Biospecimen Issues:
For Researchers - continued

Biospecimen Analysis

Various tests are used to analyze the genetic and bio-chemical properties of biospecimens.

Tests must be performed consistently in order to produce reliable and comparable results. Often in today's environment, individual research labs develop their own analysis protocol. This makes comparisons of test results from lab to lab difficult. Tests must be validated, i.e., they must test what they claim to test and be specific for the marker, protein or gene that it is designed to identify. The sensitivity of the test must also be great enough to detect only what it is looking for and not other elements that confuse the issue.

It should be noted that CLIA (Clinical Laboratory Improvement Act) regulations that enforce standard documentation that each clinical laboratory test is performed the same way and that all variables are controlled for, are not required in research labs as they are in hospitals and commercial patient labs.

Biobank Biospecimen Storage

Translational research is facilitated by the collection of human tissue. Therefore biobanks are actively contributing to advances in translational research by offering opportunities to safely collect and store these samples and link laboratory research to clinical practice.

Biobanks must carefully store and document access to samples and donor information. The samples must be maintained reliably with minimal deterioration over time, and they must be protected from physical damage, both accidental and intentional. The registration of each sample entering and exiting the system is centrally stored, usually on a computer-based system that can be backed up frequently. The physical location of each sample is noted to allow the rapid location of specimens. Archival systems de-identify samples to respect the privacy of donors and allow blinding of researchers during analysis.

The database, including clinical data, is kept separately with a secure method to link clinical information to tissue samples.

Room temperature storage of samples is sometimes used, and was developed in response to perceived disadvantages of low-temperature storage, such as high costs and potential for freezer failure. Current systems are small and are capable of storing nearly 40,000 samples in about one tenth of the space required by a -80 °C (-112 °F) freezer. Replicates or split samples are often stored in separate locations for security.

In the news:

Biobanks are listed as number 8 in the "10 Ideas Changing the World Right Now" in the TIME magazine issue that hit the news stands March 23, 2009.

"Now that major banks in the U.S. are getting by on a government bailout, the idea of creating yet another repository to safeguard your most valuable assets might seem downright ludicrous. And even irresponsible.

But that's exactly what some federal officials are hoping to do. Relax - it's not your money they're after. It's your blood. Folks at the National Cancer Institute (NCI) are heading up an effort to establish the U.S.'s first national biobank - a safe house for tissue samples, tumor cells, DNA and, yes, even blood - that would be used for research into new treatments for diseases.

Think of it as an organic bank account. You put your biomaterial in and earn medical interest in the form of knowledge and therapies that grow out of that deposit - no monetary reward, just the potential that you might benefit from the accumulated data at some later date. (Sorry, no shiny new toaster to inspire you to open up such an account either - just an appeal to the greater medical good.)"

- Quote and image from the Time.com article, 10 Ideas Changing the World Right Now

Examples of groups working in the Biobank field:

1) The NCI's Office of Biorepositories and Biospecimen Research (OBBR's) director, Carolyn Compton, M.D., Ph.D., and her staff are currently developing the concept for a new national biobank: a unique, non-profit public resource that will ensure the adequate and continuous supply of human biospecimens and associated measurable, high-quality data, all acquired with the highest ethical standards.

For more information: http://plan.cancer.gov/Biobanking.htm

2) The caBIG®Tissue/Biospecimen Banking and Technology Tools Knowledge Center is an NCI-supported entity led by the Siteman Cancer Center, Washington University at St. Louis, MO.

The Knowledge Center provides a centralized, authoritative repository of knowledge, information, and web-based support to facilitate the ongoing development of caBIG® tools, standards, and infrastructure in the tissue/biospecimen management domain.

For more information: https://cabig-kc.nci.nih.gov/Biospecimen/KC/index.php/Main_Page

3) Kaiser Permanente has launched a drive to obtain 500,000 volunteers to donate blood and saliva for genetic analysis to study how life style, environmental factors and genes interact to contribute to a range of diseases including cancer.

4) UK Biobank is recruiting up to half a million participants between the ages of 45 and 69 years to contribute blood samples, life-style details and medical histories for epidemiology studies.

5) Biobank Japan is creating a DNA repository of 300,000 individuals.

Data Management

One of the first steps in ensuring compliance with international best practices requires the adoption of a biobank data management system capable of integrating all the heterogeneous data types associated with a sample in a secure yet accessible manner.

Coupled with regulation and administrative requirements is the pressing need to provide a data management platform that readily allows the selection of appropriate patient/sample populations for studies based on heterogeneous search criteria across epidemiological, clinical and omic data domains. Public, academic and private data collection platforms exist today.

Ideally, the process of collecting biological specimens should be linked to a database containing clinical information and a tracking system for stored samples. This enables researchers to recover and be aware of the potential development of translational research applications as well as to recover samples needed to develop their projects very rapidly. In this context, it is particularly important to identify samples from patients entering in clinical trials using innovative therapeutic approaches and connect such information with biological and clinical databases.

Distribution of Samples

Who has access to a biospecimen? What requirements need to be met in order to receive them? These and other questions must be part of a standard set of requirements to ensure patient rights as well as move the science forward as quickly as possible.

An understanding of the balance that needs to be struck between the interests of society and the rights of individual patients, central to the ethical use of human tissues and the use of clinical outcome information for research, must form the basis for the distribution of any national tissue resource.

 

CISN Summary:

We at CISN support the idea that ALL biospecimen data collected with public funds should reside in the public domain in order to best ensure the prompt development from specimen collection to new discoveries that benefit patients.

• Standardization of collection and processing is crucial for accuracy.
• Security, privacy and confidentiality are all issues to be dealt with.