What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research

Emanuel, Ezekiel J.; Wendler, David; Killen, Jack; Grady, Christine

doi:10.1086/381709

Cited by 693 publications

(477 citation statements)

References 41 publications

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“…However, in order to deliver “well‐reasoned judgements” (p. 457) 22 and avoid “poorly justified responses” or “unjustified variations” 23 (p.15) in judgements we hope that RECs will use norms in guidance to render their judgements (more below), while not undermining “efficient processes” 22, 23. We also argue that review of engagement is supported by a leading ethics framework, namely, the “Emanuel Framework” 24, 25. The Emanuel Framework 24 provides a comprehensive and coherent way for “ethics reviewers” to “evaluate a protocol and to determine whether it fulfils ethical standards” (p. 131‐132).…”

Section: Discussionmentioning

confidence: 99%

Strengthening stakeholder engagement through ethics review in biomedicalHIVprevention trials: opportunities and complexities

et al. 2018

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IntroductionClinical trials of biomedical HIV prevention modalities require the cooperation of multiple stakeholders. Key stakeholders, such as community members, may have stark vulnerabilities. Consequently, calls for HIV prevention researchers to implement “stakeholder engagement” are increasingly common. Such engagement is held to benefit inter‐stakeholder relations, stakeholders themselves and the research itself. The ethics review process presents a unique opportunity to strengthen stakeholder engagement practices in HIV prevention trials. However, this is not necessarily straightforward. In this article, we consider several complexities. First, is stakeholder engagement a legitimate component of what Research Ethics Committees (RECs) should review for HIV prevention trials? Second, what are the core features of engagement that should be under ethics review? Third, what are the key practices that should be highlighted in ethics review?MethodsTo address these questions, we examined the international ethics guidelines specialized for such trials (UNAIDS 2012, UNAIDS‐AVAC GPP 2011) and directly applicable to such trials (CIOMS 2016; WHO 2011). Thematic analysis was used to code and analyse these guidelines.Results and discussionEthics guidelines support REC review of engagement. Guidance recommends that engagement be broad and inclusive; early and sustained; and dynamic and responsive. Broad engagement practices include evaluating the context, planning in writing, and resourcing. RECs should assess engagement as part of a comprehensive review, and recommend revisions where necessary. Researchers should profile key elements of engagement valued in ethics guidance, when they draft ethics submissions. Importantly, the ethics review process should not undermine the ‘dynamic responsiveness’ required for excellent engagement in this field.ConclusionsAs evidence‐informed engagement strategies emerge, these should inform the ethics submission and review process. Both parties in the review process should strive to avoid a superficial, check‐list type approach that caricatures what should be a thorough, nuanced ethics review of a rich, responsive engagement process.

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Section: Discussionmentioning

confidence: 99%

Strengthening stakeholder engagement through ethics review in biomedicalHIVprevention trials: opportunities and complexities

et al. 2018

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“…The experiences from the HIV/AIDS epidemic demonstrated that an environment allowing the rigorous evaluation of potential treatments is dependent on an extensive dialogue between affected communities, scientists, and regulatory agencies. Emanuel et al [70] (adapted by Lane et al [71]) formulated core ethical and scientific principles for trial conduct in an outbreak setting in developing countries: 1) ethical conduct to avoid exploitation, including respect for volunteers, local community engagement, and carefully informed consent involving the community to establish recruitment procedures and incentives; 2) partnership with investigators and officials in affected countries, including the identification of interested local investigators, strengthen the local trial infrastructure, and shared best practices of regulator oversight; 3) scientific validity, including a favorable risk-benefit ratio to the study population and sound trial design; 4) independent review and scientific oversight, ensuring public accountability through transparency and mandated reviews, including the oversight of an independent and skilled Data and Safety Monitoring Board; and 5) transparency, including the prompt sharing of data with practitioners and affected communities. To improve clinical trial Breadiness^in outbreak settings, prospective planning may include the installation of clinical trial networks, centralized institutional review board approvals [72], as well as novel trial designs such as platform trials, which allow a rapid implementation of therapies once they become available [73].…”

Section: Clinical Trials In An Outbreak Settingmentioning

confidence: 99%

Clinical Trials in Neurovirology: Successes, Challenges, and Pitfalls

Haubenberger

Clifford

2016

Neurotherapeutics

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Clinical trials in neurovirology illustrate the special challenges confronting investigators planning to study these conditions, as well as the contributions of successful trials in establishing appropriate management for these devastating diseases. This article reviews key examples of progress in neurovirology that have been spurred by clinical trials, emphasizing human herpes virus encephalitis, HIV, and JC virus. Clinical trials in the setting of neurovirological diseases are characterized by specific challenges, which may include small sample sizes, clinical presentations from life-threatening conditions to chronic courses of disease, regional and temporally restricted outbreaks scenarios, and the unavailability of validated diagnostic tests that can be rapidly deployed at the bedside. This review aims to highlight these methodological challenges and pitfalls in designing and executing clinical neurovirology trials, as well as to outline innovative trial designs, which could be useful in addressing common challenges.

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“…Responsible development of AAL technologies demands substantial analysis of the ethical issues, which might occur during R&D, clinical trials or eventual clinical application (Emanuel, Wendler, and Grady, 2000;Emanuel, Wendler, Killen, et al, 2004). During these stages of development, various claims and interests emerge from different stakeholders.…”

Section: Scope Of Papermentioning

confidence: 99%

A Review of Contemporary Work on the Ethics of Ambient Assisted Living Technologies for People with Dementia

Novitzky

Smeaton

Chen³

et al. 2014

Sci Eng Ethics

117

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Ambient assisted living (AAL) technologies can provide assistance and support to persons with dementia. They might allow them the possibility of living at home for longer whilst maintaining their comfort and security as well as offering a way towards reducing the huge economic and personal costs forecast as the incidence of dementia increases worldwide over coming decades. However, the development, introduction and use of AAL technologies also trigger serious ethical issues. This paper is a systematic literature review of the on-going scholarly debate about these issues. More specifically, we look at the ethical issues involved in research and development (R&D), clinical experimentation, and clinical application of AAL technologies for people with dementia and related stakeholders. In the discussion we focus on: 1) the value of the goals of AAL technologies, 2) the special vulnerability of persons with dementia in their private homes, 3) the complex question of informed consent for the usage of AAL technologies.

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What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research

Cited by 693 publications

References 41 publications

Strengthening stakeholder engagement through ethics review in biomedicalHIVprevention trials: opportunities and complexities

Strengthening stakeholder engagement through ethics review in biomedicalHIVprevention trials: opportunities and complexities

Clinical Trials in Neurovirology: Successes, Challenges, and Pitfalls

A Review of Contemporary Work on the Ethics of Ambient Assisted Living Technologies for People with Dementia

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