This book is a comprehensive and unique text and reference in medical ethics. By far the most inclusive set of primary documents and articles in the field ever published, it contains over 100 selections. Virtually all pieces appear in their entirety, and a significant number would be difficult to obtain elsewhere. The volume draws upon the literature of history, medicine, philosophical and religious ethics, economics, and sociology. A wide range of topics and issues are covered, such as law and medicine, (...) truth-telling by the physician, research, population policy, genetics, abortion, dying, and individual rights in medical care. The selections span the centuries, beginning with material from the works of Hippocrates, continuing through Thomas Percival, John Stuart Mill, and Claude Bernard, down to modern commentators like Henry K. Beecher, Walsh McDermott, David L. Bazelon, Paul Freund, H. L. A. Hart, John Rawls, Paul Ramsey, Richard McCormick, Rashi Fein, and Bernard Barber. The text has eight major divisions, beginning with sections on the ethical dimensions of the physician-patient relationship in history; the moral bases of medical ethics; and regulation, compulsion, and protection of the consumer in clinical medicine and public health. Each of these sections includes key essays that appear for the first time. All of the book's major divisions contain primary documents: codes such as the Hippocratic Oath, Medieval Law for the Regulation of Medicine, and the first as well as the most recent code of the American Medical Association; court decisions, including those on Karen Quinlan and on abortion in the United States and West Germany; government documents such as the statement of the National Commission on the Protection of Human Subjects, the Tuskegee Syphilis Report, the British Parliamentary debate on euthanasia, and the Council of Europe on rights of the sick and dying; and various published guidelines such as the Harvard Medical School brain death criteria, the American Hospital Association on patient's rights, and Pope Pius XII on the prolongation of life. Cases that illustrate moral dilemmas are provided for discussion purposes. Each section is preceded by a succinct editor's introduction. The documents and essays are of practical value for practitioners and students in medicine, law, ethics, and counselling, and for individual patients and groups concerned with medical care. Through encompassing divergent viewpoints, the essays and primary documents were selected to encourage humane practices and deepen understanding of the multiple traditions that shaped and do shape the development of medicine. (shrink)

This study investigates the hypothesis that the advantage corporate social performance (CSP) yields in attracting human resources depends on the degree of job choice possessed by the job seeking population. Results indicate that organizational CSP is positively related to employer attractiveness for job seekers with high levels of job choice but not related for populations with low levels suggesting advantages to firms with high levels of CSP in the ability to attract the most qualified employees.

This anthology collects some of the most important papers on what is believed to be the major force in evolution, natural selection. An issue of great consequence in the philosophy of biology concerns the levels at which, and the units upon which selection acts. In recent years, biologists and philosophers have published a large number of papers bearing on this subject. The papers selected for inclusion in this book are divided into three main sections covering the history of the subject, (...) explaining its conceptual foundations, and focusing on kin and group selection and higher levels of selection.One of the book's interesting features is that it draws together material from the biological and philosophical literatures. The philosophical literature, having thoroughly absorbed the biological material, now offers conceptual tools suitable for the reworking of the biological arguments. Although a full symbiosis has yet to develop, this anthology offers a unique resource for students in both biology and philosophy.Robert N. Brandon is Professor in the Philosophy Department, Duke University. Richard M. Burian is Professor of Philosophy and Department Chairman, Virginia Polytechnic Institute and State University.A Bradford Book. (shrink)

This paper describes a cross-cultural research project on the relation between how people conceptualize nature and how they act in it. Mental models of nature differ dramatically among and within populations living in the same area and engaged in more or less the same activities. This has novel implications for environmental decision making and management, including dealing with commons problems. Our research also offers a distinct perspective on models of culture, and a unified approach to the study of culture (...) and cognition. We argue that cultural transmission and formation does not consist primarily in shared rules or norms, but in complex distributions of causally-connected representations across minds in interaction with the environment. The cultural stability and diversity of these representations often derives from rich, biologically-prepared mental mechanisms that limit variation to readily transmissible psychological forms. This framework addresses a series of methodological issues, such as the limitations of conceiving culture to be a well-defined system or bounded entity, an independent variable, or an internalized component of minds. (shrink)

