The collection of big data - i.e. the integration of various personalised databases - has important societal benefits. It enables the creation of innovative knowledge to serve a public good. The success of big data initiatives depends heavily on the willingness of people to share information and to accept central registration. This project looks into an ambitious biobank project which facilitates research into healthy ageing. A first result of the project is a new perspective on the role of informed consent in protecting the autonomy of participants.

Consent forms not adequate

In medical research, the prerequisite that participants give their written consent has become the golden standard for complying with ethical principles. Consent forms include more and more details and are increasingly subject to strict regulations. The researchers claim that this method to protect autonomy is not appropriate for untraditional and innovative research methods. This is especially the case for the increasing use of data collected outside traditional clinical trial research, such as patient records and longitudinal biobank studies linked with other data sources (see ‘Big Data in Healthcare’).

Given the current digital revolution, the researchers argue that values like patient autonomy need to be reassured in a novel way. Dynamic, continuous, and interactive methods of informing do more justice to the underlying principles of informed consent. This project will develop such methods.

Vulnerability

Recent public discussions reveal that the collection of big data make people feel vulnerable. This project started from the assumption that two types of factors determine people’s feelings of vulnerability and individual perceptions on big data:

• Ethical factors (e.g. consent, confidentiality, access, social utility)
• Psychological factors (e.g. feelings of threat, trust in public institutions, social identification)

With an interdisciplinary team of researchers the project develops responsible, innovative ways to stimulate sharing personal data. Together with different companies these approaches will be tested in practice.

Trust

The decision to participate in Big Data collection might be seen as a public goods dilemma, a conflict of interest between the individual and the social level. The stronger this dilemma, the more relevant ‘trust’ will be as predictor of individual compliance. The first results of this project show that the amount of trust in big data depends on the context and goal of data collection and usage (e.g. healthcare or commerce). Further factors relevant to trust are for example behaviour of representatives from the organisation, indications of independency of the organisation, and societal benefits.

Privacy

To safeguard privacy while collecting, storing and using Big Data, several concerns should be taken into account. Examples are usability and quality of research data, anonymisation, and feedback to participants. The project will develop guidelines specifying which aspects of the data are crucial to be preserved, which aspects should be anonymised, and what benefits to individuals should look like.

Healthy ageing

The LifeLines biobank, which started in 2006, is used as a case study. More than 165.000 inhabitants of the provinces Drente, Friesland and Groningen will be followed for 30 years to gain new knowledge about healthy ageing and factors which influence the development of chronic diseases. The data collected on the participants is stored during this whole period and can be used by health researchers from all over the world. The researchers in this project will interview participants in the programme as well as a selection of people who withdrew from participation, about their experiences with LifeLines.

big data, vulnerability, trust, privacy, privacy, healthy ageing, biobank, medical research, autonomy, informed consent, participation

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