A new paradigm for investigating real-world social behavior and its neural underpinnings.

Eye tracking and other behavioral measurements collected from patient-participants in their hospital rooms afford a unique opportunity to study natural behavior for basic and clinical translational research. We describe an immersive social and behavioral paradigm implemented in patients undergoing evaluation for surgical treatment of epilepsy, with electrodes implanted in the brain to determine the source of their seizures. Our studies entail collecting eye tracking with other behavioral and psychophysiological measurements from patient-participants during unscripted behavior, including social interactions with clinical staff, friends, and family in the hospital room. This approach affords a unique opportunity to study the neurobiology of natural social behavior, though it requires carefully addressing distinct logistical, technical, and ethical challenges. Collecting neurophysiological data synchronized to behavioral and psychophysiological measures helps us to study the relationship between behavior and physiology. Combining across these rich data sources while participants eat, read, converse with friends and family, etc., enables clinical-translational research aimed at understanding the participants' disorders and clinician-patient interactions, as well as basic research into natural, real-world behavior. We discuss data acquisition, quality control, annotation, and analysis pipelines that are required for our studies. We also discuss the clinical, logistical, and ethical and privacy considerations critical to working in the hospital setting.

Bioethics in the Current Climate.

Drawing on insights from feminist epistemology and experience in genomics-related bioethics research, this essay offers three suggestions that may enable bioethics to contribute more persuasively to urgent issues affecting the health and well-being of individuals, communities, and the world they inhabit. First, it suggests that bioethics pay more attention to people's feelings, particularly those that help constitute their self-identities, and to the role of those feelings in their health-relevant behaviors. Further, it proposes conceiving of health-relevant behaviors expansively. Second, it suggests that bioethics advocate for a longer time horizon for the conduct of empirical bioethics research and other types of research addressing complex, systemic factors influencing health. Third, it suggests that bioethics play a larger role in illuminating and applauding the evolving nature of scientific knowledge.

The Ethics of Tobacco Harm Reduction: An Analysis of E-Cigarette Availability From the Perspectives of Utilitarianism, Bioethics, and Public Health Ethics.

Much evidence suggests e-cigarettes are substantially less harmful than combustible cigarettes. Assuming this is true, we analyze the ethical case for a policy of e-cigarette availability (ECA) as a tobacco harm reduction strategy. ECA involves making e-cigarettes available to allow smokers to switch to them, and informing smokers of the lower risks of e-cigarettes vis-à-vis smoking. After suggesting that utilitarian/consequentialist considerations do not provide an adequate ethical analysis, we analyze ECA using two other ethical frameworks. First, ECA is supported by a public health ethics framework. ECA is a population-level intervention consistent with respecting individual autonomy by using the least restrictive means to accomplish public health goals, and it supports equity and justice. Second, ECA is supported by four principles that form a biomedical ethics framework. By reducing smokers' health risks and not harming them, ECA fulfills principles of beneficence and non-maleficence. Because ECA allows smokers to make informed health decisions for themselves, it fulfills the principle requiring respect for persons and their autonomy. Here, we consider whether nicotine addiction and thus ECA undermine autonomy, and also discuss the ethical warrant for special protections for youth. Finally, ECA can also advance justice by providing a harm reduction alternative for disadvantaged groups that disproportionately bear the devastating consequences of smoking. Policies of differential taxation of cigarettes and e-cigarettes can facilitate adoption of less harmful alternatives by those economically disadvantaged. We conclude that public health and biomedical ethics frameworks are mutually reinforcing and supportive of ECA as a tobacco harm reduction strategy. Implications: Making e-cigarettes and information about them available is supported as ethical from multiple ethical perspectives.

Normative and conceptual ELSI research: what it is, and why it's important.

