Rights and protection of subjects
Each subject’s inalienable rights are:
- the right to make an autonomous and free decision whether to participate in a clinical trial or not
- the right to withdraw from a clinical trial at any time without consequences or loss of rights (to treatment and other)
- the right to receive complete, accurate and understandable information about the trial, and
- the right to the protection of data privacy.
The same ethical and legal principles applicable to normal medical practice apply to clinical trials. In addition, clinical trials are strictly regulated by international and national laws and regulations. The purpose of these legal instruments is to provide the highest possible degree of protection of subjects’ rights and safety.
The most important instruments governing clinical trials are:
- the Helsinki Declaration and the Nuremberg Code
- the International Conference on Harmonization Good Clinical Practice Guidelines (ICH GCP)
- the Medicines and Medicinal Products Act of the Republic of Croatia
- the Medical Devices Act of the Republic of Croatia, and
- the Ordinance on Clinical Trials of Medicinal Products and Good Clinical Practice of the Republic of Croatia.
All professionals involved in conducting clinical trials must adhere to the above instruments and principles. High safety standards for subjects are ensured by using diverse control and inspection mechanisms.
Due to the highly sensitive nature of information gathered in clinical trials, which includes personal and medical information on each subject, numerous regulations and mechanisms are in force to ensure subject privacy. This is why most trials only use subject identification numbers to identify patients in order to ensure that the data gathered, after being forwarded and processed, cannot be linked to a subjects’ name and other confidential information.
All clinical trials in the Republic of Croatia are approved by the Ministry of Health of the Republic of Croatia, subject to prior positive opinion of the Central Ethics Committee for Clinical Trials of Medicines and Medicinal Products (CEC). CEC is an independent authority whose members are healthcare professionals in different medical specialties as well as persons in nonmedical professions (e.g. lawyers, theologians, patient representatives). When issuing its positive opinion for a clinical trial, CEC is required to consider whether the trial is safe for its subjects, whether the foreseeable risks are justified and whether the rights and wellbeing of the subjects in the clinical trial are protected. In addition to providing its positive opinion on a clinical trial, CEC also oversees its conduct.