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During the review process of the study by Erb et al., in this issue of Anaesthesia [[1], several issues of both scientific and ethical nature have been raised [[2]]. Research ethics committees are a central part of the process for screening, monitoring and overseeing research in humans, and here I welcome the opportunity to present the rationale of the committee involved, the Ethikkommission beider Basel (EKBB), in approving this study.

Did the research ethics committee make a real informed decision?

  1. Top of page
  2. Did the research ethics committee make a real informed decision?
  3. Was the risk/benefit analysis correct?
  4. Were the parents informed correctly?
  5. Competing interests
  6. References

Erb et al.'s study, submitted in 2007, was discussed intensively at the review session of the EKBB. A final decision could not be made, since many members had additional questions. Therefore, in addition to providing written responses, the investigators were invited to participate during a common meeting. There was also a visit by members of the EKBB to the site of the proposed research, to meet with the research team and observe their clinical practice. In making their final decision, the EKBB was fully aware that there was no personal benefit for the participating children, that important pathophysiological questions concerning laryngospasm may be answered and that all measures to minimise the risks of laryngeal challenge were taken. All documents were available to the EKBB: information for the parents; informed consent forms; scientific protocol; and insurance policy. The final positive decision was made unanimously.

Was the risk/benefit analysis correct?

  1. Top of page
  2. Did the research ethics committee make a real informed decision?
  3. Was the risk/benefit analysis correct?
  4. Were the parents informed correctly?
  5. Competing interests
  6. References

This is the most important and also the most difficult ethical task. Extending an invitation to the investigators to participate at a common meeting is not a routine procedure in our system and underlines that the members of the EKBB realised the special nature of this study. Laryngospasm is a critical problem in paediatric anaesthesia. Some specialists even argue that this is an important reason for having specialised paediatric anaesthetists. Therefore, there is little doubt that additional knowledge in the field is urgently required.

The appraisal of the risk-reducing measures proposed by the investigators remained, of course, partially subjective, but this is counterbalanced by the detailed presentation, the open discussion and the very different professional backgrounds (physicians, pharmacologists, nurses, lawyers, biostatitisticians) of the members of the EKBB. From the beginning of the review process, we realised that there were difficult issues. We took a positive decision; others may have taken a negative one.

Were the parents informed correctly?

  1. Top of page
  2. Did the research ethics committee make a real informed decision?
  3. Was the risk/benefit analysis correct?
  4. Were the parents informed correctly?
  5. Competing interests
  6. References

The acceptance rate for participation in the study was only 30%. This is not necessarily an argument against the study, but indicates that the investigators were informing and not pressurising the parents. The described complications are one explanation, the lack of personal benefit to the participating child, another.

The information provided to the parents in the written information was correct. The EKBB came to the decision that the setting proposed by the investigators minimised the risks to the greatest extent, and that the parents were adequately informed of these.

The work of a research ethics committee consists of balancing risks and benefits to participants and future patients on a daily basis. We have reviewed the documentation and discussions relating to Erb et al.'s study and are satisfied that all the relevant factors received due consideration in reaching our decision.

References

  1. Top of page
  2. Did the research ethics committee make a real informed decision?
  3. Was the risk/benefit analysis correct?
  4. Were the parents informed correctly?
  5. Competing interests
  6. References
  • 1
    Erb TO, von Ungern-Sternberg BS, Keller K, et al. The effect of intravenous lidocaine on laryngeal and respiratory reflex responses in anaesthetised children. Anaesthesia 2012; doi: 10.1111/j.1365-2044.2012.07295.x.
  • 2
    Durward A. Research in children and ethical limits: the water laryngospasm challenge. Anaesthesia 2012; doi: 10.1111/anae.12005.