This book provides in-depth analyses of a wide range of topics surrounding ethical issues in community and patient stakeholder–engaged health research, and highlights where consensus exists, is emerging, or remains elusive. Topics in this book cover the history of stakeholder engagement in health research; how codes of ethics and regulations have (or have not) addressed stakeholder engagement; how to promote equitable collaboration; the ethical perspectives of different stakeholders; and the unique challenges posed by stakeholder- engaged research to the protection of (...) human research participants and the research ethics review process. The book includes discussion of unique issues that arise in stakeholder engagement relevant to different populations, settings, and research designs. This book is relevant for anyone with a role or interest in stakeholder-engaged research, including patient and community research partners; academic researchers; research ethics scholars and educators; and funders. (shrink)

Institutional Review Board decisions hinge on the availability and interpretation of information. This is demonstrated by the following well-known historical example. In 2001, 24-year-old Ellen Roche died from respiratory distress and organ failure as a result of her participation in a study at Johns Hopkins Asthma and Allergy Center. The non-therapeutic physiological study, “Mechanisms of Deep Inspiration-Induced Airway Relaxation,” was designed to examine airway hyperresponsiveness in healthy individuals in order to better understand the pathophysiology of asthma. Participants inhaled hexamethonium, a (...) chemical ganglionic blocker that was not FDA-approved for use as specified in the experimental protocol. Risks of inhaling hexamethonium, including lung damage, had been reported in the 1950s and ‘60s. An investigation conducted after Roche's death determined that the study's principal investigator had failed to adequately search the medical literature; the protocol submitted for IRB review cited articles indexed in online literature databases that went back only as far as the 1970s. (shrink)

Volume 19, Issue 9, September 2019, Page 62-64.

Volume 20, Issue 5, June 2020, Page 28-30.

In the target article “Promoting Ethical Payment in Human Infection Challenge Studies,” Fernandez Lynch et al. call for more information sharing about research payment amounts to study parti...

Graphical AbstractBy combining phylogeography and zooarchaeology, the spatial distribution and temporal dynamics within species lineages can be reconstructed. Both approaches should be used with four rat species (black, Asian house, Pacific, and brown) to understand the minimum dates of commensalism, urbanization dynamics, and connections among human societies. More details can be found in article number 1900160 by Emily E. Puckett et al.

Phylogeography and zooarchaeology are largely separate disciplines, yet each interrogates relationships between humans and commensal species. Knowledge gained about human history from studies of four commensal rats (Rattus rattus, R. tanezumi, R. exulans, and R. norvegicus) is outlined, and open questions about their spread alongside humans are identified. Limitations of phylogeographic and zooarchaeological studies are highlighted, then how integration would increase understanding of species’ demographic histories and resultant inferences about human societies is discussed. How rat expansions have informed the understanding (...) of human migration, urban settlements, trade networks, and intra‐ and interspecific competition is reviewed. Since each rat species is associated with different human societies, they identify unique ecological and historical/cultural conditions that influenced their expansion. Finally, priority research areas including nuclear genome based phylogeographies are identified using archaeological evidence to understand R. norvegicus expansion across China, multi‐wave colonization of R. rattus across Europe, and competition between R. rattus and R. norvegicus. (shrink)

This article investigates the ways in which discourses and experiences of health and healing have shaped the development of contemporary dance in France. It confronts the problem of how to situate contemporary dance in relation to other dance genres and suggests Robert Desjarlais’ concept of the ‘aesthetic of experience’ as a helpful framework for understanding the ways in which technique and virtuosity operate differently in contemporary dance than in other dance forms. The article is ethnographic and historical and attempts to (...) create a dialogue between dance studies and medical anthropology. The ethnographic and historical material has three parts. First, I offer an analysis of the cultural idiom of illness as blocageand argue that contemporary dancers in Aix-en-Provence experience their work as a form of healing or dÈblocage. Next, I show how two historical and political events in France led to the promotion of dance as a means of social reform: (1) the Situationist art movement of the 1960s and its idea of ‘awakening’ society through public art; and (2) the renovation of the French Ministry of Culture in 1982 and its subsequent promotion of contemporary dance in state-funded community outreach projects in the 1980s. Finally, drawing on rich narratives from fieldwork interviews, I define awareness, expression and presence as the primary technical elements of contemporary dance in Aix-en-Provence, France, in 2002, and explain their relationship to the notion of ‘dance as l'intervention’ that has grown out of the historical context of contemporary dance in France. (shrink)

