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Participants in clinical trials frequently fail to appreciate key differences between research and clinical care. This phenomenon, known as therapeutic misconception, undermines informed consent to clinical research, but to date there have been no effective interventions to reduce it and concerns have been expressed that to do so might impede recruitment. We determined whether a scientific reframing intervention reduces therapeutic misconception without significantly reducing willingness to participate in hypothetical clinical trials. This prospective randomized trial was conducted from 2015 to 2016 to test the efficacy of an informed consent intervention based on scientific reframing compared to a traditional informed consent procedure (control) in reducing therapeutic misconception among patients considering enrollment in hypothetical clinical trials modeled on real-world studies for one of five disease categories. Patients with diabetes mellitus, hypertension, coronary artery disease, head/neck cancer, breast cancer, and major depression were recruited from medical clinics and a clinical research volunteer database. The primary outcomes were therapeutic misconception, as measured by a validated, ten-item Therapeutic Misconception Scale (range = 10-50), and willingness to participate in the clinical trial. 154 participants completed the study (age range, 23-87 years; 92.3% white, 56.5% female); 74 (48.1%) had been randomized to receive the experimental intervention. Therapeutic misconception was significantly lower (p = 0.004) in the scientific reframing group (26.4, 95% CI [23.7 to 29.1] compared to the control group (30.9, 95% CI [28.4 to 33.5], and remained so after controlling for education (p = 0.017). Willingness to participate in the hypothetical trial was not significantly different (p = 0.603) between intervention (52.1%, 95% CI [40.2% to 62.4%]) and control (56.3%, 95% CI [45.3% to 66.6%] groups. An enhanced educational intervention augmenting traditional informed consent led to a meaningful reduction in therapeutic misconception without a statistically significant change in willingness to enroll in hypothetical clinical trials. Additional study of this intervention is required in real-world clinical trials.

Since the start of the program to investigate the ethical, legal, and social implications (ELSI) of the Human Genome Project in 1990, many ELSI scholars have maintained that genetic testing should be used with caution because of the potential for negative psychosocial effects associated with receiving genetic information. More recently, though, some ELSI scholars have produced evidence suggesting that the original ELSI concerns were unfounded, exaggerated, or, at a minimum, misdirected. At least in the contexts that have been most studied, large negative impacts have not been found in the vast majority of people studied. What might explain the discrepancy between the original hypothesized outcomes and the growing impression that large negative effects appear to be few and far between? And if the original predictions of large negative psychosocial effects were simply wrong, is it time for ELSI researchers to move on? Should genetic testing be routinized, and would it be appropriate to relax or abandon the practice of engaging patients in a process of detailed informed consent before they receive genetic information? To confront those questions, we convened a conference entitled “Looking for the Psychosocial Impacts of Genomic Information” to review what is known about the negative impacts of genetic information on a variety of populations and in multiple medical and social contexts, to explore the implications of the findings, and to consider whether future research might benefit from different methods than have been used to date.

Purpose: Returning genetic results to research participants is gaining momentum in the USA. It is believed to be an important step in exploring the impact of efforts to translate findings from research to bedside and public health benefits. Some also hope that this practice will incentivize research participation, especially among people from historically marginalized communities who are commonly underrepresented in research. However, research participants’ interest in receiving nongenomic medical and nonmedical results that may emerge from precision medicine research (PMR) is understudied and no study to date has explored the views of people with disabilities about return of genomic and nongenomic results from PMR. Methods: In a national online survey of people with disabilities, participants were queried about their interest in receiving biological, environmental, and lifestyle results from PMR (n = 1,294). Analyses describe findings for all of the participants and comparisons for key demographic characteristics and disability subgroups. Results: The participants expressed high interest in biological and health-related results and less interest in other findings. However, the interest among the study participants was lower than that found in comparable studies of the general population. Moreover, this interest varied significantly across gender, race/ethnicity, and disability subgroups. Possible reasons for these differences are discussed. Conclusion: Insofar as return of results from PMR may impact translational efforts, it is important to better understand the role of sociomedical marginalization in decisions about return of results from PMR and to develop strategies to address existing barriers.

