[Ethics of scientific research using patients' archived biological material and their medical data]. / Eticki pristup znanstvenim istrazivanjima u kojima se koriste pohranjeni bioloski materijali pacijenata i njihovi medicinski podatci.

ABSTRACT

Informed consent represents the standard for adequate protection of all participants in biomedical research. This standard is affirmed in international legal documents concerning biomedical research, as well as in Croatian legislation. However, some questions regarding informed consent remain open. One of such questions that research ethics committees around the world and in the Republic of Croatia often deal with, is the question of whether to obtain informed consent for the research on archived material or previously collected research data taken from the patients during diagnostic or therapeutic procedures. This contribution provides an overview of both Croatian and international legal documents and guidelines that deal with this issue, together with an overview of the literature concerning this issue. Since in the Republic of Croatia there are no regulations regarding this type of research, the authors of this contribution are presenting conduct guidelines for researchers and ethics committees in such cases. The implementation of the proposed guidelines would facilitate scientific research and international cooperation for Croatian scientific institutions.