the ethics of using qi methods to improve health care quality & safety

8/14/2019 The Ethics of Using QI Methods to Improve Health Care Quality & Safety

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MARYANN BAILY MELISSA BOTTRELL

JOANNE LYNN BRUCE JENNINGS

T H E. . . . . . . . . . . . .

HASTING. . . . . . . . . . . . . C E N T E

A HAST IN GS CENTER SPEC IAL REPORT

THE ETHICS OF USING

QI METHODS TO

IMPROVE HEALTH CARE

QUALITY AND SAFETY

Rights were not granted to include this image in electronic media.

Please refer to the printed report.


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S2 July-August 2006 / HASTINGS CENTER REPORT

George J. Agich, PhD

Bowling Green State University

Bowling Green, OH

Mary Ann Baily, PhD

The Hastings Center

Garrison, NY

Paul Batalden, MD

Dartmouth Medical School

Hanover, NH

Nancy Berlinger, PhD, MDiv

The Hastings Center

Garrison, NY

*Melissa Bottrell, MPH, PhD

National Center for Ethics in

Health Care, Veterans Health

Administration

Seattle, WA

*Michael Carome, MD

DHHS Office for Human Research

Protections

Rockville, MD

David Casarett, MD, MA

Center for Health Equity Research

and Promotion

Philadelphia VA Medical Center

Philadelphia, PA

Janet Corrigan, PhD

National Quality Forum

Washington, DC

Linda Cronenwett, PhD, RN,

FAAN

University of North Carolina at

Chapel Hill, School of Nursing

Chapel Hill, NC

Frank Davidoff, MD, MACP

Institute for Healthcare

Improvement

Wethersfield, CT

Nancy Neveloff Dubler, LLB

Montefiore Medical Center

Bronx, NY

*Arnold Farley, PhD

Centers for Medicare and Medicaid

Services

Baltimore, MD

*J. Michael Fitzmaurice, PhD

Agency for Healthcare Research and

Quality

Rockville, MD

*Ellen Fox, MD

National Center for Ethics in

Health Care, Veterans Health

Administration

Washington, DC

Brent James, MD, MSTAT

Intermountain Institute for Health

Care Delivery Research

Salt Lake City, UT

*Stephen F. Jencks, MD, MPH

Centers for Medicare and Medicaid

Services

Baltimore, MD

Bruce Jennings, MA

Center for Humans and Nature

New York, NY

Robert J. Levine, MD

Yale University

New Haven, CT

Joanne Lynn, MD, MA, MS

The RAND Corporation

Arlington, VA

Karen Maschke, PhD

The Hastings Center

Garrison, NY

Ethel Mitty, EdD, RN

New York University

College of Nursing

New York, NY

Robyn Y. Nishimi, PhD

National Quality Forum

Washington, DC

Margaret OKane, MHA

National Committee for Quality

Assurance

Washington, DC

Paul Schyve, MD

Joint Commission on Accreditation

of Healthcare Organizations

Oakbrook Terrace, IL

Theodore Speroff, PhD

Vanderbilt University Medical Center

Nashville, TN

Sean Tunis, MD, MSc

HealthTech

San Francisco, CA

Matthew K. Wynia, MD, MPH

American Medical Association

Institute for Ethics

Chicago, IL

*Note: The authors of this report are re-

sponsible for its content. Statements in

this report should not be construed as

endorsement by the Agency for Health-

care Research and Quality or the U.S De-

partment of Health and Human Services.

The federal government employees list-

ed above participated in the meeting dis-

cussions in an advisory capacity. Howev-

er, in addition to the preceding dis-

claimer, it should be further emphasized

that the statements in this report should

not be construed as endorsement by the

Department of Veterans Affairs or any

other department of the U.S. govern-

ment, nor do they represent the policies

of any federal departments, agencies, or

offiices.

PROJECT PARTICIPANTS Organizational affiliations for identification purposes only; affiliations current as of 2006

This project was funded by the

Agency for Healthcare Research

and Quality, grant #1R13HS13369.


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S3SPECIAL REPORT / The Ethics of Using QI Methods to Improve Health Care Quality and Safety

PREFACE

Powerful forces of change are at work within the

American health care system. The public debateconcerning health care financing and access to in-

surance coverage is intensifying. But below the surface ofthe media and policy debate about cost and access, a qui-eter but perhaps more significant process of change isunder way: the transformation of health care management

and deliveryindeed, health professional work itselfthrough health care quality improvement.

The innovative, interdisciplinary quality improvement(QI) movement has begun to significantly upgrade deliv-ery of health care in the United States. Taking its cue fromreform approaches in other industries, and driven espe-cially by studies indicating a shockingly widespread inci-dence of medical errors and a striking lack of consistencyin the standard of care patients receive in different facili-ties and from different practitioners, the QI movementhas arrived in health care. Using knowledge gained fromthe disciplines of medicine, nursing, health care manage-

ment, and medical and health services research, it at-tempts to mobilize people within the health care system to work together in a systematic way to improve the carethey provide. In this work, discipline-specific knowledgeis combined with experiential learning and discovery tomake improvements.

Ethical issues arise in QI because attempts to improvethe quality of care for some patients may sometimes inad-vertently cause harm, or may benefit some at the expenseof others, or may waste scarce health care resources. Ethi-cal issues also arise because some activities aimed at im-provement have been interpreted as a form of medical re-search in which patients are used as subjects. If this inter-

pretation is correct, QI would come under the same com-plex review and regulatory requirements that have beenset up to govern biomedical and other types of research.But is this type of regulation necessary, given what QI in-volves? Is it the most effective and reasonable way to regu-late QI to ensure that it is carried out in an ethical fash-ion? These are important questions, both conceptuallyand practically. Thus far, however, relatively few attemptshave been made to address QI from an ethical perspective,and the interface between research and quality improve-ment has not been adequately explored or defined.

Federal agencies with responsibilities in this area havedisagreed on where the interface between medical researchand QI lies and how it should be handled. (See Box 1 fora particularly dramatic example of such a conflict.) Thestrict ethical rules of oversight, regulation, and patientconsent for human subjects research, including the re-quirement for institutional review board (IRB) approval,

have significant implications for the feasibility and cost ofpursuing QI activities. More specifically, the mechanismdeveloped to govern ethical conduct in one importantareahuman subjects researchcould have the perverse,if unintended, consequence of interfering directly with anequally important ethical imperative in another areathat is, unceasing efforts by health care professionals tomake clinical care safer and more effective. The currentstate of uncertainty about what is ethically and legally re-quired to safeguard participants in QI activities has al-ready become a disincentive to engage in QI, making itmore difficult to bring about the system transformation

urgently needed if health care is to be made better andsafer for patients.In 2002 The Hastings Center began a project to ad-

dress these issues and to investigate more generally theethical and value issues that arise in the theory and prac-tice of quality improvement in health care. The project, ti-tled The Ethics of Improving Health Care Quality andSafety, was funded by grant #1R13HS13369 from the

Agency for Healthcare Research and Quality (AHRQ).The Hastings Center project assembled a group of ex-

perts from a number of interrelated fields and disciplinesinvolved in health care quality improvement, includingmedicine, nursing, law, social science, health care manage-

ment, medical editing and publishing, health policy andregulation, health services research, and bioethics. Theprojects goals were: (1) to develop an ethical frameworkthat can be applied to ethical issues arising in quality im-provement practice, (2) to make practical policy recom-mendations for quality improvement oversight, and (3) tohelp promote a constructive dialogue both within andoutside the quality improvement community on pertinentethical issues.

Over a two-year period, the project group met fourtimes for two-day working sessions. Project members and


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other invited guests presented and debated thefindings of their own research and drafts of com-missioned papers focusing on ethical issues in

quality improvement. Those papers will be pub-lished in an edited volume in 2007. In addition toour deliberations with project participants, wehave also made presentations at professional andacademic meetings and communicated electroni-cally with a larger group interested in health caresystem improvement by setting up a moderated e-mail listserv. Following the publication of this re-port, The Hastings Center will continue to serveas a resource in the process of translating the con-clusions and recommendations of the project intopractical policies through the listserv, presenta-tions at professional and academic meetings, pro-

duction of additional written materials, and direct

contacts with persons and organizations interestedin the ethics of QI.

