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Challenges of a tertiary hospital's clinical ethics research committee in evaluating research during the COVID-19 pandemic. The CEICOV study.
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  • Judit Riera-Arnau,
  • Elena Guillén Benítez,
  • Carla Sans-Pola,
  • Esperanza Zuriguel-Pérez,
  • Lina María Leguízamo-Martínez,
  • Valentina Balasso,
  • Francesca Filippi-Arriaga,
  • María Luján Iavecchia,
  • Mireia Navarro,
  • Alexis Rodríguez Gallego,
  • Mireia Tomás,
  • Esther Cucurull Folguera
Judit Riera-Arnau
Hospital Vall d'Hebron
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Elena Guillén Benítez
Vall d'Hebron Hospital Universitari
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Carla Sans-Pola
Vall d'Hebron Hospital Universitari

Corresponding Author:carlasanspola@gmail.com

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Esperanza Zuriguel-Pérez
Vall d'Hebron Hospital Universitari
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Lina María Leguízamo-Martínez
Vall d'Hebron Hospital Universitari
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Valentina Balasso
Vall d'Hebron Institut de Recerca
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Francesca Filippi-Arriaga
Vall d'Hebron Hospital Universitari
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María Luján Iavecchia
Vall d'Hebron Hospital Universitari
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Mireia Navarro
Vall d'Hebron Institut de Recerca
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Alexis Rodríguez Gallego
Vall d'Hebron Hospital Universitari
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Mireia Tomás
Vall d'Hebron Institut de Recerca
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Esther Cucurull Folguera
Vall d'Hebron Hospital Universitari
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Abstract

Background: The COVID-19 pandemic led to an increase in research activity worldwide. The Vall d’Hebron University Hospital Research Ethics Committee (VH-REC) adapted its procedures to give out the opinion rapidly. We aimed to describe the characteristics of the VH-REC activity and studies evaluated during the first outbreak. Methods: Clinical trials (CT), post-authorization studies (PAS) and research projects (RP) on COVID-19 were included and followed up. Variables were described through usual descriptive methods. Results: 157 studies were evaluated: 10 CT, 16 PAS and 131 RP, in 25 bi-weekly online meetings. Non-commercial, unicentric and national studies predominated (95%, 54% and 88%, respectively). The main objective of CT and PAS studies was to test efficacy and safety, and for RP to describe patients’ outcomes. Some studies focused on specific interest groups, such as healthcare professionals or immunosuppressed patients (10% both). The median time of protocols’ evaluation was 3 days. 58.6% (92) required further clarifications, mainly due to aspects of data protection, informed consent, and biological samples. The final opinion was favourable in 93% (146). Regarding follow-up, 123 studies had been initiated and 64 also finalized. Results have been published in 59% (51) of studies. Conclusions and implications: COVID-19 pandemic has led to greater academic and local research, especially through research projects. Electronic sources were implemented for evaluation shortening and ease follow-up. These measures should remain to streamline VH-REC processes, and trends to publish results favoured. This study could allow comparisons with other activity periods (e.g. pre or post-pandemic), or with other REC’