International biobanking: overview of key practices and policies

Published on February 29, 2016   30 min
0:00
Hello, I'm Jim Vaught. I'm President of the International Society for Biological and Environmental Repositories or ISBER, which I'll be referring to a lot during the presentation. And I'm also Editor-in-Chief of the Journal Biopreservation and Biobanking. In this presentation, we'll be talking about international biobanking and overview of key practices and policies.
0:22
The outline of my presentation. I will be going through biobanking basics, best practices, infrastructure, quality management, for example, international efforts to develop and harmonize best practices for biobanks, controlling variability, which is critical to international exchange of specimens and data, biobanking networks and factors for their success, the economics and sustainability of biobanks, which is a very hot topic at present and other current hot topics in international biobanking. And then, I'll present some additional resources, such as biobanking organizations, web sites and relevant publications.
1:06
So what is a biobank? A biobank is an entity that receives, stores, processes and, or disseminates specimens. And some examples are blood, tissue samples, urine samples, saliva and others that's needed for the investigation. And the biobanking term encompasses the physical location as well as the full range of operational activities. And it can be one freezer or a free-standing entity within a laboratory or clinical operation or part of a larger institution. And a biobank has a professional staff and a commitment to maintain and preserve specimens and records for future reference and historical continuity. Biobanks may also be called biorepositories, biospecimen resources or biological resource centers.
1:55
Slide number five has a photograph of a US National Cancer Institute epidemiologic biorepository, which is a fairly large biorepository comprised of both liquid nitrogen freezers and mechanical or -80 or -20 degrees centigrade freezers. And such a large repository, in this case, a commercial repository, these are among the biobanks which originated the best practices that we'll be talking about later, i.e., these types of large commercial repositories initiated some of the standard procedures which became best practices among various organizations.
2:33
Slide number 6 shows important considerations for setting up a biobank. Among these considerations are careful planning of facilities and equipment needs, establishing a quality management system such as standard operating procedures or SOPs for all processes and policies. Developing or procuring an appropriate information system for tracking samples and data, knowledge of and adherence to ethical, regulatory and legal standards, which we'll talk about later as well, adherence to a set of best practices such as those from ISBER, which I mentioned in the beginning, or the National Cancer Institute in the US among other organizations which have developed best practices. Long-term custodianship and business plans and consideration of pre-analytical variables, which may affect specimen quality, which we'll also talk later in presentation.
3:22
Slide number 7 shows some factors affecting biobank facility design, such as knowledge of materials being stored, required storage and handling equipment, projected retention periods of specimens, projected growth of specimen numbers, projected use of materials, the plan for multiple sample storage temperatures and also storage for supplies, information technology, devices and records.
3:47
Slide number 8 shows other facility considerations such as, it's important to have backup generators for mechanical freezers with on-site fuel and weekly testing and uninterruptible power supply for IT protection, multiple-level facility access security such as keys, cardkeys, electronic entry and exit tracking, and highest-restricted access areas, visitor access policy, and intrusion detection, fire alarms and fire prevention systems, written disaster recovery, incident response, business contingency plan and preparedness practices.
4:23
Slide number 9 shows some of the types of records that should be maintained by a biobank and there are two basic categories, work-related and specimen donor-related. The work related include SOPs for every practice, training documents, procurement and delivery documents, testing results, equipment maintenance, audit and review records, specimen storage locations, chain of custody tracking, sample distribution and quality assurance activities. Specimen donor-related include informed consent documents, study protocols, specimen requested removal or destruction by the patient or donor, any confidential patient information, with access to records strictly on a need-to-know basis.
Hide

International biobanking: overview of key practices and policies

Embed in course/own notes