We live in a global society and our research is no different. Regardless of your country of residence, it is likely that at least one research project you are involved in has an international aspect. International guidelines and regulations influence research regulations and guidelines in many countries. While many of these influences have been around for decades (such as the influence of the Nuremburg code on informed consent), international standards in areas of emerging technologies within clinical research, such as biobanking, are still being developed. Biobanking research was a topic of conversation at the International Society for Biological and Environmental Repositories (ISBER) conference, held April 5-9, 2016.
First, for the purposes of getting everyone on the same page, let’s define a biobank. Ms. Rial-Sebbag (France) gave an excellent definition at the conference. She defined a biobank as, “human biological samples and attached data collected, stored and distributed through an organized infrastructure.” For example, a biobank can be a collection of human biological samples that were collected in the course of a biomedical project to be stored at the end of the project. They could also be samples originally collected for clinical/health purposes or primarily and directly collected for the repository. The purpose of a biobank is to create a resource for multiple projects with reuse over time. Therefore, a biobank does not have a specific scientific objective and serves as a research support function. They can be housed within numerous types of infrastructures, such as academic institutions, a pharmaceutical company, or as a standalone company.
In a symposium on the ethics of biospecimens in industry-sponsored research, the takeaway point for me was that governance is key. With so many unknowns about what will be done with the specimens, governance is key to ensuring that subject rights, safety, and welfare are maintained. So, what goes into the governance of the biobank? The governance document associated with a biobank should include an in-depth discussion of the bank’s operational processes, including decision-making processes. It should include all policies, management expectations, requirements, processes and controls that ensure functions of the biobank are performed properly. Repositories should be transparent about their operations to all stakeholders, including donors, researchers, and regulators. This transparency includes policies regarding the protection of privacy and security of specimens and data.
Good governance moves from the top-down. Top management of the bank or parent company (in the case that a biobank is embedded in a larger corporation) must commit to good governance and build a culture of such. Communicating the importance of biobank and specimen quality to the rest of the company is essential to ensure that downstream research supporting discovery and development of safe and efficacious products can be performed. This quality performance delivers benefits for patients and society through the advancement of science that informs medical practice. The benefit of good governance to the bank/company is that it leads to an efficient business. The bank will have a competitive advantage over poorly run banks. Transparency to the public will lead to willing sample donors and/or clinical trial participants. Potential subjects will be seen as partners in research, with exact knowledge of their contribution. Better efficiency and ethical practices will lead to better science and biobank success.
As eloquently stated by Brian Clark with Novo Nordisk, transparency is the best antidote to public distrust. He went on to say that transparency and good governance is more than a moral responsibility of the biobank, but necessary for proper function and management.