Perneger, Thomas V.

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International Journal for Quality in Health Care 2004; Volume 16, Number 5: pp. 343–344 10.1093/intqhc/mzh075International Journal for Quality in Health Care vol. 16 no. 5© International Society for Quality in Health Care and Oxford University Press 2004; all rights reserved 343EditorialWhy we need ethical oversight of quality improvement projectsThe jury is still out on whether ethical oversight is needed forquality improvement projects. Many quality practitionersargue that as long as the quality improvement project is notprimarily research, ethical review is unnecessary. In this editorial,I would like to defend the opposite view, that ethical over-sight is indeed desirable for most initiatives to improve thequality of health care.Let us redefine the nature of health care. Much of healthcare would amount to reckless endangerment or even to bodilyharm if it were not covered by the tacit covenant betweenpatient and doctor (think of surgery or chemotherapy). Underthis covenant, the doctor is allowed to perform potentiallydangerous treatments as long as she or he acts solely in theinterest of the patient. If the doctor served any master otherthan the patient’s welfare, his or her actions would be unlawful.This is why strict oversight by an external body is needed whendoctors perform research, an activity that aims to produceknowledge for the benefit of society, and not necessarily tohelp the patient.Clearly, the rule should be: for anything the patient requestedyou do not need external ethical oversight, for anything elsethat affects patient care you do. Unfortunately, the rule that isprevalent today has perversely shifted to this: for medicalresearch you need ethical oversight, for anything else you don’t.Several authors have endeavoured to define ‘research’ todelimit the jurisdiction of ethics committees [1–3]. Othershave argued that the emphasis on research is misguided: whatmatters is whether an activity entails risk to patients [4]. Sincehealth care is intrinsically risky, all decisions that bear on healthcare should be subjected to ethical oversight—except, that is,when they are specifically authorized by the patient in thecourse of clinical care. Many management and policy deci-sions that may have a significant impact on care are made inthe background, unbeknownst to the patient. Here are a fewexamples: ‘gag rules’ that limit the doctor’s ability to discusstreatment options not covered by a health insurance contract,reductions in health care personnel to improve productivity,structural overwork of doctors in training, limitation ofresources to investigate medical mishaps, reliance on paper-based patient records, pharmacy formulary decisions, closure(or opening) of hospital beds. Such decisions may threaten orenhance patients’ welfare yet are not made in response to patients’demands. That they are not overseen by an ethics committeesuggests that health care management in 2004 is like medicalresearch before Nuremberg: unsupervised and possibly harmful.Quality improvement projects face the same predicament.While such projects aim to improve or maintain the quality ofpatient care, those in charge cannot be sure that the interventionwill be effective. A risk exists that the proposed innovation willbe ineffective or even harmful. Furthermore, evaluations ofquality improvement projects are much like research in termsof the risks they pose for patients. The key difference is thattheir goal is to produce locally relevant knowledge, not generallyapplicable scientific knowledge. As with medical research, theproponents of the project have too much at stake to be trustedwith an even-keeled assessment of potential harms and benefits.Such an assessment should be done by a body whose solemandate would be to look after patients’ interests—let us call ita ‘management ethics committee’. This committee wouldassess the merits of all proposed quality improvement projects(and by extension, any management decision that may impacton the quality of care), and decide whether the project may ormay not go forth. The analysis would be guided by ethicsframeworks proposed for public health activities, and focuson the expected effectiveness of the intervention, the associatedrisks and burdens, and fairness in the distribution of benefitsand risks [5]. The committee should include representatives ofmanagement, of the health professions and possibly of patients.Several objections can be raised to this proposal. Some wouldsay that quality improvement does not require ethical over-sight because it is a moral obligation of health care systems—not to do it would be unethical. This is correct, and the sameargument is true for medical research. However, that the generalarea of activity is commendable does not imply that any givenproject is acceptable. ‘Quality improvement’ is the aim of theproject, not a guaranteed result.Another objection to ethical oversight of quality improve-ment projects is that it would be impractical or impossible toobtain individual informed consent [2]. This is also correct.However, ethical oversight does not necessarily imply individualinformed consent [6,7]. The requirement for individual consentis routine in medical research, where the proposed interventionis to be applied to the individual, and the risks and benefitsare borne by the same. In contrast, most quality improvementprojects are systemic. If doctors’ working hours are reduced inorder to decrease fatigue and the likelihood of errors, an indi-vidual patient cannot elect to be treated by an intern at theend of a 36-hour shift. Individual consent is simply not relevantin such a case [7]. I would suggest that obtaining an independentassessment of risks and benefits for the project is sufficient inmost cases, and formal consent to participate is unnecessary.In some circumstances, the patient population directlyaffected by the project may need to be formally consulted.How such a community informed consent can be obtained isan open question—perhaps from a panel of former patients,or from other representatives of society at large, much like theEditorial: T. V. Perneger344Citizens Council established by the National Institute for ClinicalExcellence in the UK (www.nice.org.uk). The body that grantsconsent should be independent from the ethics committee thathas authorized the launch of the quality improvement initiative.Community informed consent may be particularly useful whenthe proposed systemic intervention poses a substantial risk topatient health, and not merely, say, to the confidentiality ofmedical records. For individual interventions, individual consentremains an option.Another possible objection is that ethical oversight wouldadd an unseemly layer of bureaucracy to hospital operations,stifling, rather than encouraging, quality improvement initi-atives. Similar arguments are sometimes heard from medicalresearchers who consider the review of their projects byresearch ethics committees as an obstacle to research. No doubtthis is in part true. But surely principle should take precedenceover practicality. Furthermore, even though ethical oversightrequirements may reduce the number of quality improvementprojects, those that will get done will be better formalized andmore thoroughly evaluated than is currently the case. Qualityimprovement projects are sometimes felt to require less rigourin conception and less care in implementation than scientificresearch projects. There is little justification for such unevenstandards.Finally, ethical oversight of quality improvement projectsappears to place an unfair burden on innovations, as opposedto the status quo. This is true, but one has to start somewhere.Hopefully, hospital processes that pose the most problemsare the most likely to be subjected to a quality improvementinitiative. Hence, ethical oversight will be directed at the mostproblematic areas first. Furthermore, with time, most hospitalprocedures that affect patient care will change, and hence will bescreened by the management ethics committee. In this way,the work of management ethics committees will ensure that thefunctioning of hospitals is primarily concerned with the needsof patients.Thomas V. PernegerEditor-in-chiefQuality of Care UnitGeneva University HospitalsCH-1211 Geneva 14, SwitzerlandReferences1. Casarett D, Karlawish JHT, Sugarman J. Determining whenquality improvement initiatives should be considered research.Proposed criteria and potential implications. J Am Med Assoc 2000;283: 2275–2280.2. Amoroso PJ, Middaugh JP. Research vs. public health prac-tice: when does a study require IRB review? Prev Med 2003; 36:250–253.3. Nerenz DR, Stoltz PK, Jordan J. Quality improvement and theneed for IRB review. Qual Manag Health Care 2003; 12: 159–170.4. Bellin E, Nevelhoff Dubler N. The quality-improvement–research divide and the need for external oversight. Am J PublicHealth 2001; 91: 1512–1517.5. Kass NE. An ethics framework for public health. Am J PublicHealth 2001; 91: 1776–1782.6. Lo B, Groman M. Oversight of quality improvement. Arch InternMed 2003; 163: 1481–1486.7. Cassell J, Young A. Why we should not seek individual informedconsent for participation in health services research. J Med Ethics2002; 28: 313–317.

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