PURPOSE

There has been growing concern about whether and when quality improvement activities require Institutional Review Board (IRB) review and informed consent. We sought to determine whether quality officers, IRB chairs, and journal editors share similar views about the role of IRB review and informed consent in quality improvement.

METHODS

A survey consisting of six quality improvement scenarios detailing the development, implementation, and evaluation of a clinical practice guideline for the management of patients with acute myocardial infarction was mailed to all medical directors of quality and IRB chairpersons at hospitals with at least 400 beds that are members of the Council of Teaching Hospitals of the Association of American Medical Colleges. The same survey was mailed to the editors of all U.S. medical journals that appear in Abridged Index Medicus.

RESULTS

Quality officers were less likely than IRB chairs to believe that IRB review was required for all but one of the scenarios. When a clinical practice guideline developed by a national specialty society was implemented locally and its effects evaluated by chart review and telephone calls to patients, 47% (44/94) of IRB chairs, 66% (25/38) of journal editors, but only 20% (20/100) of quality officers believed the activity should be subjected to IRB review. Among those who thought that IRB review was required, there were similar but less striking differences in the perceived need for informed consent. Agreement between quality officers and IRB chairs within the same institution was poor, ranging from 44% to 52% for three of the six scenarios.

CONCLUSION

In light of the pressing need to improve quality while protecting the rights of patients, efforts should be supported to clarify the role of the IRB in quality improvement activities.