Informed Consent in COVID-19-Research: An Ethical Analysis of Clinical Studies Performed during the Pandemic

Voit, Katja; Skuban, T.; Orzechowski, Marcin; Steger, Florian

doi:10.3390/healthcare11121793

Cited by 3 publications

(1 citation statement)

References 26 publications

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“… 5 10 11 12 Ethical questions has been raised for exceptional allowances during a pandemic such as delayed consent or consent by a proxy, waiver of informed consent for studies using electronic medical charts or surveys under public health emergencies. 13 14 15 16 Despite growing scholarly reflections on pandemic responses for research ethics at the level of institutions and academic communities, government responses for research ethics have been left as lacuna in the literature. Although previous studies called for government policy changes on research ethics, what governments actually implemented those measures during the COVID-19 pandemic have been less explored comprehensively.…”

Section: Introductionmentioning

confidence: 99%

Government Initiatives for Research Ethics During COVID-19 Pandemic in Korea

Park,

Kim

2024

J Korean Med Sci

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Background Despite the growing necessity for government-led policy changes on clinical research ethics during pandemic, the scope of previous literature is limited to Korean government’s pandemic response strategies or reflections of research ethics at the level of institutions and academic societies. This paper examines the proactive policy changes and responses by the South Korean government in addressing the challenges and issues of research ethics against the backdrop of the urgency of rapid development and emergency supply of medical products during the coronavirus disease 2019 (COVID-19) pandemic. Methods We conducted searches of various government documents, using predetermined keywords related to research ethics and integrity during the COVID-19 pandemic. Only documents issued by governments or public institutions were included. A total of 24 documents were selected for analysis. They were divided into two phases: the first phase for urgent response (January 2020–February 2021) and the second phase (March 2021–February 2023) for long-term preparedness. Results The Korean government recommended several measures of research governance to accelerate the ethical review of COVID-related research to be shortened less than one week: the joint operation of Institutional Review Boards (IRBs), exempted or expedited review by a special review committee, guidelines for urgent reviews, and designation of the Korean Academy of Medical Sciences as the supervising agency for the Clinical Trial Safety Support Institution as well as the Central IRB. It allowed temporary non-face-to-face methods for informed consent process (telephone explanations and a photo of the original signed consent) and clinical trials (telephone counselling and prescription, proxy prescription, and drug delivery and supply to clinical trial participants, and online ethics training). Conclusion As a result of South Korea’s commitment to ethical principles in their pandemic response, the medical system did not experience collapses due to the pandemic, and pandemic research was conducted with careful ethical considerations. The pandemic ethics immunization during the Middle East respiratory syndrome epidemic in 2015 laid the foundation for prompt government initiatives that ensured both pandemic research ethics and pandemic response ethics.

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Section: Introductionmentioning

confidence: 99%

Government Initiatives for Research Ethics During COVID-19 Pandemic in Korea

Park,

Kim

2024

J Korean Med Sci

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Research ethics and integrity in the DACH region during the COVID-19 pandemic: balancing risks and benefits under pressure

Seedall,

Tambornino

2024

Research Ethics

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This scoping review maps research ethics and integrity challenges and best practices encountered by research actors in the DACH countries (Germany, Austria, and Switzerland), including researchers, funders, publishers, research ethics committees, and policymakers, during the COVID-19 pandemic. The COVID-19 pandemic brought research and, in turn, research ethics and integrity, into public focus. This review identified challenges related to changing research environments, diversity in research, publication and dissemination trends, scientific literacy and trust in science, recruitment, research redundancy and study termination, placebo and human challenge studies, data management, and informed consent. These challenges are linked to two crucial factors: first, actors in the DACH research ecosystem lacked a sound knowledge base to assess the risks and benefits of research during the COVID-19 pandemic. Second, researchers in the DACH region faced pressure from policymakers, funders, and the public to generate relevant, timely, and consistent findings to mitigate the impacts of the COVID-19 pandemic. In addition, this review highlights best practices to mitigate the effects of future crises on research ethics and integrity, including enhanced cooperation among actors, continuous ethics assessments, and support for public scientific literacy.

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A scoping review of ethics review processes during public health emergencies in Africa

Orievulu,

Hinga,

Nkosi

et al. 2024

BMC Med Ethics

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Background The COVID-19 pandemic forced governments, multilateral public health organisations and research institutions to undertake research quickly to inform their responses to the pandemic. Most COVID-19-related studies required swift approval, creating ethical and practical challenges for regulatory authorities and researchers. In this paper, we examine the landscape of ethics review processes in Africa during public health emergencies (PHEs). Methods We searched four electronic databases (Web of Science, PUBMED, MEDLINE Complete, and CINAHL) to identify articles describing ethics review processes during public health emergencies and/or pandemics. We selected and reviewed those articles that were focused on Africa. We charted the data from the retrieved articles including the authors and year of publication, title, country and disease(s) reference, broad areas of (ethical) consideration, paper type, and approach. Results Of an initial 4536 records retrieved, we screened the titles and abstracts of 1491 articles, and identified 72 articles for full review. Nine articles were selected for inclusion. Of these nine articles, five referenced West African countries including Liberia, Guinea and Sierra Leone, and experiences linked to the Ebola virus disease. Two articles focused on South Africa and Kenya, while the other two articles discussed more general experiences and pitfalls of ethics review during PHEs in Africa more broadly. We found no articles published on ethics review processes in Africa before the 2014 Ebola outbreak, and only a few before the COVID-19 outbreak. Although guidelines on protocol review and approval processes for PHEs were more frequently discussed after the 2014 Ebola outbreak, these did not focus on Africa specifically. Conclusions There is a gap in the literature about ethics review processes and preparedness within Africa during PHEs. This paper underscores the importance of these processes to inform practices that facilitate timely, context-relevant research that adequately recognises and reinforces human dignity within the quest to advance scientific knowledge about diseases. This is important to improve fast responses to PHEs, reduce mortality and morbidity, and enhance the quality of care before, during, and after pandemics.

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Informed Consent in COVID-19-Research: An Ethical Analysis of Clinical Studies Performed during the Pandemic

Cited by 3 publications

References 26 publications

Government Initiatives for Research Ethics During COVID-19 Pandemic in Korea

Government Initiatives for Research Ethics During COVID-19 Pandemic in Korea

Research ethics and integrity in the DACH region during the COVID-19 pandemic: balancing risks and benefits under pressure

A scoping review of ethics review processes during public health emergencies in Africa

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