Purpose of Review Genetic testing for mental illness is likely to become increasingly prevalent as the science behind it is refined. This article identifies anticipated ethical challenges for patients, psychiatrists, and genetic counselors and makes recommendations for addressing them. Recent Findings Many of the ethical challenges of psychiatric genetic testing are likely to stem from failures to comprehend the nature and implications of test results. Recent studies have identified gaps in the knowledge base of psychiatrists and genetic counselors, which limit their abilities to provide patients with appropriate education. A small number of studies have demonstrated the value of counseling in empowering patients to deal with relevant genetic information. Summary Psychiatrists and other health professionals must be able to assist patients and families in making informed decisions about genetic testing and interpreting test results. Filling their knowledge gaps on these issues will be a critical step towards meeting these responsibilities.

A 75-year-old woman has type 2 diabetes mellitus, peripheral vascular disease, and a gangrenous ulcer of her left foot. A below-the-knee amputation is recommended, but she declines, saying that she has lived long enough and wants to die with her body intact. Her internist is concerned about her increasing confusion over the past year and notes that she appears to be depressed. How should her physician determine whether her decision is competent? A 75-year-old woman has a gangrenous ulcer of her left foot. A below-the-knee amputation is recommended, but she declines. How should her physician determine whether her decision is competent? Foreword This Journal feature begins with a case vignette highlighting a common clinical problem. Evidence supporting various strategies is then presented, followed by a review of formal guidelines, when they exist. The article ends with the author's clinical recommendations. Stage A 75-year-old woman with type 2 diabetes mellitus and peripheral vascular disease is admitted with a gangrenous ulcer of the plantar aspect of her left foot. A surgical consultation results in a recommendation for a below-the-knee amputation, but the patient declines the procedure on the grounds that she has lived long enough and wants to die with her body intact. Her internist, who has known her for 15 years, is concerned that she has been increasingly confused over the past year and now appears to be depressed. How should her physician determine whether her decision is a competent one? . . .

Comprehensive genomic analysis including exome and genome sequencing is increasingly being utilized in research studies, leading to the generation of incidental genetic findings. It is unclear how researchers plan to deal with incidental genetic findings. We conducted a survey of the practices and attitudes of 234 members of the US genetic research community and performed qualitative semistructured interviews with 28 genomic researchers to understand their views and experiences with incidental genetic research findings. We found that 12% of the researchers had returned incidental genetic findings, and an additional 28% planned to do so. A large majority of researchers (95%) believe that incidental findings for highly penetrant disorders with immediate medical implications should be offered to research participants. However, there was no consensus on returning incidental results for other conditions varying in penetrance and medical actionability. Researchers raised concerns that the return of incidental findings would impose significant burdens on research and could potentially have deleterious effects on research participants if not performed well. Researchers identified assistance needed to enable effective, accurate return of incidental findings. The majority of the researchers believe that research participants should have the option to receive at least some incidental genetic research results.

Clinical trials of psychedelic drugs impose constraints that make it difficult to judge how effective they will be in treating people. Clinical trials of psychedelic drugs impose constraints that make it difficult to judge how effective they will be in treating people.