The stories in this volume shed light on the potential of narrative inquiry to fill gaps in knowledge, particularly given the mixed results of quantitative research on patient views of and experiences with genetic and genomic testing. Published studies investigate predictors of testing (particularly risk perceptions and worry); psychological and behavioral responses to testing; and potential impact on the health care system (e.g., when patients bring DTC genetic test results to their primary care provider). Interestingly, these themes did not dominate (...) the narratives published in this issue. Rather, these narratives included consistent themes of expectations and looking for answers; complex emotions; areas of contradiction and conflict; and family impact. More narrative research on patient experiences with genetic testing may fill gaps in knowledge regarding how patients define the benefits of testing, changes in psychological and emotional reactions to test results over time, and the impact of testing on families. (shrink)

Only somewhat recently has a specific literature emerged focused on the ethics of engaging patient and community stakeholders in health research. This literature is informed by a broad range of disciplinary frameworks and norms. It also overlaps with – and diverges from – traditional research ethics scholarship in interesting and important ways. This volume is an effort to bring together, in one place, important perspectives on the ethics of stakeholder engagement in health research. Here, ethics, patient and community stakeholders, and (...) health-related research are all conceptualized broadly. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Re-examining Empirical Data on Conflicts of Interest Through the Lens of Personal NarrativesEmily E. Anderson and Elena M. KrausIntroductionThe personal stories submitted by physicians and researchers for this symposium add much–needed dimension to conversations on conflicts of interest in medicine and research. Narratives from individuals living with conflicts of interest can serve as a unique lens through which to consider psychological and economic theories and survey data on physician (...) and patient views. In our reading of these personal narratives, we identified four primary themes that will serve as springboards for our commentary. We aim to triangulate clusters of meaning drawn from the narratives with relevant data from published empirical studies and identify gaps in knowledge where more research is needed. These themes are: the unique environments of medicine and research; weighing the potential benefits of conflicts of interest against the risks; conflict of interest management; and the roles and responsibilities of diverse stakeholder groups.The Unique Challenges of the Medical and Research EnvironmentsThe reflections of the narrative authors draw attention to many of the unique environmental aspects of medicine and medical research that make physicians and researchers especially vulnerable to conflicts of interest. Conflicts of interest may be more ubiquitous in medicine than in any other industry (Kassirer, 2006). As the narratives demonstrate, conflicts of interest emerge across a range of health care delivery and research activities. Surveys have shown that 94 percent of physicians have some kind of relationship with industry (Campbell, Gruen, Mountford, et al., 2007). There is also evidence that physician interactions with medical industry begin early and are a regular part of a physician’s professional practice along the career continuum (Wazana, 2000).Medicine as a profession is distinct from banking or law. It is often said that medicine is an art; in treating patients, creative individualized solutions and gut instinct are as (if not more) important than the application of scientific knowledge. Uncertainty surrounds medical decision making. There is limited precision with respect to diagnoses and prognoses, limited data regarding the effectiveness of many treatments, and a range of patient values and preferences. Because of this uncertainty, rules about practice standards, especially with respect to avoidance and management of conflicts of interest, cannot be as explicit as they are in law or business. As demonstrated by the story presented by Sal Cruz–Flores, research and practice often intersect. And, there is no system in greater need of reform—and no system about which there are more divergent opinions as to what shape that reform should take—than the United States health care [End Page 91] system. The narratives of Tony Mikulec, Govind Nagaldinne, and David M. Zientek demonstrate how various aspects of the structure of healthcare service provision and third–party payer arrangements have the potential to harm patients. Conflicts of interest comprise more than relationships with pharmaceutical and medical device manufacturers.The narratives of Laura Jean Bierut and David M. Zientek also discuss examples of conflicts of interest that arise from factors beyond relationships with industry or the direct potential for financial gain. This may be somewhat unique to the medical milieu. Non-financial conflicts such as a desire for the prestige bestowed upon scientists who make key discoveries, a requirement to publish for tenure and promotion, the need to maintain one’s license or other privileges, or simply the pressure of a competitive environment can influence physician and researcher behavior. As noted by Bierut, more research on how to identify and manage non-financial conflicts is needed.The Potential Benefits and Harms of Conflicts of InterestConflicts of interest are usually presented in a negative light, particularly those that involve physician relationships with the pharmaceutical industry. To “have a conflict of interest” is to be in a situation or role where there is potential for personal interests to be prioritized over professional responsibilities. However, in terms of public perception, it seems that conflicts of interest have become almost synonymous with wrongdoing. Perhaps this is due to the barrage of media reports during the last decade on significant harms caused by financial conflicts of interest in business, journalism, and sports as well as in medicine (Steinbrook, 2004). Amidst... