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Place and Role of Ethics Committees in Croatia: First Practical Experiences

The founding of first ethics committees in Croatian health institutions began in 1997, based on the Health Care Act voted by the Croatian Parliament. It was then established that an ethical committee of a certain health care institution is a corporate body that provides for the performing of activities based on the principles of medical ethics and deontology. The Administrative Council of the health care institution appoints it, and it consists of five members: three health care representatives and two non-medical representatives, most commonly a theologian and a lawyer. According to the Health Care Act of the Croatian Republic, the role of a health care institution ethical committee is to: 1) follow the employment of ethical and deontological principles of the medical profession in performing activities of the medical institution ; 2) observe research on medicaments and medical products ; 3) approve scientific trials in health care institutions ; 4) approve clinical research on medicaments and supervise its execution ; 5) control the retrieving of human body parts after an autopsy, for medical and scientific-educational purposes ; 6) solve other ethical issues of health care institution activities. Previously, the first systematical activities from the ethics field in Croatia, began in the late 70ties following the establishment of hospital commissions for medicaments that dealt mainly with the problem of methodology and ethics of clinical therapy trials. The Government of the Croatian Republic founded the National Bioethical Committee for Medicine on 25th October 2001. In 2002 it conducted a research that included 241 health care institutions, and ascertained that 80 of them possessed an ethical committee. Eighty-nine percent of ethical committees have five members, of that number 22 do not have a representative of the religious communities in their committee, and 26 do not have a lawyer. Thirty-four committees besides physicians have nurses as their members, and only one has a philosopher. Of the total of 241 institutions, 19 have a commission for medicaments that also analyzes research protocols. According to the mentioned research, all ethical committees state the analysis of clinical research protocols as their basic activity. The first ethical committee of the Clinical Hospital Centre in Rijeka (1997-2000) acted based on the Health Care Act provisions and Regulations for the conduct or Ethical Committees. During that period, 24 meetings were held and 59 scientific-research proceedings were given approval. The mean time from submitting the demand to the ethical committee to approving it was 20 days, and the process from the sole decision making to delivering the approval lasted eight days. The committee also resolved cases of mutual accusations amongst colleagues, immediately received complaints from patients, that is, complaints received through the Ministry of Health. The objective for a better education of committee members actuated the arrangement of short duration workshops where participants exchanged knowledge and discussed tasks of ethical committees and the place and role of bioethics in ethical committees. Although the establishing of ethical committees in health care institutions is a step forward to solving numerous ethical issues in Croatian health care, it must be stated that the present situation does not satisfy completely. Therefore, a new, detailed study on the national level is planned, a study that will give insight, not only to the number of committees, frequency of sessions and number of subject-matters, but that will also analyse in detail each case that arrives before the ethical committee. The study's objective is to create concrete guidelines for the activity of the committee that will enable an equal quality of bioethical judgment in all Croatian health care institutions.

Croatia; development; ethics committees; history

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