethics committees in Africa which informed the development of an ethics and governance framework for best practices in genomic research and biobanking in Africa. The paper highlights the engagement process and the lessoned learned. (shrink)

Paper providing an ethical framework for stem cell research in Europe.

This work presents the case of the Yanomami indigenous people from Brazil that were the object of US ethnography initiated in the 1960s. The research brought harmful repercussions to the life of the Indigenous people of Brazil for several decades, and it took more than 40 years until the beginning of a process of reparation involving the Brazilian government and American universities. Objective: to discuss the meaning of the return of Yanomami blood samples, as well as contributions (...) from the epistemologies of traditional Indigenous knowledge to the debate about research ethics and the structuring of means for the social control of researchers and the protection of participants in scientific studies, having as an example the Yanomami indigenous people from Brazil, subjected to noxious ethnography in the 1960s and the 1970s. This work used data reports recorded in secondary sources. In this article we argue that Bioethics needs to further diversify its epistemological foundations and to consider epistemologies and cosmologies beyond the frontiers of Western science, as the case of the abusive research involving the Yanomami indigenous people in Brazil reveals. We argue that traditional knowledge, such as those of indigenous and quilombolas, with their epistemologies and cosmologies, are fundamental for the election of less colonized and more efficient principles of research ethics, regarding the protection of the participants' rights in scientific studies. Traditional indigenous populations can teach us a great deal about doing research. (shrink)

Calls are increasing for American health care to be organized as a learning health care system, defined by the Institute of Medicine as a health care system “in which knowledge generation is so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the healthcare delivery process and leads to continual improvement in care.” We applaud this conception, and in this paper, we put forward a new ethics framework for it. (...) No such framework has previously been articulated. The goals of our framework are twofold: to support the transformation to a learning health care system and to help ensure that learning activities carried out within such a system are conducted in an ethically acceptable fashion. (shrink)

In a recent issue of Journal of Medical Ethics (JME), we discussed the ethical review of evaluations of interventions that would occur whether or not the evaluation was taking place. We concluded that standard research ethics frameworks including the Ottawa Statement, which requires justification for all aspects of an intervention and its roll-out, were a poor guide in this area. We proposed that a consideration of researcher responsibility, based on the consequences of the research taking place, (...) would be a more appropriate way delineate the scope of research ethics review. Weijer and Taljaard present a counterargument to our proposal, which we address in this reply. They claim that a focus on researcher responsibility will weaken the protection of research participants and link it to ‘unethical research’ and a ‘government experimenting on its own people’. However, the moral responsibility of researchers is defined in terms of the consequences of the research on human welfare and harm, not in opposition to it. Weijer and Taljaard argue that researchers must justify what they are studying whether or not they have any control over it and that governments must justify their programmes, including by demonstrating equipoise, to a research ethics committee if they implement them in a randomised way. We strongly disagree that this is a defensible way to define the scope of research ethics review and argue that this provides no further protections to research participants beyond what we propose, but places a potential barrier to learning from government programmes. (shrink)

This paper presents a conceptual framework proposed by the Loka Initiative for building inner, community, and planetary resilience as a unified vision and goal. Titled “A Framework for Deep Resilience in the Anthropocene,” the framework emerged from a three-day dialogue with over 40 researchers, academics, community experts, clinical psychologists, and contemplative leaders who participated in the Resilience in the Anthropocene Summit from August 8–10, 2023. We propose that a unified goal of inner, community, and planetary resilience is (...) necessary to subvert and overturn systems built upon the unsustainable extraction and exploitation of natural resources, including humans. We posit that individuals, communities, organizations, Indigenous communities and faith groups, and governments can benefit from considering how they integrate this framework of Deep Resilience as part of their internal, strategic, design, and management decision-making processes. (shrink)

This book provides a comprehensive description and ethical analysis of one of the most challenging areas: international health research. Furthermore, it provides a vivid portrait of the current situation of global governance for health research and its main challenges and suggests a comprehensive and universal ethical framework based on the existing theories and frameworks. This work is a must-read for all the students, scholars, professionals, activists, and policy-makers who are involved or interested in the global health (...) class='Hi'>research enterprise and its governance and ethics. (shrink)

