Declaration of Helsinki

Declaration of Helsinki Deklaration von Helsinki
In clinical research, the Declaration of Helsinki is considered to be one of the most fundamental documents. It lays out the basis for ethical standards that should apply for medical research on humans. The Declaration of Helsinki was adopted during the 18 General Assembly of the World Medical Association (MWA) in 1964.

The Declaration of Helsinki first laid out principles that are still in use today in medical research. On one hand, the declaration stated that research needs people to make progress in the treatment of diseases. However, on the other hand, the rights of the individual in research were stated as unalienable. Many of the principles, which are recognized worldwide through the ICH-GCP, originate from the Declaration of Helsinki:

  • right of self-determination of the study participants
  • informed consent of the study participants
  • voluntary participation of study participants in studies
  • confidentiality of the data of study participants
  • qualification of study investigators
  • risk/benefit evaluations
  • protection of particularly vulnerable groups of people
  • implementation of studies according to previously defined study protocols

The Declaration of Helsinki has been modified on several occasions. The WMA considered the latest version to be valid. In contrast, EU Directive 2001/20/EC and EU Directive 2005/28/EC refer to the 1996 version of Somerset West, South Africa. In this respect, the 1996 version is crucial for European research.

Deutsche Erklärung