How does the NCI Best Practices relate to other Government agencies and ongoing work by other organizations?
The NCI does not develop regulations but it is working with other Federal agencies (e.g., the Department of Health and Human Services [HHS] Office for Human Research Protections and the U.S. Food and Drug Administration) to harmonize the NCI Best Practices with existing laws and regulations. The problem of inconsistencies between guidance from various governmental agencies has been discussed at the highest levels within the HHS; harmonization is a work-in-progress. At the level of the NIH, the Trans-NIH Bioethics Committee has formed the Human Data and Specimen Committee to address this issue. At the global level, biospecimen resource standardization efforts are underway in both the European Union and Asia. At this time, the NCI is interested in forming partnerships to educate the research community about the importance of best practices and their impact on biospecimen quality and the scientific research in which they are used.
