Should Raw Genomic Data be Returned to Research Participants?: The Results of an Empirical Study.
Carolyn Johnston1, Jane Nielsen1, Margaret Otlowski1, Mark Cowley2, Vanessa Tyrell2, Faculty of Law, University of Tasmania Hobart2, Sydney NSW 1Faculty of Law, University of Tasmania, Hobart, Tasmania, Australia2Children’s Cancer Institute, Sydney, NSW, Australia
Abstract
There is a reported increase in requests for access to raw genomic data by participants in translational genomic research. In Australia the return of data has been dealt with on a case-by-case basis; to date no protocol for return has been available for clinicians nor researchers to guide their decision making and the circumstances under which raw genomic data should be returned.
Whether raw genomic data should be provided raises ethical and legal questions. The NHMRC National Statement on Ethical Conduct in Human Research provides that researchers are not expected to return raw genomic data to participants (para 3 .3.28). Yet privacy legislation provides an individual with a right to access (upon request) a copy of records containing their data, including health data (see APP 12, Privacy Act 1988 (Cth)). A legal duty to return data might be argued on the basis of contractual and fiduciary obligations; or a consideration of whether a duty of care encompasses a return of raw genomic data in the research context.
This panel will present qualitative data from the research study ‘Returning Raw Genomic Data: Patient Autonomy or Legal Minefield?” (MRFF, 2019) and the key themes emerging from interviews with stakeholders including clinicians, researchers, bioinformaticians, genetic counsellors, participants/patients and their families, advocacy and policy groups. We consider:
•whether raw data from translational research can identify an individual;
•the practical process for return;
•legal regimes impacting on the return of raw genomic data;
•ethical issues around return of raw data;
•potential harms if recipients upload their raw data to third party interpretative services.
The panel will use project findings to frame a discussion on whether a ‘protocol’ for return of raw genomic data would assist clinicians and researchers receiving such requests, and how such a protocol might usefully be constructed
Biography
Carolyn Johnston: Senior Research Fellow, Returning Raw Genomic Data Project; lecturer, Monash Bioethics Centre, Monash University and Clinical Ethicist Monash Children’s Hospital.
Jane Nielsen: CI Returning Raw Genomic Data Project; Associate Professor, School of Law in the College of Arts, Law and Education University of Tasmania.
Margaret Otlowski: Professor, School of Law in the College of Arts, Law and Education University of Tasmania; Director, Centre of Law and Genetics, University of Tasmania and Commissioner for the Voluntary Assisted Dying Commission Tasmania.
Mark Cowley: conjoint Associate Professor, School of Clinical Medicine UNSW; computational biologist; Head, Computational Biology Group and co-head of the Luminesce Alliance Childhood Cancer Computational Biology Program at CCI.
Vanessa (Ness) Tyrrell: Adjunct Associate Professor, School of Women’s and Children’s Health, UNSW Medicine, Program Leader, Zero Childhood Cancer.