[Algorithm for application of the "ethical guidelines for epidemiological research" and taxonomy of public health research].
BACKGROUND: "Ethical Guidelines for Epidemiological Research" took effect in July 2002, with a moral duty of all researchers to comply when conducting epidemiological studies although it is not legally binding. Public health research entails various forms of studies including not only epidemiological studies but also attention to psychological, societal and economic aspects, which are outside of the jurisdiction of the guidelines. Hence, confusion may arise among members of Japanese Society of Public Health as to whether the study they conduct falls within the definition of epidemiological research. The author discusses legal interpretations of the guidelines arising in the course of translation work as part of government-funded project, "Dissemination of the 'Ethical Guidelines for Epidemiological Research' via Internet (principal investigator: Toru Doi)" and argues that a case-method approach would be best suited to enhance understanding by researchers with diverse, non-legal backgrounds. METHODS: The author proposes an algorithm for classification of studies as to whether the guideline applies, and applies it to all original articles published in the Japanese Journal of Public Health (JJPH) in one year (March 2002 thru February 2003). The rationale for classification is discussed from the strict legal viewpoint in each case. RESULTS: Sixteen out of 46 original articles published in JJPH for one year were classified as epidemiological studies to which the guidelines apply. Those classified otherwise were psychological studies (10), epidemiological studies not targeting specific diseases and are exempt form the guidelines (3), purely methodological studies (4), economics studies (3), fact-finding or opinion surveys with no hypothesis testing (2), as well as studies authorized by law (4) or using unlinkable anonymous data only (4), all of which are exempt from the guidelines. Reference to ethical considerations in the methodology section as required by the instructions for authors was generally well performed in epidemiological studies although some shortcomings were noted. DISCUSSIONS: The guidelines affect approximately a third of original articles published in the JJPH. The ratio of applicable to non-applicable articles was roughly 1 to 2. This gives both authors and reviewers confusion as to whether articles are subject to the guidelines and would require ethical approval. This case-method approach using actual articles readily available to members should help unnecessary confusion and enhance appropriate application of the guidelines. (366 words).