The Ethical, Legal, and Social Implications (ELSI) Research Program of the National Human Genome Research Institute sponsors research examining ethical, legal, and social issues arising in the context of genetics/genomics. The ELSI Program endorses an understanding of research not as the sole province of empirical study, but instead as systematic study or inquiry, of which there are many types and methods. ELSI research employs both empirical and nonempirical methods. Because the latter remain relatively unfamiliar to biomedical and translational scientists, this paper seeks to elucidate the relationship between empirical and nonempirical methods in ELSI research. It pays particular attention to the research questions and methods of normative and conceptual research, which examine questions of value and meaning, respectively. To illustrate the distinct but interrelated roles of empirical and nonempirical methods in ELSI research, including normative and conceptual research, the paper demonstrates how a range of methods may be employed both to examine the evolution of the concept of incidental findings (including the recent step toward terming them 'secondary findings'), and to address the normative question of how genomic researchers and clinicians should manage incidental such findings.

Narrative methods for assessing "quality of life" in hand transplantation: five case studies with bioethical commentary.

Despite having paved the way for face, womb and penis transplants, hand transplantation today remains a small hybrid of reconstructive microsurgery and transplant immunology. An exceptionally limited patient population internationally (N < 200) complicates medical researchers' efforts to parse outcomes "objectively." Presumed functional and psychosocial benefits of gaining a transplant hand must be weighed in both patient decisions and bioethical discussions against the difficulty of adhering to post-transplant medications, the physical demands of hand transplant recovery on the patient, and the serious long-term health risks of immunosuppressant drugs. This paper relates five narratives of hand transplantation drawn from an oral history project to show how narrative methods can and should inform ethical evaluations and the clinical process of hand transplantation. The interviews with patients and their partners analyzed here lead us to suggest that qualitative accounts of patient experiences should be used to complement clinical case studies reported in medical journals and to help develop instruments to assess outcomes more systematically.

The Precision Medicine Initiative's All of Us Research Program: an agenda for research on its ethical, legal, and social issues.

The Precision Medicine Initiative (PMI) is an innovative approach to developing a new model of health care that takes into account individual differences in people's genes, environments, and lifestyles. A cornerstone of the initiative is the PMI All of Us Research Program (formerly known as PMI-Cohort Program) which will create a cohort of 1 million volunteers who will contribute their health data and biospecimens to a centralized national database to support precision medicine research. The PMI All of US Research Program is the largest longitudinal study in the history of the United States. The designers of the Program anticipated and addressed some of the ethical, legal, and social issues (ELSI) associated with the initiative. To date, however, there is no plan to call for research regarding ELSI associated with the Program-PMI All of Us program. Based on analysis of National Institutes of Health (NIH) funding announcements for the PMI All of Us program, we have identified three ELSI themes: cohort diversity and health disparities, participant engagement, and privacy and security. We review All of Us Research Program plans to address these issues and then identify additional ELSI within each domain that warrant ongoing investigation as the All of Us Research Program develops. We conclude that PMI's All of Us Research Program represents a significant opportunity and obligation to identify, analyze, and respond to ELSI, and we call on the PMI to initiate a research program capable of taking on these challenges.Genet Med advance online publication 01 December 2016.

Caring for Patients or Organs: New Therapies Raise New Dilemmas in the Emergency Department.

Two potentially lifesaving protocols, emergency preservation and resuscitation (EPR) and uncontrolled donation after circulatory determination of death (uDCDD), currently implemented in some U.S. emergency departments (EDs), have similar eligibility criteria and initial technical procedures, but critically different goals. Both follow unsuccessful cardiopulmonary resuscitation and induce hypothermia to "buy time": one in trauma patients suffering cardiac arrest, to enable surgical repair, and the other in patients who unexpectedly die in the ED, to enable organ donation. This article argues that to fulfill patient-focused fiduciary obligations and maintain community trust, institutions implementing both protocols should adopt and publicize policies to guide ED physicians to utilize either protocol for particular patients, in order to address the appearance of conflict of interest arising from the protocols' similarities. It concludes by analyzing ethical implications of incentives that may influence institutions to develop the expertise required for uDCDD but not EPR.

