Background Achieving meaningful consent can be challenging, particularly in contexts of diminished literacy, yet is a vital part of participant protection in global health research. Method We explored the challenges and potential solutions of achieving meaningful consent through a qualitative study in a predominantly hill tribe ethnic minority population in northern Thailand, a culturally distinctive population with low literacy. Semi-structured interviews were conducted with 37 respondents who had participated in scrub typhus clinical research, their family members, researchers and other key (...) informants. A thematic analysis was conducted. Results Our analysis identified four interrelated themes surrounding participants’ ability to give consent: varying degrees of research understanding, limitations of using informal translators, issues impacting decisions to join research, and voluntariness of consent. Suggestions for achieving more meaningful consent included the use of formal translators and community engagement with research populations. Conclusions Participant’s agency in decision making to join research should be supported, but research information needs to be communicated to potential participants in a way that they can understand. We found that improved understanding about the study and its potential benefits and harms goes beyond literacy or translation and requires attention to social and cultural factors. (shrink)

The medical profession and medical ethics currently place a greater emphasis on physician responsibility than patient responsibility. This imbalance is not due to accident or a mistake but, rather is motivated by strong moral reasons. As we debate the nature and extent of patient responsibility it is important to keep in mind the reasons for giving a relatively minimal role to patient responsibility in medical ethics. It is argued that the medical profession ought to be characterized by two moral asymmetries: (...) (1) Even if some degree of responsible behavior from patients is called for, placing the dominant emphasis on professional responsibility over patient responsibility is largely correct. The value of protecting the right to refuse treatment and arguments against paternalism block a more expansive account of patient responsibility and support a strong notion of professional responsibility. (2) Insofar as we do want to encourage an increase in patient responsibility, we have good reasons to emphasize prospective rather than retrospective notions of responsibility in clinical practice. Concerns about patient vulnerability along with the determined factors in disease leave little room for blame at the bedside. These two asymmetries generate normative limits on any positive account of patient responsibility. (shrink)

We conducted focus groups to assess patient attitudes toward research on medical practices in the context of usual care. We found that patients focus on the implications of this research for their relationship with and trust in their physicians. Patients view research on medical practices as separate from usual care, demanding dissemination of information and in most cases, individual consent. Patients expect information about this research to come through their physician, whom they rely on to identify and filter associated risks. (...) In general, patients support this research, but worry that participation in research involving randomization may undermine individualized care that acknowledges their unique medical histories. These findings suggest the need for public education on variation in practice among physicians and the need for a collaborative approach to the governance of research on medical practices that addresses core values of trust, transparency, and partnership. (shrink)

BackgroundCarefully planned research is critical to developing policies and interventions that counter physical, psychological and social challenges faced by young people living with HIV/aids, without increasing burdens. Such studies, however, must navigate a ‘vulnerability paradox’, since including potentially vulnerable groups also risks unintentionally worsening their situation. Through embedded social science research, linked to a cohort study involving Adolescents Living with HIV/aids (ALH) in Kenya, we develop an account of researchers’ responsibilities towards young people, incorporating concepts of vulnerability, resilience, and agency (...) as ‘interacting layers’.MethodsUsing a qualitative, iterative approach across three linked data collection phases including interviews, group discussions, observations and a participatory workshop, we explored stakeholders’ perspectives on vulnerability and resilience of young people living with HIV/aids, in relation to home and community, school, health care and health research participation. A total of 62 policy, provider, research, and community-based stakeholders were involved, including 27 ALH participating in a longitudinal cohort study. Data analysis drew on a Framework Analysis approach; ethical analysis adapts Luna’s layered account of vulnerability.ResultsALH experienced forms of vulnerability and resilience in their daily lives in which socioeconomic context, institutional policies, organisational systems and interpersonal relations were key, interrelated influences. Anticipated and experienced forms of stigma and discrimination in schools, health clinics and communities were linked to actions undermining ART adherence, worsening physical and mental health, and poor educational outcomes, indicating cascading forms of vulnerability, resulting in worsened vulnerabilities. Positive inputs within and across sectors could build resilience, improve outcomes, and support positive research experiences.ConclusionsThe most serious forms of vulnerability faced by ALH in the cohort study were related to structural, inter-sectoral influences, unrelated to study participation and underscored by constraints to their agency. Vulnerabilities, including cascading forms, were potentially responsive to policy-based and interpersonal actions. Stakeholder engagement supported cohort design and implementation, building privacy, stakeholder understanding, interpersonal relations and ancillary care policies. Structural forms of vulnerability underscore researchers’ responsibilities to work within multi-sectoral partnerships to plan and implement studies involving ALH, share findings in a timely way and contribute to policies addressing known causes of vulnerabilities. (shrink)

We face significant challenges in the translation of basic biomedical research into meaningful improvements in patients' health, moving research from “bench to bedside.” The federal government's ne...