The theory of sexual selection suggests several possible explanations for the development of standards of physical attractiveness in humans. Asymmetry and departures from average proportions may be markers of the breakdown of developmental stability. Supernormal traits may present age- and sex-typical features in exaggerated form. Evidence from social psychology suggests that both average proportions and (in females) “neotenous” facial traits are indeed more attractive. Using facial photographs from three populations (United States, Brazil, Paraguayan Indians), rated by members of the (...) same three populations, plus Russians and Venezuelan Indians, we show that age, average features, and (in females) feminine/neotenous features all play a role in facial attractiveness. (shrink)

Background HIV prevention trials conducted among disadvantaged vulnerable at-risk populations in developing countries present unique ethical dilemmas. A key concern in bioethics is the validity of informed consent for trial participation obtained from research subjects in such settings. The purpose of this study was to investigate the effectiveness of a continuous informed consent process adopted during the MDP301 phase III vaginal microbicide trial in Mwanza, Tanzania. Methods A total of 1146 women at increased risk of HIV acquisition working as (...) alcohol and food vendors or in bars, restaurants, hotels and guesthouses have been recruited into the MDP301 phase III efficacy and safety trial in Mwanza. During preparations for the trial, participatory community research methods were used to develop a locally-appropriate pictorial flipchart in order to convey key messages about the trial to potential participants. Pre-recorded audio tapes were also developed to facilitate understanding and compliance with gel-use instructions. A comprehension checklist is administered by clinical staff to all participants at screening, enrolment, 12, 24, 40 and 50 week follow-up visits during the trial. To investigate women's perceptions and experiences of the trial, including how well participants internalize and retain key messages provided through a continuous informed consent process, a random sub-sample of 102 women were invited to participate in in-depth interviews conducted immediately after their 4, 24 and 52 week follow-up visits. Results 99 women completed interviews at 4-weeks, 83 at 24-weeks, and 74 at 52 weeks. In all interviews there was evidence of good comprehension and retention of key trial messages including that the gel is not currently know to be effective against HIV; that this is the key reason for conducting the trial; and that women should stop using gel in the event of pregnancy. Conclusions Providing information to trial participants in a focussed, locally-appropriate manner, using methods developed in consultation with the community, and within a continuous informed-consent framework resulted in high levels of comprehension and message retention in this setting. This approach may represent a model for researchers conducting HIV prevention trials among other vulnerable populations in resource-poor settings. Trial registration Current Controlled Trials ISRCTN64716212. (shrink)

In discussing the effects of grandparents on child survival in natural fertility populations, Coall & Hertwig (C&H) rely extensively on the review by Sear and Mace (2008). We conducted a more detailed summary of the same literature and found that the evidence in favor of beneficial associations between grandparenting and child survival is generally weak or absent. The present state of the data on human alloparenting supports a more restricted use of the term Human stem family situations with celibate (...) helpers-at-the-nest can be described as cooperatively breeding, but the term is a poor fit to many human family systems. (shrink)

Sedlakova and Trachsel (2023) identify a major benefit of conversational artificial intelligence (CAI) in psychotherapy as its ability to expand access to mental healthcare for vulnerable populatio...

This study examines the role of acculturation in shaping consumers’ views of ethics. Specifically, it examines the relationships between the desire to keep one’s original culture, the desire to adopt the host culture, and the four dimensions of the Muncy and Vitell (Journal of Business Research Ethics 24(4), 297, 1992) consumer ethics scale. Using two separate immigrant populations – one of former Middle-Eastern residents now living in the U.S. and the other of Asian immigrants in the U.S. – results (...) indicate that those who want to keep their original culture are less tolerant of unethical consumer activities, while those who are more willing to adopt the host culture are more tolerant of these same consumer activities. Furthermore, the immigrants in both studies who are more tolerant of unethical consumer activities are those who are generally somewhat younger and with less formal education. The relationship between gender and consumer ethics was not significant. (shrink)

