Centre for Research Ethics & Bioethics (CRB)

Direct-to-consumer genetic testing companies lack clear consent processes for biobanking and research

2016-03-14

Whole genome and exome sequencing are becoming cheaper and more available. High throughput techniques are no longer for research only. Today, both patients and consumers can have their genome sequenced. But the information consumers receive about this is often inadequate and could undermine the validity of the consent process.

Emilia Niemiec and Heidi C. Howard have studied the policies for storage and future use of consumer’s data and samples on four company websites. Some of these companies may store and use consumer’s samples and sequencing data for unspecified research and share the data with third parties. But the information consumers receive about this is often not adequate, or transparent, and could undermine the validity of the consent process.

All four companies stated that they provide privacy safeguards for data. They also mention the limitations of these, but they are not providing information about the possibility of re-identification based on large amounts of sequencing data. Despite the fact that these companies include information regarding proprietary claims and commercialization of results of (possible) future research, it is not clear whether consumers are aware of the consequences of these policies.

Emilia Niemiec is part of the Joint International PhD Programme in Law, Science and Technology at the University of Bologna and Heidi C. Howard is senior researcher at CRB. According to them, companies need to improve the transparency regarding the handling of consumer’s samples and data. This includes having an explicit and clear consent process for research activities.

Soon, these tests may be much more difficult to market and offer in Europe. Right now, the European Commission is proposing changes to the European Directive (98/79 EC) on in vitro diagnostic medical devices. In a recent article, Heidi C. Howard and colleagues at KU Leuven outline the main changes and amendments suggested by the European Parliament affecting genetic tests. This includes a clarification of scope of devices, a new risk based classification system, enhanced safety and performance requirements, the need for genetic counseling and prescription to obtain a health-related genetic test, and banning of advertising of tests direct to consumers. These developments have already provoked controversy among stakeholders. If they are adopted we will see a radical change in the European direct-to-consumer genetic testing landscape.

By Josepine Fernow

Read articles

Ethical issues in consumer genome sequencing: Use of consumers’ samples and data, Niemiec E, Howard HC, Applied & Translational Genomics advance online publication February 2, 2016.

Current developments in the regulation of direct-to-consumer genetic testing in Europe, Kalokairinou L, Howard HC, Borry P, Medical Law International, advance online publication December 7, 2015.

Emilia Niemiec & Heidi C. Howard

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