Moleras‑Serra et al. BMC Primary Care (2023) 24:91 BMC Primary Care https://doi.org/10.1186/s12875-023-02025-5 RESEARCH Open Access Primary health care research in COVID‑19: analysis of the protocols reviewed by the ethics committee of IDIAPJGol, Catalonia Anna Moleras‑Serra1,2 , Rosa Morros‑Pedros1,2,3 , Mónica Monteagudo1,2 , Cristina Vedia‑Urgell1,2,3    and Ainhoa Gómez‑Lumbreras1,4*    Abstract Background 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. Methods 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 investi‑ gators (gender, PhD degree, professional role…) and outcomes of the Ethics Committee process (requirements of modifications and time until approval) were analyze. Results 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%). Conclusions 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 accord‑ ing 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. Keywords COVID-19, Primary health care, Research, Ethics committees, Workload *Correspondence: Ainhoa Gómez‑Lumbreras agomez@idiapjgol.info Full list of author information is available at the end of the article © The Author(s) 2023. 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The Creative Commons Public Domain Dedication waiver (http://​creat​iveco​ mmons.​org/​publi​cdoma​in/​zero/1.​0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Moleras‑Serra et al. BMC Primary Care (2023) 24:91 Page 2 of 7 Introduction coverage health system funded mainly from citizens In December 2019 a novel coronavirus causing a severe taxes which allows provision of healthcare free of acute respiratory syndrome with high mortality rates was charge with partial coverage for outpatient prescribed identified as SARS-CoV2 in Wuhan (China); the world medications [13] The Spanish health care system went was hit by the disease COVID-19, which was declared through a decentralization in the late 1900 and Cata- as global pandemic by the World Health Organization lunya created the “Catsalut” (Catalan Health Service) (WHO) on 11 March 2020 [1]. In Spain, it was declared in charge of providing public healthcare for Catalo- on 14 March 2020 [2]. nia [14]. The main healthcare provider for Primary Since the first COVID-19 outbreak in March 2020 the Health Care (PHC) in Catalonia is the Catalan Health scientific community has been engaging a marathon to Institute (ICS) [15]. PHC is the access for patients to answer the different questions that the pandemic has the healthcare system. The principal settings are pri- brought. Conduction of clinical trials to get the most effi- mary care centers which primary care teams are cacy treatments, observational studies to characterize the formed by primary care physicians, nurses, pediatri- clinical and epidemiological features and vaccines devel- cians, dentistries and social workers [16]. The Spanish opment to provide immunity have been one of the main PHC has become the first contact with health services aims of health institutions to achieve quickly results. By for people with mild COVID-19 symptoms, as well as December 2021 over 7,353 studies on COVID-19 have the institution to answer doubts and control people been registered in clinicaltrials.gov [3]. In Spain, the in quarantine from their homes [17]. PHC has been Spanish Medicines Agency (AEMPS) has registered 207 leading and helping the collapsed health system dur- studies to that same date [4]. ing the pandemic without leaving aside its mission not COVID-19 pandemic has forced health systems update only to investigate but also to provide tools to improve their assistance and research protocols periodically and the health and well-being of citizens [18]. The main the Different medical societies have published guide- research potential of PHC is population-based clinical lines to keep on