Professional Documents
Culture Documents
P
owerful forces of change are at work within the Federal agencies with responsibilities in this area have
American health care system. The public debate disagreed on where the interface between medical research
concerning health care financing and access to in- and QI lies and how it should be handled. (See Box 1 for
surance coverage is intensifying. But below the surface of a particularly dramatic example of such a conflict.) The
the media and policy debate about cost and access, a qui- strict ethical rules of oversight, regulation, and patient
eter but perhaps more significant process of change is consent for human subjects research, including the re-
under way: the transformation of health care management quirement for institutional review board (IRB) approval,
and delivery—indeed, health professional work itself— have significant implications for the feasibility and cost of
through health care quality improvement. pursuing QI activities. More specifically, the mechanism
The innovative, interdisciplinary quality improvement developed to govern ethical conduct in one important
(QI) movement has begun to significantly upgrade deliv- area—human subjects research—could have the perverse,
ery of health care in the United States. Taking its cue from if unintended, consequence of interfering directly with an
reform approaches in other industries, and driven espe- equally important ethical imperative in another area—
cially by studies indicating a shockingly widespread inci- that is, unceasing efforts by health care professionals to
dence of medical errors and a striking lack of consistency make clinical care safer and more effective. The current
in the standard of care patients receive in different facili- state of uncertainty about what is ethically and legally re-
ties and from different practitioners, the QI movement quired to safeguard participants in QI activities has al-
has arrived in health care. Using knowledge gained from ready become a disincentive to engage in QI, making it
the disciplines of medicine, nursing, health care manage- more difficult to bring about the system transformation
ment, and medical and health services research, it at- urgently needed if health care is to be made better and
tempts to mobilize people within the health care system to safer for patients.
work together in a systematic way to improve the care In 2002 The Hastings Center began a project to ad-
they provide. In this work, discipline-specific knowledge dress these issues and to investigate more generally the
is combined with experiential learning and discovery to ethical and value issues that arise in the theory and prac-
make improvements. tice of quality improvement in health care. The project, ti-
Ethical issues arise in QI because attempts to improve tled “The Ethics of Improving Health Care Quality and
the quality of care for some patients may sometimes inad- Safety,” was funded by grant #1R13HS13369 from the
vertently cause harm, or may benefit some at the expense Agency for Healthcare Research and Quality (AHRQ).
of others, or may waste scarce health care resources. Ethi- The Hastings Center project assembled a group of ex-
cal issues also arise because some activities aimed at im- perts from a number of interrelated fields and disciplines
provement have been interpreted as a form of medical re- involved in health care quality improvement, including
search in which patients are used as subjects. If this inter- medicine, nursing, law, social science, health care manage-
pretation is correct, QI would come under the same com- ment, medical editing and publishing, health policy and
plex review and regulatory requirements that have been regulation, health services research, and bioethics. The
set up to govern biomedical and other types of research. project’s goals were: (1) to develop an ethical framework
But is this type of regulation necessary, given what QI in- that can be applied to ethical issues arising in quality im-
volves? Is it the most effective and reasonable way to regu- provement practice, (2) to make practical policy recom-
late QI to ensure that it is carried out in an ethical fash- mendations for quality improvement oversight, and (3) to
ion? These are important questions, both conceptually help promote a constructive dialogue both within and
and practically. Thus far, however, relatively few attempts outside the quality improvement community on pertinent
have been made to address QI from an ethical perspective, ethical issues.
and the interface between research and quality improve- Over a two-year period, the project group met four
ment has not been adequately explored or defined. times for two-day working sessions. Project members and
SPECIAL REPORT / The Ethics of Using QI Methods to Improve Health Care Quality and Safety S3
1. The Pittsburgh ESRD Case
In October 2000, a nephrologist coauthored OHRP responded that the design of the quality
an article about a project to improve the dialysis improvement project met the definition of
care delivered to patients in Medicare’s End human subjects research and that the CMS de-
Stage Renal Disease (ESRD) program.1 Some termination that the project was exempt from
time after the article appeared, the university at IRB review “was not made in collaboration with
which he held a faculty appointment notified OHRP.” OHRP and CMS have had discussions
him that an audit of faculty publications had and exchanged memoranda as to whether this
identified this project as a quality improvement and other quality improvement activities meet
effort that met the definition of human subjects the regulatory definition of human subjects re-
research but had not undergone IRB review. The search and require IRB review; however, these is-
nephrologist responded that he had participated sues have not yet been resolved. This issue has
in the project as the chair of the local ESRD caused concern among other volunteer physi-
Network’s Medical Review Board, that the cians in the eighteen ESRD Networks about the
ESRD Network conducted the project under implications for ongoing quality improvement
contract to the Center for Medicare and Medi- projects and the possible impact if their conduct
caid Services (CMS), and that the CMS scientif- is found to violate the regulations for protecting
ic officer overseeing the project had told him human research subjects.
that, as a CMS-directed quality improvement
project, it was not subject to oversight by the 1. P.M. Palevsky et al., “Improving Compliance with
university’s IRB. Later, CMS reaffirmed this the Dialysis Prescription as a Strategy to Increase the De-
livered Dose of Hemodialysis: An ESRD Network 4
opinion in a letter to the university. The univer- Quality Improvement Project,” Advances in Renal Re-
sity submitted the dispute to the Department of placement Therapy 7, no. 4, supplement 1 (2000): S21-
Health and Human Service’s Office for Human S30.
Research Protections (OHRP) for review.
other invited guests presented and debated the contacts with persons and organizations interested
findings of their own research and drafts of com- in the ethics of QI.
missioned papers focusing on ethical issues in This report presents the analysis, findings, and
quality improvement. Those papers will be pub- conclusions that emerged from the deliberations
lished in an edited volume in 2007. In addition to of the project participants and staff research con-
our deliberations with project participants, we ducted for this project. The authors are Mary Ann
have also made presentations at professional and Baily, Melissa Bottrell, Joanne Lynn, and Bruce
academic meetings and communicated electroni- Jennings. This report is not a consensus docu-
cally with a larger group interested in health care ment in the sense that each project participant
system improvement by setting up a moderated e- agrees with it in all details, but we have done our
mail listserv. Following the publication of this re- best to present an accurate and faithful reflection
port, The Hastings Center will continue to serve of the thinking of the group as a whole, and this
as a resource in the process of translating the con- analysis certainly would not have been possible
clusions and recommendations of the project into without the benefit of their insights and expertise.
practical policies through the listserv, presenta-
tions at professional and academic meetings, pro- —Mary Ann Baily, Melissa Bottrell,
duction of additional written materials, and direct Joanne Lynn, Bruce Jennings
Q uality improvement in health care takes many meet accepted ethical standards for protection of human
forms, ranging from changes in financing to research subjects. The regulations that are relevant to this
reforms in professional education to invest- report are codified at Title 45 CFR 46 as Department of
ments in new facilities and equipment. In this Health and Human Services, Protection of Human Sub-
report, we are concerned with the form of improvement jects. The core requirements (Subpart A) are that individ-
that occurs through clinical and managerial innovations uals be selected equitably to participate in research; that
and adaptations in the delivery of care. These changes research subjects give full, voluntary written consent; and
have always been an integral part of health care delivery, that an IRB review proposed research and approve it only
but in the past they were often introduced informally and if risks to subjects have been minimized and are reason-
idiosyncratically, without careful attention to all of their able in relation to anticipated benefits.2 There are addi-
effects. In recent years, people in health care have begun tional requirements (Subparts B, C, and D) for research
to use many new formal, explicit methods, some of which that involves especially vulnerable subjects, such as preg-
were developed in other industries, to make the process of nant women, prisoners, and children. The DHHS regula-
continual adjustment more self-reflective and systematic, tions do not cover non-federally funded research, but or-
and thus increase the likelihood that it produces positive ganizations engaged in research are encouraged to provide
change. In other settings, this approach to improving formal assurances to the government that all their human
quality is often referred to as “QI.” subject research will comply with the DHHS regulations
When we use the term “QI” in this report, we mean whatever the funding source. Also, although Subpart A
systematic, data-guided activities designed to bring about explicitly exempts some categories of human subject re-
immediate, positive changes in the delivery of health care
in particular settings. While QI uses a wide variety of
methods, they all involve deliberate actions to improve Although systematic empirical information on
care, guided by data reflecting the effects. Depending on
the activity, QI can look like a type of practical problem the quality of care is limited—which is itself
solving, an evidence-based management style, or the ap-
plication of a theory-driven science of how to bring about surprising—what is available is disturbing.