This report presents the analysis, findings, and

conclusions that emerged from the deliberationsof the project participants and staff research con-ducted for this project. The authors are Mary AnnBaily, Melissa Bottrell, Joanne Lynn, and Bruce

Jennings. This report is not a consensus docu-ment in the sense that each project participantagrees with it in all details, but we have done ourbest to present an accurate and faithful reflectionof the thinking of the group as a whole, and thisanalysis certainly would not have been possible

without the benefit of their insights and expertise.

Mary Ann Baily, Melissa Bottrell,

Joanne Lynn, Bruce Jennings

In October 2000, a nephrologist coauthoredan article about a project to improve the dialysiscare delivered to patients in Medicares EndStage Renal Disease (ESRD) program.1 Some

time after the article appeared, the university at which he held a faculty appointment notifiedhim that an audit of faculty publications hadidentified this project as a quality improvementeffort that met the definition of human subjectsresearch but had not undergone IRB review. Thenephrologist responded that he had participatedin the project as the chair of the local ESRDNetworks Medical Review Board, that theESRD Network conducted the project undercontract to the Center for Medicare and Medi-caid Services (CMS), and that the CMS scientif-ic officer overseeing the project had told him

that, as a CMS-directed quality improvementproject, it was not subject to oversight by theuniversitys IRB. Later, CMS reaffirmed thisopinion in a letter to the university. The univer-sity submitted the dispute to the Department ofHealth and Human Services Office for HumanResearch Protections (OHRP) for review.

OHRP responded that the design of the qualityimprovement project met the definition ofhuman subjects research and that the CMS de-termination that the project was exempt from

IRB review was not made in collaboration withOHRP. OHRP and CMS have had discussionsand exchanged memoranda as to whether thisand other quality improvement activities meetthe regulatory definition of human subjects re-search and require IRB review; however, these is-sues have not yet been resolved. This issue hascaused concern among other volunteer physi-cians in the eighteen ESRD Networks about theimplications for ongoing quality improvementprojects and the possible impact if their conductis found to violate the regulations for protectinghuman research subjects.

1. P.M. Palevsky et al., Improving Compliance withthe Dialysis Prescription as a Strategy to Increase the De-livered Dose of Hemodialysis: An ESRD Network 4Quality Improvement Project, Advances in Renal Re-

placement Therapy7, no. 4, supplement 1 (2000): S21-S30.

1. The Pittsburgh ESRD Case


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uality improvement in health care takes manyforms, ranging from changes in financing to

reforms in professional education to invest-ments in new facilities and equipment. In this

report, we are concerned with the form of improvementthat occurs through clinical and managerial innovationsand adaptations in the delivery of care. These changeshave always been an integral part of health care delivery,but in the past they were often introduced informally andidiosyncratically, without careful attention to all of theireffects. In recent years, people in health care have begunto use many new formal, explicit methods, some of which

were developed in other industries, to make the process ofcontinual adjustment more self-reflective and systematic,and thus increase the likelihood that it produces positive

change. In other settings, this approach to improvingquality is often referred to as QI.

When we use the term QI in this report, we meansystematic, data-guided activities designed to bring aboutimmediate, positive changes in the delivery of health carein particular settings. While QI uses a wide variety ofmethods, they all involve deliberate actions to improvecare, guided by data reflecting the effects. Depending onthe activity, QI can look like a type of practical problemsolving, an evidence-based management style, or the ap-plication of a theory-driven science of how to bring aboutsystem change. Introducing QI methods often means en-

couraging people in the clinical care setting to use theirdaily experience to identify promising ways to improvecare, implement changes on a small scale, collect data onthe effects of those changes, and assess the results. Thegoal is to find interventions that work well, implementthem more broadly, and thereby improve clinical practice.

Alternatively, a QI activity might begin with a review ofaggregate data at the patient, provider, clinical unit, or or-ganizational level to identify a clinical or managementchange that can be expected to improve care. The changeis made, the effects are monitored, and conclusions aredrawn about whether the change should be made perma-nent. QI can also mean collecting data from multiple or-

ganizations, analyzing it to understand what drives posi-tive change, and using the results to design and imple-ment a strategy to achieve a specific improvement acrossorganizations. At its heart, QI is a form of experientiallearning and discovery.1

QI work is data-guided, usually involves human par-ticipants, and sometimes uses methods that are also usedin medical research. Thus, it is not surprising that theissue of its relationship to federal regulations governing re-search with humans has arisen. These regulations were putin place to ensure that federally funded research projects

meet accepted ethical standards for protection of humanresearch subjects. The regulations that are relevant to this

report are codified at Title 45 CFR 46 as Department ofHealth and Human Services, Protection of Human Sub-

jects. The core requirements (Subpart A) are that individ-uals be selected equitably to participate in research; thatresearch subjects give full, voluntary written consent; andthat an IRB review proposed research and approve it onlyif risks to subjects have been minimized and are reason-able in relation to anticipated benefits.2 There are addi-tional requirements (Subparts B, C, and D) for researchthat involves especially vulnerable subjects, such as preg-nant women, prisoners, and children. The DHHS regula-tions do not cover non-federally funded research, but or-ganizations engaged in research are encouraged to provide

formal assurances to the government that all their humansubject research will comply with the DHHS regulations

whatever the funding source. Also, although Subpart Aexplicitly exempts some categories of human subject re-

search from the regulations, the DHHS Office forHuman Research Protections (OHRP) has issued guid-ance stating that researchers should not be allowed to de-cide on their own that their projects are exempt. Many in-stitutions require determination of exempt status to bemade by an IRB. In practice, a substantial proportion ofboth federally funded and nonfederally funded humansubject research, especially biomedical research, must besubmitted to an IRB. (For a brief summary of the DHHSregulations, see Box 2.)

Discussion of ethical issues raised by QI has tended tocenter around the legal question, Is this QI projecthuman subjects research as defined by federal regulations

and therefore subject to IRB review and the regulatory re-quirements for informed consent? The case outlined inBox 1 is but one example of many in an ongoing contro-versy in the literature, in IRBs, and in organizations doingQI about whether QI is research and therefore covered bythe regulations.

Framing the issue in this way may not be the best wayto proceed, however. The goal is to ensure that QI activi-ties are carried out in an ethical manner and that theirhuman participants are treated appropriately, however theactivities are planned and structured and whatever the ac-


Q

Although systematic empirical information on

the quality of care is limitedwhich is itself

surprisingwhat is available is disturbing.


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tivities are called. Focusing on IRB review and the defini-tion of research may implicitly suggest that IRB review

would be adequate and that it is the only way to protectQI participants. This is an overly narrow perspective. Inthis report, we explore the similarities and differences be-tween research and QI, but rather than focus entirely onIs QI research? and IRB review, yes or no? we stepback to look at the bigger picture. We ask: What is theplace of QI in the operation of the health care system?What makes a QI activity ethical? and What institu-tional arrangements should be in place to ensure that spe-

cific QI activities meet ethical requirements? Only afterthat do we return to the question of how QI activitiesshould relate to IRB review and other procedures for theprotection of human subjects in research.

Organization of the Report

Section I explains why quality improvement is impor-tant in health care and discusses the role of QI meth-ods in the management of health care delivery. We thenconsider the underlying ethical question of who has re-

sponsibility for improving the quality of care. We con-clude that engaging in quality improvement is not purelydiscretionary; health professionals, managers, delivery or-ganizations, patients, and government all have an ethicalresponsibility to cooperate with one another to improvethe quality of care. Section II compares and contrasts QIand research in terms of each activitys goals, methods,role in the health care system, and impact on human par-ticipants. We use the principles of research ethics that un-derlie the current system for protecting human researchsubjects as a base from which to explore and define the re-

quirements for ethical conduct of QI activities. We thenconsider the use of IRBs for ethical oversight of the con-duct of QI and conclude that, for a variety of reasons,IRBs as currently constituted are not appropriate for thispurpose. Section III discusses the institutional arrange-ments that should be in place to ensure that QI activitiesmeet ethical requirements. Section IV addresses imple-mentation, and Section V briefly summarizes the conclu-sions and policy recommendations of the report.