with the clinical assistance during the studies, but the research on PHC it is not exempt from pandemic Regulatory bodies such as European Medicine difficulties such as lack of time, pressure on healthcare Agency (EMA), Food and Drug Administration (FDA) assistance, scarce resources, or lack of recognition, or Spanish Agency of Medicines and Medical Devices especially in comparison with the major research in (AEMPS) have also adapted research to the pandemic other fields closer to the hospital settings like oncology including guidance for researchers to ensure trials of or cardiology [19]. In Spain, there are few ECs of PHC medicinal products are safe and ethical [5–9]. institutions, among them the IDIAPJGol EC, which In this mobilization of health and research teams, evaluates research protocols from the public health sys- the Ethics Committees (EC) or Institutional Review tem of the Catalonian PHC setting. The IDIAPJGol EC Boards (IRB) have played and play an important role was created on August 1996. It was the first EC to be in reviewing of all COVID-19 protocols ensuring that accredited for PHC in Spain. The ICS considered the the protocol quality and ethics quality of scientific EC a key element to promote research in PHC, where research is not relaxed by the hasty need for answers. the diagnosis of the more prevalent diseases takes In March 2020, WHO published that pandemics such place and where most medicines are prescribed. The as COVID-19 do not overrule the need to uphold ethi- IDIAPJGol EC supervises the 87% of PHC centers of cal standards [10]. The challenge to EC/IRB during the Catalonia, including the ICS, which is the main health COVID-19 era is how to maintain research standards provider in Catalonia with more than 400 primary care of quality and integrity and to ensure the protection of centers [20]. human beings, all in record times, as results are needed The aim of this research is to describe the characteris- as soon as possible. The European Network of Research tics of the research protocols and their principal inves- Ethics Committees published a position paper about tigators reviewed by the IDIAPJGol EC and to compare the responsibility of research EC during the COVID- the workload of the committee during the COVID-19 19 pandemic focused on the prioritization of protocols pandemic in Catalonia, Spain to a year before the starts related to COVID-19, the need for updated processes of the pandemic. for ethics reviews and the maintained importance of informed consent of participants in COVID-19 related Methods research [11]. The Spanish Bioethics Committee pub- This is an observational retrospective descriptive and lished a report in December 2020 with specific ethical comparative study from the protocols evaluated by the and legal requirements for research in the framework IDIAPJGol EC from January 2019 to December 2021, dif- of the COVID-19 pandemic [12]. Spain has a universal ferentiating COVID-19 protocols. Moleras‑Serra et al. BMC Primary Care (2023) 24:91 Page 3 of 7 The IDIAPJGol EC uses its own software of manage- categories (0 days, 1–31 days, 32–90 days, 91–180 days ment system called Comprehensive Management of and more than 180 days). Continuous variables were Research [Gestió Integral de la Recerca (GIR) in Catalan], compared using the T-test or Mann–Whitney U test https://​p ortal.​idiap​jgol.​org:​6443/​g ir/​login/​index.​php?