Intended for healthcare professionals


Meta consent: a flexible and autonomous way of obtaining informed consent for secondary research

BMJ 2015; 350 doi: (Published 07 May 2015) Cite this as: BMJ 2015;350:h2146
  1. Thomas Ploug, professor of applied ethics1,
  2. Søren Holm, professor of bioethics2
  1. 1Centre for Applied Ethics and Philosophy of Science, Aalborg University Copenhagen, Department of Communication, AC Meyers Vænge 15, København SV 2450, Denmark
  2. 2University of Manchester, School of Law, Oxford Road, Manchester M13 9PL, UK
  1. Correspondence to: T Ploug ploug{at}
  • Accepted 25 March 2015

A rapidly increasing capability for storing, linking, and analysing health data has led to new opportunities for research. However, it also raises new ethical and regulatory concerns. Central among these is the question of the conditions under which secondary research can use data that were collected as part of routine healthcare practice or for a specific research project. Does secondary use require renewed informed consent from the original participants?

New developments in data handling and analysis throw up new problems, such as whether it is possible to make patient data unidentifiable, and to what degree.1 2 If the use of identifiable data requires informed consent, we must carefully reconsider whether informed consent is robust enough to withstand the more complex ethical challenges that technology brings with it; for example, in relation to the level of privacy protection that can be offered now and in the future.3 In this paper we propose a model for resolving these tensions—“meta consent.”

Informed consent

Historically, informed consent in clinical healthcare gave doctors permission to perform acts that would otherwise have been classed as physical assaults. Later, the requirements were extended to protect the individual against risk of harm, to protect personal autonomy (defined as the right to form and pursue one’s own goals and values), and to protect the individual’s privacy and right to control personal information.

At least two factors have the potential to override the requirement for informed consent. Firstly, society may have an interest in gaining access to personal health data to, for example, make research possible. Secondly, it may be impossible to obtain consent. The current focus on “big data” sets these two factors in sharp relief. On the one hand, building and linking vast databases of individual health data has considerable potential for promoting health and benefiting society, as …

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