| Abstract [eng] |
In this dissertation, the models of a person's consent to biobanking (hereinafter referred to as ‘consent’) and the return of health-related findings important to biobank participants (hereinafter referred to as ‘return of health-related findings’) are analyzed. Additionally, the ethical and legal issues of consent and the return of health-related findings in Lithuania are examined. The models of consent and the return of health-related findings are analyzed in the context of international research ethics guidelines, the General Data Protection Regulation, the legal and ethical regulations of different countries, biobank practices, and the use of new generation sequencing technologies. Theoretical analysis is supplemented by qualitative (expert interviews) and quantitative (public survey) studies. Theoretical analysis revealed that the prevailing problematic areas for consent to biobanking are: broadly defined future research purposes (the problematic nature is also exacerbated by the uneven interpretation of the breadth of research areas/aims in international research ethics guidelines and the General Data Protection Regulation), variety of health data collected, open-ended use of samples and data (including after death), conducting research abroad, commercial research, and the return of health-related findings. The prevailing problematic area for returning health-related findings to biobank participants is the wide range of findings that may be discovered. The overall results of this work showed that the evaluation of consent models by Lithuanian experts and Lithuanian public favours the further development of a broad consent model over a dynamic consent model. The results of the work also revealed that Lithuanian experts consider it appropriate to return clinically actionable findings discovered during biobanking activities to biobank participants, while Lithuanian public would like to know more than just clinically actionable information discovered through biobanking activities. The results of this work establish the prerequisites for targeted improvement of models of consent and the return of health-related findings, as well as for the dissemination of information about biobank activities. |
