Precision medicine research is rapidly taking a lead role in the pursuit of new ways to improve health and prevent disease, but also presents new challenges for protecting human subjects. The extent to which the current “web” of legal protections, including technical data security measures, as well as measures to restrict access or prevent misuse of research data, will protect participants in this context remains largely unknown. Understanding the strength, usefulness, and limitations of this constellation of laws, regulations, and procedures is critical to ensuring not only that participants are protected, but also that their participation decisions are accurately informed. To address these gaps, we conducted in-depth interviews with a diverse group of 60 thought-leaders to explore their perspectives on the protections associated with precision medicine research.

Precision medicine research is underway to identify targeted approaches to improving health and preventing disease. However, such endeavors raise significant privacy and confidentiality concerns. The objective of this study was to elucidate the potential benefits and harms associated with precision medicine research through in-depth interviews with a diverse group of thought leaders, including primarily U.S.-based experts and scholars in the areas of ethics, genome research, health law, historically-disadvantaged populations, informatics, and participant-centric perspectives, as well as government officials and human subjects protections leaders. The results suggest the prospect of an array of individual and societal benefits, as well as physical, dignitary, group, economic, psychological, and legal harms. Relative to the way risks and harms are commonly described in consent forms for precision medicine research, the thought leaders we interviewed arguably emphasized a somewhat different set of issues. The return of individual research results, harm to socially-identifiable groups, the value-dependent nature of many benefits and harms, and the risks to the research enterprise itself emerged as important cross-cutting themes. Our findings highlight specific challenges that warrant concentrated care during the design, conduct, dissemination, and translation of precision medicine research and in the development of consent materials and processes.

Background: EHR phenotyping offers the ability to rapidly assemble a precisely defined cohort of patients prescreened for eligibility to participate in health-related research. Even so, stakeholders in the process must still contend with the practical and ethical challenges associated with research recruitment. Patient perspectives on these matters are particularly important given that the success of research recruitment depends on patients' willingness to participate. Methods: We conducted 15 focus groups (n = 110 participants) in four counties in diverse regions of the southeastern US: Appalachia, the Mississippi Delta, and the Piedmont area of North Carolina. Based on a hypothetical study of a behavioral intervention for type 2 diabetes, we asked about the acceptability and appropriateness of direct investigator versus physician-mediated contact with patients for research recruitment, and whether patients should be asked to opt in or opt out of further contact in response to recruitment letters. Results: For initial contact, nearly all participants said it would be acceptable for researchers to contact patients directly and three-fourths said that it would be acceptable for researchers to contact patients through their physicians. When we asked which would be most appropriate, a substantial majority chose direct contact. Themes that arose in the discussion included trust and transparency, decision-making power, the effect on research, and the effect on patient care. For response expectations, the vast majority of participants said both opt-in and opt-out would be acceptable-typically finding neither especially problematic and noting that both afford patients the opportunity to make their own decisions. Conclusions: External validity relies heavily on researchers' success enrolling eligible patients and failure to reach accrual targets is a costly and common barrier to advancing scientific knowledge. Our results suggest that patients recognize multiple advantages and disadvantages of different research recruitment strategies and place value on the implications not just for themselves, but also for researchers and healthcare providers. Our findings, including rich qualitative detail, contribute to the body of empirical and ethical literature on improving research recruitment and suggest specific ways forward as well as important areas for future research.

