Informed consent

BMJ 1997; 315 doi: https://doi.org/10.1136/bmj.315.7102.247 (Published 26 July 1997) Cite this as: BMJ 1997;315:247

***We have received an unprecedented response to our cluster of articles on informed consent. Readers can see from these letters and the previous group that we published that correspondents hold very different views on what policy we should set. Because we think that the voices of patients have not been adequately heard we plan to publish further responses from them. We will also publish brief responses from the two authors who introduced the debate.

We plan then to hold a meeting of all interested parties—including researchers, ethicists, and patients—to discuss what policy we should adopt. We hope that that meeting will be able to reach a consensus, but if (as seems likely) it cannot then the editorial team will decide our policy. We will report on the meeting and our decision in the journal.–Editor

The central problem is often poor design and conduct of trials

  1. Naomi Pfeffer, Honorary treasurera,
  2. Priscilla Alderson, Honorary secretarya
  1. a Consumers for Ethics in Research, PO Box 1365, London N16 0BW
  2. b University of Edinburgh, Edinburgh EH8 9AG
  3. c University of Western Ontario, London, Ontario, Canada
  4. d Community Health Department, University of Malawi, Private Bag 360, Chichiri, Blantyre 3, Malawi
  5. e Liverpool School of Tropical Medicine, Liverpool L3 5QA
  6. f Department of Physiology, Royal Free Hospital School of Medicine, London NW3 2PF
  7. g Medical Statistics Unit, London School of Hygiene and Tropical Medicine, London WC1E 7HT
  8. h National Perinatal Epidemiology Unit, Oxford OX2 6HE
  9. i The (Cleveland) Plain Dealer, Washington Bureau, Washington, DC, USA
  10. j 42 Hazel Grove, Lichfield WS14 9AS
  11. k General Hospital, Southampton SO16 6YD
  12. l Department of General Practice, UMDS, London SE11 6SP
  13. m 11 Craigallian Avenue, Glasgow G72 8DQ
  14. n 148 Battlefield Road, Glasgow G42 9JT
  15. o Department of Liaison Psychiatry, Leeds General Infirmary, Leeds LS1 3EX
  16. p Research School of Medicine, University of Leeds, Leeds LS2 9JT
  17. q York YO3 7BY
  18. r Nuffield Institute for Health, Leeds LS2 9PL. For Leeds-Wakefield study
  19. s South-East Institute for Public Health, Tunbridge Wells TN3 0XT. For East Sussex study
  20. t National Breast Screening Training Centre, City Hospital, Nottingham NG5 1PB. For Nottingham study
  21. u Whittington Hospital NHS Trust, London N19 5NF
  22. v London School of Hygiene and Tropical Medicine, London WC1E 7HT
  23. w St Raphaels Way Medical Centre, London NW10 0NU
  24. x Sandringham Practice, London E8 2PG
  25. y University of Bristol, Department of Social Medicine, Bristol BS8 2PR
  26. division of public health and primary health care
  27. department of clinical geratology
  28. z Radcliffe Infirmary, Oxford OX2 6HE
  29. aa Rivermead Rehabilitation Centre, Oxford OX1 4XD
  30. bb University of Glasgow, Royal Infirmary, Glasgow G4 0SF
  31. cc University of Newcastle upon Tyne, Newcastle upon Tyne NE1 7RU
  32. dd Hillingdon Outreach Support Team, Uxbridge, Middlesex UB8 1AR
  33. ee Flat 82, The Cloisters, Pegasus Grange, Whitehouse Road, Oxford OX1 4QQ
  34. ff Department of Medicine (Geriatrics), University of Newcastle, Newcastle upon Tyne NE4 6BE

    Editor—We are concerned about some aspects of the recent articles on consent.1 2 Len Doyal claims that informed consent may not be necessary for three most vulnerable groups: young children, patients with learning difficulties, and unconscious or semiconscious patients. Yet young children (unlike all adult groups) have the protection of their parents' consent, and this should always be respected.3 The other two groups show the limitations of applying Kantian respect for autonomy, designed for property owning 18th century gentlemen, to vulnerable dependent patients. There is an urgent need to agree new ways of making research decisions with and for these minority groups.

    As is usual in arguments against seeking informed consent, there is a tendency to concentrate on dramatic extremes: patients with severe mental impairment and patients receiving heroic cancer treatment. The development of principles from extremes is dangerous and should be discouraged. Difficulties with relatively small groups should not be used to excuse researchers from requesting the consent of the vast majority of …

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