system change. Introducing QI methods often means en-
couraging people in the clinical care setting to use their search from the regulations, the DHHS Office for
daily experience to identify promising ways to improve Human Research Protections (OHRP) has issued guid-
care, implement changes on a small scale, collect data on ance stating that researchers should not be allowed to de-
the effects of those changes, and assess the results. The cide on their own that their projects are exempt. Many in-
goal is to find interventions that work well, implement stitutions require determination of exempt status to be
them more broadly, and thereby improve clinical practice. made by an IRB. In practice, a substantial proportion of
Alternatively, a QI activity might begin with a review of both federally funded and nonfederally funded human
aggregate data at the patient, provider, clinical unit, or or- subject research, especially biomedical research, must be
ganizational level to identify a clinical or management submitted to an IRB. (For a brief summary of the DHHS
change that can be expected to improve care. The change regulations, see Box 2.)
is made, the effects are monitored, and conclusions are Discussion of ethical issues raised by QI has tended to
drawn about whether the change should be made perma- center around the legal question, “Is this QI project
nent. QI can also mean collecting data from multiple or- ‘human subjects research’ as defined by federal regulations
ganizations, analyzing it to understand what drives posi- and therefore subject to IRB review and the regulatory re-
tive change, and using the results to design and imple- quirements for informed consent?’’ The case outlined in
ment a strategy to achieve a specific improvement across Box 1 is but one example of many in an ongoing contro-
organizations. At its heart, QI is a form of experiential versy in the literature, in IRBs, and in organizations doing
learning and discovery.1 QI about whether QI is research and therefore covered by
QI work is data-guided, usually involves human par- the regulations.
ticipants, and sometimes uses methods that are also used Framing the issue in this way may not be the best way
in medical research. Thus, it is not surprising that the to proceed, however. The goal is to ensure that QI activi-
issue of its relationship to federal regulations governing re- ties are carried out in an ethical manner and that their
search with humans has arisen. These regulations were put human participants are treated appropriately, however the
in place to ensure that federally funded research projects activities are planned and structured and whatever the ac-
SPECIAL REPORT / The Ethics of Using QI Methods to Improve Health Care Quality and Safety S5
2. Summary of DHHS Policy for the Protection of Human Subjects (Subparts A-D)
Department of Health and Human Services policy monitoring, when appropriate; provisions are made for
sets out a complex set of provisions for the protection of subject privacy and confidentiality of data, when ap-
human research subjects. It: propriate (45 CFR 46.111)
extends to research funded by the Department of
requires IRBs to ensure that additional safeguards
Health and Human Services and to nonfederally fund-
are included in a study when participants will likely be
ed research conducted at or in conjunction with an in-
vulnerable to coercion or undue influence (45 CFR
stitution that agrees through its federal-wide assurance
46.111)
to extend the regulations to all research regardless of
funding source. Six categories of research activities are
prohibits institutional officials from approving re-
exempt from the regulations (45 CFR 46.101(b)(1)-
search that has not received IRB approval (45 CFR
(6))
46.112)
requires prior review and approval of nonexempt re-
permits IRBs to suspend or terminate research ap-
search by a duly constituted institutional review board
proval when a study is not conducted in accordance
(IRB), and continuing IRB review of ongoing research
with IRB requirements or is associated with unexpect-
(45 CFR 46.103)
ed serious harm to participants (45 CFR 46.113)
permits expedited review (conducted by IRB chair-
requires that specific information be provided to re-
person or by one or more experienced reviewers) when
search participants to satisfy the general requirements
certain criteria are met (45 CFR 46.110 and Guidance
for informed consent (45 CFR 26.116)
on the Use of Expedited Review Procedures)
permits IRBs to approve a consent procedure that
requires seven items to be satisfied for IRB approval
omits or alters some or all of the elements of informed
of research: risks to subjects are minimized; risks are
consent when certain criteria are met (45 CFR 46.116)
reasonable in relation to anticipated benefits; subjects
are selected equitably; informed consent will be ob-
requires additional protections for pregnant women,
tained from prospective subjects or their legally autho-
human fetuses and neonates (45 CFR 46.201), prison-
rized representatives; there will be written documenta-
ers (45 CFR 46.301), and children (45 CFR 46.401)
tion of informed consent; the trial will receive safety
tivities are called. Focusing on IRB review and the defini- sponsibility for improving the quality of care. We con-
tion of research may implicitly suggest that IRB review clude that engaging in quality improvement is not purely
would be adequate and that it is the only way to protect discretionary; health professionals, managers, delivery or-
QI participants. This is an overly narrow perspective. In ganizations, patients, and government all have an ethical
this report, we explore the similarities and differences be- responsibility to cooperate with one another to improve
tween research and QI, but rather than focus entirely on the quality of care. Section II compares and contrasts QI
“Is QI research?” and “IRB review, yes or no?” we step and research in terms of each activity’s goals, methods,
back to look at the bigger picture. We ask: “What is the role in the health care system, and impact on human par-
place of QI in the operation of the health care system?” ticipants. We use the principles of research ethics that un-
“What makes a QI activity ethical?” and “What institu- derlie the current system for protecting human research
tional arrangements should be in place to ensure that spe- subjects as a base from which to explore and define the re-
cific QI activities meet ethical requirements?” Only after quirements for ethical conduct of QI activities. We then
that do we return to the question of how QI activities consider the use of IRBs for ethical oversight of the con-
should relate to IRB review and other procedures for the duct of QI and conclude that, for a variety of reasons,
protection of human subjects in research. IRBs as currently constituted are not appropriate for this
purpose. Section III discusses the institutional arrange-
Organization of the Report ments that should be in place to ensure that QI activities
meet ethical requirements. Section IV addresses imple-
S ection 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 then
mentation, and Section V briefly summarizes the conclu-
sions and policy recommendations of the report.
