Declaration of Helsinki

Oral presentation

The Declaration of Helsinki (DoH) is the most important international ethical guideline on biomedical research involving humans. First published in 1964 by the World Medical Association (WMA) it has been revised in 1975, 1983, 1989, 1996, and in 2000. While earlier revisions have widely been accepted, the revision of Edinburgh published in 2000 has raised many questions and discussions and led to non-acceptance in some parts of the world, especially regarding the use of placebo in clinical trials.

The workshop will give a brief historical review on the development of the declaration and its revisions and will discuss the differences between the revisions of 1996 and 2000. Particular interest will be focused on the use of placebo as defined by section 29 of the DoH and later clarified by the WMA in 2002. Another aspect will be old and new functions of independent ethical committees prior and during trial conduct as also claimed by the upcoming EU-GCP guidelines. Further discussion topics will be contents and manner of obtaining "informed consent", participation of legally incompetent subjects, the principle of "distributive justice" and its relevance in different study populations, the obligation to publish research results - favorable as well as unfavorable, and questions regarding premature study termination.

Finally, the workshop will use the opportunity to discuss the acceptance of the DoH in Germany in general as well as in current implementations of the different Medical Associations' professional code of conduct.

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