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Grand Manner Aesthetics in LandscapeFrom Canvas to CelluloidEmily E. Auger (bio)Popular films about the environment and related human and material resource issues, particularly colonialism, tend to enhance the appeal of their subject matter by aesthetically transforming it according to audience preferences and tastes. Such mediating strategies are perhaps too familiar to contemporary artists of all types who would prefer to work beyond the limits of what their readers or (...) viewers are prepared to tolerate as entertainment, but the particular emphases and accommodations made by film artists to convey messages about the environment are little changed from those strategies used by painters over the past three centuries to a similar end. The methods by which environmental issues are aestheticized in late-twentieth-century film is directly and historically related to those established for grand manner painters by Nicholas Poussin (1594-1665) and taught at the French academy from the seventeenth through the nineteenth centuries. That these fundamentals were part of the training of artists who would be willing and able to enhance the glory of Louis XIV's absolutist monarchy seems not to have undermined the popular enthusiasm their association with the "classical" past generated outside of France. Thus, the grand manner ideal was repeated, elaborated, and adapted by subsequent British and American artists, teachers, and aestheticians, both amateur and professional, including Joshua Reynolds (1723-92), president of the British academy; theoretician Edmund Burke (1729-97); and such American painters as Benjamin West (1738-1820), Thomas Cole (1801-48), Frederic Church (1826-1900), and Albert Bierstadt (1830-1902).Examples of filmic adaptations of grand manner aesthetics considered here include English director John Boorman's The Emerald Forest (1985) and Anglo-French director Roland Joffé's The Mission (1986), both British productions; Kevin Costner's Dances with Wolves (1990) and John McTiernan's [End Page 96] Medicine Man (1992), both American productions with American directors; and Australian director Bruce Beresford's Black Robe (1991), a Canadian/Australian production based on Irish-born, Canadian novelist Brian Moore's best-selling novel of the same title (1985). While it might be argued that these films merely show the adaptation of academy-based grand manner ideals and principles to new imperialist interests, this article demonstrates how they educate and draw public sympathy to global environmental concerns, albeit with reference to a recognizably Western aesthetic tradition. Thus, the interest of this study to educators and students of the visual arts is twofold: first, it demonstrates the continued adaptation and application of aesthetic principles originally developed in the seventeenth century to a technology-based medium; and second, it shows how those aesthetic principles are currently applied in film to direct and modulate public opinion on matters well beyond the domain of pure or theoretical aesthetics.The grand manner aesthetic, first defined with reference to seventeenth-century painting and still apparent in twentieth-century film, is largely attributable to Poussin since he was an artist who wrote—and wrote well—about his understanding of artistic quality and priorities. He was deeply committed to classicism; he thought the elements of a painting should be idealized rather than realistic and particularized, that those elements should be clearly delineated in a linear manner, that exotic subjects and excessive color should be avoided as both appeal too much to the senses and not enough to the mind, and that figures should always predominate over landscape. Poussin's ideals became the model for students training at the French Academy, an institution officially formed in 1648 under the direct control of the government. Aspiring academicians were exhorted to produce images that were usually composites of the better, and sometimes imagined, aspects of the appearance, character, and deeds of the fictional and historical people, events, and locations that were their subjects. They were never allowed to forgot the hierarchy of value that placed genre painting forever below history painting, yet it cannot have escaped their notice that a certain number of well-executed examples of the lowly still life, domestic interior, and picturesque landscape on the exhibition walls made the "grandness" of more ambitious works more apparent by contrast.The French Academy soon became the envy of foreign upper-level bureaucrats cognizant... (shrink)

