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.