Encouraging translational research through harmonization of FDA and common rule informed consent requirements for research with banked specimens.
Evans
Barbara J
BJ
Program in Pharmacogenomics, Ethics, and Public Policy, Indiana University Center for Bioethics, Indianapolis 46202, USA. bjevans@iupui.edu
Meslin
Eric M
EM
D018070:Biological Specimen Banks / Q000331:legislation & jurisprudence*; D035843:Biomedical Research / Q000941:ethics / Q000331:legislation & jurisprudence*; D003132:Commerce / Q000331:legislation & jurisprudence; D003219:Confidentiality / Q000331:legislation & jurisprudence*; D033161:Government Regulation; D017408:Guidelines as Topic; D020408:Health Insurance Portability and Accountability Act; D006805:Human Experimentation / Q000941:ethics / Q000331:legislation & jurisprudence; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D011640:Public Policy; D013048:Specimen Handling / Q000941:ethics / Q000379:methods; D014481:United States; D014486:United States Food and Drug Administration