The umbrella-term ‘executive functions’ includes various domain-general, goal-directed cognitive abilities responsible for behavioral self-regulation. The influential unity and diversity model of EF posits the existence of three correlated yet separable executive domains: inhibition, shifting and updating. These domains may be influenced by factors such as socioeconomic status and culture, possibly due to the way EF tasks are devised and to biased choice of stimuli, focusing on first-world testees. Here, we propose a FREE test battery that includes two open-access tasks for (...) each of the three abovementioned executive domains to allow latent variables to be obtained. The tasks were selected from those that have been shown to be representative of each domain, that are not copyrighted and do not require special hardware/software to be administered. These tasks were adapted for use in populations with varying SES/schooling levels by simplifying tasks/instructions and using easily recognized stimuli such as pictures. Items are answered verbally and tasks are self-paced to minimize interference from individual differences in psychomotor and perceptual speed, to better isolate executive from other cognitive abilities. We tested these tasks on 146 early adolescents of both sexes and varying SES, because this is the age group in which the executive domains of interest become distinguishable and in order to confirm that SES effects were minimized. Performance was determined by Rate Correct Scores, which consider speed-accuracy trade-offs. Scores were sensitive to the expected improvement in performance with age and rarely/inconsistently affected by sex and SES, as expected, with no floor or ceiling effects, or skewed distribution, thus suggesting their adequacy for diverse populations in these respects. Using structural equation modeling, evidence based on internal structure was obtained by replicating the three correlated-factor solution proposed by the authors of the model. We conclude that the FREE test battery, which is open access and described in detail, holds promise as a tool for research that can be adapted for a wide range of populations, as well as altered and/or complemented in coming studies. (shrink)

An orthodox view in marketing ethics is that it is morally impermissible to market goods to specially vulnerable populations in ways that take advantage of their vulnerabilities. In his signature article “Marketing and the Vulnerable,” Brenkert (Bus Ethics Q Ruffin Ser 1:7–20, 1998) provided the first substantive defense of this position, one which has become a well-established view in marketing ethics. In what follows, we throw new light on marketing to the vulnerable by critically evaluating key components of Brenkert’s (...) general arguments. Specifically, we contend that Brenkert has failed to offer us any persuasive reasons to think that it is immoral to market to the vulnerable in ways that take advantage of their vulnerability. Although Brenkert does highlight the fact that the specially vulnerable are at greater risk of being harmed by already immoral marketing practices (e.g., deception, manipulation), he fails to establish that the specially vulnerable are a unique moral category of market clients or that there are special moral standards that apply to them. Moreover, even if Brenkert’s position were theoretically defensible, the practical implications of his position are far less tenable than he suggests. If our criticisms are sound, then Brenkert and others who endorse his position are seriously mistaken regarding how one can permissibly market products to vulnerable populations, and, in addition, they have improperly categorized certain morally permissible marketing practices as being immoral. (shrink)

Biologists and philosophers differ on whether selection should be analyzed at the level of the gene or of the individual. In Peter Godfrey-Smith’s book, Darwinian Populations and Natural Selection, he argues that individuals can be good members of Darwinian populations, whereas genes rarely can. I take issue with parts of this view, and suggest that Godfrey-Smith’s scheme for thinking about Darwinian populations is also applicable to populations of genes.

### ­ In Who shall go first? A multicriteria approach to patient selection for first clinical trials of cardiac xenotransplantation, Kögel et al recommend the inclusion of patients who (1) have a (high) medical need for an allograft, (2) have the capacity to benefit from a xenograft, (3) have a ‘real’ choice between enrolment in a first-in-human clinical trial and an alternative life-sustaining treatment option and (4) have no clear record of previous non-compliance.1 As the authors discuss, patient selection must (...) promote the goal of gaining reliable and valid knowledge about the risks and benefits of cardiac xenotransplantation. While the four criteria outlined above certainly promote this goal, we argue it is crucial to add a fifth criterion emphasising the need to include diverse populations, particularly regarding sex, age, ethnicity and socioeconomic background.i In this commentary, we present two arguments for our claim and discuss the impact of neglecting diversity from the first trials on. ### The scientific rationale for including diverse populations First, including diverse populations in the first clinical trials of cardiac xenotransplantation enhances the scientific value of the data by assessing safety and efficacy among various populations. Treatment response can differ among patient (sub)groups as a result of genetic, physiological and socioeconomic factors.2 By including diverse populations from the first trials on, researchers can identify these …. (shrink)

Spite (in the biological or evolutionary sense) is behavior that harms others at a cost to the actor. The presence of spite in human and animal populations presents an evolutionary puzzle. Recent work has suggested small populations and pre-play signaling can have a significant effect on the evolution of spite. Here, we use computational methods to explore these factors in fluctuating populations that may go extinct. We find that the presence of spite can make a population significantly (...) more likely to go extinct, but that this does not preclude the possibility of spite reliably evolving. Additionally, we find that the stochastic effects of small fluctuating populations allow for the evolution and predominance of signal-mediated conditional spite across a wide range of conditions. These results suggest that directed harm, even if costly, can play a significant early role in the evolution of social behaviors and this provides a possible origin for punishment. (shrink)

Burt's target article oddly misses the important intellectual contribution of sociogenomics to our understanding of genetic evolution in contemporary human populations. Although social scientists' immediate research agendas are often not evolutionary in nature, I call for a better appreciation of the role of sociogenomics in answering important evolutionary questions.

