Table 1.
Ethical guideline | Year | Formulation |
---|---|---|
Oviedo Convention | 1998 |
Article 2 “The interests and welfare of the human being shall prevail over the sole interest of society or science” |
Directive 2001/20/EC | 2001 |
Article 4, par. i, and Article 5, par. h “The interests of the patient always prevail over those of science and society” |
Universal Declaration on Bioethics and Human Rights | 2005 |
Article 3, par. 2. “The interests and welfare of the individual should have priority over the sole interests of science or society” |
Ethical Considerations for Clinical Trials on Medicinal Products Conducted with the Paediatric Population | 2006 |
(11) “The child’s interest should always prevail over that of science and society. This is paramount when assessing and monitoring risk. Risk is to be viewed in balance to the benefit” |
Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing the Directive 2001/20/EC | 2012 |
Article 28, par. 2. “The rights, safety and well-being of the subjects shall prevail over the interests of science and society” |
Declaration of Helsinki | 2013 |
Section I, Paragraph 8 “While the primary purpose of medical research is to generate new knowledge this goal can never take precedence of the rights and interests of individual subjects” |