​ and categorical variables were compared using the χ2 or entorn=​IDIAP) which collects all the variables related Fisher exact test when applicable. to researchers and research protocols conducted in ICS The results were described using hazard ratios with a PHC centers and other health institutions providers of 95% confidence interval (CI 95%) and value p < 0.05 was Health Department of Catalonia. considered significant. All statistical analyses were per- The following GIR variables were used for the study formed using the statistical software package Statistical analysis: Package for Social Science (SPSS) version 25.0. – Research protocol variables: study design (interven- Results tional, observational, qualitative study, and others), Since the beginning of the COVID-19 pandemic the funding source (external or internal grant (grants number of protocols reviewed by the IDIAPJGol from IDIAPJGol or ICS), private funding, no fund- EC has increased, as well as the number of sessions. ing), COVID-19 study objective topic (epidemiology, With fluctuations the number of protocols evaluated pharmacotherapy, diagnosis and seroprevalence, and monthly raised from 2019 to 2021, with 2 peaks in population impact). April 2021 and July 2021 (41 and 37 protocols, respec- – Principal Investigator (PI) characteristics: gender, tively); Focused on COVID-19 protocols, the peak professional category, PhD degree, membership to a was in April 2020 and in April 2021. (See Fig. 1 for the research group. monthly distribution). – Outcomes of the EC process: result of the evaluation In total 751 protocols were evaluated during the study (approval, modification required, denied) and time period, 223 (29.7%) in 2019, 235 (31.3%) in 2020 and 293 until approval. (39.0%) in 2021 (Table 1). A total of 513 research proto- cols (68.3%), had an observational design and more than A sub-analysis has been conducted comparing COVID- half (434, 57.8%) had no funding. The PI was a women in 19 versus non-COVID-19 protocols evaluated since the 491 (65.4%) protocols; a GP in 330 (43.9%) protocols; 272 pandemic hit (April 2020 – December 2021). of the PIs (36.2%) hold a PhD degree, and 203 (27.0%) are members of an accredited research group. Statistical analysis The mean number of days for a protocol to be Annual descriptive statistics were used to summarize the approved by the IDIAPJGol EC in the overall study different variables. Continuous variables were reported period was 42.09 days (SD 60.2), 2019 to 2021 it as mean and standard deviation (SD) as appropriate, cat- decreased in 20.1 days (from an average of 55.0 (SD egorical variables were reported as proportions (%). For 73.0) days in 2019 to 34.9 (SD 40.6) days in 2021). By the days to approval variable, these were stratified in 5 the end of the study period 614 (81.6%) protocols were Fig. 1 Number of Protocols reviewed per month by Ethics Committee during the study period Red: COVID-19 Green: non COVID-19 Moleras‑Serra et al. BMC Primary Care (2023) 24:91 Page 4 of 7 Table 1 Descriptive of the Ethics Committee Activity by Year 2019 2020 2021 TOTAL N (%) 223 (29.7) 235 (31.3) 293 (39.0) 751 (100.0) Study design Interventional study 42 (18.8) 43 (18.3) 39 (13.3) 124 (16.5) Observational study 155 (69.5) 161 (68.5) 197 (67.2) 513 (68.3) Qualitative study 18 (8.1) 18 (7.7) 40 (13.7) 76 (10.1)  ­Othersa 8 (3.6) 13 (5.5) 17 (5.8) 38 (5.1) Funding External/Public grant 26 (11.7) 39 (16.6) 52 (17.7) 117 (15.6) Internal grant 39 (17.5) 14 (6.0) 9 (3.1) 62 (8.3) Private funding 36 (16.1) 34 (14.5) 68 (23.2) 138 (18.4) No funding 122 (54.7) 148 (63) 164 (56) 434 (57.8) PI characteristics Gender (Female) 156 (70.0) 152 (64.7) 183 (62.5) 491 (65.4) Holds a PhD degree (yes) 78 (34.5) 90 (38.3) 104 (35.5) 272 (36.2) Member of a research group (yes) 56 (24.8) 71 (30.2) 76 (25.9) 203 (27) Professionals General Practitioners (GP) 104 (46.6) 106 (45.1) 120 (41.0) 330 (43.9) Physicians other than GP 27 (12.1) 34 (14.5) 36 (12.3) 97 (12.9) Pediatricians 7 (3.1) 10 (4.3) 4 (1.4) 21 (2.8) Physicians (Gynecologist) 2 (0.9) 2 (0.9) 4 (1.4) 8 (1.1) Nurse 49 (22.0) 47 (20.0) 63 (21.5) 159 (21.2) Other health professionals 18 (8.1) 10 (4.3) 