ArticleHealthcare (Basel, Switzerland)2023
Informed Consent in COVID-19-Research: An Ethical Analysis of Clinical Studies Performed during the Pandemic.
Article in Healthcare (Basel, Switzerland), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- A scoping review of ethics review processes during public health emergencies in Africa.BMC medical ethics · 2024Article
- Government Initiatives for Research Ethics During COVID-19 Pandemic in Korea.Journal of Korean medical science · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Health crises such as the current COVID-19 pandemic pose challenges to the conduct of clinical studies. Aspects of research ethics, such as obtaining informed consent (IC), can be complicated. We are concerned with whether or not the proper IC procedures were followed in the context of clinical studies at Ulm University in the years 2020 to 2022. We identified all protocols of clinical studies dealing with COVID-19 that the Research Ethics Committee of Ulm University has reviewed and voted on in the years 2020 to 2022. We then performed a thematic analysis regarding the following aspects: study type, handling of IC, type of patient information, means of communication, applied security precautions, and the approach to participants from vulnerable groups. We identified n = 98 studies that dealt with COVID-19. In n = 25 (25.51%), IC was obtained traditionally in written form, in n = 26 (26.53%) IC was waived, in n = 11 (11.22%) IC was obtained delayed, and in n = 19 (19.39%) IC was obtained by proxy. No study protocol was accepted that waived IC in case IC would have been required in times outside of pandemics. It is possible to obtain IC even in times of severe health crises. In the future, it is necessary to address in greater detail and with legal certainty which alternative methods of obtaining IC are possible and under which circumstances IC can be waived.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.