The Declaration of Helsinki originates from the World Medical Association and defines ethical principles for medical studies conducted in humans. The basic principle is respect for each human individual (Article 8), his or her rights to self-determination and his or her right to make independent decisions after adequate information (Articles 20, 21, 22). The well-being of the trial patient always takes precedence over the interests of science and society (Article 5). Ethical principles always take precedence over laws and social / political guidelines (Article 9).
The Declaration of Helsinki has bindingly stipulated that participation in clinical trials is voluntary, that the patient can withdraw his or her consent (Informed Consent Form - ICF) to participate in the trial at any time without personal disadvantages and that the potential benefit of the trial must be greater than the risk for the patient.
The Declaration of Helsinki was first issued at the 18th World Medical Congress in 1964 and last amended in 2013. Other guidelines such as GCP - Good Clinical Practice are based on the principles of the Declaration of Helsinki.