Informed consent in medical research

doi:10.1136/bmj.314.7092.1477

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Doctors are arrogant to think they need to debate issue of patient consent

David E Bratt, Paediatriciana

^a 5 La Croix Avenue, Diego Martin, Trinidad and Tobago, West Indies
^b Hammersmith Hospitals NHS Trust, London W12 0NW
^c St George's Hospital Medical School, London SW17 0RE
^d University of Southampton, Primary Medical Care, Aldermoor Health Centre, Southampton SO16 5ST
^e BRI International, Battle, East Sussex TN33 0TX
^f Health Services Research Unit, Department of Public Health, University of Oxford, Oxford OX3 7LF
Consumers' Advisory Group for Clinical Trials
^g 31 Regent Street, Rowhedge, Colchester CO5 7EA
^h International Health Programs, Key Centre for Women's Health, University of Melbourne, 211 Grattan Street, Carlton, Victoria 3053, Australia
ⁱ Luton LU3 1PB
^j Neonatal Intensive Care Unit, Addenbrookes Hospital, Hospital Box 226, Cambridge CB2 2QQ
^k Parkview Clinic, Birmingham B13 3QE
^l Department of Psychiatry and Behavioural Sciences, University College London Medical School, London W1N 8AA
^m Moorfields Eye Hospital, London EC1V 2PD
ⁿ Department of Clinical Neurosciences, Western General Hospital, Edinburgh EH4 2XU
^o Royal Shrewsbury Hospital, Shrewsbury SY3 8XQ
^p Department of Surgery, Institute of Surgical Studies, University College London Medical School, Charles Bell House, London W1P 7LD
^q Wonford House Hospital, Exeter EX2 5AF
^r Royal Devon and Exeter Hospital, Exeter EX2 5DW
^s University of Exeter, Postgraduate Medical School Department of Mental Health, Wonford House Hospital, Exeter EX2 5AF
^t Ipswich, Suffolk IP8 4NN
^u St Mary's Hospital, London W2 1NY
^v Charing Cross Hospital, London W6

Editor—The editorial by Richard Smith raised the issue of publishing studies in which the researchers did not seek patients' consent.1 Firstly, I would think that of all the professions, only in medicine would there be any sort of debate about whether people need to be told that they, their bodies, their body fluids, their emotions, or whatever were to be subjects of research. This is arrogance on the part of doctors. Has anyone thought of asking these “patients” what their opinions are?

Secondly, I also think that doctors in developing countries need to be especially careful about obtaining consent from patients for anything, not only research. I would like to know that when I read a paper from a developing country in the BMJ, I can be sure that the individuals on whom the research was done had given informed consent.

References

1.↵
1. Smith R
. Informed consent: the intricacies BMJ 1997;314:1059#60. (12 April.)
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No one has a monopoly on deciding what is ethical

Pat Soutter, Past chairman, research ethics committeeb

^a 5 La Croix Avenue, Diego Martin, Trinidad and Tobago, West Indies
^b Hammersmith Hospitals NHS Trust, London W12 0NW
^c St George's Hospital Medical School, London SW17 0RE
^d University of Southampton, Primary Medical Care, Aldermoor Health Centre, Southampton SO16 5ST
^e BRI International, Battle, East Sussex TN33 0TX
^f Health Services Research Unit, Department of Public Health, University of Oxford, Oxford OX3 7LF
Consumers' Advisory Group for Clinical Trials
^g 31 Regent Street, Rowhedge, Colchester CO5 7EA
^h International Health Programs, Key Centre for Women's Health, University of Melbourne, 211 Grattan Street, Carlton, Victoria 3053, Australia
ⁱ Luton LU3 1PB
^j Neonatal Intensive Care Unit, Addenbrookes Hospital, Hospital Box 226, Cambridge CB2 2QQ
^k Parkview Clinic, Birmingham B13 3QE
^l Department of Psychiatry and Behavioural Sciences, University College London Medical School, London W1N 8AA
^m Moorfields Eye Hospital, London EC1V 2PD
ⁿ Department of Clinical Neurosciences, Western General Hospital, Edinburgh EH4 2XU
^o Royal Shrewsbury Hospital, Shrewsbury SY3 8XQ
^p Department of Surgery, Institute of Surgical Studies, University College London Medical School, Charles Bell House, London W1P 7LD
^q Wonford House Hospital, Exeter EX2 5AF
^r Royal Devon and Exeter Hospital, Exeter EX2 5DW
^s University of Exeter, Postgraduate Medical School Department of Mental Health, Wonford House Hospital, Exeter EX2 5AF
^t Ipswich, Suffolk IP8 4NN
^u St Mary's Hospital, London W2 1NY
^v Charing Cross Hospital, London W6

Editor—Having just come to the end of my term as chairman of our local research ethics committee, I would like to contribute to the debate on informed consent.

I have no doubt that informed consent should be obtained in virtually all research studies. The difficulty comes in those rare instances when the need to obtain informed consent may be waived. Len Doyal has made a thoughtful and useful contribution to the debate,1 but it is interesting that, whereas I would have said that the study by Satish Bhagwanjee and colleagues qualified under his suggestions,2 he seems to imply that it would not.

The commentaries of Rajendra Kale and Sheila McLean were critical of the two studies published in the BMJ, 2 3 but they failed to address the specific issues raised by the trials and resorted instead to vague generalisations. Neither was prepared to consider seriously the harm that can be done by not …