Commentary

Minimal risk in pediatric research

Learning difficulties in atypical brain development represent serious obstacles to an individual's future achievements and can have broad societal consequences. Cognitive training can improve learning impairments only to a certain degree. Recent evidence from normal and clinical adult populations suggests that transcranial electrical stimulation (TES), a portable, painless, inexpensive, and relatively safe neuroenhancement tool, applied in conjunction with cognitive training can enhance cognitive intervention outcomes. This includes, for instance, numerical processing, language skills and response inhibition deficits commonly associated with profound learning difficulties and attention-deficit hyperactivity disorder (ADHD). The current review introduces the functional principles, current applications and promising results, and potential pitfalls of TES. Unfortunately, research in child populations is limited at present. We suggest that TES has considerable promise as a tool for increasing neuroplasticity in atypically developing children and may be an effective adjunct to cognitive training in clinical settings if it proves safe. The efficacy and both short- and long-term effects of TES on the developing brain need to be critically assessed before it can be recommended for clinical settings.

Over the past decades, considerable legislative effort has been made to facilitate and encourage clinical research in the European Union (EU). Hereby, specific attention has been paid to the urgent need to conduct research in minors. In this article, we will analyze the regulation that currently governs pediatric clinical research conduct at the supranational level of the EU and at the level of individual EU member states. Our analysis will focus on the way in which the national and supranational legal frameworks address five ethical issues that are specific to pediatric clinical research: (a) informed consent, (b) the necessity to conduct research in minor subjects, (c) the interests of the subject concerned, (d) the risks and burdens involved, and (e) the pediatric expertise of protocol review committees. We conclude by discussing the harmonization and diversification of the legal requirements that govern pediatric clinical research in the EU.

Proposals for pediatric biobanks have prompted questions of whether parental permission is sufficient to continue to use biological samples and data after the children become adults. The objective of this study was to examine adults' attitudes about continued research with their pediatric samples/data, particularly when they could not be located to provide consent.

Telephone interviews were conducted with 1186 patients from 5 academic medical centers by using a hypothetical scenario.

Most respondents, 799 (67%), would not be concerned about the use of their sample/data after they reached adulthood. Those respondents who were concerned were more likely to be more private about their medical records, less trusting of medical researchers, or African-American. A total of 543 respondents (46%) believed their consent should be obtained to continue using their sample/data for research. Of these, 407 respondents (75%) would be at least moderately willing to give consent, when asked. Of the 1186 respondents, 310 (26%) would not want researchers to use their sample/data when they could not be located to ask for consent.

The data are consistent with the normative view that when feasible, adults should be asked for consent for continued research on their data collected during childhood, but it is generally acceptable to continue to conduct research when adults cannot be located. Further public engagement may help determine how best to balance the potential social value of continued research using pediatric samples/data and the expectations for explicit consent expressed by a minority of respondents that may reflect concerns about privacy and trust.