In lieu of an abstract, here is a brief excerpt of the content:The Invisible ChildrenMaureen KelleyИсчезаю в весне,в толпе,в лужах,в синеве.И не ищите.Мне так хорошо...I fade into spring,or into a crowd,or into a puddle,sometimes into the blue.There's no sense in looking for me.I feel fine...—¾"Absentee" by Arvo Mets"You have to go through Lesha to get to Danil," Alexandra told me. Lesha was a small but unmoving dog with matted hair and a fierce growl. The dog was pressed against the little (...) boy, who looked no more than three or four years old. Alexandra later told me he was eight. Danil was wearing a Spider Man shirt that was four sizes too big and came down to his feet and mismatched sandals. He was huddled against his dog not only for security but warmth. His tiny arm circled Lesha's neck and he looked at me with a mix of curiosity and caution. I knelt and put my hand out for Lesha to smell me. Apparently I didn't pass the smell test. The dog didn't budge from his post. We stood like that for a long time, at the base of the steps to the shelter. I tried the few Russian words I had learned while visiting as a volunteer. The dog didn't understand my broken Russian, or pretended not to, but I managed to get a shy smile from Danil.Alexandra, a nurse volunteer at the shelter, eventually mediated the standoff by giving Lesha, the dog, a cookie. I introduced myself to the little boy. And just like that, he leaned up against me and put both arms around my legs. It didn't matter that I was a stranger, and a stranger who spoke terrible Russian. "Spidey" was an affectionate little guy. He gripped my hand while Alexandra led us up the steps and Lesha followed close behind. Inside was a small room, warm and full of color. One wall was covered in kids' drawings. Another had public health posters in Russian, some with instructions for condom use, others on literacy. There were about fifteen kids in the shelter that afternoon. The young ones were drawing pictures at a low table. Two teenage boys were hunched over a small TV playing a video game. There was only one teenage girl, Irina. She was cooing at the little kid's drawings, showing one girl how to draw a princess. Alexandra said quietly to me, "Most of the teenage girls are only here in the morning. The rest are back at work right now." I found out later "back at work" meant on the streets as sex workers. This city was frequented by businessmen and itinerant workers heading to the factories or lumber mills in the North. The best money for homeless girls was in prostitution. Danil unwrapped himself from me and ran over to the two older boys playing video games. One put his controller down long enough to pull Danil into his lap. The three boys stared intently as Super Mario hopped from mushroom to magic cloud, golden coins spinning above his cartoon head.To the right of the main room was a closet-sized office for the shelter director, Anya, a pediatrician who donated her time to running the shelter for homeless and orphaned youth living on the streets. Alexandra and I stood in the doorway waiting for Anya to finish a phone conversation. Her desk was covered in papers. Behind her were photos of the kids who had "graduated" from the streets. There were cards and letters pinned to a cork board. When [End Page E4] she finished, Anya greeted us with bear hugs and showed us to the clinic area. Next to her office was a small bathroom with a shower and tub. She explained that bath days were on Wednesdays. Around back, with a separate entrance was the small clinic space. The outside metal door had a sliding window that you see at some nightclubs. They ran a needle exchange program out of that door. It was funded for street youth, but from time to time they would get adult addicts. Anya was adamant that this side of the clinic remain separate from the central space for the children. In reality the distance... (shrink)

Most of professional ethics is grounded on the assumption that we can speak meaningfully about particular, insulated professions with aims and goals, that conceptually there exists a clear "inside and outside" to any given profession. Professional ethics has also inherited the two-part assumption from mainstream moral philosophy that we can speak meaningfully about agent-relative versus agent-neutral moral perspectives, and further, that it is only from the agent-neutral perspective that we can truly evaluate our professional moral aims, rules, and practices. Several (...) important changes that have occurred, or are currently taking place, in the structure of the health care professions, challenge those assumptions and signal the need for teachers of professional ethics to rethink the content of what we teach as well as our teaching methods. The changes include: influences and critique from other professions and from those who are served by the health professions, and influences and critique from professionals themselves, including increased activism and dissent from within the professions. The discussion focuses on changes that have occurred in the health-related fields, but insofar as similar changes are occurring in other professions such as law and business, these arguments will have broader conceptual implications for the way we ought to think about professional ethics more generally. (shrink)