consider the underlying ethical question of who has re-
M
any Americans have a rosy picture of the quali- quality problems were seen in preventive, acute, and
ty of their health care system. They believe that chronic care, in the care provided in different kinds of
it provides a generally high standard of care that health care facilities, in care paid for by different kinds of
is continuously updated as new research findings come health insurance, in the care received by different age
out, so that it remains the best in the world. They recog- groups, and in rural and urban settings.9 The studies they
nize, of course, that there are some access problems (espe- reviewed document unnecessary surgery; inappropriate
cially for the uninsured and underinsured) and some use of medications; failure to perform standard screening
below-par facilities and professionals—no health care sys- tests; inadequately controlled asthma, diabetes, and hyper-
tem is perfect—but overall, the sense is that the quality of tension; and significant departures from recommended
care is excellent. Unfortunately, this view is too optimistic. levels of care for patients with cardiovascular disease. A
Recent work by individual scholars and by organizations more recent study examined the care received by a large
such as the Institute of Medicine (IOM) and the Agency sample of adults in twelve cities and documented a variety
for Healthcare Research and Quality (AHRQ) has provid- of quality problems, finding that overall, participants re-
ed detailed, compelling evidence of serious problems with
the quality of American health care.3
Since quality is a complex, multifaceted concept, as- 3. Quality Framework
sessing just how well the American health care system is
doing is not easy. It requires the development of a concep- Quality is defined in the Institute of Medicine re-
tual framework for understanding quality and the transla- port, Crossing the Quality Chasm, as the degree to
tion of that framework into practical measures that can be which health services for individuals and populations
applied in specific contexts. The framework developed by increase the likelihood of desired health outcomes and
the Institute of Medicine in several influential reports de- are consistent with current professional knowledge.1
fines quality as “the degree to which health services for in-
dividuals and populations increase the likelihood of de- The report describes the following characteristics of
sired health outcomes and are consistent with current pro- quality:
fessional knowledge.”4 The core dimensions of quality are
identified as safety, effectiveness, patient-centeredness, and Safety: avoiding injuries to patients from the care
timeliness.5 Two additional aspects of care that cut across that is intended to help them
these dimensions are equity and efficiency.6 (See Box 3 for
definitions of these six quality characteristics.) Effectiveness: providing services based on scientific
The status of efficiency in the quality framework is knowledge to all who could benefit, and refraining
controversial. In Crossing the Quality Chasm, the Institute from providing services to those not likely to benefit
of Medicine Committee on the Quality of Health Care (avoiding underuse and overuse, respectively)
considers it a dimension of quality, but another IOM
committee, charged with translating the IOM’s quality Patient-centeredness: providing care that is respect-
framework into practical measures, does not, arguing that ful of and responsive to individual patient preferences,
efficiency is “an important goal of the health care system needs, and values, and ensuring that patient values
that is related to, but conceptually different from quality guide all clinical decisions
of care.”7 In this report, we work from the position that
increasing efficiency is often a goal of quality improve- Timeliness: reducing waits and sometimes harmful
ment activities, since the developers of QI methods have delays for both those who receive and those who give
traditionally considered efficiency an appropriate QI con- care
cern, and activities involving changes designed to produce
the same quality of care with fewer resources constitute an Equity: providing care that does not vary in quality
important QI category.8 because of personal characteristics such as gender, eth-
Although systematic empirical information on the nicity, geographic location, and socioeconomic status
quality of care is limited—which is itself surprising, given
the size and importance of the health care sector—what is Efficiency: avoiding waste, including waste of
available is disturbing. In a comprehensive review of the equipment, supplies, ideas, and energy
literature on quality of care from 1987 to 1998, Schuster
and colleagues found substantial evidence of overuse, un- 1. Institute of Medicine, Crossing the Quality Chasm (Wash-
deruse, and misuse of care in the United States. Serious ington, D.C.: National Academy Press, 2001).
SPECIAL REPORT / The Ethics of Using QI Methods to Improve Health Care Quality and Safety S7
ceived only a little over half of recommended care.10 There could have been made somewhat differently in that set-
is also ample evidence of equity problems: the quality of ting, and that have been made differently in other settings.
care varies in ways systematically correlated with ethnicity, Within this universe of change-related activity is a sub-
geographic location, and socioeconomic status.11 set of deliberate efforts to make positive changes in the deliv-
To help remedy the lack of information and make it ery of clinical care. Many of these “designed changes” come
easier to monitor quality over time, the IOM and AHRQ about by “just doing it”; someone decides that a change in
have developed a comprehensive set of quality measures, clinical practice or organizational arrangements seems like
and in 2003, AHRQ published the first in a projected se- a good idea and the change is made. Such innovation and
ries of periodic national quality reports. The report pro- adaptation is an intrinsic part of clinical and managerial
vided a baseline of quality information, including evi- practice. Health care practitioners must tailor a general
dence on the tremendous variation in quality of care standard of practice to individual patients, relying on their
across geographic areas and across individual care set- clinical knowledge, their unique knowledge of each pa-
tings.12 The 2004 and 2005 National Healthcare Quality tient, and the characteristics and capabilities of the local
Reports found improvement in some measures, but deteri- context in which care is being delivered. Managers must
oration on others, and concluded that the gap between the exercise judgment about how resources in a particular set-
best possible care and actual care remained large.13 AHRQ ting should be organized to carry out treatment plans for
also publishes a companion series, the annual National the patients being served.
Healthcare Disparities Report. The 2003, 2004, and 2005 When this innovation and adaptation is undertaken in
reports provided baseline and follow-up information on a systematic, data-guided way, it becomes what we are call-
the pervasive racial, ethnic, and socioeconomic disparities ing QI. The category of QI includes a wide variety of ac-
in health care access and quality in the United States.14 Fi- tivities and cannot be defined by any one method or pro-
nally, for an international comparison, in a recent survey, cedure.
one-third of patients with health problems in the United QI is closely related to clinical practice, and in fact,
States reported experiencing medical, medication, or test much of QI is simply good clinical care combined with
errors, the highest rate for the six countries included in the systematic, experiential learning. Individual practitioners
survey (the others were Australia, Canada, Germany, New are constantly learning by doing and taking steps to im-
Zealand, and the United Kingdom).15 prove their own practice. Physicians may develop personal
The more we learn about current quality, the clearer it templates for entering information in medical records and
is that safe, effective, patient-centered, timely, equitable, for tracking the lab tests they have ordered; surgeons may
and efficient health care will not happen automatically. work on their surgical techniques to reduce the time pa-
Rather, it requires and will continue to require systematic tients spend anesthetized; nurses may refine their skin care
and self-conscious management of health care delivery ex- methods to reduce the incidence of bedsores.
pressly directed at improving care. This means not only Very quickly, however, the effort of an individual clini-
the implementation of specific changes, but also the trans- cian to improve his or her practice becomes an issue for
formation of the culture of health care delivery into a cul- others working in the same environment. In health care
ture that is committed to continuous quality improve- facilities today, most clinical care is delivered to patients
ment. on a team basis, and the ability of the team to deliver good
care depends on the characteristics of the administrative
QI Activities: Part of Normal Health Care infrastructure and procedures that are in place. In other
Operations words, both patients and providers are part of systems of
care. A key insight of those promoting QI methods is that
SPECIAL REPORT / The Ethics of Using QI Methods to Improve Health Care Quality and Safety S9
derly processes that function well for people in different meet the quality expectations of patients, health care pro-
situations. After all, one could be in one of those situa- fessionals and managers must have the cooperation of the
tions oneself sometime. patients themselves, because modern health care delivery
It is abundantly clear, therefore, that health profession- is a collective enterprise. Providing safe, effective, patient-
als and health care organizations have an ethical responsi- centered, timely, efficient, equitable, and up-to-date care
bility to serve the interests of patients, and patients cer- is a health care organization’s mission.22 QI methods allow
tainly have an interest in the quality of health care. But the organization to pursue its mission in a systematic,
what is the nature of this interest? What level of quality do data-guided way. To be effective, these methods require at
patients want? What level are they entitled to? In the case least a minimum level of cooperation from patients, such
of an ordinary commodity, these questions would usually as permission for the collection and use of data on their
be answered through a market process. Buyer preferences health conditions, treatments received, and outcomes. In
and budgets would interact with seller production costs to other words, ongoing activities to maintain and improve
produce the products that buyers wanted and could af- the quality of care, including activities using QI methods,
ford—and there would probably be an array of quality are an integral part of the normal operations of the orga-
levels. nization. This means that someone seeking care from a
But given health care’s complexity, people cannot easi- health care organization cannot insist on the freedom to
ly make informed assessments of quality and develop sen- opt out completely from efforts to improve the quality of
sible and stable preferences for their health care. More- care in that organization without jeopardizing the very
over, even if they could, they would have difficulty getting benefits he or she seeks. In fact, it is in the best interest of
them implemented, because often they are not paying di- patients to cooperate with QI activities and even to seek
rectly for their care. Since future health status is uncertain, out the health care organizations that are the most com-
people need insurance to make sure they will be able to af- mitted to QI.
