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NCCN Publishes New Best Practices Resource for Researchers Using Biorepositories, Registries, and Databases

By Donna Scharff, Research Study Associate, NCCN Oncology Research Program

A task force of the NCCN IRB Directors Forum recently developed a guidance tool for researchers using biorepositories, registries, and databases. This valuable resource, Points to Consider on the Best Practices for Biorepositories, Registries and Databases, is a web-based tool that is available free-of-charge on for use by research investigators who plan to design, implement, and manage a research study which intends to deposit, transfer, and/or access specimens or data in a biorepository, registry, or database.

Researchers and those involved with specific projects are required to adhere to federal and local regulations and guidelines that govern human subject research and protected health information. In some cases, for multi-center clinical trials, there are multiple institutional requirements related to the collection, storage, access, distribution, and use of the biospecimens and data. Subsequently, investigators must proactively design their research projects in concordance with these requirements to ensure that all mandates are met from initial patient enrollment through long-term protection and storage of specimens and data.

As a response to these needs, NCCN designed Points to Consider on the Best Practices for Biorepositories, Registries and Databases to provide applicable principles, strategies, regulations, basic considerations, and best practices for research investigators to reference, as well as examples and suggestions within each section of the resource to enable the research investigator to apply them to his or her own research project.

For ease of use, the resource is broken out by 11 criteria, each featuring comments and references: Initial practical points to consider before establishing a biorepository, data, or specimen bank; design; regulatory and institutional approval and accreditation; consent; confidentiality and privacy; collection and analysis; storage, access, and distribution; retrieval, maintenance, and planned destruction; quality assurance, quality control, and quality improvement; international research; and accreditation.

In addition, the tool features a template for informed consent language that addresses the future use of biospecimens or data.

For more information or to access NCCN Points to Consider on the Best Practices for Biorepositories, Registries and Databases, visit