Home and place are two interrelated concepts that have overlapping meanings. They are both referring to physical spaces that have meanings and feelings, spaces where common experiences shape and identities are formed. The concepts of home and place are intrinsically linked and are used interchangeably but the most important line that ties these two together is through the notion of belonging and attachment that bind individuals to meaningful spaces. However, there is a gap in the home and place literature about (...) understanding these meanings through negative attributes. This chapter explores the similarities and differences of home and place through negative experiences of two groups of vulnerable people: homeless people and migrants. In this chapter we examine how a lack of physical attachments leads to a lack of belonging and how, together, they create ruptures that ironically help to understanding of the meanings of home and place by separating them from the notion of space. The chapter acknowledges that not all places are called home and not all spaces have the capacity to be made into meaningful places, but that one must focus on the theoretical distinctions underpinning the two terms. The authors suggest that focusing on two vulnerable populations (migrants and homeless people) can offer a pathway towards a theoretical understanding of these two generic concepts. By examining the negative experiences of marginalization and exclusion, in relation to the meanings of home and place, the chapter discusses how negative experiences of displacement and homelessness can offer valuable insights into further theorization of the concepts of home and place. (shrink)

In post-Revolutionary Mexico, the Indian was conceptualized as a problem that needed to be solved. Indians were believed to be weighing down the nation and thought to constitute an obstacle for fulfilling its promised modern future. Thus, the scientific study of indigenous peoples in Mexico became, in the 1930s, a focus of anthropologists, physicians, and other experts, who sought to learn more about indigenous populations in order to solve this "problem." In this paper I explore how this "problem-solving" was (...) practiced, how and why particular groups of people were used as subjects of inquiry and intervention, how they were selected, and how they enabled the production of knowledge deemed useful to... (shrink)

With the growth of precision medicine research on health data and biospecimens, research institutions will need to build and maintain long-term, trusting relationships with patient-participants. While trust is important for all research relationships, the longitudinal nature of precision medicine research raises particular challenges for facilitating trust when the specifics of future studies are unknown. Based on focus groups with racially and ethnically diverse patients, we describe several factors that influence patient trust and potential institutional approaches to building trustworthiness. Drawing on (...) these findings, we suggest several considerations for research institutions seeking to cultivate long-term, trusting relationships with patients: Address the role of history and experience on trust, engage concerns about potential group harm, address cultural values and communication barriers, and integrate patient values and expectations into oversight and governance structures. (shrink)

Background Over the last decade, the return of results (ROR) in precision medicine research (PMR) has become increasingly routine. Calls for individual rights to research results have extended the “duty to report” from clinically useful genetic information to traits and ancestry results. ROR has thus been reframed as inherently beneficial to research participants, without a needed focus on who benefits and how. This paper addresses this gap, particularly in the context of PMR aimed at increasing participant diversity, by providing investigator (...) and researcher perspectives on and questions about the assumed value of ROR in PMR.Methods Semi-structured interviews with a purposive sample of investigators and researchers across federally funded PMR studies in three national consortia, as well as observations of study activities, focused on how PM researchers conceptualize diversity and implement inclusive practices across research stages, including navigating ROR.Results Interviewees (1) validated the value of ROR as a benefit of PMR, while others (2) questioned the benefit of clinically actionable results to individuals in the absence of sufficient resources for translating findings into health care for diverse and disadvantaged populations; (3) expressed uncertainties in applying the presumed value of ROR as a benefit for non-clinical results; and (4) and debated when the promise of the value of ROR may undermine trust in PMR, and divert efforts to return value beyond ROR.Conclusions Conceptualizations of diversity and inclusion among PM researchers and investigators raise unique ethical questions where unexamined assumptions of the value of ROR inform study recruitment efforts to enroll minoritized and under-represented populations. A lack of consideration for resources and infrastructure necessary to translate ROR into actionable information may hinder trustworthy community-research relationships. Thus, we argue for a more intentional interrogation of ROR practices as an offer of benefit and for whom. (shrink)

