quantitative research proposal about covid 19

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• Volume 10, Issue 12
• Impact of the COVID-19 pandemic on mental health and well-being of communities: an exploratory qualitative study protocol
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• http://orcid.org/0000-0003-0180-0213 Anam Shahil Feroz 1 , 2 ,
• Naureen Akber Ali 3 ,
• Noshaba Akber Ali 1 ,
• Ridah Feroz 4 ,
• Salima Nazim Meghani 1 ,
• Sarah Saleem 1
• 1 Community Health Sciences , Aga Khan University , Karachi , Pakistan
• 2 Institute of Health Policy, Management and Evaluation , University of Toronto , Toronto , Ontario , Canada
• 3 School of Nursing and Midwifery , Aga Khan University , Karachi , Pakistan
• 4 Aga Khan University Institute for Educational Development , Karachi , Pakistan
• Correspondence to Ms Anam Shahil Feroz; anam.sahyl{at}gmail.com

Introduction The COVID-19 pandemic has certainly resulted in an increased level of anxiety and fear in communities in terms of disease management and infection spread. Due to fear and social stigma linked with COVID-19, many individuals in the community hide their disease and do not access healthcare facilities in a timely manner. In addition, with the widespread use of social media, rumours, myths and inaccurate information about the virus are spreading rapidly, leading to intensified irritability, fearfulness, insomnia, oppositional behaviours and somatic complaints. Considering the relevance of all these factors, we aim to explore the perceptions and attitudes of community members towards COVID-19 and its impact on their daily lives and mental well-being.

Methods and analysis This formative research will employ an exploratory qualitative research design using semistructured interviews and a purposive sampling approach. The data collection methods for this formative research will include indepth interviews with community members. The study will be conducted in the Karimabad Federal B Area and in the Garden (East and West) community settings in Karachi, Pakistan. The community members of these areas have been selected purposively for the interview. Study data will be analysed thematically using NVivo V.12 Plus software.

Ethics and dissemination Ethical approval for this study has been obtained from the Aga Khan University Ethical Review Committee (2020-4825-10599). The results of the study will be disseminated to the scientific community and to the research subjects participating in the study. The findings will help us explore the perceptions and attitudes of different community members towards the COVID-19 pandemic and its impact on their daily lives and mental well-being.

• mental health
• public health

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/ .

https://doi.org/10.1136/bmjopen-2020-041641

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Strengths and limitations of this study

The mental health impact of the COVID-19 pandemic is likely to last much longer than the physical health impact, and this study is positioned well to explore the perceptions and attitudes of community members towards the pandemic and its impact on their daily lives and mental well-being.

This study will guide the development of context-specific innovative mental health programmes to support communities in the future.

One limitation is that to minimise the risk of infection all study respondents will be interviewed online over Zoom and hence the authors will not have the opportunity to build rapport with the respondents or obtain non-verbal cues during interviews.

The COVID-19 pandemic has affected almost 180 countries since it was first detected in Wuhan, China in December 2019. 1 2 The COVID-19 outbreak has been declared a public health emergency of international concern by the WHO. 3 The WHO estimates the global mortality to be about 3.4% 4 ; however, death rates vary between countries and across age groups. 5 In Pakistan, a total of 10 880 cases and 228 deaths due to COVID-19 infection have been reported to date. 6

The worldwide COVID-19 pandemic has not only incurred massive challenges to the global supply chains and healthcare systems but also has a detrimental effect on the overall health of individuals. 7 The pandemic has led to lockdowns and has created destructive impact on the societies at large. Most company employees, including daily wage workers, have been prohibited from going to their workplaces or have been asked to work from home, which has caused job-related insecurities and financial crises in the communities. 8 Educational institutions and training centres have also been closed, which resulted in children losing their routine of going to schools, studying and socialising with their peers. Delay in examinations is likewise a huge stressor for students. 8 Alongside this, parents have been struggling with creating a structured milieu for their children. 9 COVID-19 has hindered the normal routine life of every individual, be it children, teenagers, adults or the elderly. The crisis is engendering burden throughout populations and communities, particularly in developing countries such as Pakistan which face major challenges due to fragile healthcare systems and poor economic structures. 10

The COVID-19 pandemic has certainly resulted in an increased level of anxiety and fear in communities in terms of disease management and infection spread. 8 Further, the highly contagious nature of COVID-19 has also escalated confusion, fear and panic among community residents. Moreover, social distancing is often an unpleasant experience for community members and for patients as it adds to mental suffering, particularly in the local setting where get-togethers with friends and families are a major source of entertainment. 9 Recent studies also showed that individuals who are following social distancing rules experience loneliness, causing a substantial level of distress in the form of anxiety, stress, anger, misperception and post-traumatic stress symptoms. 8 11 Separation from family members, loss of autonomy, insecurity over disease status, inadequate supplies, inadequate information, financial loss, frustration, stigma and boredom are all major stressors that can create drastic impact on an individual’s life. 11 Due to fear and social stigma linked with COVID-19, many individuals in the community hide their disease and do not access healthcare facilities in a timely manner. 12 With the widespread use of social media, 13 rumours, myths and inaccurate information about COVID-19 are also spreading rapidly, not only among adults but are also carried on to children, leading to intensified irritability, fearfulness, insomnia, oppositional behaviours and somatic complaints. 9 The psychological symptoms associated with COVID-19 at the community level are also manifested as anxiety-driven panic buying, resulting in exhaustion of resources from the market. 14 Some level of panic also dwells in the community due to the unavailability of essential protective equipment, particularly masks and sanitisers. 15 Similarly, mental health issues, including depression, anxiety, panic attacks, psychotic symptoms and even suicide, were reported during the early severe acute respiratory syndrome outbreak. 16 17 COVID-19 is likely posing a similar risk throughout the world. 12

The fear of transmitting the disease or a family member falling ill is a probable mental function of human nature, but at some point the psychological fear of the disease generates more anxiety than the disease itself. Therefore, mental health problems are likely to increase among community residents during an epidemic situation. Considering the relevance of all these factors, we aim to explore the perceptions and attitudes towards COVID-19 among community residents and the impact of these perceptions and attitude on their daily lives and mental well-being.

Methods and analysis

Study design.

This study will employ an exploratory qualitative research design using semistructured interviews and a purposive sampling approach. The data collection methods for this formative research will include indepth interviews (IDIs) with community members. The IDIs aim to explore perceptions of community members towards COVID-19 and its impact on their mental well-being.

Study setting and study participants

The study will be conducted in two communities in Karachi City: Karimabad Federal B Area Block 3 Gulberg Town, and Garden East and Garden West. Karimabad is a neighbourhood in the Karachi Central District of Karachi, Pakistan, situated in the south of Gulberg Town bordering Liaquatabad, Gharibabad and Federal B Area. The population of this neighbourhood is predominantly Ismailis. People living here belong mostly to the middle class to the lower middle class. It is also known for its wholesale market of sports goods and stationery. Garden is an upmarket neighbourhood in the Karachi South District of Karachi, Pakistan, subdivided into two neighbourhoods: Garden East and Garden West. It is the residential area around the Karachi Zoological Gardens; hence, it is popularly known as the ‘Garden’ area. The population of Garden used to be primarily Ismailis and Goan Catholics but has seen an increasing number of Memons, Pashtuns and Baloch. These areas have been selected purposively because the few members of these communities are already known to one of the coinvestigators. The coinvestigator will serve as a gatekeeper for providing entrance to the community for the purpose of this study. Adult community members of different ages and both genders will be interviewed from both sites, as mentioned in table 1 . Interview participants will be selected following the eligibility criteria.

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Study participants for indepth interviews

IDIs with community members

We will conduct IDIs with community members to explore the perceptions and attitudes of community members towards COVID-19 and its effects on their daily lives and mental well-being. IDI participants will be identified via the community WhatsApp group, and will be invited for an interview via a WhatsApp message or email. Consent will be taken over email or WhatsApp before the interview begins, where they will agree that the interview can be audio-recorded and that written notes can be taken. The interviews will be conducted either in Urdu or in English language, and each interview will last around 40–50 min. Study participants will be assured that their information will remain confidential and that no identifying features will be mentioned on the transcript. The major themes will include a general discussion about participants’ knowledge and perceptions about the COVID-19 pandemic, perceptions on safety measures, and perceived challenges in the current situation and its impact on their mental well-being. We anticipate that 24–30 interviews will be conducted, but we will cease interviews once data saturation has been achieved. Data saturation is the point when no new themes emerge from the additional interviews. Data collection will occur concurrently with data analysis to determine data saturation point. The audio recordings will be transcribed by a transcriptionist within 24 hours of the interviews.

An interview guide for IDIs is shown in online supplemental annex 1 .

Supplemental material

Eligibility criteria.

The following are the criteria for inclusion and exclusion of study participants:

Inclusion criteria

Residents of Garden (East and West) and Karimabad Federal B Area of Karachi who have not contracted the disease.

Exclusion criteria

Those who refuse to participate in the study.

Those who have experienced COVID-19 and are undergoing treatment.

Those who are suspected for COVID-19 and have been isolated/quarantined.

Family members of COVID-19-positive cases.

Data collection procedure

A semistructured interview guide has been developed for community members. The initial questions on the guide will help to explore participants’ perceptions and attitudes towards COVID-19. Additional questions on the guide will assess the impact of these perceptions and attitude on the daily lives and mental health and well-being of community residents. All semistructured interviews will be conducted online via Zoom or WhatsApp. Interviews will be scheduled at the participant’s convenient day and time. Interviews are anticipated to begin on 1 December 2020.

Patient and public involvement

No patients were involved.

Data analysis

We will transcribe and translate collected data into English language by listening to the audio recordings in order to conduct a thematic analysis. NVivo V.12 Plus software will be used to import, organise and explore data for analysis. Two independent researchers will read the transcripts at various times to develop familiarity and clarification with the data. We will employ an iterative process which will help us to label data and generate new categories to identify emergent themes. The recorded text will be divided into shortened units and labelled as a ‘code’ without losing the main essence of the research study. Subsequently, codes will be analysed and merged into comparable categories. Lastly, the same categories will be grouped into subthemes and final themes. To ensure inter-rater reliability, two independent investigators will perform the coding, category creation and thematic analyses. Discrepancies between the two investigators will be resolved through consensus meetings to reduce researcher bias.

Ethics and dissemination

Study participants will be asked to provide informed, written consent prior to participation in the study. The informed consent form can be submitted by the participant via WhatsApp or email. Participants who are unable to write their names will be asked to provide a thumbprint to symbolise their consent to participate. Ethical approval for this study has been obtained from the Aga Khan University Ethical Review Committee (2020-4825-10599). The study results will be disseminated to the scientific community and to the research subjects participating in the study. The findings will help us explore the perceptions and attitudes of different community members towards the COVID-19 pandemic and its impact on their daily lives and mental well-being.

The findings of this study will help us to explore the perceptions and attitudes towards the COVID-19 pandemic and its impact on the daily lives and mental well-being of individuals in the community. Besides, an indepth understanding of the needs of the community will be identified, which will help us develop context-specific innovative mental health programmes to support communities in the future. The study will provide insights into how communities are managing their lives under such a difficult situation.

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Supplementary materials

Supplementary data.

This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.

• Data supplement 1

ASF and NAA are joint first authors.

Contributors ASF and NAA conceived the study. ASF, NAA, RF, NA, SNM and SS contributed to the development of the study design and final protocols for sample selection and interviews. ASF and NAA contributed to writing the manuscript. All authors reviewed and approved the final version of the paper.

Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

Competing interests None declared.

Patient consent for publication Not required.

Provenance and peer review Not commissioned; externally peer reviewed

Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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Methodologies for COVID-19 research and data analysis

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Open Access

Peer-reviewed

Research Article

Competing with a pandemic: Trends in research design in a time of Covid-19

Roles Conceptualization, Data curation, Methodology, Supervision, Validation, Writing – original draft, Writing – review & editing

Affiliation Department of Radiation Oncology, University of Southern California, Los Angeles, California, United States of America

Roles Conceptualization, Data curation, Formal analysis, Investigation, Methodology, Visualization, Writing – original draft, Writing – review & editing

* E-mail: [email protected]

Affiliation Division of Nephrology and Hypertension, Department of Medicine, University of Southern California, Los Angeles, California, United States of America

• Shelly X. Bian, 

• Published: September 10, 2020
• https://doi.org/10.1371/journal.pone.0238831
• Reader Comments

Introduction

During the Covid-19 pandemic, major journals have published a significant number of Covid-19 related articles in a short period of time. While this is necessary to combat the worldwide pandemic, it may have trade-offs with respect to publishing research from other disciplines.

To assess differences in published research design before and after the Covid-19 pandemic.

We performed a cross-sectional review of all 322 full-length research studies published between October 1, 2019 and April 30, 2020 in three major medical journals. We compared the number of randomized controlled trials (RCTs) and studies with a control group before and after January 31, 2020, when Covid-19 began garnering international attention.

The number of full-length research studies per issue was not statistically different before and after the Covid-19 pandemic (from 3.7 to 3.5 per issue, p = 0.17). Compared to before January 31, 2020, 0.7 fewer non-Covid-19 studies per issue were published versus after January 31, 2020 (p<0.001), a change that was offset by Covid-19 studies. Among non-Covid-19 studies, 0.9 fewer studies with a control group per issue were published after January 31, 2020, with RCTs contributing to nearly all the decline (p<0.001, p = 0.001, respectively). In the same timeframe, non-Covid-19 studies without a control group and non-Covid-19 studies without randomization experienced relatively small changes that did not meet our threshold for statistical significance (increases of 0.1 and 0.1 per issue, p = 0.80, p = 0.88, respectively).

Limitations

Using a simple heuristic for assessing research design and lack of generalizability to the general medical literature.

Conclusions

In summary, the increase in Covid-19 studies coincided with a decrease of mostly non-Covid-19 RCTs.

Citation: Bian SX, Lin E (2020) Competing with a pandemic: Trends in research design in a time of Covid-19. PLoS ONE 15(9): e0238831. https://doi.org/10.1371/journal.pone.0238831

Editor: Daniele Fanelli, London School of Economics and Political Science, UNITED KINGDOM

Received: June 10, 2020; Accepted: August 25, 2020; Published: September 10, 2020

Copyright: © 2020 Bian, Lin. This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Data Availability: All relevant data are available at DOI 10.17605/OSF.IO/A2HQR .

Funding: This work was supported in part by the National Institutes of Health (NIH) through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): EL receives support from NIDDK K08DK118213. EL also receives support from the University Kidney Research Organization. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Competing interests: The authors have declared that no competing interests exist.

The Covid-19 pandemic has severely disrupted medical research, from shutting down laboratory facilities, to delaying clinical trials, to halting funding [ 1 , 2 ]. Simultaneously, the volume of Covid-19 research has proliferated as experts from all disciplines seek to combat the new threat [ 3 , 4 ]. In the months following the onset of Covid-19, there has been an unprecedented increase in the number of registered clinical trials, preprints, and publications related to Covid-19 [ 5 ].

As of May, 2020, ClinicalTrials.gov listed over 1000 Covid-19 studies. Although some will advance our clinical knowledge, many are small, poorly designed, redundant, and unlikely to prove clinically useful [ 6 ]. Meanwhile the peer review process for Covid-19 studies has accelerated substantially. An analysis of 14 medical journals found a 50% reduction in average turnaround time from submission to publication for Covid-19 related research. This study, however, did not include several of the most influential journals including The Journal of the American Medical Association , The Lancet , and The New England Journal of Medicine [ 7 ]. The proliferation of Covid-19 literature has permeated into non-peer reviewed preprint websites, such as BioRxiv and MedRxiv. As of May 7, MedRxiv and BioRxiv had close to 2800 Covid-19 related articles combined. This has led to several editorials expressing concern over the quality of Covid-19 related research [ 8 , 9 ].

Many people look to most influential medical journals as having the highest standards for publication. The shifting of our research priorities is appropriate and necessary to address the pandemic. However, this diversion may also have unintended consequences on research in other disciplines. To evaluate whether the Covid-19 pandemic had negative effects on published research in other disciplines, we studied characteristics of Covid-19 and non-Covid-19 related research in three of the most cited medical journals: The Journal of the American Medical Association , The Lancet , and The New England Journal of Medicine . Although prior studies have evaluated the proliferation, quality, and design of Covid-19 related publications, none to our knowledge have addressed the pandemic’s effect on the study design of non-Covid-19 medical research. In this cross-sectional study, we investigated whether the design of published non-Covid-19 research changed in three of the highest impact medical journals aimed at a predominantly clinical audience after the onset of the Covid-19 pandemic.

Identifying research studies

We reviewed all full-length research studies published between October 1, 2019 and April 30, 2020 in three of the highest impact medical journals, The New England Journal of Medicine (NEJM) , the Journal of the American Medical Association (JAMA) , and The Lancet . These included “Original Articles” from NEJM (including “Brief Reports” and “Special Reports”), “Original Research” from JAMA (including “Preliminary Communications” and “Special Communications”), and “Research Articles” from The Lancet .

Many Covid-19 studies are case series published as short research studies and letters to the editor. In a sensitivity analysis, we additionally included short research studies published in letter format: “Correspondences” from NEJM and The Lancet and “Research Letters” from JAMA . The Correspondence sections from the NEJM and The Lancet have a broad range and include letters addressing previous articles, primary research, and opinions. From these, we manually identified all letters with a primary data collection effort (including case series and translational research) or secondary analysis of already collected data. We included all of JAMA’s Research Letters. We excluded sections dedicated for case reports (e.g., the “Case Records from the Massachusetts General Hospital in The New England Journal of Medicine ” or “Brief Reports” from JAMA ) but included case reports or case series published as short research studies or letters to the editor. Our publication selection process is outlined in a Prisma flow diagram in Fig 1 .

