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1.
J Infect Dis ; 225(6): 934-937, 2022 03 15.
Article in English | MEDLINE | ID: covidwho-1740886

ABSTRACT

The world's first coronavirus disease 2019 human challenge trial using the D614G strain of severe acute respiratory syndrome 2 (SARS-CoV-2) is underway in the United Kingdom. The Wellcome Trust is funding challenge stock preparation of the Beta and Delta variant for a follow-up human challenge trial, and researchers at hVIVO are considering conducting these trials. However, little has been written thus far about the ethical justifiability of human challenge trials with SARS-CoV-2 variants of concern. We explore 2 specific characteristics of some variants that may initially be thought to make such trials unethical and conclude that SARS-CoV-2 variant challenge trials can remain ethical.


Subject(s)
COVID-19 Vaccines/administration & dosage , COVID-19/prevention & control , Ethics, Research , SARS-CoV-2/genetics , COVID-19 Vaccines/adverse effects , COVID-19 Vaccines/immunology , Ethics , Humans , United Kingdom , Vaccines
2.
Am J Bioeth ; 22(1): 64-65, 2022 Jan.
Article in English | MEDLINE | ID: covidwho-1603216
3.
J Korean Med Sci ; 36(50): e338, 2021 Dec 27.
Article in English | MEDLINE | ID: covidwho-1596045

ABSTRACT

Generating a testable working hypothesis is the first step towards conducting original research. Such research may prove or disprove the proposed hypothesis. Case reports, case series, online surveys and other observational studies, clinical trials, and narrative reviews help to generate hypotheses. Observational and interventional studies help to test hypotheses. A good hypothesis is usually based on previous evidence-based reports. Hypotheses without evidence-based justification and a priori ideas are not received favourably by the scientific community. Original research to test a hypothesis should be carefully planned to ensure appropriate methodology and adequate statistical power. While hypotheses can challenge conventional thinking and may be controversial, they should not be destructive. A hypothesis should be tested by ethically sound experiments with meaningful ethical and clinical implications. The coronavirus disease 2019 pandemic has brought into sharp focus numerous hypotheses, some of which were proven (e.g. effectiveness of corticosteroids in those with hypoxia) while others were disproven (e.g. ineffectiveness of hydroxychloroquine and ivermectin).


Subject(s)
COVID-19/drug therapy , Research Design , SARS-CoV-2 , COVID-19/epidemiology , Ethics, Research , Humans , Peer Review , Pilot Projects , Publishing
4.
EMBO Rep ; 23(1): e54184, 2022 01 05.
Article in English | MEDLINE | ID: covidwho-1572993

ABSTRACT

Human challenge trials to deliberately infect volunteers with SARS-CoV-2 should inspire wider debates about research ethics and participants' motivations to take part in such studies.


Subject(s)
COVID-19 , Pandemics , Ethics, Research , Humans , Pandemics/prevention & control , SARS-CoV-2
5.
J Empir Res Hum Res Ethics ; 17(1-2): 213-222, 2022.
Article in English | MEDLINE | ID: covidwho-1518237

ABSTRACT

The global COVID-19 pandemic and quarantine/distancing measures have forced researchers to cope with a new situation. This paper aimed to analyze how the pandemic and its associated constraints have affected social researchers' approach to research ethics. Drawing on an online qualitative survey with 193 Polish social researchers conducted in April and May 2020, we distinguished three approaches: nothing has changed, opportunity-oriented, and precautionary. According to the first, the pandemic was not regarded as a situation that required additional reflection on ethical issues or changes in research approaches. By contrast, the other two were based on the assumption that the pandemic affected research project ethics. The difference was in the assessment of changes in the area of ethics. The pandemic presented an opportunity and a threat to the ethicality of research, respectively. We discuss the implications of all three approaches for research and education.


