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 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.
Case Western Reserve University, School of Nursing, 19000 Euclid Ave, Cleveland, OH 44106, USA. lsg7@case.edu
L S
LS
Gittner
M J
MJ
Roach
G
G
Kikano
S
S
Grey
N V
NV
Dawson
D035843:Biomedical Research / Q000941:ethics* / Q000331:legislation & jurisprudence; D028744:Ethics Committees, Research / Q000941:ethics* / Q000331:legislation & jurisprudence; D006302:Health Services Research / Q000941:ethics* / Q000331:legislation & jurisprudence; D006801:Humans; D007258:Informed Consent / Q000941:ethics* / Q000331:legislation & jurisprudence; D012107:Research Design / Q000331:legislation & jurisprudence