ford the care they want if they get sick. In addition, like As an ethical matter, the responsibility of patients to
most societies, the United States recognizes a societal eth- cooperate in QI activities is justified by the benefits each
ical obligation to provide at least some basic health care patient receives because of the cooperation of the others in
without regard to ability to pay.20 Third-party payment the collective enterprise. To reap the benefits of such a sys-
adds a social dimension to decision-making. When re- tem without participating in it—to be a “free-rider”—
sources are pooled, whether through private insurance or would be unfair.23 A patient’s responsibility to cooperate
through publicly funded social insurance, collective deci- is, of course, subject to a standard of reasonableness,
sions must be made about how the pooled resources which presumes that adequate protections against individ-
should be spent. These decisions play a key role in deter- ual harm and violation of rights are in place. For example,
mining both the quality and the quantity of care to which patients can reasonably expect to have the confidentiality
patients are entitled. of their personal health information protected, and to
Within the framework of these collective decisions, have the opportunity to choose whether to participate in
health professionals and health care managers have an eth- a QI activity that exposes them to more than minimal risk
ical responsibility to meet socially determined quality ex- compared to routine medical care. We will address the na-
pectations, which may take the form of a threshold of ture of these protections and what constitutes minimal
minimally acceptable care with a range of permissible additional risk over and above that found in routine med-
quality variation above it. They have an ethical (and often ical care in greater detail later in this report.
a legal) responsibility to cooperate in activities to improve In sum, health professionals, health care organizations,
the performance of the teams and the organizations they and patients have an ethical responsibility to cooperate in
belong to in order to meet those expectations. They also maintaining and improving the quality of health care. In
have an ethical responsibility to cooperate in societal ef- its traditional role of protector of the health and safety of
forts to improve the overall health care system to accord its citizens, government also has ethical responsibilities
with those expectations. These obligations follow directly with respect to the quality of care. In particular, it should
from their underlying professional responsibility to serve help to clarify the content of the ethical and legal respon-
the interests of patients. sibilities of health care professionals and organizations to-
The responsibility to improve has been stated in terms ward their patients and to ensure that the responsibilities
of meeting current expectations. That is, it is a responsi- are met.
bility to reach at least a threshold standard of quality.
What makes it a responsibility for ongoing improvement is
the understanding that the societal expectation is one of
continuous progress in medicine—progress that produces
its 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
A
lthough QI is closely related to clinical and man- exploited in the scientist’s search for insight—or more
agerial practice, it also has much in common with pragmatically, the search for funding, publication, and ca-
research. QI uses the kind of reasoning that is in- reer advancement. To counter these pressures to use peo-
herent in the scientific method, it involves systematic in- ple wrongly to further the ends of other people and justi-
vestigations of working hypotheses about how a process fy the research, the subject’s decision to participate in the
might be improved, and it frequently employs qualitative research must be voluntary and fully informed.
and quantitative methods and analytic tools that are also In health-related research, the independent nature of
used in research projects. It is these similarities between QI the enterprise is obvious when the research takes place
activities and research projects that have touched off the away from a health care delivery setting and the human
debate about whether QI activities should be subject to subjects are healthy. When the research takes place in a
the DHHS regulations on human subjects research. clinical setting and involves sick patients who are receiving
How does QI differ from research? The definition of care, research and therapy may be mixed, complicating
research in the DHHS regulations highlights the knowl- matters significantly. Nevertheless, even research on an in-
edge-seeking aspect of research as the element that sepa- tervention that holds out the prospect of direct benefit to
rates it from other activities: “Research means a systemat- the subjects is seen to have a different relationship to its
ic investigation, including research development, testing setting when compared to QI. Research with human sub-
and evaluation, designed to develop or contribute to general- jects in a clinical setting is usually conceived, funded, and
izable knowledge.”24 In this definition, research is designed
to develop new knowledge, not to implement knowledge;
implementation happens later and separately, if it happens QI is an ongoing process undertaken as a
at all. Dissemination of research results, such as through
publication in scientific journals, is thus of fundamental consequence of health care providers’
importance. Allowing research subjects to assume the bur-
dens and risks of research is justified by the expectation of responsibility to serve their patients’
societal benefits from the new knowledge produced; pub-
lication is an important step in conveying the new knowl- interests. This makes it very different
edge to those who can put it into practice and thereby cre-
ate the social benefits. from research.
Although the definition does not make it explicit, the
regulations implicitly reflect a view of research as a knowl- managed as discrete projects, each led by a principal inves-
edge-seeking enterprise that is independent of routine medical tigator who is responsible for the project’s design and con-
care. Opinions differ on whether a society has an obliga- duct. For research in a clinical setting, the resources often
tion to engage in research, including research that will ul- come from outside the organization in which it is carried
timately yield important benefits to human health. But out (from a federal agency, private foundation, or biotech
even if such an obligation exists, there is a presumption in or pharmaceutical corporation, for example); or, if from
research ethics that the research enterprise should rely on inside, from a separate research budget, not from clinical
volunteers.25 Investigators choose to do research, and peo- care resources. Most important, there is significant uncer-
ple should be able to choose whether to be research sub- tainty about whether the intervention is in fact beneficial,
jects. This ethical paradigm emerged in response to re- and the activity is designed to produce generalizable
search that imposed substantial risks on subjects yet of- knowledge about the intervention, not immediately im-
fered them no prospect of direct benefit (such as the Nazi proved care. This usually means that research has a proto-
experiments and the U.S. Public Health Service Study of col that is constructed to minimize the effect of specific
Untreated Syphilis, commonly known as the “Tuskegee local variables and is maintained unchanged during the
syphilis study”), and it builds on the observation that the period of the research. It also means that there is relatively
interests of researchers are inherently tangential to, and little urgency to disseminate the results, and the results
possibly even at odds with, the interests of the subjects. may not be made known to the scientific community for
Since researchers want to produce successful research, they many months, even years, after the research is begun. Fi-
have a strong interest in enrolling subjects in their studies, nally, there is no presumption that the results will be in-
keeping them in, and getting them to conform to study corporated into the local care delivery process, and fre-
rules. People who do not know themselves to be involved quently little or no attention is paid to the challenges and
in research, or who do not have the opportunity to discern opportunities for implementation of the findings in any
the merits of their own involvement, are at risk of being setting at all.
SPECIAL REPORT / The Ethics of Using QI Methods to Improve Health Care Quality and Safety S11
Research QI Clinical &
Managerial
Innovation &
Research Adaptation
on QI QI/
Research
on QI
QI/
Research
Figure 1.
In contrast, QI is an integral part of the ongoing man- able insights for a QI practitioner in another setting.
agement of the system for delivering clinical care, not an in- Moreover, QI activities that have theory-based designs in-
dependent, knowledge-seeking enterprise. QI practition- evitably become examples that in the long run tend to in-
ers design QI activities to bring about immediate im- crease or decrease the level of confidence in the theories
provements in care, relying on theory and evidence from on which they are based. With careful, systematic report-
research and practical experience to identify changes that ing, the insights from QI are of use to people in other set-
are very likely to be beneficial. QI activities take place in a tings, just as case reports on individual patients are useful
particular localized health care setting, their design is ex- (although they too are not research). Given this, QI prac-
pected to incorporate the specific features of the setting, titioners should be encouraged to share information
they are led by people who work in that setting, and they about their QI activities with others in the health care sys-
incorporate rapid feedback of results to bring about posi- tem.
tive change for the patients in that setting. Instead of a Furthermore, although QI and research are conceptu-
fixed protocol implemented for a time period that may ally distinct, in practice they are sometimes combined in
last for years, QI methods often require repeated modifi- one activity. In other words, some systematic, data-guided
cations in the initial protocol as experience accumulates activities designed to bring about immediate local change
over time and as the desired changes engage the local are also “investigations designed to develop or contribute
structures, processes, patterns, habits, and traditions. The to generalizable knowledge”; they are both QI and re-
term “continuous quality improvement” (CQI), used al- search.