Subject(s)
COVID-19 , Pandemics , Ethics, Research , Humans , Research Personnel , SARS-CoV-2
6.
BMC Med Ethics ; 22(1): 147, 2021 11 06.
Article in English | MEDLINE | ID: covidwho-1506573

ABSTRACT

BACKGROUND: Research has been an essential part of the COVID-19 pandemic response, including in Latin American (LA) countries. However, implementing research in emergency settings poses the challenge of producing valuable knowledge rapidly while upholding research ethical standards. Research ethics committees (RECs) therefore must conduct timely and rigorous ethics reviews and oversight of COVID-19 research. In the LA region, there is limited knowledge on how countries have responded to this need. To address this gap, the objective of our project is to explore if LA countries developed policies to streamline ethics review and oversight of research in response to the pandemic while ensuring its adherence to ethical standards, and to analyze to what extent these governance frameworks are in accordance with international guidance. METHODS: We conducted a descriptive and exploratory study assessing the COVID-19 research ethics governance frameworks of 19 LA countries, considering 4 dimensions based on international COVID-19 ethics guidance documents: (i) ethics review organizational model adopted, (ii) measures to coordinate between RECs and other research stakeholders, (iii) operational guidance for RECs, and (iv) key ethical issues for review and oversight of COVID-19 research. RESULTS: 10 out of 19 LA countries have some policy to streamline ethics review of COVID-19 research. Of these countries only 6 issued comprehensive documents following international guidance that contemplate strategies with recommendations for concrete actions for a timely and rigorous review. CONCLUSION: LA countries adopted partial strategies and operational guidance that may demonstrate a lack of a comprehensive view of research ethics for the review and oversight of COVID-19 research. Continuing efforts should be directed to strengthen LA countries' research capacity to respond timely and ethically to future health emergencies. Past lessons and the ones from this pandemic should be the basis to develop international standards and operational guidelines for ethics review and oversight of any research for public health emergencies.


Subject(s)
COVID-19 , Ethics Committees, Research , Ethics, Research , Humans , Latin America , Pandemics , SARS-CoV-2
8.
J Infect Dis ; 225(6): 934-937, 2022 03 15.
Article in English | MEDLINE | ID: covidwho-1462360

ABSTRACT

The world's first coronavirus disease 2019 human challenge trial using the D614G strain of severe acute respiratory syndrome 2 (SARS-CoV-2) is underway in the United Kingdom. The Wellcome Trust is funding challenge stock preparation of the Beta and Delta variant for a follow-up human challenge trial, and researchers at hVIVO are considering conducting these trials. However, little has been written thus far about the ethical justifiability of human challenge trials with SARS-CoV-2 variants of concern. We explore 2 specific characteristics of some variants that may initially be thought to make such trials unethical and conclude that SARS-CoV-2 variant challenge trials can remain ethical.


Subject(s)
COVID-19 Vaccines/administration & dosage , COVID-19/prevention & control , Ethics, Research , SARS-CoV-2/genetics , COVID-19 Vaccines/adverse effects , COVID-19 Vaccines/immunology , Ethics , Humans , United Kingdom , Vaccines
10.
Ethics Hum Res ; 43(5): 42-44, 2021 Sep.
Article in English | MEDLINE | ID: covidwho-1396864

ABSTRACT

With the rapid spread of SARS-CoV2 has come a rapid proliferation of clinical research studies, resulting in considerable strain on research ethics committees (RECS), which need to review study proposals. RECs are pressured to move through the review process quickly so that studies can get underway to address the pandemic. These committees are also asked to increase efficiency without relaxing the standards for ethical review. RECs are accustomed to external pressure for approval from investigators; however, in the Covid-19 era, this pressure is coming from not only the sponsors and investigators but also many other stakeholders, including world leaders, the community, the media, and professional organizations. Drawing on the authors' experiences on a central REC reviewing complex multicenter Covid-19 studies, this commentary describes challenges that are inherent to Covid-19 research studies, such as the difficulty of obtaining informed consent from patients ill with the highly infectious virus. The commentary recommends several steps that RECs can take to ensure ethical review of research studies during the Covid-19 pandemic and future infectious disease outbreaks.