Department of Health and Human Services policysets out a complex set of provisions for the protection ofhuman research subjects. It:

extends to research funded by the Department ofHealth and Human Services and to nonfederally fund-ed research conducted at or in conjunction with an in-stitution that agrees through its federal-wide assuranceto extend the regulations to all research regardless offunding source. Six categories of research activities areexempt from the regulations (45 CFR 46.101(b)(1)-(6))

requires prior review and approval of nonexempt re-search by a duly constituted institutional review board(IRB), and continuing IRB review of ongoing research(45 CFR 46.103)

permits expedited review (conducted by IRB chair-person or by one or more experienced reviewers) whencertain criteria are met (45 CFR 46.110 and Guidanceon the Use of Expedited Review Procedures)

requires seven items to be satisfied for IRB approvalof research: risks to subjects are minimized; risks arereasonable in relation to anticipated benefits; subjectsare selected equitably; informed consent will be ob-tained from prospective subjects or their legally autho-rized representatives; there will be written documenta-tion of informed consent; the trial will receive safety

monitoring, when appropriate; provisions are made forsubject privacy and confidentiality of data, when ap-propriate (45 CFR 46.111)

requires IRBs to ensure that additional safeguardsare included in a study when participants will likely bevulnerable to coercion or undue influence (45 CFR46.111)

prohibits institutional officials from approving re-search that has not received IRB approval (45 CFR46.112)

permits IRBs to suspend or terminate research ap-proval when a study is not conducted in accordance

with IRB requirements or is associated with unexpect-ed serious harm to participants (45 CFR 46.113)

requires that specific information be provided to re-search participants to satisfy the general requirementsfor informed consent (45 CFR 26.116)

permits IRBs to approve a consent procedure thatomits or alters some or all of the elements of informedconsent when certain criteria are met (45 CFR 46.116)

requires additional protections for pregnant women,human fetuses and neonates (45 CFR 46.201), prison-ers (45 CFR 46.301), and children (45 CFR 46.401)

2. Summary of DHHS Policy for the Protection of Human Subjects (Subparts A-D)


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M

any Americans have a rosy picture of the quali-ty of their health care system. They believe thatit provides a generally high standard of care that

is continuously updated as new research findings comeout, so that it remains the best in the world. They recog-nize, of course, that there are some access problems (espe-cially for the uninsured and underinsured) and somebelow-par facilities and professionalsno health care sys-tem is perfectbut overall, the sense is that the quality ofcare is excellent. Unfortunately, this view is too optimistic.Recent work by individual scholars and by organizationssuch as the Institute of Medicine (IOM) and the Agencyfor Healthcare Research and Quality (AHRQ) has provid-ed detailed, compelling evidence of serious problems withthe quality of American health care.3

Since quality is a complex, multifaceted concept, as-

sessing just how well the American health care system isdoing is not easy. It requires the development of a concep-tual framework for understanding quality and the transla-tion of that framework into practical measures that can beapplied in specific contexts. The framework developed bythe Institute of Medicine in several influential reports de-fines quality as the degree to which health services for in-dividuals and populations increase the likelihood of de-sired health outcomes and are consistent with current pro-fessional knowledge.4 The core dimensions of quality areidentified as safety, effectiveness, patient-centeredness, andtimeliness.5 Two additional aspects of care that cut across

these dimensions are equity and efficiency.6

(See Box 3 fordefinitions of these six quality characteristics.)The status of efficiency in the quality framework is

controversial. In Crossing the Quality Chasm, the Instituteof Medicine Committee on the Quality of Health Careconsiders it a dimension of quality, but another IOMcommittee, charged with translating the IOMs qualityframework into practical measures, does not, arguing thatefficiency is an important goal of the health care systemthat is related to, but conceptually different from qualityof care.7 In this report, we work from the position thatincreasing efficiency is often a goal of quality improve-ment activities, since the developers of QI methods have

traditionally considered efficiency an appropriate QI con-cern, and activities involving changes designed to producethe same quality of care with fewer resources constitute animportant QI category.8

Although systematic empirical information on thequality of care is limitedwhich is itself surprising, giventhe size and importance of the health care sectorwhat isavailable is disturbing. In a comprehensive review of theliterature on quality of care from 1987 to 1998, Schusterand colleagues found substantial evidence of overuse, un-deruse, and misuse of care in the United States. Serious

quality problems were seen in preventive, acute, andchronic care, in the care provided in different kinds ofhealth care facilities, in care paid for by different kinds of

health insurance, in the care received by different agegroups, and in rural and urban settings.9 The studies theyreviewed document unnecessary surgery; inappropriateuse of medications; failure to perform standard screeningtests; inadequately controlled asthma, diabetes, and hyper-tension; and significant departures from recommendedlevels of care for patients with cardiovascular disease. Amore recent study examined the care received by a largesample of adults in twelve cities and documented a varietyof quality problems, finding that overall, participants re-


I. The Place of Quality Improvement in Health Care

Qualityis defined in the Institute of Medicine re-port, Crossing the Quality Chasm, as the degree to

which health services for individuals and populationsincrease the likelihood of desired health outcomes andare consistent with current professional knowledge.1

The report describes the following characteristics ofquality:

Safety: avoiding injuries to patients from the carethat is intended to help them

Effectiveness: providing services based on scientificknowledge to all who could benefit, and refrainingfrom providing services to those not likely to benefit(avoiding underuse and overuse, respectively)

Patient-centeredness:providing care that is respect-ful of and responsive to individual patient preferences,needs, and values, and ensuring that patient valuesguide all clinical decisions

Timeliness: reducing waits and sometimes harmfuldelays for both those who receive and those who give

care

Equity: providing care that does not vary in qualitybecause of personal characteristics such as gender, eth-nicity, geographic location, and socioeconomic status

Efficiency: avoiding waste, including waste ofequipment, supplies, ideas, and energy

1. Institute of Medicine, Crossing the Quality Chasm (Wash-ington, D.C.: National Academy Press, 2001).

3. Quality Framework


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ceived only a little over half of recommended care.10 Thereis also ample evidence of equity problems: the quality ofcare varies in ways systematically correlated with ethnicity,geographic location, and socioeconomic status.11

To help remedy the lack of information and make iteasier to monitor quality over time, the IOM and AHRQhave developed a comprehensive set of quality measures,

and in 2003, AHRQ published the first in a projected se-ries of periodic national quality reports. The report pro-vided a baseline of quality information, including evi-dence on the tremendous variation in quality of careacross geographic areas and across individual care set-tings.12 The 2004 and 2005 National Healthcare QualityReportsfound improvement in some measures, but deteri-oration on others, and concluded that the gap between thebest possible care and actual care remained large.13AHRQalso publishes a companion series, the annual NationalHealthcare Disparities Report. The 2003, 2004, and 2005reports provided baseline and follow-up information onthe pervasive racial, ethnic, and socioeconomic disparities

in health care access and quality in the United States.14 Fi-nally, for an international comparison, in a recent survey,one-third of patients with health problems in the UnitedStates reported experiencing medical, medication, or testerrors, the highest rate for the six countries included in thesurvey (the others were Australia, Canada, Germany, NewZealand, and the United Kingdom).15

The more we learn about current quality, the clearer itis that safe, effective, patient-centered, timely, equitable,and efficient health care will not happen automatically.Rather, it requires and will continue to require systematicand self-conscious management of health care delivery ex-

pressly directed at improving care. This means not onlythe implementation of specific changes, but also the trans-formation of the culture of health care delivery into a cul-ture that is committed to continuous quality improve-ment.

QI Activities: Part of Normal Health CareOperations

Efforts to improve quality take place in a health care en-vironment that is continually experiencing change.Some of this change occurs in response to fluctuations inmarket conditions as, for example, the age distribution of

the population evolves, new diseases emerge, or careers inhealth care are considered more or less attractive. Some ofthe change occurs in response to scientific progress as, forexample, a known disease is better understood, a new drugis developed, or new diagnostic technology becomes avail-able. Managing this constant change is a core responsibil-ity of the people and the organizations that make up thehealth care system. The specific patterns and processes ofcare in one clinical setting are the product of thousands ofsmall and large decisions about handling change that

could have been made somewhat differently in that set-ting, and that have been made differently in other settings.

