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1.
Mayo Clin Proc ; 96(1): 165-173, 2021 01.
Article in English | MEDLINE | ID: covidwho-1065439

ABSTRACT

Biospecimen research is a prominent investigative strategy that aims to provide novel insights into coronavirus disease 2019 (COVID-19), inform clinical trials, and develop effective, life-saving treatments. However, COVID-19 biospecimen research raises accompanying ethical concerns and practical challenges for investigators and participants. In this special article, we discuss the ethical issues that are associated with autonomy, beneficence, and justice in COVID-19 biospecimen research and describe strategies to manage the practical challenges, with an emphasis on protecting the rights and welfare of human research participants during a pandemic response. Appropriate institutional review board oversight and bioethics guidance for COVID-19 biospecimen research must maintain their focus on protecting the rights and welfare of research participants, despite the urgent need for more knowledge about the virus and the threat it poses to communities and nations.


Subject(s)
Biomedical Research/ethics , Ethicists , Ethics Committees, Research , Ethics, Research , Biological Specimen Banks , Humans , Pandemics
2.
Am J Public Health ; 111(2): 212-214, 2021 02.
Article in English | MEDLINE | ID: covidwho-1060327
4.
BMC Med Ethics ; 22(1): 6, 2021 01 25.
Article in English | MEDLINE | ID: covidwho-1045603

ABSTRACT

BACKGROUND: Critical public health measures implemented to mitigate the spread of the novel coronavirus disease (COVID-19) pandemic have disrupted health research worldwide, including HIV prevention research. While general guidance has been issued for the responsible conduct of research in these challenging circumstances, the contours of the dueling COVID-19 and HIV/AIDS pandemics raise some critical ethical issues for HIV prevention research. In this paper, we use the recently updated HIV Prevention Trials Network (HPTN) Ethics Guidance Document (EGD) to situate and analyze key ethical challenges related to the conduct of HIV prevention research during the COVID-19 pandemic as well as identify potential areas for refinement of the guidance document based on this unprecedented state of affairs. MAIN BODY: Necessary actions taken for HIV prevention research studies due to the COVID-19 pandemic involve an array of ethical issues including those related to: (1) risk mitigation; (2) behavior change; (3) compounding vulnerability; (4) community engagement; (5) trial reopening; and 6) shifting research priorities. CONCLUSIONS: In the context of the dueling HIV and COVID-19 global pandemics, research teams and sponsors must be nimble in responding to the rapidly changing environment by being sensitive to the associated ethical issues. The HTPN EGD provides a rich set of tools to help identify, analyze and address many of these issues. At the same time, future refinements of the HPTN EGD and other research ethics guidance could be strengthened by providing explicit advice regarding the ethical issues associated with disrupted research and the reopening of studies. In addition, additional consideration should be given to appropriately balancing domains of risk (e.g., physical versus social), addressing the vulnerability of research staff and community partners, and responding to un-anticipatable ancillary care needs of participants and communities. Appropriately addressing these issues will necessitate conceptual work, which would benefit from the careful documentation of the actual ethical issues encountered in research, the strategies implemented to overcome them, and their success in doing so. Throughout all of these efforts, it is critical to remember that the HIV pandemic not be forgotten in the rush to deal with the COVID-19 pandemic.


Subject(s)
Biomedical Research/ethics , Codes of Ethics , Ethics , HIV Infections/prevention & control , Pandemics , /epidemiology , Ethics, Research , Global Health , Health Services , Health Services Research/ethics , Humans , Public Health , Research Personnel , Residence Characteristics , Risk
6.
Vaccine ; 39(4): 633-640, 2021 01 22.
Article in English | MEDLINE | ID: covidwho-894255

ABSTRACT

This report of the WHO Working Group for Guidance on Human Challenge Studies in COVID-19 outlines ethical standards for COVID-19 challenge studies. It includes eight Key Criteria related to scientific justification, risk-benefit assessment, consultation and engagement, co-ordination of research, site selection, participant selection, expert review, and informed consent. The document aims to provide comprehensive guidance to scientists, research ethics committees, funders, policymakers, and regulators in deliberations regarding SARS-CoV-2 challenge studies by outlining criteria that would need to be satisfied in order for such studies to be ethically acceptable.


