Principles of Human Subjects Protections Applied in an Opt-Out, De-identified Biobank

• Published in: Clinical and translational science Vol. 3; no. 1; pp. 42 - 48
• Main Authors: Pulley, Jill, Clayton, Ellen, Bernard, Gordon R., Roden, Dan M., Masys, Daniel R.
• Format: Journal Article
• Language: English
• Published: Malden, USA Blackwell Publishing Inc 01.02.2010
• Subjects: Adult; Aged; Aged, 80 and over; Belmont Report; Biomedical Research - ethics; BioVU; Databases, Nucleic Acid; DNA Databank; electronic medical record; Ethics, Medical; Female; Human Experimentation - ethics; Human Experimentation - legislation & jurisprudence; Humans; Informed Consent; Male; Medical Records Systems, Computerized; Middle Aged; Models, Organizational; Risk; synthetic derivative

BioVU, the Vanderbilt DNA Databank, is one of few biobanks that qualifies as non‐human subjects research as determined by the local IRB and the federal Office of Human Research Protections (OHRP). BioVU accrues DNA samples extracted from leftover blood remaining from routine clinical testing. The re...