Challenges of a tertiary hospital's clinical ethics research committee
in evaluating research during the COVID-19 pandemic. The CEICOV study.
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’