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Ethical international research on human subjects research in the absence of local institutional review boards
  1. S B Bhat1,
  2. T T Hegde2
  1. 1Box 143 Frist Campus Center, Princeton University, Princeton, New Jersey, USA
  2. 2Indian Medical Association Kumta Branch, Kumta, Karnataka, India
  1. Correspondence to:
 S B Bhat
 Box 143 Frist Campus Center, Princeton University, Princeton, NJ 08544, USA; sbhat{at}


International health-related research on human subjects entails unique ethical responsibilities and difficulties. Often, these difficulties are augmented by the lack of a local ethical review infrastructure. In a recent cross-national study conducted by us, three critical components of ethical regulation were identified—external oversight, local oversight and subject involvement—and integrated into the study design. These three concepts are outlined and established as an important aspect of ensuring ethical coherence in the local context, particularly when reviews by the local institutional review boards cannot practically be obtained. The three levels of ethical oversight identified are suggested to be the framework within which future field studies on human subjects are developed and a standard for maintaining ethical rigorousness in research on humans.

  • IRB, institutional review board

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  • Funding: This paper and the project it was based on were supported by research funding and alumni grants from the Princeton University. The funding sources had no involvement with study design, data collection, analysis, interpretation of data or the decision to submit the paper for publication.

  • Competing interests: None.

  • Ethical approval: Princeton University Institutional Review Panel reviewed and approved the study, on which this paper is based, on 17 May 2004.

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