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https://doi.org/10.1371/journal.pone.0238831.g001

We assigned each study an organ system (S1 Table in S1 Appendix ) and determined whether it was (i) Covid-19 related, (ii) a study with a control group, and (iii) a randomized controlled trial (RCT). We defined Covid-19-related research as having any Covid-19 related words in the title of the article including “Covid-19”, “novel coronavirus”, “2019-nCoV”, “Coronavirus disease 2019”, or SARS-CoV-2”. We defined a control group as whether the investigators performed a hypothesis-driven analysis, comparing two or more groups. Studies describing trends over time were considered uncontrolled unless the investigators tested a specific hypothesis, such as analyzing the putative effect of a policy intervention. Both authors reviewed all studies, adjudicating conflicts by consensus (see S1 Appendix for additional formal designations).

Statistical analyses

We compared study characteristics before and after the end of January 2020, when Covid-19 began garnering international attention. We defined the pre-Covid-19 era as January 31, 2020 and prior, and the post-Covid-19 era as February 1, 2020 and after. We chose this cutoff because the last week of January, 2020 marked the public announcement of the first cases of Covid-19 outside of China. Simultaneously, the World Health Organization (WHO) began warning other countries of the virus’ global spread and the importance of formulating strategic plans for virus containment around this time. Furthermore, the first Covid-19 publication in the three medical journals of interest was published on February 15, 2020 in The Lancet .

We first plotted the number of published Original Research studies, studies that were Covid-19 related, studies with and without a control group, and studies that were RCTs over time. We performed this descriptive analysis by assigning each issue to a given week, anchoring to the Monday of that week. We computed the average number of studies per week before and after the end of January 2020 to visually demonstrate changes in before and after Covid-19.

Subsequently, we assessed per issue differences in study type before and after the end of January 2020. For each of the three journals examined, issues are published weekly with the rare exception of an omitted week. We used the Mann-Whitney-Wilcoxan test to assess whether the average number of Covid-19 related studies, studies with and without a control group, and studies that were RCTs per issue was different before and after January 31, 2020. We performed analyses using the number of studies per issue instead of the proportion of studies per issue because counts reflect the zero-sum nature of publications and provide meaningful information on the volume of studies published. For instance, a large decrease in the total number of published studies might not change the proportion of published RCTs but would likely decrease the number of published RCTs. Because the total number of published studies per issue did not change substantially over time, this distinction was unlikely material to our results.

Our primary focus was on all full-length research studies and on the non-Covid-19 related subgroup of studies. In a sensitivity analyses, we expanded our sample to all research studies including those in letter format.

To assess changes in publication by organ system, we aggregated the total number of full-length research articles into pre-Covid-19 and post-Covid-19 cohorts. We did this because of the scarcity of some organ systems at an issue level. Because the pre-Covid-19 study period had more months, we plotted the percent of published full-length research studies before and after the onset of Covid-19. For each organ system, we compared the significance of the change in proportion before and after Covid-19 using Fisher’s exact test.

We acknowledge that we did not pre-register our study with a predetermined statistical protocol. Additionally, we performed a large number of statistical tests. Therefore, we performed a conservative Bonferroni correction [ 10 ] to adjust the threshold for rejecting the null hypothesis. Because we performed 21 tests in our primary analysis, we required a p-value of 0.0024 when determining whether a difference was statistically significant.

We identified 322 total full-length research studies, 188 before and 134 after the end of January, 2020. The distribution of full-length research articles by journal for each month is detailed in Table 1 .

https://doi.org/10.1371/journal.pone.0238831.t001

The total number of full-length research studies did not statistically differ before and after Covid-19 (from 3.7 to 3.5 per issue, p = 0.17). After January 2020, non-Covid-19 full-length studies decreased by 0.7 per issue on average (p<0.001), which was offset by Covid-19 full-length studies. The total number of full-length studies with a control group decreased by 0.8 per issue on average (p<0.001) and the number of RCTs decreased by 0.9 per issue (p = 0.001). Fig 2 shows changes in full-length articles by week, which usually includes 1 issue from each journal.

Figure includes all full-length research studies in counts per week. A) Covid-19 versus non-Covid-19 studies, B) controlled versus uncontrolled studies, C) RCTs versus non-RCTs. P-values estimated using a two-sample t-test. The gray vertical lines denote January 31, 2020, the boundary between the pre- and post-Covid-19 eras. Solid horizontal lines denote average values of the solid dots and dashed horizontal lines denote average values of the hollow dots.

https://doi.org/10.1371/journal.pone.0238831.g002

Among non-Covid-19 full-length studies, the number of studies with a control group decreased by 0.9 per issue on average with RCTs contributing to nearly all the decline (p<0.001, p = 0.001, respectively). In the same timeframe, non-Covid-19 full-length studies without a control group and non-Covid-19 full-length studies without randomization did not statistically differ (p = 0.80, 0.88, respectively). Fig 3 shows weekly changes in full-length non-Covid-19 articles.

Figure includes all non-Covid-19 full-length research studies in counts per week. A) controlled versus uncontrolled studies B) RCTs versus non-RCTs. P-values estimated using a two-sample t-test. The gray vertical lines denote January 31, 2020, the boundary between the pre- and post-Covid-19 eras. Solid horizontal lines denote average values of the solid dots and dashed horizontal lines denote average values of the hollow dots.

https://doi.org/10.1371/journal.pone.0238831.g003

Cardiology and obstetrics/gynecology had the largest declines in full-length published studies, from 23% to 13% (9% decline, p = 0.04) and from 4% to 0% (4% decline, p = 0.02, respectively. Meanwhile infectious diseases had the largest increase, from 9% to 28% (19% increase, p<0.001) ( Fig 4 , Table 2 ).

P-values were estimated using Fisher’s Exact Test. (an asterisk, *, denotes p < 0.0025). January 31, 2020 is the boundary between the pre- and post-Covid-19 eras.

https://doi.org/10.1371/journal.pone.0238831.g004

https://doi.org/10.1371/journal.pone.0238831.t002

In a sensitivity analysis, we included an additional 104 short research studies (57 pre- and 47 post-Covid-19) typically published in Letter format. The sensitivity analysis included a total of 426 research studies, 425 pre- and 181 post-Covid-19 and was not materially different from our primary analysis.

The total number of studies overall did not statistically differ before and after Covid-19 (from 4.9 to 4.8 per issue, p = 0.95). After January 31, 2020, non-Covid-19 studies decreased by 1.2 per issue on average (p<0.001), which was offset by Covid-19 studies. We observed a decrease in number of studies pre- and post-Covid-19 with a control group of 0.9 per issue on average (p = 0.001), which was almost entirely explained by a decrease in RCTs (p = 0.002). Fig 5 shows weekly changes in all articles.

Figure includes full-length research studies as well as research studies in Letter form in counts per week. A) Covid-19 versus non-Covid-19 studies, B) controlled versus uncontrolled studies, C) RCTs versus non-RCTs. P-values estimated using a two-sample t-test. The gray vertical lines denote January 31, 2020, the boundary between the pre- and post-Covid-19 eras. Solid horizontal lines denote average values of the solid dots and dashed horizontal lines denote average values of the hollow dots.

https://doi.org/10.1371/journal.pone.0238831.g005

Among non-Covid-19 studies, the number of studies with a control group decreased by 0.9 per issue on average with RCTs contributing to nearly all the decline (p<0.001, p = 0.002, respectively). In the same timeframe, non-Covid-19 studies without a control group and non-Covid-19 studies without randomization did not statistically differ (p = 0.27, 0.26, respectively). Fig 6 shows weekly changes in all non-Covid-19 articles.

Figure includes all non-Covid-19 full-length research studies as well as research studies in Letter form. A) controlled versus uncontrolled studies B) RCTs versus non-RCTs. P-values estimated using a two-sample t-test.

https://doi.org/10.1371/journal.pone.0238831.g006

In contrast, none of the Covid-19 studies (20 full-length and 21 in letter format) were RCTs, and only one had a control group. Table 3 shows changes in articles per issue in all articles as well as full-length articles before and after January 31, 2020.

https://doi.org/10.1371/journal.pone.0238831.t003

We found that in three of the highest impact medical journals, the increase in Covid-19-related research studies coincided with a concomitant decrease in non-Covid-related RCTs. Unsurprisingly, most Covid-19 studies published in the first three months of the pandemic comprised case reports and case series. No Covid-19 related RCT’s were published from February 1, to April 30, 2020. We observed a decreasing trend in cardiology and obstetrics/gynecology studies post-Covid-19, though the decrease did not meet our threshold for statistical significance.

Prioritizing Covid-19 research is critical to combating the pandemic [ 1 ]. The medical community needs and expects the quick dissemination of Covid-19 research. However, hasty research may result in suboptimal study designs, though some have argued for the need to balance scientific rigor for speed [ 11 ]. Similarly, Kim et. al. recently argued in the Annals of Internal Medicine has stated that “Given the urgency of the situation, some limitations… may be acceptable, including the small sample size, use of an unvalidated surrogate end point, and lack of randomization or blinding” [ 8 ]. Still, researchers and publishers must use caution. In the last month alone, four high-profile Covid-19 articles have been retracted from the Annals of Internal Medicine , The Lancet , and NEJM due to inadequate scientific rigor [ 12 – 15 ]. We similarly observed a large increase in Covid-19 studies that did not have a control group, mostly case reports and series. As Covid-19 researchers have time to apply more rigorous methods to their studies, RCTs and studies with control groups will undoubtedly become more widespread. In the meantime, researchers and journal editors will need to balance the trade-off between accommodating the rapid dissemination of information with Covid-19 research that do not report a control group.

However, we were concerned to observe substitutions occurring at the expense of non-Covid-19 studies with a control group, with substitutions occurring almost entirely at the expense of RCTs. In comparison, we observed minimal changes among non-Covid-19 studies without a control group. If we project these changes over a course of 6 months (a conservative time frame for the Covid-19 pandemic), non-Covid-19 studies with a control group could decrease by 60 and non-Covid-19 RCTs by 70 in these three medical journals combined. Notably, in the field of obstetrics/gynecology, zero studies were published in the post-Covid-19 era despite constituting 4% of full-length publications prior to the outbreak. The decline in non-Covid-19 publications with a control group and especially RCTs likely has multiple reasons. Publication of already accepted studies may be postponed in lieu of emerging Covid-19 research. Journals in the JAMA Network have received 53% more submissions in the first quarter of 2020 than in the first quarter of 2019 [ 16 ]. The flood of submissions and the demand for Covid-19 related work presents publishers and editors with the dilemma of accepting fewer non-Covid-19 publications, quality notwithstanding.

Reviewers and editors might also perceive non-Covid-19 research as overall less relevant given the pandemic. The WHO, national disease organizations, and media have Covid-19 in the forefront of public health. Since January, 2020, COVID-19 papers have been downloaded more than 150 million times, according to the International Association of Scientific, Technical and Medical Publishers [ 17 ]. Major publications have a responsibility to assess the interest of their readership and adjust their publication profile accordingly. Finally, authors might delay submissions until after the pandemic subsides because of unavoidable disruptions in their research or a perception that non-Covid-19 research is viewed less favorably. Many laboratories and non-Covid-19 clinical trials have closed due to social distancing [ 18 ]. Additionally, resources and priorities may have shifted away from non-Covid-19 research to support Covid-19 studies [ 19 ].

Unfortunately, these rejections and delays contribute to a growing backlog of unpublished non-Covid-19 research, hindering future dissemination. The backlog will likely worsen as non-Covid-19 research resumes with long-term negative consequences to published research [ 9 ]. Disruptions in medical research attributable to Covid-19 could thus mirror public health experts’ concerns about delays in non-Covid-19 medical care [ 20 ].

Limitations of our study include using a simple heuristic for assessing study design (e.g., RCT versus not, controlled versus uncontrolled), not accounting for contemporaneous idiosyncratic events (e.g., vaping), and not observing submitted but unpublished work. Additionally, we did not produce a written protocol and preplanned analysis prior to data collection. We also limited our sample to three select high impact journals, and our results do not necessarily generalize to the entire medical literature. We were unable to estimate changes pre- and post-Covid-19 by organ system with precision, likely owing to small sample size. Finally, we used the 3 months preceding the start of Covid-19 to assess the pre-Covid-19 baseline for the three journals of interest. However this surrogate may not be a suitable counterfactual for these journals in the absence of Covid-19. Thus, our findings should be corroborated in a wider sample of journals and time periods.

Substitutions of non-Covid-19 research are inevitable. To alleviate delays in publication, editors could consider establishing dedicated channels for Covid-19 studies that do not compete with non-Covid-19 studies.

Supporting information

S1 appendix. additional details for “competing with a pandemic: research quality in a time of covid-19”..

https://doi.org/10.1371/journal.pone.0238831.s001

Acknowledgments

We would like to thank Gemma Lin for her review of the manuscript.

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Review article, challenges during review of covid-19 research proposals: experience of faculty of medicine, ain shams university research ethics committee, egypt.

• 1 Faculty of Medicine, Ain Shams University, Cairo, Egypt
• 2 Misr International University, US Naval Medical Research Unit No.3 (NAMRU-3), Cairo, Egypt
• 3 Faculty of Medicine, October 6 University, Giza, Egypt

The COVID-19 pandemic resulted in an overwhelming increase in research studies submitted to research ethics committees (RECs) presenting many ethical challenges. This article aims to report the challenges encountered during review of COVID-19 research and the experience of the Faculty of Medicine, Ain Shams University Research Ethics Committee (FMASU REC). From April 10, 2020, until October 13, 2020, the FMASU REC reviewed 98 COVID-19 research protocols. This article addressed the question of how to face an overwhelming amount of research submitted to the REC while applying the required ethical principles. Ethical challenges included a new accelerated mode of review, online meetings, balance of risks vs. benefits, measures to mitigate risks, co-enrolment in different studies, protection of a vulnerable COVID-19 population, accelerated decisions, online research, how to handle informed consent during the pandemic, and justification of placebo arm.

Introduction

The majority of the RECs in North African countries are registered with the Office for Human Research Protections and have Federal Wide Assurance (FWA) active numbers ( 1 ). Egypt has a National Ethics Committee, active institutional committees and the Egyptian Medical Research Regulation Law for the regulation of clinical trials and human research ethics issued December 2020; the Egyptian National Ethical Committee collaborates with the United Nations Educational, Scientific and Cultural Organization ( 2 ).

The FMASU REC was established in October 2007, to review research conducted at the Faculty of Medicine, Ain Shams University, in Cairo, Egypt. It holds a Federal Wide Assurance Number (FWA 00017585). The committee trained 220 staff members as reviewers working in 32 faculty departments over 23 training events. Since its establishment, the FMASU REC reviewed 414 international and multicentre projects, 5,033 theses, and free research. Since April 10, 2020, the FMASU REC reviewed 98 COVID-19 research studies, Figure 1 .

Figure 1 . FMASU REC Workload from January 1st, 2008 to October 13th, 2020.

During the COVID-19 pandemic in the year 2020, investigators began research to understand the novel virus, its epidemiology and pathogenicity, as well as to find ways for prevention and control, including discovering a treatment and/or vaccine. Worldwide, more than 4,900 studies and trials have been registered on “ Clinicaltrials.gov ” since the start of the pandemic ( 3 ). This rise in the number of emerging COVID-19 research projects has recently resulted in an overwhelming number of research project submissions to RECs.

To ensure ethical research during the COVID-19 pandemic, the World Health Organization (WHO) summarized the key universal ethical standards that should be adhered to by researchers, review bodies, funders, publishers, and manufacturers during a pandemic ( 4 ), identifying the main ethical standards as scientific validity, reasonable risk-benefit ratio, fair and voluntary participation, and independent review ( 5 ).

The European Network of Research Ethics Committees (EUREC) issued a statement that was adopted by the EUREC Board on April 27, 2020, stressing the fact that the administrative processes for reviewing research protocols during the COVID-19 pandemic must be accelerated and simplified if these protocols are related to the treatment, prevention or diagnosis of infections caused by SARS-CoV-2 ( 6 ). However, all research must be guided by the principle that RECs will not compromise the quality of the review process under these extraordinarily stressful circumstances. Furthermore, an accelerated procedure cannot be at the expense of the safety of research participants. The recognized ethical principles must always be respected, and the free and informed consent procedure must remain in accordance with international and national regulations.

In Egypt, there are 115 university hospitals ( 7 ) conducting research on human beings which needs approval from institutional RECs which are either internationally recognized and have an international FWA number and/or are registered with the Ministry of Health and Population (MOHP), or are newly developed and have been submitted for registry with the MOHP. International projects need other final approval from the MOHP REC.

The Clinical Medical Research Regulation Law (the Egyptian law for the conduct of research) was issued on December 23, 2020; its bylaws are currently being written. The Egyptian law is aligned with international guidelines for health research ethics review. The research studies protocols described in this manuscript were submitted during the period April 10 to October 13, 2020, to Ain Shams REC and were reviewed according to the international guidelines.

This article tried to answer the question of how the REC can effectively apply ethical principles when faced with an overwhelming number of research projects submitted.

The aim of this article is to report the challenges encountered and the experience of the FMASU REC during review of COVID-19 research, starting from April 10 to October 13, 2020, and to give an overview about the challenges that the committee faced and how it overcame them.

Modified Standard Operating Procedures

The article tried to illustrate how a governmental university REC in a low-middle income country modified its standard operating procedures (SOPs) to cope with a fast-track review of the overwhelming COVID-19 research and continue reviewing non-COVID-19 research. During the first wave of the pandemic there were no international guidelines for reviewing COVID-19 research. This challenge was increased by a scarcity of information about the disease, governmental lockdown periods, and lack of extra budget allocation.

The FMASU REC was confronted by multiple challenges in reviewing COVID-19 research during the pandemic, necessitating out-of-the box solutions to maintain an effective, accelerated review while at the same time practicing the ethical principles required.

