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. 2014 Jul 31;18(1):103–112. doi: 10.1007/s11019-014-9586-5

Table 1.

Formulations of the principle of precedence of individual interests

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”