Ethics
Ethical aspects regarding handling of human and animal materials in the SPIDIA project
The SPIDIA consortium is working towards improved sample handling and storage during the normal curative and diagnostic pathways aiming to increase the sample quality for medical research and diagnostics. The main idea behind this is that an increased sample quality results in better and more significant medical research ultimately leading to an increased quality of patient care.
Such research implies that within SPIDIA, human and sometimes animal blood and tissue samples collected and stored under different but controlled conditions need to undergo quality analyses. Within the SPIDIA consortium, many partners are involved in collecting and storing blood and tissue samples under these controlled conditions, whereas others are involved in the quality evaluation and analysis.
To do this properly, all members of the SPIDIA consortium need to adhere to the rules and regulations for working with human and animal materials. The participants in the SPIDIA project are institutes and enterprises situated in many different European countries. Exchanging human samples and data between institutes across the borders of European countries is very complex due to the diversity of rules and regulations in the different countries.
Human materials:
According to the Code of conduct developed earlier by the OECI-TuBaFrost project, the country of origin determines the limitations of use of a human sample. This means that the local law and regulations determine what requirements need to be met to allow use of human materials. The most important regulations are obtaining proper (informed) consent as well as approval from the local Ethics Committee or Internal Review Board.
For the SPIDIA studies, no personal data is used in the exchange and analysis of human samples. The only data needed for proper sample analysis is no more than the disease state and tissue type of origin.
Animal materials:
The SPIDIA consortium requires that all partners comply to the 3R’s (reduction, refinement and replacement) in relation to animal work. To spare animals from being needlessly sacrificed, mostly residual materials are used from animals sacrificed for other experiments than for SPIDIA. All institutes involved are following the local rules and regulations for using animal materials. At the local institutes, an animal ethics committee is involved in approval of experiments concerning animals.
SPIDIA Ethics on using animal and human material for experiments:
Within the consortium, an entire work package is devoted to the Legal Ethical and Social Issues. Within this activity, a Project Ethics Committee is active.
First priority is of course to be sure all participants adhere to the local regulations for working with human and animal material. Second is that the participants learn about regulations in other countries. Third is to let the research participants think about the ethical and social issues considering the donor, juridical and research implications when working with animal and human materials.
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