Informed Consent Rates For Neonatal Randomized Controlled Trials In Low And Lower-Middle Income Countries Versus High-Income Countries: A Systematic Review

Informed Consent Rates For Neonatal Randomized Controlled Trials In Low And Lower-Middle Income Countries Versus High-Income Countries: A Systematic Review
Denise Jones, Syed Taha, Michael S. Jones, Melissa Bauserman, Stuti Pant, Carl Bose, Sudhin Thayyil, Jackie K. Patterson and Paolo Montaldo
Pediatrics, March 2021; 147(3) pp 246-247
Abstract
Background – Consent rates for research studies in low- and lower middle-income countries (LMICs) are often greater than 90%. Uniformly high consent rates raise ethical concerns regarding the extent to which consent is both autonomous and informed. This study aimed to characterize consent rates for neonatal randomized controlled trials (RCTs) in LMICs compared to high-income countries (HICs). Methods – We searched MEDLINE, EMBASE and Cochrane for neonatal RCTS in LMICs or HICs published between 2013 and 2018. Given the disproportionately high number of HIC articles in the initial search, we used a random number generator to select a subset of HIC…

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