Technologic advances mean automated, wearable cameras are now feasible for investigating health behaviors in a public health context. This paper attempts to identify and discuss the ethical implications of such research, in relation to existing guidelines for ethical research in traditional visual methodologies. Research using automated, wearable cameras can be very intrusive, generating unprecedented levels of image data, some of it potentially unflattering or unwanted. Participants and third parties they encounter may feel uncomfortable or that their privacy (...) has been affected negatively. This paper attempts to formalize the protection of all according to best ethical principles through the development of an ethical framework. Respect for autonomy, through appropriate approaches to informed consent and adequate privacy and confidentiality controls, allows for ethical research, which has the potential to confer substantial benefits on the field of health behavior research. (shrink)

The challenge for those responsible for funding, brokering and assessing the merit of proposed Indigenous research is to identify and then work co-operatively with appropriate representatives of Indigenous interests in order to increase the flow of benefits from research to Indigenous peoples. Experience in Australia has shown that this is not a straightforward process. In this paper we indicate some reasons why it is important for the research community to broker research with representative (...) Indigenous organisations and to involve Indigenous peoples in the ethical assessment and conduct of research. We then identify some barriers to the achievement of these objectives and outline recently developed interventions from the field of health research that aim to promote a more effective working relationship between Indigenous peoples and members of the research community. (shrink)

Background Citizen science and models for public participation in health research share normative ideals of participation, inclusion, and public and patient engagement. Academic researchers collaborate in research with members of the public involved in an issue, maximizing all involved assets, competencies, and knowledge. In citizen science new ethical issues arise, such as who decides, who participates, who is excluded, what it means to share power equally, or whose knowledge counts. This article aims to present an ethics (...) class='Hi'>framework that offers a lens of understanding and heuristic guidelines to deal with ethical issues in citizen science. -/- Methods We conducted seven case studies between 2015 and 2021 to attune and validate the ethics framework for the context of citizen science. The cases related to studies with older adults, people with a psychiatric vulnerability, people dependent on community care, people who are unemployed or living in poverty or both, and young adults with respiratory disease. -/- Results Ethics in citizen science reaches beyond the ethical issues in traditional biomedical and health research. It entails more than following procedures about informed consent and privacy and submitting a proposal to a Medical Research Ethics Committee. Ethics in citizen science relates to everyday ethical issues during the study, including relational and moral complexities concerning collaboration, sharing power, and democratic decision-making. Dealing with these issues requires ethics work of researchers. This entails seeing ethically salient issues and reflecting on everyday ethical issues. Ethics work consists of seven features: framing work, role work, emotion work, identity work, reason work, relationship work, and performance work. All are relevant for researchers in citizen science. -/- Conclusions Ethical issues in citizen science often relate to power differentials, partnership, and collaboration between academics and non-academics. The ethics framework prepares researchers for the work needed in citizen science to act responsibly and offers a heuristic guide to reflect on ethics. Reflection on ethics is a pathway towards ethical citizen science, especially if researchers collaboratively reflect in partnership with non-academics who are subject to the moral issue. (shrink)

ABSTRACT:A wide range of research uses patterns of genetic variation to infer genetic similarity between individuals, typically referred to as genetic ancestry. This research includes inference of human demographic history, understanding the genetic architecture of traits, and predicting disease risk. Researchers are not just structuring an intellectual inquiry when using genetic ancestry, they are also creating analytical frameworks with broader societal ramifications. This essay presents an ethics framework in the spirit of virtue ethics for these (...) researchers: rather than focus on rule following, the framework is designed to build researchers’ capacities to react to the ethical dimensions of their work. The authors identify one overarching principle of intellectual freedom and responsibility, noting that freedom in all its guises comes with responsibility, and they identify and define four principles that collectively uphold researchers’ intellectual responsibility: truthfulness, justice and fairness, anti-racism, and public beneficence. Researchers should bring their practices into alignment with these principles, and to aid this, the authors name three common ways research practices infringe these principles, suggest a step-by-step process for aligning research choices with the principles, provide rules of thumb for achieving alignment, and give a worked case. The essay concludes by identifying support needed by researchers to act in accord with the proposed framework. (shrink)

PurposeThe purpose of this paper is to look at some of the issues surrounding access to and the use of new media technologies by Indigenous people in Australia and question why this is an area of study that receives a marginal focus in academic work.Design/methodology/approachDrawing on previous literature in the area of information and communications technology (ICT) adoption and social exclusion, this paper combines the methodological frameworks adopted by hegemony research and more general studies of new media.FindingsThe paper (...) discusses the impacts of new media use by Indigenous communities, within the framework of discussions about a “global Digital Age”. The paper also briefly looks at the social implications of new media adoption.Originality/valueIt questions the assumption that adoption and use of new media is for the “good” or “benefit” of all. It will be of value to researchers of ICT adoption by Indigenous communities. (shrink)