Subject(s)
Biomedical Research/ethics , /prevention & control , Human Experimentation/ethics , Informed Consent/ethics , /pathogenicity , Antiviral Agents/administration & dosage , /immunology , Ethics Committees, Research/organization & administration , Healthy Volunteers , Human Experimentation/legislation & jurisprudence , Humans , Patient Selection/ethics , Vaccination/ethics , World Health Organization
8.
Annu Rev Virol ; 7(1): 475-494, 2020 09 29.
Article in English | MEDLINE | ID: covidwho-865856

ABSTRACT

The conduct of clinical trials during the West Africa Ebola outbreak in 2014 highlighted many ethical challenges. How these challenges were addressed, what clinical studies were conducted during that outbreak, and the lessons learned for dealing with future outbreaks were the subject of a National Academy of Medicine committee report titled Integrating Clinical Research into Epidemic Response: The Ebola Experience. This report suggested improvements for research during subsequent emerging or re-emerging outbreaks and is summarized in this review. We also discuss the current Ebola outbreak in the Democratic Republic of the Congo and highlight how the dialogue has changed and how successful clinical trials have been implemented. We conclude with a description of productive efforts to include pregnant women and children in therapeutic and vaccine trials during outbreaks that are currently ongoing.


Subject(s)
Biomedical Research/ethics , Clinical Trials as Topic/ethics , Disease Outbreaks , Ebolavirus/pathogenicity , Hemorrhagic Fever, Ebola/epidemiology , Patient Selection/ethics , Adult , Africa, Western/epidemiology , Antiviral Agents/therapeutic use , Biomedical Research/organization & administration , Child , Clinical Trials as Topic/organization & administration , Ebola Vaccines/administration & dosage , Female , Hemorrhagic Fever, Ebola/immunology , Hemorrhagic Fever, Ebola/mortality , Hemorrhagic Fever, Ebola/prevention & control , Humans , International Cooperation , Male , Pregnancy , Survival Analysis
11.
Vaccine ; 38(41): 6381-6387, 2020 09 22.
Article in English | MEDLINE | ID: covidwho-708025

ABSTRACT

BACKGROUND: A sense of urgency exists to develop vaccines against SARS CoV-2, responsible for numerous global cases and deaths, as well as widespread social and economic disruption. Multiple approaches have been proposed to speed up vaccine development, including accelerated randomized controlled trials (RCT), controlled human challenge trials (CHI), and wide distribution through an emergency use authorization after collecting initial data. There is a need to examine how best to accelerate vaccine development in the setting of a pandemic, without compromising ethical and scientific norms. METHODS: Trade-offs in scientific and social value between generating reliable evidence about safety and efficacy while promoting rapid vaccine availability are examined along five ethically relevant dimensions: (1) confidence in and generalizability of data, (2) feasibility, (3) speed and cost, (4) participant risks, and (5) social risks. RESULTS: Accelerated individually randomized RCTs permit expeditious evaluation of vaccine candidates using established methods, expertise, and infrastructure. RCTs are more likely than other approaches to be feasible, increase speed and reduce cost, and generate reliable data about safety and efficacy without significantly increasing risks to participants or undermining societal trust. CONCLUSION: Ethical analysis suggests that accelerated RCTs are the best approach to accelerating vaccine development in a pandemic, and more likely than other approaches to enhance social value without compromising ethics or science. RCTs can expeditiously collect rigorous data about vaccine safety and efficacy. Innovative and flexible designs and implementation strategies to respond to shifting incidence and test vaccine candidates in parallel or sequentially would add value, as will coordinated data sharing across vaccine trials. CHI studies may be an important complementary strategy when more is known. Widely disseminating a vaccine candidate without efficacy data will not serve the public health nor achieve the goal of identifying safe and effective SARS Co-V-2 vaccines.


Subject(s)
Betacoronavirus/immunology , Biomedical Research/ethics , Coronavirus Infections/prevention & control , Drug Development/ethics , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Humans , Vaccination/ethics , Viral Vaccines/immunology
12.
mBio ; 11(4)2020 08 07.
Article in English | MEDLINE | ID: covidwho-705638

ABSTRACT

Proponents of the use of gain-of-function (GOF) experiments with pathogens with pandemic potential (PPP) have argued that such experiments are necessary because they reveal important facets of pathogenesis and can be performed safely. Opponents of GOF experiments with PPP have argued that the risks outweigh the knowledge gained. The COVID-19 pandemic demonstrates the vulnerability of human societies to a new PPP, while also validating some arguments of both camps, questioning others, and suggesting the need to rethink how we approach this class of experiments.


