title: Lawsuit claims that informed consent procedures did not follow regulations.
authors.affiliation: The Deem Corporation, P.O. Box 44069, Omaha, NE 68144, USA.
authors.forename: Dennis M
authors.initials: DM
authors.lastname: Maloney
mesh_terms: D015316:Genetic Therapy / Q000009:adverse effects*; D033161:Government Regulation; D019983:Guideline Adherence; D006805:Human Experimentation / Q000331:legislation & jurisprudence*; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D010414:Pennsylvania; D014481:United States; D014486:United States Food and Drug Administration