14 (4.8) 42 (5.6) Pharmacists 8 (3.6) 7 (3.0) 11 (3.8) 26 (3.5) Biostatisticians/IT 0 (0.0) 0 (0.0) 5 (1.7) 5 (0.7) Others 3 (1.3) 3 (1.3) 11 (3.8) 17 (2.3) Unknown 5 (2.2) 16 (6.8) 25 (8.5) 46 (6.1) Number of sessions held 12 25 18 55 EC Results Approval 185 (83.0) 188 (80.0) 241 (82.3) 614 (81.6)    Days until approval    0 47 (25.4) 55 (29.3) 66 (27.4) 168 (27.4)    1–30 41 (22.2) 54 (28.7) 73 (30.3) 168 (27.4)    31–90 51 (27.6) 42 (22.3) 75 (31.1) 168 (27.4)    91–180 30 (16.2) 28 (14.9) 25 (10.4) 83 (13.5)    > 6 months 16 (8.6) 9 (4.8) 2 (0.8) 27 (4.4) Modification required 38 (17.0) 44 (18.7) 51 (17.4) 133 (17.8) Withdrawn 0 (0.0) 3 (1.3) 0 (0.0) 3 (0.4) Denied 0 (0.0) 0 (0.0) 1 (0.3) 1 (0.1) Days to be approved (mean, SD) 55 (73.0) 41.5 (65.4) 34.9 (40.6) 42.9 (60.2) Covid-19 study objective topic 86 (41.3) 122 (58.7) 208 (100.0) Epidemiology 26 (30.2) 24 (19.7) 50 (24.0) Pharmacological treatment 9 (10.5) 37 (30.3) 46 (22.1) Diagnoses tests 24 (27.9) 17 (13.9) 41 (19.7) Population impact of COVID-19 27 (31.4) 44 (36.1) 71 (34.1) a Others: economist, sociologists, engineer, journalists, geography and history, trade and marketing approved, 336 (54.8%) at least in the first 30 days, half Analyzing the COVID-19 protocols by objective topic, of them at their initial submission and the rest after most of them were related to COVID-19 impact on the required modifications. population (71, 34.1%), followed by those protocols focus Moleras‑Serra et al. BMC Primary Care (2023) 24:91 Page 5 of 7 on pharmacological treatment (vaccines included) (46, Table 2 Comparative between COVID-19 and Non-COVID-19 22.1%). These pharmacological ones showed the high- Protocols (Apr 2020 – Dec 2021) est increase from 9 (10.5%) in 2020 to 37 (30.3%) in 2021 Total protocols 469 COVID-19 No p value while a decrease in the epidemiology ones (from 26, COVID-19 30.2% in 2020 to 24, 19.7% in 2021). N (%) 208 (44.3) 261 (55.7) 0.016 Table 2 shows the comparison between COVID-19 Study design protocols and the rest of protocols during the period of Interventional study 17 (8.2) 48 (18.4) 0.001 pandemics (April 2020 to December 2021). Of all the Observational study 162 (77.9) 161 (61.7) 0.000 protocols reviewed since the beginning of the COVID- Qualitative study 18 (8.7) 34 (13.0) 0.134 19 pandemic (March 2020), 208 (44.3%) were COVID-  ­Othersa 11 (5.3) 18 (6.9) 0.473 19 protocols being 87 (41.8%) in 2020 and 121 (58.2%) in Funding 2021. External/Public grant 47 (22.6) 37 (14.2) 0.018 In relation to the study design, we found significant Internal grant 7 (3.4) 12 (4.6) 0.501 differences in the observational studies [162, (77.9%) in Private funding 33 (15.9) 64 (24.5) 0.021 COVID-19 protocols vs. 161 (61.7%) in non-COVID-19 No funding 121 (58.2) 148 (56.7) 0.749 ones, p < 0.01] and in interventional studies [17 (8.2%) PI characteristics vs. 48 (18.4%), p < 0.01), COVID-19 and non-COVID-19, Gender (Female) 122 (58.7) 174 (66.7) 0.002 respectively]. Significant differences were also found for Holds a PhD degree (yes) 86 (41.3) 88 (33.7) 0.019 COVID-19 protocols funded by external or public grants Research group membership (yes) 74 (35.6) 61 (23.4) 0.004 [47 (22.6%) vs. 37 (14.2%), p = 0.018 for COVID-19 and Professionals non-COVID-19, respectively], as well as for those with private funding, [33 (15.9%) vs. 64 (24.5%), p = 0.021 for General Practitioners (GP) 100 (48.1) 91 (34.9) 0.004 COVID-19 and non-COVID-19 protocols, respectively]. Physicians other than GP 34 (16.3) 33 (12.6) 0.255 Comparing the PI COVID-19 protocols, fewer had a Pediatricians 7 (3.4) 6 (2.3) 0.485 woman as a PI [122 (58.7%) vs. 174 (66.7%); p = 0.002]; Physicians (Gynecologist) 0 (0.0) 6 (2.3) 0.008 and more COVID-19 protocols’ PI were GPs [100 Nurse 29 (13.9) 66 (25.3) 0.002 (48.1%) vs. 91 (34.9%); p = 0.004)] and those non Other health professionals 10 (4.8) 14 (5.4) 0.786 COVID-19 had more nurses as PI [29 (13.9%) vs. 66 Pharmacists 6 (2.9) 10 (3.8) 0.575 (25.3%); p = 0.002]. Biostatisticians/IT 2 (1.0) 3 (1.1) 0.844 COVID-19 protocols approved within the first month Others 4 (1.9) 10 (3.8) 0.228 after the evaluation (1–31 days) were non-COVID-19 Unknown 16 (7.7) 22 (8.4) 0.771 ones [67 (38.3%) vs. 54 (25.8%), p = 0.009]. EC Results Approval 175 (84.1) 209 (80.1 0.257    Days until approval Discussion    0 46 (26.3) 57 (27.3) 0.828 The IDIAPJGol EC work overload has increased from    1–30 16 (9.1) 54 (25.8) 0.009 2019 during 2020 and this increase is maintained during    31–90 67 (38.3) 65 (31.1) 0.197 2021. This overload has been not only in the number of    91–180 44 (25.1) 28 (13.4) 0.192 research protocols to be reviewed but also in the num-    > 6 months 2 (1.1) 5 (2.4) 0.362 ber of meetings held by the EC. Other ECs in Spain and Modification required 32 (15.4) 49 (18.8) 0.335 abroad have published similar trends in their work over- Withdrawn 1 (0.5) 2 (0.8) 0.696 load [21–23]. Denied 0 (0.0) 1 (0.4) 0.279 The number of observational studies increased in the Days to be approved (mean, SD) 33.3 (45.0) 40.1 (52.1) 0.101 research carried out in PHC in Catalonia and one of the a Others: Others: economist, sociologists, engineer, journalists, geography and possible reason lies in the PHC research goals, the dis- history, trade and marketing ease epidemiology whose approach could be describing patients’ characteristics, monitoring signs and symptoms and trying to identify preventive and predictive factors. conducted even with no funding. Research that even Also, PHC can analyze the impact of the disease at a involved overexertion and extra work for PHC teams was community level [19]. carried out, making PHC workers invest their own time There was an increase in the number of protocols with- and resources in trying to get the desired answers. The out funding in 2020 and 2021, we would like to think great awareness of the Spanish researchers obtained a that at a time of urgent need for answers our health quick response from the government, which soon pub- care workers standards prevailed, so many studies were lished external public calls [24]. Moleras‑Serra et al. BMC Primary Care (2023) 24:91 Page 6 of 7 However, in the COVID-19 protocols we could see an considered. COVID-19 research done in PHC instead of increase in private funded projects, especially in 2021, as hospitals may have differed in their objectives. The data well as an increase in drug studies possibly due to safety have been extracted from a management database but is studies on COVID-19 vaccines, which are mainly con- not error-free. Likewise, the urgency to give a quick opin- ducted by the pharmaceutical industry [25]. In this con- ion and the adaptation to the news ways of work during text, PHC plays an important role due to its accessibility the lockdown may have led to missing information on the to reach the population, allowing the recruitment of indi- funding entity, total amount achieved or research grant. viduals from the entire population [26]. The COVID-19 studies were mainly led by GPs due to their involvement in fight against the pandemic. Like- Conclusion wise it seems that COVID-19 studies were carried out Despite of the work overload during the pandemic due by more experienced researchers since a higher percent- to the increase in the number of protocols, the IDIAP- age of PI hold a PhD and are members of an accredited JGol EC kept with its activity, mainly by incrementing research group. the number of meetings. (COVID-19 or not) this led to a In order to be able to maintain the rhythm of reviews quick response in the EC opinion reducing considerably and not