Informed consent during pandemics: Experimental medicine, experienced consent

M Botes


No known cure exists for COVID-19, and medical practitioners are exhausted and at their wits’ end trying to find treatments that prevent patients from ending up in hospital or intensive care, or even dying. A variety of treatments tried by medical practitioners include standard registered medicine, investigational or so-called experimental, unapproved or preapproved medicines, emergency or compassionate-use authorised medicine and pre-market approved medicine. However, the medicines that can be accessed via each of these categories are at different stages of efficacy testing and knowledge about adverse effects, dosages and risks. To obtain ethical and legal informed consent, medical practitioners must deal with a lot of medical uncertainty, and care must be taken to ensure that the patient understands the difference in risks they may be willing to take depending on the medicine’s stage of development. Often additional information is required to obtain ethical consent as opposed to legal consent. A purely legal approach to informed consent, especially when dealing with the medical uncertainties of health emergencies and pandemics, may lead to patients’ consent lacking in enough substance to be truly considered legal and ethical. Informed consent as respect for autonomy in this sense requires more than the patient’s explicit agreement or compliance with a certain treatment proposal. This article explains the difference in consent content attached to each different stage of a medicine’s development, especially considering the additional difficulties posed by obtaining truly informed consent during a pandemic with uncertain characteristics, treatment and solutions.

Author's affiliations

M Botes, SnT Interdisciplinary Centre for Security, Reliability and Trust, University of Luxembourg, Esch-sur-Alzette, Luxembourg, and School of Law, College of Law and Management Studies, University of KwaZulu-Natal, Durban, South Africa

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Cite this article

South African Journal of Bioethics and Law 2021;14(3):93. DOI:10.7196/SAJBL.2021.v14i3.770

Article History

Date submitted: 2022-01-28
Date published: 2022-01-28

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