586. Ethics beyond borders in psychopharmacological research

Abstract

Abstract Background Ethical considerations are fundamental to psychopharmacological research, particularly when studies involve vulnerable populations. Individuals with mental disorders may exhibit reduced autonomy and impaired decision-making capacity, increasing their susceptibility within research settings. This vulnerability is further accentuated among war veterans, who often experience additional psychological, social, and trauma-related burdens. Moreover, transcultural and cross-national research poses specific ethical challenges, including historical, political, and cultural sensitivities that may influence trust, perceived risk, and willingness to participate. Consequently, research collaborations involving populations from regions with a history of conflict require heightened attention to informed consent procedures, transparency, and respect for participants’ values and experiences. Aims & Objectives The primary aim of this study was to assess potential ethical barriers to participation in psychopharmacological research among patients treated at the Neuropsychiatric Hospital Dr. Ivan Barbot Popovača in Croatia. Particular emphasis was placed on identifying possible refusals during the informed consent process, especially among war veteran patients. A secondary objective was to evaluate whether the transcultural nature of the research, including collaboration with patients from countries in the region, affected participants’ willingness to provide informed consent. Method The study was conducted in 2021 at the Neuropsychiatric Hospital Dr. Ivan Barbot Popovača and included adult patients diagnosed with mental disorders who were invited to participate in a psychopharmacological research project. This investigation constituted part of a multicenter cross-sectional study involving 1,574 adult patients from 14 psychiatric clinics across Serbia, Croatia, Bosnia and Herzegovina, and Montenegro. The multicenter study examined the prevalence and patterns of unsupervised psychiatric medication discontinuation, explored motivations for independent discontinuation, and assessed associated factors, including fear of discontinuation, trust in psychiatrists, perceived psychiatrist support, clinical diagnosis, and differences between independent and psychiatrist-guided discontinuation. The informed consent process at the Croatian site followed established ethical standards and included comprehensive information on study aims, procedures, potential risks and benefits, voluntariness of participation, and confidentiality safeguards. Particular emphasis was placed on clearly explaining the international and transcultural aspects of the study. Participants were encouraged to ask questions and were given sufficient time to consider participation prior to providing consent. The primary outcome measure was the occurrence of refusal to participate following disclosure of the study’s scope and transcultural framework. Results No refusals to participate were recorded during the informed consent process. This finding was consistent across the entire sample, including the subgroup of war veteran patients. The inclusion of participants from other countries in the region did not result in resistance, withdrawal, or expressed ethical concerns. Discussion & Conclusions The absence of refusals indicates that psychopharmacological research involving doubly vulnerable populations and transcultural collaboration can be ethically acceptable when conducted with rigorous ethical oversight, transparency, and cultural sensitivity. These findings underscore the importance of a well-structured and respectful informed consent process, particularly in post-conflict and regional research contexts. Future studies employing larger samples and qualitative approaches are warranted to further explore participants’ ethical perceptions and decision-making processes in similar settings.