Abstract
There is considerable heterogeneity in the way that patients’ biospecimens (tissues, blood, urine for example) are collected, processed and stored in biorepositories. This unknown or uneven quality of biospecimens used for research can lead to unreliable and irreproducible results. In addition to technical and operational issues, many ethical, legal and policy guidelines and concerns must be addressed when conducting research involving the use of biospecimens from cancer patients and other research participants. After an extensive review of its own biorepostories, in 2007 the NCI Office of Biorepositories and Biospecimen Research (OBBR) published the NCI Best Practices for Biospecimen Resources (http://biospecimens.cancer.gov/practices/). The Best Practices do not comprise detailed procedures and are intended to be adapted, as appropriate, based on the mission and scientific needs of the individual biorepository. The technical best practices include recommendations for the collection, processing, storage and shipping of biospecimens, as well as quality control of processes and the proper collection of clinical data. The ethical, legal and policy practices provide guidance on informed consent, privacy and confidentiality, custodianship and intellectual property concerns. In response to questions and comments from the research community a new version of the Best Practices is being published in 2011. Major revisions include the addition of sections on biorepository management and operations and conflicts of interest, and expansion of recommendations related to custodianship and informed consent, harmonization with current Federal guidance documents and recommendations from international organizations. The revised Best Practices will be launched using an interactive web format, to provide a mechanism for more frequent updates and to encourage feedback from the community. The Best Practices will continue to evolve as the field of biospecimen biology advances; novel scientific, technological and clinical practices develop; and new ethical and legal policies and regulations emerge. The NCI is committed to maintaining current and scientifically accurate best practices for biorepositories and will continue to solicit input from stakeholders in the cancer research community.
Citation Information: Cancer Epidemiol Biomarkers Prev 2011;20(10 Suppl):ED01-01.
RSS Feeds