The ethical, legal, and social issues arising from perinatal specimen collection and storage at biobanks for medical research

Abstract

　　Research biobanks in Japan have recently started to collect and store perinatal specimens such as cord blood and placenta tissue. These specimens are an important resource for the study of genetic epidemiology and regenerative medicine. However, there are no laws specifically covering biobanks in Japan, so these projects are currently governed by the “Ethical Guidelines for Medical and Health Research Involving Human Subjects,” as well as other guidelines and the Civil Code.

　　The National Cerebral and Cardiovascular Center’s Biobank has collected and stored several kinds of perinatal specimens and donors’ medical records since April 2014, and is now confronting new ethical, legal, and social issues (ELSI) related to these activities. These conflicts must be resolved. The ELSI relating to perinatal specimen storage differ from those relating to adult or dead fetus specimens. In most cases, mothers give informed consent regarding their child(ren)’s perinatal specimen collection and storage during pregnancy. However, other questions have now arisen: How long does proxy consent hold good, do fathers have the right to consent to (or refuse) what is done with specimens, and when should a donor be informed about such storage and any long-term observation studies? These issues are arising because such donors are not yet adults, but they will be eventually. More discussions about the ELSI relating to stored perinatal specimens, informed consent of all parties, and the legal character of human tissue are needed in Japan. Management issues relating to perinatal specimen storage at the time of informed consent concern proxy consent, and issues relating to how long specimens are stored concern informing the donor children themselves. We will consider practical management solutions to resolve these issues.