A significant change for patients and families during SARs-CoV-2 has been the restriction of visitors for hospitalized patients. We analyzed SARs-CoV-2 hospital visitation policies and found widespread variation in both development and content. This variation has the potential to engender inequity in access. We propose guidance for hospital visitation policies for this pandemic to protect, respect, and support patients, visitors, clinicians, and communities.
Inpatient insertion of long-acting reversible contraceptives (LARC) (intrauterine devices and implants) is increasingly offered to women immediately after childbirth. Enthusiasm for this approach stems from robust safety, effectiveness, and cost-effectiveness data, and responsiveness to women’s needs and preferences. While clinical evidence for immediate postpartum LARC is well-established, the ethical implications of enhancing access to this care have not been fully considered. Contraceptive policies and practices often embody a tension between fostering liberal availability and potentially coercive promotion of some methods. Historical contraceptive policies and contemporary disparities in LARC use point to the need to consider if health policies and health care practices support all women’s reproductive wishes. Immediate postpartum LARC services need to be designed and implemented with the goal of ensuring autonomy and equity in postpartum contraceptive care. To this end, these services should include strategic plans to promote universal availability, prevent coercion, and enable device removal.
Given the dearth of established safe and effective interventions to respond to COVID-19, there is an urgent ethical imperative to conduct meaningful clinical research. The good news is that interventions to be tested are not in short supply. Unfortunately, the human and material resources needed to conduct these trials are finite. It is essential that trials be robust and meet enrollment targets and that lower-quality studies not be permitted to displace higher-quality studies, delaying answers to critical questions. Yet, with few exceptions, existing research review bodies and processes are not designed to ensure these conditions are satisfied. To meet this challenge, we offer guidance for research institutions about how to ethically consolidate and prioritize COVID-19 clinical trials, while recognizing that consolidation and prioritization should also take place upstream (among manufacturers and funders) and at a higher level (e.g. nationally). In our proposed three-stage process, trials must first meet threshold criteria. Those that do are evaluated in a second stage to determine whether the institution has sufficient capacity to support all proposed trials. If it does not, the third stage entails evaluating studies against two additional sets of comparative prioritization criteria: those specific to the study and those that aim to advance diversification of an institution’s research portfolio. To implement these criteria fairly, we propose that research institutions form COVID-19 research prioritization committees. We briefly discuss some important attributes of these committees, drawing on the authors’ experiences at our respective institutions. Although we focus on clinical trials of COVID-19 therapeutics, our guidance should prove useful for other kinds of COVID-19 research, as well as non-pandemic research, which can raise similar challenges due to the scarcity of research resources.
As we enter an era of precision medicine and targeted therapies in the treatment of metastatic cancer, we face new challenges for patients and providers alike as we establish clear guidelines, regulations, and strategies for implementation. At the crux of this challenge is the fact that patients with advanced cancer may have disproportionate expectations of personal benefit when participating in clinical trials designed to generate generalizable knowledge. Patient and physician goals of treatment may not align, and reconciliation of their disparate perceptions must be addressed. However, it is particularly challenging to manage a patient's expectations when the goal of precision medicine-personalized response-exacerbates our inability to predict outcomes for any individual patient. The precision medicine informed consent process must therefore directly address this issue. We are challenged to honestly, clearly, and compassionately engage a patient population in an informed consent process that is responsive to their vulnerability, as well as ever-evolving indications and evidence. This era requires a continual reassessment of expectations and goals from both sides of the bed.
Medical biobanks often struggle to obtain sustainable funding. Commercialization of specimens is one solution, but disclosure of commercial interests to potential contributors can be dissuasive. Recent revisions to the federal human subjects research regulations will soon mandate such commercialization disclosure in some circumstances, which raises questions about implications for practice. In this nationally representative, probability-based survey sample of the US adult population, we found that 67 percent of participants agreed that clear notification of potential commercialization of biospecimens is warranted, but only 23 percent were comfortable with such use. Sixty-two percent believed that profits should be used only to support future research, and 41 percent supported sharing profits with the public. We also considered other factors related to disclosure in our analysis and argue for a "disclosure plus" standard: informing potential contributors that their biospecimens might be accessed by commercial organizations and explaining how profits would be used to both enhance transparency and facilitate contributors' altruistic motivations.
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