Prenatal whole-exome sequencing: parental attitudes.

OBJECTIVE: The aim of this study was to survey the opinions of expectant parents regarding prenatal whole-exome sequencing. METHODS: The study used a questionnaire that focused on acceptability of prenatal whole-exome sequencing to individuals who pursued first-trimester prenatal screening in a tertiary academic medical center. A total of 186 expectant individuals completed the questionnaire. The results of the questionnaire were analyzed using descriptive statistics and logistic regression models. RESULTS: Eighty-three percent of the participants answered that prenatal whole-exome sequencing should be offered, 14.8% were neutral, and only 2.2% disagreed. Fifty-four percent of the participants were interested in having prenatal whole-exome sequencing for their fetus, 40.1% were neutral, and 6.6% disagreed. The majority of participants expressed a desire to know about treatable (96.2%) and non-treatable (86.3%) childhood conditions, and most said the same for treatable (76.0%) and non-treatable (74.3%) adult-onset conditions. Over half of the participants (59.7%) indicated a maximum acceptable turnaround time of 3 weeks or less for prenatal whole-exome sequencing. CONCLUSIONS: The majority of respondents felt prenatal whole-exome sequencing should be offered. Moreover, the majority wanted to know prenatally about treatable and non-treatable childhood and adult conditions.

Sickle Cell Trait Screening of Collegiate Athletes: Ethical Reasons for Program Reform.

The National Collegiate Athletic Association (NCAA) requires all student-athletes have their sickle cell trait (SCT) status confirmed prior to athletic participation. The NCAA approved the screening program in 2010 for institutions participating in Division I athletics and extended it in subsequent years to institutions at Division II and III levels. Ethical concerns about the controversial policy focus on its mandatory nature and potential impact on student-athletes, particularly through stigmatization of and discrimination against those with SCT. Organizations, such as the American Society of Hematology (ASH), oppose the imposition of SCT testing and instead recommend universal precautions that would protect the entire student-athlete population without revealing student-athletes' SCT statuses. This paper discusses these issues and offers recommendations, including genetic counseling, which would improve the current SCT screening program. It argues that implementation of universal precautions would ensure that the most ethically sound practices are afforded to every student-athlete.

Knowledge & attitudes of mental health professionals regarding psychiatric research.

BACKGROUND & OBJECTIVES: Mental health professionals have varied attitudes and views regarding informed consent and confidentiality protections in psychiatric research and clinical care. The present study was designed to understand the knowledge and views of mental health professionals (MHPs) regarding informed consent and confidentiality protection practices. METHODS: Mental health professionals (n=121) who were members of the Delhi Psychiatric Society, were invited to participate in this questionnaire-based study of their knowledge and attitudes regarding informed consent and confidentiality. Half of them expressed willingness to discuss participation and gave initial oral consent (n=62); of these, 31 gave written informed consent to participate and completed the questionnaires. The questionnaires included both forced choice (yes / no / do not know) and open-ended questions. Questionnaires content reflected prominent guidelines on informed consent and confidentiality protection. RESULTS: Attitudes of the majority of the participants towards informed consent and confidentiality were in line with ethical principles and guidelines. All expressed the opinion that confidentiality should generally be respected and that if confidentiality was breached, there could be mistrust of the professional by the patient/participant. The mean knowledge scores regarding informed consent and confidentiality were 8.55 ± 1.46 and 8.16 ± 1.29, respectively. INTERPRETATION & CONCLUSIONS: The participating mental health professionals appeared to have adequate knowledge of basic ethical guidelines concerning informed consent and confidentiality. Most respondents were aware of ethical issues in research. Given the small sample size and low response rate, the significance of the quantitative analysis must be regarded with modesty, and qualitative analysis of open-ended questions may be more valuable for development of future research. Increased efforts to involve mental health professionals in research on ethical concerns pertinent to their work must be made, and the actual practices of these professionals with regard to ethical guidelines need to be studied.