Natural languages vary in their quantity expressions, but the variation seems to be constrained by general properties, so-calleduniversals. Their explanations have been sought among constraints of human cognition, communication, complexity, and pragmatics. In this article, we apply a state-of-the-art language coordination model to the semantic domain of quantities to examine whether two quantity universals—monotonicity and convexity—arise as a result of coordination. Assuming precise number perception by the agents, we evolve communicatively usable quantity terminologies in two separate conditions: a numeric-based condition (...) in which agents communicate about a number of objects and a quotient-based condition in which agents communicate about the proportions. We find out that both universals take off in all conditions but only convexity almost entirely dominates the emergent languages. Additionally, we examine whether the perceptual constraints of the agents can contribute to the further development of universals. We compare the degrees of convexity and monotonicity of languages evolving in populations of agents with precise and approximate number sense. The results suggest that approximate number sense significantly reinforces monotonicity and leads to further enhancement of convexity. Last but not least, we show that the properties of the evolved quantifiers match certain invariance properties from generalized quantifier theory. (shrink)

The constraint-handling methods using multiobjective techniques in evolutionary algorithms have drawn increasing attention from researchers. This paper proposes an efficient conical area differential evolution algorithm, which employs biased decomposition and dual populations for constrained optimization by borrowing the idea of cone decomposition for multiobjective optimization. In this approach, a conical subpopulation and a feasible subpopulation are designed to search for the global feasible optimum, along the Pareto front and the feasible segment, respectively, in a cooperative way. In particular, the (...) conical subpopulation aims to efficiently construct and utilize the Pareto front through a biased cone decomposition strategy and conical area indicator. Neighbors in the conical subpopulation are fully exploited to assist each other to find the global feasible optimum. Afterwards, the feasible subpopulation is ranked and updated according to a tolerance-based rule to heighten its diversity in the early stage of evolution. Experimental results on 24 benchmark test cases reveal that CADE is capable of resolving the constrained optimization problems more efficiently as well as producing solutions that are significantly competitive with other popular approaches. (shrink)

The proliferation of Generative Artificial Intelligence (Generative AI) has led to an increased reliance on AI‐generated content for designing and deploying digital health interventions. While generative AI has the potential to facilitate and automate healthcare, there are concerns that AI‐generated content and AI‐generated health advice could trigger, perpetuate, or exacerbate prior traumatic experiences among vulnerable populations. In this discussion article, I examined how generative‐AI‐powered digital health interventions could trigger, perpetuate, or exacerbate emotional trauma among vulnerable populations who rely (...) on digital health interventions as complementary or alternative sources of seeking health services or information. I then proposed actionable strategies for mitigating AI‐generated trauma in the context of digital health interventions. The arguments raised in this article are expected to shift the focus of AI practitioners against prioritizing dominant narratives in AI algorithms into seriously considering the needs of vulnerable minority groups who are at the greatest risk for trauma but are often invisible in AI data sets, AI algorithms, and their resultant technologies. (shrink)

This case involves invasive research on captive wild populations of birds to study aggressive animal behavior. The case and associated commentaries raise and examine fundamental issues: whether and under what conditions, such research is ethically justified when the research has no expected, direct application to the human species; the moral status of animals and how one balances concern for the animal’s interests against the value of gains in scientific knowledge. They also emphasize the issue of the importance of a (...) thorough literature search to ensure appropriate research design and experimental design to minimize animal suffering. It raises the issue of circumstances in which such research should be modified or terminated. (shrink)

This commentary suggests that there is more continuity in pre- and post-demographic transition populations with respect to grandparental investments than is assumed by Coall & Hertwig (C&H). Recent research employing high-quality data supports the claim that sex-biased grandparental investments are likely to exist in industrialized societies, and that the economic status of grandparents is related to their long-term fitness.

In “A Public Health Ethics Framework for Populations with Limited English Proficiency,” Chipman and colleagues present a valuable framework for addressing health disparities linked to limited Engli...