The researchers, as well as the REC members, were encouraged to transform these challenges into opportunities. The SOPs followed by the REC were updated, regarding protocol submission changes to adopt digital submission route, rather than hard-copy paper submissions. Training of the employees on the use of digital technology for submissions and archiving followed. An electronic signature for the head of the committee was introduced. An accelerated, fast-track mode for reviewing protocols was adopted to cope with the pace of the pandemic. While the reviewers had previously been allowed up to 1 month for response for randomized controlled trials (RCTs), they were now expected to respond within one-seven days during the pandemic. The expedited process was meant to help in generating desperately needed knowledge out of the submitted research.

The REC resorted to on-line conferencing to overcome the inability to hold face-to-face meetings due to the Faculty lockdown. The first wave of research was received on April 10, 2020, with seven research projects reviewed in two online meetings over 3 days, including five clinical trials and two observational studies. That new mode of reviewing was dynamic, accelerated, and fast-tracked, in accordance with international guidelines and the REC's updated SOPs.

As the number of submitted research protocols increased rapidly, the REC had to increase the frequency of meetings to every other day, then every week or 2 weeks instead of the previous monthly schedule. Reviewing was done in a shorter time as the institution and investigators were expecting a rapid response. The usual review process that was adhered to by the REC was as follows: all the above minimal-risk protocols were initially reviewed by two reviewers and then discussed in full board meetings. To acquire a faster review track of the COVID-19-related proposals, clinical trials, or repurposed drugs, the number of initial reviewers was increased to three members, then discussed in full board online meetings. The number of members attending the virtual meetings ranged from 9 to 13 members, out of the 15 members comprising the committee.

For this article we reviewed the list of all protocols submitted to FMASU REC for review during the COVID-19 time from April 10, 2020, until October 13, 2020. We listed the titles, principal investigators (PI) names, date of submission and date of response to the investigators. We analyzed the frequencies from these data. We also reviewed the meeting minutes to pin out the most interesting and challenging issues that were discussed during the meetings. Additionally, we reviewed the current procedures and changes that were instituted to the SOPs. Finally, we asked the members to provide their input about their concerns in the review process during the COVID-19 time. Last, we incorporated all the data into the article.

Review Processes

Reviewing research during COVID-19 pandemic lockdown included shortened average duration of review, rapid request for clarifications and reply of investigators and quick provision of decisions. The duration of review was shortened to a minimum of 1 day and a maximum of 7 days. Before the pandemic, for more than minimal risk (low risk studies) and commercially-sponsored studies, the REC adopted a two-reviewer system, followed by discussion by the full Board. During the pandemic, to accomplish a shorter review time, this system was replaced by a three-member review, followed by the online meeting. As for minimal risk studies, the pre-pandemic system was also a two-reviewer, expedited review system, while during the pandemic for COVID-19 protocols, two reviewers were still assigned to review each protocol, but in a shorter reviewing period of 1-7 days.

To overcome the challenges of the short review time, the reviewing process of COVID-19 research stressed the rationale or justification as tackled by many researchers all over the world, the research question, hypothesis, social value, and benefits to the community. The novelty of the research idea was also an important point of discussion during the review process.

“Good science is itself an ethical requirement, as it is meaningless to apply ethical principles to a scientifically flawed product or plan. Bad science can only be bad ethics” ( 8 ). A rigorous revision of the research methodology was conducted, including study design, sample size and type, study procedures, randomization, and blinding. Many studies needed redesigning to specify inclusion and exclusion criteria of subjects, or to rigorously define the diagnosis of mild, moderate, and severe COVID-19 cases according to the National Guidelines reported and updated by the Egyptian MOHP.

Ensuring the well-being of researchers and research participants in the context of a pandemic was a very important objective of the REC. For research participants' well-being, hospital beds and equipment disinfection were under control of the Infection Control Unit, thus conforming to all international guidelines. As for mental health studies (some included healthcare professionals as well as patients), the committee recommended providing medical assistance for those who had high scores (e.g., recommending adding a paragraph in the questionnaire telling participants that if they had high scores for depression, to seek medical consultation). As for researchers, the REC insisted on following international, local governmental, and institutional recommendations. They were supplied with personal protective equipment including surgical, N95 masks, face shields, and goggles.

The REC was rigorous about sample size calculation in the protocol, urging the investigators to have a precise, predefined sample-size calculation, in order to receive REC approval of the study. As a standard procedure, the investigators were required, as a prerequisite before submission to the REC, to refer to the accredited statistics unit at the Department of community medicine in FMASU, to obtain the sample size calculation for any research. While some researchers chose to conduct a pilot study and a convenience sampling because of lack of sufficient data for new or repurposed drugs, the investigators had to provide strong justifications in such instances. The REC required an interim analysis and power calculation, to see if the sample size was large enough, or needed revision to find out if the efficacy of the tested drugs had been reached.

Special Concerns During Review

The balance of risks and benefits is a pivotal element for the protection of human subjects in research. The REC exerted a great effort to mitigate research risks to provide maximum possible protection of research participants. The REC members spent long hours reviewing recent COVID 19-related publications, with special emphasis on adverse events reported involving drugs under trial and drug interactions. Clarifications were required on how to minimize the risks of these side effects, and suggestions were offered to the researchers. For instance, REC recommended additional investigations such as a baseline electrocardiogram, complete blood counts, requested exclusion of high-risk participants, or recommended increased frequency of monitoring visits.

The COVID-19 submitted protocols posted a novel risk-benefit evaluation to the reviewers. For example, in many instances, the REC could not ignore the risk to the researchers who had to interact face-to-face with COVID-19 patients in intensive care units (ICU). The REC had to ensure performance of enrolment and study procedures in unconventional circumstances, such as instances when researchers might not have been allowed in the research setting. The ICU physicians and nurses had to be trained to perform the study procedures. The PI had to keep close contact with the ICU staff and get monitoring reports about the enrolled participants. Whenever possible, the PI could see the patients following the standard safety infection control precautions.

One of the challenges faced by the FMASU REC was the lack of or insufficient animal studies and combining of Phases II and III for testing new drugs. The REC did not encounter Phase I protocols at that time. While the side effects and risks of the proposed therapies were not yet fully studied, Phase II usually includes more patients, and combining Phases II and III usually results in larger sample sizes than Phase II alone.

The REC responded by evaluating the risks and benefits, while maintaining strict requirements for risk minimization. The direct, potential patient benefit was the hope for effectiveness of new drugs, and the indirect benefit was withdrawing drugs from the list of potential drugs if proven non-effective.

The REC faced a big challenge with the large number of protocols, exceeding by far the routine work of the committee. Repurposed drugs, innovative drugs, and vaccines necessitate enormous steps to be approved. During the first 6 months of the pandemic, there was a relatively greater flow of RCTs, Phase III (2/5.85%) and Phase II (15/0.52%), compared to the period before the pandemic. The majority of studies were low risk observational studies (79.86%). Low risk studies are usually reviewed in an expedited manner by two reviewers, but in a shorter reviewing period of 1-7 days. The duration of the initial review was shortened to a minimum of 1 day and a maximum of 7 days compared to a minimum 1-month clinical trial review time, according to the REC SOPs. The total review time in the first rush of protocols during the pandemic was 1 week, but later the total review time was within 1 month, depending on how rapidly the investigators responded to the REC's comments.

The REC members devoted all their time to pandemic work, as most of the submitted protocols, even the non-commercial research, were to find an effective treatment for the emerging COVID-19 disease, either through using a repurposed drug, steroids, or antiviral drugs used earlier in management of Ebola virus, HCV, HIV, or antimalarial drugs. The flow of routine research as multicentre studies between Egyptian research centers, international centers and single center, non-commercial international project submissions, amendments, renewals and theses was slower than before the pandemic, but was reviewed in the same, accelerated manner.

The thesis topics submitted during the early wave of the COVID-19 pandemic were not yet related to the pandemic, but later in 2020 the topics were related to COVID-19.

The refusal rate was minimal; one study was deferred until more information could be obtained, as per the REC reviewers' request. Further details cannot be mentioned in this manuscript for protection of the confidentiality of the research topics.

The most frequent types of research submitted to the REC during the COVID-19 pandemic were observational studies (76.86%) to know the nature of this new emerging disease, followed by Phase III RCTs (5.85%), trying to find the most effective treatment through novel or repurposed drugs, such as drugs previously used in diseases other than COVID-19 such as EBOLA, Hepatitis C Virus, Human Immune Deficiency Virus and malaria Table 1 .

Table 1 . Frequency of clinical trial phases reviewed by FMASU REC from April to October 2020.

The protocols might not have been written as state of the art, as investigators submitted them in an expedited manner. This necessitated more frequent and more rapid than usual communication between the FMASU REC and the investigators. In some instances, the REC required the investigators to provide more information to be able to make informed decisions. The direct communication between the REC members and the investigators was effective in enhancing the quality of the protocols and their scientific validity, in view of the scarce and controversial information concerning COVID-19.

Defining the target population of COVID-19 patients and the vulnerability of this population was another challenge. The investigators had to define their study population with regard to the severity of the disease, the state of consciousness, and addressing what the REC defined as a new vulnerability group; the COVID-19 patients were desperate for treatment and might have agreed to participate in any research project without proper consideration. The protection of moderate and severe cases of COVID-19, as vulnerable groups, was extremely important to the REC. Therefore, the REC insisted that mild and moderate cases give consent for themselves and did not allow a legally-authorized representative to give consent on their behalf.

Allowing enrolment of severe disease cases engendered a wide range of discussion. Although the severe cases were in great need of the benefit of any drug at a time when no proven cure was available, the opposing committee members were hesitant to allow severely ill cases to be enrolled in the studies, if the investigators could not provide enough preliminary evidence of a potential direct benefit. Some investigators requested that in severe cases, the ICU manager might sign the consent on behalf of the subjects, but the REC refused this idea and insisted that the patient be conscious enough to give his or her own consent. Otherwise, the investigators would have to obtain the legal guardian's consent outside the isolation hospital due to rules on who was allowed in an isolation hospital.

Reviewing Telemedicine Studies

The review process had previously been accomplished through hard copies and online communication, as per the preference of the involved REC reviewers. During the pandemic, the shift to electronic communication became mandatory among researchers, the REC administrative office, the REC board, and the reviewers. The institution administration, as well, supported this shift and provided online meeting platforms in support of the digital transformation.

The COVID-19 pandemic resulted in greater use of online surveys and telemedicine. Telemedicine for clinical care started in 2016 at the Faculty of Medicine, Ain Shams University in the Neurology Department to help communication with patients being seen in clinical practice and was later extended to include other departments. To counteract the effects of the lockdown due to COVID-19, FMASU offers different telemedicine services, including consultation and outpatient clinics. Seven departments offer these services: Family Medicine, Clinical Oncology, Internal Medicine, Psychiatry, Paediatrics, Geriatrics and Obstetrics and Gynaecology. Services are offered through a secure link, where data, images and laboratory results can be uploaded and stored in the patient's medical record. The REC received this new type of telemedicine research as another challenge, Table 2 . The use of online surveys to study the behavioral and psychiatric well-being of the community by different age groups, different study populations and in different places, was a new type of research for the REC to review, constituting 13% of the submitted COVID-19 research at that time and the second most frequent type of studies to be reviewed after therapeutic research (18%). The lack of experience in reviewing this type of research was challenging. Breeching of confidentiality and assurance were the major concerns. Additionally, telemedicine services are not common in developing countries like Egypt due to high illiteracy rate, 24.6% in July 2019 as announced by the Central Agency for Public Mobilization and Statistics ( 9 ). While the REC tried to ensure optimization of the research protocol and data collection and follow up, the REC experienced difficulties in interpretation of the PIs or physicians' instructions and data collection by phone. However, the REC also requested that the patient have an educated relative beside him to ensure proper comprehension of the instructions of the PI and for easier communication.

Table 2 . Most common COVID-19 research topics reviewed by FMASU REC from April to October 2020.

Ain Shams University includes eight hospitals and several health centers. The total number of beds affiliated with the university is 2,300. Research is allowed in all hospitals and health centers except the specialized hospitals (the Specialized Hospital on within the FMASU campus and the Obour Specialized Hospital in Obour city).

During the first wave of the pandemic from February to October 2020, two main hospitals were transformed into isolation hospitals for moderate and severe adult cases, Obour Specialized Hospital, and the Geriatric Hospital; one new hospital was established, Al Maidany Hospital. Ain Shams student dorms were transformed into hospitals to receive moderate COVID-19 cases. The Internal Medicine and Surgery Departments were allocated for adult COVID-19 cases and the Paediatric Department for pediatric COVID-19 cases. The rest of the hospitals offered the same services as usual, except that every patient being admitted was instructed to do a Polymerase Chain Reaction (PCR) test before admission. If the PCR was positive, the patient would be transferred to Obour Specialized Isolation Hospital.

Ain Shams University designated some of its hospitals and ICUs as “Isolation Hospitals” for the management of COVID-19 patients, which became the target for many, if not all, of the COVID-19 research studies. In view of the overwhelming number of research protocols, more than one research protocol targeted the same population in the same isolation hospital or ICU. In a few instances, the same PI was involved in more than one study. While there are no regulations against this, the REC was concerned about the involvement of the same patient in more than one study. The FMASU REC did not allow enrolment of subjects in more than one ongoing clinical trial. This decision conflicts with Cinnella and Gertner who reported that co-enrolment does not affect the safety of patients, the study outcome, or side effects, provided that the inclusion and exclusion criteria are appropriately set ( 10 , 11 ).

Before COVID-19, the REC stressed on selecting the appropriate control groups for the study, especially regarding how healthy controls were selected. For the COVID-19 protocols the controls were usually sick patients, hence risk mitigation was the major issue. During review of COVID-19 protocols, the REC noticed that several RCTs control groups did not receive interventional medication and had similar characteristics and inclusion criteria, e.g., the severity of the disease. To decrease the number of subjects included in the studies, the REC suggested the use of the same set of controls, whenever applicable and possible, in more than one study. This meant that the subjects were enrolled only once, and their data was shared with other investigators performing their studies at the same time in the same place. The intervention arm, however, included different subjects, receiving different medications according to the trial they were enrolled in. The committee also required the intervention group to control group ratio to be 1:1, and not more, in order to avoid enrolment of more subjects than required in the RCTs.

In many clinical trials placebo control arm is recommended, especially where the effect of the drug is still not well-documented, or as obvious as in cancer research where a drug causes shrinkage of the tumor ( 12 ). For the placebo-controlled trials, the REC decided that all participants must receive the updated standard of care treatment as per the Egyptian MOHP protocol for COVID-19 patients, while the participants receive the new drug under trial as add-on therapy. This way the clinical trial design was an add-on design, where the controls received the standard care MOHP protocol, rather than receiving a sham medication. The REC thought that this could minimize the risk, although the standard protocols at the start of the pandemic had no clear evidence of benefit.

The inclusion of the Egyptian MOHP COVID-19 management protocol was a challenge to the investigators, as the treatment protocol was constantly updated according to new information arising in that arena. The FMASU REC recommended that the standard of care set by the Egyptian MOHP always be updated in the submitted protocols and provided to all COVID-19 study participants.

Regarding the clinical trial endpoints, the FMASU REC had lengthy discussions on the use of measurable achievement vs. patient-related outcomes in the pandemic research. Several protocols used “the time to clinical improvement” as the measure for outcome. Clinical improvement in some studies was defined as the time from randomization to either an improvement of two points on a six or eight-category ordinal scale. Some members of the committee considered the scale as very subjective and required the use of more objective or measurable outcomes. The FMASU REC resorted to the time to clinical improvement scale, in addition to the patient-related outcome scales, the investigators should use more objective outcome measures in their studies, such as persistent positive PCR tests after treatment, or time until the emergence of antibodies against the novel virus. The use of objective tests as outcomes would be a dynamic process as new information is published.

Ensuring the provision of a clear informed consent form was a big challenge for the committee, and certainly for the investigators as well. The motivational force behind the willingness of the patients to enroll in the clinical trials is complex, and therapeutic misconception had to be clearly avoided in the consent language. Due to the scarcity of available information about the virus and the use of novel drugs, the committee ensured that the investigators simplify the information provided to the participants in a manner that the participants could comprehend, as there were so many unknown facts about the virus. The committee understood how challenging it was to describe and explain unknown risks to the potential participants. Still, the FMASU REC required the explanation of risks to be clear and in a language the participants could understand. Furthermore, the prospect of direct benefits was in no way to be promised or overestimated. The FMASU REC members conducted a meticulous review of the wording of the informed consent to ensure the message was clearly communicated to the potential participants and their guardians, regarding the lack of scientific evidence of the efficacy of the used drugs, as well as the unknown side effects, while still providing convincing rationale for the performance of the study.

Additional minor concerns in some of the studies included the completion of a diary for drug doses to be completed by the patients. The FMASU REC was concerned about how a severely ill participant would record his/her daily doses of drugs under trial, especially for the non-educated participants. The FMASU REC requested that this be confined to moderate or highly educated cases only.

The FMASU REC requested the timely reporting of all adverse events as soon as they occurred, not only the serious ones as per the standard procedures which assign a medical monitor in all COVID-19 clinical trials. The medical monitor should be a medical doctor, not involved in the study, but who observes the progress of the study and provides reports to the FMASU REC in case of adverse events. In studies assessing psychological risks to healthcare workers, the FMASU REC requested that participants who tested positive on screening, receive free management and referral to receive psychiatric help if proven to be suffering from anxiety or depression.

Common modifications and clarifications requested by the FMASU REC were the inclusion criteria and the age range of the recruited subjects. Enrolment of subjects not receiving other medicines under trial was a challenge during review. Detailed data of the study procedures were requested in many submitted research studies. More frequent progress reports were requested.

To mitigate risks, more frequent electrocardiograms, complete blood counts, x-rays, and chest Computed Tomographies were requested to safeguard against serious adverse events of the drugs under investigation, such as Hydroxychloroquine and other repurposed drugs. Regarding the control groups in the RCTs, the REC recommended that controls obtain the standard MOHP protocol for COVID-19 management. The REC requested monthly progress reports and swift notification of serious adverse events.