Jones's (1991) issue-contingent model of ethical decision making posits that six dimensions of moral intensity influence decision markers' recognition of an issue as a moral problem and subsequent behavior. He notes that "organizational settings present special challenges to moral agents" (1991, p. 390) and that organizational factors affect "moral decision making and behavior at two points: establishing moral intent and engaging in moral behavior" (1991, p. 391). This model, however, minimizes both the impact of organizational setting and organizational factors on (...) these experiences of ethical issues. In this theory, context is modeled as affecting the moral intent and behavior of the actor rather than directly affecting the issue's moral intensity. Here we look specifically at the effect of context on the moral intensity of ethical issues through a phenomenological study. Our results indicate that in certain environments, context may be critical in affecting the moral intensity of ethical issues. Thus, researchers should consider it more fully when assessing these issues' moral intensity. (shrink)

In the target article, McGuire and colleagues (2009) found that 54% of social networkers would consider using direct-to-consumer personal genome testing (DTC PGT) for their child and that 63% agree...

Few medievalists today would deny that the massive social and economic changes of the central Middle Ages affected the character and institutions of medieval Christianity. Generations of scholars, especially those influenced by the Annales school, have explored the social and economic roots of religious change. Despite widespread acceptance of the connection between socioeconomic factors and religious change, detailed explanations of exactly how social and economic development transformed medieval Christianity are still lacking for numerous important issues. My goal here is to (...) address one such issue: the connection between the emergence of new social groups and the development of new kinds of ecclesiastical institutions. (shrink)

This is the story of Lisa 1 —a woman like so many others who has been abused—and of her healing journey using music and creative arts experiences. It is also a story about how music, song, poetry, art, and dance awakened her to a new consciousness and provided the necessary empowerment she needed in order to reclaim the woman she had been before experiencing the trauma of abuse. While the question of how utilization of music and the creative arts encourages (...) personal transformation and healing is also deserving of a theoretical exploration, in this article I have chosen to foreground Lisa's story as narrative, in order to also engage the reader with the transformative potential of empowerment that comes through listening. I have chosen an approach that foregrounds Lisa's experience over theory explicitly, for, it is with the process of "finding voice" and of engaging the listener in that process, that transformation of consciousness and empowerment occurs. (shrink)

Despite advances in theory, often driven by feminist ethicists, research ethics struggles in practice to adequately account for and respond to the agency and autonomy of people considered vulnerable in the research context. We argue that shifts within feminist research ethics scholarship to better characterise and respond to autonomy and agency can be bolstered by further grounding in discourses from the social sciences, in work that confirms the complex nature of human agency in contexts of structural and other sources of (...) vulnerability. We discuss some of the core concepts and critiques emerging from the literature on women and children's agency in under‐resourced settings, highlighting calls to move from individualistic to relational models of agency, and to recognise the ambiguous, value‐laden, and heterogeneous nature of the concept. We then draw out what these conceptual shifts might mean for research ethics obligations and guidance, illustrating our analysis using a case vignette based on research ethics work conducted in South Africa. We conclude that if research practices are to be supportive of agency, it will be crucial to scrutinise the moral judgements which underpin accounts of agency, derive more situated definitions of and responses to agency, and enable people and participants to influence these based on their own experiences and self‐perceptions. (shrink)

We examine when and how police officers may avoid costly errors under stress by leveraging theoretical and empirical work on the biopsychosocial (BPS) model of challenge and threat. According to the BPS model, in motivated performance contexts (e.g., test taking, athletics), the evaluation of situational and task demands in relation to one’s perceived resources available to cope with those demands engenders distinct patterns of peripheral physiological responding. Individuals experience more challenge-like states in which blood circulates more efficiently in the periphery (...) when they evaluate their coping resources as meeting or exceeding the task demands. Conversely, individuals experience more threat-like states in which blood circulates less efficiently in the periphery when they view the situation or task demands as exceeding their coping resources. Patterns of response consistent with challenge and threat states have been shown to predict important performance and decision-making outcomes in stressful contexts, and repeated experiences of threat-like patterns of physiological activity are thought to have detrimental effects on long-term cardiovascular health. To date, however, research has not used the biopsychosocial model to understand police decision-making under stress. Here, we review relevant empirical work from the perspective of the BPS model concerning how minority status and power can shape challenge and threat responding and contribute to decision making under stress. We then detail a research agenda aimed at improving the translational value of research being conducted within the BPS model for understanding complex performance and decision making in the real world, including among law enforcement personnel. (shrink)

Stillbirths are largely excluded from international measures of mortality and morbidity. Zeshan Qureshi and colleagues argue that stillbirth should be higher on the global health agenda.