Within this universe of change-related activity is a sub-set ofdeliberate efforts to make positive changes in the deliv-ery of clinical care. Many of these designed changes comeabout by just doing it; someone decides that a change inclinical practice or organizational arrangements seems like

a good idea and the change is made. Such innovation andadaptation is an intrinsic part of clinical and managerialpractice. Health care practitioners must tailor a generalstandard of practice to individual patients, relying on theirclinical knowledge, their unique knowledge of each pa-tient, and the characteristics and capabilities of the localcontext in which care is being delivered. Managers mustexercise judgment about how resources in a particular set-ting should be organized to carry out treatment plans forthe patients being served.

When this innovation and adaptation is undertaken ina systematic, data-guided way, it becomes what we are call-ing QI. The category of QI includes a wide variety of ac-

tivities and cannot be defined by any one method or pro-cedure.

QI is closely related to clinical practice, and in fact,much of QI is simply good clinical care combined withsystematic, experiential learning. Individual practitionersare constantly learning by doing and taking steps to im-prove their own practice. Physicians may develop personaltemplates for entering information in medical records andfor tracking the lab tests they have ordered; surgeons may

work on their surgical techniques to reduce the time pa-tients spend anesthetized; nurses may refine their skin caremethods to reduce the incidence of bedsores.

Very quickly, however, the effort of an individual clini-cian to improve his or her practice becomes an issue forothers working in the same environment. In health carefacilities today, most clinical care is delivered to patientson a team basis, and the ability of the team to deliver goodcare depends on the characteristics of the administrativeinfrastructure and procedures that are in place. In other

words, both patients and providers are part ofsystemsofcare. A key insight of those promoting QI methods is thatquality and safety are largely systems issues, and under-standing the interdependencies and relationships withinsystems is at the heart of QI work.16 In systems, manage-ment practices may be as significant to good outcomes as

the clinical practices of individual care providers, so learn-ing by doing in management is also important. Many QIactivities involve clinicians cooperating with each otherand with management and support staff around improve-ments in scheduling procedures, encounter forms, med-ication handling, patient flow within and across clinicaldepartments, communication within patient care teams,record-keeping, and other administrative procedures.

QI methods include a variety of tools for motivatingand structuring the cooperation, changing the process orsystem, monitoring what happens, and evaluating the



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change. In addition to local learning by doing, QI in-volves deliberate applications in local settings of newknowledge developed elsewhere. The goal of many QI ac-tivities is to introduce a new clinical practice based on anadvance in medical science or a new administrative prac-tice based on managerial experience or social science re-search. Moreover, QI activities often use the science of or-

ganizational change to design strategies for changing be-havior in the local settingfor example, to get adherenceto a new practice guideline or a new patient safety proto-col.

In sum, QI is a particular form of the clinical and man-agerial innovation and adaptation that has always been anintegral part of health care operations. To the process ofchange, it adds systematic, self-reflective design, monitor-ing, data analysis, and assessment of the effects of changesto ensure that they are in fact beneficial, and it feeds thisinformation back into the delivery setting. It uses newknowledge developed in the medical and social sciences tohelp identify positive changes and design practical strate-

gies to implement them in the local setting. In the process,the QI practitioner implicitly or explicitly uses each at-tempt to improve care to deepen his or her understandingof the content and process of bringing about positivechange in that setting. Ideally, over time, the successful useof QI methods helps to transform the culture of an orga-nization into one in which everyone is committed to con-tinuous quality improvement and has the skills to partici-pate in it. Thus, QI has the potential to make a substantialcontribution to solving the quality problems in Americanhealth care.

The Ethics of Improving Health Care Quality

Before we can discuss the ethical issues that arise whenQI methods are used in health care, we must addressthe underlying question of who is responsible for improv-ing the quality of care. Health care is of unusual conse-quence because of the role it plays in relieving suffering,preventing premature death, restoring function, increasingopportunity, providing vital information about an individ-uals condition, and giving evidence of a communitys mu-tual empathy and compassion. As a result, health care ac-cess, quality, and cost have always been matters of societalethical concern.17

Since antiquity and across different cultures, healershave been revered as persons with special knowledge of themysteries of life and death, and the relationship betweenpatient and physician has held deep moral and religioussignificance. Physicians, nurses, and other health profes-sionals have been understood to have a special ethical re-sponsibility to serve the interests of their patients, includ-ing the responsibility to maintain and continually strive toimprove the quality of the care they provide.

Over time, the concept of medicine as a profession hastaken hold and science has replaced religion as the basis of

medicine. With scientific progress has come better under-standing of bodily processes and more effective treatmentsfor illness. As these treatments have been embodied in newtechnology, the provision of health care has become amore complex process, involving an array of organizationsand specialized professionals working together in complexsystems of care.

Nevertheless, even as medical practice has changed, themoral and ethical aspects of medicine have remained cen-tral to the understanding of what it means to be a memberof a health profession.18 Since health outcomes are inher-ently uncertain and vary under different treatment op-tions, health care decisions are complicated. Patients findit difficult to understand their choices, especially whenuncertainty and the risk of adverse events are involved,and they must rely on physicians and other health careproviders for help. Given the importance of health to well-being, patients are vulnerable to exploitation in this de-pendent role.

Therefore, society continues to expect physicians to ac-

cept a special ethical responsibility to serve each patientsinterest. As other health professionals and health care or-

ganizations have played increasingly important roles incare delivery, analogous ethical responsibilities to serve thepatients interest have been recognized for them.19

The understanding of these ethical responsibilities hassharpened as health care has evolved from a simple pa-tient-physician interaction to todays complex interactionsbetween patients and caregiving teams and organizations.It is more evident now than in years past that the ethicalimperative to serve the patients interests does not meanignoring the interests of every patient except the one pre-sent at the moment. Since health care organizations servegroups of patients, clearly they must manage the process

of care with policies and procedures that balance the needsof all the patients they serve. Characterizing this as wetreat populations now, not patients or the patients inter-est must now be subordinated to the populations interestis misleading, however. Physicians have always had multi-ple patients in their practices, and hospital-based nurseshave always managed care for multiple patients simultane-ously. They have thus had to consider the interests of alltheir patients in allocating personal resources of time andenergy to their practices. Moreover, it is in an individualpatients interest to have health care providers follow or-


Improvements in the quality of health care

will not happen automatically. Systematic and

self-conscious management of health care

delivery is needed.


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derly processes that function well for people in differentsituations. After all, one could be in one of those situa-tions oneself sometime.

It is abundantly clear, therefore, that health profession-als and health care organizations have an ethical responsi-bility to serve the interests of patients, and patients cer-tainly have an interest in the quality of health care. But

what is the nature of this interest? What level of quality dopatients want? What level are they entitled to? In the caseof an ordinary commodity, these questions would usuallybe answered through a market process. Buyer preferencesand budgets would interact with seller production costs toproduce the products that buyers wanted and could af-fordand there would probably be an array of qualitylevels.

But given health cares complexity, people cannot easi-ly make informed assessments of quality and develop sen-sible and stable preferences for their health care. More-over, even if they could, they would have difficulty gettingthem implemented, because often they are not paying di-

rectly for their care. Since future health status is uncertain,people need insurance to make sure they will be able to af-ford the care they want if they get sick. In addition, likemost societies, the United States recognizes a societal eth-ical obligation to provide at least some basic health care

without regard to ability to pay.20 Third-party paymentadds a social dimension to decision-making. When re-sources are pooled, whether through private insurance orthrough publicly funded social insurance, collective deci-sions must be made about how the pooled resourcesshould be spent. These decisions play a key role in deter-mining both the quality and the quantity of care to which

patients are entitled. Within the framework of these collective decisions,health professionals and health care managers have an eth-ical responsibility to meet socially determined quality ex-pectations, which may take the form of a threshold ofminimally acceptable care with a range of permissiblequality variation above it. They have an ethical (and oftena legal) responsibility to cooperate in activities to improvethe performance of the teams and the organizations theybelong to in order to meet those expectations. They alsohave an ethical responsibility to cooperate in societal ef-forts to improve the overall health care system to accord

with those expectations. These obligations follow directly

from their underlying professional responsibility to servethe interests of patients.

