Emily Anderson

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.

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.

As the field of clinical ethics consultation sets standards and moves forward with the Quality Attestation process, questions should be raised about what ethical issues really do arise in practice. There is limited data on the type and number of ethics consultations conducted across different settings. At Loyola University Medical Center, we conducted a retrospective review of our ethics consultations from 2008 through 2013. One hundred fifty-six cases met the eligibility criteria. We analyzed demographic data on these patients and conducted a content analysis of the ethics consultation write-ups coding both the frequency of ethical issues and most significant, or key, ethical issue per case. Patients for whom ethics consultation was requested were typically male, white, between 50 and 69 years old, of non-Hispanic origin, and of Roman Catholic faith. Nearly half were in the intensive care unit and 44.2 % died in the hospital. The most frequent broad ethical categories were decision-making, goals of care/treatment, and end-of-life. More specifically, capacity, patient’s wishes/autonomy, and surrogate decision maker were the most frequent particular ethical issues. The most common key ethical issues were withdrawing/withholding treatment, patient wishes/autonomy, and capacity. Our findings provide additional data to inform the training of clinical ethics consultants regarding the ethical issues that arise in practice. A wider research agenda should be formed to collect and compare data across institutions to improve education and training in our field.

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.

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.

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.

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

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.

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]

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...