The quality of informed consent: mapping the landscape. A review of empirical data from developing and developed countries

Abstract

Objective: Some researchers claim that the quality of informed consent of clinical research participants in developing countries is worse than in developed countries. To evaluate this assumption, we reviewed the available data on the quality of consent in both settings.

Methods: We conducted a comprehensive PubMed search, examined bibliographies and literature reviews, and consulted with international experts on informed consent in order to identify studies published from 1966 to 2010 that used quantitative methods, surveyed participants or parents of paediatric participants in actual trials, assessed comprehension and/or voluntariness, and did not involve testing particular consent interventions. Forty-seven studies met these criteria. We compared data about participant comprehension and voluntariness. The paucity of data and variation in study methodology limit comparison and preclude statistical aggregation of the data.

Results and discussion: This review shows that the assertion that informed consent is worse in developing countries than in developed countries is a simplification of a complex picture. Despite the limitations of comparison, the data suggest that: (1) comprehension of study information varies among participants in both developed and developing countries, and comprehension of randomisation and placebo controlled designs is poorer than comprehension of other aspects of trials in both settings; and (2) participants in developing countries appear to be less likely than those in developed countries to say they can refuse participation in or withdraw from a trial, and are more likely to worry about the consequences of refusal or withdrawal.

Figure 1

PRISMA 2009 flow diagram (adapted from Moher D, Liberati A, Tetziaff J, et al; The PRISMA Group. Preferred reporting items for systemic reviews and meta analyses: the PRISMA statement. PLoS Med 2009;6: e1000097. For more information, visit http://www.prisma-statement.org). This figure is produced in colour in the online journal—please visit the website to view the colour figure.