Today’s business students are tomorrow’s business leaders. To ensure they have skills in creating profitable, pro-social, ethical organizations, we need to consider alternative methods of teaching CSR. In this proposed symposium, we will present different approaches to international CSR/Service-Learning.

Ethics researchers have scrutinized ethical business problems, which have been demonstrated through the actions of managers at Enron, WorldCom, and Arthur Andersen, among others. In response to these business transgressions, the US government has implemented the Sarbanes–Oxley Act to shore up businesses’ ethics infrastructures. However, universities, too, struggle with ethics problems. These include NCAA (National Collegiate Athletic Association) violations, discrimination issues, sexual harassment, endowment admits, plagiarism, and research funding manipulation. Despite these problems, we have little knowledge regarding universities’ ethics infrastructures (...) and codes of conduct, and insignificant empirical research on academic ethics issues (Kelley & Chang, Journal of Higher Education, under review, 2006; Morgan & Korschgen, College Student Journal, Sept., 2001). This lack of knowledge exists despite the critical role universities play in shaping the moral behavior of future generations (Langlais, The Chronicle of Higher Education, January 13:B11, 2006; Woo, BizEd, May/June:22–27, 2003). In this paper, we conduct exploratory research to identify the elements of universities ethics’ infrastructures. From our research, we develop an understanding of the ethics policies and infrastructure elements in place at a representative group of universities. We compare these infrastructures to those in business as well as across Carnegie Classifications. We then conclude with recommendations for developing university ethics infrastructures and suggestions for future research. (shrink)

Building on philosophy of science literature and two original studies, this paper argues for the necessity of incorporating all three portions of Wood''s (1991) theoretical model of corporate social performance (CSP) into its measurement. It begins by describing the two studies of an organizational phenomenon not commonly studied – internal fund drives to employees. Insights from these studies of corporate PAC and United Way campaigns are then used to illustrate how important it is to incorporate all three portions of Wood''s (...) model into the measurement of CSP to prevent drawing faulty conclusions. The paper concludes by providing a matrix for use in testing the validity of CSP measures. (shrink)

Older adults often have long-term relationships, and many of their goals are intertwined with their respective partners. Joint goals can help or hinder goal progress. Little is known about how accurately older adults assess if a goal is joint, the role of over-reporting in these perceptions, and how joint goals and over-reporting may relate to older partners' relationship satisfaction and physical health. Two-hundred-thirty-six older adults from 118 couples listed their three most important goals and whether they thought of them as (...) goals they had in common with and wanted to achieve together with their partner. Two independent raters classified goals as “joint” if both partners independently listed open-ended goals of the same content. Goal progress and relationship satisfaction were assessed 1 week later. Allostatic load was calculated using nine different biomarkers. Results show that 85% self-reported at least one goal as joint. Over-reporting– the perception that a goal was joint when in fact it was not mentioned among the three most salient goals of the spouse – occurred in one-third of all goals. Multilevel models indicate that the number of externally-rated joint goals was related to greater goal progress and lower allostatic load, but only for adults with little over-reporting. More joint goals and higher over-reporting were each linked with more relationship satisfaction. In conclusion, joint goals are associated with goal progress, relationship satisfaction, and health, but the association is dependent on the domain of functioning. (shrink)

Background: The factors influencing parents’ willingness to enroll their children in biobanks are poorly understood. This study sought to assess parents’ willingness to enroll their children, and their perceived benefits, concerns, and information needs under different consent and data-sharing scenarios, and to identify factors associated with willingness. Methods: This large, experimental survey of patients at the 11 eMERGE Network sites used a disproportionate stratified sampling scheme to enrich the sample with historically underrepresented groups. Participants were randomized to receive one of (...) three consent and data-sharing scenarios. Results: In total, 90,000 surveys were mailed and 13,000 individuals responded (15.8% response rate). 5737 respondents were parents of minor children. Overall, 55% (95% confidence interval 50–59%) of parents were willing to enroll their youngest minor child in a hypothetical biobank; willingness did not differ between consent and data-sharing scenarios. Lower educational attainment, higher religiosity, lower trust, worries about privacy, and attitudes about benefits, concerns, and information needs were independently associated with less willingness to allow their child to participate. Of parents who were willing to participate themselves, 25% were not willing to allow their child to participate. Being willing to participate but not willing to allow one’s child to participate was independently associated with multiple factors, including race, lower educational attainment, lower annual household income, public health care insurance, and higher religiosity. Conclusions: Fifty-five percent of parents were willing to allow their youngest minor child to participate in a hypothetical biobank. Building trust, protecting privacy, and addressing attitudes may increase enrollment and diversity in pediatric biobanks. (shrink)

