Regulatory Guidance for the Return of Raw Genomic Data to Research Participants: A Qualitative Interview Study

Abstract

This paper reports the results of an Australian qualitative study investigating the return of raw genomic data to research study participants. Increasing numbers of participants request access to their raw genomic data, although the legal position in relation to whether data should be returned lacks clarity, particularly in Australia. Interviews were conducted with stakeholders involved in two research studies where participants have undergone whole genome sequencing: ZERO Childhood Cancer, and the Australian Pancreatic Cancer Genome Initiative. Four major themes were identified: whether raw genomic data should be returned; reasons for seeking access; risks in returning data; and processes for return. Our findings indicate that health professionals, scientists, bioinformaticians, patients and patient advocates overwhelmingly support the return of raw data upon request, with ethical imperatives providing a strong basis for this support. Many stakeholders went on to stress the importance of adequate support for participants to ensure risks associated with the return of raw genomic data are minimized, including the provision of explanation and, where necessary, counselling and clinical advice. Our findings provide a basis for arguing that adequate resourcing must be built into research projects from the outset, given expected increases in participant demand for genomic data.