During the Research Ethics Book Group Lunch and book signing of A Life Everlasting: The Extraordinary Story of One Boy’s Gift to Medical Science, I was equally heartbroken, curious, and pensive, but by the end of the presentation, I was restored and enlightened. I can’t imagine I was the only person affected this way during this poignant session.
Author Sarah R. Gray, MA and moderator Barbara E. Bierer, MD worked together to recount and reflect on Gray’s story. After learning that one of her unborn twins had a terminal condition, Gray decided his organs would be donated to research. Though baby Thomas’ life only lasted six days, his legacy has lasted much longer: his organs, eyes, tissues, and blood were donated to institutions across the country and played pivotal roles in the advancement of scientific research. Gray offered an insightful perspective as a family member of a donor, detailing the confidentiality and IRB issues she navigated as she searched for the researchers who received her son’s donations.
Gray’s story got me thinking about my role as an IRB staff member, human being, and recent IRB201 graduate—the last being where I learned the difference between privacy and confidentiality. During IRB201, I learned that privacy refers to a person’s desire to control the sharing of his or her information, whereas confidentiality refers to the methods of properly maintaining that information. Essentially, privacy is about people, and confidentiality is about data. That seems straightforward enough— a statement rarely declared in an IRB office—but that’s because, like most things IRB, there is always the “what about in this situation?” question.
What about biospecimens? Throughout the conference, we heard the terms “biospecimen” and “data” when really we were talking about tissue, cells, blood, or some other material taken from a human being’s body. If we define these materials as data once they leave their living hosts, then where does that leave someone like Sarah Gray? She had to jump through hoops to find her son’s “data” because that was how it was recognized. When Sarah wanted to learn where her son’s donations were sent and how they were being used, she was faced with many roadblocks because of well-intended confidentiality procedures that limited her access to her son’s “material.” I recognize we do an exceptional job protecting those we think about—participants, researchers, and data—but what about the Sarah Grays of the world? I never thought about them before this, which is part of the problem, but I intend to start now.
Sydney Boone, IRB research operations assistant at Westat, is a member of the PRIM&R Blog Squad for the 2016 AER Conference. The PRIM&R Blog Squad is composed of PRIM&R members who are blogging here, on Ampersand, to give our readers an inside peek of what happened at the conference in Anaheim, CA.
Syndey, thank you. As you may, I also was moved by her presentation, and by her book as well. I highly recommend it.
A question that had not been addressed was the status of parents who give permission for their child to give biospecimens and permission for researchers to obtain biospecimens from their child. I do not understand why the parents in that case are prevented by HIPAA, research ethics, or 45 CFR 46 from obtaining information about the use of those biospecimens. Would adults who donated biospecimens to a central repository that in turn sent one or more to other labs be prohibited by HIPAA etc. from finding out how at least what labs the biospecimens were sent to, and also how they were used? Bill Freeman