Health service research: the square peg in human subjects protection regulations
Protection of human participants is a fundamental facet of biomedical research. We report the activities of a health service research study in which there were three institutional review boards (IRBs), three legal departments and one research administration department providing recommendations and m...
| Authors: | ; ; ; ; |
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| Format: | Electronic Article |
| Language: | English |
| Check availability: | HBZ Gateway |
| Journals Online & Print: | Drawer...
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| Fernleihe: | Fernleihe für die Fachinformationsdienste |
| Published: |
BMJ Publ.
2011
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| In: |
Journal of medical ethics
Year: 2011, Volume: 37, Issue: 2, Pages: 118-122 |
| Online Access: |
Volltext (JSTOR) Volltext (lizenzpflichtig) Volltext (lizenzpflichtig) |
| Summary: | Protection of human participants is a fundamental facet of biomedical research. We report the activities of a health service research study in which there were three institutional review boards (IRBs), three legal departments and one research administration department providing recommendations and mandating changes in the study methods. Complying with IRB requirements can be challenging, but can also adversely affect study outcomes. Multiple protocol changes mandated from multiple IRBs created a research method that was not reflective of how substance use screening would be performed in a clinical setting. There was direct conflict between the IRBs' perceptions of participants' protection with the researchers' need to use research methodology that assures the clinical relevancy of results. |
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| ISSN: | 1473-4257 |
| Contains: | Enthalten in: Journal of medical ethics
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| Persistent identifiers: | DOI: 10.1136/jme.2010.037226 |