GBBRB Think Tank on the Identifiability of Biospecimens and “-Omic” Data Summary Now Available!

Concerns regarding the potential identifiability of individuals from genomic or other "-omic" data, and from donated biospecimens coupled with publicly accessible information, have given rise to privacy policies and data security requirements which could limit the pace of progress in cancer research. It is not clear whether such policies and requirements are in sync with research participant concerns, or further the protection of human subjects in meaningful ways. In a July 26, 2011 Advance Notice of Proposed Rulemaking, the U.S. Department of Health and Human Services' Office for Human Research Protections proposed that a human biospecimen be considered identifiable in and of itself. This approach would make any and all research with biospecimens, including research using "de-identified" tissue, subject to data security regulation. While many in the research community dispute the merits of requiring data protection for research with biospecimens that does not involve associated clinical data, the concept of anonymizing biological samples in today's rapidly evolving bioinformatics environment may be misleading.

The NCI Think Tank on the Identifiability of Biospecimens and "-Omic" Data was designed to address these issues in a thoughtful and constructive multi-disciplinary context. The Think Tank brought together a small group of experts from various disciplines: researchers, ethicists, privacy law experts, patient advocates, and industry representatives, to review the state of the science and to explore the ramifications of suggested policy alternatives.

The workshop summary report and agenda can be found here