The innovative approaches adopted by the REC in the earlier wave of the COVID-19 pandemic were acceleration of submission of pre-requisite paperwork needed for application, increased frequency of virtual meetings, expansion of meeting agendas, direct contact with the PIs by phone and fast-track review within 1-7 days (compared to the usual 1-month review of clinical trials according to the SOPs.

FMASU REC experience, being active for 13 years since 2007 would be beneficial for other Egyptian RECs, numbering approximately 85 committees in 2021 with variable experience. Seventy Egyptian RECS are linked through a non-governmental body named the Egyptian Network of Research Ethics Committees (also known as ENREC), established in 2008, that enhances REC networking, standardizing the SOPs among RECs all over Egypt, the exchange of knowledge of research review challenges and obstacles, as well as finding solutions through regular annual meetings ( 13 ). Thirty-five RECs are registered with the MOHP.

Data confidentiality is fundamental in both COVID-19 and non-COVID-19 research to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of research subjects. It has been practiced since the establishment of the committee according to the Declaration of Helsinki ( 14 ).

During the review of COVID-19 research, the REC was more diligent in reviewing the parts of the protocol where the investigators detailed the precautions for data confidentiality, including databases and computer files, as well as paper copies of questionnaires and informed consents. REC members followed the REC review checklist to review the protocols with confidentiality adequately listed in the checklist. Digital tracking technologies were not allowed, so there were no concerns regarding generated data confidentiality.

Some of the strengths of this analysis at the organizational level were REC resilience and at the research level, the researchers continued conduct of research in spite of the discussed challenges in order to generate knowledge for this new disease and to accomplish investigator career progress. Regarding the research participants: COVID-19 investigation results, including PCR, lab and radiology and all medications given to research participants were provided free of charge. Participants were offered the autonomy to participate in research under strict REC oversight during that period, which was characterized by little and misinformation. Regarding inclusiveness and diversity, participants included healthcare professionals, literate and illiterate patients, and the elderly without discrimination in research enrolment while maintaining equity of healthcare.

Our research prioritization during the COVID-19 pandemic is in line with that of Kheng-Wei Yeoh and Ketan Shah, who provided recommendations for RECs on research prioritization and fast-tracking research, without compromising the participants' safety and well-being. Priority should be given to research that helps find a cure for the patients, while other research should be re-evaluated for public health concerns and precautions incorporated into the studies. As for the design, the authors recommend incorporating the study design into clinical care and look for new information due to the increased demand ( 15 ).

The Pan American Health Organization (PAHO), website on April 15, 2020 published guidance for the development of SOPs for RECs for the review of research during the COVID-19 pandemic. In addition to the revised SOPs, the PAHO recommended that RECs should accelerate reviews and initiate a system for follow up on COVID-19 research ( 16 ).

Due to confidentiality issues, the authors provided minimal details about the studies. We would have liked to expand on the types of research, but many of the studies included new drugs about which we could not provide details. Another limitation is that this article's scope is limited to the performance of the REC and the challenges it faced, rather than a predesigned research study or survey.

During the COVID-19 pandemic the FMASU REC was overwhelmed with a huge number of COVID-19 -related research protocols. The increased amount of research protocols to be reviewed in a short time presented several logistic and ethical challenges. The committee had to adopt different methods of review to ensure adherence to the ethical principles. The ethics training background of the members proved beneficial to balance the risks and benefits to the patients among novel ethical dilemmas.

Author Contributions

All authors listed have made a substantial, direct and intellectual contribution to the work, and approved it for publication.

This study was self-funded by the authors, who have not received any monetary or financial support for the writing and publishing.

Conflict of Interest

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Publisher's Note

All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.

Acknowledgments

The authors would like to acknowledge the efforts of all the FMASU REC members and office staff during the first wave of the COVID-19 pandemic and FMASU administration's support.

Abbreviations

RECs, Research ethics committees; EUREC, European Network of Research Ethics Committees; FMASU REC, Faculty of Medicine, Ain Shams University Research Ethics Committee; ICU, Intensive care units; MOHP, Ministry of Health and Population; PAHO, Pan American Health Organization; PCR, Polymerase Chain Reaction; PI, Principal investigator; RCTs, Randomized controlled trials; SOPs, Standard operating procedures; WHO, World Health Organization.

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Keywords: research ethics committees, Faculty of Medicine Ain Shams University, COVID-19 research, ethical challenges, accelerated review

Citation: Marzouk D, Sharawy I, Nakhla I, El Hodhod M, Gadallah H, El-Shalakany A, Elwakil R, Moussa MM, Ismail A and Tash FM (2021) Challenges During Review of COVID-19 Research Proposals: Experience of Faculty of Medicine, Ain Shams University Research Ethics Committee, Egypt. Front. Med. 8:715796. doi: 10.3389/fmed.2021.715796

Received: 27 May 2021; Accepted: 29 September 2021; Published: 02 November 2021.

Reviewed by:

Copyright © 2021 Marzouk, Sharawy, Nakhla, El Hodhod, Gadallah, El-Shalakany, Elwakil, Moussa, Ismail and Tash. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY) . The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

*Correspondence: Diaa Marzouk, diaamarzouk@med.asu.edu.eg

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• Published: 04 April 2024

Compromised values: a comparative response during the COVID-19 crisis by ethical vegans and vegetarians

• Estela M. Díaz 1 ,
• Núria Almiron 2 &
• Olatz Aranceta-Reboredo 2  

Humanities and Social Sciences Communications volume  11 , Article number:  485 ( 2024 ) Cite this article

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• Cultural and media studies

Animal advocacy is a complex phenomenon. As a social movement encompassing diverse moral stances and lifestyle choices, veganism and vegetarianism (veg*) are at its core, and animal testing raises as a notably contentious issue within its members. This paper addresses this critical topic. Employing data from an international quantitative survey conducted between June and July 2021, our research explores how ethical vegans and vegetarians responded during the COVID-19 crisis. By comparing the experiences and choices between the two groups, we aimed to understand the variances in attitudes and behaviors in the face of an ethical dilemma, highlighting the interplay between personal beliefs and social pressures in times of a health crisis. Our findings reveal stark contrasts in how vegans and vegetarians navigated the pandemic; vegans displayed less conformity yet experienced a significant compromise of their ethical values, particularly in their overwhelming acceptance of vaccination. This study enhances the field of veg* research and social movement studies by exploring how a social crisis shapes members’ behaviors and perspectives. Our findings also contribute to a better understanding of the challenges and prejudices that a minority group such as vegans may face and how they cope with the pressure to go against the mainstream at a time when society is polarized by a single discourse that goes against their moral values.

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Introduction

The enduring concern of animal experimentation sits at the heart of the animal defense movement, propelled by the humanitarian ethos established in the 19th century and the principles of anti-speciesism that emerged in the 20th century. At the same time, within the spectrum of animal advocacy, animal testing is one of the most contentious issues due to the scarcity of viable non-animal alternatives for drug testing and the broad spectrum of stances within the movement. These range from advocating for the outright abolition of animal testing to endorsing its restricted use under specific circumstances (Díaz, 2016 ; Newton, 2013 ). Animal testing intersects with a deeply personal and critical issue: human health.

The COVID-19 crisis, with its heavy reliance on preventive pharmacological interventions developed through animal testing, posed a profound ethical conundrum for animal advocates. Confronted with this unprecedented challenge, we conducted an exploratory study investigating how animal advocates navigated this situation. To capture and picture their perspectives during the COVID-19 2020–2021 period, we conducted an international quantitative study of self-identified vegans and vegetarians (hereafter also referred to as veg*), focusing primarily on their reactions to the mass vaccination drive—the only pharmacological measure against the crisis. We chose these two groups because of the inherent challenge of engaging with a diverse, dynamic, and evolving community. This choice aimed to encompass a breadth of animal advocates whose ethical stances might have been tested by the crisis. Moreover, contrasting these two communities provided a valuable comparative analysis, shedding light on the intricacies within the current animal defense movement.

Since the development of COVID-19 vaccines required animal testing by law, it left no compassionate alternatives that respected the interests of animals (Pruski, 2021 ). Simultaneously, massive media coverage following authorities and governmental organizations was deployed on the situation and measures (Krawczyk et al., 2021 ). In this context, it was reasonable to think that members of the veg* community, especially vegans, were at an ethical crossroads for facing the potential moral dilemma of choosing between safeguarding animals and protecting humanity.

This study offers a nuanced exploration of the moral quandaries confronted by the vegan and vegetarian community during a worldwide health crisis. Moreover, it illuminates the broader question of moral decision-making within groups whose values deviate from the mainstream, revealing the intricate interplay among personal convictions, societal pressures, and ethical considerations in times of unparalleled challenge.

Before presenting our findings, we will first delineate the distinctions between vegetarianism and veganism, focusing mainly on their stances regarding animal testing, describing the role of animal experimentation in the COVID-19 solution, and the social and media pressure during the period. Subsequently, we elaborate on our methodological approach. The article concludes with a discussion of our findings, exploring the broader implications of the COVID-19 crisis for the vegetarian and vegan communities.

Vegetarian and vegan views on animal testing

Contemporary vegetarianism has served as an umbrella term encompassing a variety of philosophical stances and dietary practices, each delineating varying degrees of animal product exclusion. This broad category encompasses those who identify as vegetarians yet engage in occasional meat consumption, as well as pescatarians and diverse classifications of ovo-lacto-vegetarians (Beardsworth and Keil, 1991 ; Beardsworth and Bryman, 1999 ; Jabs et al., 2000 ; Janda and Trocchia, 2001 ). However, the most holistic form of vegetarianism is “veganism,” sometimes referred to as authentic or proper vegetarianism (Willetts, 1997 , p. 117) or strict vegetarianism (Rothgerber, 2014a ). Introduced in 1944, the term veganism was initially intended to be distinguished from vegetarianism to cover a broader ethical philosophy that advocates living without harming, exploiting, or using nonhuman animals in any way (Díaz and Horta, 2020 ; The Vegan Society, 2022 ).

The literature has often confused vegetarianism with veganism without distinguishing between these distinct philosophies and lifestyles. However, their distinct identity is now increasingly recognized and supported by both theoretical and empirical research, highlighting the need for nuanced investigation of these separate phenomena (Kalof et al., 1999 ; Knight et al., 2004 ; Meng, 2009 ; Okamoto, 2001 ; Pribis et al., 2010 ; Povey et al., 2001 ; Rothgerber, 2014a ). In addition, previous studies have highlighted the importance of paying attention to the underlying motivations that drive individuals towards these choices when studying veg* communities.

Both vegetarianism and veganism can be adopted for a variety of reasons. Traditionally, vegetarianism has been associated with health and personal well-being, and contemporary research supports that health remains one of the main reasons for its adoption (Fox and Ward, 2008 ; Hargreaves et al., 2021 ; Hopwood et al., 2020 ; Salehi et al., 2023 ). As for veganism, although a significant and growing number of people are adopting vegan dietary practices because of health benefits and, to a lesser extent, environmental concerns (Giraud, 2021 ; Janssen et al., 2016 ; Oliver, 2023 ; Peggs, 2020 ), its origin and practice are deeply rooted in animal rights and anti-speciesism movements (e.g., Díaz and Horta, 2020 ; Ploll and Stern, 2020 ). These fundamental tenets of “ethical veganism” bring animal advocacy to the forefront (BBC, 2020 ; Diaz, 2016 , 2017a , 2017b ; Panizza, 2020 ; Ruby, 2012 ) and have given way to what is now also known as “political veganism,” a stance that actively challenges “the routine harms created by social structures and systems […]; and which is conceived as a form of collective activism” (Cochrane and Cojocaru, 2022 , p. 60; Kalte, 2020 ). It is also argued that veganism aligns with social justice principles, often associated with progressive or left-wing ideologies (Díaz, 2012 , 2018 ; Dickstein et al., 2022 ). In the literature, it is crucial to distinguish between “ethical” vegetarians and vegans—who prioritize animal welfare and animal rights—and other figures, such as the “health conscious”, who are primarily guided by personal health benefits (Rozin et al., 1997 ).

Agreeing on definitive descriptions for veganism and vegetarianism presents its challenges. Despite this, it is widely acknowledged that both communities are united by shared moral values; most notably, a concern for animal welfare that varies in degree (Lund et al., 2016 ). These shared values have faced challenges, particularly when intersecting with health concerns, as seen during the Covid-19 crisis. The comparative analysis of the vegan and vegetarian communities enhances our understanding of the animal advocacy movement. This comparison becomes especially crucial in the context of animal experimentation, illuminating the process of moral decision-making in situations that test people’s foundational values. While vegetarians may have diverse views on animal experimentation, it is not a defining characteristic of the vegetarian ethic as defined by the Vegetarian Society ( https://vegsoc.org/lifestyle/ ). Vegetarians tend to adopt a “usoanimalistic” approach, focusing primarily on dietary choices (Díaz, 2017b ). In contrast, veganism encompasses a broader ethical commitment that goes beyond dietary choices and rejects all forms of animal use—including in products and services—with animal testing being a defining concern within vegan ethics (The Vegan Society, 2022 ; Díaz, 2017b ).

Animal experimentation is a very sensitive and controversial issue in society in general and, especially, in the veg* community Footnote 1 (Greenebaum, 2012 ; Pruski, 2021 ). There is a lack of literature comparing vegans and vegetarians in terms of their concerns about animal testing, but some research has already suggested a significant difference. For instance, vegans surveyed by Ploll and Stern ( 2020 , p. 3259) self-reported a statistically higher level of animal-friendly behavior than vegetarians (and all other respondents) about animal testing and animal-based ingredients in their consumption of cosmetics. On the other hand, Miguel ( 2021 ) has shown that the UK Vegan Society’s labeling is stricter for products tested on animals than for food, confirming the differential nature of veganism in this respect.

Other empirical studies have provided evidence to support notable discrepancies between vegans and vegetarians that may impact how they perceive animal experimentation. For instance, research indicates that vegans harbor more favorable attitudes towards animals, perceive a more significant similarity between humans and other species, and attribute a broader range of emotional and cognitive capacities to nonhuman animals compared to vegetarians (e.g., Filippi et al., 2010 ; Rothgerber, 2014a ). Furthermore, vegans tend to express stronger condemnation of animal killing and experience higher guilt associated with such practices when juxtaposed with vegetarians (Ruby and Heine, 2011 ). Regarding emotional responses, vegans show elevated levels of disgust and sensitivity towards the consumption of animals, along with greater empathy for animal suffering (Rothgerber, 2014b ; Rothgerber, 2015 ). Lastly, veganism is usually associated with a greater emphasis on nonhuman animal advocacy (Hoffman et al., 2013 ; Piazza et al., 2015 ).

Animal experimentation and discrimination in COVID-19

More than 192.1 million nonhuman animals are used in research worldwide every year on average, according to estimations (“Facts and Figures on Animal Testing”, n.d. ). However, the exact number is unknown due to the lack of transparency by both regulators and experimenters. Mice, rats, and other rodents are used the most, yet many other species—such as cats, dogs, horses, birds, pigs, fishes, sheeps Footnote 2 , goats, reptiles, and nonhuman primates—are also used in experiments devised by scientists and approved by public and private scientific committees under strict rules of confidentiality. In these experiments, nonhumans are used in several types of research. Among the most common are basic research (e.g., genetics, developmental biology, behavioral studies), applied research (e.g., biomedical research, xenotransplantation), drug and toxicology testing, education research (mainly at universities), breeding research (genetic selection), and defense research (by governments and the military). Details of the practices to which they are subjected (e.g., smoke inhalation, ingestion of chemicals, infection with disease, brain damage) are often kept secret from the public, who are increasingly sensitive to cruelty to animals. However, occasionally, information about research involving animals that humans are fonder of—such as dogs and cats—and leaks of malpractice reach the media (e.g., Kassam and Grover, 2021 ).

At least since Ancient Greece, animal research has been used for scientific and medical purposes (Guerrini, 2022 ). However, controversy about the efficacy of animals as research models for human medicine is high at present, with strong evidence showing very poor results from the animal model due to methodological, scientific, and technical problems (Akhtar, 2012a , 2012b , 2015 ; Herrmann and Jayne, 2019 ; Knight, 2011 ; Leyton, 2019 ) Footnote 3 . Despite this, animal experimentation is currently compulsory worldwide by law or de facto for drugs and toxicology, being authorized by regulators before any human test is conducted and launched into the market (Knight, 2011 ; Leyton, 2019 ) Footnote 4 .

Animal testing has particularly been a critical component of vaccine development. Since Jenner, at the end of the 18th century, animals have been used as potential models for human infectious diseases (Gerdts et al., 2007 ). Mainly since Pasteur, during the 19th century, animal pathogens have been used attenuated or as vectors in vaccines, and researchers have been experimenting with the transmission of different pathogens to different animal species and between individuals of different animal species. In addition, most vaccines have been developed using small animals like rodents as test subjects—so-called “‘models” by the industry, animals that the industry makes sick to test drugs on them. However, studying and testing on larger animals, including calves, horses, sheep, pigs, guinea pigs, and nonhuman primates, has also become common. Sometimes, their body parts or body fluids are used for scientific purposes. For instance, for the last 70 years, the most common way of manufacturing flu vaccines has used hens’ eggs (“How Flu Vaccines are Made”, n.a. ).

The technology most used for COVID-19 inoculations (messenger RNA-based, or mRNA) does not use attenuated pathogens anymore, but animal experimentation has also played an important role in these drugs. The mRNA technology has been researched in laboratories since at least 1990, including nonhuman animals in the different stages of research (Pardi et al., 2018 ). Scientists also conducted specific animal tests with, at least mice and nonhuman primates in the preclinical phase of the specific preparations marketed for COVID-19 (NIAID Now, 2021 ). Therefore, even if the animal trials for the COVID-19 mRNA vaccines were faster than usual (because there were no long-term studies) and thus fewer animals were used for shorter periods, these drugs still involved the testing and killing of a considerable number of small and large animals over more than two decades.

