Ethical frameworks in clinical research processes during COVID-19: a scoping review

Abstract

ObjectivesIn response to the COVID-19 pandemic there have been significant developments in research, its conduct and the supporting ethical framework. While many protocols have been delayed, halted or modified, other research efforts have been accelerated, generating controversy. The goal of this paper is to determine the rates of references surrounding the ethical oversight of research as reported in current COVID-19-related research publications.DesignScoping review.SettingPopulation-based observational or interventional studies from December 2019 to May 2020 with sample size of two or more. Studies were searched through electronic databases including Medline, EMBASE, and Cochrane CENTRAL Register of Controlled Trials.ParticipantsEligibility criteria included participants within published studies who tested positive for COVID-19.Main outcomes and measuresData were extracted and charting methods included taking note of references to ethical frameworks, institutional review board (IRB), ethics committee (EC) or research ethics board (REB) involvement, consent processes, and other variables.Results11 556 articles were screened, with 656 included in the final analysis. References to ethics were present in 530 (80.8%) studies, with 491 (74.8%) involving IRB/ECs/REBs and 126 (19.2%) not referencing ethics. Consent processes were outlined in 201 (30.6%) studies, with 198 (30.2%) reporting that they obtained consent waivers, however, 257 (39.2%) did not mention consent at all. Differences (p<0.001) in ethics-related references were apparent when analysed by continent, publication type, sample size and IF.ConclusionsThe majority of published articles pertaining to COVID-19 research made mention of ethical considerations, however, national and regional variations in research ethics review requirements introduce heterogeneity between studies and raise important questions about the conduct of scientific research during global public emergencies.Trial registration numberOpen Science Framework: https://osfio/z67wb.

The Impact of the COVID-19 Pandemic on Oncology Care and Clinical Trials

“…In practice this means more hospital and health check visits, both prior to initiating the treatment and once the treatment has begun. This combination of the potential risk of severe SARS-CoV-2 infection in cancer patients and the stringent requirements of trial monitoring has had a significant impact on clinical trial activity [33].…”

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“…Researchers and scientists were under pressure to conduct research and find rapid solutions to contain the spread of the virus and mitigate its impact. 36,37 While the urgency of the situation called for expedited research, it was crucial that COVID-19 research adhered to scientific standards and ethical compliance.…”

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“…These critical positions focus not only on the lack of innovative attitudes but also on other research deficits that can also affect psychology. Various authors complain about the following shortcomings of COVID-19 research, partly deriving the criticisms from surveys of scientists themselves (Carley et al, 2020; Holmes et al, 2020; Kasherman et al, 2021; Rijs & Fenter, 2021; Zeeb et al, 2021):Research has been carried out with predominantly small studies.Longitudinal studies have remained comparatively rare.There are only a few randomized studies (e.g., on preventive measures).Shortcomings in ethical obligations are highlighted (e.g., a lack of informed consent).Clinical studies that have also investigated the effect on other diseases from the point of view of their course are presented too rarely.Various risk groups were neglected (e.g., people with diabetes).The pandemic has had only a minor impact on everyday research; it has become of little importance for topic-related fundraising. It is also feared that the pandemic will hinder the funding of other research topics.There has been a low transfer of scientific findings to political decision-makers.Networked research in interdisciplinary contexts and in the sense of future preparatory cooperative activities is lacking.The criteria of Evidence-Based Medicine (EBM) have not been sufficiently flexible (e.g., to allow for the use of new methodologies). It remains to be examined whether and in which places the following Special Issue takes these criticisms into account and does not also present only affirmative research results.…”

“…These critical positions focus not only on the lack of innovative attitudes but also on other research deficits that can also affect psychology. Various authors complain about the following shortcomings of COVID-19 research, partly deriving the criticisms from surveys of scientists themselves (Carley et al, 2020;Holmes et al, 2020;Kasherman et al, 2021;Rijs & Fenter, 2021;Zeeb et al, 2021): 1. Research has been carried out with predominantly small studies.…”