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

Abstract

Participant non-compliance and withdrawal from randomized clinical trials has increased focus on analysing the results from the "perprotocol" 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 bioetiquettethe set of rules specifying "proper" and "improper" trial subjects and behaviourswhich runs in the shadow of formal bioethics in trials and requires careful transdisciplinary examination.

The hidden burden of medical testing: public views and experiences of COVID-19 testing as a social and ethical process

“…People were primarily motivated to seek testing by a sense of civic duty to protect ‘society’, by a sense of solidarity with others [ 26 , 29 ] and by ethical obligations towards specific individuals within their social network. Changing social norms and expectations around symptomatic behaviours also had an influence, with evidence of an emerging testing ‘etiquette’ in the context of visible cold symptoms [ 71 ]. Trust in government and the testing system were found to be important positive enablers of participation [ 22 ].…”

SARS-CoV-2 (COVID-19) Vaccine Development and Production: An Ethical Way Forward

“…Magical thinking ("my test vaccine will work") will invariably attract participants who may enroll in the trial to be a hero: a member of the test of a vaccine that could save the world from SARS-CoV2 and prioritize their country for receiving the vaccine. 14 While RCTs are considered to be the most reliable method to assure that the resulting vaccine is safe and effective, because these trials take so long, it is highly unlikely that most novel SARS-CoV-2 vaccine trials will use RCTs with standard TPPs (i.e., proving long-lasting antibody production, minimal side effects, and appropriate dosing schedule).…”