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
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.
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.
Read the full text or download the PDF:
Other content recommended for you
- Developing capacity to protect human research subjects in a post-conflict, resource-constrained setting: procedures and prospects
- The ESRC research ethics framework and research ethics review at UK universities: rebuilding the Tower of Babel REC by REC
- Clinical Research From Proposal to Implementation
- Ethical review of health research: a perspective from developing country researchers
- Hidden risks associated with clinical trials in developing countries
- Strengthening ethics committees for health-related research in sub-Saharan Africa: a scoping review
- Ethics committees for biomedical research in some African emerging countries: which establishment for which independence? A comparison with the USA and Canada
- What are local issues? The problem of the local review of research
- New governance arrangements for research ethics committees: is facilitating research achieved at the cost of participants’ interest
- Partnership as an ethical model for medical research in developing countries: the example of the “implementation trial”