The original lecture was delivered by the author in the Ateneo of Madrid, as part of the series called 'Tendencias actuales del pensamiento europeo' , on 20th April 1955.

This study considers the relationship between perceptions of ethical behavior and the demographic characteristics of sex, age, education level, job title, and job tenure among a sample of marketing researchers. The findings of this study indicate that female marketing researchers, older marketing researchers, and marketing researchers holding their present job for ten years or more generally rate their behavior as more ethical.

Koonin argues that CRISPR-Cas systems present the best-known case in point for Lamarckian evolution because they satisfy his proposed criteria for the specific inheritance of acquired adaptive characteristics. We see two interrelated issues with Koonin’s characterization of CRISPR-Cas systems as Lamarckian. First, at times he appears to confuse an account of the CRISPR-Cas system with an account of the mechanism it employs. We argue there is no evidence for the CRISPR-Cas system being “Lamarckian” in any sense. Second, it is unclear (...) whether the mechanism is more “Lamarckian” than many other forms of genetic change already well-characterized in Darwinian terms. We present three conceptually distinct senses in which the mechanism of IAC may be considered Lamarckian and argue that only the strongest sense of goal-directed IAC would be difficult to accommodate in a Darwinian account. As the CRISPR-Cas mechanism does not qualify as “Lamarckian” in this strong sense, we argue there is no conceptual value in calling it “Lamarckian”. Finally, we suggest that CRISPR-Cas systems do hold the potential for genuinely non-Darwinian, directed evolution in a way that Koonin did not discuss, involving their potential use as a human gene-editing tool. (shrink)

Multilevel research strategies characterize contemporary molecular inquiry into biological systems. We outline conceptual, methodological, and explanatory dimensions of these multilevel strategies in microbial ecology, systems biology, protein research, and developmental biology. This review of emerging lines of inquiry in these fields suggests that multilevel research in molecular life sciences has significant implications for philosophical understandings of explanation, modeling, and representation.

The discovery and ongoing investigation of microRNAs suggest important conceptual and methodological lessons for philosophers and historians of biology. This paper provides an account of miRNA research and the shift from viewing these tiny regulatory entities as minor curiosities to seeing them as major players in the post-transcriptional regulation of genes. Conceptually, the study of miRNAs is part of a broader change in understandings of genetic regulation, in which simple switch-like mechanisms were reinterpreted as aspects of complex cellular and genome-wide (...) processes. Among them are the activities of small RNAs, previously regarded as non-functional. Methodologically, the miRNA story suggests new ways of characterizing biological research that should prove helpful to philosophers of science who seek to develop more pluralistic, pragmatic models of scientific inquiry. miRNA research displays iterative movements between multiple modes of investigation that include not only the proposal and testing of hypotheses but also exploratory, technology-oriented and question-driven modes of research. As an exemplary story of scientific discovery and development, the miRNA case illustrates transitions from genetics to genomics and systems biology, and it shows how diverse configurations of research practice are related to major scientific advances. (shrink)

Microbial model systems have a long history of fruitful use in fields that include evolution and ecology. In order to develop further insight into modelling practice, we examine how the competitive exclusion and coexistence of competing species have been modelled mathematically and materially over the course of a long research history. In particular, we investigate how microbial models of these dynamics interact with mathematical or computational models of the same phenomena. Our cases illuminate the ways in which microbial systems and (...) equations work as models, and what happens when they generate inconsistent findings about shared targets. We reveal an iterative strategy of comparative modelling in different media, and suggest reasons why microbial models have a special degree of epistemic tractability in multimodel inquiry. (shrink)

