New ethical considerations in vaccine trials

Molyneux, Malcolm E.

doi:10.1080/21645515.2016.1272744

Cited by 9 publications

(8 citation statements)

References 13 publications

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“…The exclusion of children and pregnant women was an ethical concern during the Ebola outbreak in LMICs [18,69], compounded by challenges of obtaining complex consent [2, 4, 5, 15, 18, 21, 25, 32, 34, 44-46, 50, 69, 70]. Ethical issues also arose around equity in access to health care for participants and nonparticipants [44,50,59]. There were calls for international standards for the conduct of emergency research [21,51,60,62], [51], acceptable study designs [14] and simplified consent methods [2,3,6,25,37,46,51,70,74].…”

Section: Disseminationmentioning

confidence: 99%

“…Integrating all stakeholders into each step of the developing research programme [3,48,69], engaging communities as partners [1,3] and gaining an understanding of power dynamics [34] were facilitators cited to address this. It was also emphasised that interventions need to be culturally sensitive [27,29,44,50,51,58] and respond to national as well as global need [36]. Examples of community engagement included regular information sessions [3,5,16,29,34,42,[69][70][71], joint communication plans [20,29], outreach health promotion teams [69] and formation of community advisory boards [69].…”

Section: Community Engagementmentioning

confidence: 99%

“…Key actions identifiedDomainKey actions identified Political and economic challenges Establish effective, coordinated, equitable collaborations between international and national organisations involved in public health emergencies at all levels[1,3,7, ,13, 14, 18, 19, 21, 22, 24, 26, 27, 35, 37, 39-41, 51, 52, 54, 57-60] include national stakeholders[26,38] and systems for evaluating the impact, regular reviews and updating[19] Develop pre-designed and pre-approved study protocols and associated tools for different scenarios[1,3,4, 13, 15, 17, 20, 29, 34, 37, 41, 46, 48, 50, 51, 55, 56, 61-63] Establish accelerated pathways for regulatory and ethical joint approvals [1, 2, 6, 7, 13, 18, 20, 21, 32, 34, 37, 40, 41, 45, 49, 51, 53, 56, 64-66] Set up pre-approved site agreements [4, 15, 38, 45, 46, 48, 61] Establish international data and sample sharing agreements and templates [7, 13, 18, 20, 22, 24, 25, 27, 28, 35, 44, 48, 52, 57, 58, 62, 67, 68] Establish coordinated, effective internal and external stakeholder communication and communication plans [3, 5, 14, 16, 18, 20, 23, 25, 29, 32, 34, 42, 46, 58, 65, 69-72] Ethical emergency publication agreements with focus on timely, open data sharing[2,22,38,52,68,73] Ethical and social challenges Explore and trial less complex consent models during emergencies[2,6,15,25,32,37,44,46,48,51,69,70,74] Develop frameworks for ethical and scientifically robust study designs for various epidemic and pandemic scenarios[6, 13, 14, 17-19, 22, 27, 34, 36, 40, 42, 48, 51, 60, 61, 66, 75-77] Develop international guidelines on ethical standards and conduct for emergencies, including inclusion of vulnerable groups[5,18,21,22,27,…”

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confidence: 99%

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Addressing challenges for clinical research responses to emerging epidemics and pandemics: a scoping review

Sigfrid

Maskell

Bannister

et al. 2020

BMC Med

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Background: Major infectious disease outbreaks are a constant threat to human health. Clinical research responses to outbreaks generate evidence to improve outcomes and outbreak control. Experiences from previous epidemics have identified multiple challenges to undertaking timely clinical research responses. This scoping review is a systematic appraisal of political, economic, administrative, regulatory, logistical, ethical and social (PEARLES) challenges to clinical research responses to emergency epidemics and solutions identified to address these. Methods: A scoping review. We searched six databases (MEDLINE, Embase, Global Health, PsycINFO, Scopus and Epistemonikos) for articles published from 2008 to July 2018. We included publications reporting PEARLES challenges to clinical research responses to emerging epidemics and pandemics and solutions identified to address these. Two reviewers screened articles for inclusion, extracted and analysed the data. Results: Of 2678 articles screened, 76 were included. Most presented data relating to the 2014-2016 Ebola virus outbreak or the H1N1 outbreak in 2009. The articles related to clinical research responses in Africa (n = 37), Europe (n = 8), North America (n = 5), Latin America and the Caribbean (n = 3) and Asia (n = 1) and/or globally (n = 22). A wide range of solutions to PEARLES challenges was presented, including a need to strengthen global collaborations and coordination at all levels and develop pre-approved protocols and equitable frameworks, protocols and standards for emergencies. Clinical trial networks and expedited funding and approvals were some solutions implemented. National ownership and community engagement from the outset were a key enabler for delivery. Despite the wide range of recommended solutions, none had been formally evaluated.

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Section: Disseminationmentioning

confidence: 99%

Section: Community Engagementmentioning

confidence: 99%

mentioning

confidence: 99%

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Addressing challenges for clinical research responses to emerging epidemics and pandemics: a scoping review

Sigfrid

Maskell

Bannister

et al. 2020

BMC Med

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“…4 For example, the presence of severe risks to populations during an epidemic may limit the ability of human subjects to give legitimate, uncoerced consent. 5 Additionally, emergency circumstances can heighten the risk that research ethics are deprioritised or disregarded; for instance, the urgency of an active outbreak may compel researchers to speed up, abbreviate or modify informed consent procedures. 3 In other cases, emergencies will inspire proposals for new, extraordinary research strategies, such as the human challenge trials that recently have received renewed attention as a potential component of stage III clinical trials for COVID-19 vaccines.…”

Section: Introductionmentioning

confidence: 99%

Ethical considerations for epidemic vaccine trials

Monrad

2020

J Med Ethics

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Vaccines are a powerful measure to protect the health of individuals and to combat outbreaks such as the COVID-19 pandemic. An ethical dilemma arises when one effective vaccine has been successfully developed against an epidemic disease and researchers seek to test the efficacy of another vaccine for the same pathogen in clinical trials involving human subjects. On the one hand, there are compelling reasons why it would be unethical to trial a novel vaccine when an effective product exists already. First, it is a firm principle of medical ethics that an effective treatment or vaccine should not be withheld from patients if their life may depend on it. Second, since epidemic outbreaks often emerge in settings with less-resourced health systems, there is a pronounced risk that any trial withholding an effective vaccine would disproportionately affect the vulnerable populations that historically have been exploited for biomedical research. Third, clinical trials for novel vaccines may be at odds with efforts to control active outbreaks. On the other hand, it may be justified to conduct a trial for a candidate vaccine if it is expected to have certain advantages compared with the existing product. This essay discusses key factors for comparing vaccines against epidemic pathogens, including immunological, logistical and economic considerations. Alongside a case study of the development of vaccines for Ebola, the essay seeks to establish a general framework that should be expanded and populated by immunologists, epidemiologists, economists and bioethicists, and ultimately could be applied to the case of COVID-19 vaccines.

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“…The ethical issues differ in each category; for example, ethical guidelines for clinical research is a critical area that has been much discussed and debated with focus on areas such as informed consent 8 . Transparency in the way the trials are being conducted and the ability to adhere to the various guidelines on clinical trials due to the fast tracking are important areas of scrutiny from a public accountability point of view.…”

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confidence: 99%