Analysis And Comment Confidentiality and consent in medical research

Consent for the use of personal medical data in research

BMJ 2006; 333 doi: http://dx.doi.org/10.1136/bmj.333.7561.255 (Published 27 July 2006) Cite this as: BMJ 2006;333:255
  1. Peter Singleton (peter.singleton@chi-group.com), principal research fellow1,
  2. Michael Wadsworth, professor of social and health life course research and director of the MRC national survey of health and development2
  1. 1 Centre for Health Informatics and Multi-professional Education (CHIME), University College London, London N19 5LW
  2. 2 MRC National Survey of Health and Development, Department of Epidemiology and Public Health, Royal Free and University College London Medical School, London WC1E 6BT
  1. Correspondence to: P Singleton
  • Accepted 24 March 2006

Properly obtained consent is needed for all clinical trials, yet one size doesn't necessarily fit all. This article looks at different consent models and emphasises the need to support choice rather than just observing the formalities of “gaining consent”

This article deals mainly with the secondary use of medical records in research; primary use may have been for a clinical trial or for medical treatment. Well known examples of successful secondary use of data are discovery of the links between antidepressants and suicide and between tranquilisers and road accidents.1 2 These insights are important, even if they are not conclusive and may need to be confirmed by specific studies or trials.

Explicit consent is needed for all aspects of clinical trials, including the retention of medical records, either as identifiable data or in anonymised form.3 Consent is usually for that trial only (this can go to extremes; see box 1). Difficulties can arise over re-use of data, either for new questions that arise within the study, or for questions that could be considered once the data have been gathered but were not anticipated at the outset when consent was gained. In terms of efficiency and consistency of results, it is preferable to re-use data rather than re-collect it. Projects should therefore allow participants to choose at the outset whether data (and possibly tissues) can be retained for future research in a secure and confidential form.

The two main legal instruments are the Data Protection Act 1998 (DPA98) and the common law of confidence (confidentiality), which are discussed in another article in this series.4 Essentially, consent is needed to use personal data in medical research unless the person is dead; the researchers are all healthcare professionals or equivalent; or the data do not identify the person.

Box 1: How much consent is enough?

Recently, one …

Sign in

Free trial

Register for a free trial to thebmj.com to receive unlimited access to all content on thebmj.com for 14 days.
Sign up for a free trial

Subscribe