title: A relative standard for minimal risk is unnecessary and potentially harmful to children: lessons from the Phambili trial.
authors.affiliation: U.S. Food and Drug Administration, Office of Pediatric Therapeutics, Silver Spring 20993-0002, USA. robert.nelson@fda.hhs.gov
authors.forename: Robert M
authors.initials: RM
authors.lastname: Nelson
mesh_terms: D016915:AIDS Vaccines / Q000008:administration & dosage* / Q000009:adverse effects* / Q000276:immunology; D000293:Adolescent; D002986:Clinical Trials as Topic / Q000941:ethics* / Q000379:methods / Q000592:standards; D055812:Community-Based Participatory Research / Q000941:ethics* / Q000379:methods / Q000592:standards; D026689:Ethical Analysis; D005189:False Positive Reactions; D014943:Global Health; D015658:HIV Infections / Q000276:immunology / Q000517:prevention & control* / Q000635:transmission; D006801:Humans; D033281:Nontherapeutic Human Experimentation / Q000941:ethics; D018579:Patient Selection / Q000941:ethics*; D011322:Primary Prevention / Q000941:ethics* / Q000379:methods; D012306:Risk; D012309:Risk-Taking; D013019:South Africa
chemical_list: D016915:AIDS Vaccines