The responsibility to improve has been stated in termsof meeting current expectations. That is, it is a responsi-bility to reach at least a threshold standard of quality.

What makes it a responsibility for ongoingimprovement isthe understanding that the societal expectation is one ofcontinuous progress in medicineprogress that producesits benefits when it is incorporated into medical practice.

As part of the system of care, patients also have a re-sponsibility to participate in quality improvement.21 To

meet the quality expectations of patients, health care pro-fessionals and managers must have the cooperation of thepatients themselves, because modern health care deliveryis a collective enterprise. Providing safe, effective, patient-centered, timely, efficient, equitable, and up-to-date careis a health care organizations mission.22 QI methods allowthe organization to pursue its mission in a systematic,

data-guided way. To be effective, these methods require atleast a minimum level of cooperation from patients, suchas permission for the collection and use of data on theirhealth conditions, treatments received, and outcomes. Inother words, ongoing activities to maintain and improvethe quality of care, including activities using QI methods,are an integral part of the normal operations of the orga-nization. This means that someone seeking care from ahealth care organization cannot insist on the freedom toopt out completely from efforts to improve the quality ofcare in that organization without jeopardizing the verybenefits he or she seeks. In fact, it is in the best interest ofpatients to cooperate with QI activities and even to seek

out the health care organizations that are the most com-mitted to QI.

As an ethical matter, the responsibility of patients tocooperate in QI activities is justified by the benefits eachpatient receives because of the cooperation of the others inthe collective enterprise. To reap the benefits of such a sys-tem without participating in itto be a free-rider

would be unfair.23A patients responsibility to cooperateis, of course, subject to a standard of reasonableness,

which presumes that adequate protections against individ-ual harm and violation of rights are in place. For example,patients can reasonably expect to have the confidentiality

of their personal health information protected, and tohave the opportunity to choose whether to participate ina QI activity that exposes them to more than minimal riskcompared to routine medical care. We will address the na-ture of these protections and what constitutes minimaladditional risk over and above that found in routine med-ical care in greater detail later in this report.

In sum, health professionals, health care organizations,and patients have an ethical responsibility to cooperate inmaintaining and improving the quality of health care. Inits traditional role of protector of the health and safety ofits citizens, government also has ethical responsibilities

with respect to the quality of care. In particular, it should

help to clarify the content of the ethical and legal respon-sibilities of health care professionals and organizations to-

ward their patients and to ensure that the responsibilitiesare met.


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A

lthough QI is closely related to clinical and man-agerial practice, it also has much in common withresearch. QI uses the kind of reasoning that is in-

herent in the scientific method, it involves systematic in-vestigations of working hypotheses about how a processmight be improved, and it frequently employs qualitativeand quantitative methods and analytic tools that are alsoused in research projects. It is these similarities between QIactivities and research projects that have touched off thedebate about whether QI activities should be subject tothe DHHS regulations on human subjects research.

How does QI differ from research? The definition ofresearch in the DHHS regulations highlights the knowl-edge-seeking aspect of research as the element that sepa-rates it from other activities: Research means a systemat-ic investigation, including research development, testing

and evaluation, designed to develop or contribute to general-izable knowledge.24 In this definition, research is designedto develop new knowledge, not to implement knowledge;implementation happens later and separately, if it happensat all. Dissemination of research results, such as throughpublication in scientific journals, is thus of fundamentalimportance. Allowing research subjects to assume the bur-dens and risks of research is justified by the expectation ofsocietal benefits from the new knowledge produced; pub-lication is an important step in conveying the new knowl-edge to those who can put it into practice and thereby cre-ate the social benefits.

Although the definition does not make it explicit, theregulations implicitly reflect a view of research as a knowl-edge-seeking enterprise that is independent of routine medicalcare. Opinions differ on whether a society has an obliga-tion to engage in research, including research that will ul-timately yield important benefits to human health. Buteven if such an obligation exists, there is a presumption inresearch ethics that the research enterprise should rely onvolunteers.25 Investigators choose to do research, and peo-ple should be able to choose whether to be research sub-

jects. This ethical paradigm emerged in response to re-search that imposed substantial risks on subjects yet of-fered them no prospect of direct benefit (such as the Nazi

experiments and the U.S. Public Health Service Study ofUntreated Syphilis, commonly known as the Tuskegeesyphilis study), and it builds on the observation that theinterests of researchers are inherently tangential to, andpossibly even at odds with, the interests of the subjects.Since researchers want to produce successful research, theyhave a strong interest in enrolling subjects in their studies,keeping them in, and getting them to conform to studyrules. People who do not know themselves to be involvedin research, or who do not have the opportunity to discernthe merits of their own involvement, are at risk of being

exploited in the scientists search for insightor morepragmatically, the search for funding, publication, and ca-reer advancement. To counter these pressures to use peo-

ple wrongly to further the ends of other people and justi-fy the research, the subjects decision to participate in theresearch must be voluntary and fully informed.

In health-related research, the independent nature ofthe enterprise is obvious when the research takes placeaway from a health care delivery setting and the humansubjects are healthy. When the research takes place in aclinical setting and involves sick patients who are receivingcare, research and therapy may be mixed, complicatingmatters significantly. Nevertheless, even research on an in-tervention that holds out the prospect of direct benefit tothe subjects is seen to have a different relationship to itssetting when compared to QI. Research with human sub-

jects in a clinical setting is usually conceived, funded, and

managed as discrete projects, each led by a principal inves-tigator who is responsible for the projects design and con-duct. For research in a clinical setting, the resources oftencome from outside the organization in which it is carriedout (from a federal agency, private foundation, or biotechor pharmaceutical corporation, for example); or, if frominside, from a separate research budget, not from clinicalcare resources. Most important, there is significant uncer-tainty about whether the intervention is in fact beneficial,and the activity is designed to produce generalizableknowledge about the intervention, not immediately im-proved care. This usually means that research has a proto-

col that is constructed to minimize the effect of specificlocal variables and is maintained unchanged during theperiod of the research. It also means that there is relativelylittle urgency to disseminate the results, and the resultsmay not be made known to the scientific community formany months, even years, after the research is begun. Fi-nally, there is no presumption that the results will be in-corporated into the local care delivery process, and fre-quently little or no attention is paid to the challenges andopportunities for implementation of the findings in anysetting at all.

II. QI and Research: Similarities and Differences

QI is an ongoing process undertaken as a

consequence of health care providers

responsibility to serve their patients

interests. This makes it very different

from research.


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In contrast, QI is an integral part of the ongoing man-agement of the system for delivering clinical care, not an in-dependent, knowledge-seeking enterprise. QI practition-ers design QI activities to bring about immediate im-provements in care, relying on theory and evidence fromresearch and practical experience to identify changes thatare very likely to be beneficial. QI activities take place in aparticular localized health care setting, their design is ex-pected to incorporate the specific features of the setting,they are led by people who work in that setting, and theyincorporate rapid feedback of results to bring about posi-tive change for the patients in that setting. Instead of a

fixed protocol implemented for a time period that maylast for years, QI methods often require repeated modifi-cations in the initial protocol as experience accumulatesover time and as the desired changes engage the localstructures, processes, patterns, habits, and traditions. Theterm continuous quality improvement (CQI), used al-most interchangeably with the term QI, highlights thefact that QI is not so much the implementation of dis-crete projects as it is an ongoing process of continual, self-conscious change, undertaken as a natural consequence ofhealth care providers ethical responsibility to serve the in-terests of their patients. This makes it a very different kindof endeavor from research and generates the prima facie

case for questioning whether the publics interests wouldbe best advanced by subjecting QI to exactly the sameprocess of review and evaluation that has been designedfor discrete research projects.

QI and research are thus both conceptually and practi-cally distinct and play different roles in health care. Nev-ertheless, in the process of making change, QI does yieldinformation about what works and the way in whichchange can come about. When the results of QI activitiesin various settings are looked at together, patterns mayemergeand even a single QI endeavor may yield valu-

able insights for a QI practitioner in another setting.Moreover, QI activities that have theory-based designs in-evitably become examples that in the long run tend to in-crease or decrease the level of confidence in the theorieson which they are based. With careful, systematic report-ing, the insights from QI are of use to people in other set-tings, just as case reports on individual patients are useful(although they too are not research). Given this, QI prac-titioners should be encouraged to share informationabout their QI activities with others in the health care sys-tem.

