Research subjects who are minors when they join a protocol typically must be reconsented after they turn 18 to be able to continue on the study. While the IRB can waive this reconsent requirement when such a waiver is justified, this issue falls into an ethical gray area when it comes to the long-term storage of biological samples for future, unspecified research.
For example, parents may agree to allow their infants’ biological specimens be stored indefinitely. Should those infants be asked to provide their consent for continued storage and use years later, after they turn 18? Can those children even be found that many years later? Obtaining their reconsent may not be feasible. However, waiving that reconsent means their samples may be used for potentially sensitive research, such as genetics research, or for research that involves practices and technologies that didn’t even exist when the samples were collected.
The convened IRB has had some heated discussions about this reconsenting-for-future-use-after-age-18 issue. The IRB is cognizant of both the practical and ethical issues surrounding the reconsent-or-waive question. One paper recently brought to our attention argues reconsent should not be necessary for such storage for future use. Some of the points raised may help both researchers and IRB reviewers think through the ethical implications of this question.
Our thanks to IRB reviewer Lyndsay Dupree for bringing this article to our attention.