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. (shrink)

The existing model for ethical review of medical research consists primarily of regulations designed to prevent exploitation of participants. This model may fail when reviewing other ethical obligations, particularly the responsibility to provide valuable knowledge to society. Such failure is most apparent in developing countries, in which many stakeholders lack incentives or power to uphold society’s interests. An alternative ethical model is that of partnership, which actively involves all partners during ethical review and aims to secure partners’ best interests through (...) compromise. Unlike the existing “regulatory” model, the partnership model effectively addresses ethical obligations to provide positive benefits to society. For the partnership model to be effective, power must be shared among partners; thus, the partnership model can be harmonised with the “regulatory” model through explicit consideration of power structures. One opportunity for crafting power balance in developing countries is apparent in “implementation trials”—randomised trials motivated by and integrated into the implementation of long term public health interventions. Given the failings of the existing ethical review model, alternative models—for example, partnership—and means to balance power—for example, implementation trials—must be explored to ensure that medical research provides knowledge of value to societies in the developing world. (shrink)

This article presents a review of the literature, summarizes current initiatives, and provides a heuristic for assessing the effectiveness of a range of institutional review board collaborative strategies that can reduce the regulatory burden of ethics review while ensuring protection of human subjects, with a particular focus on international research. Broad adoption of IRB collaborative strategies will reduce regulatory burdens posed by overlapping oversight mechanisms and has the potential to enhance human subjects protections.