In order to consider how best to address relationship concerns with potential research participants arising in this study, we will first describe unique features...

Given that many clinical research studies struggle to meet their recruitment goals, researchers are eager to identify and employ strategies that will maximize reach to eligible and int...

Using medical advances to enhance human athletic, aesthetic, and cognitive performance, rather than to treat disease, has been controversial. Little is known about physicians? experiences, views, and attitudes in this regard. We surveyed a national sample of physicians to determine how often they prescribe enhancements, their views on using medicine for enhancement, and whether they would be willing to prescribe a series of potential interventions that might be considered enhancements. We find that many physicians occasionally prescribe enhancements, but doctors hold (...) nuanced and ambiguous views of these issues. Most express concerns about the potential effects of enhancements on social equity, yet many also believe specific enhancements that are safe and effective should be available but not covered by insurance. These apparently contradictory views might reflect inherent tensions between the values of equity and liberty, which could make crafting coherent social policies on medical enhancements challenging. [Supplementary materials are available for this article. Go to the publisher's online edition of American Journal of Bioethics for the following free supplemental resource(s): An additional table (Table 5) referred to on p. 5]. (shrink)

The profession of medicine is predicated upon an ethical mandate: first do no harm. However, critics charge that the medical profession’s culture and its public health mission are being undermined by the pharmaceutical industry’s wide-ranging influence. In this article, we analyze how drug firms influence psychiatric taxonomy and treatment guidelines such that these resources may serve commercial rather than public health interests. Moving beyond a conflict-ofinterest model, we use the conceptual and normative framework of institutional corruption to examine how organized (...) psychiatry’s dependence on drug firms has distorted science. We suggest that academic-industry relationships have led to the corruption of the evidence base upon which accurate diagnosis and sound treatment depend. We describe the current dependency corruption and argue that transparency alone is not a solution — and sometimes even produces iatrogenic effects. Furthermore, we argue that the corruption of the evidence base for diagnostic and practice guidelines renders obsolete the traditional informed consent process, and we offer suggestions for reforming this process. (shrink)

The possibility that industry is exerting an undue influence on the culture of medicine has profound implications for the profession's public health mission. Policy analysts, investigative journalists, researchers, and clinicians have questioned whether academic-industry relationships have had a corrupting effect on evidence-based medicine. Psychiatry has been at the heart of this epistemic and ethical crisis in medicine. This article examines how commercial entities, such as pharmaceutical companies, influence psychiatric taxonomy and treatment guidelines. Using the conceptual framework of institutional corruption, we (...) show that organized psychiatry's dependence on drug firms has led to a distortion of science. We describe the current dependency corruption and argue that transparency alone is not a solution. We conclude by taking the position that the corruption of the evidence base in diagnostic and practice guidelines has compromised the informed consent process, and we suggest strategies to address this problem. (shrink)

ABSTRACTPrevious research suggests that labelling emotions, or describing affective states using emotion words, facilitates emotion regulation. But how much labelling promotes emotion regulation? And which emotion regulation strategies does emotion labelling promote? Drawing on cognitive theories of emotion, we predicted that labelling emotions using fewer words would be less confusing and would facilitate forms of emotion regulation requiring more cognitively demanding processing of context. Participants mentally immersed themselves in an emotional vignette, were randomly assigned to an exhaustive or minimal emotion (...) labelling manipulation, and then completed an emotion regulation strategy planning task. Minimal emotion labelling promoted higher subjective emotional clarity. Furthermore, in terms of specific emotion regulation strategies, minimal emotion labelling prompted more plans for problem solving and marginally more plans for reappraisal, but did not affect plans for behav... (shrink)

The American Journal of Bioethics, Volume 12, Issue 10, Page 54-55, October 2012.