Early intervention in pregnant women with elevated anxiety and depressive symptoms: efficacy of a cognitive-behavioral group program.

To examine whether a cognitive-behavioral group program among pregnant women with elevated levels of anxiety or depression may reduce anxious and depressive symptoms and has a positive impact on risk factors for anxiety disorders and depression. A total of 753 participants were recruited. After completion of the clinical standardized interview, 160 participants were randomized to an intervention group or a control condition. Psychometric assessments took place at T1 (preintervention), T2 (antenatal follow-up), and T3 (3 months postpartum). Analyses included women who took part in all 3 assessments (intervention group, N = 21; control group, N = 53). The subjective program evaluation by the participants was highly positive, but with the exception of a short-term effect on the quality of an intimate partnership (F1/67 = 4.056; P < .05], intervention effects on anxiety or depressive symptoms were not found. However, there was an intervention effect 3 months postpartum for participants with high depressive symptoms at T1 (Edinburgh Postnatal Depression Scale score of ≥10) (F1/69 = 5.410; P < .05). The results argue against a general efficacy of a cognitive-behavioral group program for pregnant women with rather low levels of anxiety and depression. For women with higher depressive symptoms during pregnancy, a cognitive-behavioral group program may have a positive impact on the course of depressive symptoms during the postpartum period.

Managing incidental findings and research results in genomic research involving biobanks and archived data sets.

Biobanks and archived data sets collecting samples and data have become crucial engines of genetic and genomic research. Unresolved, however, is what responsibilities biobanks should shoulder to manage incidental findings and individual research results of potential health, reproductive, or personal importance to individual contributors (using "biobank" here to refer both to collections of samples and collections of data). This article reports recommendations from a 2-year project funded by the National Institutes of Health. We analyze the responsibilities involved in managing the return of incidental findings and individual research results in a biobank research system (primary research or collection sites, the biobank itself, and secondary research sites). We suggest that biobanks shoulder significant responsibility for seeing that the biobank research system addresses the return question explicitly. When reidentification of individual contributors is possible, the biobank should work to enable the biobank research system to discharge four core responsibilities to (1) clarify the criteria for evaluating findings and the roster of returnable findings, (2) analyze a particular finding in relation to this, (3) reidentify the individual contributor, and (4) recontact the contributor to offer the finding. We suggest that findings that are analytically valid, reveal an established and substantial risk of a serious health condition, and are clinically actionable should generally be offered to consenting contributors. This article specifies 10 concrete recommendations, addressing new biobanks as well as those already in existence.

In sport and social justice, is genetic enhancement a game changer?

The possibility of genetic enhancement to increase the likelihood of success in sport and life's prospects raises questions for accounts of sport and theories of justice. These questions obviously include the fairness of such enhancement and its relationship to the goals of sport and demands of justice. Of equal interest, however, is the effect on our understanding of individual effort, merit, and desert of either discovering genetic contributions to components of such effort or recognizing the influence of social factors on the development and exercise of individual effort. This paper analyzes arguments about genetic enhancement with the goal of raising questions about how sport and justice regard unchosen, undeserved inequalities and what is assumed to be their opposite-namely, the exercise and results of individual effort. It is suggested that contemplating enhancement of natural assets previously outside human control may reinforce recognition of responsibility to intervene with regard to social advantages so as to support individual effort and improve individuals' life prospects.

Practices and Attitudes toward Returning Genomic Research Results to Low-Resource Research Participants.

