Structural under-reporting of informed consent, data handling and sharing, ethical approval, and application of Open Science principles as proxies for study quality conduct in COVID-19 research: a systematic scoping review.

BACKGROUND: The COVID-19 pandemic required science to provide answers rapidly to combat the outbreak. Hence, the reproducibility and quality of conducting research may have been threatened, particularly regarding privacy and data protection, in varying ways around the globe. The objective was to investigate aspects of reporting informed consent and data handling as proxies for study quality conduct. METHODS: A systematic scoping review was performed by searching PubMed and Embase. The search was performed on November 8th, 2020. Studies with hospitalised patients diagnosed with COVID-19 over 18 years old were eligible for inclusion. With a focus on informed consent, data were extracted on the study design, prestudy protocol registration, ethical approval, data anonymisation, data sharing and data transfer as proxies for study quality. For reasons of comparison, data regarding country income level, study location and journal impact factor were also collected. RESULTS: 972 studies were included. 21.3% of studies reported informed consent, 42.6% reported waivers of consent, 31.4% did not report consent information and 4.7% mentioned other types of consent. Informed consent reporting was highest in clinical trials (94.6%) and lowest in retrospective cohort studies (15.0%). The reporting of consent versus no consent did not differ significantly by journal impact factor (p=0.159). 16.8% of studies reported a prestudy protocol registration or design. Ethical approval was described in 90.9% of studies. Information on anonymisation was provided in 17.0% of studies. In 257 multicentre studies, 1.2% reported on data sharing agreements, and none reported on Findable, Accessible, Interoperable and Reusable data principles. 1.2% reported on open data. Consent was most often reported in the Middle East (42.4%) and least often in North America (4.7%). Only one report originated from a low-income country. DISCUSSION: Informed consent and aspects of data handling and sharing were under-reported in publications concerning COVID-19 and differed between countries, which strains study quality conduct when in dire need of answers.

Ethics of Digital Mental Health During COVID-19: Crisis and Opportunities.

Social distancing measures due to the COVID-19 pandemic have accelerated the adoption and implementation of digital mental health tools. Psychiatry and therapy sessions are being conducted via videoconferencing platforms, and the use of digital mental health tools for monitoring and treatment has grown. This rapid shift to telehealth during the pandemic has given added urgency to the ethical challenges presented by digital mental health tools. Regulatory standards have been relaxed to allow this shift to socially distanced mental health care. It is imperative to ensure that the implementation of digital mental health tools, especially in the context of this crisis, is guided by ethical principles and abides by professional codes of conduct. This paper examines key areas for an ethical path forward in this digital mental health revolution: privacy and data protection, safety and accountability, and access and fairness.

Digital Contact Tracing, Privacy, and Public Health.

Digital contact tracing, in combination with widespread testing, has been a focal point for many plans to "reopen" economies while containing the spread of Covid-19. Most digital contact tracing projects in the United States and Europe have prioritized privacy protections in the form of local storage of data on smartphones and the deidentification of information. However, in the prioritization of privacy in this narrow form, there is not sufficient attention given to weighing ethical trade-offs within the context of a public health pandemic or to the need to evaluate safety and effectiveness of software-based technology applied to public health.