US Vice President Joe Biden recently launched The Genomic Data Commons, an open-access database that contains genomic and clinical data of 12,000 patients.
The aim is to allow researchers to better understand cancer’s development, which will help tailor treatments to individuals’ particular cancers.
This kind of approach is called personalised medicine and is said to be the next frontier in health care. A recent study in the journal Nature, for instance, reported groundbreaking research on the genetic causes of breast cancer. The study’s lead author described it as “a step closer to personalised health care for cancer”.
Personalised medicine has many benefits, such as treatment for cancers previously considered untreatable. This high-tech medical field also presents some regulatory problems, as outlined by a group of international experts – of which we were part – in the Journal of Law and the Biosciences. These are:
• personal privacy – the genetic research and testing needed for personalised medicine reveals people’s deepest genetic secrets
• consumer protection – a growing private industry is selling genetic tests to consumers, sidestepping the traditional relationship between doctor and patient
• health care costs – worries about genetic risk factors for disease drive some people to undergo costly, and possibly unnecessary, tests and treatments.
Personal privacy
To find out how genes contribute to diseases, large collections of human tissue, blood, urine and saliva are stored in repositories called biobanks. Biobanks – much like the Genomic Data Commons – can be set up by public or private sector entities, such as government health departments, university research institutes and even drug companies. Researchers can then access the biobank collections for a variety of projects.
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Members of the public and people with specific conditions “participate” in biobanks by donating their materials. A research team or a health care provider might invite them to participate. Participants are asked to share personal details about their lifestyle and medical and family history.
UK Biobank is a leading international example. It holds biological samples from half-a-million people. Closer to home, the Australasian Biospecimen Network is a network of 35 domestic and international biobanks for cancer research.
People become participants in biobanks without knowing what their genes might reveal and how researchers will use them in the future. Research studies can uncover a person’s genetic future – such as a predisposition to Alzheimer’s disease – and genetic past, including ancestry details.
Many of the non-profit biobanks, like UK Biobank, ask people to give broad consent for use of their materials in unspecified future health studies, including after their death.
These types of biobanks have established their own robust governance frameworks to ensure that laws and ethical principles are followed and participants’ wishes are respected. However, this kind of regulation doesn’t apply everywhere.