To the Editor:
In medicine, distinctions between quality improvement initiatives (QII) and research are ambiguous. QII usually are conducted in reaction to sentinel events, cost containment, or outcome improvement. In contrast, research evaluates hypotheses that may benefit future patients and typically is published in peer-reviewed journals. Since QII utilizes research methodology, which may not directly benefit participants, and/or results are published, distinctions between QII and research lessen.
IRB requirements for QII are a legal conundrum. The U.S. Department of Health and Human Services1 defines research as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” IRB approval also depends on intent to publish, patient risk, testing new or nonstandard care, or confidentiality requirements. In contrast, federal regulations permit health care providers to conduct QII that include individually identifiable indicators. Similarly, the Health Insurance Portability and Accountability Act of 1996 does not require QII confidentiality stringency greater than that required for clinical care guidelines. The National Bioethics Advisory Commission2 recommends excluding QII (except for untested interventions) from federal research regulations because it improves clinical care. Critics argue that institutions are ethically obligated to conduct QII and should not require ethical oversight. In some instances, obtaining informed consent is impossible, such as in pre- and postintervention comparisons. Increased QII costs are another criticism.
Many ethicists and scientists favor intermediary approaches and require IRB review of nonmandated QII activities, permitting expedited review of QII data or specimens collected for nonresearch purposes or that present minimal risk. In the near future, electronic medical records may alleviate conflict by enabling deidentified analysis. While our teaching hospital transitions to electronic records, QII to improve national patient safety compliance (1) require IRB notification but are IRB exempt if deidentified or (2) are eligible for expedited IRB review if the data include personal identifiers or test a hypothesis, and/or if publication is anticipated.3 An IRB-QI subcommittee may be an alternate venue for fast-tracking QI proposals.
Kera F. Weiserbs, MHS, PhD
Statistician, Department of Medicine, Staten Island University Hospital, 475 Seaview Avenue, Staten Island, New York; ([email protected]).
Lori Lyutic, RPA-C
IRB manager, Staten Island University Hospital, Staten Island, New York.
Jeffrey Weinberg, MD, MBA
Chairman, Rehabilitation Medicine, Staten Island University Hospital, Staten Island, New York.
1 U.S. Department of Health and Human Services. 45 CFR Part 160—General Administrative Requirements and 45 CFR Part 164—Security and Privacy. Available at: (http://www.wedi.org/snip/public/articles/45CFR160&164.pdf
). Accessed June 30, 2008.
2 National Bioethics Advisory Commission. Ethical and Policy Issues in Research Involving Human Participants. Volume I: Report and Recommendations of the National Bioethics Advisory Commission. Available at: (http://bioethics.georgetown.edu/nbac/human/overvol1.pdf
). Accessed June 18, 2008.
3 The Joint Commission. 2005 National patient safety goals. Available at: (http://www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/05_npsgs.htm
). Accessed June 18, 2008.