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Archives of Disease in Childhood 2004;89:899-901; doi:10.1136/adc.2003.045666
Copyright © 2004 BMJ Publishing Group Ltd & Royal College of Paediatrics and Child Health.
Archives of Disease in Childhood 2004;89:899-901
© 2004 BMJ Publishing Group & Royal College of Paediatrics and Child Health

LEADING ARTICLE

Medical research

Legal aspects of records based medical research

S E Parkes

Correspondence to:
Correspondence to:
S E Parkes
WMRCTR, Birmingham Children’s Hospital NHS Trust, Steelhouse Lane, Birmingham, B4 6NH, UK; sheila.parkes@bch.nhs.uk


Ethical medical research must continue despite the legal problems of records based medical research

Keywords: confidentiality; consent; law; records-based; research

The first 150 words of the full text of this article appear below.

All that may come to my knowledge in the exercise of my profession... which ought not to be spread abroad, I will keep secret and will never reveal (Hippocratic Oath)

Patient confidentiality is a fundamental component of medicine, but as late as 1994 the Royal College of Physicians determined that there was a duty to use available information for the general good where that could be done without detriment to individuals.1 The British Medical Association Ethical Committee in 1988 said that information could be used without consent as long as a local research ethics committee had approved the study.2 In 1997, Doyal3 proposed that epidemiological research, involving only access to medical records, should be an exception to the requirement for informed patient consent.

SO WHAT’S THE (LEGISLATIVE) PROBLEM?

Data Protection Act 1998

The situation was radically modified in March 2000, when the Data Protection Act 1998 (DPA)4 came into force in the UK, thus curtailing the relative . . . [Full text of this article]


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This article has been cited by other articles:

  • Metcalfe, C, Martin, R M, Noble, S, Lane, J A, Hamdy, F C, Neal, D E, Donovan, J L (2008). Low risk research using routinely collected identifiable health information without informed consent: encounters with the Patient Information Advisory Group. J. Med. Ethics 34: 37-40 [Abstract] [Full Text]  

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