Pažeidžiamų asmenų dalyvavimo ir psichikos ligonių sutikimo dalyvauti klinikiniuose vaistinių preparatų tyrimuose teisinio reguliavimo problemos Lietuvoje

Abstract

EU and national legal acts regulate authorization, conduction and control of clinical trials of medicinal products (CTMP). The purpose of legal norms regulating CTMP is to ensure that data generated in these trials is of a good quality and that rights and wellbeing of trial participants are protected. Individuals whose consent to participate in a clinical trial may be unduly influenced by the external circumstances are regarded as vulnerable subjects.

This article analyses international, EU, and Lithuanian legal acts, judicial practice and the doctrine of law in order to assess whether Lithuanian regulations of vulnerable subjects participation in CTMP and the procedure of informed consent in psychiatric clinical trials provide sufficient protection of rights and interests of trial subjects and does not place unfounded obstacles to the conduction of CTMP. The problematic aspects of analyzed regulation are emphasized and possible solutions are given in the article.

The analysis leads to a few main conclusions. The lists of vulnerable populations provided in Law on Ethics of Biomedical Research of the Republic of Lithuania, Good clinical practice and Clinical trial Application Form endorsed at EU and national levels disagree. It would be purposeful to include pregnant, nursing women and women of child bearing potential into the vulnerable subjects list provided in Law on Ethics of Biomedical Research. In comparison to other countries and international documents Lithuanian legal regulation establishes strict rules of protection of these subjects. According to Law on Ethics of Biomedical Research clinical trials involving vulnerable subjects shall be permitted only where: 1) such biomedical research may be undertaken only on vulnerable subjects; 2) the results of the biomedical research may be of direct and real benefit to the health of these subjects; 3) the biomedical research will not pose a risk to the health or life of the subject. Law on Ethics of Biomedical Research should be changed to allow in exceptional cases to conduct nontherapeutic CTMP with vulnerable subjects and to clarify the acceptable level of risk to the health of the vulnerable subject in biomedical research. Complex regulation of the informed consent procedure in psychiatric research also has to be improved as it posses difficulties not only for the conduction but also for control of CTMP and does not provide sufficient protection of psychiatric patients.