title: Institutional review board consideration of chart reviews, case reports, and observational studies.
abstract: Though the need for human-subjects review is readily apparent to investigators when conducting a randomized clinical trial, that same requirement is often less obvious when considering activities such as chart reviews, observational studies, or even case reports. In some cases all that is needed is notification of the institutional review board, which might then exempt the research. In other cases, waiver of consent and Health Insurance Portability and Accountability Act authorization may be granted, whereas in some situations risk to privacy may be considered too great and approval denied. In all cases, including case reviews, quality-improvement projects, and chart reviews, the most cautious approach for the investigator is to discuss regulatory requirements with the institutional review board official to ensure compliance. I will review what constitutes human-subjects research and how investigators may access protected health information, and consider some examples of observational research.
authors.affiliation: Division of Pulmonary and Critical Care Medicine, Harborview Medical Center, 325 9th Avenue, Box 359762, Seattle, WA 98104, USA. mneff@u.washington.edu
authors.forename: Margaret J
authors.initials: MJ
authors.lastname: Neff
mesh_terms: D035843:Biomedical Research / Q000941:ethics* / Q000331:legislation & jurisprudence; D002986:Clinical Trials as Topic / Q000941:ethics* / Q000331:legislation & jurisprudence; D028744:Ethics Committees, Research / Q000458:organization & administration*; D033161:Government Regulation; D006805:Human Experimentation / Q000941:ethics* / Q000331:legislation & jurisprudence; D006801:Humans; D007258:Informed Consent / Q000941:ethics* / Q000331:legislation & jurisprudence; D019370:Observation; D012955:Societies, Medical; D014481:United States