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

Journal of Medical Ethics 38 (6):356-365 (2012)

Authors
Evita Emanuel
Eastern Michigan University
Bernie Campbell
Santa Fe Community College
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
Keywords No keywords specified (fix it)
Categories (categorize this paper)
DOI 10.1136/medethics-2011-100178
Options
Edit this record
Mark as duplicate
Export citation
Find it on Scholar
Request removal from index
Revision history

Download options

Our Archive


Upload a copy of this paper     Check publisher's policy     Papers currently archived: 46,179
Through your library

References found in this work BETA

View all 14 references / Add more references

Citations of this work BETA

Informed Consent to HIV Cure Research.Danielle Bromwich & Joseph R. Millum - 2017 - Journal of Medical Ethics 43 (2):108-113.

View all 14 citations / Add more citations

Similar books and articles

Race, Religion, and Informed Consent - Lessons From Social Science.Dayna Bowen Matthew - 2008 - Journal of Law, Medicine and Ethics 36 (1):150-173.
Informed Consent and Genetic Information.O. O'Neill - 2001 - Studies in History and Philosophy of Science Part C: Studies in History and Philosophy of Biological and Biomedical Sciences 32 (4):689-704.
Informed Consent, Autonomy, and the Law.David B. Annis - 1984 - Philosophy Research Archives 10:249-259.
Informed Consent as Waiver: The Doctrine Rethought?Emma C. Bullock - 2010 - Ethical Perspectives 17 (4):529-555.
Informed Consent Practices in Nigeria.Emmanuel R. Ezeome & Patricia A. Marshall - 2009 - Developing World Bioethics 9 (3):138-148.

Analytics

Added to PP index
2012-02-10

Total views
139 ( #59,166 of 2,285,434 )

Recent downloads (6 months)
7 ( #159,537 of 2,285,434 )

How can I increase my downloads?

Downloads

My notes

Sign in to use this feature