Subject(s)
Betacoronavirus/genetics , Coronavirus Infections/virology , Gain of Function Mutation , Pneumonia, Viral/virology , Biomedical Research/ethics , Biomedical Research/standards , Bioterrorism , Containment of Biohazards/ethics , Containment of Biohazards/standards , Coronavirus Infections/epidemiology , Coronavirus Infections/prevention & control , Humans , Influenza A Virus, H5N1 Subtype/genetics , Influenza, Human/epidemiology , Influenza, Human/virology , Pandemics/prevention & control , Pneumonia, Viral/epidemiology , Pneumonia, Viral/prevention & control
15.
Vaccine ; 38(33): 5085-5088, 2020 07 14.
Article in English | MEDLINE | ID: covidwho-680832

ABSTRACT

While a human challenge study holds the prospect of accelerating the development of a vaccine for the coronavirus SARS-CoV-2, it may be opposed due to risks of harm to participants and researchers. Given the increasing number of human deaths and severe disruption to lives worldwide, we argue that a SARS-CoV-2 challenge study is ethically justifiable as its social value substantially outweighs the risks. Such a study should therefore be seriously considered as part of the global research response towards the COVID-19 pandemic. In this paper, we contribute to the debate by addressing the misperception that a challenge study for the coronavirus would lower scientific and ethical standards for vaccine research and development, and examine how it could be ethically conducted. We also set out information that needs to be disclosed to prospective participants to obtain their consent.


Subject(s)
Biomedical Research/ethics , Coronavirus Infections/prevention & control , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Vaccination/ethics , Viral Vaccines/therapeutic use , Betacoronavirus , Humans , Informed Consent , Pandemics/ethics , Risk , Viral Vaccines/administration & dosage
16.
BMC Med ; 18(1): 209, 2020 07 07.
Article in English | MEDLINE | ID: covidwho-656279

ABSTRACT

Rapid development of an effective vaccine for SARSCoV2 is a global priority. A controlled human infection model (CHIM) would accelerate the efficacy assessment of candidate vaccines. This strategy would require deliberate exposure of volunteers to SARSCoV2 with no currently available treatment and a small but definite risk of serious illness or death. This raises complex questions about the social and ethical acceptability of risk to individuals, given the potential benefit to the wider population, and as such, a study cannot be done without public involvement. We conducted a structured public consultation with 57 individuals aged 20-40 years to understand public attitudes to a CHIM, and pre-requisites for enrolment. The overall response to this strategy was positive, and many would volunteer altruistically. Carefully controlled infection is viewed as safer than natural exposure to wild virus. The prolonged social isolation required for the proposed CHIM is considered an obstacle but not insurmountable, with reasonable compensation and supportive care. Given the significant level of public interest, a CHIM should be done as open science with regular, controlled dissemination of information into the public domain. Importantly, there was a strong view that the final decision whether to conduct a CHIM should be in the hands of qualified and experienced clinician-scientists and the authorities.


Subject(s)
Attitude to Health , Biomedical Research/ethics , Coronavirus Infections/prevention & control , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Viral Vaccines/therapeutic use , Adult , Betacoronavirus , Drug Development , Female , Focus Groups , Humans , Male , Patient Selection , Public Opinion , Referral and Consultation , United Kingdom , Young Adult
19.
mSphere ; 5(4)2020 07 15.
Article in English | MEDLINE | ID: covidwho-646344

ABSTRACT

Human infection challenge studies involving the intentional infection of research participants with a disease-causing agent have recently been suggested as a means to speed up the search for a vaccine for the ongoing coronavirus disease 2019 (COVID-19) outbreak. Calls for challenge studies, however, rely on the expected social value of these studies. This value represents more than the simple possibility that a successful study will lead to the rapid development and dissemination of vaccines but also some expectation that this will actually occur. I show how this expectation may not be realistic in the current political moment and offer potential ways to make sure that any challenge trials that arise actually achieve their goals.


Subject(s)
Biomedical Research/ethics , Biomedical Research/methods , Clinical Trials as Topic/ethics , Coronavirus Infections/drug therapy , Coronavirus Infections/prevention & control , Pandemics/prevention & control , Pneumonia, Viral/drug therapy , Pneumonia, Viral/prevention & control , Betacoronavirus , Ethics, Research , Humans , Social Values , Viral Vaccines/therapeutic use
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