Informed Consent for Scholarly Articles during the COVID-19 Pandemic

Jones, Xaviar Michael; Zimba, Olena; Gupta, Latika

doi:10.3346/jkms.2021.36.e31

Cited by 4 publications

(4 citation statements)

References 28 publications

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“…COVID-19 continues to disrupt scientific and clinical studies and to shift research, publishing ethics, and the dynamics of the peer reviewing process to a new normal. 17 18 However, research quality and integrity should not be compromised despite the innovations in research methodology and situations related to the current health crisis.…”

Section: Discussionmentioning

confidence: 99%

Impact of COVID-19 Pandemic on Biomedical Publications and Their Citation Frequency

et al. 2022

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Background The coronavirus disease 2019 (COVID-19) pandemic has resulted in enormous related publications. However, the citation frequency of these documents and their influence on the journal impact factor (JIF) are not well examined. We aimed to evaluate the impact of COVID-19 on biomedical research publications and their citation frequency. Methods We searched publications on biomedical research in the Web of Science using the search terms “COVID-19,” “SARS-Cov-2,” “2019 corona*,” “corona virus disease 2019,” “coronavirus disease 2019,” “novel coronavirus infection” and “2019-ncov.” The top 200 journals were defined as those with a higher number of COVID-19 publications than other journals in 2020. The COVID-19 impact ratio was calculated as the ratio of the average number of citations per item in 2021 to the JIF for 2020. Results The average number of citations for the top 200 journals in 2021, per item published in 2020, was 25.7 (range, 0–270). The average COVID-19 impact ratio was 3.84 (range, 0.26–16.58) for 197 journals that recorded the JIF for 2020. The average JIF ratio for the top 197 journals including the JIFs for 2020 and 2021 was 1.77 (range, 0.68–8.89). The COVID-19 impact ratio significantly correlated with the JIF ratio (r = 0.403, P = 0.010). Twenty-five Korean journals with a COVID-19 impact ratio > 1.5 demonstrated a higher JIF ratio (1.31 ± 0.39 vs. 1.01 ± 0.18, P < 0.001) than 33 Korean journals with a lower COVID-19 impact ratio. Conclusion COVID-19 pandemic infection has significantly impacted the trends in biomedical research and the citation of related publications.

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Section: Discussionmentioning

confidence: 99%

Impact of COVID-19 Pandemic on Biomedical Publications and Their Citation Frequency

et al. 2022

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“…Pandemics like these may even call for common documents for risk disclosure and audio/video/electronic consent. 33 34 …”

Section: Research Submission Process and Exemptionsmentioning

confidence: 99%

Ethics Committees: Structure, Roles, and Issues

Mehta,

Zimba,

Gasparyan

et al. 2023

J Korean Med Sci

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An Ethics Committee (EC) is an independent body composed of members with expertise in both scientific and nonscientific arenas which functions to ensure the protection of human rights and the well-being of research subjects based on six basic principles of autonomy, justice, beneficence, nonmaleficence, confidentiality, and honesty. MEDLINE, Scopus, and Directory of Open Access Journals were searched for studies relevant to this topic. This review is focused on the types of research articles that need EC approval, the submission process, and exemptions. It further highlights the constitution of ECs, their duties, the review process, and the assessment of the risk-benefit of the proposed research including privacy issues. It’s pertinent for academicians and researchers to abide by the rules and regulations put forth by ECs for upholding of human rights and protecting research subjects primarily, as well as avoiding other issues like retraction of publications. Despite various issues of cost, backlogs, lack of expertise, lesser representation of laypersons, need for multiple approvals for multisite projects, conflicts of interest, and monitoring of ongoing research for the continued safety of participants, the ECs form the central force in regulating research and participant safety. Data safety and monitoring boards complement the ECs for carrying out continuous monitoring for better protection of research subjects. The establishment of ECs has ensured safe study designs, the safety of human subjects along with the protection of researchers from before the initiation until the completion of a study.

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“…Moreover, most documents were lacking some fundamental information, such as the indication of what would happen to the placebo group in case other vaccines were proven safe and effective. 74 Moreover, with regards to the broader consent procedures, scant time was made available for face-to-face communication between the participant and investigator, as the latter had to fulfill the dual responsibility of treating patients and researching possible cures and vaccines in clinical trials 75 ; in some cases, consent had to be obtained virtually. 76 In such a scenario, further characterized by the need to proceed with a swift enrollment of participants, too small emphasis was put on the informed consent procedure.…”

Section: Issues In the Informed Consentmentioning

confidence: 99%

Fast‐tracking development and regulatory approval of COVID‐19 vaccines in the EU: A review of ethical implications

Beretta

Marelli

2023

Bioethics

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The rapid spread of SARS‐CoV‐2 worldwide has triggered intense activity in the field of biotechnology, leading to the development and regulatory approval of multiple COVID‐19 vaccines in less than 1 year while raising sustained scrutiny as to the ethical issues associated with this process. This article pursues a twofold objective. First, it reconstructs and provides a thorough overview of the different steps, from clinical trial design to regulatory procedures, underpinning the “fast‐tracking” of COVID‐19 vaccine R&D and approval. Second, drawing on a review of published literature, the article identifies, outlines, and analyzes the most ethically challenging aspects related to such process, including concerns around vaccine safety, issues in study design, the enrollment of study participants, and the challenges in obtaining valid informed consent. By scrutinizing relevant aspects of COVID‐19 vaccine development and regulatory processes leading to market authorization, this article ultimately aims to provide a comprehensive overview of the regulatory and ethical issues underpinning the roll‐out of this key pandemic‐containment technology worldwide.

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Informed Consent for Scholarly Articles during the COVID-19 Pandemic

Cited by 4 publications

References 28 publications

Impact of COVID-19 Pandemic on Biomedical Publications and Their Citation Frequency

Impact of COVID-19 Pandemic on Biomedical Publications and Their Citation Frequency

Ethics Committees: Structure, Roles, and Issues

Fast‐tracking development and regulatory approval of COVID‐19 vaccines in the EU: A review of ethical implications

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