Framework for bioethical assessment of an article on therapy.

OBJECT: Frameworks for scientific assessment of articles on therapy published in the medical literature have become available and will likely enhance the quality of medical research that is published in peer-reviewed journals. Comprehensive frameworks do not exist for the assessment of bioethical issues pertaining to research on human volunteers. METHODS: The authors have developed a framework consisting of ethical dimensions or questions that they suggest should be applied to assess the bioethical integrity of articles on therapy. Thirteen questions were developed and discussed in the context of current bioethical principles, and examples were applied where possible. CONCLUSIONS: The simple framework the authors have developed offers a method to assess key bioethical issues surrounding an article on therapy and probably defines the minimum standard to which such articles should be held. Many ethical questions cannot yet be answered based on available information or bioethical theories. The authors are not suggesting that their framework is comprehensive; refinements and individualization of it to fit specific studies are probably required by each clinician-researcher who designs a therapy trial and reports its results.