Informed Consent in Clinical Studies in the Republic of Srpska

Abstract

As human medicine is developing at a galloping pace, continuously offering new medical products, diagnostic methods and preventive programmes, there is almost no time gap between their creation and application in medical practice. All these biomedical achievements are primarily intended to improve public health and the patient’s quality of life and health. Hence, it is important to define potential risks, side effects, and unwanted outcomes when applying a medical product/treatment before integrating it into healthcare. Unlike any other product/treatment intended for human use, medical products/treatments require prior clinical testing on human subjects (sick or sound). The authors of this paper have restricted their scientific interest to the participant (human subject) of a clinical study as one of the core elements of a clinical investigation, representing at the same time its means and its aim. By analyzing relevant international as well as national legal rules and ethical principles of the Republic of Srpska related to the participation of humans in clinical studies, it will be concluded that the participants’ safety and right to self-determination, integrity, and autonomy manifested through their independent right to either consent or refuse to participate in a clinical study supersedes the interests of science or society. However, clinical trial-related statistical data obtained from randomly chosen healthcare institutions in the Republic of Srpska will show certain derogations from prescribed ethical policies. Considering this fact, the authors have paid special attention to thematising the ethicality of recruiting participants for a clinical study based on partial or no information related to the purpose, methods, potential risks and side effects of the investigation in the name of the greater good for humanity. Such practice has accentuated the discretionary powers of ethical review committees on the one side and the uncertainty of the right to informed consent on the other.