Informed consent rates for neonatal randomized controlled trials in low- and lower middle-income versus high-income countries: A systematic review.

ABSTRACT:

Objective

Legal, ethical, and regulatory requirements of medical research uniformly call for informed consent. We aimed to characterize and compare consent rates for neonatal randomized controlled trials in low- and lower middle-income countries versus high-income countries, and to evaluate the influence of study characteristics on consent rates.

Methods

In this systematic review, we searched MEDLINE, EMBASE and Cochrane for randomized controlled trials of neonatal interventions in low- and lower middle-income countries or high-income countries published 01/01/2013 to 01/04/2018. Our primary outcome was consent rate, the proportion of eligible participants who consented amongst those approached, extracted from the article or email with the author. Using a generalised linear

SUBMITTER: Patterson JK 

PROVIDER: S-EPMC7943024 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature