Regulating biobanking in Malta : implications of dynamic consent in biomedical research

Abstract

Biobanking and biomedical research are dependent on individuals to donate and share their biospecimens together with their personal and genetic data. For this process to occur the obtainment of consent from the participants is a fundamental legal and ethical principle. Consent revolves around the autonomy and self-determination of the individual in making personal decisions. Due to the functioning structure of biobanks, the process of informed consent encounters challenges due to the possibility of future biomedical research performed through stored biospecimens and data. Furthermore, with the innovation of information technology that allows greater data sharing in an era when information is shared digitally, contributing to rapid evolvements in how biomedical research is conducted, the means of acquiring consent have remained static relying on the paper-based format. In addition, the General Data Protection Regulation contains rigorous requirements for consent for the processing of personal data, including the process of such data for scientific research. Dynamic Consent was developed in response to these concerns, delivering a wider concept that offers a modern approach to consent, through personalized, online communicative platforms, designed to accommodate such innovations and providing a way for researchers to comply with legal and regulatory requirements while abiding by the highest ethical standards for research conduct. This dissertation aims to provide a legal overview of the important aspects pertaining to Dynamic Consent in Biomedical Research in a biobanking context in Malta.