Megan Campbell|Ezra Susser|Sumaya Mall|Sibonile G. Mqulwana|Michael M. Mndini|Odwa A. Ntola|Mohammed Nagdee|Zukiswa Zingela|Stephanus van Wyk|Dan J. Stein
Using iterative learning to improve understanding during the informed consent process in a South African psychiatric genomics study
University of Cape Town|New York Psychoanalytic Society and Institute|Columbia University|University of Cape Town|University of Cape Town|University of Cape Town|University of Cape Town|Rhodes University|Walter Sisulu University|Walter Sisulu University|University of Cape Town
obtaining informed consent great challenge global health research need tools screen improve potential research participants understanding research study time recruitment limited empirical research conducted low middle income countries evaluating informed consent processes genomics research sought investigate quality informed consent obtained south african psychiatric genomics study xhosa language version university california san diego brief assessment capacity consent questionnaire ubacc used screen capacity consent improve understanding iterative learning sample 528 xhosa people schizophrenia 528 controls address two questions firstly whether research participants understanding research study improved iterative learning secondly predictors better understanding research study initial screening screening 290 55 cases 172 33 controls scored 145 cutoff acceptable understanding research study elements however iterative learning 38 7 cases 13 25 controls continued score cutoff significant variables associated increased understanding consent included psychiatric nurse recruiter conducting consent screening higher participant level education control ubacc proved effective tool improve understanding research study elements consent cases controls tool holds utility complex studies involving genomics iterative learning used make significant improvements understanding research study elements ubacc may particularly important groups severe mental illness lower education levels study recruiters play significant role managing quality informed consent process