Because of historical mistreatment of ethnic minorities by research and medical institutions, it is particularly important for researchers to be mindful of ethical issues that arise when conducting research with ethnic minority populations. In this article, we focus on the ethical issues related to the inclusion of ethnic minorities in clinical trials of psychosocial treatments. We highlight 2 factors, skepticism and mistrust by ethnic minorities about research and current inequities in the mental health care system, that researchers should consider (...) when developing psychosocial interventions studies that include ethnic minorities. (shrink)

This study explored the challenges of informed consent and understanding of the research process among Black and Latino men under community supervision. Between February and October 2012, we conducted cognitive face-to-face interviews using open-ended questions on the significant areas of research participation among 259 men aged 35 to 67 under community supervision in Bronx, New York. Content analysis of the open-ended questions revealed limited knowledge concerning the understanding of research participation. The study participants appeared to generally understand concepts such as (...) compensation after research participation and confidentiality. Participants demonstrated a lack of understanding of certain aspects of the research process—informed consent, human subject, Institutional Review Board, and clinical trials. These findings are informative to researchers conducting studies with criminal justice populations and Institutional Review Boards reviewing research studies. (shrink)

In a series of papers, Forber and Smead :151–166, 2014, Biol Philos 30:405–421, 2015) and Smead and Forber :698–707, 2013) make a valuable contribution to the study of cooperation in finite populations by analyzing an understudied model: the prisoner’s delight. It always pays to cooperate in the one-shot prisoner’s delight, so this model presents a best-case scenario for the evolution of cooperation. Yet, what Forber and Smead find is highly counterintuitive. In finite populations playing the prisoner’s delight, increasing (...) the benefit of cooperation causes selection to favor defection. Here, I extend their model by considering the effects of non-linear payoffs. In particular, I show that interesting subtleties arise when payoffs are synergistic. Indeed, analysis reveals that increasing the benefit of cooperation does not always favor the spread of defection if payoffs are synergistic. I conclude by drawing some general considerations about robustness analysis in evolutionary models. (shrink)

Background: The development of implicit tests for measuring biases and behavioral predispositions is a recent development within psychology. While such tests are usually researched within a social-cognitive paradigm, behavioral researchers have also begun to view these tests as potential tests of conditioning histories, including in the sexual domain. Objective: The objective of this paper is to illustrate the utility of a behavioral approach to implicit testing and means by which implicit tests can be built to the standards of behavioral psychologists. (...) Design: Research findings illustrating the short history of implicit testing within the experimental analysis of behavior are reviewed. Relevant parallel and overlapping research findings from the field of social cognition and on the Implicit Association Test are also outlined. Results: New preliminary data obtained with both normal and sex offender populations are described in order to illustrate how behavior-analytically conceived implicit tests may have potential as investigative tools for assessing histories of sexual arousal conditioning and derived stimulus associations. Conclusion: It is concluded that popular implicit tests are likely sensitive to conditioned and derived stimulus associations in the history of the test-taker rather than ‘unconscious cognitions’, per se. Keywords: implicit association test; function acquisition speed test; relational frame theory; stimulus equivalence; sex offenders; sexual interests (Published: 15 March 2012) Citation: Socioaffective Neuroscience & Psychology 2012, 2 : 17335 - DOI: 10.3402/snp.v2i0.17335. (shrink)

This article provides an analysis of the issues and ethical challenges faced in a study with LGBTIQ student participants concerning their experiences of violence, harassment and bullying in tertiary settings. The authors detail the ethical challenges behind the development of the project, and around conducting research with a minority and vulnerable population. The article illustrates how the utilization of feminist and queer theory has impacted the process of conducting ethical research, including approaches to recruitment and participant autonomy. The dilemmas of (...) confidentiality within a self-labelled and easily identifiable population are resolved. Further, unexpected challenges and risks to participant safety created through adherence to institutional ethical research frameworks are rectified. Importantly, the authors seek to avoid revictimization of participants and to instead empower students in their responses to violence, harassment and bullying that they may have experienced. The authors point to utilization of theoretical foundations and continual reflexive improvement as elements of best practice for those seeking to research minority populations, and in projects marked by the participation of those deemed vulnerable and high-risk. (shrink)

Although the importance of including vulnerable populations in medical research is widely accepted, identifying how to achieve such inclusion remains a challenge. Ensuring that the language of informed consent is comprehensible to this group is no less of a challenge. Although a variety of interventions show promise for increasing the comprehensibility of informed consent and increasing a climate of exchange, consensus is lacking on which interventions should be used in which situations and current regulations provide little guidance. We argue (...) that the notion of individual autonomy — a foundational principle of informed consent — may be too narrow for some vulnerable populations by virtue of its failure to acknowledge their unique histories and current circumstances. It has a different meaning for members of structured groups like American Indians than for unstructured groups, such as African Americans, whose complicated histories foster group identity. Ensuring broad participation in research and selecting appropriate methods for obtaining informed consent — namely, methods aligned with the source of vulnerability and level of risk — require new ways of thinking that might produce guidelines for matching informed consent models and processes with subpopulations. (shrink)

