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Ethical review of off-label drugs during the COVID-19 pandemic.

ABSTRACT: High-quality scientific research is very important in attempting to effectively control the coronavirus disease 2019 (COVID-19) pandemic and ensure people's health and safety. Chloroquine (CQ) and hydroxychloroquine (HCQ) have received much attention. This article comprehensively investigates the ethical review of off-label CQ and HCQ research during the COVID-19 pandemic with regard to strictly abiding by review standards, improving review efficiency, ensuring the rights and interests of subjects and that ethics committees conduct independent reviews, and achieving full ethics supervision of research conducted during an emergency. Research must be both rigorous and prudent to ensure the best outcome, with the maximization of benefits as the core principle. Standardization of the application, implementation and ethical review processes are needed to prevent unnecessary risk.

SUBMITTER: Li QY

PROVIDER: S-EPMC9258355 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature

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Ethical review of off-label drugs during the COVID-19 pandemic.

Li Qiu-Yu QY Lv Ye Y An Zhuo-Yu ZY Dai Ni-Ni NN Hong Xue X Zhang Yu Y Liang Li-Jun LJ

World journal of clinical cases 20220601 17

High-quality scientific research is very important in attempting to effectively control the coronavirus disease 2019 (COVID-19) pandemic and ensure people's health and safety. Chloroquine (CQ) and hydroxychloroquine (HCQ) have received much attention. This article comprehensively investigates the ethical review of off-label CQ and HCQ research during the COVID-19 pandemic with regard to strictly abiding by review standards, improving review efficiency, ensuring the rights and interests of subjec ...[more]

PMID: 35979109

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Project description:BackgroundECMO is a particularly scarce resource during the COVID-19 pandemic. Its allocation involves ethical considerations that may be different to usual times. There is limited pre-pandemic literature on the ethical factors that ECMO physicians consider during ECMO allocation. During the pandemic, there has been relatively little professional guidance specifically relating to ethics and ECMO allocation; although there has been active ethical debate about allocation of other critical care resources. We report the results of a small international exploratory survey of ECMO clinicians' views on different patient factors in ECMO decision-making prior to and during the COVID-19 pandemic. We then outline current ethical decision procedures and recommendations for rationing life-sustaining treatment during the COVID-19 pandemic, and examine the extent to which current guidelines for ECMO allocation (and reported practice) adhere to these ethical guidelines and recommendations.MethodsAn online survey was performed with responses recorded between mid May and mid August 2020. Participants (n = 48) were sourced from the ECMOCard study group-an international group of experts (n = 120) taking part in a prospective international study of ECMO and intensive care for patients during the COVID-19 pandemic. The survey compared the extent to which certain ethical factors involved in ECMO resource allocation were considered prior to and during the pandemic.ResultsWhen initiating ECMO during the pandemic, compared to usual times, participants reported giving more ethical weight to the benefit of ECMO to other patients not yet admitted as opposed to those already receiving ECMO, (p < 0.001). If a full unit were referred a good candidate for ECMO, participants were more likely during the pandemic to consider discontinuing ECMO from a current patient with low chance of survival (53% during pandemic vs. 33% prior p = 0.002). If the clinical team recommends that ECMO should cease, but family do not agree, the majority of participants indicated that they would continue treatment, both in usual circumstances (67%) and during the pandemic (56%).ConclusionsWe found differences during the COVID-19 pandemic in prioritisation of several ethical factors in the context of ECMO allocation. The ethical principles prioritised by survey participants were largely consistent with ECMO allocation guidelines, current ethical decision procedures and recommendations for allocation of life-sustaining treatment during the COVID-19 pandemic.

Project description:BackgroundEthical conflict is a problem with negative consequences, which can compromise the quality and ethical standards of the nursing profession and it is a source of stress for health care practitioners', especially for nurses.ObjectivesThe main aim of this study was to analyze Spanish critical care nurses' level of exposure to ethical conflict and its association with sociodemographic, occupational, and COVID-19-related variables. Research Design, Participants, and Research context: This was a quantitative cross-sectional descriptive study conducted among 117 nurses working in critical care units. Data collection tools were sociodemographic, occupational, and COVID-19-related questionnaires and previously validated Spanish version of Ethical Conflict in Nursing Questionnaire-Critical Care Version.Ethical considerationsWe obtained permission from the Ethics Committee and participants' informed consent.FindingsData indicates a moderate level of exposure to ethical conflicts. The most frequent ethical conflicts were related to situations about "treatment and clinical procedures." The most intensity of ethical conflicts was related to situations about "treatment and clinical procedures" and "dynamics of the service and working environment." No statistical significance was identified between the socio-demographic variables and level of exposure to ethical conflicts. However, for critical care nurses working in ICU, nurses with perceived worked stress had a higher level of exposure to ethical conflicts. Likewise, critical care nurses whose family/friends were infected with COVID-19 had a higher level of exposure.ConclusionsCritical care nurses experience a moderate level of exposure to ethical conflicts which is consistent with the results of previous studies. A deeper understanding of ethical conflicts in conflictive situations allows recognition of the situations that occur in everyday clinical practice, identification of the ethical conflicts, and facilitation of the nurses working in the challenging clinical situation.

Project description: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.

Dataset Information

Ethical review of off-label drugs during the COVID-19 pandemic.

Publications

Ethical review of off-label drugs during the COVID-19 pandemic.

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