title: Relative versus absolute standards for everyday risk in adolescent HIV prevention trials: expanding the debate.
abstract: The concept of minimal risk has been used to regulate and limit participation by adolescents in clinical trials. It can be understood as setting an absolute standard of what risks are considered minimal or it can be interpreted as relative to the actual risks faced by members of the host community for the trial. While commentators have almost universally opposed a relative interpretation of the environmental risks faced by potential adolescent trial participants, we argue that the ethical concerns against the relative standard may not be as convincing as these commentators believe. Our aim is to present the case for a relative standard of environmental risk in order to open a debate on this subject. We conclude by discussing how a relative standard of environmental risk could be defended in the specific case of an HIV vaccine trial among adolescents in South Africa.
authors.affiliation: Snyder, Simon Fraser University, Health Sciences, 8888 University Drive, Blusson Hall 11300, Burnaby, British Columbia, V5A 1S6, Canada. jcs12@sfu.ca
authors.forename: Jeremy
authors.initials: J
authors.lastname: Snyder
authors.forename: Cari L
authors.initials: CL
authors.lastname: Miller
authors.forename: Glenda
authors.initials: G
authors.lastname: Gray
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; D032984:Ethics, Research; D005260:Female; D014943:Global Health; D015658:HIV Infections / Q000276:immunology / Q000517:prevention & control* / Q000635:transmission; D006505:Hepatitis / Q000517:prevention & control; D006801:Humans; D007326:Institutionalization; D008607:Intellectual Disability; D008297:Male; D033281:Nontherapeutic Human Experimentation / Q000941:ethics; D018579:Patient Selection / Q000941:ethics*; D011322:Primary Prevention / Q000941:ethics* / Q000379:methods; D012108:Research Personnel / Q000941:ethics; D012306:Risk; D012309:Risk-Taking; D013019:South Africa; D057212:Therapeutic Equipoise; D047568:Unsafe Sex; D035862:Vulnerable Populations; D055815:Young Adult
chemical_list: D016915:AIDS Vaccines