title: Consent for research with biological samples: one-time general consent versus a gift model.
abstract: This analysis suggests that one-time general consent is better than a gift model for addressing 5 central challenges that arise in the context of obtaining and storing human biological samples for future research. This conclusion supports the suggestion made in a recent Advance Notice of Proposed Rulemaking to incorporate one-time general consent for research with human biological samples into any revisions of the federal regulations.
authors.affiliation: National Institutes of Health Clinical Center, Bethesda, Maryland 20892-1156, USA. dwendler@nih.gov
authors.forename: David
authors.initials: D
authors.lastname: Wendler
mesh_terms: D035843:Biomedical Research; D006801:Humans; D007258:Informed Consent; D009927:Tissue and Organ Procurement / Q000331:legislation & jurisprudence*; D014481:United States