delay the EC opinions the IDIAPJGol EC, fol- the time until approval. lowed the recommendations of EUREC [11], to adopt new strategies, such as increasing in the frequency of Abbreviations meetings from monthly to weekly and meeting virtually. AEMPS Spanish Agency of Medicines and Medical Devices This has been a common strategy adopted by other EC/ EC Ethics Committee EMA European Medicines Agency IRB, reducing the time until the approval without delay- EUREC European Network of Research Ethics Committees ing the assessment of all the protocols [27, 28]. With the FDA Food and Drug Administration procedural changes applied, especially the increase in the GIR Comprehensive Management of Research GP General Practitioner number of meetings, protocols were approved in 21 days IDIAPJGol Foundation University Institute for Primary Health Care Research less in 2021 respect to 2019. Moreover, online meetings Jordi Gol i Gurina (IDIAPJGol) have additional benefits such as saving time and costs, as IRB Institutional Review Board NICE National Institute for Health and Care Excellence well as avoiding unnecessary movements [29]. It has to be PHC Primary Health Care mention that the IDIAPJGol EC has never diminished its PI Principal Investigator ethical requirements and has maintain all the strictness, SD Standard Deviation SPSS Statistical Package for Social Science COVID-19 pandemic included, according to the WHO WHO World Health Organization ethic guidance in research during outbreaks and the Spanish Bioethics Committee COVID-19 report [10, 12]. Acknowledgements The authors want to thank the members of the IDIAPJGol Ethics committee for COVID-19 protocols took an average of 7 days less their implication during the COVID-19 pandemic, and Patryk Bialoskorski for to be approved than non-COVID-19 protocols favor- his help in translation and English revision. ing the progress of the COVID-19 research at a time Authors’ contributions of exceptional urgency. Although there is a reasonable AM, AG, CV and RM developed the study concept and design. AM compiled doubt about COVID-19 protocols having been able to the initial draft of the manuscript with support from AG and CV. RM helped maintain the same research quality than the other pro- supervise the project and MM helped with statistical analysis and reviewing the manuscript. All authors discussed the results and contributed to the final tocols. Some articles have shown that research proto- manuscript. The author(s) read and approved the final manuscript. cols assessed by EC during the pandemic were often incomplete and the urgency made that researchers did Funding This study has no funding. not consider all the aspects related to the research [30]. A systematic review of the research methodological Availability of data and materials quality during the pandemic showed that the clinical The datasets generated and analyzed during the current study are not pub‑ licly available due to these are in the institution management system and it is research was mainly observational with modest scores an administrative database used to the proper functioning of the institution in methodological quality. COVID-19 papers were asso- and for its internal dashboard but they are available from the corresponding ciated with a lower methodological quality score when author on reasonable request. published with a shorter time frame and in lower impact factor (IF) journals [31]. Declarations Ethics approval and consent to participate Limitations and strengths Not applicable. This study analyzed a PCH EC so no information on Consent for publication those studies conducted in the hospital setting has been Not applicable. Moleras‑Serra et al. BMC Primary Care (2023) 24:91 Page 7 of 7 Competing interests 16. Atencio Primaria. Gencat. [cited 2023 Feb 8]. Available from: https://​ics.