The collection, linking and use of data in biomedical research and health care: ethical issues

The report does not intend to offer a universal set of instructions to be followed when creating a new data initiative – there can be no ‘one-size-fits-all’ solution. Rather, it considers the kind of questions that need to be addressed, and the principles that should be kept in mind when doing so.

Data initiatives as human practices

The formation of a data initiative is a complex social practice where tensions and conflicts of interests may exist at many levels: for example, at the level of the individual, of professions, or of the public.

Any data initiative will involve a number of different people, including regulators, commercial firms, doctors, researchers, patients and the wider public, each with their own values, interests and expectations. Nevertheless, there needs to be a legitimate means of reaching decisions about the use of data.

An optimised approach to decision-making

The report argues that an ethically appropriate use of data should respect certain core moral standards, reflecting the basic rights that underpin the legal system, rather than simply aiming to satisfy the requirements of the law. A proposed course of action can be lawful, but still morally questionable.

Involving people in the design and governance of a data initiative allows their interests and values to be expressed, transformed and reconciled. It can also help to secure their commitment to the outcome and build trust.

Ethical principles for data initiatives

The report sets out four ethical principles for the use of data in biomedical research and health care:

• Respect for persons: the terms of any data initiative must take into account both private and public interests. Enabling those with relevant interests to have a say in how their data are used and telling them how they are, in fact, used is a way in which data initiatives can demonstrate respect for persons.
• Respect for human rights: the terms of any data initiative should respect people’s basic rights, such as the right to protection of private or family life. This includes limitations on the power of states and others to interfere with the privacy of individual citizens in the public interest.
• Participation: decision makers should not merely imagine how people ought to expect their data to be used, but should take steps to discover how people do, in fact, expect their data to be used, and engage with those expectations.
• Accounting for decisions: data initiatives should include formal accountability, through regulatory, judicial and political procedures, as well as social accountability through periodic engagement with a broader public, as a way of re-calibrating expectations. Data initiatives must tell affected people what will be done with their data, and must report what actually has been done, including clear reports of any security breaches or other departures from the established policy. [Chapter 5]

The report considers how these principles are reflected in the design of data initiatives with regard to four key elements:

• Arrangements for data storage: whether data are retained close to the point of collection, more widely distributed, or gathered together in safe havens.
• How data are disclosed/accessed: whether data are published, subject to controlled disclosure or access, or subject only to indirect access.
• The role of consent or other forms of authorisation: for example, from explicit individual consent, through implicit consent with opt out, to authorisation by committees and other bodies.
• The range of approved users: including academic researchers and commercial users, and how they demonstrate (or not) that their aims are in the public interest.

The report examines a number of data initiatives in health care and biomedical research in relation to our ethical principles and the elements outlined above. Some of these examples are summarised in this guide.