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Low risk research using routinely collected identifiable health information without informed consent: encounters with the Patient Information Advisory Group
  1. C Metcalfe1,
  2. R M Martin1,
  3. S Noble1,
  4. J A Lane1,
  5. F C Hamdy2,
  6. D E Neal3,
  7. J L Donovan1
  1. 1
    Department of Social Medicine, Bristol University, Bristol, UK
  2. 2
    Academic Urology, University of Sheffield, Sheffield, UK
  3. 3
    Department of Oncology, University of Cambridge, Cambridge, UK
  1. Dr C Metcalfe, Department of Social Medicine, Bristol University, Canynge Hall, Whiteladies Road, Bristol BS8 2PR, UK; chris.metcalfe{at}bristol.ac.uk

Abstract

Current UK legislation is impacting upon the feasibility and cost-effectiveness of medical record-based research aimed at benefiting the NHS and the public heath. Whereas previous commentators have focused on the Data Protection Act 1998, the Health and Social Care Act 2001 is the key legislation for public health researchers wishing to access medical records without written consent. The Act requires researchers to apply to the Patient Information Advisory Group (PIAG) for permission to access medical records without written permission. We present a case study of the work required to obtain the necessary permissions from PIAG in order to conduct a large scale public health research project. In our experience it took eight months to receive permission to access basic identifying information on individuals registered at general practices, and a decision on whether we could access clinical information in medical records without consent took 18 months. Such delays pose near insurmountable difficulties to grant funded research, and in our case £560 000 of public and charitable money was spent on research staff while a large part of their work was prohibited until the third year of a three year grant. We conclude by arguing that many of the current problems could be avoided by returning PIAG’s responsibilities to research ethics committees, and by allowing “opt-out” consent for many public health research projects.

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Footnotes

  • Trial registration: The CAP Study was registered on the 29th November 2004 at http://www.controlled-trials.com/isrctn. Registration number: ISRCTN92187251.

  • Funding: The CAP study is funded by Cancer Research UK and the UK Department of Health. The views and opinions expressed herein are those of the authors and do not necessarily reflect those of Cancer Research UK or the Department of Health.

  • Competing interests: None.

  • Ethics approval: The CAP Study has been approved by the Trent Multi-centre Research Ethics Committee (MREC). Reference numbers are MREC/03/4/093 (12th February 2004) and 05/MRE04/78 (24th November 2005).

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