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ETHICAL ASPECTS

Ethical aspects regarding handling of data, human and animal materials, copyrights and intellectual property in the SPIDIA4P project.
 

The SPIDIA4P consortium is working towards improved sample handling and storage during the normal therapeutic and diagnostic pathways aiming to increase sample quality for medical research and diagnostics. The main idea behind this is that increased sample quality results in better and more significant medical research, ultimately leading to an increased quality of patient care.

SPIDIA4P has not planned new research on sampling quality issues, but is planning to use already established data. Proficiency testing schemes are planned to be newly designed and implemented. The biomaterials used to design the test must be of good quality, but after selection criteria are met the data are no longer needed for adequate testing. In addition, the required quality and quantities of animal material used as for proficiency testing can be purchased from the local butcher shop, because no research on animals is performed. Many consortium partners are involved in testing the proficiency tests or external quality programs developed in one institute specifically accredited and equipped for this purpose. To do this properly, all members of the SPIDIA4P consortium need to adhere to the rules and regulations for working with human and animal materials. The participants in the SPIDIA4P 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:

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 Medical Ethics Committee or Internal Review Board. For the SPIDIA4P 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. Nonetheless, the recently introduced European privacy legislation must be followed, which now recognises coded data as well as personal data. Vigilance is needed to make sure rules are followed correctly.

 

Animal materials:

The SPIDIA4P consortium requires that all partners comply with the 3Rs (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 SPIDIA4P. All institutes involved follow the local rules and regulations for use of animal materials. At the local institutes, an animal ethics committee is involved in approval of experiments concerning animals.

 

Copyrights:

SPIDIA4P partners develop CEN and ISO technical standards and disseminate general knowledge to speed up their implementation, while the technical contents may not be disseminated to those that have not purchased the documents.

 

Consortium ethical protocols:

Within the consortium, an entire work package is devoted to Legal Ethical and Social Issues. To safeguard the way SPIDIA4P deals with human and animal biomaterials, personal data, copyrights and Intellectual Property (IP), an Ethics and Intellectual Property Committee (EIPC) has been appointed. The EIPC sets up protocols for the consortium which enable the EIPC to ensure the right rules and regulations are followed. The first priority is, of course, to be sure that all participants adhere to the local regulations for working with data, human and animal material. Second is to ensure that copyrights and IP are dealt with properly. Third is to make participants more aware of the current and expected ethical and social issues.

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.