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Gwen Lemey; Trésor Zola; Ynke Larivière; Solange Milolo; Engbu Danoff; Lazarre Bakonga; Emmanuel Esanga; Peter Vermeiren; Vivi Maketa; Junior Matangila; Patrick Mitashi; Pierre Van Damme; Jean-Pierre Van geertruyden; Raffaella Ravinetto; Hypolite Muhindo-Mavoko – Research Ethics, 2024
In this paper, we discuss challenges associated with implementing a policy for Ancillary Care (AC) for related and unrelated (serious) adverse events during an Ebola vaccine trial conducted in a remote area of the Democratic Republic of the Congo. Conducting clinical trials in resource-constrained settings can raise context-related challenges that…
Descriptors: Foreign Countries, Immunization Programs, Communicable Diseases, Researchers
Tiwonge K. Mtande; Carl Lombard; Gonasagrie Nair; Stuart Rennie – Research Ethics, 2024
Although the use of the cluster randomized trial (CRT) design to evaluate vaccines, public health interventions or health systems is increasing, the ethical issues posed by the design are not adequately addressed, especially in low- and middle-income country settings (LMICs). To help reveal ethical challenges, qualitative interviews were conducted…
Descriptors: Stakeholders, Ethics, Randomized Controlled Trials, Medical Research
Klaus Leisinger; Doris Schroeder – Research Ethics, 2024
The COVID-19 pathogen led to a fast expanding pandemic because it proved lethal in certain populations but could be transmitted by persons who appeared healthy. As a result, researchers came under unprecedented time pressure to develop a vaccine. This case study focuses on the first COVID-19 vaccine, which was approved for use in humans, known as…
Descriptors: Scientific Research, Research Methodology, Immunization Programs, COVID-19
Charles Weijer – Research Ethics, 2024
The COVID-19 pandemic touched off an unprecedented search for vaccines and treatments. Without question, the development of vaccines to prevent COVID-19 was an enormous scientific accomplishment. Further, the RECOVERY and Solidarity trials identified effective treatments for COVID-19. But all was not success. The urgent need for COVID-19…
Descriptors: COVID-19, Pandemics, Immunization Programs, Research and Development
Tambornino, Lisa; Lanzerath, Dirk – Research Ethics, 2020
To reduce the global burden of the COVID-19 pandemic, there is an urgent need to develop a safe vaccine. Vaccine development usually takes many years as it goes through several different phases. To hasten COVID-19 vaccine development, it has been suggested that the final stage could be replaced with a human challenge trial (HCT). Volunteers would…
Descriptors: COVID-19, Pandemics, Immunization Programs, Ethics
Dawson, Angus – Research Ethics, 2020
It has been proposed that the urgency of having a vaccine as a response to SARS-CoV-2 is so great, given the potential health, economic and social benefits that we should override the established steps in the research development process. In this article I argue that whilst there are some opportunities to expedite the production of a vaccine, it…
Descriptors: COVID-19, Pandemics, Immunization Programs, Research Methodology
Bompart, Francois – Research Ethics, 2020
Hundreds of clinical trials of potential treatments and vaccines for the "coronavirus 19 disease" (COVID-19) have been set up in record time. This is a remarkable reaction to the global pandemic, but the absence of a global coordination of clinical research efforts raises serious ethical concerns. Some COVID-19 patients might carry the…
Descriptors: COVID-19, Pandemics, Medical Research, Ethics
Tangwa, Godfrey B.; Munung, Nchangwi Syntia – Research Ethics, 2020
COVID-19 is a very complex pandemic. It has affected individuals, different countries and regions of the world equally in some senses and differently in other senses. While sub-Saharan Africa has weathered a range of outbreaks of emerging and re-emerging infectious diseases, the manner in which the COVID-19 pandemic has evolved necessitates some…
Descriptors: Foreign Countries, COVID-19, Pandemics, African Culture
Chappell, Richard Yetter; Singer, Peter – Research Ethics, 2020
There is too much that we do not know about COVID-19. The longer we take to find it out, the more lives will be lost. In this paper, we will defend a principle of "risk parity": if it is permissible to expose some members of society (e.g. health workers or the economically vulnerable) to a certain level of "ex ante" risk in…
Descriptors: COVID-19, Pandemics, Medical Research, Risk
Kumar, Nandini K.; Muthuswamy, Vasantha – Research Ethics, 2020
The COVID-19 pandemic has brought unprecedented, major challenges to the ethical conduct of research including challenges for the rapid and robust ethical review of biomedical research. The Indian Council of Medical Research's "National Guidelines for Ethics Committees Reviewing Biomedical and Health Research during COVID-19 Pandemic"…
Descriptors: COVID-19, Pandemics, Medical Research, Ethics