Biomedical Research on Vulnerable Subjects in Bosnia and Herzegovina

Medical research involving human subjects can enhance the well-being of individual patients and provide enormous social benefits. It enables the acquisition of new scientific knowledge and the development of novel therapeutic and diagnostic procedures but also raises significant ethical and legal issues. This kind of medical research is controversial and implies a clash of values that are not always easy to balance. Particularly contentious is research on subjects who are incapable of giving consent or are in a position of subordination and more susceptible to manipulation and mistreatment. Such subjects are considered vulnerable and under special protection. The paper deals with the legal framework of medical research on vulnerable subjects in Bosnia and Herzegovina (its entities: the Republic of Srpska and the Federation of Bosnia and Herzegovina). In the first part of the paper, the notion and basic forms of medical research will be explored, as well as the concept of vulnerability. Reference will be made to relevant international documents defining the standards of medical research on vulnerable subjects. The paper will also provide a comparative overview of provisions governing vulnerable subjects research adopted in different national legislations. In the second part of the paper, the legal framework of medical research on vulnerable subjects in Bosnia and Herzegovina will be analyzed, and suggestions for possible changes will be made.