Document Detail

Institutional review board consideration of chart reviews, case reports, and observational studies.
MedLine Citation:
PMID:  18811999     Owner:  NLM     Status:  MEDLINE    
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.
Margaret J Neff
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Publication Detail:
Type:  Journal Article; Review    
Journal Detail:
Title:  Respiratory care     Volume:  53     ISSN:  0020-1324     ISO Abbreviation:  Respir Care     Publication Date:  2008 Oct 
Date Detail:
Created Date:  2008-09-24     Completed Date:  2008-12-09     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7510357     Medline TA:  Respir Care     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1350-3     Citation Subset:  IM    
Division of Pulmonary and Critical Care Medicine, Harborview Medical Center, 325 9th Avenue, Box 359762, Seattle, WA 98104, USA.
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MeSH Terms
Biomedical Research / ethics*,  legislation & jurisprudence
Clinical Trials as Topic / ethics*,  legislation & jurisprudence
Ethics Committees, Research / organization & administration*
Government Regulation
Human Experimentation / ethics*,  legislation & jurisprudence
Informed Consent / ethics*,  legislation & jurisprudence
Societies, Medical
United States

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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