Paper short abstract:

The negotiations of standard operating procedures (SOP) in the context of vaccine trials conducted during the recent Ebola outbreak, took place between WHO, governments, researchers and clinical staff. Consent and participation posed a challenge, as SOPs and epidemiological needs were not congruent.

Paper long abstract:

Clinical trials are governed by rational and standard operating procedures (SOPs) to ensure correct procedure, scientific validity - and govern emotional implications of risks and hopes. Powerful hierarchies in personnel and institutions exist to ensure SOPs' application into the routine practices of trials, separating clinicians' and researchers' charges.

This paper examines the negotiations of SOPs in the context of vaccine trials developed and executed during the 2014-15 outbreak of Ebola Virus Disease (EVD). International and national research and clinical staff's debates of "humanitarian use" or epidemiological necessities of trial substances during the heights of the different outbreaks are at the centre of the paper. Questions of limitations of SOPs arose due to an overall perception of "crisis", a highly emotional state that allowed for arguments of exceptionality, necessity and compromise as opposed to the routine rational of clinical trials that these professionals are otherwise signatory to. Informed consent protocols were not easily harmonised with national epidemiological measures, for example in ring trials, resulting in compromising SOPs through harsh security measures.