most interchangeably with the term QI, highlights the At this point, a diagram is useful to illustrate the rela-
fact that QI is not so much the implementation of dis- tionships among the activities under discussion. In Figure
crete projects as it is an ongoing process of continual, self- 1, the set “Clinical and Managerial Innovation and Adap-
conscious change, undertaken as a natural consequence of tation” is shown as a large oval and consists of activities
health care providers’ ethical responsibility to serve the in- designed to bring about immediate local improvements in
terests of their patients. This makes it a very different kind clinical and managerial practice. The set “QI” is shown as
of endeavor from research and generates the prima facie a subset of that oval; it consists of clinical and managerial
case for questioning whether the public’s interests would innovation and adaptation activities that are designed and
be best advanced by subjecting QI to exactly the same carried out in a systematic, data-guided way.
process of review and evaluation that has been designed “Research” is the large circle and consists of systematic
for discrete research projects. investigations designed to develop or contribute to gener-
QI and research are thus both conceptually and practi- alizable knowledge. The “Research” set includes basic and
cally distinct and play different roles in health care. Nev- applied medical research, of course. It also includes other
ertheless, in the process of making change, QI does yield categories of research with a potential impact on health
information about what works and the way in which care quality, such as epidemiological research, health ser-
change can come about. When the results of QI activities vices research, management research, and educational re-
in various settings are looked at together, patterns may search. The activities that are both QI and research are
emerge—and even a single QI endeavor may yield valu-
SPECIAL REPORT / The Ethics of Using QI Methods to Improve Health Care Quality and Safety S13
ture patients in the local setting, as well as any social ben- risks in the usual work situation. For example, in the un-
efits that may result from sharing the insights gained. likely event that a QI activity exposes workers to extra ra-
Forming an estimate of the impact of the local change can diation or toxic chemicals, or invades privacy by collecting
be a complex professional and management task that re- information employers are not normally entitled to have
quires a detailed understanding of the local system of care (as might happen with surveys of the use of alcohol, ciga-
delivery. rettes, or illegal drugs outside the workplace), the potential
One must also assess the potential risks to those who effects on workers should be included in the assessment of
participate in the QI activity itself. The chief difficulty QI-associated risk. On the other hand, one should not in-
here lies in the identification of the appropriate baseline clude the harm to a worker’s economic security that might
from which to measure the risks to participants attribut- result if a QI activity reveals that the worker is incompe-
able to the QI activity. In a freestanding research project, a tent or the organization can provide quality care with
person is either getting an intervention or not, and the fewer workers. A health care employer has a moral and
baseline for measuring harm and risk is ordinary life with legal right—and responsibility—to ensure that employees
no intervention. In a clinical treatment research project, are competent and conscientious, and the operations of
the fact that the subject would be receiving clinical care in the organization are efficient. The collection of informa-
any case complicates the assessment, but typically, the re- tion on individual and system performance is a feature of
search has a control group receiving a carefully specified normal working conditions, and the risk that it will pro-
standard treatment that is the appropriate baseline from duce information that leads to adverse job actions is part
which to measure the risks to subjects receiving the un- of the baseline job risk.
proven treatment.
In the QI context, the risks related to extra visits, ques- Scientific validity: Is the research methodologically sound—
tionnaires, or procedures needed for data collection and for example, is it properly structured to achieve its goals?
monitoring can be distinguished and attributed to the QI This requirement is also justified by the scarcity of re-
activity. Although these burdens are usually small, they sources and the need to avoid exposing subjects to possible
should be weighed in deciding on the merits of proceed- harm without benefit, and it also applies to both research
ing. But how should one assess the net risks to the partic- and QI. The interpretation of “scientific validity” and
ipant associated with the proposed change itself? Here it is “methodologically sound” must be adjusted to QI, howev-
important to note that the care delivery process to which a er. Since the primary goal of QI is local improvement, QI’s
patient is entitled is not specified in all its details; in fact, methods and the local knowledge they generate can be
it is always changing. Even in a single clinical setting, the quite different from the methods designed to enhance the
attributes of the care patients receive can vary from day to opportunity to gain generalizable knowledge through re-
day, depending on the availability of staff, the number of search.29 QI methods should be chosen on the basis of
patients scheduled, and other factors. Managers and clini- knowledge of the context, the requirements for connect-
cians have the professional discretion to make changes in ing evidence to the context, and the requirements of actu-
care within certain (fuzzy) limits related to the range of ally “making something happen” in the local setting while
variation in existing health care delivery. Over time, they balancing the importance of the improvement sought and
are actually required to make changes in order to remain in the clarity needed in the assessment of changes against the
compliance with evolving minimum standards of care and practical costs of monitoring the effects. A randomized
to avoid malpractice liability. For many of the changes in- controlled trial seeks to eliminate context—key to QI—as
troduced through QI methods, the difference for patients a variable and thus would usually be inappropriate for the
between being in or out of the QI activity may be no kinds of questions and changes that QI addresses, while
greater than the existing variation in the patterns of care changes that are already known to be worth their costs and
across organizations, or within the same organization. readily implemented should in general simply go for-
Moreover, the methods of QI guide practitioners to use ward.30
theory, evidence, and practical experience systematically in
order to identify and implement changes that are very Fair subject selection: Are the subjects of the research selected
likely to be beneficial. We are not suggesting that it is im- so that vulnerable individuals are not targeted to bear the
possible to recognize that a specific change has the poten- risks of the projects while the rich and socially powerful are fa-
tial to cause significant harm. Rather, we are noting that vored for receiving the benefits?
patients cannot expect that services will only be presented In the selection of research subjects, there should be
in one way, or that those services can be specified fully in similar treatment of equals, and both the burdens and
advance. This fact is relevant in the assessment of the risk benefits of the research should be distributed in a fair
attributable to inclusion in a QI activity. manner. But, to quote Emanuel and colleagues: “This
A related issue arises for staff members, the other major does not mean that individual subjects and members of
group of human participants in QI activities. For them, groups from which they are selected must directly benefit
the appropriate baseline for measuring QI effects is the from each clinical research project or that people who are
SPECIAL REPORT / The Ethics of Using QI Methods to Improve Health Care Quality and Safety S15
sociated with more than minimal additional risk, patients of protected health information in both clinical care and
must be asked for their specific informed consent before QI. (See Box 4.)
inclusion, and they are free to refuse it. In the latter case, When the human participants in a QI activity are staff,
patients must receive full information about the activity consent requirements play out a little differently. Health
and the risks to them personally when they are asked to professionals, management, and other workers have a gen-
participate, just as for any clinical consent. If later on they eral ethical obligation to cooperate to improve the quality
would like information about the activity’s results, they of care, and a specific contractual obligation to cooperate
should be able to obtain it.34 with their organization’s QI program (since it is part of
Organizations should not be required to distribute de- normal health care operations). The obligation is not un-
tailed information proactively about the results of individ- limited, however. Specific consent is required when the QI
ual QI activities. Most people would find the detail super- represents more than minimal risk to the worker, as mea-
fluous, and the effort would waste their own resources sured from the baseline of normal working conditions.
since they ultimately pay the bill for the health care sys- Therefore, consent would be required for a QI activity
tem. QI practitioners and the organization as a whole that exposed workers to more than minimal additional
should, however, willingly provide information to anyone risk of physical or mental harm compared to their current
who asks about any QI activity, to the extent possible working conditions (exposure to radiation or toxic chemi-
while respecting patients’ and providers’ right to privacy. cals, for instance) or collected information about workers
The most common examples of QI activities that do that was outside the category of information employers are
not require consent are those activities that use routine normally entitled to have about their employees (such as
personal health information to implement a change in the their use of tobacco, alcohol, or illegal drugs outside of the
care process and impose no additional risk on participants workplace). Consent is not required, however, for QI that
beyond that associated with the information use. For ex- is risky to the worker simply because it might generate ev-
ample, a group practice might decide to modify schedul- idence of incompetence on the job or lead to a reduction
ing practices to reduce the time patients spend waiting to in force for efficiency reasons. The formal contracts with
see their physicians when they come for an appointment. workers and the informal workplace expectations should
The QI team might begin by reviewing patient visit reflect the understanding that cooperation with minimal
records to develop data on the types of visits, the average risk QI activities is part of the job. As with patient partic-
time needed for each type, the pattern of visit types over a ipants, confidentiality of personally identifiable informa-
typical month, and so on, and then use the data to devel- tion about workers should be appropriately protected
op new scheduling practices, implement them, monitor within the organization.
