Clinical trials in South Africa, key ethical issues in the process of realising a valid informed consent
Date
2012-04
Authors
Green-Thompson, Marilene Wendy
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Abstract
A valid Informed consent (IC) is the cornerstone of good
research ethics practice from clinical trials to social science
research. My research report will explore the idea of IC from its
first known beginnings to its many facets as now recognised in
the literature. One of my focuses is on the Nuremberg Code
which I consider to still carry the fundamental ethical ideals
concerning research involving human participants. As I identify
the many obstacles to achieving a valid informed consent, it will
be clear that in the context of a developing or ‘low income’
country, that a valid informed consent should be taken very
seriously as it involves much more than just a research
participant putting his or her signature on a piece of paper. In
research, particularly in clinical trials where the scientific or
clinical impact is potentially very great and in which much money
has been invested, researchers should be aware that often their
participants hold different views of what participation involves.
For example, some may view participation in a clinical trial as a
means of obtaining medical treatment they would otherwise not
receive. One of the many barriers to realizing a valid informed
consent that I consider is the problem of the increasing length of
informed consent forms. This, I will suggest represents a shift
from the ethical ideal of protecting human participants in
research.
Rather, it seems to represent as a protection from possible
liability on the part of the industry-sponsor. In my
research report, I also identify particular South African legislation
and research ethics guidelines which should guide good
research practice in South Africa. I point out that there are
many laws, research ethics guidelines and regulations that have
been implemented due to the atrocities of the past (and present)
regarding using people in experimentation and the gross human
right violations that accompanied these. Yet, in spite of these, I
identify the many barriers that are present in obtaining a valid
informed consent as well as the recognition that it is a process. A
valid informed consent has at its ethical grounding respect for
the dignity and worth of every human being. This research report
hopes to add to the discussion concerning the importance of a
valid informed consent in research involving human participants.
Description
A research report submitted to the Faculty of Health Sciences,
University of the Witwatersrand, in partial fulfilment of the
requirements for the degree
Master of Science in Medicine (Bio-Ethics and Health Law)
Johannesburg 2012