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1.  Improving Participant Understanding of Informed Consent in an HIV-Prevention Clinical Trial: A Comparison of Methods 
AIDS and behavior  2012;16(2):412-421.
Empirical research on informed consent has shown that study participants often do not fully understand consent information. This study assessed participant understanding of three mock consent approaches describing an HIV-prevention clinical trial in Lilongwe, Malawi prior to trial implementation. Pregnant women (n = 297) were systematically selected from antenatal-care waiting lines and sequentially allocated to receive an enhanced standard consent form (group 1), a context-specific consent form (group 2), or context-specific counseling cards (group 3). Understanding of research concepts and study procedures was assessed immediately postintervention and at 1-week follow-up. At postintervention, participants in groups 2 and 3 understood more about research concepts and study procedures compared with group 1. Group 3 participants also understood more about study procedures compared with group 2. At follow-up, participants in groups 2 and 3 continued to understand more about research concepts and study procedures. Context-specific approaches improved understanding of consent information in this study.
doi:10.1007/s10461-011-9977-z
PMCID: PMC3923514  PMID: 21656146
Informed consent; Evaluation; Comprehension; Africa
2.  USING FORMATIVE RESEARCH TO DEVELOP A CONTEXT-SPECIFIC APPROACH TO INFORMED CONSENT FOR CLINICAL TRIALS 
Participant understanding is of particular concern when obtaining informed consent. Recommendations for improving understanding include disclosing information using culturally appropriate and innovative approaches. To increase the effectiveness of the consent process for a clinical trial in Malawi on interventions to prevent mother-to-child transmission of HIV during breastfeeding, formative research was conducted to explore the community’s understanding of medical research as well as how to explain research through local terms and meanings. Contextual analogies and other approaches were identified to explain consent information. Guided by theory, strategies for developing culturally appropriate interventions, and recommendations from the literature, we demonstrate how the formative data were used to develop culturally appropriate counseling cards specifically for the trial in Malawi. With appropriate contextual modifications, the steps outlined here could be applied in other clinical trials conducted elsewhere, as well as in other types of research.
doi:10.1525/jer.2006.1.4.45
PMCID: PMC3140046  PMID: 19385837
Formative research; informed consent; theory; culturally appropriate; HIV/AIDS
3.  Predicting Minority Student Performance in the First Medical School Year 
Impressions and anecdotal evidence have raised concerns that traditional cognitive measures of past performance may not be predictive of the performance among minority students in medical school. This study assessed the relationship between nine objective measures and actual first year academic performance for cohorts of minority students enrolled in a single medical school between 1973 and 1976.
The findings support previous impressions that objective measures together explain less than half of the variance in academic performance. Furthermore, the cumulative undergraduate college average and the competitiveness of the undergraduate college are consistently the strongest predictors of academic performance among this group.
PMCID: PMC2537291  PMID: 529325

Results 1-3 (3)