Guidelines
There are a number of Guidelines which determine the ethical acceptability of placebo use as a clinical research comparator. These guidelines are laid down by the Council for International Organizations of Medical Sciences otherwise known as CIOMS and they were published by CIOMS in October 2002. It is important to note that the revision process was all inclusive and it brought together a constellation of research ethics experts from all over the world as well as a number of institutions.
The revision process which took three years was also informed by a number of consultative meetings and in this regard, the views of a number of stakeholders were also undertaken mainly through the website of CIOMS. It is however equally important to note that the revision process was not smooth all the way as there were some objections which were raised mostly in regard to the use of placebo in clinical trials that were largely controlled
.Apart from the occasional dissenting views, the revision process was also informed by extensive discussions in regard to but not entirely limited to comparators rational use (Council for International Organizations of Medical Science, WHO, 2002).
In the end however, CIOMS was able to publish what was seen by some as the fruit of vast consultative discussions and careful consideration. These guidelines are made up of detailed directives on the use of placebo in clinical research and it can be noted that there is also an inclusion of the WMA Declaration of Helsinki current version reference. However the WMA Declaration of Helsinki included in the Ethical Guidelines for Biomedical Research Involving Human Species is a 2000 revised draft of an earlier version.
References
Council for International Organizations of Medical Science, WHO (2002). International
Ethical guidelines for biomedical research involving human subjects. CIOMS
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