Re: Broad consent is informed consent
Broad consent has been adopted as a practical solution for biobanks since it has been impossible to apply the requirements of informed consent as articulated in the Declaration of Helsinki. This is because consent to involvement in a biobank must be obtained before the biobank commences when all of the researchers and research users are not known. Biobanks such as the UK Biobank and other cohort studies incorporate various kinds of medical information from different sources with DNA samples to build up detailed information on people over many years that can be used by researchers to help to understand the aetiology of disease. However, even in such studies, informed consent is always obtained for new studies if they are not encompassed within the existing consent. Re-consent is often necessary unless the information can be anonymised for use by researchers or s251 exemption is obtained. Unlike other research, biobanks are exempt from obtaining consent for secondary research uses if ethics approval has been given, which means that broad consent covers a range of different research uses. Broad consent has been a practical solution since, until now, we did not have the capabilities or mechanisms to go back to individuals to obtain informed consent for further studies. Because of these limitations, broad consent, though strongly contested in the bioethics literature, has had to suffice.
In the EnCoRe project [www.encore-project.info] we have built a patient-centric IT system which uses a 'dynamic consent' approach. In this model, consent is not a mere communication exercise but a bidirectional, ongoing, interactive process between patients and researchers. Through the IT interface, individuals can make and express preferences about the choices they are given about the use of their data and samples for research. This system enables individuals to change their mind and preferences over time, to have their choices revoked where appropriate, to track and audit any changes made, and, significantly, to choose when and how they are contacted. The benefit of this interface is that it enables individuals to exercise their autonomy by giving informed consent for new types of research in real time rather than being asked to give a broad consent at the beginning of the research process when they are recruited into a biobank. The benefits for the research process are that recruitment is easier, less costly and more efficient; the legal and ethical requirements of consent can be met with ease; there is greater transparency and accountability in the research process and research findings can be returned to research participants as part of a personalised medicine approach. Dynamic consent has the potential to enhance patient confidence and enable long term patient-researcher collaborations in research [Trinidad SB et al, 'Research Practice and Participant Preferences: The Growing Gulf' Science, 2011 Jan 21;331(6015):287-8].
This interface moves away from manual, paper-based processes to an e-governance system. Implementing our 'dynamic consent' model offers the opportunity to transform the debate from questions of public good versus individual autonomy, cost versus practicality to one where the concerns of the patient are aligned with the needs of medical research. We anticipate that 'dynamic consent' will become an essential and sustainable component of research infrastructure and will further advance translational research initiatives. If this is the case, then concerns about the appropriateness of broad consent for biobanks may cease to have the significance that they have had and we will have different legal and ethical issues to deal with.
- Jane Kaye, Director, HeLEX Centre for Health, Law and Emerging Technologies, Department of Public Health, University of Oxford, Old Road Campus, Oxford OX3 7LF
- Edgar A. Whitley, Information Systems and Innovation Group, Department of Management, London School of Economics and Political Science, Houghton Street, London WC2A 2AE
- Nadja K. Kanellopoulou, Researcher in Law, HeLEX Centre for Health, Law and Emerging Technologies, Department of Public Health, University of Oxford, Old Road Campus, Oxford OX3 7LF
- Sadie Creese, Professor of Cybersecurity, Department of Computer Science, University of Oxford, Wolfson Building, Parks Road, Oxford OX1 3QD
- Kay J. Hughes, Principle IA Analyst, QinetiQ, WW A009, Malvern Technology Centre, St. Andrews Road, Malvern, Worcestershire ,WR14 3PS
- David Lund, EnCoRe Implementation Lead, HW Communications Ltd, Parkfield, Greaves Road, Lancaster, LA1 4TZ
Competing interests: None declared.