Some authors point out that this crisis has brought some (apparently) positive results for animals; for example, the increase in the number of “companion animal” guardians, mainly to alleviate social isolation measures during this crisis (with some associated market booms) (see on this van Wyk, 2022 ). However, the period has also brought an escalation of prejudice, neglect, abuse, and the killing of animals, along with an increase in speciesism, which undoubtedly challenges vegan values. For instance, the COVID-19 crisis involved the mistreatment of animals in ways other than experimentation that are likely to concern vegans and animal rights advocates; amongst the most important is the augmented prejudice raised against some free-living animals (Bittel, 2020 ), “companion” animals (Zhang et al., 2020 ; Berry, 2020 ; Feng, 2021 ), captive animals (Haworth, 2020 ), or farmed animals (Kesslen, 2020 ).

Veg* philosophies and lifestyles are increasingly common in Western societies, but people who embrace them remain a source of stigma (Rosenfeld and Tomiyama, 2020 ; Vandermoere et al., 2019 ). As MacInnis and Hodson ( 2017 ) point out, it is paradoxical that vegetarians and vegans become the subject target of bias or prejudice even though they do less harm to animals and the environment. Veg* individuals are seen as “symbolic threats”, understood as “intangible threats to an ingroup’s beliefs, values, attitudes, or moral standards” (p. 724). Furthermore, research on perceptions of the veg* community by the non-veg* community shows that vegans experience more prejudice and discrimination than vegetarians (MacInnis and Hodson, 2017 ; Judge and Wilson, 2019 ). The media often contributes to exacerbating this view. For example, Cole and Morgan ( 2011 ), who studied the representation of veganism in UK newspapers, found that veganism was portrayed as “contrary to common sense” because it fell outside the dominant discourses on animal exploitation. Not only did the newspapers tend to discredit veganism, but vegans were also stereotyped as “ascetics, faddists, sentimentalists, or in some cases, hostile extremists” (p. 134). The authors refer to this pejorative discourse as “vegaphobia”: a cultural reproduction of speciesism that helps mask and perpetuate the exploitation of nonhuman animals while marginalizing veganism and vegans (Cole, 2015 ). From a philosophical stance, Horta ( 2018 ) has also labeled the bias against vegans as an unjustified “second-order discrimination, that is, discrimination against those who oppose another (first-order) form of discrimination” (p. 1).

This backdrop of misunderstanding and hostility towards the veg* individuals set the stage for the challenges presented during the COVID-19 crisis. General vaccination coverage varied widely from 62% to 82% (proportion of people with a complete initial protocol) (Our World in Data, n.d. ). However, specific data on vegan vaccination rates—globally or by country—is notably absent, which leaves a gap in our understanding of how this community navigated the pandemic’s unique ethical landscape. During our studied 2020–2021 period, the moral dilemma posed by animal-tested COVID-19 vaccines framed the veg* community within a complex media narrative by subjecting their choices to intense scrutiny within broader public health discourse and highlighting an ethical quandary more acute for vegans than for vegetarians. Vegans are often depicted as grappling with the moral implications of receiving vaccines tested on animals. They are frequently mentioned in this context and sometimes portrayed in a pejorative light, with descriptors such as “dogmatic,” “ultra-pedantic,” and “no different than a blindly partisan Trump follower who would rather harm their country than lose a political fight” (Catalunya Press, 2021 ; Bramble, 2021 ; Herzog, 2022 ; Sun, 2021 ).

Nevertheless, public discourse from vegans primarily reflects a neutral or pro-vaccination stance (Sainz, 2021 ; De la Paz, 2021 ; Turner, 2021 ). Influential figures within the vegan community have promoted vaccination, often sharing their own vaccination experiences on social media (Nelson, 2022 ) and participating in advocacy campaigns (Esselstyn Family Foundation, 2021 ). At the same time, many dissenting opinions received no media coverage, as in the case of the summit of critical vegans discussing vaccination (Worldwide Vegan Summit for Truth and Freedom, 2022 ), whereas individual vegans supporting vaccination (Francione, 2020 ; Singer, 2021 ) were given visibility in the media worldwide. For instance, Singer ( 2021 ) did not refer to the cost of the vaccine to animals and asserted that the COVID-19 vaccine should be mandatory. In this context, some vegetarians requested vegans to make an exception and avoid “extremism” (e.g., Bramble, 2021 ; Davis, 2021 ; Enerio, 2021 ; Sun, 2021 ). This public pressure on vegans was intensified with the publicized statements of key vegan organizations, such as PETA (Sachkova, 2021 ), Animal Aid (“COVID-19 Vaccines and Veganism”, 2021 ), and The Vegan Society (“Vegan Society response to COVID-19 vaccine”, 2020 ); PETA explicitly recommended vegans to get vaccinated to preserve the health of others and their own health to continue defending animals, and the same idea is evident in the Vegan Society’s official statement on the COVID-19 vaccine.

This context provides fertile ground for academic inquiry. As far as the authors know, only a few studies on veganism and COVID-19 have been published to date. Most of these studies have focused on examining consumption trends and perceptions of veganism (Loh et al., 2021 ; Park and Kim, 2022 ; You, 2020 ; Tumanyan, 2021 ) or vegan food and products (Dinh and Siegfried, 2023 ; Lee and Kwon, 2022 ). On the other hand, Pruski ( 2021 ), a clinical scientist, recalls the legitimate safety and conscience concerns about vaccination and cites vegans as an example of a morally committed community that does not agree with animal testing. However, none of these studies specifically address attitudes, experiences, and opinions or focus on animal testing. Similarly, none of these studies examine possible differences between vegans and vegetarians about vaccination and other measures taken during the COVID-19 crisis.

The current study

This study delves into the intricate moral conundrum ethical vegans and ethical vegetarians (hereafter, vegans and vegetarians) faced during the COVID-19 crisis. By comparing the experiences and choices between the two groups, we aim to understand the variances in attitudes and behaviors in the face of a global ethical dilemma, highlighting the interplay between personal beliefs and social pressures in times of a health crisis. Specifically, the study focuses on analyzing possible differences between self-proclaimed vegans and vegetarians on (1) attitudes and behavior towards vaccination; (2) attitudes towards COVID-19 Certificate, also known as “the Green Certificate” or “the Green Passport”, as proof of vaccination to facilitate free movement between countries; (3) the level of trust towards different groups about decisions made regarding COVID-19; (4) the sources of information used to learn about COVID-19; (5) the perceived level of censorship of information about COVID-19; and (6) the level of stress encountered during 2020 and 2021. In addition, we studied the extent to which being vegan or vegetarian, and the factors mentioned above affected the uptake of the COVID-19 vaccine.

Our starting point was that vegans and vegetarians might exhibit different attitudes and behaviors toward various COVID-19-related issues based on distinctions identified in existing literature. Particularly concerning COVID-19 vaccination, which involved animal testing, we hypothesized a significant divergence in acceptance rates between vegans and vegetarians, with the former being less likely to accept vaccination. Additionally, we anticipated potential disparities between the two groups regarding their trust in social actors (such as the media), their choice of information sources, and their perceptions of information censorship during the pandemic. These expectations stem from the perception of veganism as the “most radical” stance within the veg* community and its minority status in a predominantly non-vegan society. It stands to reason that vegans might exhibit more skepticism, critique, or detachment from conventional information channels and societal institutions. However, we do not formulate specific hypotheses on these aspects—or the level of stress suffered by the two groups—given the unprecedented nature of the COVID-19 crisis and the paucity of research in this area.

Questionnaire

The study used a structured, non-randomized online survey available in English or Spanish. Data were collected between June and July 2021. In addition to sociodemographic data (age, gender, country of residence, educational level, employment status, and political ideology), the survey included questions related to the following issues:

Lifestyle/philosophy of life : Participants were asked to indicate which option seemed most appropriate to describe their current lifestyle/philosophy: vegan, vegetarian, ovo-vegetarian, lacto-vegetarian, ovo-lacto vegetarian, flexitarian, pescatarian, plant-based diet, or others (presented as an open question).

Motivations for maintaining the lifestyle/philosophy of life : On a 5-point Likert scale, participants rated the relevance of the following motivations to maintaining their veg* lifestyle/philosophy of life: animal defense, environment, health, beauty, climate change, personal circle, spirituality, religion, and disgust.

Rejection and acceptance of animal use : Participants rated their acceptance of the use of animals in experimentation, food, entertainment, and fashion using a 5-point Likert scale, ranging from “Strongly disagree” to “Strongly agree”. The variable was also used to determine the differential stance between vegans and vegetarians on the use of animals, with a particular focus on experimentation.

COVID-19 : This section covered a variety of questions related to vaccination: doses received, motivations, opinions on mandatory vaccination, and possession of a COVID-19 passport (hereafter referred to as a green passport). The types of questions varied: some were dichotomous (e.g., “Have you received the COVID-19 vaccine? 1. no; 2. yes”), others offered multiple choices (e.g., “I have not been vaccinated …. 1. but I plan to do it as soon as possible”). Some questions allowed for multiple responses, with an open question (e.g., “If vaccinated, the main reasons are…: own health protection”). For some questions, a 5-point Likert scale was used (e.g., “Please rate your agreement with the statement: “COVID-19 vaccination should be compulsory for all citizens”, where 1 means “strongly disagree” and 5 means “strongly agree”).

Trust: We measured participants’ trust in different social actors during COVID-19 using a single 5-point Likert scale question: “Please rate your confidence that the following institutions will perform adequately during COVID-19”. There were eight categories: “Intergovernmental Institutions (WHO, agencies, etc.)”; “Government Institutions (state, federal, local, etc.)”; “Media”; “Pharmaceutical companies”; “Non-pharmaceutical companies”; “NGOs”; “Scientists”; “Healthcare professionals”. This question was designed according to the Trust Barometer methodology used globally by the independent communications firm Edelman Trust Institute (2021) for the past two decades.

Source of information: We measured this variable with two 5-point Likert scale questions, one on general topics and one on COVID-19: “How often do you use the listed sources to get general news?” And “How often have you used the listed sources to get updates related to COVID-19 (developments, vaccines, etc.)?”. Sources of information included: “Traditional media (both print and digital associated with large media groups)”; “Alternative media (both print and digital not associated with large media groups)”; “Social networks (Facebook, Twitter, YouTube, etc.)”; “Private chats (WhatsApp, Telegram, etc.)”; “Personal networks (family, friends, etc.)”; “Experts (sociologists, psychologists, political scientists, doctors, philosophers, etc.)”; and “Other.”

Stress: We asked participants to evaluate in two 5-point Likert scale questions the level of stress they suffered, respectively, during 2020 and at the time of responding to the questionnaire, 2021.

Procedure and sample

The online survey, hosted on the website [details omitted for double-anonymized peer review] and administered through EncuestaFacil.com, was disseminated through vegetarian communities (e.g., animal protection groups), social networks (e.g., Twitter, Facebook, Instagram, Reddit) and the researchers’ networks. We also used snowball sampling, asking participants to distribute the survey among their veg* contacts. The resulting data were analyzed for missing entries, outliers, and errors, and problematic data were excluded. As a result of this analysis, the initial sample of 1073 individuals was reduced to 936 persons. Of this sub-sample, 66% declared themselves vegans, 27% vegetarians (ovo-vegetarians, lacto-vegetarians, and ovo-lacto-vegetarians), 3% pescatarians, 2% plant-based diet, and 2% flexitarians. However, the final sample used for the analysis in this study consisted of 853 individuals as a result of applying two selection steps. First, flexitarians, pescatarians, and plant-based were excluded; the first two figures include animal consumption, and the last one remains ambiguous in the literature. Secondly, the analysis was specifically tailored to focus on individuals committed to veganism or vegetarianism for ethical reasons. Consequently, participants who did not identify animal protection as “important” or “very important”—using a 5-point Likert scale—as a reason for their dietary choices were excluded from the study.

Our final sample ( n  = 853) included a vegan sample of 66% ( n  = 587) and a vegetarian sample of 34% ( n  = 266). Regarding gender, 69% identified themselves as “women”, 27% as “men”, and 4% as “other”, with an average age of 36.7 years—37.6 years for vegans and 34.8 years for vegetarians. Almost all participants were highly educated. They predominantly identified with progressive, socialist, or anarchist political ideologies and supported feminist and environmentalist causes. Over half were paid-employed (see Table 1 for more detailed sample demographics). The sample boasted an international profile, with participants spanning 48 nations, primarily from Spain (53%) and the United States (15%). Notable representations also came from the United Kingdom (4%), Canada, Germany, Switzerland, Argentina (3% each), and smaller percentages (2%) from other countries, Austria, Australia, Portugal, and Mexico. Other participants came from Belgium, Colombia, Italy, India, Ireland, and the Netherlands, each representing 1%. All other nations accounted for less than 1% each. Given the strategy to collect the data, it should be noted that the results cannot be deemed statistically representative of the entire veg* community.

Analytical strategy

Due to the non-normal distribution in most cases, non-parametric tests were used in the analyses. Specifically, Spearman’s tests were used to study correlations between variables, while Chi-square and Mann–Whitney tests (with Bonferroni correction) were used to examine differences between vegan and vegetarian groups. Finally, binomial logistic regression was performed to assess the impact of the main factors studied, including vegetarianism or veganism, on vaccination decisions. Before analyzing COVID-19-related differences between vegans and vegetarians, we examined whether their views on the use of animals differed. As Table 2 indicates, both groups showed significant differences in all items, with a p  < 0.001 and an effect size ranging from low to moderate. Vegans showed a more critical attitude towards all uses of animals. Using animals in experimentation is the least rejected for both groups when comparing all the uses included in the study.

Attitudes, behavior, and reasons regarding vaccination

Differences in attitudes towards vaccination.

The descriptive analysis of participants’ attitudes towards vaccines in 2021 (the time of the survey) revealed that the majority considered the vaccine safe or very safe for humans (68%) and effective or very effective against COVID-19 (71%). When we compared the attitudes of vegans and vegetarians concerning these attributes, we found that vegans rated them more negatively (see Table 3 ). In the case of safety, 64% of vegans versus 77% of vegetarians considered it “safe” or “very safe”; in contrast, 11% of vegans and 6% of vegetarians rated it “not very” or “not at all safe”. As for the vaccine’s efficacy, 66% of vegans vs. 82% of vegetarians considered it “effective or very effective”. In comparison, 10% of vegans vs. 5% of vegetarians perceived it as “not very” or “not at all effective”. However, the Mann–Whitney U -test indicated that the only significant difference (with a p  = 0.025) was in the case of safety.

We also looked more closely at the group that chose the “don’t know enough” (DK) option about the attributes of safety (12% of the total sample) and vaccine efficacy (8% of the total sample). When comparing the two groups, we found that more vegans (13% for safety and 10% for efficacy) than vegetarians (10% and 3%, respectively) had chosen that option. However, these differences were significant for the assessment of vaccine efficacy ( χ 2 (1, N  = 68) = 12.98, p  < 0.001) but not for vaccine safety ( χ 2 (1, N  = 101) = 2.30, p  = 0.129).

When participants were asked about their views on mandatory vaccination against COVID-19, 41% of all participants agreed or strongly agreed with the measure. Comparing this attitude between the two groups, a more positive assessment was observed among vegetarians. On the one hand, 37% of vegans versus 51% of vegetarians accepted the measure (with 12% and 23%, respectively, responding “very agree”); on the other hand, 45% of vegans versus 26% of vegetarians rejected it (with 25% and 11%, respectively being “strongly disagree”). The Mann–Whitney U test confirmed these differences as statistically significant (see Table 3 ).

Regarding the possible implementation of the Green Passport, 52% of the sample considered it appropriate. Again, differences were observed when comparing the two groups: 48% of vegans and 60% of vegetarians agreed with its implementation (21% vs. 33% answered “strongly agree”); at the same time, 30% of vegans and 128% of vegetarians disagreed (19% and 11% respectively chose “strongly disagree”). The Mann–Whitney U -test confirmed that these differences were statistically significant (see Table 3 ).

We also examined the “don’t know enough” (DK) option on the Green Passport implementation. In this case, we also found that more vegans (13% and 10% for safety and effectiveness, respectively) than vegetarians (10% and 3%) chose DK. However, the difference was not significant ( χ 2 (1, N  = 74) = 1.06, p  = 0.303).

We conducted a correlation analysis to explore the relationship between the four variables. We found strong and significant correlations between them for both groups (slightly stronger among vegans) (see Table 12 in Annex ). Lastly, we also observe positive and significant correlations between the DK options. We found an association between vaccine safety and effectiveness ( rho  = 0.51, p  < 0.001) as well as Green Passport with vaccine safety ( rho  = 0.11, p  < 0.001) and effectiveness ( rho  = 0.12, p  < 0.001).

Differences in behavior toward vaccination

Of all the participants, 85% reported being vaccinated against COVID-19 at least once. However, this percentage varied significantly between the two groups, with a lower proportion among vegans (82%) than vegetarians (94%) ( χ 2 (1, N  = 853) = 21.1, p  < 0.001).

When examining the average number of doses received by participants in more detail, we found differences between the two groups (see Table 4 ). Specifically, although most respondents reported receiving two doses (73%), the percentage was significantly lower among vegans (69%) than among vegetarians (81%). We also analyzed the vaccinated individuals’ intention to receive additional booster doses (see Table 4 ). Data show that participants’ attitudes varied depending on whether they considered receiving a second, third, or subsequent dose. For instance, among those who had already received two doses, over 70% were willing to receive a third dose if necessary; however, only 3% expressed a willingness to receive a fourth dose. When comparing the two groups, we found no significant differences in the willingness to receive subsequent doses after the first shot (see Table 4 ). However, the findings regarding the number of doses received should be interpreted with caution due to potential variations in health recommendations, protocols, and vaccine brands, both between and within countries.

