Objective:In response to the COVID-19 pandemic, hospitals have developed visitor restriction policies in order to mitigate spread of infection. We reviewed hospital visitor restriction policies for consistency and to develop recommendations to highlight fair and transparent restrictions, exceptions, and appeals in policy development and implementation. Design: Collection and analysis of public-facing visitor restriction policies during the first 3 months of the pandemic. Setting: General acute care hospitals representing 23 states across all 4 major regions of the United States. Participants: A cohort of the 70 largest hospitals by total bed capacity. Measurements: Characteristics of visitor restriction policies including general visitor restriction statement, changes/ updates to policies over time, exceptions to policies, and restrictions specific to COVID-19-positive patients. Results: Sixty-five of the 70 hospitals reviewed had public-facing visitor restriction policies. Forty-nine of these 65 policies had general "no-visitor" statements, whereas 16 allowed at least 1 visitor to accompany all patients. Sixty-three of 65 hospitals included exceptions to their visitor restriction policies. Setting-specific exceptions included pediatrics, obstetrics/gynecology, emergency department, behavioral health, inpatient rehabilitation, surgery, and outpatient clinics. Exceptions that applied across settings included patients at end of life and patients with disabilities. Conclusion:Visitor restriction policies varied significantly among hospitals in this review. These variances create challenges in that their fair application may be problematic and ethical issues related to allocation may arise. Five recommendations are offered for hospitals revising or creating such policies, including that offering transparent, accessible, public-facing policies can minimize ethical dilemmas. In addition, hospitals would benefit from communicating with each other in the development of visitor policies to ensure uniformity and support patients and family members as they navigate hospital visitation.
Introduction The South East Asia Research Collaboration in HIV (SEARCH) RV411 clinical trial in Thailand was a systematic investigation of analytic treatment interruption (ATI) in individuals diagnosed and treated since Fiebig stage I acute HIV infection. Here, we explore decision‐making processes and perceptions of trial participation in a phase I trial that raised important ethical considerations, to identify potential areas of improvement in this relatively new field of HIV research. Similar considerations apply to other HIV phase I trials, especially those involving ATI, making this trial a model to identify challenges and opportunities in promoting informed choice. Methods Using longitudinal semi‐structured interviews and a validated questionnaire, we examined how decisions to join or decline the trial were made, whether there was evidence of decisional conflict, and reactions to the trial outcomes. We also explored contrasting views and experiences in this small trial cohort. We report analyses of data from these questionnaires and interviews, conducted from February through December of 2016 with the 14 SEARCH cohort participants who either joined (n = 8) or declined (n = 6) participation in RV411. Results The eight participants and six decliners had low overall decisional conflict, which remained low over time. Decision making was more difficult for decliners than participants, at least initially. While all interviewees described being satisfied with their decisions, our study identified important negative consequences for a few individuals, including seroconversion, negative experiences with optional procedures and disappointment due to rapid viral rebound. Conclusions Although our results reflect the experiences of a small group invited to join this trial, our overall finding of low decisional conflict even while some individuals reported negative experiences provides lessons for clinical trial investigators. We developed points‐to‐consider in helping participants make informed choices, to support participants during the trial and to support decliners in their decisions.
Purpose In genomics, the return of negative screening results for rare, medically actionable conditions in large unselected populations with low prior risk of disease is novel and may involve important and nuanced concerns for communicating their meaning. Recruitment may result in self-selection because of participants’ personal or family history, changing the characteristics of the screened population and interpretation of both positive and negative findings; prior motivations may also affect responses to results. Methods Using data from GeneScreen, an exploratory adult screening project that targets 17 genes related to 11 medically actionable conditions, we address four questions: 1) Do participants self-select based on actual or perceived risk for one of the conditions? 2) Do participants understand negative results? 3) What are their psychosocial responses? 4) Are negative results related to changes in reported health-related behaviors? Results We found disproportionate enrollment of individuals at elevated prior risk for conditions being screened, and a need to improve communication about the nature of screening and meaning of negative screening results. Participants expressed no decision regret and did not report intention to change health-related behaviors. Conclusion This study illuminates critical challenges to overcome if genomic screening is to benefit the general population.
Background: Since the National Institutes of Health (NIH) Revitalization Act of 1993, focus on the equitable inclusion of women in clinical research has been ongoing. NIH's 2015 sex as a biological variable (SABV) policy aims to transform research design, analysis, and reporting in the preclinical sphere by including male and female organisms in vertebrate animal research as well as human studies. However, questions remain regarding how researchers and members of research oversight committees perceive the value and need of the SABV policy. Materials and Methods: Based on 62 interviews with animal researchers and oversight personnel, we analyze what the animal research community knows about the policy and sees as the benefits and challenges of implementation. Results: We found that the 62 interviewees disagreed about the need for the policy, with some being supportive and others questioning whether the policy is based on science or is politically motivated. There were also tensions in how interviewees conceptualized the challenges to and resources needed for implementing the SABV policy. For instance, while some thought implementation would require a significant increase in numbers of animals used for each study, others explicitly rejected this claim. Conclusions: We conclude by discussing the practical and social implications of our findings about the views of members of the animal research community regarding the SABV policy.
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