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Informed consent for randomised controlled trials in neonates
  1. J A F ZUPANCIC,
  2. P GILLIE,
  3. DL STREINER,
  4. J L WATTS,
  5. B SCHMIDT
  1. Department of Paediatrics
  2. McMaster University
  3. Hamilton
  4. Ontario
  5. Canada L8N 3Z5

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    Editor—We read with some concern the Annotation by Mason et al 1 in which she seems to endorse a major paradigm shift in the informed consent process for neonatal randomised trials. But she does not provide sufficient evidence (as opposed to opinions) that such a shift is really needed. Although reference has been made to an ongoing European study which will “determine the validity of the consent process from the viewpoint of...parents of babies requested to provide proxy consent,” Dr Mason has already concluded that “the existing position with regard to informed consent for neonatal research is problematic.” She questions the rational basis of the consent process, especially for “those who are poorly educated and emotionally stressed.” She also states that voluntariness may be undermined because of the complexity of the medical arguments, feelings of parental powerlessness, and inadequate time for information transfer.

    We recently published the first study to correlate the determinants of parental authorisation for the involvement of newborn infants in clinical trials with the direction of the consent decision.2

    It should be reassuring to your readers that we found no association between the consent decision and the sociodemographic characteristics of the parents, or the severity of the infant’s illness. Moreover, we showed that parents assessed the probability and magnitude of risks and benefits. Importantly, those parents who did not feel free to decide or who felt that the consent process was too complex, were, in fact, least likely to authorise their infant’s participation in a trial.

    Our study results call into question many of Dr Mason’s assumptions, and we eagerly await the results of the European study to see whether European parents differ in attitude from those in our Canadian sample. We would also like to differentiate the process from the substance of the consent process. Issues of complexity or coercion are process problems which may be resolved with more conscientious attention to the demands of the current format, or if necessary, with new ways of approaching parents for authorisation.

    One final point: Dr Mason observes that the need for equipoise in a randomised trial “involves the need to admit uncertainty,” and she asserts that this may lead patients to doubt the doctor’s ability. Equipoise will be an issue in any controlled trial, regardless of who makes the decision, and should not be an argument for an overhaul of the system. As for the necessity to admit uncertainty, many parents would argue that this is long overdue, both in the context of informed consent for research and in daily clinical practice.3 4Where is the evidence that honesty may lead patients to doubt the doctor’s ability?

    Ethicists, too, should take heed of the rules of evidence, and in considering action should recall Claude Bernard’s admonition: “True science teaches us to doubt and, in ignorance, to refrain.”

    References

    Dr Mason responds: Contrary to the supposition of Zupancic et al, I do not “endorse a major paradigm shift in the informed consent process for neonatal randomised trials.” Indeed, I have rejected alternative approaches as neither providing adequate protection nor conforming to the central ethical principle of respect for autonomy of the individual.1-5

    I do entirely concur with the point made that the admission of uncertainty in medical practice is desirable. I pointed out that education about randomised controlled trials would be helpful as a long term approach to increasing their general acceptability. This would thus include discussion of uncertainty of treatment options as being a part of this process.

    Where I disagree with Zupancic at al is in their suggestion that informed consent in neonatal research is not problematic. Evidence suggests that parents do not always fully understand the randomisation process.1-6 Indeed, the Euricon project arose initially out of concerns in this area, expressed by neonatologists at the European Neonatal Brain Club at their meeting in October 1994 in Leeds, UK.

    In Zupancic et al’s Canadian study2 32% of all parents of neonates (103 who consented to research and 37 who declined) agreed with the statement “I would prefer to have the doctors advise me whether my baby should be in the study, rather than asking me to decide.” To me, this implies the reluctance of “a significant minority of parents” to shift entirely from a more paternalistic approach, and it is a factor to take into consideration when aiming for emphasis on patient autonomy in research.

    To ignore inconsistencies and concerns in the area of informed consent would be to do a disservice to parents and neonates. To debate and explore the problems, to raise awareness and improve the situation is to act ethically, in the best interests of the patient, and with respect for individual autonomy.

    References

    1. 1-5.
    2. 1-6.
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