Hypoxic responses in infants

BMJ 1998; 317 doi: http://dx.doi.org/10.1136/bmj.317.7159.675 (Published 5 September 1998)
Cite this as: BMJ 1998;317:675

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Subjecting infants to low oxygen concentrations seems unethical

  1. Charles West, General practitioner
  1. Church Stretton Medical Centre, Church Stretton, Shropshire SY6 6BL
  2. Local Research Ethics Committee, West Glasgow Hospitals University NHS Trust, Glasgow G11 6NT
  3. University of Colorado School of Medicine, Section of Neonatology, Children's Hospital, Denver CO 80218, USA
  4. University of Colorado, Denver and Health Sciences Center, Cardiovascular Pulmonary Laboratory, Denver CO 80262, USA
  5. Newcastle Neonatal Service, Royal Victoria Infirmary, Newcastle upon Tyne NE1 4LP
  6. Bristol Royal Hospital for Sick Children, Bristol BS2 8BJ
  7. Unit of Paediatric and Perinatal Epidemiology, Bristol BS8 1TQ
  8. Nuffield Institute for Health, Leeds LS2 9PL
  9. Nuffield Department of Obstetrics and Gynaecology, John Radcliffe Hospital, Oxford OX3 9DU
  10. Centre for Human Bioethics, Monash University, Melbourne, Australia 3168
  11. Wolfson Hyperbaric Medicine Unit, University of Dundee, Ninewells Hospital and Medical School, Dundee DD1 9SY
  12. Directorate of Child Health, Department of Academic Paediatrics, North Staffordshire Hospital, Stoke-on-Trent, Staffordshire ST4 6QG

    EDITOR—The ethics of Parkins et al's study depend partly on whether there is any potential benefit to the infants from the experiment.1 If parents subject their infant to low oxygen concentrations in an aeroplane they take a risk which is balanced against the benefit of air travel. Unless there is some real prospect of identifying infants at risk and offering useful protection against the sudden infant death syndrome, it seems to me to be unethical to subject those infants to the risk of exposure to low oxygen concentration. The fact that some of the families had previously experinced the loss of a child may have increased the likelihood of compliance. This makes me even more worried about the ethics of the study.

    References

    Research should contain element of treatment

    1. Nicholas Pace, Vice-chairman
    1. Church Stretton Medical Centre, Church Stretton, Shropshire SY6 6BL
    2. Local Research Ethics Committee, West Glasgow Hospitals University NHS Trust, Glasgow G11 6NT
    3. University of Colorado School of Medicine, Section of Neonatology, Children's Hospital, Denver CO 80218, USA
    4. University of Colorado, Denver and Health Sciences Center, Cardiovascular Pulmonary Laboratory, Denver CO 80262, USA
    5. Newcastle Neonatal Service, Royal Victoria Infirmary, Newcastle upon Tyne NE1 4LP
    6. Bristol Royal Hospital for Sick Children, Bristol BS2 8BJ
    7. Unit of Paediatric and Perinatal Epidemiology, Bristol BS8 1TQ
    8. Nuffield Institute for Health, Leeds LS2 9PL
    9. Nuffield Department of Obstetrics and Gynaecology, John Radcliffe Hospital, Oxford OX3 9DU
    10. Centre for Human Bioethics, Monash University, Melbourne, Australia 3168
    11. Wolfson Hyperbaric Medicine Unit, University of Dundee, Ninewells Hospital and Medical School, Dundee DD1 9SY
    12. Directorate of Child Health, Department of Academic Paediatrics, North Staffordshire Hospital, Stoke-on-Trent, Staffordshire ST4 6QG

      EDITOR—Parkins et al and Hughes, the chairman of the local ethics research committee, in their reply to the commentary by Savulescu, repeat that the parents knew of the potential risks and gave consent.1 This does not justify the research. In the case of proxy consent the people—in this case the parents—vested with that power must use it reasonably. The law regarding the participation of children in non-therapeutic research is unclear. The most favourable suggestion, from the researchers' point of view, is that the validity of consent should be based on whether the parents are clearly not acting against the best interests of the child. Thus the amount of risk that the child is exposed to becomes relevant.2

      According to the British Paediatric Association it would be unethical to submit child subjects to more than minimal risk when the research offers no or minimal benefit to them.3 The Institute of Medical Ethics has defined minimal as a risk of death of less than 1:1 000 000, a risk of major complications of less than 1:100 …

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