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To ascertain the extent of similarities and differences in the guidance documents relevant to clinical research in South Africa, we compared the following documents: International Conference on Harmonisation: E6 Consolidated Guidelines for Good Clinical Practice, 1996 (ICH GCP); (2) SA GCP 2006;1 Declaration of Helsinki (2004) as incorporated in SA GCP 2006 (World Medical Association at its 55th General Assembly, Tokyo, 2004); (3) Declaration of Helsinki (2008) (World Medical Association at its 59th General Assembly, Seoul, 2008); (4) Ethics in Health Research: Principles, Structures and Processes (Department of Health 2004--'ethical guidelines' for the purpose of this paper); (5) the Constitution of the Republic of South Africa (1996); (6) and the National Health Act 61 of 2003.
In time, Declaration of Helsinki begat a son, a new version of itself, which begat versions three on to eight.
In 1964, the Declaration of Helsinki, which set out the principles for human studies, was adopted.
MATERIALS AND METHODS The study was approved by the review board of the Israeli Defense Force's (IDF) Medical Corps and was conducted according to the Declaration of Helsinki.
For those readers who would like to know why placebo-controlled trials and the Declaration of Helsinki remain controversial from an ethical perspective, however, two useful and interesting starting points are articles by Carlson, Boyd, and Web (2004) and Wolinsky (2006), respectively.
International documents such as the Nuremberg Code and the Declaration of Helsinki were composed to require the voluntary, informed consent of all human subjects.
24) While the Declaration of Helsinki has received acclaim, it is also a non-binding proposal.
Another important medical code of ethics is that issued by the World Medical Association (WMA) since 1964 and amended periodically as its Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects (www.