The legal and ethical implications of using health data

Reported by Paul Henry, BBSRC funded policy intern

How can medical researchers fulfil their legal and ethical obligations to patients in the age of big data analysis?

Health research must balance complex questions of public trust, ethical obligation, legal compliance and practicality regarding the legal basis for the use of sensitive personal data. This requires data governance to be transparent and trustworthy; people must understand and have confidence in the decision making process which their data will be subjected to.

CSaP's Policy Workshop explored the legal and ethical aspects of consent to use patient data in medical research.

A panel of experts discussed the legal, ethical and technical implications of rapid advancements in the fields of data science and genomics. Conducting population level studies on big datasets have become an integral part of modern medical research, complex datasets including lifestyle choices and genetic information can be invaluable subjects of study. The roundtable discussion centred on the legal and ethical obligations of medical researchers and data managers to protect individuals from the risks associated with releasing their personal data.

How should the NIHR Bioresource respond to changes in the technical, legal and social context for collecting and using health data in research?

Professor John Bradley, Director of the National Institute for Health Research Bioresource, asked the participants to discuss the legal basis of medical research on large health datasets. Currently individuals are asked to sign a consent form for their data to be used in medical studies, however, the precise legal definition of consent has a number of stipulations including the need to for the subject to be informed of the risks and able to rescind their consent as easily as it is given. This could be problematic for health research as fully informing participants of all of the downstream applications of their data would become and unwieldy administrative task for most research projects, and should an individual rescind their consent for the use of their data it may not be possible to extract their information from the computing and statistical aspects of the study.

A potential alternative to using consent as the legal basis for this kind of research could be sufficiently deperonalisation to the point where the data is no longer considered sensitive. For this to be used as a legal basis for research there must be a clear discussion about what level of depersonalisation is necessary to reasonably mitigate harm to participants.

What are the relevant insights from recent research and from the Understanding Patient Data initiative on public attitudes to the collection, use and governance of personal health data?

Clinicians and medical researchers enjoy a unique level of trust amongst the public, people are typically cooperative in releasing their data to medical research, believing that it will be safe, responsible and in the public good. Such trust is contingent on the data collection and processing adhering to strict legal and ethical standards, otherwise medical research could concede its social licence to operate.

This social licence is the cooperation of the public with health research and trust in managers to take safe and responsible decisions. This cooperation is related to various warrants of trust, which can include cues from institutional logos and uniforms. The signing of a consent form is a vital part of this process, as it signifies a responsibility the data manger has to the individual. This would indicate that the consent form cannot be done away with, as bypassing consent would breach the confidence the public has in the health professions.

Health research must balance complex questions of public trust, ethical obligation, legal compliance and practicality regarding the legal basis for the use of sensitive personal data. This requires data governance to be transparent and trustworthy, people must understand and have confidence in the decision making process which their data will be subjected to.

Thumbnail image courtesy of MamaYe Africa on Flickr

Banner image courtesy of Dean Morley on Flickr