the effect on waiting time, and refine them until the de- Does any of this analysis change if those leading the QI
sired result is achieved. If confidentiality is appropriately project publish or otherwise share their process and ac-
protected, then using patient information for QI activities complishments with others? Do participants have to give
without specific consent is ethically acceptable on the specific consent to the publication of QI results? QI prac-
same grounds that its use is acceptable in other normal titioners should be encouraged to share QI results through
health care operations. Since QI is part of the care process, publication and other means, since sharing yields benefits
the people doing QI have the same status as others in the to individual patients and to society as a whole. The peo-
care process. Often this is literally true, since QI teams are ple who receive care from health care organizations pay as
often made up of the people who provide direct care; how- a group for the development of this knowledge, and over a
ever, the rationale is the same when access to protected lifetime, people receive care from many different organiza-
health information is granted to someone more removed, tions. Although some organizations may consider QI re-
such as an epidemiologist abstracting information from sults proprietary information and wish to maintain secre-
medical records for statistical analysis. cy for competitive advantage, patients are better off if
The Privacy Rule of the Health Insurance Portability health care providers cooperate by sharing QI results.
and Accountability Act (HIPAA) has established standards Even though most QI can be carried out ethically with-
for the protection of the confidentiality of personal health out explicit patient consent, published results must be pre-
information in normal health care operations, and has in- sented in a form that preserves patient confidentiality;
cluded QI (but not research) within that category.35 Con- otherwise, the team must have the patients’ specific con-
sent to the use of protected health information for QI ac- sent to publication. Similarly, individual worker informa-
tivities is provided as one item in the list of routine uses tion must be nonidentifiable or worker consent to publi-
the patient agrees to as a condition of treatment. Accord- cation must be obtained, unless there are overriding con-
ing to HIPAA standards, a QI practitioner’s access to pro- tractual or legal rules relating to the provision of informa-
tected health information is limited to the information tion on worker performance.
needed for the activity, persons engaged in QI have the The ethical acceptability of the QI activity itself and
same confidentiality obligations as other health care work- the ethical acceptability of the form in which the results
ers, and the same precautions must be in place for the use are disseminated are conceptually distinct, and the deci-
defines health information as “any information, • PHI will be disclosed to business associates provid-
whether oral or recorded in any form or medium that: ed certain arrangements in place (45 CFR 164.502 (e))
(1) is created or received by a health care provider, health • the disclosure is required by law, authorized by law
plan, public health authority, employer, life insurer, for public health purposes, or required by the FDA for
school or university, or health care clearinghouse; and (2) adverse event reporting (45 CFR 164.512)
relates to the past, present, or future physical or mental
• an institutional review board (IRB) or privacy board
health or condition of an individual; the provision of
waives or alters the authorization requirement to use or
health care to an individual; or the past, present, or fu-
disclose PHI for research, which is possible when certain
ture payment for the provision of health care to an indi-
conditions are met (45 CFR 164.512(i))
vidual” (45 CFR 160.103)
• a researcher satisfies certain conditions to use PHI
defines protected health information (PHI) as “indi- for review preparatory to research (45 CFR
vidually identifiable health information that, subject to 164.512(i)(1)(ii))
exceptions, is (i) transmitted by electronic media; (ii)
• a researcher satisfies certain conditions for research
maintained in any medium described in the definition of
solely on information of decedents (45 CFR
electronic media; (iii) transmitted or maintained in any
164.512(ii))
other form or medium” (45 CFR 164.501)
• the PHI has been deidentified in accordance with
extends to a defined set of covered entities that trans- specific Privacy Rule standards (which makes the data no
mit health information electronically in connection with longer PHI [45 CFR 164.514(a)-(c)])
certain defined HIPAA transactions (45 CFR 160.13):1
• the covered entity releases the information in the
• health plans form of a limited data set that includes the removal of
• health care clearinghouses certain identifiers and a data use agreement between the
• health care providers researcher and the covered entity (45 CFR 164.514(e))
• nonemployee business associates of covered entities
QI (but not research) is included in health care oper-
• researchers who are health care providers engaging
ations and specifically exempted from the above require-
in any of the covered electronic transactions
ment for project-specific written permission (“authoriza-
prohibits a covered entity from using or disclosing tion”)
PHI about an individual without the individual’s specif-
ic written permission (“authorization”) unless: 1. For additional information see U.S. Department of Health
and Human Services, OCR Privacy Brief, Summary of the HIPAA
• PHI will be used/disclosed for treatment, payment, Privacy Rule, at http://www.hhs.gov/ocr/privacysummary.pdf.
and health care operations (45 CFR 164.506(c))
sion about whether to publish and in what form may rea- takes judgment calls, and conflicts of interest may distort
sonably be made after the results are in. Therefore, it is ac- the researcher’s judgment (consciously or unconsciously),
ceptable and may be desirable to separate ethical assess- potentially causing harm to participants or taking away
ment of the activity itself and ethical review of the form in their opportunity for voluntary consent. Review can pro-
which the results are disseminated. Thus, organizations tect against such distortion and help potential research
might well have different procedures for ensuring ethical subjects have confidence in the honesty and integrity of
implementation of QI and ethical dissemination of the the offer to volunteer to participate. In the United States,
findings. this ethical review takes the form of review of research pro-
tocols and relevant documents by the institution’s IRB.
Independent review: Is there review of the design of the re- In the discussion of the first six categories of ethical re-
search, its proposed subject population, and its risk-benefit quirements for human research subject protection, we
ratio by individuals unaffiliated with the project? have concluded that QI activities with human participants
In research, the purpose of ethical review by individu- should meet similar ethical requirements, but the require-
als unaffiliated with the proposed research activities is to ments must be interpreted and applied somewhat differ-
ensure that the researcher has understood the require- ently. (See Box 5.) As with research, some considerations
ments for ethical research and applied them properly in might justify review of QI activities to ensure that the re-
developing the proposed activities. Applying requirements quirements for ethical conduct of QI are met. Review
SPECIAL REPORT / The Ethics of Using QI Methods to Improve Health Care Quality and Safety S17
might be justified, for example, if the QI might pose sub- ments. The research protocol specifies the goals of the pro-
stantial risks or waste substantial resources, and if review ject, the subject population, methodology, and time peri-
by a nonparticipant could raise those issues and stop the od for the research. After reviewing the documents, the
activity. As QI becomes a desirable skill and care systems IRB either approves the research project or requires the
invest in QI budgets, the leaders of QI might find them- principal investigator to make changes to the protocol, the
selves invested in QI work that has become unresponsive associated consent form, or other documents until all are
to the real needs of patients and families—a conflict of in- acceptable. Then the project begins and continues un-
terest that would echo that which gave rise to research re- changed unless the PI obtains IRB approval for modifica-
view. Furthermore, the focus on QI is relatively new, and tions. In addition, the PI is required to report any unan-
the practices that support it are still in flux. Thus the ticipated problems involving risks to subjects or others to
boundaries between QI and research and between QI and the IRB. Although the research is carried on under the
routine treatment are not well understood. Review by a auspices of the institution and receives continuing IRB re-
nonparticipant would be useful if a project that should view (at least once per year), the PI takes full responsibili-
have counted as research is not being managed as such, or ty for its day-to-day conduct.38
if a project that offers no particular opportunity for im- Most QI activities are unlike the activities that IRBs
provement over usual practice is being touted as QI. routinely approve and monitor. Instead of a fixed protocol
Since these arguments justify some review, at least for with fixed goal, methodology, population, and time peri-
some projects, the question is what form it should take. od, QI activities ordinarily entail frequent adjustments in
Should QI also receive IRB review, or would some other the intervention, the measurement, and even the goal over
approach to ethical oversight be more appropriate? In the time as experience accumulates. Even in cases where a QI
next section, we will discuss why we have concluded that activity produces insights useful in other settings as well as
IRB review is not ethically required and would not even local change, the activity is not a knowledge-seeking en-
be generally beneficial or effective for QI activities. terprise that is independent of ongoing clinical care. It is
designed to produce local change and is closely linked to
IRB Review of QI: Why Not? the normal operations of the institution in which it takes
place. QI occurs in the context of the professional obliga-
SPECIAL REPORT / The Ethics of Using QI Methods to Improve Health Care Quality and Safety S19
Optimal oversight of change requires learning how to as- cepting “value for money” as a quality characteristic has
sess the dangers of specific changes to patients, and QI is a practical advantages. In considering the ethics of using QI
systematic approach to improving decisions about change. methods to evaluate a designed change, it is best to avoid
By providing evidence on the effects of changes, QI meth- creating a bright-line distinction between efforts to im-
ods are valuable tools in holding health care providers ac- prove quality and efforts to reduce cost. When assessing
countable for the care they deliver and can be used to re- quality, people often disagree about what weights to apply
spond effectively to past failures to live up to quality stan- to different dimensions of care. If several dimensions
dards. We conclude that to the extent that health care change at once, some may consider the result higher qual-
managers have a conflict of interest in managing cost-re- ity care and others lower quality care. Thus, when a pro-
ducing change in health care, QI methods are not the ject reduces cost and also changes quality characteristics,
problem, but an integral part of the solution. there may be no consensus on whether the change is qual-
Our discussion has brought us back to the question ity improvement that also lowers cost or cost containment
raised in Section I of this report: should increasing effi- achieved at the expense of quality. Either way, manage-
ciency by providing the same quality of care at lower cost ment should know what the consequences of the change
count as an improvement in quality? One way to answer is are, and QI methods can be used to find out.
