Biobanking Guidance

Workshop Summaries

At the Crossroads of Social Media and Clinical Trials: A Workshop on the Future of Clinician, Patient and Community Engagement  

During this highly interactive workshop, clinical trial experts, community oncologists, cancer advocates, patients, and social media and communications experts explored innovative ways to successfully connect and engage with patients, physicians, and the community at large online. By sharing experiences and planned initiatives, participants considered ways to enhance awareness and understanding of clinical trials through social media. At the Crossroads of Social Media and Clinical Trials Executive Summary; At the Crossroads of Social Media and Clinical Trials Workshop Summary. 

2015 Genotype Tissue Expression (GTEx) Symposium: All Things Considered 

The Genotype Tissue Expression (GTEx) Symposium: All Things Considered – Biospecimens, Omics Data, and Ethical Issues covered a broad range of topics that focused on the collection of normal biospecimens for GTEx. Topics included an overview of the GTEx program, the biospecimen challenges for GTEx, establishing the approach for GTEx prospective collections, new systems that were developed to implement the program, ethical, legal, and societal investigations within the program, and scientific outcomes from the GTEx Project. 

Day 1: http://videocast.nih.gov/Summary.asp?File=19024&bhcp=1
Day 2: http://videocast.nih.gov/Summary.asp?File=19026&bhcp=1

2012 BBRB Think Tank on the Identifiability of Biospecimens and "-Omic" Data

Meeting discussing the science and regulation of identifiability and potential best practices. Published meeting summary. 

2011 Workshop on Biospecimen Reference Sets and Drug-Diagnostic Co-development (PDF) 

Workshop convened to identify the biospecimen needs and challenges in the co-development of a drug and diagnostic assay. Summary: Biospecimen Reference Sets and Drug-Diagnostic Co-development (PDF Document)

2010 Biospecimen Quality Assessment and Standards Development Workshop 

NCI BBRB and the National Institute of Standards and Technology (NIST) co-sponsored workshop to discuss the need for biospecimen quality assessment metrics and standards. Working groups composed of participants with expertise in basic, clinical, and regulatory science held breakout discussions that centered on quality assessment for DNA, RNA, serum proteomics, and formalin-fixed and paraffin-embedded tissue.  Executive Summary Quality Assessment and Standards Development Workshop (PDF Document: 80 KB) 

2010 Release of Research Results to Participants in Biospecimen Studies 

The workshop engaged participants with general and breakout discussions and generated recommendations in three key areas: (1) the appropriate handling of diagnostic discrepancies or incidental findings that are discovered during the pathology review of biospecimens; (2) the mechanisms by which individual or aggregate research results might be provided to participants in clinical studies; and (3) the conditions that warrant disclosure of aggregate research findings. NCI Return Research Results Summary (PDF Document: 846 KB) 

2008 The Ethical Use of Pediatric Biospecimens in Research 

This one-day workshop addressed the ethical issues involved in the storage and use of pediatric biospecimens in research. Topics included whether pediatric research participants should be re-consented for ongoing research involving their biospecimens once they obtain the age of majority. Workshop Summary (PDF Document: 162 KB) 

2007 Custodianship and Ownership Issues 

Workshop to define the parameters of custodianship that would allow biospecimen resources to operate in a culture of transparency, fairness, and accountability to all stakeholders. The following topics were addressed: (1) Considerations for research participants, investigators, and institutions; (2) financial conflicts of interest (COIs); (3) intellectual property (IP); and (4) access to products and benefits. Workshop Summary (PDF Document: 125 KB)

Reports

The scientific, policy, and advocacy communities have become increasingly aware of the important role that biospecimens play in driving translational and personalized medicine. Formal reports and policy documents reflect the importance of this issue at the national and international levels. 

Case Studies of Existing Human Tissue Repositories 

Human tissue has been collected and stored at institutions in the United States for more than 100 years. Each of these institutions, or repositories, was established to meet a specific set of objectives, and its design is integrally linked to those objectives. Tissue collection, processing, and storage techniques vary depending on the purpose of the repository, as do the quality and extent of information collected with the biospecimens. 

In 2002-2003, the National Biospecimen Network (NBN) Design Team, a subset of the Tissue Access Working Group (TAWG) convened by the National Dialogue on Cancer (NDC) to address “access to appropriately collected, consented, and annotated tissue,” drafted a blueprint for a national biospecimen network. The overall goal of the TAWG was to establish a national, pre-competitive, regulatory compliant and genetic-privacy protected, standardized, inclusive, highest quality network of biological sample(s) banks; developed in partnerships with and supported by cancer survivors/advocates; shared, readily accessible, and searchable using appropriate informatics systems (e.g., amenable to molecular profiling capability). 

To assist in its examination of existing tissue resources, the NBN Design Team requested that the RAND Corporation conduct case studies of existing human tissue resources to evaluate their utility for genomics- and proteomics-based cancer research and that RAND identify "best practices" at these institutions. This report presents the RAND findings for each repository evaluated and identifies best practices that could be used by the TAWG in its strategic planning process for the development of a new NBN. 

View the RAND report (PDF Document: 739 KB) 

National Biospecimen Network Blueprint 

Advances in the fields of genomics and proteomics have provided new ways to derive valuable data for cancer research from human biospecimens. Advances in informatics support the compilation and analysis of genetic and clinical data on an unprecedented scale. Applications of genomic and informatic technologies to interrogate biospecimens represent unparalleled opportunities for the discovery and development of new cancer diagnostic, therapeutic, and preventive agents. To accelerate discovery for cancer research, scientists need timely and equitable access to biospecimens that are annotated with clinical information and collected under the appropriate conditions for genomic and proteomic studies. Current access to existing specimens is often uneven which can impede scientific progress 

With the recognition that a national tissue resource, although ambitious, is necessary to realize the promise of genomics and proteomics for the prevention and cure of cancer and other diseases, the National Dialogue on Cancer Tissue Access Working Group, in collaboration with the National Cancer Institute, commissioned a Design and Engineering Blueprint for an NBN (the "NBN Blueprint"). The Blueprint outlines a key infrastructure to harness the potential of new technologies for cancer research, while ensuring the preservation of privacy interests of biospecimen donors. 

View the NBN Blueprint (PDF Document: 7.06 MB)