Furthermore, although QI and research are conceptu-

ally distinct, in practice they are sometimes combined inone activity. In other words, some systematic, data-guidedactivities designed to bring about immediate local changeare also investigations designed to develop or contributeto generalizable knowledge; they are both QI and re-search.

At this point, a diagram is useful to illustrate the rela-tionships among the activities under discussion. In Figure1, the set Clinical and Managerial Innovation and Adap-tation is shown as a large oval and consists of activitiesdesigned to bring about immediate local improvements inclinical and managerial practice. The set QI is shown asa subset of that oval; it consists of clinical and managerial

innovation and adaptation activities that are designed andcarried out in a systematic, data-guided way.

Research is the large circle and consists of systematicinvestigations designed to develop or contribute to gener-alizable knowledge. The Research set includes basic andapplied medical research, of course. It also includes othercategories of research with a potential impact on healthcare quality, such as epidemiological research, health ser-vices research, management research, and educational re-search. The activities that are both QI and research are

Research QI Clinical &

Managerial

Innovation &

AdaptationResearchon QI QI/

Researchon QI

QI/Research

Figure 1.

Note: The figures are not drawn to scale.


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shown in the diagram as QI/Researchthe overlappingsection of the QI set and the Research set.

One important research category, Research on QI, isexplicitly depicted in Figure 1. It consists of systematic in-vestigations designed to produce generalizable knowledgerelevant to the design and implementation of QI activities.The application of evidence-based medicine requires the

generation of new knowledge on the behavior of systems,and research on QI contributes to this knowledge by help-ing to answer questions such as What are the principlesof change? How do these principles work within differ-ent organizational contexts? and How can one spreaddesired change across an organization or between organi-zations?

Research on QI can be independent of the QI activitiesit studies. For example, an investigator could do a retro-spective study of QI activities carried out in different or-ganizations with the aim of testing a hypothesis about theeffects of organizational characteristics on results. Alterna-tively, QI and research on QI can be combined in a single

activity designed to produce both immediate local changeand generalizable knowledge about the process of change.For example, a health care organization with multiple de-livery sites could conduct an activity in which the sites aredivided into two groups, a different strategy is used ineach group to introduce a new practice, and the results ofthe strategies are compared, with elements included in theactivitys design to facilitate generalization of the results toother organizations. In Figure 1, the set of such hybrid ac-tivities is the region of overlap between the sets Researchon QI and QI, and is labeled QI/Research on QI.26

Protection of Human Participants in QI andResearch

Both research and QI can adversely affect the peoplewho participate in them. Todays human research subject protection system was inspired by research projectsthat offered subjects no direct benefit and exposed them tosubstantial harm. In QI, however, the changes made in theprocess of delivering care are expected to be improve-ments, and given the serious quality and safety problemsin health care, patients are often at greater risk if a currentpractice is allowed to continue than they are if a QI activ-ity goes forward. Nevertheless, any change may have un-

expected negative consequences, and even the data collec-tion and monitoring that makes the change a QI activitymay itself impose burdens on the QI participants.

Burdens can take the form of direct physical harms,mental and psychological harms, hassle harms such astime consumed in completing surveys or submitting toextra clinical or administrative procedures, or harms relat-ed to loss of privacy and confidentiality. Often, there isuncertainty about whether a harm will occur and how se-vere it will be if it does occur. In the rest of this report, we

will use the broad term risk to refer to the various kinds

of burdens that may fall on participants as a result of a QIactivity.

Researchers have a recognized ethical responsibility toensure that the human subjects of their research are ap-propriately protected. The people using QI methods tomanage the quality of care also have an ethical responsibil-ity to participants in their QI activities. The need to meet

ethical standards creates a potential need for explicit struc-tures and oversight to ensure that research and QI arepracticed appropriately. It does not necessarily follow,however, that the standards and oversight should take thesame form for both activities.

To address this issue, we must first consider the gener-al principles and values that are at stake. We begin withthe principles of research ethics that form the foundationfor the current system for protecting human research sub-

jects. The discussion is organized around seven ethical re-quirements: social or scientific value, scientific validity, fairsubject selection, favorable risk/benefit ratio, respect forpotential and enrolled subjects, informed consent, and in-

dependent review.27We discuss the justifications given foreach requirement in the context of research and then ask

whether the same reasoning applies to QI work. (The re-sults of the latter portion of this analysis are summarizedin Box 5 near the end of this section.)

Social or scientific value: Is the research worth doing? Do thepotential gains from doing it justify the resources spent and therisks imposed?28

To be ethical, research must be worth doing, becausethere is an ethical obligation to use scarce resources re-sponsibly. Also, it would be wrong to expose human sub-

jects to risk without social or scientific benefit. This meansthat researchers have an ethical obligation to share theknowledge gained from research with others, throughpublication in peer-reviewed journals or by other means,so that the benefit can actually be achieved.

Obviously, QI should also be worth doing for the samereasons. The potential gains must justify the resourcesspent on the activity and any risks imposed. The primarygains from QI are the benefits from the local improve-ments that result. Broader social benefits are also possible

when reports of QI activities in different settings generateinsights about the nature and process of improvement. Toachieve the social benefits, those who conduct QI activi-

ties should be willing to share information about themwith others in the health care system.

This requirement is thus the same for QI and research.Its application is different, howeverand in some waysmore difficultin the QI context. To establish the worthof a research project, one must assess the net benefit to so-ciety from the knowledge it might produce. Usually, thisamounts to ensuring that the research question is appro-priate and the research design adequate. To establish the

worth of a QI activity, one must assess the expected net ef-fects of the proposed process of change on present and fu-


14/40


ture patients in the local setting, as well as any social ben-efits that may result from sharing the insights gained.Forming an estimate of the impact of the local change canbe a complex professional and management task that re-quires a detailed understanding of the local system of caredelivery.

One must also assess the potential risks to those who

participate in the QI activity itself. The chief difficultyhere lies in the identification of the appropriate baselinefrom which to measure the risks to participants attribut-able to the QI activity. In a freestanding research project, aperson is either getting an intervention or not, and thebaseline for measuring harm and risk is ordinary life withno intervention. In a clinical treatment research project,the fact that the subject would be receiving clinical care inany case complicates the assessment, but typically, the re-search has a control group receiving a carefully specifiedstandard treatment that is the appropriate baseline from

which to measure the risks to subjects receiving the un-proven treatment.

In the QI context, the risks related to extra visits, ques-tionnaires, or procedures needed for data collection andmonitoring can be distinguished and attributed to the QIactivity. Although these burdens are usually small, theyshould be weighed in deciding on the merits of proceed-ing. But how should one assess the net risks to the partic-ipant associated with the proposed change itself? Here it isimportant to note that the care delivery process to which apatient is entitled is not specified in all its details; in fact,it is always changing. Even in a single clinical setting, theattributes of the care patients receive can vary from day today, depending on the availability of staff, the number of

patients scheduled, and other factors. Managers and clini-cians have the professional discretion to make changes incare within certain (fuzzy) limits related to the range ofvariation in existing health care delivery. Over time, theyare actuallyrequiredto make changes in order to remain incompliance with evolving minimum standards of care andto avoid malpractice liability. For many of the changes in-troduced through QI methods, the difference for patientsbetween being in or out of the QI activity may be nogreater than the existing variation in the patterns of careacross organizations, or within the same organization.Moreover, the methods of QI guide practitioners to usetheory, evidence, and practical experience systematically in

order to identify and implement changes that are verylikely to be beneficial. We are not suggesting that it is im-possible to recognize that a specific change has the poten-tial to cause significant harm. Rather, we are noting thatpatients cannot expect that services will only be presentedin one way, or that those services can be specified fully inadvance. This fact is relevant in the assessment of the riskattributable to inclusion in a QI activity.

