consent, assent, reconsent, rare diseases, biobanking, children
Many collections of human biospecimens are available and used worldwide for biomedical research, including tissue samples from children. These samples are vital for research to advance and improve pediatric health care, especially since many pediatric diseases are rare. Human biospecimen collections are either in the form of prospective cohorts or samples gathered by doctors in a treatment setting. Because children research participants are considered to be vulnerable, pediatric biobanking practices raise a unique set of challenges. In most pediatric research and biobanking activities, informed consent (or “permission”) is usually obtained from parents or legal guardians, and only assent is obtained from children.
A researcher in a Southeast Asian country has been collecting research samples from children for almost 2 decades and works with an institutional biobank. A large portion of the samples in this biobank are from pediatric patients with rare diseases such as inborn errors of metabolism. When these samples were collected, the researcher obtained informed consent from parents or legal guardians, since children are not legally allowed to provide consent for themselves. Contributed samples have been used for biomedical research over the course of many years, and those initially collected from children are still stored and used even when these participants have become adults. The research team and the institutional biobank now wonder whether it is ethically necessary to recontact and obtain consent from these individuals who are now adults.
This matter was raised during an internal scientific review, and the biobank decided to apply to a research ethics committee (REC) for a waiver to recontact and obtain consent from these individuals.1,2
Questions
To what degree should pediatric patients take part in the informed consent process for biobanking?
In the scenario above, should children who were enrolled in research be recontacted once they reach adulthood to provide informed consent?
Was the decision to request for waiver to recontact and consent these participants by the institutional biobank appropriate? What are some of the considerations that the REC should take into account when determining whether or not to grant the waiver?
