Research on Human Biological Materials: What Consent Is Needed, and When
Requirement for informed, express, and specific consent is one of the key principles of research ethics that evolved as a reaction to the atrocities of the Nazi medicine as well as a response to the unethical human experimentation revealed during the post
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Research on Human Biological Materials: What Consent Is Needed, and When Eugenijus Gefenas, Vilius Dranseika, Asta Cekanauskaite, and Jurate Serepkaite
7.1 Introduction Requirement for informed, express and specific consent is one of the key principles of research ethics that evolved as a reaction to the atrocities of the Nazi medicine as well as a response to the unethical human experimentation revealed during the post World War II period. Such consent is thought to be the default position in clinical research and any softening of the requirement is usually perceived as an exception which requires justification. However, in some areas of human research the requirement is more and more often both weakened in practice and criticised by the members of research community and ethicists (e.g. Chadwick and Bere 2001; Hansson et al. 2006; Helgesson et al. 2007). In this chapter we discuss circumstances under which research on human biological materials is in fact conducted without specific consent or re-consent of a donor. We start our discussion with a short note on the relationship between consent and identifiability of human biological materials. The main part of the chapter is concerned with issues of consent in research on identifiable archived human biological materials. This covers three main scenarios. First, we explore the research use of materials that were collected for broadly-defined research purposes for which broad consent was initially secured. Second, we discuss the possibility to waive consent in research use of biological materials that were initially collected for non-research purposes without consent for research use. Third, we address three alternative regulatory regimes allowing turning residual biological materials into research collections during the collection procedure. These alternatives that justify research use of biological materials collected for non-research purposes can be based on precautionary consent, presumed consent and no consent. Before drawing conclusions we will also briefly discuss the removal of biological materials for research purposes from the deceased.
E. Gefenas (B) Department of Medical History and Ethics, Vilnius University, Vilnius, Lithuania e-mail: [email protected]
C. Lenk et al. (eds.), Biobanks and Tissue Research, The International Library of Ethics, Law and Technology 8, DOI 10.1007/978-94-007-1673-5_7, C Springer Science+Business Media B.V. 2011
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Our scope in this chapter is mainly European. However, there is no unified legally binding European policy in relation to any of these fields of research and different countries often set different regulations. Therefore we face the risk of presenting the situation as more uniform and orderly than it really is. While recognising these risks, we hope to describe the general landscape and identify some of the emerging trends by referring to some examples taken from a number of European countries.
7.2 Identifiability and Non-Identifiability The possibility to link human biological
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