Ethical decision-making frameworks assist in identifying the issues at stake in a particular setting and thinking through, in a methodical manner, the ethical issues that require consideration as well as the values that need to be considered and promoted. Decisions made about the use, sharing, and re-use of big data are complex and laden with values. This paper sets out an Ethics Framework for Big Data in Health and Research developed by a working group convened by the (...) Science, Health and Policy-relevant Ethics in Singapore Initiative. It presents the aim and rationale for this framework supported by the underlying ethical concerns that relate to all health and research contexts. It also describes a set of substantive and procedural values that can be weighed up in addressing these concerns, and a step-by-step process for identifying, considering, and resolving the ethical issues arising from big data uses in health and research. This Framework is subsequently applied in the papers published in this Special Issue. These papers each address one of six domains where big data is currently employed: openness in big data and data repositories, precision medicine and big data, real-world data to generate evidence about healthcare interventions, AI-assisted decision-making in healthcare, public-private partnerships in healthcare and research, and cross-sectoral big data. (shrink)

The purpose of this paper is to provide a simple yet comprehensive organizing scheme for the responsible conduct of research (RCR). The heuristic offered here should prove helpful in research ethics education, where the many and heterogeneous elements of RCR can be bewildering, as well as research into research integrity and efforts to form RCR policy and regulations. The six domains are scientific integrity, collegiality, protection of human subjects, animal welfare, institutional integrity, and social responsibility.

This syllabus engages dialogue about indigenous philosophical ideas and issues that frame contemporary global indigenous thought, perspective, and worldview. We explore how presuppositions of indigenous philosophy, including epistemology (how/what we know), metaphysics (what is), science (stories), and ethics (practices), affect global research programs, intellectual cultural property, economic policies, ecology, biodiversity, taxonomy, health, housing, food, employment, economic sustainability, peace negotiations, climate justice, human/treaty rights, colonial law, refugees and incarceration, self-determination, sovereignty, nation building, and digital information. Readings (...) provide an understanding of traditional and contemporary indigenous philosophical frameworks of interpretation, developments of the 1994-2004 United Nations Decade of Indigenous Peoples, the UN Permanent Forum of Indigenous Peoples, and the recent Indigenous Conference in Cancun (philosophical importance of the World Trade Organization [WTO], the World Bank [WB], the International Monetary Fund [IMF], and NAFTA). (shrink)

Background Biomedical and ethnographic studies among indigenous people are common practice in health and geographical research. Prior health research misconduct has been documented, particularly when obtaining genetic material. The objective of this study was to crossmatch previously published data with the perceptions of the Waorani peoples about the trading of their genetic material and other biological samples. Methods We conducted a mixed methods study design using a tailored 15-item questionnaire in 72 participants and in-depth interviews in 55 (...) participants belonging to 20 Waorani communities about their experiences and perceptions of participating in biomedical research projects. Additionally, we conducted a systematic review of the literature in order to crossmatch the published results of studies stating the approval of an ethics committee and individual consent within their work. Results A total of 40 men and 32 women, with a mean age of 57 ± 15 years agreed to be interviewed for inclusion. Five main categories around the violation of good clinical practices were identified, concerning the obtention of blood samples from a recently contacted Waorani native community within the Amazonian region of Ecuador. These themes are related to the lack of adequate communication between community members and researchers as well as the voluntariness to participate in health research. Additionally, over 40 years, a total of 38 manuscripts related to the use of biological samples in Waorani indigenous people were published. The majority of the studies did not state within their article obtaining research ethics board approval, and 71% did not report obtaining the informed consent of the participants prior to the execution of the project. Conclusion Clinical Research on the Waorani community in the Ecuadorian Amazon basin has been performed on several occasions. Unfortunately, the majority of these projects did not follow the appropriate ethical and professional standards in either reporting the results or fulfilling them. The results of our investigation suggest that biological material, including genetic material, has been used by researchers globally, with some omitting the minimum information required to guarantee transparency and good clinical practices. We highlight the importance of stating ethics within research to avoid breaches in research transparency. (shrink)

The enthusiasm for research in an Indigenous context has led to the introduction of formal guidelines for researchers to visit communities. While welcome, this has not been achieved without increased bureaucratization of research relationships. It appears that many Indigenous communities, with their limited resources, are ill-equipped to deal with the administrative imperatives of Indigenous research protocols. Based on the experiences of anthropological field research in the Innu context, this article shows how respectful (...) class='Hi'>research relationships could be established outside the bureaucratic and administrative framework generally advocated by research protocols. The heart of this approach lies in the researcher’s radical participation in social life, and more specifically in taking seriously the social premises of the people with whom he works. The mistake would be to think that this collaborative approach is situated in informality: rather, it takes place within an eminently formal framework that corresponds to the criteria and values of the researcher’s Indigenous collaborators. (shrink)