Subject(s)
COVID-19 , Ethics Committees, Research/standards , Ethics, Research , Biomedical Research/ethics , Biomedical Research/standards , Humans , Informed Consent
12.
J Postgrad Med ; 67(3): 134-138, 2021.
Article in English | MEDLINE | ID: covidwho-1367979

ABSTRACT

Objectives: We evaluated the extent of consent declines and consent withdrawals during the COVID-19 pandemic as seen in published randomized controlled trials (RCTs) and compared it with non-COVID-19 RCTs published at the same time and two historical controls. Methods: PubMed/Medline only was searched using key-word "COVID-19" and "RCTs" separately, and filtered for COVID-19 RCTs and non-COVID-19 RCTs respectively, published during a nine-month period (1 Feb - 1 Nov 2020). Exclusions were study protocols, observational studies, interim analysis of RCT data and RCTs with missing data. Primary outcome measures were the proportion of consent declines and consent withdrawals as percentage of total participants screened and randomized respectively in COVID-19 RCTs. We compared consent declines and consent withdrawals of COVID-19 RCTs with non-COVID-19 RCTs and two earlier studies on the same topic that served as historical controls (non-pandemic setting). Results: The search yielded a total of 111 COVID-19 RCTs and 49 non-COVID-19 RCTs. Of these, 39 (35.13%) COVID-19 RCTs and 11 (22.45%) non-COVID-19 RCTs were finally analysed. A total of 770/17759 (4.3%) consent declines and 100/7607 (1.31%) consent withdrawals were seen in 39 COVID-19 RCTs. A significant difference was observed in consent declines between COVID-19 vs non-COVID-19 RCTs [4.3% vs 11.9%, p < 0.0001] and between COVID-19 RCTs vs two historical controls [(4.3% vs 8.6%, p < 0.0001) and (4.3% vs 21.1%, p < 0.0001), respectively]. Conclusion: RCTs conducted during the COVID-19 pandemic appear to have significantly lower consent declines relative to non-COVID-19 RCTs during pandemic and RCTs conducted in non-pandemic settings.


Subject(s)
COVID-19 , Informed Consent , Patient Selection/ethics , Randomized Controlled Trials as Topic , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19/therapy , Ethics, Research , Humans , Informed Consent/ethics , Informed Consent/legislation & jurisprudence , Informed Consent/standards , Randomized Controlled Trials as Topic/ethics , Randomized Controlled Trials as Topic/methods , SARS-CoV-2
13.
Narrat Inq Bioeth ; 11(1): 1-6, 2021.
Article in English | MEDLINE | ID: covidwho-1344143

ABSTRACT

This symposium is separated into two sections. The first includes twelve personal stories from IRB members, administrators, or staff about their experiences during the COVID-19 pandemic. The second section includes twelve personal stories from researchers. Six commentaries on these narratives are offered by experts in research ethics, regulatory oversite, IRB administration, the logistics of clinical research, and investigator responsibilities. These narratives and commentaries offer an inside look at how the COVID-19 pandemic affected the physical logistics of clinical research already underway, demanded immediate investment in scientific investigation of vaccines and treatments, and rerouted the usual decision pathways that guide ethical practice.


Subject(s)
Biomedical Research/ethics , COVID-19 , Ethics Committees, Research , Pandemics , COVID-19 Vaccines , Committee Membership , Ethics, Research , Humans , Narration , Research Personnel , SARS-CoV-2
14.
Narrat Inq Bioeth ; 11(1): 101-105, 2021.
Article in English | MEDLINE | ID: covidwho-1337556

ABSTRACT

In early 2020, clinicians and researchers rushed to understand the SARS-CoV-2 virus and how to go about treating and preventing it. Caring for patients while simultaneously learning about a disease not seen before created challenges on several levels. Much of the spotlight was on the researchers doing this critical work; however, these narratives remind us of the enormous effort and commitment shown by IRB members and research administrators responsible for research infrastructure. Despite the sense of urgency and obligation to plan and conduct clinical research during the pandemic, IRBs guaranteed that researchers still adhered to the core ethical principles that protect the rights and welfare of human subjects so that critical research could continue. Many themes emerge in these stories, including the need for flexibility in processes for both staff and research participants and the perception that IRB members serve as "research gatekeepers." With approaches to clinical research evolving, the SARS-CoV-2 pandemic may be the catalyst needed to make sustainable improvements to our research processes, roles, and goals.


Subject(s)
Biomedical Research/ethics , COVID-19 , Ethics Committees, Research , Pandemics , Ethics, Research , Gatekeeping , Humans , Narration , Research Personnel , Research Subjects , SARS-CoV-2
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