Dr Carolyn Johnston1, Associate Professor Jane Nielsen
1University of Tasmania, Hobart, Australia
Raw genomic data is the genomic sequence of an individual before analysis and interpretation. It has been described as ‘meaningless’ data in the absence of further analysis, although individuals could seek interpretation from a clinical genetics service or through Third-Party Interpretation services. There is increased debate about the rights of research participants and patients undergoing genomic sequencing (often as part of a research study) to receive their raw genomic data. Ethical issues of reciprocity, fairness, and agency underpin arguments for access, but the legal rights of patients and research participants are not clear cut.
The European General Data Protection Regulation provides a right for patients and participants to receive their raw genomic data but in Australia the NHMRC guidelines (updated 2018) state that researchers are not expected to return raw genomic data to research participants. In practice the boundary between clinical and research roles is blurred and the legal right to access data and obligations to return raw data requires analysis and justification.
This presentation will explore legal avenues through which an individual could access raw genomic data, including property, contract and privacy law, and the potential for a remedy in tort where this data is not provided on request. We will report on preliminary findings from the research study Returning Raw Genomic Data: Patient Autonomy or Legal Minefield? and discuss whether the Australian legal framework provides sufficient clarity for clinicians, researchers, the public health system and those making requests to deal with the return of raw genomic sequence data
Biography:
Research Fellow at University of Tasmania, contributing to the Returning Raw Genomic Data: Patient Autonomy or Legal Minefield? Project, and holds an honorary appointment (Senior Fellow, law) with Melbourne University. Carolyn is Clinical Ethicist at Monash Children’s Hospital and provides academic input to Australian Network for Art & Technology.