Results of the Inquiry and Citation Review

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Bioethics issues in human studies


Access to the biobank, ownership and exchange of samples

State of discussion

The European Society of Human Genetics [24] recommends, that while protecting confidentiality, the free circulation and the availability of genetic information and samples for research should be promoted.

Agreements of ownership of samples and data, and access to biological material and information should be determined by multiparty contracts and not regulated by legislation. Practices should be based on the principles that the subject should always be considered as a primary controller of its DNA and clinical information directly derived from it. Once the information has been processed, it becomes research data unless there is agreed private ownership. Generally, the processor or the principle investigator should be considered as a custodian of the DNA and the genetic data. He or she has to take appropriate steps to protect the data, its storage, use and access.

The use of collections by third parties should be allowed, provided there is no transfer of ownership and the use is in agreement with the present guidelines.

For exchange of samples, the status of the collection and the validity of informed consent play a central role. Different rules exist across European countries, which is why one of The 25 Recommendations on Ethical, Legal and Social Implications of Genetic Testing [16] concerns the harmonization of standards for the research use of human samples and associated data, highlights that relevant international conventions on cross-border exchange of samples should be taken into account.

States should regulate, in accordance with their domestic law and international agreements, the cross-border flow of human genetic and proteomic data and biological samples so as to foster international medical scientific cooperation and ensure fair access to this data. Such a system should seek to ensure that the receiving party provides adequate protection in accordance with the principles set out in the International Declaration on Human Genetic Data and the European Directive on data protection [14, 28].

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