Premium
NCI's first generation guidelines for biospecimen resources
Author(s) -
Vaught Jim,
Schneider Julie,
Lockhart Nicole,
Fore Ian,
Moore Helen,
Gillespie John,
Scott Elizabeth,
Barker Anna,
Carolyn Compton
Publication year - 2007
Publication title -
the faseb journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.709
H-Index - 277
eISSN - 1530-6860
pISSN - 0892-6638
DOI - 10.1096/fasebj.21.5.a64-b
Subject(s) - biorepository , process management , set (abstract data type) , process (computing) , engineering ethics , computer science , knowledge management , business , biobank , political science , engineering , bioinformatics , biology , programming language , operating system
Biospecimen resources are crucial to the research community in the performance of postgenomics cancer research. In 2005 NCI established the Office of Biorepositories and Biospecimen Research (OBBR). One of the goals of the OBBR is to unify policies and procedures for NCI‐supported biospecimen resources. A 2004 study showed that NCI‐supported biorepositories are not optimized in terms of operational, legal, and ethical policies and procedures. In 2005 the NCI organized two workshops to inform the development of specific recommendations on policy and operational issues. The workshops' recommended approaches form the basis of the “First‐Generation Guidelines for NCI Supported Biospecimen Resources.” The Guidelines were published in the Federal Register in April, 2006. Public comments included suggestions to: clarify the operational, informed consent and privacy guidelines; provide a more consistent set of terms and definitions; and provide a more well‐defined pathway for compliance with the informatics guidelines. The final Guidelines will be published in early 2007. Producing a workable set of guidelines is an evolving process that will require periodic revision. The Guidelines will be revised iteratively, with input from researchers, biorepository managers, advocates, policymakers, and related stakeholders.