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
Bibliographic Data
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
Alternative medicine · Biobank · Business · Data quality · Data sharing · Family medicine · Informed consent · MEDLINE · Pathology · Political science · Psychiatry · Research ethics · Data Analysis and Archiving · Ethics in Clinical Research · Focus Groups and Qualitative Methods · Law · Medicine
Open Science now
Covid-19 mortality and deprivation
Prediction models for diagnosis and prognosis of covid-19
Strengthening the reporting of observational studies in epidemiology (STROBE) statement
Recommendations for the extraction, analysis, and presentation of results in scoping reviews
The PRISMA 2020 statement
The Fair Guiding Principles for scientific data management and stewardship
Research Ethics and Data Quality
A manifesto for reproducible science
| Unique citing works | 1 |
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| Citation types | Neutral: 1 |