Among the unvaccinated (15% of the total sample), most participants reported not intending to receive any doses; this percentage was significantly higher among vegetarians. A significant difference was also observed for the option “I am still evaluating the possibility of getting vaccinated”, where the percentage was higher among vegans (see Table 5 ).

Differences in reasons for vaccination

In the total sample, three reasons appear as the most relevant for participants to be vaccinated: the feeling of “social responsibility”; “the desire to protect significant others (e.g. family, friends) as well as people in vulnerable situations”; and “the desire to safeguard their own health” (Table 6 ). It should be noted that participants could choose a maximum of three motives.

When comparing the vegan and vegetarian groups concerning these motives, we found significant differences in “protection of the significant others and vulnerable people (e.g., family, friends)” as well as in “protection of one’s health.” In both cases, the vegetarian sample indicated higher values (see Table 6 ).

To better understand the differences between the two groups in their decision-making regarding vaccination, we asked them to rate their agreement level on six questions related to vaccination, their lifestyle/philosophy, and animal welfare. As summarized in Table 7 , the data revealed significant differences in all questions. First, a higher percentage of vegans (46%) than vegetarians (21%) believed that vaccination was not coherent with their lifestyle/philosophy. Additionally, 11% of vegans and 21% of vegetarians stated that they “did not think about its coherence.” It should be noted that this variable correlated positively and significantly with the attitudes towards mandatory vaccination ( rho  = 0.40; p  < 0.001). Specifically, the less they considered the consistency of vaccination with their values, the more they supported mandatory vaccination.

Second, a higher percentage of vegans indicated that their lifestyle/philosophy had a significant influence on their vaccination decision; specifically, 12% of vegans, compared to 5% of vegetarians, stated that their veganism or vegetarianism influenced their decision quite a lot, while 50% of vegans and 70% of vegetarians responded that it did not influence their decision at all.

Third, vegans are less likely than vegetarians to accept the idea that vaccine testing on animals was done for a good cause or the common good (12% vs. 32%, respectively). Furthermore, vegans—compared to vegetarians—are more likely to recognize that vaccination involves animal suffering (80% versus 49%) and to express that they took this suffering into account in their decision-making process regarding vaccination (55% vs. 19%, respectively).

Lastly, the data revealed that a more significant proportion of vegans (4%) than vegetarians (1%) attempted to compensate for the perceived suffering associated with the COVID-19 vaccine by donating to various causes, such as sanctuaries or alternative animal testing centers ( χ 2 (1, N  = 852) = 7.82, p  = 0.005; ⌀  = 0.10).

Differences in trust, the use of sources of information, censorship, and stress during COVID-19 crisis

We also examined possible differences in four variables that could influence veg* decisions and experiences during the period: (1) the level of trust in various social actors; (2) the use of different sources of information on COVID-19-related issues; (3) the perception of information censorship during the COVID-19 crisis; and (4) the level of stress in 2020 and 2021. Tables 8 and 9 summarize the results.

As for assessing the performance of the different social actors during the COVID-19 crisis, we found that healthcare—followed by scientists—was the best rated, while the media was the worst rated by the entire sample. When comparing vegans and vegetarians in this assessment, the data show that vegetarians were significantly more positive about the decisions made by four actors that were key during the crisis: healthcare, scientists, intergovernmental institutions, and pharmaceutical companies.

Regarding the different sources of information consumed to keep up to date, the Mann–Whitney U -test revealed two significant differences between the two groups (see Table 9 ). First, vegetarians consumed significantly more information from traditional media than vegans, both for information on COVID-19 issues and world events in general. Second, vegetarians relied more on information from their close circle to keep them informed about COVID-19 issues.

Additionally, the analyses showed that vegans significantly considered that there was more censorship of information about COVID-19 than vegetarians; however, this result should be taken with great caution given the p-value so close to the cut-off point. Finally, we compared the perceived stress levels of the two groups during 2020 and 2021. The man Whitney U-test revealed that vegetarians felt more stressed than vegans, but the difference was only significant for 2020.

Finally, we compared the perceived stress levels of the two groups during 2020 and 2021. The man Whitney U-test revealed that vegetarians felt more stressed than vegans, but the difference was only significant for 2020. It should be noted that higher levels of perceived stress and, especially, higher levels of censorship were positively and significantly related to being vaccinated ([stress2020] χ 2 (4, N  = 645) = 0.26, p  < 0.001; [stress2021] χ 2 (4, N  = 645) = 0.18, p  < 0.001; [censorship] χ 2 (4, N  = 645) = 0.59, p  < 0.001). In addition, they are related to attitudes toward vaccination, trust in different social actors, and the use of information sources (see Table 12 in Annex ).

Factors influencing the decision to be vaccinated

To investigate the drivers of inclination to vaccinate within the total sample and each group, we conducted a binomial logistic regression, with the probability of vaccination (No/Yes) as the dependent variable. The following independent variables were included in the analysis: being vegan (versus vegetarian), vaccine attributes (safety, effectiveness, coherence, implications for animal suffering), trust in social actors, sources of information (in general and regarding COVID-19 issues), perceived censorship, and perceived stress (2020 and 2021) and sociodemographic variables (age, gender, educational level, countries of residence, and political ideology) as control variables. We first analyzed only the influence of veganism in the model. In the second step, non-significant variables were excluded using a joint omitted variables approach to improve the model fit. We analyzed the whole sample and the two groups (vegans and vegetarians) separately (see Tables 13 – 15 in the Annex for more models).

When we analyzed the factor of being vegan versus vegetarian in the decision to vaccinate, we found that it significantly and negatively influenced the decision to vaccinate (Model #1). However, the explanatory value was very low, as shown by the two pseudo- R 2 s ( R 2 McFadden or R ²McF; R 2 Nagelkerke or R ²N), which accounted for 2% and 3% of the variability.

In the final binomial logistic regression, keeping all significant variables together (Model #2) showed five significant predictors of the vaccination decision for the whole sample. As shown in Table 10 , participants were significantly more likely to be vaccinated if they considered the vaccine safe for humans, effective against COVID-19, and coherent with their veg* values. Furthermore, participants who exhibited lower trust in non-pharmaceutical companies or higher trust in media sources were significantly more inclined to get vaccinated. More importantly, identifying as vegan (versus vegetarian) was no longer a significant predictor of the decision to vaccinate when considered alongside other variables in our statistical model. Mediation effects in the model could explain this, as we found vaccine safety, veg* coherence, and trust as mediators during the analyses (see Table 13 in Annex). The final model fit measures indicated a good fit with lower complexity (AIC = 339; BIC = 400). The two pseudo-R 2 showed that the model explained 56% and 66% of the variability.

We found some differences when we analyzed the groups separately (Table 10 ). In the vegan group, three factors influenced the likelihood of being vaccinated. Specifically, having a positive perception of the vaccine’s safety for humans, the vaccine’s efficacy, and the perception of its coherence with their vegan lifestyle/philosophy increased the likelihood of vaccination. The two pseudo- R 2 showed that the model explained 51% ( R ²McF) and 63% (R²N) of the variability. In the vegetarian group, only having a positive perception of the vaccine’s safety for humans increased the likelihood of vaccination. In this case, the two pseudo- R 2 tests showed that the model explained 70% ( R ²McF) and 74% ( R ²N) of the variability.

Despite the persistent exploitation of nonhuman animals for human benefit across industries, there is growing recognition of animals as sentient beings—a status that is catalyzing legislative protections, integration of welfare policies into corporate practices, and changes in individual behaviors in different countries (Animal Welfare (Sentience) Act, 2022 ; Blattner, 2019 ; Harris, 2021 ; Ley 17/2021, 2021 ; Treaty on the Functioning of the European Union, 2009 ). Primarily driven by animal advocates, the movement is diverse and dynamic, and rooted in varied philosophical beliefs (Wolf, 2014 ) that give rise to numerous moral positions and lifestyle choices regarding animal defence and human use. Animal experimentation emerges within this field as an especially contentious subject, stirring up division within the animal advocacy movement and sparking vigorous ethical discourse. Faced with COVID-19, a global crisis of unprecedented proportions, the challenge to this movement was also unprecedented. To our knowledge, our study is the first to explore the specific reactions of self-identified ethical vegans and vegetarians to the dilemmas posed by the COVID-19 crisis, exploring their attitudes, behavior, and experiences during 2020 and 2021. We now turn to the key findings of our research.

Despite its exploratory nature, our study reveals distinct differences between vegans and vegetarians during the COVID-19 crisis. Our findings broadly delineate the following differences: (i) attitudes and behavior towards vaccination and vaccination rates; (ii) motivations behind choosing to vaccinate and factors explaining their decision to be vaccinated; (iii) perceptions of vaccination consistency with their veg* lifestyle or philosophy; (iv) degrees of conformity with decisions from social actors and crisis-related information; and (v) preferences for traditional information sources on general and COVID-19 specific topics and level of perceived censorship.

Firstly, our vegan respondents are less complacent about vaccination during the COVID-19 crisis than vegetarians. Specifically, vegans show a more negative view of vaccinations, mandatory regulations, and restrictive passports than vegetarians. We also found significant differences between vaccination rates, with fewer vegans being vaccinated. Furthermore, vegans show greater intention to remain unvaccinated as well as more reluctance to continue vaccination when they are already vaccinated. Additionally, vegans not only consider that there has been a higher degree of censorship than vegetarians but also have less trust in the three institutions that made critical decisions during the crisis: intergovernmental bodies, pharmaceutical companies, and scientists. Thus, our results suggest that there is a difference of opinion between vegans and vegetarians regarding the response of institutions and society to vaccination, which places vegans in a more critical stance towards an activity that involves animal testing. This finding aligns with the fact that the literature critical of animal experimentation is typically led by vegan authors (e.g., Horta and Cancino-Rodezno, 2022 ).

Vaccination rates within our sample—82% for vegans and 94% for vegetarians—surpass the international averages recorded during our study period, which ranged from 62% to 82% (these international averages include the ten countries that account for 87% of our respondents). However, it is crucial to recognize the challenges in comparing vaccination data, especially coming from different countries. Consistent, comparable, and internationally aggregated data are scarce. Caution is advised when comparing the number of doses received between the two groups and internationally, as the disparity may be due to multiple factors beyond lifestyle (or diet) choices to including areas or country-specific vaccine accessibility, specific indications for each vaccine brand, public health recommendations, or vaccination protocols.

Secondly, the motivations for vaccination varied between vegetarians and vegans. Although both vegans and vegetarians consider the protection of others as a primary reason for vaccination, it is noteworthy that vegans attach comparatively less importance to the protection of their personal health. This result is reinforced in the logistic regression when it turns out that, for vegetarians, the factor that explains a large amount of variance is the concept of human security. In contrast, for vegans, the likelihood of vaccination was explained by multiple factors, including the assessment of the level of consistency of the vaccine with their philosophy of life. This difference may suggest a variation in motivational focus, with vegans showing a relatively more complex decision and higher priority on altruism. This pattern supports previous findings, including those indicating that vegans score higher levels on several aspects of “heartfulness” than vegetarians (Voll et al., 2023 ), a quality associated with mindfulness and prosocial behavior—characterized by caring, compassion, gratitude, and nurturance. Additional research has shown that vegetarians and vegans differ in their empathic responses at the neural level; specifically, vegans show more intense activation of the mirror neuron motor system and brain structures linked to empathy, social cognition, and prosocial behavior (Filippi et al., 2010 , 2013 ; Moya-Albiol et al., 2010 ). This distinction is relevant, as it has been established that an egalitarian attitude towards animals and humans shares empathy as the underlying factor (e.g., Braunsberger and Flamm, 2019 ).

Thirdly, vegans stated that their values significantly influenced their vaccination decisions more than vegetarians. Additionally, they were more likely to question the justification that animal testing of vaccines was done for a good cause and to recognize the animal suffering involved in the development of the COVID-19 vaccine. This increased awareness and the idea that experimentation is directly and strongly related to vegan concerns rather than vegetarianism may explain this difference. However, it should be noted that, as mentioned above, being vegan or vegetarian was not a good predictor of the final decision to vaccinate.

Lastly, and importantly, a higher percentage of vegans than vegetarians felt that vaccination did not align with their lifestyle or philosophy, thus explicitly acknowledging a direct conflict between their values and their attitudes and behaviors towards COVID-19 vaccination. This perception is not only reflected in the vegans’ statements but is supported by other analyses. Thus, data suggest a more significant cognitive dissonance among vegans, leading to a stronger sense of compromised values.

That said, it is remarkable that, although vegans showed more reluctance or suspicion towards vaccination than vegetarians—and despite initial reluctance towards vaccination—a large majority of vegans eventually demonstrated a high acceptance of vaccines during the health crisis. This apparent contradiction between their convictions and their actions leads to a crucial question: What were the underlying reasons that led vegans to compromise their moral values or relax their altruistic principles against animal experimentation? We propose two main factors that may have influenced this decision: (1) social stress and perceived peer pressure; and (2) the complex moral dilemmas that animal experimentation poses for its ethics.

On the one hand, social stress, and pressure, exacerbated during the pandemic, could have played an important role since it has been pointed out as a common factor in vaccination behavior in the general population, including getting vaccinated because of expectations and feelings of being “targeted” or “bullied” (Lin et al., 2022 ; Walsh et al., 2022 ). Thus, we might think that peer influence and the feeling of being judged or even bullied might have led to decisions that would not otherwise be made. As mentioned at the beginning of this article, we have seen that the debate on vegans and vaccination has been part of mainstream media during the COVID-19 crisis with consistency, unlike the one towards the veggie community. Moreover, although we observed significant differences in the consumption of information about COVID-19 in traditional media by the two groups, vegans have relied heavily on them for information about crisis-related issues, even more so than for other issues. This shows the high likelihood that vegans anticipate vegan stigma—especially with the media’s well-known speciesist bias (Khazaal and Almiron, 2016 ), stigmatization of animal rights advocacy (MacInnis and Hodson, 2021 ) and stigmatization for disrupting social conventions (Markowski and Roxburgh, 2019 ).

It is worth noting that COVID-19 has been starkly politicized and polarized since the beginning. In some countries, acceptance or rejection of the measures, including the progressive media, labeling vaccine dissent as sheer science denial (Bardon, 2021 ). Although the risk of being discriminated against for not being vaccinated was also high regardless of being vegan or not (Bor et al., 2023 ; Caplan, 2022 ; Schuessler et al., 2022 ), this is likely to have a more significant impact on vegans. The stigmatization of all types of dissent as anti-vax, science denial, free-riders, and misinformation (Francés et al., 2021 ) instead of engaging with reasonable concerns (Pruski, 2021 ) was a threat to critical thinking in general but likely had a higher impact on a community like vegans—already singled and stereotyped by media (Cole, 2015 )—as marketing efforts for canceling the “vegan identity” in COVID-19 vaccination showed (Beverland, 2022 ).

Overall, the period saw unprecedented political, corporate, and media pressure on all citizens to accept the vaccine as the only solution—a pharmacological treatment that involved animal experimentation—which may have had a more significant impact on the psychology of vegans due to their willingness to avoid further stigmatization. It is well known that in times of crisis, the public and the media tend to “rally around the flag”, leading to more unreserved support for the authorities and less criticism (a term coined by Mueller, 1973 ; also identified for the COVID-19 crisis, Cunningham, 2020 ). In the case of COVID-19, the period experienced a pervasive and relatively homogeneous media and corporate representation of the crisis based on war metaphors (Chatti, 2021 ; Gui, 2021 ; Panzeri et al., 2021 ; Wicke and Bolognesi, 2020 ; Uysal and Aksak, 2022 ), fear and propaganda (Broudy and Hoop, 2021 ; Francés et al., 2021 ; Nwakpoke Ogbodo et al., 2020 ) and patriotism (Almiron et al., 2022 ; Basir et al., 2020 ) following the political authorities’ narrative (Castro Seixas, 2020 ; Loayssa and Petruccelli, 2022 ) under the intense lobbying of the pharmaceutical industry (Corporate Europe Observatory, 2021 ; Deruelle, 2022 ; Fang, 2021 ). All this emphasizes the imperative of vaccination and puts extraordinary pressure on the whole population, including the veg* community, especially vegans. As Park and Kim ( 2022 ) pointed out, “the pandemic certainly produced dramatic changes in vegans’ lives and sometimes even escalated tensions between vegans and nonvegans” (p. 8).

In terms of animal testing, the discursive positioning of the COVID-19 vaccine may pose a significant challenge to vegan values. Currently, there are no animal-free alternatives for many conventional drugs and medical procedures—there was none for the COVID-19 vaccines—as well as no animal-free alternative medicine in general for vegan individuals favoring options different from chemically synthesized drugs. However, this ethical challenge does not have a single or straightforward interpretation. For instance, amid the crisis, the Vegan Society reminded that the definition of veganism includes the idea that “‘it is not always possible or feasible for vegans to avoid the use of animals,” which, they added, is particularly relevant to medical situations. Furthermore, even though the vegan organization directly acknowledges that the COVID-19 vaccine is tested on animals, it defends its acceptance because “it is playing a key role in tackling the pandemic and saving lives” (“Vegan Society response to COVID-19 vaccine”, 2020 ). The notion that veganism is about choosing the ‘least bad’ option when it comes to animal suffering is widely understood. Similarly, the narrative promoted by PETA ( 2021 ) and The Vegan Society ( 2020 ), among others, suggests that vegans must first take care of themselves to be capable of taking care of other animals. However, this does not imply that vegans are compelled to use animal-based medicines; choosing the “least bad” option does not mean that one must always choose a bad option. They may opt out entirely, just as other members of society might. Although not rigorously studied for this movement, the ethical dilemmas posed by animal experimentation are likely one of the sources of significant controversy amongst vegans, linked to human health and a dominant biomedical paradigm that often leaves little room for alternative health models (Sheldrake, 2012 ; Morcan and Morcan, 2015 ). While vegans call for the abolition of animal experimentation, there is a broad spectrum of beliefs on what is considered acceptable practice in the interim. Peter Singer, for instance, has defended animal experimentation under limited and specified circumstances (Crawley, 2006 ).