Introduction Ethical concerns have been raised by both current and historically controversial neurosurgical interventions for treatment-refractory schizophrenia and schizoaffective disorder (TR-SZ). Considering advances in next-generation deep brain stimulation (DBS), initial success in treating a few cases of TR-SZ, and how challenging trial enrollment is, transparency and disseminating knowledge about DBS is important, as is input from involved groups. Here information was presented about DBS as an experimental treatment option for TR-SZ to stakeholders to gauge enthusiasm after consideration of potential risks and benefits. Methods Stakeholders were presented with information about DBS (total n  = 629). Opinions about whether DBS should be an option for people with TR-SZ and acceptable response rates considering DBS risks were collected from research participants with SZ, treatment-refractory Parkinson’s disease (TR-PD) approved for DBS, caregivers for either SZ or TR-PD participants, and attendees at medical school presentations. In addition, the attendees were asked to decide whether DBS is appropriate for 4 cases who want DBS, one with PD, 2 with OCD and 1 with SZ. Chi-square, pairwise comparisons, and Duncan Multiple Range Test were performed with significance at p  < 0.05. Results Most (83%) research participants and presentation audience members agreed that DBS should be an option for TR-SZ and 40% thought the potential benefits outweigh the risks of DBS with at least a 41–60% response rate. Audience approval of DBS was similar for the PD (30%), SZ (52%) and the OCD case with psychosis (56%), but there was a higher rate of approval (77%) for the OCD case whose compulsions involved self-harm. The majority (73–86%) of the audience thought that they would want to try DBS if they had TR-PD, TR-OCD, or TR-SZ. Conclusions Despite difficulty in recruiting patients for DBS clinical trials for TR-SZ, the consensus among 83% of stakeholders was that DBS should be an option for people with severe TR-SZ. Our approach to disseminate general knowledge then gather opinions among diverse stakeholders was to ensure the development of DBS clinical trials for the new indication TR-SZ is a relevant option despite the known difficulties in enrollment. These findings may help prevent disparities in access to advanced DBS therapeutics.

Objectives: Mass murder is associated with a lifetime history of substance use. We aimed to examine cannabis involvement among those who committed mass shootings in the United States from 1900 to 2019. Methods: We identified mass shooting events in the United States from 1900 to 2019 using publicly available English-language media reports and court/police records. People who perpetrated mass murders using methods other than firearms (eg, knives, automobiles) were used as a comparison group. Events were dichotomised into either prior to 1996 or from 1996 onward (first legalisation for medical use by California). Post-1960 data were used for additional analyses of a more modern era. Results: The proportion of those who committed mass shootings who had used, possessed, and/or distributed cannabis was significantly higher for events that occurred from 1996 onward, compared with prior to 1996 (11.2% vs 4.9%, p equivalent 0.002). The proportion of those committed mass murders by other methods who had used, possessed, and/or distributed cannabis did not significantly differ for events that occurred from 1996 onward, compared with prior to 1996 (4.8% vs 5.7%, p equivalent 0.76). When 58 mass shooting events and 31 mass murder events by other methods perpetrated before 1960 were excluded, results were similar when 1996 was used as a cutoff for the respective events (p equivalent 0.02 and p equivalent 0.40). Among those who committed mass shootings, those with cannabis involvement (n equivalent 74) were younger than those without (n equivalent 754) [28.7 vs 33.5 years, p < 0.001] and were of younger age group than older age group (11.9% vs 5.8%, p equivalent 0.002). Conclusion: Cannabis use May be harmful in subgroups of individuals (eg, those who committed mass shootings) who are vulnerable to cannabis use. This should be considered by policymakers, individuals with commercial interests, the public, and mental health and medical professionals when they debate related public health issues.

This article considers key ethical, legal, and medical dilemmas arising for people with disabilities in the COVID-19 pandemic. We highlight the limited application of existing frameworks of emergency planning with and for people with disabilities in the COVID-19 pandemic, explore key concerns and issues affecting the health care of people with disabilities (i.e., access to information and clinician–patient communication, nondiscrimination and reasonable accommodations, and rationing of medical goods), and indicate possible solutions. Finally, we suggest clinical and public health policy measures to ensure that people with disabilities are included in the planning of future pandemic-related efforts. The devastation evoked by the COVID-19 pandemic raises challenging dilemmas in bioethics. It also speaks to social justice issues that have plagued historically marginalized communities in the United States. Responses to the pandemic must be bound by legal standards, principles of distributive justice, and societal norms of protecting vulnerable populations—core commitments of public health—to ensure that inequities are not exacerbated, and should provide a pathway for improvements to ensure equitable access and treatment in the future.