Exploring the legal regime that govern proxy consent in biomedical research in Ethiopia

Abstract

t has become a trend throughout the world for biomedical researchers to rely on proxy consent. Many countries have specific legislation dealing with proxy consent which is not, however, the case in Ethiopia as the Ethiopian law recognizes only two types of consent: implicit consent and explicit consent. These types of consent are not suitable for biomedical research since they can only be made by patients who are competent enough to understand the legal consequences of their decision. Biomedical researchers who want to do clinical trial/research on incompetent patients normally rely on proxy consent. If a person cannot make a decision by himself due to lack of capacity, there must be someone (a proxy/surrogate) who is legally empowered to make a decision for him. The proxy should rely on advance directives/living wills for making a decision. In the absence of advance directive, the proxy needs to have a legal backing while making medical and care decisions on behalf of an incapacitated person. If there is no such legal protection, the proxy and the researcher will obviously face uncertainty. This Article aims at exploring the Ethiopian law on proxy consent and the possibility of introducing new legislation on the same subject matter. To this end, the pertinent domestic and international laws as well as relevant literature are analyzed. It is argued that the current legal system of Ethiopia is deficient in many respects when it comes to the issue of patient-proxy relationship. Therefore, a comprehensive legislation should be introduced for the purpose of regulating proxy consent and other matters that would affect the health and well-being of incapacitated persons.