Lastly, the challenges raised by animal experimentation also bring contradictions to the surface about the values vegans hold. While veganism is a philosophy of life and social movement that opposes violence towards nonhuman animals, vegans have a different rating scale for different forms of violence. The latter is reflected in our results when we asked vegans about their acceptance of animal use. We found that, compared to use in clothing, food, and entertainment, animal testing is the category least condemned by vegans.

In summary, our findings illuminate the contrasts in how vegans and vegetarians navigated the COVID-19 crisis—with vegans displaying less conformity but, ultimately, facing a profound and greater compromise of their core ethical values.

Our study has illuminated some aspects of the behavioral responses of vegetarians and vegans during the COVID-19 vaccination campaign. Nevertheless, it is essential to recognize the limitations that accompany our findings and to contemplate their influence on the study’s scope and applicability. First, relying on self-reported data from questionnaires was appropriate for our focus on self-identification but may not fully capture the behavioral adherence to ethical vegan or vegetarian lifestyles. Additionally, questionnaires were distributed and collected via convenience and snowball sampling methods. While these are common approaches, they present three fundamental limitations: the sample sizes are relatively small compared to the overall veg* population, participant numbers vary by country, and the results cannot be deemed statistically representative of the entire veg* community.

Third, our approach treated ethical vegans and vegetarians as a single, unified group. Future research might be enhanced by delving into the nuances within each group. Such studies could investigate participants’ personal interpretations of veganism or vegetarianism and the duration and strictness with which they follow these lifestyles. Considering the importance of these variables in the adoption process and the construction of individual and social identity (Nezlek and Forestell, 2020 ; Rosenfeld and Burrow ( 2018 ), could provide valuable insights into the matter. Political ideology may also influence perspectives on vaccination and responses to the crisis, with those holding critical views of political and economic institutions (e.g., veganarchists) possibly exhibiting more negative attitudes.

Lastly, our research prompts questions that extend beyond the scope of the quantitative approach. A significant limitation lies in the complexity of ethical dilemmas, which quantitative data alone cannot fully encapsulate. Vaccination decisions are emotionally charged and imbued with moral significance, particularly for individuals committed to animal advocacy. This study has primarily taken a cognitivist approach, focusing on rational variables. However, the subtleties of ethical decision-making—such as how individuals reconcile their values with the choice to vaccinate—represent a complex landscape that our methods could not thoroughly investigate. Moreover, the delicate equilibrium between public health imperatives and personal ethical beliefs has posed a moral quandary for many, prompting a spectrum of responses influenced by ethical, emotional, and social factors. While comprehensive, our study may not have captured the full intricacy of the veg* community’s response to the crisis, including the roles of individual rationalizations. Future research would thus benefit from qualitative methodologies that delve into the psychological, social, and moral terrains navigated by vegans in decision-making processes. In-depth interviews could illuminate the internal conflicts and justifications surrounding vaccination decisions. Narrative analysis might also reveal how vegans and vegetarians construct their identities and make health-related decisions amidst societal pressures and ethical dilemmas. Adopting a qualitative perspective would complement our findings and provide a richer understanding of the lived experiences of vegetarians and vegans during this unparalleled global health crisis. Moreover, pursuing these lines of inquiry would contribute to the broader discourse on how vegetarians and vegans manage contradictions in a non-vegan world, an area of interest that has been notably explored by other authors (e.g., Greenebaum, 2012 ).

The veg* community encountered significant challenges to their values during COVID-19, particularly regarding vaccination decisions. With the vaccine—a product based on animal experimentation—presented as the sole solution to end the crisis and promoted by government authorities and the media, these individuals faced profound ethical decisions. This exploratory research has presented findings that compare the responses of ethical vegans and vegetarians to the vaccination challenge. Our results indicate that the veg* community is diverse, with vegans exhibiting the least conformist attitudes and behaviors towards the pandemic management measures. Nonetheless, the findings also reveal that despite their critical stance and their aim to protect vulnerable populations, the vegan community has largely compromised their moral values by accepting the vaccine. This research enhances the expanding field of veg* studies and animal rights literature by exploring how a health crisis impacts the behaviors and perspectives of ethical vegetarians and vegans. Our study also contributes to shed light on the challenges and biases that a minority group, such as vegans, may face and how they cope with the pressure to go against the mainstream at a time when society is polarized by a single possible discourse that goes against its moral values.

Data availability

The datasets generated and analyzed during the current study are available from the corresponding author upon reasonable request.

In this paper, the term veg* will be used to include both vegetarian and vegan options.

In this paper, we use non-speciesist language, that is, we avoid using language that commodifies and objectifies nonhuman animals-like singular words used for collectives and thus hiding the individuals in them (fish, sheep, etc.).

For instance, Akhtar (2012a, 2012b) revealed that only 8% of new compounds passing preclinical tests (where animal experimentation is involved) reach the market. The 92% failing to make it to the market proved to be ineffective and/or unsafe in humans. This leads this and other authors to define animal experimentation not only as unethical but also as unreliable and unnecessary.

From January 2023, the US Food and Drugs Administration no longer needs to require animal testing before human trials of drugs (Wadman, 2023 ). https://www.science.org/content/article/fda-no-longer-needs-require-animal-tests-human-drug-trials .

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Díaz, E.M., Almiron, N. & Aranceta-Reboredo, O. Compromised values: a comparative response during the COVID-19 crisis by ethical vegans and vegetarians. Humanit Soc Sci Commun 11 , 485 (2024). https://doi.org/10.1057/s41599-024-02861-5

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The Impact of COVID-19 on the Careers of Women in Academic Sciences, Engineering, and Medicine (2021)

Chapter: 8 major findings and research questions, 8 major findings and research questions, introduction.

The COVID-19 pandemic, which began in late 2019, created unprecedented global disruption and infused a significant level of uncertainty into the lives of individuals, both personally and professionally, around the world throughout 2020. The significant effect on vulnerable populations, such as essential workers and the elderly, is well documented, as is the devastating effect the COVID-19 pandemic had on the economy, particularly brick-and-mortar retail and hospitality and food services. Concurrently, the deaths of unarmed Black people at the hands of law enforcement officers created a heightened awareness of the persistence of structural injustices in U.S. society.

Against the backdrop of this public health crisis, economic upheaval, and amplified social consciousness, an ad hoc committee was appointed to review the potential effects of the COVID-19 pandemic on women in academic science, technology, engineering, mathematics, and medicine (STEMM) during 2020. The committee’s work built on the National Academies of Sciences, Engineering, and Medicine report Promising Practices for Addressing the Underrepresentation of Women in Science, Engineering, and Medicine: Opening Doors (the Promising Practices report), which presents evidence-based recommendations to address the well-established structural barriers that impede the advancement of women in STEMM. However, the committee recognized that none of the actions identified in the Promising Practices report were conceived within the context of a pandemic, an economic downturn, or the emergence of national protests against structural racism. The representation and vitality of academic women in STEMM had already warranted national attention prior to these events, and the COVID-19

pandemic appeared to represent an additional risk to the fragile progress that women had made in some STEMM disciplines. Furthermore, the future will almost certainly hold additional, unforeseen disruptions, which underscores the importance of the committee’s work.

In times of stress, there is a risk that the divide will deepen between those who already have advantages and those who do not. In academia, senior and tenured academics are more likely to have an established reputation, a stable salary commitment, and power within the academic system. They are more likely, before the COVID-19 pandemic began, to have established professional networks, generated data that can be used to write papers, and achieved financial and job security. While those who have these advantages may benefit from a level of stability relative to others during stressful times, those who were previously systemically disadvantaged are more likely to experience additional strain and instability.

As this report has documented, during 2020 the COVID-19 pandemic had overall negative effects on women in academic STEMM in areas such productivity, boundary setting and boundary control, networking and community building, burnout rates, and mental well-being. The excessive expectations of caregiving that often fall on the shoulders of women cut across career timeline and rank (e.g., graduate student, postdoctoral scholar, non-tenure-track and other contingent faculty, tenure-track faculty), institution type, and scientific discipline. Although there have been opportunities for innovation and some potential shifts in expectations, increased caregiving demands associated with the COVID-19 pandemic in 2020, such as remote working, school closures, and childcare and eldercare, had disproportionately negative outcomes for women.

The effects of the COVID-19 pandemic on women in STEMM during 2020 are understood better through an intentionally intersectional lens. Productivity, career, boundary setting, mental well-being, and health are all influenced by the ways in which social identities are defined and cultivated within social and power structures. Race and ethnicity, sexual orientation, gender identity, academic career stage, appointment type, institution type, age, and disability status, among many other factors, can amplify or diminish the effects of the COVID-19 pandemic for a given person. For example, non-cisgender women may be forced to return to home environments where their gender identity is not accepted, increasing their stress and isolation, and decreasing their well-being. Women of Color had a higher likelihood of facing a COVID-19–related death in their family compared with their white, non-Hispanic colleagues. The full extent of the effects of the COVID-19 pandemic for women of various social identities was not fully understood at the end of 2020.

Considering the relative paucity of women in many STEMM fields prior to the COVID-19 pandemic, women are more likely to experience academic isolation, including limited access to mentors, sponsors, and role models that share gender, racial, or ethnic identities. Combining this reality with the physical isolation stipulated by public health responses to the COVID-19 pandemic,

women in STEMM were subject to increasing isolation within their fields, networks, and communities. Explicit attention to the early indicators of how the COVID-19 pandemic affected women in academic STEMM careers during 2020, as well as attention to crisis responses throughout history, may provide opportunities to mitigate some of the long-term effects and potentially develop a more resilient and equitable academic STEMM system.

MAJOR FINDINGS

Given the ongoing nature of the COVID-19 pandemic, it was not possible to fully understand the entirety of the short- or long-term implications of this global disruption on the careers of women in academic STEMM. Having gathered preliminary data and evidence available in 2020, the committee found that significant changes to women’s work-life boundaries and divisions of labor, careers, productivity, advancement, mentoring and networking relationships, and mental health and well-being have been observed. The following findings represent those aspects that the committee agreed have been substantiated by the preliminary data, evidence, and information gathered by the end of 2020. They are presented either as Established Research and Experiences from Previous Events or Impacts of the COVID-19 Pandemic during 2020 that parallel the topics as presented in the report.

Established Research and Experiences from Previous Events

___________________

1 This finding is primarily based on research on cisgender women and men.

Impacts of the COVID-19 Pandemic during 2020

Research questions.

While this report compiled much of the research, data, and evidence available in 2020 on the effects of the COVID-19 pandemic, future research is still needed to understand all the potential effects, especially any long-term implications. The research questions represent areas the committee identified for future research, rather than specific recommendations. They are presented in six categories that parallel the chapters of the report: Cross-Cutting Themes; Academic Productivity and Institutional Responses; Work-Life Boundaries and Gendered Divisions of Labor; Collaboration, Networking, and Professional Societies; Academic Leadership and Decision-Making; and Mental Health and Well-being. The committee hopes the report will be used as a basis for continued understanding of the impact of the COVID-19 pandemic in its entirety and as a reference for mitigating impacts of future disruptions that affect women in academic STEMM. The committee also hopes that these research questions may enable academic STEMM to emerge from the pandemic era a stronger, more equitable place for women. Therefore, the committee identifies two types of research questions in each category; listed first are those questions aimed at understanding the impacts of the disruptions from the COVID-19 pandemic, followed by those questions exploring the opportunities to help support the full participation of women in the future.

Cross-Cutting Themes

• What are the short- and long-term effects of the COVID-19 pandemic on the career trajectories, job stability, and leadership roles of women, particularly of Black women and other Women of Color? How do these effects vary across institutional characteristics, 2 discipline, and career stage?

2 Institutional characteristics include different institutional types (e.g., research university, liberal arts college, community college), locales (e.g., urban, rural), missions (e.g., Historically Black Colleges and Universities, Hispanic-Serving Institutions, Asian American/Native American/Pacific Islander-Serving Institutions, Tribal Colleges and Universities), and levels of resources.

• How did the confluence of structural racism, economic hardships, and environmental disruptions affect Women of Color during the COVID-19 pandemic? Specifically, how did the murder of George Floyd, Breonna Taylor, and other Black citizens impact Black women academics’ safety, ability to be productive, and mental health?
• How has the inclusion of women in leadership and other roles in the academy influenced the ability of institutions to respond to the confluence of major social crises during the COVID-19 pandemic?
• How can institutions build on the involvement women had across STEMM disciplines during the COVID-19 pandemic to increase the participation of women in STEMM and/or elevate and support women in their current STEMM-related positions?
• How can institutions adapt, leverage, and learn from approaches developed during 2020 to attend to challenges experienced by Women of Color in STEMM in the future?

Academic Productivity and Institutional Responses

• How did the institutional responses (e.g., policies, practices) that were outlined in the Major Findings impact women faculty across institutional characteristics and disciplines?
• What are the short- and long-term effects of faculty evaluation practices and extension policies implemented during the COVID-19 pandemic on the productivity and career trajectories of members of the academic STEMM workforce by gender?
• What adaptations did women use during the transition to online and hybrid teaching modes? How did these techniques and adaptations vary as a function of career stage and institutional characteristics?
• What are examples of institutional changes implemented in response to the COVID-19 pandemic that have the potential to reduce systemic barriers to participation and advancement that have historically been faced by academic women in STEMM, specifically Women of Color and other marginalized women in STEMM? How might positive institutional responses be leveraged to create a more resilient and responsive higher education ecosystem?
• How can or should funding arrangements be altered (e.g., changes in funding for research and/or mentorship programs) to support new ways of interaction for women in STEMM during times of disruption, such as the COVID-19 pandemic?

Work-Life Boundaries and Gendered Divisions of Labor

• How do different social identities (e.g., racial; socioeconomic status; culturally, ethnically, sexually, or gender diverse; immigration status; parents of young children and other caregivers; women without partners) influence the management of work-nonwork boundaries? How did this change during the COVID-19 pandemic?
• How have COVID-19 pandemic-related disruptions affected progress toward reducing the gender gap in academic STEMM labor-force participation? How does this differ for Women of Color or women with caregiving responsibilities?
• How can institutions account for the unique challenges of women faculty with parenthood and caregiving responsibilities when developing effective and equitable policies, practices, or programs?
• How might insights gained about work-life boundaries during the COVID-19 pandemic inform how institutions develop and implement supportive resources (e.g., reductions in workload, on-site childcare, flexible working options)?

Collaboration, Networking, and Professional Societies

• What were the short- and long-term effects of the COVID-19 pandemic-prompted switch from in-person conferences to virtual conferences on conference culture and climate, especially for women in STEMM?
• How will the increase in virtual conferences specifically affect women’s advancement and career trajectories? How will it affect women’s collaborations?
• How has the shift away from attending conferences and in-person networking changed longer-term mentoring and sponsoring relationships, particularly in terms of gender dynamics?
• How can institutions maximize the benefits of digitization and the increased use of technology observed during the COVID-19 pandemic to continue supporting women, especially marginalized women, by increasing accessibility, collaborations, mentorship, and learning?
• How can organizations that support, host, or facilitate online and virtual conferences and networking events (1) ensure open and fair access to participants who face different funding and time constraints; (2) foster virtual connections among peers, mentors, and sponsors; and (3) maintain an inclusive environment to scientists of all backgrounds?
• What policies, practices, or programs can be developed to help women in STEMM maintain a sense of support, structure, and stability during and after periods of disruption?

Academic Leadership and Decision-Making

• What specific interventions did colleges and universities initiate or prioritize to ensure that women were included in decision-making processes during responses to the COVID-19 pandemic?
• How effective were colleges and universities that prioritized equity-minded leadership, shared leadership, and crisis leadership styles at mitigating emerging and potential negative effects of the COVID-19 pandemic on women in their communities?
• What specific aspects of different leadership models translated to more effective strategies to advance women in STEMM, particularly during the COVID-19 pandemic?
• How can examples of intentional inclusion of women in decision-making processes during the COVID-19 pandemic be leveraged to develop the engagement of women as leaders at all levels of academic institutions?
• What are potential “top-down” structural changes in academia that can be implemented to mitigate the adverse effects of the COVID-19 pandemic or other disruptions?
• How can academic leadership, at all levels, more effectively support the mental health needs of women in STEMM?

Mental Health and Well-being

• What is the impact of the COVID-19 pandemic and institutional responses on the mental health and well-being of members of the academic STEMM workforce as a function of gender, race, and career stage?
• How are tools and diagnostic tests to measure aspects of wellbeing, including burnout and insomnia, used in academic settings? How does this change during times of increased stress, such as the COVID-19 pandemic?
• How might insights gained about mental health during the COVID-19 pandemic be used to inform preparedness for future disruptions?
• How can programs that focus on changes in biomarkers of stress and mood dysregulation, such as levels of sleep, activity, and texting patterns, be developed and implemented to better engage women in addressing their mental health?
• What are effective interventions to address the health of women academics in STEMM that specifically account for the effects of stress on women? What are effective interventions to mitigate the excessive levels of stress for Women of Color?

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The spring of 2020 marked a change in how almost everyone conducted their personal and professional lives, both within science, technology, engineering, mathematics, and medicine (STEMM) and beyond. The COVID-19 pandemic disrupted global scientific conferences and individual laboratories and required people to find space in their homes from which to work. It blurred the boundaries between work and non-work, infusing ambiguity into everyday activities. While adaptations that allowed people to connect became more common, the evidence available at the end of 2020 suggests that the disruptions caused by the COVID-19 pandemic endangered the engagement, experience, and retention of women in academic STEMM, and may roll back some of the achievement gains made by women in the academy to date.

