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Articles

No. 3 (41) (2022)

Clinical Trials on Medicinal Products Involving Vulnerable Subjects in the European Union Law

Submitted
22 April 2022
Published
20-10-2022

Abstract

The author discusses the legal framework of clinical trials on vulnerable subjects set out in Regulation (EU) No 536/2014 of the European Parliament and the Council of 16 April 2014 on clinical trials on medicinal products for human use and repealing Directive 2001/20/EC. It addresses the issue of changes introduced by Regulation No 536/2014 to the current legal situation in the context of demands for wider involvement of vulnerable subjects in medical research and conflicts of values generated by these demands. Although Regulation No 536/2014 enumerates more vulnerable groups than Directive 2001/20/EC, it specifies the conditions of clinical trials for only four of them: minors, incapacitated subjects, subjects in emergencies, as well as pregnant and breastfeeding women. The participation of these groups in clinical trials requires meeting additional conditions, i.e. subsidiarity of
given research, pursuing a legally defined research objective, and risk minimisation. From the perspective of the human dignity principle, the most controversial of these conditions is the admissibility of a clinical trial without individual direct benefit. As compared to Directive 2001/20/EC, Regulation No 536/2014 extends the admissibility of clinical trials involving incapacitated subjects but tightens the conditions for conducting them on minors. RegulationNo 536/2014 also strengthens the protection of the autonomy of subjects incapable of giving
consent aiming at their maximum inclusion in the decision-making process.

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