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.
J Med Ethics. 2017 Dec;43(12):824-828. doi: 10.1136/medethics-2016-103414. Epub 2017 Mar 27.
: 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.
参与者安全和数据完整性，在新的研究性药物试验中至关重要，通过诚实的参与者报告和程序执行的精确性来实现。在中等收入国家进行的 HIV 预防试验后准入研究可能为参与者带来许多益处，包括获得已证明有效的但未获得许可的技术、通常超过当地护理标准的辅助护理、参与的经济补偿，以及如果参与者选择分享或出售研究性药物，可能会获得意外的益处。本案例研究探讨了在经济挑战普遍存在的中等收入国家，这种综合益处可能对某些参与者构成不正当诱导的可能性。本案例研究介绍了 382 名参与者中的一名参与者，她使用隐瞒、伪造和欺骗手段，确保有资格参加一项未获得许可的 HIV 预防技术的试验后准入研究，这可能对她的健康和胎儿健康构成风险。根本原因分析揭示了她在与一个不忠的伴侣意外怀孕时，渴望获得 HIV 预防的愿望。研究人员应考虑实施系统，以便在不影响大多数参与者的情况下，有效地识别类似情况。试验注册号：NCT01691768。
