This study examined the quality of children's assent to a clinical trial. In subjects younger than 9 years of age, understanding of most aspects of the study was found to be poor to non-existent. Understanding of procedures was poor in almost all subjects. In addition, voluntariness may have been compromised in many subjects by their belief that failure to complete the study would displease others. If the fact that a child's assent has been obtained is used to justify the exposure (...) of that child to the potential harm of a non-therapeutic blood sample, the assent must be meaningful. In the nutrition study observed here, the quality of the assent of children younger than 9 years of age was very poor. The assent therefore did not provide a valid justification for requesting a blood sample from these children. This study indicates that most children younger than 9 years of age cannot be expected to consent or assent to clinical research in a meaningful way. The current age of 7 years for initiating assent (in addition to parental consent) is possibly not appropriate and should be reconsidered. (shrink)

The age of maturity of children to consent for medical research is under debate, as different authorities regard the capacity of young teenagers as either satisfactory or not to grant consent without parental participation in the process. The present paper contrasts the generally accepted guideline for ethics in paediatric research in Canada with what the same children are allowed and expected to be able to do as babysitters. This comparison reveals deep incongruences in the way the maturity of the same (...) children is appreciated for two different tasks. (shrink)

As part of the preparations to establish a population-based biobank in a large Israeli health organization, we aimed to investigate through focus groups the knowledge, perceptions and attitudes of insured Israelis, toward biobanking, and then, after input from focus groups’ participants, to empirically assess the impact of a revised recruitment process on recruitment rates. 1) Six Focus group discussions were conducted with individuals who had routine blood laboratory tests taken in the last 2 years. 2) After addressing the issues raised (...) in the focus groups and revising the recruitment process, individuals undergoing routine blood tests in phlebotomy clinics were invited to participate in the future biobank. Six Focus group discussions were conducted with individuals who had routine blood laboratory tests taken in the last 2 years. After addressing the issues raised in the focus groups and revising the recruitment process, individuals undergoing routine blood tests in phlebotomy clinics were invited to participate in the future biobank. At the outset of the focus groups there was an overall positive response to the prospect of a population-based biobank. Concerns revolved around infringement on privacy, fears of the “big brother”, and anxiety about inequality. Reaction to the language of the informed consent document revolved around concerns over ability to maintain anonymity, to withdraw consent, involvement of commercial entities, and the general tenor of the informed consent, which was perceived as legalistic and unilateral. In general, the longer participants were exposed to discussion about the biobank, the less likely they were to consent to sign in. Overall, only 20% of the 60 participants stated they would agree to sign in by the end of the 2 hour group session. The feedback obtained from the focus groups was used in the second stage of the study. A team of recruiters received extensive training to enable fruitful discussion and a detailed explanation to questions and concerns raised during the recruitment process. During the second stage of the study, after revising the consent form and training recruiters, a 53% consent rate was observed among 10,262 participants, more than 4 fold higher than estimated at the focus group stage. The qualitative focus group research helped identify important perceptions and concerns, which were subsequently addressed in the revised consent form and in the discussion the recruiters had with potential biobank donors. (shrink)

Recruitment of healthy children for drugresearch has emerged due in part to several newAmerican laws and policies that have led to asurge in pharmaceutical research involvingchildren-subjects. In this paper, I review theethical and scientific issues and the argumentsin favor and against this new practice.