Pregledni rad

https://doi.org/10.11613/BM.2018.030201

Informed consent and ethics committee approval in laboratory medicine

Ana Borovecki orcid.org/0000-0001-8635-195X ; “Andrija Štampar” School of Public Health, University of Zagreb School of Medicine, Zagreb, Croatia
Ana Mlinaric ; Research Integrity Editor, Biochemia Medica; Department of Laboratory Diagnostics, University Hospital Centre Zagreb, Zagreb, Croatia
Martina Horvat ; Research Integrity Editor, Biochemia Medica; Department of Medical Laboratory Diagnostics, University Hospital Centre Split, Split, Croatia
Vesna Supak Smolcic ; Research Integrity Editor, Biochemia Medica; Clinical Institute of Laboratory Diagnostics, Clinical Hospital Center Rijeka, Rijeka, Croatia; Department of Medical Informatics, Rijeka University School of Medicine, Rijeka, Croatia

Sažetak

Informed consent is a process in which a human subject who is to participate in research needs to give his or her consent after being properly informed of the expected benefits as well as the potential harm of the research that will be performed. The function and purpose of the research ethics committee is to ensure that the research that will take place is in accordance with the relevant ethical standards. This means that the committee must assess the appropriateness of the design of the study reviewed. Research in the field of laboratory medicine has specific features, i.e. the use of samples that remain after routine analysis, data collection from databases containing patient information, data mining, collection of laboratory management data, method/instrument comparisons and validation, etc. As most of such research is either retrospective or not directly associated with patients, the question arises as to whether all types of research require informed consent and ethics committee approval. This article aims to clarify what is specific about obtaining informed consent and ethical approval in laboratory medicine, to provide general guidance on informed consent and ethical approval requirements based on the type of study, and what information should be included in applications for ethical approval and
informed consent. This could also provide some guidance for future contributors to the Biochemia Medica.

Ključne riječi

informed consent; ethical approval; research; laboratory medicine; ethics committees

Hrčak ID:

206650

URI

https://hrcak.srce.hr/206650

Datum izdavanja:

15.10.2018.

Posjeta: 3.592 *