In this article we describe our approach to understanding wrongdoing in medical research and practice, which involves the statistical analysis of coded data from a large set of published cases. We focus on understanding the environmental factors that predict the kind and the severity of wrongdoing in medicine. Through review of empirical and theoretical literature, consultation with experts, the application of criminological theory, and ongoing analysis of our first 60 cases, we hypothesize that 10 contextual features of the medical environment (...) (including financial rewards, oversight failures, and patients belonging to vulnerable groups) may contribute to professional wrongdoing. We define each variable, examine data supporting our hypothesis, and present a brief case synopsis from our study that illustrates the potential influence of the variable. Finally, we discuss limitations of the resulting framework and directions for future research. (shrink)

Recruiting research participants based on genetic information generated about them in a prior study is a potentially powerful way to study the functional significance of human genetic variation, but it also presents ethical challenges. To inform policy development on this issue, we conducted a survey of U.S. institutional review board chairs concerning the acceptability of recontacting genetic research participants about additional research and their views on the disclosure of individual genetic results as part of recruitment. Our findings suggest there is (...) unlikely to be a “one-size-fits-all” solution, but rather several ethically acceptable approaches to genotype-driven recruitment, depending on context. Disclosures made during the consent process for the original study and the clinical validity of the results are key considerations. Researchers must be prepared to communicate and answer questions in clear lay language about what is known and not known regarding the role of genetics in their proposed area of research. (shrink)

With an overall estimated 5-year survival rate of 67 percent, bone marrow transplant is a potential cure for patients with primary immune regulatory diseases. Given that Sa...

Background Institutional review board (IRB) expertise is necessarily limited by maintaining a manageable board size. IRBs are therefore permitted by regulation to rely on outside experts for review. However, little is known about whether, when, why, and how IRBs use outside experts.Methods We conducted a national survey of U.S. IRBs to characterize utilization of outside experts. Our study uses a descriptive, cross-sectional design to understand how IRBs engage with such experts and to identify areas where outside expertise is most frequently (...) requested.Results The survey response rate was 18.4%, with 55.4% of respondents reporting their institution’s IRB uses outside experts. Nearly all respondents who reported using outside experts indicated they do so less than once a month, but occasionally each year (95%). The most common method of identifying an outside expert was securing a previously known subject matter expert (83.3%). Most frequently, respondents sought consultation for scientific expertise not held by current members (69.6%). Almost all respondents whose IRBs had used outside experts reported an overall positive impact on the IRB review process (91.5%).Conclusions Just over half of the IRBs in our sample report use of outside experts; among them, outside experts were described as helpful, but their use was infrequent overall. Many IRBs report not relying on outside experts at all. This raises important questions about what type of engagement with outside experts should be viewed as optimal to promote the highest quality review. For example, few respondents sought assistance from a Community Advisory Board, which could address expertise gaps in community perspectives. Further exploration is needed to understand how to optimize IRB use of outside experts, including how to recognize when expertise is lacking, what barriers IRBs face in using outside experts, and perspectives on how outside expert review impacts IRB decision-making and review quality. (shrink)

