| The birth of a baby is a momentous occasion. It is not a time when parents want to think about the details of medical research. In some cases, however, they may be forced to, as when they are approached by a physician wishing to obtain “informed consent” to enroll their newborn in a clinical trial. This touchy situation has complex dynamics. In fact, some have questioned whether the informed consent process accomplishes what it sets out to do, namely, retrieve valid parental permission.
Researchers from nine European countries conducted an interview study on the informed consent process for recruiting subjects in neonatal randomized control trials. The goal was to probe its effectiveness and gain information on improving the consent forms and procedure (Lancet 2000, 356, 2045–2051). Questions were posed to neonatologists and to parents who had been approached about trials for their infants. Validity was assessed against four components: parental competence, completeness of information given, parent al understanding, and voluntariness of consent.
Of the parents, 70.5% reported an impeding problem with one or more of the four areas. They expressed almost equal concern about the first three components but had fewer complaints about the level of perceived voluntariness. All but three of the clinicians had issues with at least one of the categories. The area of greatest concern for clinicians was the perceived competency of the parents, particularly their ability to “think clearly” in some emotional situations.
The study suggested that there is important room for improvement in doctor–parent communication. It stated that physicians rely too much on information sheets, often preferring them to verbal explanation, and that physicians frequently do not convey the regulatory evaluations that trial protocols have successfully passed through. The researchers note that it is important for doctors to attend training on the appropriate conduct for seeking informed consent.
Despite the concerns, both parents and doctors value the informed consent process. The ability to have a say in what is done to their baby is of crucial importance to parents. Clinicians generally realize the utility of the process, but they also think that the delays and costs that come with it may hamper treatments that are needed quickly and could hinder or prevent some useful projects.
To better understand the situation, future study is needed in determining the degree to which each of the four components affects parental decision making.
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