​ The authors declare no competing interests. gencat.​cat/​ca/​assis​tencia/​atenc​io-​prima​ria/. 17. Llor C, Moragas A. Coronavirus and primary care. Aten Primaria. Author details 2020;52(5):294–6. 1 Fundació Institut Universitari Per a La Recerca a L’Atenció Primària de Salut 18. de Nicolás Jiménez JM, Blázquez Recio LM, Fabregat Domínguez MT, Jordi Gol I Gurina (IDIAPJGol), Barcelona, Spain. 2 Universitat Autònoma de Bar‑ Palomo CL. COVID-19 and assistance effort in Primary Care. Aten Primaria. celona, Bellaterra (Cerdanyola del Vallès), Barcelona, Spain. 3 Direcció d’Atenció 2020;52(8):588–90. Primària Metropolitana Nord, Institut Català de La Salut, Barcelona, Spain. 19. Violán Fors C, Odriozola GG, Zabaleta-del-Olmo E, Moral EG. La inves‑ 4 College of Pharmacy, Department of Pharmacotherapy, University of Utah, tigación en atención primaria como área de conocimiento. Informe Salt Lake City, USA. SESPAS 2012. Gac Sanit. 2012;26(SUPPL.1):76–81. 20. IDIAPJGol Website. [cited 2021 Nov 3]. Available from: https://​www.​idiap​ Received: 11 April 2022 Accepted: 2 March 2023 jgol.​org/​index.​php/​en/​about-​ceic. 21. Cereda G, Viscardi C, Gottard A, Mealli F, Baccini M. Analysis and future scenarios of the SARS-CoV-2 epidemic in Tuscany region (Central Italy). Epidemiol Prev. 2020;44(5–6):120–7. 22. Monaco E, Pisano L, Nasato L, Lorenzoni G, Gregori D, Martinato M. Ethics References committees in the time of covid-19. Epidemiol Prev. 2020;44(5–6):113–8. 1. Cucinotta D, Vanelli M. WHO declares COVID-19 a pandemic. Acta 23. Bugarín González R, María Romero-Yuste S, ­Ma López Vázquez P, Biomed. 2020;91(1):157–60. Casariego Rosón J, Carballeda Feijóo N, ­Ma Cruz del Río J, et al. Experi‑ 2. Royo S. Responding to COVID-19: The Case of Spain. Eur Policy Anal. encia de un Comité de Ética de la Investigación durante la pandemia por 2020;6(2):180–90. COVID-19. Rev Esp Salud Pública. 2020;94:e202011146. Available from: 3. Clinical Trials. [cited 2021 Oct 11]. Available from: https://​clini​caltr​ials.​gov/​ www.​mscbs.​es/​respC​orres​ponde​ncia: ct2/​resul​ts?​cond=​COVID-​19. 24. Kasherman L, Madariaga A, Liu Q, Bonilla L, McMullen M, Liu SL. Ethical 4. Registro Español de Estudios Clínicos (REEC) [Internet]. [cited 2022 Feb frameworks in clinical research processes during COVID-19: A scoping 13]. Available from: https://​reec.​aemps.​es/​reec/​public/​list.​html. review. BMJ Open. 2021;11(7):e047076. 5. European Society of Cardiology. ESC Guidance for the Diagnosis and 25. Chambers C. Using observational epidemiology to evaluate COVID-19 Management of CV Disease during the COVID-19 Pandemic. Eur Heart J. vaccines: integrating traditional methods with new data sources and 2020;1–115. tools. Can J Public Heal. 2021;112(5):867–71. 6. Cohen SP, Baber ZB, Buvanendran A, McLean BC, Chen Y, Michael Hooten 26. Fagnan LJ, Walunas TL, Parchman ML, Dickinson CL, Murphy KM, Howell W, et al. Pain management best practices from multispecialty organiza‑ R, et al. Engaging Primary Care Practices in Studies of Improve-ment: tions during the COVID-19 pandemic and public health crises. Pain Med Did You Budget Enough for Practice Recruitment? Ann Fam Med. (United States). 2020;21(7):1331–46. 2018;16(Suppl 1):S72-9. https://​doi.​org/​10.​1370/​afm.​2199. 7. European Medicines Agency. Guidance on the Management of Clinical 27. Zhang H, Shao F, Gu J, Li L, Wang Y. Ethics Committee Reviews of Applica‑ Trials During the Covid-19 (Coronavirus) Pandemic. 2021 [cited 2021 Feb tions for Research Studies at 1 Hospital in China during the 2019 Novel 15]. Available from: https://​ec.​europa.​eu/​health/​system/​files/​2022-​02/​ Coronavirus Epidemic. Vol. 323, JAMA - Journal of the American Medical guida​ncecl​inica​ltria​ls_​covid​19_​en_1.