to say: “No, it is a good thing, but it is cost containment, Note that the methods used in QI are also useful for
not quality improvement.” Another way to answer is to the study of changes that everyone agrees are not good for
say: “Yes, ‘value for money’ is a quality characteristic of patients but that are made anyway: for example, changes
health care.” Both positions have conceptual merit, but ac- forced by budget deficits, such as cuts in nursing staff or
T
o ensure that QI meets ethical requirements, there government regulators, contracting health plans, and the
must be a set of regular procedures, understood public.
obligations, and clear standards to hold health care Within the clinical accountability system, the arrange-
professionals and organizations accountable. ments for ensuring that QI is conducted ethically should
Many organizations and policies within the health care be designed to be flexible. The specific practices should be
system intertwine to create the existing system of account- able to vary across organizations to accommodate varia-
ability for the quality and safety of health care.41 First, of tion in the local environment and in the QI activities con-
course, is the widely understood social contract, articulat- ducted. The interaction between the characteristics of a
ed in statements of professional ethics, which calls on QI activity and the characteristics of the local setting is
practitioners to be allegiant to the needs of their patients. critical in determining whether the activity is ethical and
Formal accountability organizations include state licensing what kind of review and supervision it should receive. In
bodies, private sector accrediting bodies, the Centers for general, if participants are at more than minimal risk,
Medicare and Medicaid Services, and certification and there must be more clarity about review and more super-
credentialing organizations. Managed care organizations vision. However, for a given level of risk, an organization
and large employers often impose quality performance re- whose employees are very familiar with QI methods and
quirements on the professionals and organizations with ethical requirements can allow QI to be done with a lower
whom they contract. Medical staff in hospitals and group level of supervision than an organization whose employees
practices undertake responsibility for credentialing their have lesser skills. A large organization may choose to have
members and awarding staff privileges. Many hospitals a specialized QI oversight system that a small organization
now support clinical ethics committees. Under certain cir- cannot afford; however, the small organization may not
cumstances, health care organizations are subject to the ac- need any formal review if its QI activities are simpler and
countability requirements included in the HIPAA Privacy its size allows everyone in the organization to know what
Rule and the DHHS regulations for the protection of is going on. For example, an HMO with multiple delivery
human research subjects. The malpractice litigation sys- sites might have formal procedures, while a small nursing
tem allows patients to pursue compensation from health home might simply require an informal review by the
care providers for harms caused by negligence in the deliv- nurse executive.
ery of care. Within this accountability system, the various The practices should be able to vary over time. Since
parties may hold each other accountable over different QI is part of a process of continual change in health care,
content areas. For example, a hospital may evaluate the ac- it would be a mistake to impose an ethical oversight struc-
tivities of its physicians, but then in turn be accountable to ture that cannot respond quickly and appropriately to
SPECIAL REPORT / The Ethics of Using QI Methods to Improve Health Care Quality and Safety S21
changing conditions. If the QI regulatory procedures erect explicit promises about the kind of care they will receive.
artificial barriers to new ways to organize care delivery and Sometimes the reasons are not directly related to ethical is-
reimbursement in health care, they may prevent desirable sues but to other organizational concerns. For example,
change, or even create perverse incentives that encourage the organization may be seeking to maintain market posi-
undesirable change. tion and reputation, remain financially solvent, avoid law-
The practices should be designed to ensure that ethical suits, or prevent bad publicity. The ethics-related oversight
oversight produces its benefits at affordable cost. The ad- of QI, including the oversight of the protection of human
ministrative complexity of doing QI should be as low as participants, must be incorporated into the overall system
possible so that people employed in direct care are not dis- of management and supervision of health care delivery.
couraged from initiating QI projects. This consideration In discussing how this can be done, it is useful to dis-
reinforces the conceptual arguments for building ethical tinguish three broad categories of oversight: professional
oversight of QI into the ongoing management of care de- responsibility for QI; local management review and super-
livery. vision of QI; and QI-IRB review for QI that is also human
We recommend that the primary responsibility for the subjects research. In addition, there should be procedures
ethical conduct of QI be lodged in individual organiza- in place for ethical oversight of QI activities that are car-
tions, where it should be seen as a normal clinical care ried out through collaborations across organizations.
obligation and integrated into normal supervision and
management, with the organizations’ leaders responsible Professional responsibility for QI
for seeing that the integration occurs and is effective. The Some QI activities are so closely tied to clinical practice
organization doing QI could be, for example, a practice of that no additional oversight beyond normal management
one or a few physicians and support personnel, a large supervision and professional ethics is needed. Activities
multispecialty physician group practice, a hospital, a nurs- appropriate for this category are of minimal risk, in the
ing home, a hospice, a staff model HMO, or a more loose- sense that confidentiality is protected and no additional
ly configured managed care plan. It could also be a hospi- risk or harm is imposed on patients compared to that ex-
tal chain, a nursing home chain, or an integrated, compre- pected from clinical care in the absence of the activity.
hensive multisite managed care organization like Kaiser or (And often, a priori evidence exists that suggests that sub-
Intermountain Health Care. It could be the Veterans stantial benefits are likely for the patients or staff in-
Health Administration. Whatever the organization is, it volved.) Therefore, specific informed consent is not re-
must have a set of practices in place to ensure that QI ac- quired. The activities are simple in design, so there is no
tivities are done, and that they are done in conformity need for methodological review. The effects of the activi-
with ethical requirements. The organization must also ties are very local, in the sense that their success or failure
have a procedure in place to provide basic information to will have no repercussions on other parts of the organiza-
patients and staff about the organization’s QI activities. tion. The activities do not use significant additional orga-
We call this internal accountability for the ethical conduct nizational resources beyond the usual resources for clinical
of QI. care.
