Press | Monday, 29 April 2024
Framework conditions for clinical studies involving vulnerable groups – conference on the Declaration of Helsinki revision process
In Germany, as a rule, clinical studies involve adults between the ages of 18 and 70. The World Medical Association’s “Declaration of Helsinki” policy statement defines ethical principles for medical research involving humans. The principles accord special protection to vulnerable groups, such as children, adolescents, and adults not capable of giving consent. Generally speaking, these groups are therefore not involved in clinical studies. In some cases, however, vulnerable groups could particularly benefit from participation in such studies. An international conference involving the German National Academy of Sciences Leopoldina and the German Medical Association (BÄK), in cooperation with the World Medical Association (WMA) and the American Medical Association (AMA), and with support from the Bavarian Chamber of Physicians (Bayerische Landesärztekammer, BLÄK), will take place in Munich/Germany on Tuesday, 14 and Wednesday, 15 May and examine this contradiction.
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