Ethics and etiquette in an emergency vaccine trial. The orchestration of compliance.

Global Bioethics = Problemi Di Bioetica
Arsenii Alenichev

Abstract

Participant non-compliance and withdrawal from randomized clinical trials has increased focus on analysing the results from the "per-protocol" population that complies with a trial's protocols. There is no clear understanding of what shapes protocol compliance in practice. In this paper, I theorize clinical research from the perspective of participants in an Ebola vaccine trial by analysing the practices that contributed to very high compliance rates. In this setting, per-protocol compliance became an essential component in forming a class of "proper" researchers and participants working together in the rapidly expanding market of clinical research. Bioethics supports participants' right to withdraw from research as an ethical safeguard in the process. But participants seeking affiliations with powerful institutions may voluntarily embrace their trial responsibilities over a right to withdraw. To understand this phenomenon, this analysis uses the notion of bioetiquette - the set of rules specifying "proper" and "improper" trial subjects and behaviours - which runs in the shadow of formal bioethics in trials and requires careful transdisciplinary examination.

References

Jul 1, 1982·Perspectives in Biology and Medicine·Stephen Toulmin
Oct 20, 2001·Perspectives in Biology and Medicine·Judith Martin, Gunther S Stent
Mar 1, 1992·Medical Anthropology Quarterly·Patricia A Marshall
Apr 16, 2002·The American Journal of Bioethics : AJOB·T Lemmens, C Elliott
Aug 2, 2003·Journal of Neuro-oncology·Mark Bernstein
Jan 7, 2006·Statistics in Medicine·M Matilde Sanchez, Xun Chen
Jan 6, 2009·Lancet·Jonathan KimmelmanEric M Meslin
Jul 28, 2016·Perspectives in Clinical Research·Priya RanganathanRakesh Aggarwal
Oct 28, 2019·Clinical Trials : Journal of the Society for Clinical Trials·Olga ZvonarevaEvgeny Kulikov

❮ Previous
Next ❯

Citations

Jun 6, 2020·Cambridge Quarterly of Healthcare Ethics : CQ : the International Journal of Healthcare Ethics Committees·Kenneth V Iserson

❮ Previous
Next ❯

Methods Mentioned

BETA
pregnancy test
blood drawing
pregnancy tests

Software Mentioned

bioetiquette

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.

© 2021 Meta ULC. All rights reserved