The primary purpose of Institutional Review Boards (IRBs) is to protect the rights and welfare of human research participants. Evaluation and measurement of how IRBs satisfy this purpose and other important goals are open questions that demand empirical research. Research on IRBs, and the Human Research Protection Programs (HRPPs) of which they are often a part, is necessary to inform evidence-based practices, policies, and approaches to quality improvement in human research protections. However, to date, HRPP and IRB engagement in empirical (...) research about their own activities and performance has been limited. To promote engagement of HRPPs and IRBs in self-reflective research on HRPP and IRB quality and effectiveness, barriers to their participation need to be addressed. These include: extensive workloads, limited information technology systems, and few universally accepted or consistently measured metrics for HRPP/irb quality and effectiveness. Additionally, institutional leaders may have concerns about confidentiality. Professional norms around the value of participating in this type of research are lacking. Lastly, obtaining external funding for research on IRBs and HRPPs is challenging. As a group of HRPP professionals and researchers actively involved in a research consortium focused on IRB quality and effectiveness, we identify potential levers for supporting and encouraging HRPP and IRB engagement in research on quality and effectiveness. We maintain that this research should be informed by the core principles of patient- and community-engaged research, in which members and key stakeholders of the community to be studied are included as key informants and members of the research team. This ensures that relevant questions are asked and that data are interpreted to produce meaningful recommendations. As such, we offer several ways to increase the participation of HRPP professionals in research as participants, as data sharers, and as investigators. (shrink)

Research Ethics, Volume 18, Issue 2, Page 132-150, April 2022. Limited research has been done among pregnant people participating in investigational drug trials. To enhance the ethical understanding of pregnant people’s perspectives on research participation, we sought to describe motives and risk perceptions of participants in a phase 1 trial of ledipasvir/sofosbuvir treatment for chronic Hepatitis C virus during pregnancy. Pregnant people with chronic HCV infection enrolled in an open-label, phase 1 study of LDV/SOF participated in semi-structured, in-depth interviews to (...) explore their reasons for participation and experiences within the study. Pregnant people took 12 weeks of LDV/SOF and were interviewed at enrollment and at the end of study. We recorded the interviews, transcribed them verbatim, coded them using NVivo software, and performed inductive thematic analysis. Nine women completed the study yielding 18 interview transcripts. We identified two themes regarding motives and one regarding risk perception. Motives— Women conceptualized study participation as part of the caregiving role they associate with motherhood; participating was viewed as an act of caregiving for their infants, their families, themselves, and other pregnant women with chronic HCV. Women also noted that they faced multiple barriers to treatment prior to pregnancy that created a desire to receive therapy through trial participation. Risk perception— Women acknowledged personal and fetal risk associated with participation. Acceptance of risk was influenced by women’s concepts of motherhood, preexisting knowledge of HCV and medical research, family members, intimate partners, or by the study design. Women enrolled in a phase 1 trial for chronic HCV therapy during pregnancy acknowledged risks of participation and were motivated by hopes for fetal and personal benefit and by lack of prenatal access to treatment. Ethical inclusion of pregnant people in research should acknowledge structural factors that contribute to vulnerability and data deficiencies for treatment in pregnancy. (shrink)

In this special issue we explore practices of scientific inquiry into human populations in Latin America in order to generate new insights into the complex historical and sociopolitical dynamics that have made certain human groups integral to the production of scientific knowledge in and about the region. In important contributions, other scholars have shown that the science of human difference is racist and all too often has been a mediator of development ideologies. To further unpack these arguments we focus attention (...) on the complex interaction between scientists and the populations they study. We explore cases from across the fields of evolutionary biology, demography, epidemiology... (shrink)

Serious ethical violations in medicine, such as sexual abuse, criminal prescribing of opioids, and unnecessary surgeries, directly harm patients and undermine trust in the profession of medicine. We review the literature on violations in medicine and present an analysis of 280 cases. Nearly all cases involved repeated instances of intentional wrongdoing, by males in nonacademic medical settings, with oversight problems and a selfish motive such as financial gain or sex. More than half of cases involved a wrongdoer with a suspected (...) personality disorder or substance use disorder. Despite clear patterns, no factors provide readily observable red flags, making prevention difficult. Early identification and intervention in cases requires significant policy shifts that prioritize the safety of patients over physician interests in privacy, fair processes, and proportionate disciplinary actions. We explore a series of 10 questions regarding policy, oversight, discipline, and education options. Satisfactory answers to these questions will require input from diverse stakeholders to help society negotiate effective and ethically balanced solutions. (shrink)