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Background Trauma surgeons face a challenge when deciding whether to resuscitate lethally injured patients whose organ donor status is unknown. Data suggests practice pattern variability in this setting, but little is known about why. Materials and Methods We conducted semi-structured interviews with trauma surgeons practicing in Level 1 or 2 trauma centers in Tennessee. Interviews focused on ethical dilemmas and resource constraints. Analysis was performed using inductive thematic analysis. Results Response rate was 73% (11/15). Four key themes emerged. All described resuscitating patients to buy time to collect more definitive clinical information and to identify family. Some acknowledged this served the secondary purpose of organ preservation. 11/11 participants felt a primacy of obligation to the patient in front of them even after it became apparent, they could not personally benefit. For 9/11 (82%), the moral obligation to consider organ preservation was secondary/balancing; 2/11 (18%) felt it was irrelevant/immoral. Resource allocation was commonly considered. All participants expressed some limitation to resources they would allocate. All participants conveyed clear moral agency in determining resuscitation extent when the goal was to save the patient’s life, however this was less clear when resuscitating for organ preservation. Across themes, perceptions of a “standard practice” existed but the described practices were not consistent across interviewees. Discussion Widely ranging perceptions regarding ethical and resource considerations underlie practices resuscitating toward organ preservation. Common themes suggest a lack of consensus. Despite expressed beliefs, there is no identifiable standard of practice amongst trauma surgeons resuscitating in this setting.

The zebrafish (Danio rerio) has been at the forefront of neurobiological research and is steadily gaining favor as a model for behavioral applications. The ease of handling, high yield of progeny, and efficient mode of drug delivery make this species a particularly useful model for behavior. Here, we append to the growing body of literature on zebrafish behavior by introducing a novel behavioral battery of tests aimed at identifying drug induced alterations in social and motoric behaviors. In a series of experiments, zebrafish were exposed to MK-801 (0, 2 µM, 20 µM), SFK 38393 (0, 10 µM, 100 µM), and ethanol (0, 0.5%, 1.0%) for one hour and overt locomotor behaviors were scored. Following a one-hour treatment exposure, circling behavior (a thigmotaxic display typical of dysregulated glutamate function) was scored from videotape at specific time points over a 37-minute session. In a separate experiment the zebrafish's natural tendency to shoal (social display) was analyzed using a novel open-field paradigm that examined fish distribution over quadrants. Most notably, MK-801 (20 µM) significantly increased circling behavior compared to controls. However, shoaling displays were disrupted when zebrafish were exposed to both MK-801 and SKF 38393 (20 µM and 100 µM respectively). Our results, in part, complement existing knowledge about zebrafish behavior following acute drug exposure. Additionally, our novel approach to assessing shoaling behavior, reported here, introduces an alternative view of social/group behavior in the zebrafish that is sensitive to both NMDA and dopaminergic manipulation.

A growing proportion of prospective research participants in the United States speak limited or no English. We conducted cognitive interviews with native Spanish speakers to test Spanish‐language translations of simplified and traditional biobank consent forms. Comprehension was generally high and did not differ by form. Most of those who received the simplified form felt it contained the right amount of information, compared with fewer than half of those who received the traditional form. Qualitative results allowed us to identify overarching issues related to tone, formality, and voice that may affect prospective participants’ trust and willingness to participate. Certain characteristics of written Spanish are seemingly at odds with recommended actions to simplify consent forms; thus, even when significant empirical effort has been expended to develop simplified consent materials in English, additional work is needed to ensure the accuracy, comprehensibility, and cultural‐congruence of Spanish‐language translations.

In “Social Media, e‐Health, and Medical Ethics,” in this issue of the Hastings Center Report, Mélanie Terrasse, Moti Gorin, and Dominic Sisti address and suggest recommendations for several ethical issues central to the systematic ethical analysis of the effects of social media on clinical practice, health services research, and public health. The topic is as timely as it is important: social media data collected by device and web applications are constantly increasing and might have both individual and public health benefits. The authors focus their analysis primarily on the health care context. Yet the implications of the intersection of social media data and research warrant focused consideration, as even the most thorough ethical analysis in the clinical context is not necessarily directly applicable in the research context. While many ethical issues are present in both settings, the research context poses new challenges and calls for consideration of distinct factors. In particular, because the legal framework is less protective in research, critical ethical analysis of the research‐specific issues and considerations is essential to the ethical conduct of research using social media data as well as to the design and operation of social media device and web applications themselves.