engleski

Particularities of Regulations Surrounding the Informed Consent Procedure in Psychiatric Research Accompanied with the Implementation of the new Law in the Republic of Croatia

Objective The new Law of the Protection of Persons with Mental Disorder in the Republic of Croatia, introduced in 2015, normalized and evoked additional legal safeguards regarding the informed consent procedure – so called, “surrogate or proxy decision making” is abandoned, meaning that informed consent for biomedicinal research cannot be given nor by legal representative nor person of their trust (Article 20). Other regulations of interest include establishing of the National Board for the Protection of Persons with Mental Disorders that would have leading and crucial role in evaluation of scientific importance, its significance and ethical acceptability of proposed clinical research, and that the decisional capacity of patient should be evaluated by another independent psychiatrist selected by the above mentioned National Board (Article 19). Methods Practical implications of new safeguards proposed by the new Law were researched and elaborated. Further analysis of legal standings proposed by corresponding laws in other European Union member states was made. Results Although, the notion of “sound mind” within the procedure of informed consent is one of the first/oldest emphasized within this valuable and inevitable bioethical principle, restrictions introduced within the new Law regarding “surrogate or proxy decision making” seem to be rigid and regressive, resulting in the significant decline in the interest, number, and quality of biomedical research within this specific field, evident from the day of introduction of the Law. The position and practical function of the National Board conceived as the guardian of psychiatric patients’ rights remain elusive, paradoxically possibly contributing to their further stigmatisation. Conclusion Vulnerability of psychiatric patients creates unique interdependencies between medical and legal system. For this interdependency to be sucessful and in the best interest of those served, the intentions of „other part“ should be respected and properly valued.

law, Informed Consent Procedure

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