MSc (Med)Bioethics and Health Law, Faculty of Health Sciences, University of the Witwatersrand, 2009 / The application of informed consent in research in developing countries continues to be
a topical and complex issue. The debate concerning informed consent has become
even more relevant in light of the groundswell of international collaborative research that
is conducted in developing countries. The discussion centres on the uncertainties of the
application of informed consent in developing countries based on the normative criteria
set out in international codes and regulations. Although the ethical and legal basis of
obtaining valid informed consent is incontestable, contextual differences between
developed and developing countries is a key problem. For example, it is debated if the
tenets of ‘Western’ research ethics, mainly in the application of a written informed
consent model can truly be applied in the African context.
The question is whether the participants of research when conducted in developing
countries actually are “informed” in the consent process. There are perceptions that the
protective instruments that guide researchers on how to obtain informed consent from
research participants are not robust and sensitive enough for developing countries
needs. In literature, some have questioned the relevance of its purist application in the
context of developing countries as ‘overly paternalistic’. Others have argued from the
view point that the Eurocentric approach recommended in obtaining informed consent in
developing countries has the potential to undermine cultural norms and traditions. In the
latter argument, concerns are raised about the principle of respect for persons /
‘autonomy’ and its applicability in so-called communitarian societies. To overcome some
unique hurdles, there are voices that call for tailor-made processes for obtaining
informed consent to suit the prevailing context, suggesting therefore that there should
be some variance in its application. The importance of the issue of informed consent
becomes critical as much international collaborative research takes place in Africa
where health services are often inadequate and research is perceived by participants as
a means of ameliorating some of their suffering.
Given the philosophical and the ‘universal’ ethical foundations at the heart of the
international regulations and codes on the issue of informed consent, there is a need to
further explore the foundation of these perceptions as they raise various ethical issues
which need to be discussed.
The question concerned in this research report is “is there unfinished business not
addressed in the process of obtaining informed consent in developing countries?”
In order to answer this question, it is necessary to look at some of the requisites for the
application of informed consent principles. I will examine whether the content of the
commonly cited ethical codes and regulations (originally initiated in developed
countries) are sufficiently broad enough to explain the aims of obtaining informed
consent, the steps to be taken in obtaining informed consent and the structures
necessary for its facilitation. In addition I will examine whether the intent of the codes
and regulations take cognizance of socio-cultural variations. In other words, is the
environment sufficiently conducive to apply the concept and are the guidelines flexible
enough to deal with “unusual circumstances”. In consideration of the latter, I consider
the question of the adequacy of structures to ensure the essence of respect for persons
is not lost in dealing with “unusual circumstances”. I contend that if the answer is in the
affirmative it is only then can it be said that the principles of informed consent are being
adequately addressed and meet the moral, ethical, and legal obligations of research
activities.
| Identifer | oai:union.ndltd.org:netd.ac.za/oai:union.ndltd.org:wits/oai:wiredspace.wits.ac.za:10539/7518 |
| Date | 17 February 2010 |
| Creators | Tsotsi, Norma Mabel |
| Source Sets | South African National ETD Portal |
| Language | English |
| Detected Language | English |
| Type | Thesis |
| Format | application/pdf |
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