engleski

Informed consent in clinical psychiatric research in Croatia

This report is to present the specifics of clinical trials with special address on psychiatric research, similarities and differences between clinical trial and clinical practice, ethical principles considering ill individuals, ill population and psychiatric in general and the importance of the Informed Consent as ethical assurance for both the patient and the investigator There is no strict definition of clinical trial in Clinical practice. It is widely considered chat clinical trial is in fact sponsored study with specific research goals - diagnostic or therapeutic procedure. It is observed in everyday practice that paramedical issues are often understood to be of the greater interest than medical and professional ones. It seems is that the emphasis would be on sponsorship or academic work, and not on evaluation o f different approaches in therapy or diagnostics. Therefore, is of utmost importance to point out that clinical trial consists of clinical procedure that satisfies professional and medical principles. It means that clinical trial and everyday clinical practice are based on the same ethical principles. Modem medicine delivers new diagnostic and therapeutic procedures faster than ever. Ethical dilemmas arise because of the risk that new approaches bring since they could not be definitely evaluated in routine clinical practice as they come too fast It certainly brings out 11 e need for more intensive and frequent clinical studying. Ethical principles considering research changed from " primum non nocere" to "aiming to improvement within minimum harm". Modern ethical considerations must be precisely justified and legislated by international and national laws and declarations ( ICH-GCP, Croatian Law on Drugs ; and Medical Products). Among ôthei s, defining the Informed Consent has big importance. The written Informed Consent is used in clinical trials and not in everyday clinical practice. It represents written information about all clinical issues in the clinical trial. The basic principle of psychiatric and medical work in general is to inform the patient about required diagnostic and therapeutic procedures, expected benefits and possible risk. Informing and taking verbal approval of the patient and his family about medical procedure is routine. If the patient is taking part in the clinical trials, new legislative recognizes the importance of j protecting both the patient and the investigator. Despite of its importance, international1 results show often mistakes in fulfilling the Informed Consent forms. In psychiatry, evaluation of patient's competence to understand the issues of clinical trial has to proceed signing the Informed Consent. Free choice for the patient to decide about medical procedures is protected by implementation of recent Law on Protection of Persons with Mental Disorders. Because of the specifics of mental disorders, it is necessary to evaluate the competence of the patient to decide in his best interest by professional guidelines of psychiatric profession in order to increase impartiality and etvoid malpractice in clinical trials ( Croatian Law on Protection of Persons with Mental Disorders).

informed consent ; psychiatric research ; Croatia

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