Overcoming barriers to informed consent in neurological research: Perspectives from a national survey.

The ethical recruitment of participants with neurological disorders in clinical research requires obtaining initial and ongoing informed consent. The purpose of this study is to characterize barriers faced by research personnel in obtaining informed consent from research participants with neurological disorders and to identify strategies applied by researchers to overcome those barriers. This study was designed as a web-based survey of US researchers with an optional follow-up interview. A subset of participants who completed the survey were selected using a stratified purposeful sampling strategy and invited to participate in an in-depth qualitative interview by phone or video conference. Data were analyzed using a mixed methods approach, including content analysis of survey responses and thematic analysis of interview responses. Over 1 year, 113 survey responses were received from US research personnel directly involved in obtaining informed consent from participants in neurological research. Frequently identified barriers to informed consent included: cognitive and communication impairments (e.g. aphasia), unrealistic expectations of research participants, mistrust of medical research, time constraints, literacy barriers, lack of available social support, and practical or resource-related constraints. Strategies to enhance informed consent included: involving close others to support participant understanding of study-related information, collaborating with more experienced research personnel to facilitate training in obtaining informed consent, encouraging participants to review consent forms in advance of consent discussions, and using printed materials and visual references. Beyond conveying study-related information, researchers included in this study endorsed ethical responsibilities to support deliberation necessary to informed consent in the context of misconceptions about research, unrealistic expectations, limited understanding, mistrust, and/or pressure from close others. Findings highlight the importance of training researchers involved in obtaining informed consent in neurological research to address disease-specific challenges and to support the decision-making processes of potential research participants and their close others.

A divided community: A descriptive qualitative study of the impact of the COVID-19 pandemic on nurses and their relationships.

AIMS: To identify the personal and professional impact of the COVID-19 pandemic on clinical nurses with regard to personal and workplace safety, personal and professional relationships and perceptions of their team, organization and community, and to understand lessons learned to inform future responses to pandemics or global emergencies. DESIGN: Qualitative, descriptive free-text surveys, informed by appreciative inquiry. METHODS: Nurses working in adult COVID- and non-COVID cohort medical-surgical and intensive care units, outpatient cancer and general surgery centres were invited to participate. Data were collected between April and October 2021 and analysed using summative content analysis. RESULTS: In total, 77 participants completed free-text surveys. Five themes were identified: (1) Constraints on nursing: barriers in communication and diminished patient safety and quality of care; (2) Navigating uncertainty: the emotional toll of the pandemic; (3) Team solidarity, renewed appreciation and reaffirming purpose in nursing work; (4) Enhanced trust versus feeling expendable; and (5) Increased isolation and polarization within communities. Nurses described a perceived negative impact on a number of their relationships, including with patients, employer and community. They described a huge emotional toll that included feelings of isolation and polarization. While some nurses described feeling supported by their team and employer, others described feeling expendable. CONCLUSION: Nurses' responses provided insights into negative emotional experiences during the pandemic due to heightened uncertainty and fear, and also the importance of support received from peers, colleagues and their employer. Nurses experienced feelings of isolation and polarization within their communities. The varied responses reflect the importance of societal solidarity when faced with global emergencies, and the need for nurses to feel valued by their patients and employer. IMPACT: Effective responses to public health emergencies require individuals and communities to work together to achieve collective goals. Efforts to retain nurses are critical during global emergencies. PATIENT OR PUBLIC CONTRIBUTION: No patient and public involvement.

RESPONDER: A qualitative study of ethical issues faced by critical care nurses during the COVID-19 pandemic.

AIMS: To identify and understand ethical challenges arising during COVID-19 in intensive care and nurses' perceptions of how they made "good" decisions and provided "good" care when faced with ethical challenges and use of moral resilience. BACKGROUND: Little is known about the ethical challenges that nurses faced during the COVID-19 pandemic and ways they responded. DESIGN: Qualitative, descriptive free-text surveys and semi-structured interviews, underpinned by appreciative inquiry. METHODS: Nurses working in intensive care in one academic quaternary care centre and three community hospitals in Midwest United States were invited to participate. In total, 49 participants completed free-text surveys, and seven participants completed interviews. Data were analysed using content analysis. RESULTS: Five themes captured ethical challenges: implementation of the visitation policy; patients dying alone; surrogate decision-making; diminished safety and quality of care; and imbalance and injustice between professionals. Four themes captured nurses' responses: personal strength and values, problem-solving, teamwork and peer support and resources. CONCLUSIONS: Ethical challenges were not novel but were amplified due to repeated occurrence and duration. Some nurses' demonstrated capacities for moral resilience, but none described drawing on all four capacities. IMPLICATIONS FOR NURSING MANAGEMENT: Nurse managers would benefit from greater ethics training to support their nursing teams.

Exit from Brain Device Research: A Modified Grounded Theory Study of Researcher Obligations and Participant Experiences.

As clinical trials end, little is understood about how participants exiting from clinical trials approach decisions related to the removal or post-trial use of investigational brain implants, such as deep brain stimulation (DBS) devices. This empirical bioethics study examines how research participants experience the process of exit from research at the end of clinical trials of implanted neural devices. Using a modified grounded theory study design, we conducted semi-structured, in-depth interviews with 16 former research participants from clinical trials of DBS and responsive neurostimulation (RNS). Open-ended questions elicited motivations for joining the trial, understanding of study procedures at the time of initial informed consent, the process of exiting from research, and decisions about device removal or post-trial device use. Thematic analysis identified categories related to: limited preparedness for the end of research participation, straightforwardness of decisions to explant or keep the device, reconciling with the end of research participation, reconciling post-trial expectations, and achieving a sense of closure after exit from research. A preliminary theoretical model describes contextual factors influencing the process and experience of exit from research. Experiences of clinical trial participants should guide research practices to enhance the ethical design and conduct of clinical trials in DBS and other brain devices.

Original Research: Nurses' Knowledge and Comfort with Assessing Inpatients' Firearm Access and Providing Education on Safe Gun Storage.

PURPOSE: This study sought to evaluate nurses' knowledge and comfort with assessing inpatients' access to firearms and providing education on firearm safety and storage. Facilitators and barriers to such assessment, as well as best methods for educating nurses and patients on firearm safety and storage, were also explored. METHODS: Nurses from a general medical unit and a psychiatric unit at a large urban hospital were invited to complete a 22-question online survey. Descriptive statistics were computed to analyze survey responses for each unit. RESULTS: Forty-two nurses-21 from each unit-participated. More than 50% of nurses on each unit were unfamiliar with state law on safe gun storage, and none had prior training in educating others on firearm safety and storage. Compared with nurses on the psychiatric unit, those on the general medical unit were less comfortable asking patients about firearm access and safe gun storage. Several facilitators and barriers to assessment emerged. Facilitators identified by similar numbers of nurses on each unit included receiving relevant education and having educational information available for patients. Nurses on both units also endorsed having a safety protocol and a documentation policy in place. Barriers identified by similar numbers of nurses on each unit included lack of adequate knowledge about firearm safety and lack of patient educational materials. More medical unit than psychiatric unit nurses also named lack of time and not knowing what to do with collected information. More than 80% of nurses on each unit reported that they would feel comfortable providing patients with information on safe firearm storage if it were available; a pamphlet was endorsed most often as the best method. A one-hour class involving the security department and other disciplines was the top endorsed nurse learning strategy. CONCLUSIONS: Findings from this study highlighted several factors, including nursing specialty, that may influence inpatient assessment of firearm access and safe gun storage. These results can help inform hospital policies and nursing education initiatives aimed at improving safe gun storage practices among patients and the general public.