As thousands of healthy research participants are being included in small and large imaging studies, it is essential that dilemmas raised by the detection of incidental findings are adequately handled. Current ethical guidance indicates that pathways for dealing with incidental findings should be in place, but does not specify what such pathways should look like. Building on an interview study of researchers’ practices and perspectives, we identified key considerations for the set-up of pathways for the detection, management and communication (...) of incidental findings in imaging research. We conducted an interview study with a purposive sample of researchers at research facilities across the Netherlands. Based on a qualitative analysis of these interviews and on existing guidelines found in the literature, we developed a prototype ethical framework, which was critically assessed and fine-tuned during a two-day international expert meeting with bioethicists and representatives from large population-based imaging studies from the United Kingdom, Germany, Sweden and Belgium. Practices and policies for the handling of incidental findings vary strongly across the Netherlands, ranging from no review of research scans and limited feedback to research participants, to routine review of scans and the arrangement of clinical follow-up. Respondents felt that researchers do not have a duty to actively look for incidental findings, but they do have a duty to act on findings, when detected. The principle of reciprocity featured prominently in our interviews and expert meeting. We present an ethical framework that may guide researchers and research ethics committees in the design and/or evaluation of appropriate pathways for the handling of incidental findings in imaging studies. The framework consists of seven steps: anticipation of findings, information provision and informed consent, scan acquisition, review of scans, consultation on detected abnormalities, communication of the finding, and further clinical management and follow-up of the research participant. Each of these steps represents a key decision to be made by researchers, which should be justified not only with reference to costs and/or logistical considerations, but also with reference to researchers’ moral obligations and the principle of reciprocity. (shrink)

Contemporary research ethics policies started with reflection on the atrocities perpetrated upon concentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in (...) the wrong direction. The aim of this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research. (shrink)

With growing opportunities for medical doctors to work either in academia and industry, research ethics education for health sciences research, meaning research which includes humans and animals and/or their tissues and cells with the goal to understand underlying mechanisms of disease occurrence and disease treatment, is of paramount importance, especially in regions, such as Serbia, where comprehensive research ethics curricula for physician researchers are lacking. This article addresses the spectrum of research ethics (...) topics that were identified through analysis of the existing research ethics curricula in medical schools, international organizations, Serbian legislative codes and the PubMed database applying the key search terms: ethics, research, biomedical, education, curriculum, program, course and their combinations. Selected topics were classified in eight syllabi based on their similarity: #1 Responsible conduct of research, #2 Justice in human subjects research, #3 Research on human subjects, #4 Vulnerable population groups, #5 Conflict of interest, #6 Research on animals, #7 Research on genes, cells and embryos, and #8 Organization of research ethics. Justifications for each syllabus are discussed based on empirical evidence and local context. Higher education authorities could use this framework to strengthen, adjust or refine research ethics education for physician researchers in Serbia. (shrink)

Contemporary research ethics policies started with reflection on the atrocities perpetrated upoconcentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the (...) wrong direction. The aim of this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research. (shrink)

Western economically driven instrumental ethics fuel the dominant institutional logic in many business schools and are associated with the negative social and environmental situation widely linked to the mode of global development. Other ethical framings have been subordinated, marginalized, or denied. Through the explicit commitment of prominent international certifying bodies of management education, educators, researchers, and practitioners will be encouraged to give increasing effect to the Principles for Responsible Management Education (PRME). The PRME is a United Nations‐led, institution‐level mechanism (...) for reorienting the direction of business schools and for increasing both educator and student capacities to contribute to a more inclusive and sustainable mode of development globally. We propose greater emphasis be given to various forms of relational ethics from which to guide the functional aspirations of institutions. We explore the creative opportunity for institutional change by contrasting the prevailing Western economically driven instrumental institutional logic with indigenous ethical framings. We draw upon Seo and Creed's conceptual framework of institutional change to discuss two films—Mann v. Ford and Waste = Food—to bring greater attention to the generative potential of indigenous perspectives in institutional praxis. Our examples could equally invite an application of other systems of relational ethics that have been overshadowed by the current domination of economic instrumentalism in almost all realms of decision making. We conclude by providing some teaching resources that can be used or adapted for geographical‐ or disciplinary‐specific attention to the issues we raise. (shrink)

