What are the unique issues in sharing biospecimens?
What have speakers learned from their initiatives that could be used to find the best practices for biospecimen and data sharing?
What incentives should or need to be in place to encourage sharing of specimens and data?
What key structures or rules are required to establish a framework for sharing biospecimens and data?
The quality of the data derived from biospecimens can never be higher than the quality of the analytes from which the data are derived, said Carolyn Compton, director of the Office of Biorepositories and Biospecimen Research at the National Cancer Institute (NCI). However, the quality of human biospecimens is often either unknown or low, which can harm research that uses these samples. The question she posed was not “can I get access to existing samples?” but “do I want them?” “The roadblock to success and to greater efficiency in the translational research realm is related to the lack of high-quality human samples,” said Compton.
The NCI and other government agencies are making major investments of public dollars in research projects that depend on high-quality human samples. The NCI alone invests $50 million to $70 million annually in biobanking efforts of various kinds, but many researchers do not understand what needs to be done to achieve high quality. An evaluation of the biobanking system found different collection, processing, and storage procedures; differing degrees and types of annotation; variations in the scope of patient consent; differing material transfer agreements; inconsistent information technology support; and inadequate access policies. Most researchers also have few incentives to share their samples, further contributing to wide variation in the quality and accessibility of samples for research.
In acquiring biospecimens for the Cancer Genome Atlas Project, which is seeking to identify genomic changes occurring in cancer and make those data publicly available, NCI identified a large number of problems with existing samples. The quality of existing samples in biobanks is typically overestimated, said Compton. The collection of normal control samples is not routine, and clinical data on specimen donors are not readily available. Even if a specimen looks pristine under a microscope, according to Compton, its molecular quality may be low. The NCI was seeking to collect 1,500 high-quality samples for the pilot of the Cancer Genome Atlas Project, yet in 3 years it was unable to do so, said Compton.
Biospecimens are subjected to “industrial-strength biologic stresses” once they are collected, said Compton. Even the extent and type of molecular changes induced in acquiring a sample for research are largely unknown.