The efficacy of convalescent plasma for coronavirus disease 2019 (COVID-19) is unclear. Although most randomized controlled trials have shown negative results, uncontrolled studies have suggested that the antibody content could influence patient outcomes. We conducted an open-label, randomized controlled trial of convalescent plasma for adults with COVID-19 receiving oxygen within 12 d of respiratory symptom onset (NCT04348656). Patients were allocated 2:1 to 500 ml of convalescent plasma or standard of care. The composite primary outcome was intubation or death by 30 d. Exploratory analyses of the effect of convalescent plasma antibodies on the primary outcome was assessed by logistic regression. The trial was terminated at 78% of planned enrollment after meeting stopping criteria for futility. In total, 940 patients were randomized, and 921 patients were included in the intention-to-treat analysis. Intubation or death occurred in 199/614 (32.4%) patients in the convalescent plasma arm and 86/307 (28.0%) patients in the standard of care arm—relative risk (RR) = 1.16 (95% confidence interval (CI) 0.94–1.43, P = 0.18). Patients in the convalescent plasma arm had more serious adverse events (33.4% versus 26.4%; RR = 1.27, 95% CI 1.02–1.57, P = 0.034). The antibody content significantly modulated the therapeutic effect of convalescent plasma. In multivariate analysis, each standardized log increase in neutralization or antibody-dependent cellular cytotoxicity independently reduced the potential harmful effect of plasma (odds ratio (OR) = 0.74, 95% CI 0.57–0.95 and OR = 0.66, 95% CI 0.50–0.87, respectively), whereas IgG against the full transmembrane spike protein increased it (OR = 1.53, 95% CI 1.14–2.05). Convalescent plasma did not reduce the risk of intubation or death at 30 d in hospitalized patients with COVID-19. Transfusion of convalescent plasma with unfavorable antibody profiles could be associated with worse clinical outcomes compared to standard care.

While recognizing the reservations held about strict ethical guidelines for qualitative research, we argue for further debate of these issues so that the health services research community can move towards the adoption of agreed standards of good practice. In addition, we suggest that empirical research is desirable in order to quantify the actual risks to participants in qualitative studies.

CONTEXT Medical students increasingly wish to participate in international health electives (IHEs). The authors undertook to understand from the students' perspective the ethical challenges encountered on IHEs in lowresource settings and how students respond to these issues.METHODS Semi-structured interviews were conducted with 12 medical students upon their return from an IHE. A purposive sampling strategy was used. Inductive data analysis using a constant comparative technique generated initial codes which were later organised into higher-order themes.RESULTS Five themes relating to ethical issues were identified: (i) uncertainty about how best to help; (ii) perceptions of Western medical students as different; (iii) moving beyond one's scope of practice; (iv) navigating different cultures of medicine, and (v) unilateral capacity building.CONCLUSIONS International health electives are associated with a range of ethical issues for students. Students would benefit from formal pre-departure training, which should include an evaluation of their expectations of and motivations for participating in an IHE, careful selection of the IHE from amongst the opportunities available, learning about the local context of the IHE prior to departure, and the exploration and discussion of ethical and professionalism issues. Other factors that would benefit students include having an invested onsite colleague or supervisor, maintaining an ongoing connection with the home institution, and formal debriefing on conclusion of the IHE.ethical issues Medical Education 2011: 45: 704-711

Most of the public supported alternatives to study-specific consent, but few supported use without any notification or consent. Consent choices for research use of one's health information should be documented in the medical record. The challenge remains how best to elicit those choices and ensure that they are up-to-date.