Comprehensive genomic studies: emerging regulatory, strategic, and quality assurance challenges for biorepositories.
As part of the molecular revolution sweeping medicine, comprehensive genomic studies are adding powerful dimensions to medical research. However, their power exposes new regulatory, strategic, and quality assurance challenges for biorepositories. A key issue is that unlike other research techniques commonly applied to banked specimens, nucleic acid sequencing, if sufficiently extensive, yields data that could identify a patient. This evolving paradigm renders the concepts of anonymized and anonymous specimens increasingly outdated. The challenges for biorepositories in this new era include refined consent processes and wording, selection and use of legacy specimens, quality assurance procedures, institutional documentation, data sharing, and interaction with institutional review boards. Given current trends, biorepositories should consider these issues now, even if they are not currently experiencing sample requests for genomic analysis. We summarize our current experiences and best practices at Washington University Medical School, St Louis, MO, our perceptions of emerging trends, and recommendations.
Laboratory for Translational Pathology, Dept of Pathology and Immunology, Washington University School of Medicine, 660 Euclid Ave, Box 8118, St Louis, MO 63110, USA.
Sandra A
SA
McDonald
Elaine R
ER
Mardis
David
D
Ota
Mark A
MA
Watson
John D
JD
Pfeifer
Jonathan M
JM
Green
D018070:Biological Specimen Banks / Q000331:legislation & jurisprudence* / Q000592:standards*; D028744:Ethics Committees, Research / Q000331:legislation & jurisprudence; D036281:Genetic Research / Q000331:legislation & jurisprudence; D023281:Genomics / Q000331:legislation & jurisprudence* / Q000592:standards*; D006801:Humans; D033181:Information Dissemination / Q000331:legislation & jurisprudence; D011785:Quality Assurance, Health Care