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9 Haramaya L. Rev. 1 (2020)

handle is hein.journals/haramlr9 and id is 1 raw text is: HARAMAYALAWREVIEW, Vol. 9 (2020) ISSN: 2227-2178 (P) & 2305-3739 (E)
To cite this article: Asmelash Yohannes Teklu, Exploring the Legal Regime that Govern Proxy
Consent in Biomedical Research in Ethiopia, HARAMAYA LAW REVIEW 9 (2020):1-18
EXPLORING THE LEGAL REGIME THAT GOVERN PROXY CONSENT IN
BIOMEDICAL RESEARCH IN ETHIOPIA
Asmelash Yohannes Teklu*
Abstract
It 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.
Keywords: advance directive, biomedical research, Ethiopian legal system, incompetent patient,
proxy consent
I.    INTRODUCTION
The Ethiopian law on best interest of a person mainly covers issues that are related to
finance and property matters though best interest decisions can also be associated with medical
treatments or participation of a patient in clinical trial. The later one can involve decisions over
the life or death of an incapacitated person, which cannot be treated lightly. If a person cannot
*Mekelle University School of Law, LL.B (Mekelle University), LL.M (Erasmus Rotterdam University, the
Netherlands), PhD (University of Lincoln, UK). The author can be reached at ateklu4m & ail.com.
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