INTRODUCTION: Many research programs are challenged to accommodate low-resource research participants' (LRRP) ancillary care needs when returning genomic research results. We define LRRP as those who are low income, uninsured, underinsured, or facing barriers to act upon the results returned. This study evaluates current policies and practices surrounding return of results (RoR) to LRRP, as well as the attitudes of investigators toward providing ancillary care to LRRP. METHODS: A semi-structured interview study was conducted with representatives of 35 genomic research programs nationwide. Eligible programs were returning, or planning to return, medically actionable genomic results to participants. RESULTS: Three content categories emerged from this study, including: (1) RoR structures, (2) barriers to RoR to LRRP, and (3) solutions to meet community and LRRP needs. Three major structures of RoR emerged: (1) RoR Embedded in Clinical Care, (2) RoR Independent of Clinical Care, and (3) Reliance on Clinical Partnerships to Facilitate RoR. Inadequacy of program resources to address the needs of LRRP was commonly considered a significant obstacle. The attitudes and views of informants regarding responsibility to provide ancillary care for LRRP receiving genomic results were highly varied. Some informants believed that genomic sequencing and testing was not a priority for LRRP because of other pressing issues in their lives, such as housing and food insecurity. Research programs differ regarding whether clinical and social support for LRRP is considered within the purview of the research team. Some programs instituted accommodations for LRRP, including social work referral and insurance enrollment assistance. CONCLUSION: Support to access downstream treatment is not readily available for LRRP in many genomic research programs. Development of best practices and policies for managing RoR to LRRP is needed.

Practicing preventive ethics, protecting patients: challenges of the electronic health record.

Implementation of guidelines regarding breaches of electronic health information requires an anticipatory stance and physician and patient education regarding security and monitoring measures and methods of redress. Adopting a preventive ethics, rather than a crisis management, model may also increase physician awareness of how the information they choose to include and privilege within the health record may expose patients to added harms if not done mindfully.

Ethical Practices and Legal Challenges in Mental Health Research.

Considerations of justice and concern for well-being support conducting mental health research and addressing ethical concerns specific to mental health research are critical. We discuss these concerns, provide recommendations to enable the ethical conduct of mental health research, and argue that participants' interests should be given primary weight in resolving apparent dilemmas. We also comment on provisions of two legislative actions in India relevant to mental health research: Rights of Persons with Disability Act 2016 and the Mental Health Care Act 2017. Both conform to the 2006 United Nations Convention on Rights of Persons with Disabilities of which India is a signatory. Both provide protections and enumerate rights relevant to people with mental health conditions but with differing focus. The commonalities and differences between the three are discussed in the background of international literature on research in mental health conditions. Studies involving deception and future directions for ethical requirements regarding genetic research are discussed.

Developing a community-academic partnership to improve recognition and treatment of depression in underserved African American and white elders.

OBJECTIVE: Reducing mental health disparities among underserved populations, particularly African American elders, is an important public health priority. The authors describe the process and challenges of developing a community/academic research partnership to address these disparities. METHODS: The authors are using a Community-Based Participatory Research approach to gain access to underserved populations in need of depression treatment. The authors identify six stages: 1) Collaborating to Secure Funding; 2) Building a Communications Platform and Research Infrastructure; 3) Fostering Enduring Relationships; 4) Assessing Needs/Educating about Research Process; 5) Initiating Specific Collaborative Projects (meeting mutual needs/interests); and 6) Maintaining a Sustainable and Productive Partnership. Data from a needs assessment developed collaboratively by researchers and community agencies facilitated agreement on mutual research goals, while strengthening the partnership. RESULTS: A community/academic-based partnership with a solid research infrastructure has been established and maintained for 3 years. Using the results of a needs assessment, the working partnership prioritized and launched several projects. Through interviews and questionnaires, community partners identified best practices for researchers working in the community. Future research and interventional projects have been developed, including plans for sustainability that will eventually shift more responsibility from the academic institution to the community agencies. CONCLUSIONS: To reach underserved populations by developing and implementing models of more effective mental health treatment, it is vital to engage community agencies offering services to this population. A successful partnership requires "cultural humility," collaborative efforts, and the development of flexible protocols to accommodate diverse communities.