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Biospecimen Standard Operating Procedures (SOPs)

The use of standardized biobanking procedures is an important part of increasing the reproducibility of research findings, and providing transparency about the procedures can help scientists to better interpret results. Here we provide information about Standard Operating Procedures (SOPs) used in research programs. Some of the SOPs have been used in BBRB-led initiatives such as the Genotype-Tissue Expression Project (GTEx) and Biospecimen Pre-analytical Variables (BPV) program. Other SOPs have been contributed for public use by many reserach groups across the world and are available through BBRB’s Biospecimen Research Database (BRD).

Genoype-Tissue Expression (GTEx) SOPs

The Genotype-Tissue Expression (GTEx) Project was designed to help us better understand how the genes we were born with affect the development of disease. BBRB managed the collection of tissue and blood biospecimens for GTEx from over 900 deceased donors who were identified through organ and tissue transplant programs. Family decision makers were asked for consent prior to obtaining and using donor tissue for GTEx. Genetic analysis of the tissue was carried out and has generated an unprecedented amount of high-quality genomic data for use internationally by the medical research community. Every donor’s generous gift of biospecimens and medical information made the GTEx project possible. GTEx is contributing to help find better ways to prevent, diagnose, treat, and eventually cure common disease for future generations. Learn more about the science of GTEx.

Important Notes on GTEx SOPs

  1. The names of specific institutions, vendors, people, email addresses, phone numbers, and geographic locations have been removed in these documents.  Internal revision information relevant during the SOP development process has also been removed, as this information does not govern the biobanking operation.
  2. Brand names of supplies and reagents were retained.
  3. PAXgene® Tissue is the tissue preservation method utilized in these SOPs. Other tissue preservation methods are not described in these SOPs but users may want to substitute their own tissue preservation method(s) of choice.
  4. The Informed Consent templates provided herein were developed as initial resources that were then adapted by the Biospecimen Source Sites to accommodate their own existing processes and procedures. These templates are not the exact consent forms being used at the Biospecimen Source Sites.
  5. Since the Informed Consent Verification Forms were site-specific, one representative form was made generic (removing site name throughout the form, including the title).

View the GTEx Standard Operating Procedures Library to download SOPs. 

Biospecimen Pre-analytical Variables (BPV) SOPs

The Biospecimen Pre-analytical Variables (BPV) Program is a National Cancer Institute-sponsored study to systematically assess the effects of pre-analytical factors on the molecular profile of biospecimens. A robust biospecimen collection infrastructure was established to prospectively collect biospecimens using rigorous standard operating procedures to control for most variables while introducing experimental conditions to study specific biospecimen handling issues, including the cold ischemic time (delay to formalin fixation), time in formalin, freezing methods, as well as storage temperatures and durations. RNA and DNA from biospecimens collected under these conditions was analyzed on multiple molecular platforms. The potential effects of these pre-analytical conditions on protein integrity and detection of metabolites were also examined. Data from this study will be used to develop evidence-based biospecimen standard operating procedures and best practices for fit-for-purpose collection, processing, and storage of biospecimens. Learn more about the BPV analytical platform, BPV publications, and access BPV SOPs. 

BPV biospecimens are available for research use
The remaining specimens are currently managed through a collaboration between Van Andel Research Institute and NCI. Specimens may be accessed for biospecimen research or clinical assay development upon request. Researchers may also enter into a collaborative research agreement with NCI to extend the BPV studies; please contact us at ncibbrb@nih.gov for more information.

View the BPV Standard Operating Procedures Library to download SOPs. 

Additional SOPs

Biospecimen Research Database (BRD) Introduction 

Search biospecimen SOPs through the BRD 

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