TY - JOUR
T1 - Determining when quality improvement initiatives should be considered research
T2 - Proposed criteria and potential implications
AU - Casarett, David
AU - Karlawish, Jason H.T.
AU - Sugarman, Jeremy
PY - 2000/5/3
Y1 - 2000/5/3
N2 - Quality improvement initiatives have become a major force in shaping health care. These initiatives are diverse but share a common goal of generating knowledge that will guide improvements in health care. Although quality improvement occupies an uncertain territory between clinical care and research, this difference is extremely important. If a quality improvement initiative is research, federal regulations require a variety of procedures that must be followed to protect the human subjects involved. Conversely, if the same initiative is not research, the regulations outlining these procedures are not applicable. This article proposes 2 criteria to determine whether a quality improvement initiative should be reviewed as research. Such an initiative should be reviewed and regulated as research if (1) the majority of patients involved are not expected to benefit directly from the knowledge to be gained or (2) If additional risks or burdens are imposed to make the results generalizable. Implementation of these criteria offers the possibility that the rights and interests of those who participate in quality improvement initiatives will be protected.
AB - Quality improvement initiatives have become a major force in shaping health care. These initiatives are diverse but share a common goal of generating knowledge that will guide improvements in health care. Although quality improvement occupies an uncertain territory between clinical care and research, this difference is extremely important. If a quality improvement initiative is research, federal regulations require a variety of procedures that must be followed to protect the human subjects involved. Conversely, if the same initiative is not research, the regulations outlining these procedures are not applicable. This article proposes 2 criteria to determine whether a quality improvement initiative should be reviewed as research. Such an initiative should be reviewed and regulated as research if (1) the majority of patients involved are not expected to benefit directly from the knowledge to be gained or (2) If additional risks or burdens are imposed to make the results generalizable. Implementation of these criteria offers the possibility that the rights and interests of those who participate in quality improvement initiatives will be protected.
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U2 - 10.1001/jama.283.17.2275
DO - 10.1001/jama.283.17.2275
M3 - Article
C2 - 10807388
AN - SCOPUS:0034600270
SN - 0098-7484
VL - 283
SP - 2275
EP - 2280
JO - JAMA
JF - JAMA
IS - 17
ER -