The Impact of COVID-19 on the Careers of Women in Academic Sciences, Engineering, and Medicine identifies, names, and documents how the COVID-19 pandemic disrupted the careers of women in academic STEMM during the initial 9-month period since March 2020 and considers how these disruptions - both positive and negative - might shape future progress for women. This publication builds on the 2020 report Promising Practices for Addressing the Underrepresentation of Women in Science, Engineering, and Medicine to develop a comprehensive understanding of the nuanced ways these disruptions have manifested. The Impact of COVID-19 on the Careers of Women in Academic Sciences, Engineering, and Medicine will inform the academic community as it emerges from the pandemic to mitigate any long-term negative consequences for the continued advancement of women in the academic STEMM workforce and build on the adaptations and opportunities that have emerged.

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Impact of COVID-19 on Mental Health in Adolescents: A Systematic Review

Associated data.

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Due to lack of sufficient data on the psychological toll of the COVID-19 pandemic on adolescent mental health, this systematic analysis aims to evaluate the impact of the pandemic on adolescent mental health. This study follows the PRISMA guidelines for systematic reviews of 16 quantitative studies conducted in 2019–2021 with 40,076 participants. Globally, adolescents of varying backgrounds experience higher rates of anxiety, depression, and stress due to the pandemic. Secondly, adolescents also have a higher frequency of using alcohol and cannabis during the COVID-19 pandemic. However, social support, positive coping skills, home quarantining, and parent–child discussions seem to positively impact adolescent mental health during this period of crisis. Whether in the United States or abroad, the COVID-19 pandemic has impacted adolescent mental health. Therefore, it is important to seek and to use all of the available resources and therapies to help adolescents mediate the adjustments caused by the pandemic.

1. Introduction

The COVID-19 pandemic has created a havoc across the world, which has resulted in over 2 million deaths, globally and forced billions into isolation due to stay at home orders [ 1 ]. As a result of social isolation, and the constant concern of infectivity, mental health consequences that are associated with the COVID-19 crisis are monumental [ 2 , 3 ]. However, researchers are focusing more on the mental health impact of this rapidly evolving global crisis in the elderly population [ 4 ]. There has been very little attention to the psychological toll of COVID-19 on adolescent mental health [ 5 ].

The psychological toll of COVID-19 among adolescents should be a focal point in COVID-19 research due to the severe and enduring impact of mental health, which leads to poor mental health outcomes and to poor physical health outcomes, such as the development of cardiovascular diseases [ 6 , 7 ]. The mental toll of this impact serves as a greater challenge for adolescents because this age range (characterized as young people between the ages of 13–17) lack the psychological capabilities of resilience and coping and the physiological development of adults [ 6 , 8 ]. The mental health challenges of adolescents are even greater among adolescents with pre-existing mental health conditions during periods of crisis, which may be a result of isolation, feelings of uncertainty, lack of daily routines, lack of access to health services provided through schools, and lack of advanced emotional development [ 9 , 10 ].

Globally, 10–20% of adolescents suffer from mental health conditions [ 11 ]. This statistic is likely to be affected by the vulnerability of adolescents during the COVID-19 pandemic [ 12 ]. Due to the negative outcomes associated with poor mental health statuses among adolescents, such as suicide, behavior problems, and emotional distress and the need for quality research to build resilience and to reduce anxiety among adolescents, it is imperative to review the impact of COVID-19 on adolescent health in the United States and abroad in order to understand the global state of adolescent mental health and to provide strategies that prevent poor mental health outcomes, such as anxiety and depression, presently and in the future [ 13 ].

The aim of this systematic review is to assess the impact of the COVID-19 pandemic on adolescent mental health. Distinctively, the objectives of this review are: (1) To identity the state of adolescent mental health, globally; and (2) To provide quality research that will provide insight into strategies that can be used to address poor mental health outcomes of adolescents.

2. Materials and Methods

The systematic review included studies by following the PRISMA guidelines [ 11 ]. The study focused on published original quantitative studies on mental health issues in adolescents due to COVID-19. The inclusion and exclusion of the review are mentioned in Table 1 .

Inclusion and Exclusion Criteria.

2.1. Search Guidelines

The primary search engines that were used to identify articles included EBSCOhost, MEDLINE, APA PsychoInfo, APA Psych articles, Socindex, and CINAHL. All the investigators were involved in the search process. The studies were chosen for the review based on inclusion criteria, such as (1) articles being written in English; (2) being quantitative studies; (3) being scholarly papers; (4) using human participants between the ages of 13–17; (5) being associated with mental health illnesses; and (6) being associated with COVID-19. The search was performed on 27 January 2021. The time limit for the studies was from 2019–2021. The search string is mentioned in Table 2 .

Research Thread for all Databases.

2.2. Screening Guidelines

The Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines (2009) was used as a guide to record the review process [ 14 ]. Selected abstracts were reviewed to ensure their eligibility for inclusion. Full text articles of eligible abstracts were retrieved and assessed on whether they answered the research questions and fulfilled the inclusion criteria. Studies were included if consensus was reached by the three researchers.

Research Information System (RIS) formatted references were exported from the databases, where studies were automatically screened based on the inclusion criteria and then imported into CADIMA. The 46 studies that were imported in CADIMA were accessed based on title and abstracts. The researchers (Jones, Mitra and Bhuiyan) accessed the studies two times before discussing if the studies should be chosen for full text review. Conflicts were managed by group discussions between all three of the researchers of this study. After the initial discussion, all of the researchers agreed that 46 studies should be selected for further screening using the inclusion criteria. During this second phase of screening for having articles with full text and for excluding review articles, the three researchers again screened the 46 articles two times independently. Conflicts were managed by group discussions. After discussion, 30 more articles were excluded because they did not meet the inclusion criteria, and 16 articles were selected to be included in the systematic review. The PRISMA flow chart ( Figure 1 ) exhibits the search and inclusion process for the systematic review.

PRISMA flow chart to illustrate the article search and the inclusion process.

2.3. Quality Appraisal

Studies were appraised for quality using CADIMA. Through CADIMA, standards for the critical appraisal and the rating scale of the studies were defined. We followed the critical appraisal tools for systematic reviews developed by the University of Adelaide, South Australia [ 15 ]. A rating scale from 0 to 4 was based on the following criteria: (1) Study design—cross-sectional, case–control, or cohort study = 1, otherwise = 0; (2) Sample size—large = 1, small = 0; (3) Use of standardized instrument(s) for data collection, such as assessment of mental health by using Patient Health Questionnaire-9 (PHQ-9) or Diagnostic Manual of Mental Disorders-IV (DSM-IV) = 1, not specific = 0; and (4) Selection of participants—random selection or lack of bias = 1, non-random sample or convenience sample or presence of bias = 0 point. Based on the above-mentioned criteria, the three researchers rated each of the 16 studies independently from a range of 0 to 4. Due to having no major inter-observer variations in the evaluation of the quality of the studies, an average of the three scores was presented in Table 3 .

Impact of COVID-19 on adolescent mental health.

A summary of the methodology, characteristics of findings, impact of COVID-19 on mental health in adolescents, quality appraisal and the countries of the studies are presented in Table 3 . Of the 16 studies reviewed, 7 were conducted in China, 2 in the United States, 2 in Canada, and 1 each in Denmark, Germany, Japan, the Philippines, and the United Kingdom. All of the 16 studies utilized a quantitative methodology [ 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 ]. Among the studies, 12 (75%) were conducted online and 4 (25%) did not clearly report the study format. The studies were conducted from February 2020–May 2020, with six studies not reporting the date of data collection. Ten studies (62.5%) were conducted among adolescents only, three studies (18.8%) were conducted among children and adolescents, one study (6.3%) was conducted among adolescents and parents, and two studies (12.5%) were conducted among adults, young adults, and adolescents. In this study, we evaluated the data of adolescents only.

The total sample size used in the studies varied from 102 to 9554, having a median sample size of 1054 (1st Quartile = 693 and 3rd Quartile = 3254); 10 out of 16 (63%) had sample sizes of more than 1000. In terms of standardized tools, nine studies (56%) utilized standardized tools, and seven studies (44%) did not use standardized tools.

An average score of 4 out of 4, meant excellent in seven (44%), 2–3, meant moderate in seven (44%), and 0–1, meant poor in two (12%) studies.

3.1. Anxiety

Of the studies that addressed the impact of COVID-19 related anxiety for non-special populations, several studies established an association between the COVID-19 pandemic and rates of anxiety among adolescents [ 16 , 17 , 18 , 24 , 28 , 30 ]. One study in China [ 28 ] identified that low support (Odds Ratio [ OR ] = 3.18, 95% Confidence Intervals [ CI ]: 2.54 to 3.98) and medium support ( OR = 2.19, 95% CI : 1.94 to 2.48) increased the likelihood of anxiety. However, Chen et al. [ 19 ] did not identify a significant correlation between the COVID-19 and anxiety among adolescents.

3.2. Depression

Five studies (31%) addressed depression among non-special populations and identified an association between the pandemic and depression [ 17 , 25 , 27 , 28 , 30 ]. One study in China conducted by Duan et al. [ 17 ] identified an association between depression and COVID-19 related addiction in using social media, such as smartphone addiction ( OR = 1.844, 95% CI : 1.29 to 2.811), and internet addiction ( OR = 3.107, 95% CI : 1.252 to 7.708). Guo et al. [ 23 ] identified an association between COVID-19 related stress and depression ( β = 0.33, t = 11.49, p < 0.001). However, the study conducted by Chen et al. in China [ 19 ] failed to establish a significant correlation between depression and COVID-19 related factors.

3.3. Other Psychological Disorders/Distress

Of the studies, several considered various other forms of psychological disorders and other forms of psychological distress, such as burdensomeness, belongingness, psychological distress, stress and trauma, and drug abuse. One study in the United States [ 16 ] revealed that specific motivation to practice social distancing led to burdensomeness and belongingness among adolescents. Another study in the Philippines [ 27 ] identified that 16.3% of respondents experienced psychological impairments as moderate or severe due to the pandemic. A Chinese study by Zhang et al. [ 30 ] found that negative coping skills are risk factors for stress and trauma among junior high and high school students. A Canadian study [ 31 ] recognized the increased frequency of drug usage, such as alcohol and cannabis among adolescents during the pandemic.

3.4. Special Populations

Special populations among adolescents were assessed in several studies. These special population included Lesbian, Gay, Bisexual, Transgender, and Queer (LGBTQ) adolescents, adolescents diagnosed with anorexia nervosa, pre-pandemic maltreated adolescents, seniors, females, and adolescents diagnosed with obsessive-compulsive disorder (OCD). Through 31 synchronous text-based chats, LGBTQ adolescents expressed difficulty maintaining mental health wellness due to being forced to stay at home with unsupportive family members, and due to the lack of socialization that helps with identity [ 22 ]. Adolescents diagnosed with anorexia nervosa reported 70% increases in poor eating habits and increases in thoughts associated with eating disorders [ 21 ]. Pre-pandemic maltreated adolescents experienced higher rates of post-traumatic stress disorder (PTSD) (effect size beta = 0.16~0.27) and higher rates of anxiety (effect size beta = 0.32~0.47) [ 23 ]. Of the two studies [ 24 , 26 ] that specifically evaluated seniors, both studies established associations between poor mental health outcomes, such as psychological issues and anxiety, and factors related to the COVID-19 pandemic. Both studies that discussed gender-related data [ 26 , 27 ] established higher rates of COVID-19 related anxiety among females. The study [ 29 ] that evaluated various groups of youth, including adolescents that were diagnosed with OCD, established a worsening of symptoms (44.6%) for patients, who completed primary treatment and for patients, who were currently in psychiatric treatment.

3.5. Benefits

Of the 16 studies in this review, one study in China [ 24 ] identified both a negative and a positive impact between COVID-19 related factors, such as home quarantining and parent–child discussions with mental health outcomes. The positive benefits were related with coming in closer and having more family discussions between parents and their children during home quarantining.

4. Discussion

4.1. impact on mental health.

In this systematic review, there was conclusive evidence to support the potential negative impact of the pandemic on adolescent mental health. The stressors and motivations to practice social distancing due to the COVID-19 pandemic seem to be difficult for adolescents to process, which results in poor mental health outcomes [ 16 ]. The inefficient ability to process difficult circumstances, such as the pandemic are due to negative coping skills, which are risk factors for depression, stress and trauma among various ages of adolescents [ 30 ]. The lack of positive coping skills among adolescents is not unusual because adolescent must be provided with the tools to cope in order to be resilient and mentally well during periods of adjustments. However, the exposure to and practice of positive coping skills can lead to mentally well adolescents, who can easily adjust to rapid changes.

Social support was another major factor identified in this review in determining the mental sustainability of adolescents during periods of crisis, such as the pandemic. Adolescents had perceived high rates of low to moderate social support during the pandemic, which contributed to increases in anxiety and depression [ 28 ]. Despite the concept of social support being expressed from the point of view of adolescents, which may or may not be bias, adolescents are still experiencing authentic forms of psychological challenges, such as anxiety and depression associated with the lack of social support and the pandemic. Due to these challenges, it is imperative that support be greatly implemented in homes. Studies have shown that the implementation of social support leads to positive mental health outcomes [ 28 ].

Addiction is another concern for adolescent mental health during the pandemic. Due to stay-at home orders, school closures, or new at home learning methods, students are seeking ways to connect and to socialize in manners that may not be productive for optimal health. The result of these behaviors are smartphone addiction and internet addiction. Both forms of addiction lead to poor mental health outcomes for adolescents.

Despite being forced to remain at home, adolescents were identified as still engaging in drug use during the pandemic. Rather adolescents were increasing their use of alcohol and cannabis during the pandemic with 49.3% engaging in drug use alone [ 30 ]. An earlier study [ 32 ] showed the link between the lack of positive coping skills and the possible neurobiological pathways that may associate stress with the craving for drug use.

4.2. Impact on Mental Health of Special Populations

As the non-special populations of adolescents experience mental health challenges, the special populations are experiencing a worsening of conditions, or experiences during the pandemic, which are a result of physical and psychologically COVID-19 related factors. These adolescents are forced to deal with unsupportive families due to sexual orientation, with the lack of social and medical support in connection to various pre-pandemic disorders, with an added stress concerning their futures, and with dealing with new and old stress from previous traumas [ 21 , 22 , 23 , 26 , 29 , 33 ]. These groups of adolescents have always experienced more challenges, but the pandemic has significantly affected the quality of life of these adolescents.

5. Conclusions and Recommendations

Whether in the U.S. or abroad, the COVID-19 pandemic has impacted adolescent mental health. Stressful life events, extended home confinement, worry, overuse of the internet and social media are factors that could influence the mental health of adolescents during this pandemic. Adolescents from across the world face mental challenges due to COVID-19. Despite the uncertainty of the current crisis, it is important that adolescents receive the physical and mental care that they need to develop, to grow, and to thrive. Therefore, it is important to seek and to use all of the available resources and therapies to help adolescents mediate the adjustments caused by the pandemic. More research is needed on the improvement of adolescent mental health during COVID-19 and similar disasters. Among many interventions, more emphasis may be suggested on the global implementation of telemedicine to address the psychological needs of adolescents [ 34 ].

Author Contributions

Conceptualization, A.K.M.; Data Extraction, E.A.K.J. and A.K.M.; Validation, A.K.M.; Original Draft Preparation, E.A.K.J.; Review and Editing, A.K.M. and A.R.B. All authors have read and agreed to the published version of the manuscript.

This research received no external funding.

Institutional Review Board Statement

Informed consent statement, data availability statement, conflicts of interest.

The authors declare no conflict of interest.

Publisher’s Note: MDPI stays neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Origin Resolved? 'Smoking Gun' Evidence Shows COVID-19 Deliberately Engineered in Chinese Lab, Scientist Says

A British professor who addressed the UN recently and suggested COVID-19 may have originated in a Chinese laboratory claimed to have evidence that has reached “the level of a smoking gun.”

Richard H. Ebright , a molecular biologist from Rutgers University, raised the possibility that the virus responsible for millions of deaths worldwide could have been artificially created at the Wuhan Institute of Virology in China, according to the Wall Street Journal .

Ebright pointed to evidence from a 2018 document from the lab, indicating the potential manipulation of a virus to enhance its transmissibility to humans.

“[The document] elevates the evidence provided by the genome sequence from the level of noteworthy to the level of a smoking gun,” Ebright said in the article.

The document, associated with a grant proposal named Project DEFUSE, outlined experiments to engineer bat coronaviruses.

Although the proposal was rejected by the US Defense Advanced Research Projects Agency, there are suspicions that similar research might have been conducted in Wuhan with Chinese government support.

Nicholas Wade , a former science editor at The New York Times, suggested that viruses developed according to the DEFUSE protocol could have been available around the time when COVID-19 emerged between August and November 2019.

Wade also highlighted the unique genetic features of the coronavirus, indicating its potential laboratory origin.

Unlike most viruses, which require adaptation to infect humans, SARS-CoV-2 seemed preadapted for human transmission, resembling the conditions outlined in the DEFUSE protocol.

While the debate over the pandemic's origins continues, Ebright pointed to the EcoHealth Alliance's controversial research as potentially contributing to COVID-19's development.

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The release of the 2018 documents through a Freedom of Information Act request shed light on proposals to modify bat coronaviruses for increased transmissibility. Safety concerns at the Wuhan lab were noted, indicating conditions below US standards.

Dr. Filippa Lentzos , an associate professor at King's College London, stressed the need for stricter regulations in pandemic research during a UN session.

Lentzos presented findings from the Independent Task Force on Research with Pandemic Risks, urging global adherence to rigorous safety standards to prevent future outbreaks. Despite uncertainties surrounding COVID-19's origins, Lentzos emphasized the importance of learning from past events to prevent future ambiguous incidents, The Telegraph reported.