​pdf. Association. American Medical Association; 2020. p. 1844–6. 8. FDA. Guidance on Conduct of Clinical Trials of Medical Products during 28. IJkema R, Janssens MJPA, Van Der Post Id JAM, Licht CM. Ethical review COVID-19 Public Health Emergency: Guidance for Industry, Investigators, of COVID-19 research in the Netherlands; a mixed-method evaluation and Institutional Review Boards. FDA Guidance. 2020 [cited 2021 Jun among medical research ethics committees and investigators. PLoS One. 15]. Available from: https://​www.​fda.​gov/​regul​atory-​infor​mation/​search-​ 2021;167(7):e0255040. https://​doi.​org/​10.​1371/​journ​al.​pone.​02550​40. fda-​guida​nce-​docum​ents/​fda-​guida​nce-​condu​ct-​clini​cal-​trials-​medic​ 29. Ghooi RB. Ethics committee meetings-Online or face to face? In: Perspec‑ al-​produ​cts-​during-​covid-​19-​public-​health-​emerg​ency. tives in Clinical Research. Wolters Kluwer Medknow Publications; 2020. p. 9. Agencia Española de Medicamentos y Productos Sanitarios. Medidas 121–3. excepcionales aplicables a los ensayos clínicos para gestionar los prob‑ 30. Bahans C, Leymarie S, Malauzat D, Girard M, Demiot C. Ethical considera‑ lemas derivados de la emergencia por COVID-19. 2020. Available from: tions of the dynamics of clinical trials in an epidemic context: Studies on https://​www.​aemps.​gob.​es/​infor​ma/​notas​infor​mativ​as/​medic​ament​ COVID-19. Ethics, Med Public Heal. 2021;16:100621. osuso​humano-​3/​2020-​medic​ament​osuso​humano-​3/​medid​as-​excep​ 31. Jung RG, Di Santo P, Clifford C, Prosperi-Porta G, Skanes S, Hung A, et al. ciona​les-​aplic​ables-a-​los-​ensay​os-​clini​cos-​para-​gesti​onar-​los-​probl​emas-​ Methodological quality of COVID-19 clinical research. Nat Commun. deriv​ados-​de-​la-​emerg​encia-​por-​covid-​19/. 2021;12(1):1–10. 10. World Health Organization (WHO). Guidance for managing ethical issues in infectious disease outbreaks. World Health Organisation. 2016. 11. EUREC. Position of the European Network of Research Ethics Committees Publisher’s Note Springer Nature remains neutral with regard to jurisdictional claims in pub‑ (EUREC) on the Responsibility of Research Ethics Committees during the lished maps and institutional affiliations. COVID-19 Pandemic. 2020; Available from: http://​www.​eurec​net.​org/​ docum​ents/​Posit​ion_​EUREC_​COVID_​19.​pdf. 12. Comité de Bioética de España. Informe del Comité de Bioética de España sobre los requitisitos ético-legales en la investigación con datos de salud Ready to submit your research ? Choose BMC and benefit from: y muestras biológicas en el marco de la pandemia de COVID-19.  2020. Available from: http://​assets.​comit​edebi​oetica.​es/​files/​docum​entac​ion/​ • fast, convenient online submission Infor​me CBE investigacion COVID-19.pdf 13. Enrique Bernal-Delgado, Sandra García-Armesto, Juan Oliva, Fernando • thorough peer review by experienced researchers in your field Ignacio Sánchez Martínez, José Ramón Repullo, Luz María Peña-Longo‑ • rapid publication on acceptance bardo, Manuel Ridao-López CH-Q. Spain: Health system review. Health • support for research data, including large and complex data types Systems in Transition. 2018;20(2):1–179. Available from: www.​healt​hobse​ rvato​ry.​eu. • gold Open Access which fosters wider collaboration and increased citations 14. El CatSalut i el model sanitari català. Gencat. CatSalut. [Internet]. [cited • maximum visibility for your research: over 100M website views per year 2023 Feb 8]. Available from: https://​catsa​lut.​gencat.​cat/​ca/​coneix-​catsa​ lut/​prese​ntacio/​model-​sanit​ari-​catala/. At BMC, research is always in progress. 15. L’ICS. Institut Catalat de la Salut. [cited 2023 Feb 8]. Available from: https://​ ics.​gencat.​cat/​ca/​lics/. Learn more biomedcentral.com/submissions