A related issue arises for staff members, the other majorgroup of human participants in QI activities. For them,the appropriate baseline for measuring QI effects is the

risks in the usual work situation. For example, in the un-likely event that a QI activity exposes workers to extra ra-diation or toxic chemicals, or invades privacy by collectinginformation employers are not normally entitled to have(as might happen with surveys of the use of alcohol, ciga-rettes, or illegal drugs outside the workplace), the potentialeffects on workers should be included in the assessment of

QI-associated risk. On the other hand, one should not in-clude the harm to a workers economic security that mightresult if a QI activity reveals that the worker is incompe-tent or the organization can provide quality care withfewer workers. A health care employer has a moral andlegal rightand responsibilityto ensure that employeesare competent and conscientious, and the operations ofthe organization are efficient. The collection of informa-tion on individual and system performance is a feature ofnormal working conditions, and the risk that it will pro-duce information that leads to adverse job actions is partof the baseline job risk.

Scientific validity: Is the research methodologically soundfor example, is it properly structured to achieve its goals?

This requirement is also justified by the scarcity of re-sources and the need to avoid exposing subjects to possibleharm without benefit, and it also applies to both researchand QI. The interpretation of scientific validity andmethodologically sound must be adjusted to QI, howev-er. Since the primary goal of QI is local improvement, QIsmethods and the local knowledge they generate can bequite different from the methods designed to enhance theopportunity to gain generalizable knowledge through re-search.29 QI methods should be chosen on the basis of

knowledge of the context, the requirements for connect-ing evidence to the context, and the requirements of actu-ally making something happen in the local setting whilebalancing the importance of the improvement sought andthe clarity needed in the assessment of changes against thepractical costs of monitoring the effects. A randomizedcontrolled trial seeks to eliminate contextkey to QIasa variable and thus would usually be inappropriate for thekinds of questions and changes that QI addresses, whilechanges that are already known to be worth their costs andreadily implemented should in general simply go for-

ward.30

Fair subject selection: Are the subjects of the research selectedso that vulnerable individuals are not targeted to bear therisks of the projects while the rich and socially powerful are fa-vored for receiving the benefits?

In the selection of research subjects, there should besimilar treatment of equals, and both the burdens andbenefits of the research should be distributed in a fairmanner. But, to quote Emanuel and colleagues: Thisdoes not mean that individual subjects and members ofgroups from which they are selected must directly benefitfrom each clinical research project or that people who are


15/40


marginalized, stigmatized, powerless, or poor should neverbe included.31

This requirement applies to both research and QI. Fairsubject selection is particularly relevant to organizationsconducting entire programs of QI activities. The choice ofobjective and the design of the activity will sometimeshave implications for the fairness of the distribution of

benefits and risks across patients. For example, the distrib-ution of benefits and risks may be affected by choosing todo QI projects on treatment of heart disease rather thantreatment of diabetes or asthma, or introducing improve-ments in some parts of an organization and using theother parts as comparison groups. Such distributional ef-fects should be considered in evaluating the ethical accept-ability of QI. In particular, people who are currently dis-advantaged in the health care system should not have tobear a disproportionate share of the burden of improvingthe system, and in fact should be given priority in the dis-tribution of the benefits of QI activities.

Favorable risk-benefit ratio: Is the research designed to mini-mize the risks and maximize the potential benefits? Are therisks to an individual human subject proportionate to thebenefits to the subject and to society?

This requirement applies to both research and QI. Itrelates to the requirement of social or scientific value, butfocuses directly on the participants situation, rather thanthe activitys overall net benefit. An affirmative effortshould be made to design both research and QI activitiesto minimize the risks and maximize the benefits to theparticipants and society. For example, an activity may havea risk/benefit relationship within an acceptable range, but

if the relationship could be improved with minimaleffort/cost, both researchers and QI practitioners are ethi-cally obliged to do so.

Respect for potential and enrolled subjects: Is respect for sub-jects demonstrated by the following actions?

protecting the privacy of individuals and maintainingthe confidentiality of private information

maintaining the welfare of the subjects

informing subjects of newly discovered risks or bene-fits associated with participation

permitting withdrawal

informing subjects of the results

The first three of these requirements apply to both re-search and QI. Protecting privacy and maintaining confi-dentiality is important in QI, as is maintaining the welfareof the participants and informing them of newly discov-ered risks or benefits associated with their participation.

The other two requirements do not apply to QI as stat-ed. The next section on informed consent explains whypermitting withdrawal from QI activities does not alwaysapply. It also argues that QI participants should receivegeneral information about QI efforts and should be ableto learn more about specific projects if they are interested,but a QI practitioner is not required to provide informa-

tion automatically about a QI activitys existence or resultsto the participants.

Informed consent: Do the subjects receive information aboutthe purpose of the research, its procedures, potential risk, ben-efits, and alternatives, so that each subject understands the in-formation and can make a voluntary decision whether to en-roll and continue to participate?

This requirement differs for QI and research. In princi-ple, research participation is optional for all parties,32 but

we have argued that this is not so for QI. Continuousquality improvement is part of the mission of health care

professionals and health care managers. They owe it to

their patients to be constantly trying to improve theirpractice; QI is an important tool for doing this; and there-fore, participating in QI is not completely optional forthem. Since quality improvement is a critical ingredient inthe creation of the benefits a patient seeks from healthcare, QI is not completely optional for patients, either.

In practical terms, this means that specific informedconsent is not required every time a human participant isincluded in a QI activity. Because QI is an essential part ofnormal health care operations, it is necessaryand ethi-cally acceptableto have consent to receive health care in-clude consent to a reasonable level of cooperation with theongoing QI activities of the organization providing the

care. Through public education, people should already beaware of this before they seek care. When they presentthemselves for care, they should be reminded of the back-ground expectation and informed in general terms aboutthe QI that occurs in the particular setting and how theycan obtain more information about individual projects.33

By a reasonable level of cooperation, we mean thatpatients may be included without their specific consent inQI activities that involve no more than minimal addition-al risks to them compared with the normal risks associated

with receiving standard medical care. If a QI activity is as-

Because QI is an essential part of normal

health care, it is necessaryand

acceptableto have consent to receive

health care include consent to a reasonable

level of cooperation with QI activities.


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sociated with more than minimal additional risk, patientsmust be asked for their specific informed consent beforeinclusion, and they are free to refuse it. In the latter case,patients must receive full information about the activityand the risks to them personally when they are asked toparticipate, just as for any clinical consent. If later on they

would like information about the activitys results, they

should be able to obtain it.34Organizations should not be required to distribute de-

tailed information proactively about the results of individ-ual QI activities. Most people would find the detail super-fluous, and the effort would waste their own resourcessince they ultimately pay the bill for the health care sys-tem. QI practitioners and the organization as a wholeshould, however, willingly provide information to anyone

who asks about any QI activity, to the extent possiblewhile respecting patients and providers right to privacy.

The most common examples of QI activities that donot require consent are those activities that use routinepersonal health information to implement a change in the

care process and impose no additional risk on participantsbeyond that associated with the information use. For ex-ample, a group practice might decide to modify schedul-ing practices to reduce the time patients spend waiting tosee their physicians when they come for an appointment.The QI team might begin by reviewing patient visitrecords to develop data on the types of visits, the averagetime needed for each type, the pattern of visit types over atypical month, and so on, and then use the data to devel-op new scheduling practices, implement them, monitorthe effect on waiting time, and refine them until the de-sired result is achieved. If confidentiality is appropriately

protected, then using patient information for QI activities without specific consent is ethically acceptable on thesame grounds that its use is acceptable in other normalhealth care operations. Since QI is part of the care process,the people doing QI have the same status as others in thecare process. Often this is literally true, since QI teams areoften made up of the people who provide direct care; how-ever, the rationale is the same when access to protectedhealth information is granted to someone more removed,such as an epidemiologist abstracting information frommedical records for statistical analysis.

The Privacy Rule of the Health Insurance Portabilityand Accountability Act (HIPAA) has established standards

for the protection of the confidentiality of personal healthinformation in normal health care operations, and has in-cluded QI (but not research) within that category.35 Con-sent to the use of protected health information for QI ac-tivities is provided as one item in the list of routine usesthe patient agrees to as a condition of treatment. Accord-ing to HIPAA standards, a QI practitioners access to pro-tected health information is limited to the informationneeded for the activity, persons engaged in QI have thesame confidentiality obligations as other health care work-ers, and the same precautions must be in place for the use

of protected health information in both clinical care andQI. (See Box 4.)

