Should informed consent be sought for research on archived material or previously collected research data

Abstract

When speaking about biomedical research, either clinical trials or scientific research in general, international legal documents concerning biomedical research, as well as Croatian legislation, acknowledge two standards that are considered to be the basis in ethically sound practices in this area. First standard is the protection of the participants in biomedical research and their privacy. Second standard consist of the promotion of ethical sound research practices of the researchers themselves. Adequately obtained informed consent represents one of the prerequisites for adequate protection of the participants in biomedical research. However, it is not always simple and clear when, how and from whom to obtain the informed consent. One of such examples that Croatian research ethic committees often deal with is the issue of whether or not to obtain informed consent for the research on archived material or previously collected research data. In the Republic of Croatia the use of biological material and data acquired during the course of clinical trials is regulated by the Guidelines on clinical trials and good clinical practice. However, problem with the use of archived material or previously collected research data can in other types of biomedical research that cannot be categorized as clinical trial create a lot of problems for researchers themselves and the work of research ethics committees since there are no clear guidelines on for this type of research in the Republic of Croatia. This contribution aims at giving overview of both Croatian and international documents and guidelines that deal with this issue. Furthermore, concrete recommendations for Croatian research ethics committees on this issue are given.

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