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Chima's editorial on regulation of biomedical research in Africa is
welcome and highlights the potentially harmful lack of international
consensus in this area.
What is missing in his analysis is an exploration of the impact of
the imbalance of power,at an institutional and individual level.
Even where research ethics committees or institutional review boards
exist, problems may still arise. As I have argued elsewhere(1), how likely
is it that an African research ethics committee will turn down a research
proposal from a prestigious Western institution with the attendant
benefits of equipment,training, research linkages, and publication in peer
-reviewed international journals?
Similarly,in many African healthcare settings, the role of the health
worker carries great power and respect with it, which may distort the
process of obtaining consent.
These are not insurmountable problems- one practical suggestion has
been that consent could be obtained outside of the healthcare setting,
therefore removing the immediate vulnerability of a patient being asked to
consent to taking part in research, at the same time as they are being
seen for health care.
A more radical, if controversial suggestion is that rather than set
up a sham of a research governance process, researchers are required to
declare openly when publishing their results, what ethical framework they
have applied and what limitations they have faced in carrying out the
research- for example: "We did not obtain ethics approval from the
University of X as there was no ethics committee there at the time of our
study. We however applied the following principles in designng and
carrying out our study....."
These are some of the questions that African countries, philosophers
and researchers will need to grapple with as they work towards improving
research governance and protecting the vulnerable on the continent.
1) Anya I Ethics and research in developing countries
The Lancet - Vol. 362, Issue 9393, 25 October 2003, Page 1419
While working as a member of local ethics committees, I have felt
that the patient information sheet (PIS) is the key to effective
implementation of the informed consent process. The PIS needs to be
comprehensive and credible, but it also has to be concise and
comprehnsible. For this, scientific accuracy will have to be blended with
communication skills. This is where most PIS fail, both in English and in
the local languages. Unless efforts are made to train medical writers in
preparing appropriate PIS, and to train research personnel in using them
effectively, all rules and regulations will remain practically
unsuccessful. This has been one of the neglected areas in GCP training and
deserves urgent attention.
Power is also important
Chima's editorial on regulation of biomedical research in Africa is
welcome and highlights the potentially harmful lack of international
consensus in this area.
What is missing in his analysis is an exploration of the impact of
the imbalance of power,at an institutional and individual level.
Even where research ethics committees or institutional review boards
exist, problems may still arise. As I have argued elsewhere(1), how likely
is it that an African research ethics committee will turn down a research
proposal from a prestigious Western institution with the attendant
benefits of equipment,training, research linkages, and publication in peer
-reviewed international journals?
Similarly,in many African healthcare settings, the role of the health
worker carries great power and respect with it, which may distort the
process of obtaining consent.
These are not insurmountable problems- one practical suggestion has
been that consent could be obtained outside of the healthcare setting,
therefore removing the immediate vulnerability of a patient being asked to
consent to taking part in research, at the same time as they are being
seen for health care.
A more radical, if controversial suggestion is that rather than set
up a sham of a research governance process, researchers are required to
declare openly when publishing their results, what ethical framework they
have applied and what limitations they have faced in carrying out the
research- for example: "We did not obtain ethics approval from the
University of X as there was no ethics committee there at the time of our
study. We however applied the following principles in designng and
carrying out our study....."
These are some of the questions that African countries, philosophers
and researchers will need to grapple with as they work towards improving
research governance and protecting the vulnerable on the continent.
1) Anya I Ethics and research in developing countries
The Lancet - Vol. 362, Issue 9393, 25 October 2003, Page 1419
Competing interests:
None declared
Competing interests: No competing interests