COVID-19 Ethics and Research

Meagher, Karen M.; Cummins, Nathan W.; Bharucha, Adil E.; Badley, Andrew D.; Chlan, Linda L.; Wright, R. Scott

doi:10.1016/j.mayocp.2020.04.019

Cited by 46 publications

(54 citation statements)

References 23 publications

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“…Testing with human subjects has long been a part of the history of medicine. The deliberate infection of volunteers provides more rapid results, although inevitably, it also involves certain risks [ 27 ].…”

Section: Discussionmentioning

confidence: 99%

“…Also, ethical principles dictate that this volunteer is already at medium-high risk of infection (COVID-19 high-risk residents), for the additional risk posed by the study to be minimal. In addition to the ideal candidate, the ideal institution that would organize the study is also important: It must allow the continuous, careful monitoring of volunteers, and have the capacity for supportive treatment established rapidly, including intensive care if necessary [ 27 ].…”

Section: Ethical Recommendations For Planning a Possible Sars-cov-2 Imentioning

confidence: 99%

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COVID-19 vaccines: ethical framework concerning human challenge studies

et al. 2020

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Background The pandemic associated with the new SARS-CoV-2 coronavirus continues to spread worldwide. The most favorable epidemic control scenario, which provides long-term protection against COVID-19 outbreak, is the development and distribution of an effective and safe vaccine. The need to develop a new COVID-19 vaccine is pressing; however, it is likely to take a long time, possibly several years. This is due to the time required to demonstrate the safety and efficacy of the proposed vaccine. and the time required to manufacture and distribute millions of doses. Objectives To accelerate this development and associated safety testing, the deliberate infection of healthy volunteers has been suggested. The purpose of this short communication is to describe the ethical aspects of this type of testing, Results Deliberate infection of volunteers with a dangerous virus such as SARS-CoV-2 was initially considered unethical by researchers; but the current pandemic is so different from previous ones that these studies are considered ethical if certain criteria are met. Participants in human challenge studies must be relatively young, in good health and must receive the highest quality medical care, with frequent monitoring. Tests should also be performed with great caution and specialized medical supervision. Besides, the fact that obtaining vaccines faster through deliberate infection studies of healthy people has greater benefits than risks, has been demonstrated by obtaining other vaccines in other historical pandemics such as: smallpox, influenza, malaria, typhoid fever, Dengue fever and Zika. Conclusions One possibility to shorten the time required for the development of COVID-19 vaccines is to reduce clinical phases II and III by using human challenge studies through eliberate infection of healthy volunteers with SARS-CoV-2 after administration of the candidate vaccine. Accelerating the development of a COVID-19 vaccine even for a few weeks or months would have a great beneficial impact on public health by saving many lives. Graphical abstract

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Section: Discussionmentioning

confidence: 99%

Section: Ethical Recommendations For Planning a Possible Sars-cov-2 Imentioning

confidence: 99%

COVID-19 vaccines: ethical framework concerning human challenge studies

et al. 2020

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“…A) The Research Ethics Committees (RECs) should update and adapt procedures to evaluate research projects in a short period of time, without affecting the quality of the reviews 10 . B) RECs should emphasize that at all time, the patients' safety continue to be at the forefront of considerations.…”

Section: Possible Measures To Lessen Risksmentioning

confidence: 99%

Bioethics in the COVID-19 Pandemic Research: Challenges and Strategies

González‐Duarte

Kaufer‐Horwitz

Aguilar-Salinas

2021

RIC

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As all other aspects in times of the coronavirus disease (COVID)-19 pandemic, carrying-out quality clinical research has been challenging. Many well-established paradigms have shifted as a consequence of the rapid demand for new knowledge. New treatments are fast-moving, informed consent forms are difficult to obtain, a competitive invitation from researchers to participate in different studies is common, and non-COVID-19 research protocols are suffering continuity. However, these challenges should not imply taking shortcuts or accepting deficiencies in bioethical standards, but rather enhance the alertness for rigorous ethical approaches despite these less than ideal circumstances. In this manuscript, we point out some interrogates in COVID-19 research and outline possible strategies to overcome the difficult task to continue with high-quality research without violating the ethical principles. (REV INVEST CLIN. [AHEAD OF PRINT]

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“…Should we justify conducting urgently required research in developing countries with more treatment-naïve potential research populations, even though the peak of infection expansion in developed countries has already waned? [5][6][7][8][9][10][11][12][13][14][15][16][17] Conventionally, academic journals have been one of the most powerful venues for scholarly discussion. However, since the COVID-19 expansion, the extent to which scholarly journals of epidemiology have served as discussion forums for ethical issues on COVID-19 has become unclear, even though many of the ethical questions noted above would likely be important for epidemiologists as well.…”

mentioning

confidence: 99%

mentioning

confidence: 99%