jueves, 29 de diciembre de 2011

Overview - Office of Biorepositories and Biospecimen Research

Overview - Office of Biorepositories and Biospecimen Research

In early 2006, the OBBR initiated the Biospecimen Research Network (BRN) to systematically address the impact of specific variables in individual specimen types on molecular data from given analysis platforms. The goal of the BRN is to address these issues by sponsoring, conducting, and collaborating on studies to assess the effects of human specimen pre-analytical variables on the outcome of genomic and proteomic studies conducted for clinical diagnosis and cancer research purposes. By communicating the results of such research to the scientific community, the BRN aims to significantly improve the quality of NCI-funded biospecimen-based research. The results of BRN research will support NCI discovery efforts and contribute to the development of evidence-based best practices for the collection, processing, storage, and analysis of biospecimens, building on the "NCI Best Practices for Biospecimen Resources."
Based on this vision, the BRN has been designed to address the following challenges:
  • Bridging the gap between existing clinical practice for biospecimens and emerging technologies for personalized diagnostics and therapies
  • Defining the most significant variables for prospective collection of tissues, blood, and bodily fluids
  • Developing evidence-based biospecimen quality indicators for specific analytical platforms
The activities of the BRN program to date include the following:
  • A public outreach effort to define issues around human specimen research and identify the most pressing needs for human analyte standardization. Activities include an annual meeting, the BRN Symposium.
  • Provision of consultative services on biospecimen issues for programs within the NCI and NIH
  • A series of research projects underway at the BRN laboratory located at the Advanced Technology Center in Gaithersburg with intramural and extramural collaborators
  • Development of a searchable Web site of the existing biospecimen literature, the Biospecimen Research Database
Additional information about the Biospecimen Research Network can be found here:

One of the most widely recognized and significant roadblocks to progress is cancer research is the lack of standardized, high-quality biospecimens. The National Cancer Institute (NCI) developed the NCI Best Practices for Biospecimen Resources (NCI Best Practices) based on extensive research and expert input into the state of NCI-funded biospecimen resources and the quality of biospecimens used in cancer research. The NCI Best Practices outline the operational, technical, ethical, legal and policy best practices for NCI-supported biospecimen resources.
Scope, Applicability, Implementation

Scope, Applicability, Implementation The NCI Best Practices incorporate key principles that:
  • define state-of-the-science biospecimen resource practices
  • promote biospecimen and data quality
  • support adherence to ethical and legal requirements
The NCI Best Practices define principles to guide procedures developed by biospecimen resources. They are intended to be adapted based on the mission and scientific needs of biospecimen resources. While adoption of the NCI Best Practices is voluntary, the NCI believes that these principles optimize biospecimens for cancer research. Learn more
Technical and Operational Best Practices

Technical and Opperational Best Practices Although the specific mission of a biospecimen resource will define its collection and processing procedures, common principles apply to all biospecimen types. The best practices within this section are based on current, published information and will be revised periodically as new information is generated from ongoing research projects. Learn more
Ethical, Legal, and Policy Best Practices

Ethical, Legal, and Policy Best Practices In addition to technical considerations relating to the physical quality of a biospecimen, multiple ethical, legal, and policy issues relate to biospecimen collection activities. Key ethical issues include:
  • respecting the autonomy of research participants
  • protecting research participants from breaches of privacy and confidentiality
  • developing appropriate policies for biospecimen use
  • ensuring that biospecimens are used in scientifically sound research.
The ethical, legal, and policy best practices in this section identify key regulations relevant to biospecimen resources and provide recommendations for their consideration. Learn more
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