Sorensen asks the panel: “How are biorepositories best governed?”
Sewards answers first, describing that there are federal regulations which it is their job to implement. “We look at ‘gatekeeping’ in IRB-speak. Who is the researcher approaching, what are they collecting, where is it being placed, what are the security measures? What is the purpose of the repository? Who will have access and how do you keep track?”
In other words, they look from the beginning to the end of the process. They especially have many regulations related to whether data are stored and released with due respect to privacy.
Edwards answers that “It depends on the purpose of the biobank.” They often advocate for dynamic governing because research and our understanding is changing a lot, and because we are just starting into these areas historically speaking.
Edwards continues: some old tools like consent forms may now be outdated. You can tell people up front a certain amount or number of things, but you may need to get back in touch later when the research changes or more researchers want to be involved or do different things with the data or specimens. We need new and more flexible strategies for communications and data management, including personal interactions of participants with their own data and with the research in general.
Russell notes: “We have two IRBs plus a utilization committee looking at scientific validity. We are looking at ways of harmonizing across sites and forming some standard operating procedures, but we are also talking about the bioethics of all of it.” They are actively addressing these questions and do not feel they have it all figured out, yet.
Sorensen asks Sewards: “Who is on these IRBs?” and her answer: UW faculty, people from the community, students, lawyers — the full gamut of who makes up our society — as required by federal regulation. Scientific expertise is important but so is the general public component.