repeated assessments of informed consent comprehension among hiv-infected participants of a three-year clinical trial in botswana重复对知情同意的评估理解感染艾滋病毒的参与者博茨瓦纳的一项为期三年的临床试验.pdfVIP

Repeated Assessments of Informed Consent Comprehension among HIV-Infected Participants of a Three-Year Clinical Trial in Botswana 1 1,2 3 4 3,4 Lelia H. Chaisson , Nancy E. Kass *, Bafanana Chengeta , Unami Mathebula , Taraz Samandari 1 Berman Institute of Bioethics, Johns Hopkins University, Baltimore, Maryland, United States of America, 2 Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America, 3 Botswana-USA Partnership, Gaborone and Francistown, Botswana, 4 Division of Tuberculosis Elimination, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America Abstract Background: Informed consent (IC) has been an international standard for decades for the ethical conduct of clinical trials. Yet frequently study participants have incomplete understanding of key issues, a problem exacerbated by language barriers or lack of familiarity with research concepts. Few investigators measure participant comprehension of IC, while even fewer conduct interim assessments once a trial is underway. Methods and Findings: We assessed comprehension of IC using a 20-question true/false quiz administered in 6-month intervals in the context of a placebo-controlled, randomized trial for the prevention of tuberculosis among HIV-infected adults in Botswana (2004–2009). Quizzes were offered in both Setswana and English. To enroll in the TB trial, participants were required to have $16/20 correct responses. We examined concepts understood and the degree to which understanding changed over three-years. We analyzed 5,555 quizzes from 1,835 participants. The pa