In this paper we argue the need to reimagine research ethics frameworks to include notions of environmental sustainability. While there have long been calls for healthcareethics frameworks and decision-making to include aspects of sustainability, less attention has focused on howresearchethics frameworks could address this. To do this, we first describe the traditional approach to research ethics, which often relies on individualised notions of risk. We argue that we need to broaden this notion of individual risk to (...) consider issues associated with environmental sustainability. This is because research is associated with carbon emissions and other environmental impacts, both of which cause climate change health hazards. We introduce how bioethics frameworks have considered notions of environmental sustainability and draw on these to help develop a framework suitable for researchers. We provide a case study of data-driven health research to apply our framework. (shrink)

The recently published BRAIN 2.0 Neuroethics Report offers a very helpful overview of the possible ethical, social, philosophical, and legal issues raised by neuroscience in the context of BRAIN’s research priorities thus contributing to the attempt to develop ethically sound neuroscience. In this article, we turn to a running theme of the document: the need for an ethical framework for the BRAIN Initiative and for further integration of neuroethics and neuroscience. We assess some of the issues raised and (...) provide an explanation of how we have addressed them in the Human Brain Project. We offer our experience in the HBP as a potential contribution to the international debate about neuroethics in the big brain initiatives. Our hope is that among other things, the type of exchange proposed by this AJOB special issue will prove productive in further identifying and discussing the issues and in inspiring appropriate solutions. (shrink)

Background: Despite the growing body of knowledge about surrogate decision making, we know very little about the use of ethical frameworks (including ethical theories, principles, and concepts) to understand surrogates’ day-to-day experiences in end-of-life care planning for incapacitated adults. Objectives and Methods: This qualitative systematic review was conducted to identify the types of ethical frameworks used to address surrogates’ experiences in end-of-life care planning for incapacitated adults as well as the most common themes or patterns found in surrogate decision-making (...) class='Hi'>research. Findings: Seven research papers explicitly identified ethical theories, principles, or concepts, such as autonomy, substituted judgment, and best interest standards as guidelines for the research. Surrogate decision making themes included the responsibilities and goals of being a surrogate, factors influencing surrogates’ decision making, outcomes for surrogates, and an overarching theme of “wanting to do the right thing” for their loved one and/or themselves. Discussion: Understanding the complexity of surrogates’ experiences of end-of-life care planning is beyond the scope of conventional ethical frameworks. Conclusion: Ethical frameworks that address individuality and contextual variations related to decision making may more appropriately guide surrogate decision-making research that explores surrogates’ end-of-life care planning experiences. (shrink)

Human rights declarations are instruments used to introduce universal standards of ethics. The UN’s Protect, Respect, and Remedy Framework (Ruggie, Protect, respect, and remedy: A Framework for business and human rights. UN Doc A/HRC/8/5, 2008; Guiding principles on business and human rights: Implementing the United Nations “Protect, Respect, and Remedy” framework. UN Doc A/HRC/17/31, 2011) intends to provide guidance for corporate behavior in regard to human rights. This article applies concepts from the field of organizational justice (...) to the arena of business and human rights for the purpose of operationalizing the UN Framework. This approach facilitates the recognition of gaps between perceptions of justice held by stakeholders versus businesses and/or the State. Such recognition raises the potential for addressing issues that lead to divergent perceptions of justice, thus potentially improving the human rights performance of businesses. The research also shows the potential for complicity of businesses in human rights abuses and exposes a fundamental weakness in the UN Framework, which attempts to draw a sharp distinction between duties of States versus responsibilities of business. We illustrate this approach through analysis of the case of Goldcorp’s Marlin Mine in Guatemala; an extractive industry project that affects indigenous communities. (shrink)

The urgent drive for vaccine development in the midst of the current COVID-19 pandemic has prompted public and private organisations to invest heavily in research and development of a COVID-19 vaccine. Organisations globally have affirmed the commitment of fair global access, but the means by which a successful vaccine can be mass produced and equitably distributed remains notably unanswered. Barriers for low-income countries include the inability to afford vaccines as well as inadequate resources to vaccinate, barriers that are exacerbated (...) during a pandemic. Fair distribution of a pandemic vaccine is unlikely without a solid ethical framework for allocation. This piece analyses four allocation paradigms: ability to develop or purchase; reciprocity; ability to implement; and distributive justice, and synthesises their ethical considerations to develop an allocation model to fit the COVID-19 pandemic. (shrink)