On the Release of Raw Genomic Data to Patients and Study Participants

Position paper of the EURAT project group “Ethical and Legal Aspects of Whole Genome Sequencing”

Abstract

Background: Today genomic diagnostic based on next generation sequencing technologies not only revolutionized our understanding of the molecular basis of diseases, but has also entered the clinical world when translational research projects inform doctors and patients about possible therapeutic approaches based on a molecular analysis. Individuals from such studies increasingly ask for their raw genomic data to be released. 

Methods: Based on an comprehensive ethical and legal analysis the interdisciplinary EURAT project issued a position statement on the question whether patients and study participants have a right to raw data return and provide a policy as well as information material to empower patients. The resulting statement relates the rights of patients and study participants to the duties to inform and educate for an informed handling of raw data

Results: Based on the GDPR and the German law patients and study participants have a right to access their personal data and raw data qualify as personal data. The ethical analysis weighs potential benefits and harms in light of patients’ right for informational self-determination. Raw genomic data do not provide individuals with information without analysis and interpretation by experts. However, the data analysis can lead to very sensitive information about the disease and genetic makeup of the persons or their close relatives and children.

Conclusion: We provide a policy for the release of raw data that encompasses the information process and material, the data output procedure as well a confirmation of receipt on the part of the patient.