Non-therapeutic research on children raises ethical concerns. Such research is not only conducted on individuals who are incapable of providing informed consent. It also typically involves some degree of risk or discomfort, without prospects of medically benefiting the participating children. Therefore, these children seem to be instrumentalized. Some ethicists, however, have tried to sidestep this problem by arguing that the children may indirectly benefit from participating in such research, in ways not related to the medical intervention as such. It has (...) been argued, for example, that non-therapeutic pediatric research does not instrumentalize the children enrolled since it has the prospects of furthering their moral development. We argue that this argument is far too undeveloped to be taken seriously. (shrink)

International child rights law has the potential to change the way children are viewed and engaged by all social actors. It provides a child-centered perspective on all areas of children’s lives, including research with neonates. It differs from some bioethical perspectives by clearly articulating affirmative obligations owed to children and requiring rigorous monitoring mechanisms. The CRC’s focus on affirmative obligations and establishment of monitoring mechanisms provide additional useful elements that are not present in the dominant form of American pediatric bioethics.An (...) in-depth introduction to child rights and the U.N. Convention on the Rights of the Child is presented by Lansdown.. (shrink)

There are differences in caregivers’ literacy and health literacy levels that may affect their ability to consent to children participating in clinical research trials. This study aimed to explore the effectiveness, and caregivers’ understandings, of the process of informed consent that accompanied their child’s participation in a dental randomized control trial (RCT). Telephone interviews were conducted with a convenience sample of ten caregivers who each had a child participating in the RCT. Pre-tested closed and open-ended questions were used, and the (...) findings were produced from an inductive analysis of the latter and a descriptive analysis of the former. Participants had limited understanding of the purpose of the RCT and rated the readability of the consent form more highly than they rated their understanding of the research. All felt that informed consent was vital, but some caregivers had not read the consent documents. Some caregivers enrolled their child in the RCT because they trusted the researchers, and the majority wanted to improve dental care for children. The informed consent process was not always effective despite high readability of the informed consent documents. Researchers must consider the health literacy of the study group, and actively engaging with caregivers to achieve meaningful informed consent may be challenging. Future research could explore participants’ perspectives of informed consent in populations with low health literacy and assess whether an underlying expectation not to comprehend health-related information may be a barrier to informed consent. (shrink)

Whats human rights got to do with it? That is, whats human rights got to do with the June 2004 report of the Social Sciences and Humanities Research Ethics Special Working Committee to the Inter-Agency Advisory Panel on Research Ethics. The disturbing answer is not enough. Certain key recommendations of the working committee, it is suggested, would unacceptably weaken the researchers legal and moral accountability to research participants. Those particular recommendations rely on misguided references to academic freedom and the nature (...) of the non-medical research context. In fact, universal human rights, and the legal instruments in which they are embodied ought to inform the research endeavor at every stage; from problem selection to analysis and conclusions. This will lead us closer to shared truths rather than simply to the academic elites vision of truth. Without sufficient regard for the human rights of research participants academic freedom itself is not possible. (shrink)