In contrast to attempts that have been made to measure the clarity of reporting of the methods of clinical trials in journal articles, we report here an attempt to measure the accuracy of methods reporting. We focus in this article on eligibility criteria as a test case for the reporting of clinical trial methods. We examined the reporting of eligibility criteria in the protocol, methods paper (if applicable), journal article, and Clinical Alert for articles appearing in print between January 1988 (...) and September 1994 for which a Clinical Alert had been issued. Eligibility criteria were further classified into five categories in order to examine the content of information loss, if any. On average, 82% of protocol eligibility criteria were reported in methods papers. Journal articles and Clinical Alerts fared somewhat worse: 63% of criteria were reported in journal articles, 19% in Clinical Alerts. In all three categories of medical communication, the reporting of criteria that defined the study disease tended to be complete; reporting of criteria relating to trial precision, patient safety, legal and ethical concerns, and administrative considerations, was not complete. We found that criteria for clinical trial eligibility are frequently under-reported in medical communications. Moreover, some of the criteria omitted are of considerable clinical importance. We suggest that in the design phase of clinical trials, proposed eligibility criteria be scrutinized closely. Those criteria that survive this scrutiny and that have clinical import must be reported upon fully and accurately when communicating trial results. (shrink)

In 1966, a team made up of Brazilian and foreign scientists spent a week carefully recording the body temperature and other clinical signs and symptoms of 110 Tiriyó Indigenous people in their communities along the Brazil-Suriname border. Led by the Yale University virologist and immunologist Francis Black, the researchers faced an "epidemic" with a special profile, distinct from those most common in Indigenous populations, which usually resulted in widespread illness, the collapse of subsistence activities, hunger, and as a rule, (...) elevated mortality.Rather, what was happening with the Tiriyó was a planned event, controlled and carefully... (shrink)

Ethical research conduct is a cornerstone of research practice particularly when research participants include vulnerable populations. This study mapped the extent of reporting ethical research practices in studies conducted among refugees and war-affected populations in the Arab World, and assessed variations by time, country of study, and study characteristics. An electronic search of eight databases resulted in 5668 unique records published between 2000 and 2013. Scoping review yielded 164 eligible articles for analyses. Ethical research practices, including obtaining institutional (...) approval, access to the community/research site, and informed consent/assent from the research participants, were reported in 48.2, 54.9, and 53.7% of the publications, respectively. Institutional approval was significantly more likely to be reported when the research was biomedical in nature compared to public health and social, when the study employed quantitative compared to qualitative or mixed methodologies, and when the journal required a statement on ethical declarations. Institutional approval was least likely to be reported in papers that were sole-authored, when these did not mention a funding source, or when published in national journals. Similar results were obtained for access to the community site and for seeking informed consent/assent from study participants. The responsibility of inadequacies in adherence to ethical research conduct in crisis settings is born by a multitude of stakeholders including funding agencies, institutional research boards, researchers and international relief organizations involved in research, as well as journal editors, all of whom need to play a more proactive role for enhancing the practice of ethical research conduct in conflict settings. (shrink)

In its expansion to genomic, epidemiological and biomedical research, citizen science has been promoted as contributing to the democratisation of medical research and healthcare. At the same time, it has been criticised for reinforcing patterns of exclusion in health and biomedicine, and sometimes even creating new ones. Although citizen science has the potential to make biomedical research more inclusive, the benefits of current citizen science initiatives are not equally accessible for all people—in particular those who are resource-poor, located outside of (...) traditional networks of healthcare services, or members of minorities and marginalised groups. In view of growing public investments in participatory research endeavours, we argue that it should be considered more explicitly if, and how, citizen science could help make research more inclusive, contribute to the public good, and possibly even lead to better and more equitable healthcare. Reflecting on emerging ethical concerns for scientific conduct and best medical practice, we propose a set of relevant considerations for researchers, practitioners, bioethicists, funders and participants who seek to advance ethical practices of citizen-led health initiatives, and address profound differences in position, privilege and power in research. (shrink)