When the human participants in a QI activity are staff,consent requirements play out a little differently. Healthprofessionals, management, and other workers have a gen-eral ethical obligation to cooperate to improve the qualityof care, and a specific contractual obligation to cooperate

with their organizations QI program (since it is part ofnormal health care operations). The obligation is not un-limited, however. Specific consent is required when the QIrepresents more than minimal risk to the worker, as mea-sured from the baseline of normal working conditions.Therefore, consent would be required for a QI activitythat exposed workers to more than minimal additionalrisk of physical or mental harm compared to their current

working conditions (exposure to radiation or toxic chemi-cals, for instance) or collected information about workersthat was outside the category of information employers arenormally entitled to have about their employees (such astheir use of tobacco, alcohol, or illegal drugs outside of the

workplace). Consent is not required, however, for QI thatis risky to the worker simply because it might generate ev-idence of incompetence on the job or lead to a reductionin force for efficiency reasons. The formal contracts with

workers and the informal workplace expectations shouldreflect the understanding that cooperation with minimalrisk QI activities is part of the job. As with patient partic-ipants, confidentiality of personally identifiable informa-tion about workers should be appropriately protected

within the organization.Does any of this analysis change if those leading the QI

project publish or otherwise share their process and ac-

complishments with others? Do participants have to givespecific consent to the publication of QI results? QI prac-titioners should be encouraged to share QI results throughpublication and other means, since sharing yields benefitsto individual patients and to society as a whole. The peo-ple who receive care from health care organizations pay asa group for the development of this knowledge, and over alifetime, people receive care from many different organiza-tions. Although some organizations may consider QI re-sults proprietary information and wish to maintain secre-cy for competitive advantage, patients are better off ifhealth care providers cooperate by sharing QI results.

Even though most QI can be carried out ethically with-

out explicit patient consent, published results must be pre-sented in a form that preserves patient confidentiality;otherwise, the team must have the patients specific con-sent to publication. Similarly, individual worker informa-tion must be nonidentifiable or worker consent to publi-cation must be obtained, unless there are overriding con-tractual or legal rules relating to the provision of informa-tion on worker performance.

The ethical acceptability of the QI activity itself andthe ethical acceptability of the form in which the resultsare disseminated are conceptually distinct, and the deci-


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sion about whether to publish and in what form may rea-sonably be made after the results are in. Therefore, it is ac-ceptable and may be desirable to separate ethical assess-ment of the activity itself and ethical review of the form in

which the results are disseminated. Thus, organizationsmight well have different procedures for ensuring ethical

implementation of QI and ethical dissemination of thefindings.

Independent review: Is there review of the design of the re-search, its proposed subject population, and its risk-benefitratio by individuals unaffiliated with the project?

In research, the purpose of ethical review by individu-als unaffiliated with the proposed research activities is toensure that the researcher has understood the require-ments for ethical research and applied them properly indeveloping the proposed activities. Applying requirements

takes judgment calls, and conflicts of interest may distortthe researchers judgment (consciously or unconsciously),potentially causing harm to participants or taking awaytheir opportunity for voluntary consent. Review can pro-tect against such distortion and help potential researchsubjects have confidence in the honesty and integrity of

the offer to volunteer to participate. In the United States,this ethical review takes the form of review of research pro-tocols and relevant documents by the institutions IRB.

In the discussion of the first six categories of ethical re-quirements for human research subject protection, wehave concluded that QI activities with human participantsshould meet similar ethical requirements, but the require-ments must be interpreted and applied somewhat differ-ently. (See Box 5.) As with research, some considerationsmight justify review of QI activities to ensure that the re-quirements for ethical conduct of QI are met. Review

defines health information as any information,whether oral or recorded in any form or medium that:(1) is created or received by a health care provider, health

plan, public health authority, employer, life insurer,school or university, or health care clearinghouse; and (2)relates to the past, present, or future physical or mentalhealth or condition of an individual; the provision ofhealth care to an individual; or the past, present, or fu-ture payment for the provision of health care to an indi-vidual (45 CFR 160.103)

defines protected health information (PHI) as indi-vidually identifiable health information that, subject toexceptions, is (i) transmitted by electronic media; (ii)maintained in any medium described in the definition ofelectronic media; (iii) transmitted or maintained in any

other form or medium (45 CFR 164.501) extends to a defined set of covered entities that trans-mit health information electronically in connection withcertain defined HIPAA transactions (45 CFR 160.13):1

health plans health care clearinghouses health care providers nonemployee business associates of covered entities researchers who are health care providers engaging

in any of the covered electronic transactions

prohibits a covered entity from using or disclosing

PHI about an individual without the individuals specif-ic written permission (authorization) unless:

PHI will be used/disclosed for treatment, payment,and health care operations (45 CFR 164.506(c))

PHI will be disclosed to business associates provid-ed certain arrangements in place (45 CFR 164.502 (e))

the disclosure is required by law, authorized by lawfor public health purposes, or required by the FDA foradverse event reporting (45 CFR 164.512)

an institutional review board (IRB) or privacy boardwaives or alters the authorization requirement to use ordisclose PHI for research, which is possible when certainconditions are met (45 CFR 164.512(i))

a researcher satisfies certain conditions to use PHIfor review preparatory to research (45 CFR164.512(i)(1)(ii))

a researcher satisfies certain conditions for researchsolely on information of decedents (45 CFR164.512(ii))

the PHI has been deidentified in accordance withspecific Privacy Rule standards (which makes the data nolonger PHI [45 CFR 164.514(a)-(c)])

the covered entity releases the information in theform of a limited data set that includes the removal ofcertain identifiers and a data use agreement between theresearcher and the covered entity (45 CFR 164.514(e))

QI (but not research) is included in health care oper-ations and specifically exempted from the above require-ment for project-specific written permission (authoriza-tion)

1. For additional information see U.S. Department of Healthand Human Services, OCR Privacy Brief, Summary of the HIPAAPrivacy Rule, at http://www.hhs.gov/ocr/privacysummary.pdf.

4. Summary of the Privacy Rule of the

Health Insurance Portability and Accountability Act45 CFR 160 and 45 CFR 164, Subparts A and E


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might be justified, for example, if the QI might pose sub-stantial risks or waste substantial resources, and if reviewby a nonparticipant could raise those issues and stop theactivity. As QI becomes a desirable skill and care systemsinvest in QI budgets, the leaders of QI might find them-selves invested in QI work that has become unresponsiveto the real needs of patients and familiesa conflict of in-

terest that would echo that which gave rise to research re-view. Furthermore, the focus on QI is relatively new, andthe practices that support it are still in flux. Thus theboundaries between QI and research and between QI androutine treatment are not well understood. Review by anonparticipant would be useful if a project that shouldhave counted as research is not being managed as such, orif a project that offers no particular opportunity for im-provement over usual practice is being touted as QI.

Since these arguments justify some review, at least forsome projects, the question is what form it should take.Should QI also receive IRB review, or would some otherapproach to ethical oversight be more appropriate? In the

next section, we will discuss why we have concluded thatIRB review is not ethically required and would not evenbe generally beneficial or effective for QI activities.

IRB Review of QI: Why Not?

Much of the concern expressed about IRB review ofQI has focused on the time and effort associatedwith the preparation of documents for submission to anIRB and the time required for the IRB to complete its re-view.36 Researchers have been dissatisfied with these as-pects of IRB review for some time, and improving IRB ef-

ficiency is an acknowledged policy goal.37

This issue iseven more important for QI than for research, since thepeople who initiate QI are already employed in the deliv-ery of care, and the resources used for QI are part of thehealth care systems cost structure. Even with a more effi-cient IRB process, many valuable QI projects would beunable to muster the necessary resources and simply

would not be done if IRB review were required. For thoseQI activities that did go forward, the process would im-pose high transaction costs on improvements that areoften small in scale and represent little burden or risk toparticipants. This would be a poor use of scarce resourcesand would in itself be a kind of harm to the patients,

whose resources are thereby wasted.There is a more basic problem, however: the current

structure of IRB review is inappropriate for QI. To explainwhy, we will describe the process and discuss its limita-tions in the QI context.

the ethics of using qi methods to improve health care quality & safety

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