Ethical, legal, and policy issues: dominating the biospecimen discussion.

With over 300 million human specimens currently stored in the United States, biospecimens are invaluable to the scientific research community. In addition to technical considerations related to the physical quality of a biospecimen, multiple ethical, legal, and policy issues also affect the ability of researchers to use these resources. The National Cancer Institute (NCI) Best Practices for Biospecimen Resources was developed in response to the results of an internal NCI study that found considerable variability in the procedures and guidelines used for biospecimen resource management across NCI facilities. The study also revealed that some of the primary sources of variability were divergent approaches to ethical, legal, and policy issues. The NCI Office of Biorepositories and Biospecimen Research was established in 2005 to address these issues, resulting in publication of the FirstGeneration Guidelines for NCI-Supported Biorepositories in April 2006. Following a public comment period, the document was revised and renamed the NCI Best Practices for Biospecimen Resources (NCI Best Practices) and is available on the NCI Office of Biorepositories and Biospecimen Research Web site (1). This editorial describes some of the key ethical, legal, and policy issues related to the use of biospecimens in research. Although the NCI Best Practices attempts to address some of these issues, many remain unresolved and will require further discussion among stakeholders within the biospecimen research community. The Office of Biorepositories and Biospecimen Research has been engaged in such discussions through its involvement in an AACR panel discussion at the 2007 annual meeting and more recently through sponsorship of a workshop on biospecimen custodianship.