Primary health care research in COVID-19 : analysis of the protocols reviewed by the ethics committee of IDIAPJGol, Catalonia
Moleras-Serra, Anna (Institut Universitari d'Investigació en Atenció Primària Jordi Gol)
Morros, Rosa (Institut Universitari d'Investigació en Atenció Primària Jordi Gol)
Monteagudo, Mònica (Institut Universitari d'Investigació en Atenció Primària Jordi Gol)
Vedia Urgell, Cristina (Institut Universitari d'Investigació en Atenció Primària Jordi Gol)
Gomez-Lumbreras, Ainhoa (Institut Universitari d'Investigació en Atenció Primària Jordi Gol)
Universitat Autònoma de Barcelona

Date:	2023
Abstract:	Since March of 2020, the scientific community has been engaged a marathon to answer the different questions that COVID-19 pandemic has brought. During this time, Ethics Committees played an important role in reviewing the research protocols, COVID-19 or not, ensuring that the quality of scientific research is not relaxed by the hasty need for answers. Descriptive study from January 2019 to December 2021, comparing COVID-19 protocols to those not COVID-19 related protocols and comparing the work overload. Variables related to the characteristics of the research protocols (i. e. study design, funding…), the principal investigators (gender, PhD degree, professional role…) and outcomes of the Ethics Committee process (requirements of modifications and time until approval) were analyze. The number of sessions increased during COVID-19 pandemics (12 in 2019, 25 in 2020 and 18 in 2021). In total 751 protocols were evaluated during the study period; 513 (68. 3%) had an observational design and 434 (57. 8%) had no funding. The principal investigator was a woman in 491 (65. 4%) studies and a General Practitioner in 330 (43. 9%). The mean of the days until the protocol approval was 42. 09 days (SD 60. 2) with a decrease of 20. 1 days from 2019 to 2021. A total of 614 (81. 7%) protocols were approved, 336 (54. 7%) within the first month after their initial evaluation. Less than half of the protocols were COVID-19 related (208, 44. 3%). The COVID-19 protocols main topics were impact on the population (71, 34. 1%); and COVID-19 pharmacological treatments (including vaccines) showed a higher increase in 2021 (37, 30. 3%). Despite the work overload during the pandemic due to the increase in the number of meetings and protocols, the IDIAPJGol EC reviewed all of them (COVID-19 or not) adapting to the new situation but according to its criteria of good practices to provide a quick response in the EC opinion. In Primary Health Care the most study designs have been observational studies, many of them with no funding and led by GPs. In 2021 there was an increase in the number of protocols focused on drugs, most likely related to COVID-19 vaccines studies.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	COVID-19 ; Ethics committees ; Primary health care ; Research ; Workload
Published in:	BMC Primary Care, Vol. 24 (april 2023) , ISSN 2731-4553

DOI: 10.1186/s12875-023-02025-5
PMID: 37024845

7 p, 1.1 MB

The record appears in these collections:
Articles > Research articles
Articles > Published articles