Reconsidering the Need for Reconsent at 18

Abstract

The prevalence of research with biological specimens has led to a debate over what type of consent is needed to obtain biological specimens from minors and store them for future studies. In most cases, parental permission is needed to obtain samples from minors. In addition, almost all commentators and guidelines maintain that researchers need the consent of the donors if they want to continue to store the samples and make them available for future studies after the donors reach the age of majority. In this Ethics Rounds, we argue that this near-consensus view is mistaken on the grounds that the agreement of the parents at the time of obtaining samples provides sufficient permission to store them and use them in research even after the donors turn 18 years old.

Research Consent at the Age of Majority: Preferable but not Obligatory

“…In this Ethics Rounds, we consider the same case described by Berkman et al 1 Considering ethical and regulatory issues in turn, we conclude that parental permission does carry adequate authority to continue using pediatric samples once the donor reaches the age of majority. On the other hand, there are still important ethical reasons to obtain consent at this age.…”

“…For example, many IRBs require investigators to destroy data and samples if pediatric biorepository participants cannot be reached when they reach the age of majority, although there are a number of alternatives that would preserve the value of these samples to research. 2 This practice highlights how important it is to understand and respect the role of parental authority; Berkman et al 1 have provided important insights on this issue. There are many parental decisions that are not revisited as children reach adulthood, and this enduring influence of parental decisions is an unavoidable result of parental authority during childhood.…”

“…As we will explore in the next section, the current regulatory scheme fits this ethical framework relatively well. However, it does not allow for the radical change in practice proposed by Berkman et al 1…”

“…7 Given this recent history, there is little energy in the regulatory and health policy community to start this process anew. If it were necessary to revise the Common Rule to allow for the change in practice that Berkman et al 1 propose, it is unlikely that such a revision will be seriously considered in the next decade.…”

“…Berkman et al 1 argue that biorepository samples collected with parental permission should be available for continued research use when pediatric donors reach the age of majority, and it is not necessary to reach out to pediatric donors for their consent. Our disagreement is partial, in that we would highlight the value of contacting pediatric donors when this would not detract from important research aims.…”