What is a biobank’s role and what are its responsibilities?

A modern biobank is the interface between tissue donors—either patients or healthy individuals—in the clinical care setting and scientists performing biomedical research in an academic or pharmaceutical setting. The biobank’s role is to act as a secure yet effective bridge for samples and data to move between the two environments.

In this role, the biobank has to operate with dual responsibilities:

• To patients and healthy volunteers, the biobank has a responsibility of not interfering in their clinical care, and protecting their rights of privacy and the confidentiality of the information they have donated.
• To researchers, the biobank has a responsibility of providing high quality (i.e., accurate) data and biomaterials so that the highest-caliber research can be conducted.

What is meant by the term “chain of trust”?

One of the most important responsibilities of a biobank is to protect donors. When donors choose to provide biospecimens – such as tissue or blood – and grant access to their personal information, they have established the first link in a “chain of trust” that follows those specimens and data all the way to the researchers who apply such resources in their studies.

To understand how the “bridge” and “firewall” roles work, consider that the data and samples under the biobank’s custody are linked directly back to the donor from whom they came. So, practically speaking, the biobank knows who the donor is. Why is this necessary? The following description of a research protocol to compare molecular characteristics of a tissue sample before and after treatment will illustrate:

• A patient may donate tissue at a first point in time – for example during a biopsy – when he or she has not yet undergone any treatment. Thus, the tissue he or she first donated is in its “natural” disease state in terms of the molecular profile it carries. At this time, the biobank would collect a sub-sample of tissue and a snapshot of the data from the donor’s medical record.

• Then, at a second point in time in the future, the patient donor may come in for another biopsy or surgery. Such a surgical intervention would happen after various therapeutic treatments, possibly of a new drug in a clinical trial. The biobank would need to know who that patient is in order to collect a second sample and the second snapshot of data, and match that set with the first.

• Such collections of biospecimens over a “time course” with intervening treatments are extremely valuable to researchers because they can be used to identify which treatments are having an intended biological effect as well as to provide critical insight into what kinds of therapy may benefit patients.

However, it remains essential for the biobank to “firewall” or filter out the donor identifier before sending the samples and clinical information to the researcher who performs the molecular analysis, in order to ensure that donor privacy and confidentiality are protected.