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Quality Improvement or Research? A Report From the Trenches

I applaud Drs Morris and Dracup¹ for focusing attention on the dilemma of discerning whether a quality improvement (QI) study conducted in a healthcare setting should be regarded and scrutinized as research covered under 45 CFR (Code of Federal Regulations) 46.² I believe that the Hastings Center Special Report³ cited by the authors would be particularly helpful to QI administrators in both academic and nonacademic healthcare organizations.

Our hospital has completed its first year of administering a QI-IRB following nearly all of the recommendations from the special report authored by Baily et al.⁴ The QI-IRB contains some of the same members of our research IRB, but it is distinguished by members whose expertise lies both in clinical research and QI.

Because we work diligently to ensure that all of our QI studies are systematic inquiries, some degree of overlap always exists between QI and research activities in our setting. We are part of a healthcare network, a Qualis (Medicare) network, and are bound to employ efficient processes, so we hope that some of our findings will be sufficiently generalizable that sharing with other organizations may contribute to improvements in clinical operations at other sites. Thus, once again, the overlap between our QI activities and the federal definition of human research looms over our activities.

Providing a specialized ethics oversight body for QI studies has helped enrich our QI culture without inhibiting QI activities. QI study teams feel less isolated from the greater body of the organization. Some team members have expressed relief that they understand how the QI process can be enriched by sharing the study goals, processes, and findings with patients and families.

FINANCIAL DISCLOSURES
None reported.

REFERENCES

1. Morris PE, Dracup K. Quality improvement or research? The ethics of hospital project oversight [editorial]. Am J Crit Care. 2007;16(5):424–426.[Free Full Text]
2. Department of Health and Human Services. Code of Federal Regulations. Title 45 Public Welfare Part 46: Protection of Human Subjects; 2005. Effective June 23, 2005.
3. Lynn J, Baily MA, Bottrell M, et al. The ethics of using quality improvement methods in health care. Ann Intern Med. 2007:146(9):666–673.[Abstract/Free Full Text]
4. Baily MA, Bottrell M, Lynn J, Jennings R. The Ethics of Using QI Methods to Improve Health Care Quality and Safety: A Hasting Center Reports Special Report. Garrison, NY: The Hastings Center; 2006.

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