Human microbiome research makes causal connections between entire microbial communities and a wide array of traits that range from physiological diseases to psychological states. To evaluate these causal claims, we first examine a well-known single-microbe causal explanation: of Helicobacter pylori causing ulcers. This apparently straightforward causal explanation is not so simple, however. It does not achieve a key explanatory standard in microbiology, of Koch’s postulates, which rely on manipulations of single-microorganism cultures to infer causal relationships to disease. When Koch’s postulates (...) are framed by an interventionist causal framework, it is clearer what the H. pylori explanation achieves and where its explanatory strengths lie. After assessing this ‘simple’, single-microbe case, we apply the interventionist framework to two key areas of microbiome research, in which obesity and mental health states are purportedly explained by microbiomes. Despite the experimental data available, interventionist criteria for explanation show that many of the causal claims generated by microbiome research are weak or misleading. We focus on the stability, specificity and proportionality of proposed microbiome causal explanations, and evaluate how effectively these dimensions of causal explanation are achieved in some promising avenues of research. We suggest some conceptual and explanatory strategies to improve how causal claims about microbiomes are made. (shrink)

Human microbiome research makes causal connections between entire microbial communities and a wide array of traits that range from physiological diseases to psychological states. To evaluate these causal claims, we first examine a well-known single-microbe causal explanation: of Helicobacter pylori causing ulcers. This apparently straightforward causal explanation is not so simple, however. It does not achieve a key explanatory standard in microbiology, of Koch’s postulates, which rely on manipulations of single-microorganism cultures to infer causal relationships to disease. When Koch’s postulates (...) are framed by an interventionist causal framework, it is clearer what the H. pylori explanation achieves and where its explanatory strengths lie. After assessing this ‘simple’, single-microbe case, we apply the interventionist framework to two key areas of microbiome research, in which obesity and mental health states are purportedly explained by microbiomes. Despite the experimental data available, interventionist criteria for explanation show that many of the causal claims generated by microbiome research are weak or misleading. We focus on the stability, specificity and proportionality of proposed microbiome causal explanations, and evaluate how effectively these dimensions of causal explanation are achieved in some promising avenues of research. We suggest some conceptual and explanatory strategies to improve how causal claims about microbiomes are made. (shrink)

Human microbiome research makes causal connections between entire microbial communities and a wide array of traits that range from physiological diseases to psychological states. To evaluate these causal claims, we first examine a well-known single-microbe causal explanation: of Helicobacter pylori causing ulcers. This apparently straightforward causal explanation is not so simple, however. It does not achieve a key explanatory standard in microbiology, of Koch’s postulates, which rely on manipulations of single-microorganism cultures to infer causal relationships to disease. When Koch’s postulates (...) are framed by an interventionist causal framework, it is clearer what the H. pylori explanation achieves and where its explanatory strengths lie. After assessing this ‘simple’, single-microbe case, we apply the interventionist framework to two key areas of microbiome research, in which obesity and mental health states are purportedly explained by microbiomes. Despite the experimental data available, interventionist criteria for explanation show that many of the causal claims generated by microbiome research are weak or misleading. We focus on the stability, specificity and proportionality of proposed microbiome causal explanations, and evaluate how effectively these dimensions of causal explanation are achieved in some promising avenues of research. We suggest some conceptual and explanatory strategies to improve how causal claims about microbiomes are made. (shrink)

BackgroundWhen conducting research with Indigenous populations consent should be sought from both individual participants and the local community. We aimed to search and summarise the literature about methods for seeking consent for research with Indigenous populations.MethodsA systematic literature search was conducted for articles that describe or evaluate the process of seeking informed consent for research with Indigenous participants. Guidelines for ethical research and for seeking consent with Indigenous people are also included in our review.ResultsOf 1447 articles found 1391 were excluded (...) ; 56 were relevant and included. Articles were categorised into original research that evaluated the consent process or publications detailing the process of seeking consent and guidelines for ethical research. Guidelines were categorised into international ; national and state/regional/local guidelines. In five studies based in Australia, Canada and The United States of America the consent process with Indigenous people was objectively evaluated. In 13 other studies interpreters, voice recording, videos, pictures, flipcharts and “plain language” forms were used to assist in seeking consent but these processes were not evaluated. Some Indigenous organisations provide examples of community-designed resources for seeking consent and describe methods of community engagement, but none are evaluated. International, national and local ethical guidelines stress the importance of upholding Indigenous values but fail to specify methods for engaging communities or obtaining individual consent. In the ‘Grey literature’ concerns about the consent process are identified but no solutions are offered.ConclusionConsultation with Indigenous communities is needed to determine how consent should be sought from the community and the individual, and how to evaluate this process. (shrink)