Trial participants' understanding of randomization, double-blinding, and placebo use in low literacy populations: findings from a study conducted within a microbicide trial in Malawi

Journal of Empirical Research on Human Research Ethics : JERHRE
Paul NdebeleEsther Munalula-Nkandu

Abstract

Concerns have been raised about the limits of understanding of consent by clinical trial participants in developing countries. Consequently, this empirical study was conducted in Malawi to assess microbicide trial participants' understanding of randomization, double-blinding, and placebo use. The study used a combination of quantitative and qualitative methods, including structured questionnaire interviews with a random sample of 203 individual participants, four in-depth interviews with research nurses, and two focus group discussions with 18 study participants. Most respondents earned high scores on questions related to randomization (85%) and placebo use (72%), while a greater proportion of the same respondents obtained low scores on questions related to double-blinding (68%) and personal implications of the study procedures (63%). Overall, most respondents (61%; n = 124) obtained low scores on combined understanding of all the three concepts under study.

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Citations

Apr 10, 2015·The American Journal of Bioethics : AJOB·Anne R Simpson
Nov 11, 2016·Journal of Empirical Research on Human Research Ethics : JERHRE·Catherine SlackLinda-Gail Bekker
Oct 21, 2015·Journal of Empirical Research on Human Research Ethics : JERHRE·Marilys GuilleminLynn Gillam
May 6, 2017·Health Expectations : an International Journal of Public Participation in Health Care and Health Policy·Leila CusackTammy C Hoffmann
Dec 20, 2019·Trials·Rieke van der Graaf, Phaik Yeong Cheah

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