title: Undue inducement: a case study in CAPRISA 008.
abstract: : Participant safety and data integrity, critical in trials of new investigational drugs, are achieved through honest participant report and precision in the conduct of procedures. HIV prevention post-trial access studies in middle-income countries potentially offer participants many benefits including access to proven efficacious but unlicensed technologies, ancillary care that often exceeds local standards-of-care, financial reimbursement for participation and possibly unintended benefits if participants choose to share or sell investigational drugs. This case study examines the possibility that this combination of benefits may constitute an undue inducement for some participants in middle-income countries, where economic challenges are prevalent. A case study is presented of a single participant in a cohort of 382 participants who used concealment, fabrication and deception to ensure eligibility for a post-trial access study of an unlicensed HIV prevention technology at potential risk to her health and that of her fetus. A root cause analysis revealed her desire to access HIV prevention during an unplanned pregnancy with a partner whose faithfulness was in question. Researchers should consider implementation of systems to efficiently identify similar cases without inconveniencing the majority of participants TRIAL REGISTRATION NUMBER: NCT01691768.
authors.affiliation: Centre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal, Durban, KwaZulu-Natal, South Africa.|School of Laboratory Medicine and Medical Sciences University of Kwazulu-Natal, Durban, KwaZulu-Natal, South Africa.
authors.forename: Kathryn T
authors.identifier: 0000-0002-7847-3671
authors.initials: KT
authors.lastname: Mngadi
authors.affiliation: Centre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal, Durban, KwaZulu-Natal, South Africa.|Department of Clinical Public Health, Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Jerome A
authors.initials: JA
authors.lastname: Singh
authors.affiliation: Centre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal, Durban, KwaZulu-Natal, South Africa.
authors.forename: Leila E
authors.identifier: 0000-0002-7607-348X
authors.initials: LE
authors.lastname: Mansoor
authors.affiliation: School of Psychology, University of KwaZulu-Natal, Pietermaritzburg, South Africa.
authors.forename: Douglas R
authors.initials: DR
authors.lastname: Wassenaar
mesh_terms: D000328:Adult; D035843:Biomedical Research / Q000941:ethics*; D008192:Deception; D003906:Developing Countries; D030881:Disclosure; D032984:Ethics, Research; D005260:Female; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D007182:Income; D009042:Motivation / Q000941:ethics*; D018579:Patient Selection / Q000941:ethics*; D011203:Poverty; D011247:Pregnancy; D049168:Pregnancy, Unplanned; D012107:Research Design; D035842:Research Subjects; D012201:Reward; D012309:Risk-Taking; D012747:Sexual Partners
keywords: Autonomy; Clinical Ethics; HIV Infection and AIDS; Research Ethics