Returning raw genomic data: rights of research participants and obligations of health care professionals

Next generation sequencing technologies generate vast quantities of genomic data and can identify significant molecular markers associated with disease development and its response to treatments. Much attention has focused on the use of such data for research purposes, and on return of clinically significant findings to research participants via their clinicians.

Increasingly, patients are being recruited to research studies utilising genomics, particularly in oncology. Using whole genome sequencing, researchers may identify significant molecular markers giving rise to the potential for more targeted treatment options. The long established division between clinical care and research is becoming increasingly blurred as clinicians have a role in recruiting patients to research studies and then translating genomic results into clinical care. The scope of their obligations to individuals as both research participants and patients requires analysis, particularly in the context of what information individuals are entitled to.