title: The intersection of sound principles of environmental epidemiologic research and ethical guidelines and review: an example from Canada of an environmental case-control study.
abstract: The present article challenges the ways in which ethical guidelines are implemented in reviewing the design and conduct of research involving human participants in observational studies in Canada. Fieldwork procedures should be designed in such a way as to be valid scientifically but also acceptable in terms of local ethical considerations, such as confidentiality of participant's identity and information, and other social norms. To set the stage, I present briefly essential information regarding the valid design and conduct of observational epidemiologic studies. As an example of the difficulties encountered in implementing these procedures, I present my experience in gaining ethical approval for a population-based, case-control study of environmental causes of postmenopausal breast cancer.
authors.affiliation: Department of Medicine, McGill University, Montreal, Quebec, Canada. mark.goldberg@mcgill.ca
authors.forename: Mark S
authors.initials: MS
authors.lastname: Goldberg
mesh_terms: D001943:Breast Neoplasms / Q000453:epidemiology / Q000209:etiology; D002170:Canada / Q000453:epidemiology; D016022:Case-Control Studies; D003219:Confidentiality; D004777:Environment; D004812:Epidemiologic Methods; D028744:Ethics Committees, Research / Q000458:organization & administration; D032984:Ethics, Research; D005260:Female; D006801:Humans; D018579:Patient Selection / Q000941:ethics; D017698:Postmenopause; D012107:Research Design; D012931:Social Environment