We recommend that there also be procedures to ensure This category includes most of the routine perfor-
that individual health care organizations and their leaders mance-enhancing improvement activities undertaken by
are held accountable for having well-designed, functioning individual health professionals. Here are two examples of
internal accountability practices in place to carry out their it:
QI-related responsibilities. We call this external account-
A doctor wants a test order tracking system that
ability for the ethical conduct of QI, and we argue below
makes it easy for him to remember what tests have been
that it should be integrated into the overall system of ac-
ordered for a patient, access the test results, and make
countability for the quality and safety of clinical care.
timely and appropriate adjustments in the patient’s care.
He develops his own patient tracking system, monitors
Internal Accountability for Ethical Conduct
of QI
its performance, and refines it over time in response to
his observations until he is satisfied with it.
SPECIAL REPORT / The Ethics of Using QI Methods to Improve Health Care Quality and Safety S23
Research
Exempt Human
Subjects
HuSR Research
(HuSR) Activities Involving
Human Data Sources
Figure 2.
the QI activity meets them. When QI activities have sub- committee could be the organization’s IRB or the QI-IRB
stantial resource or staffing implications, major changes in described in the section below. An outside perspective
the providers’ or patients’ expectations, or more than min- would also be useful in cases where an organization’s staff
imal additional risk to patients compared to ordinary clin- members lack the technical skills to assess the benefits and
ical care, then they require active approval by management burdens of the activity; in such a case, the organization
above the level of the immediate managers involved with- might contract with a group such as a quality improve-
in the organization. The registration process outlined ment organization.
above could identify activities with characteristics that We believe that an organization should develop its own
make additional management approval necessary. De- approach to bringing the QI activities in this category into
pending on an organization’s structure, form, or size, ap- conformity with ethical standards. QI methods themselves
proval could be provided by a quality management staff attach considerable importance to identifying the compo-
member, QI director, facility manager, or other staff mem- nents of the existing system that must be involved in a QI
ber who is schooled in QI methods and the ethical re- activity in order for it to be done well. In each organiza-
quirements for QI. Clinical leaders most responsible for tion, the categories that managers use will be defined by
the patient population affected (a department chair or combinations of attributes, some relevant to ensuring eth-
nurse manager, for example) should also be part of the ical conduct of QI and others relevant to other superviso-
process of approval. ry goals. A wide variety of QI management configurations
Activities that pose more than minimal risks compared are likely to emerge. As long as these different configura-
to those in ordinary clinical care require specific informed tions are effective in ensuring that QI activities meet ethi-
consent and explicit review by at least one person who is cal requirements, they should be acceptable.
not directing the project and who is knowledgeable about It is worth noting that, from an ethical perspective, ex-
both ethical issues and management perspectives. This is ternal review of individual QI activities is not generally in-
true even if the proposed project also holds the potential herently better than internal review. On the one hand, an
for substantial benefits to the subjects. The possible harms outsider might provide a useful community perspective on
make it desirable to create “distance” between the organi- the acceptability of the risks involved, and for some kinds
zational units that favor the proposed changes and the of risks, this perspective should definitely be sought. On
oversight structure. A patient safety committee or clinical the other hand, an outsider might not understand the in-
policy committee could perform a structured review. In ternal environment well enough to understand the true
any case where an outsider might think the internal nature of the risks and benefits and the relationship of the
process could involve a conflict of interest, it would be ap- activity to the organization’s current standard of care and
propriate to refer the proposed activity to a committee allocation of resources. As we will discuss below, there is a
with representation from outside the organization. This need for external oversight, but it should be primarily fo-
Nonexempt QI Involving
QI/HuSR Human Data Sources
Exempt
HuSR
Human Subjects
Research (HuSR)
Activities Involving
Human Data Sources
Figure 3.
cused on review of the structure and functioning of the or- interaction with the individual, or identifiable private in-
ganization’s procedures for ensuring the ethical conduct of formation.” In the figure, the long oval is the set “Activi-
QI, rather than on the review of individual QI activities. ties Involving Human Data Sources,” where a human data
source is defined as “a living individual about whom a per-
QI-IRB review and supervision son conducting the activity obtains data through interven-
As noted earlier, some activities are both QI and re- tion or interaction with the individual, or identifiable pri-
search involving human subjects. The DHHS regulations vate information.” (The awkward term “human data
require any activity meeting the definition of human sub- source” is used rather than “human subject” because, as
jects research to be treated as such even when it is also an- shown, the regulations define a human subject as someone
other kind of activity, such as QI, education, or public about whom data is obtained for research purposes.) The
health surveillance. Therefore, these hybrid activities must overlap between this long oval and the circular Research
comply with the regulations if they are supported by fed- set (defined earlier for Figure 1) is the subset “Human
eral funds or are covered by the assurance many organiza- Subjects Research.” Within this subset, the smaller oval la-
tions give that all their human subjects research will com- beled “Exempt” consists of human subjects research that
ply with the DHHS regulations whatever the funding falls into any of the categories of research that have been
source. officially declared exempt from the regulations. (These in-
Unfortunately, it can be difficult to determine whether clude, for example, some research in educational settings
an activity is only QI or both QI and human subjects re- using normal educational practices; some research involv-
search, given the ambiguity of the phrase “designed to de- ing tests, surveys, interviews, and public behavior observa-
velop or contribute to generalizable knowledge” in the reg- tions; some research using existing data and specimens;
ulatory definition of research. The matter is of some con- and some research by public benefit programs.42) The re-
sequence, given the sanctions that may be imposed on or- maining area is the subset of human subject research ac-
ganizations that violate the human subjects protection reg- tivities covered by the regulations.
ulations. This section considers approaches to review and Figure 3 combines the diagrams in Figures 1 and 2 to
supervision of the activities that belong in this hybrid cat- show the cross-hatched subset “Nonexempt QI/Human
egory. The section that follows discusses approaches to Subjects Research Overlap (Nonexempt QI/HuSR),” the
their identification. set of QI activities that must be reviewed by an IRB and
We begin with a brief discussion of the activities to conform to other regulations, such as the requirements re-
which the regulations apply (Figure 2). The regulations lating to informed consent. Although the figure does not
define a human subject as “a living individual about show it, the boundaries of this subset are currently fuzzy,
whom an investigator (whether professional or student) given the lack of clarity about precisely which QI activities
conducting research obtains data through intervention or also meet the definition of human subjects research.
SPECIAL REPORT / The Ethics of Using QI Methods to Improve Health Care Quality and Safety S25
How do we ensure that all of the hybrid activities con-
6. Requirements for IRB Membership form to the regulations, especially given the fuzziness of
From 45 CFR 46.107 the boundary? Since the current IRB review process is not
suitable for most QI, simply sending all QI activities to ex-
isting IRBs would not be a good approach. A second ap-
A minimum of five members with varying back- proach would be to send no QI activities to IRBs, and in-
grounds must sit on the board. stead authorize the development of a robust but separate
internal accountability system. This separate system would
Members must not all be from one profession. be based on the ethical requirements developed in this re-
port (Box 5) and designed for all types of QI, including
At least one member must have primary concerns activities that are both QI and human subjects research.
that are “scientific” (a term the regulations do not de- The hybrid activities could then be exempted from the
fine). DHHS regulations but required to submit to this alterna-
tive pathway. Unfortunately, modification of the existing
At least one member must have primary concerns DHHS regulations to allow this is a project that would
that are “nonscientific” (also left undefined). take years and is not assured of a satisfactory outcome.
A third approach, and the one we recommend, is for
At least one member must be unaffiliated with the organizations to establish specialized Quality Improve-
institution in which the IRB resides and not an im- ment IRBs (QI-IRBs) to review the hybrid activities. The
mediate family member of a person affiliated with QI-IRB would be a committee that meets the minimum
the institution. regulatory requirements for IRB composition and has
standard operating procedures that conform to IRB regu-
Members cannot have a conflicting interest in any lations; however, it would design its process specifically to
project that comes before the IRB for initial or con- meet the review and supervision needs of an activity that
tinuing review. is both QI and human subjects research. This approach
seems compatible with the current regulatory framework.
The IRB may invite individuals with competence Although many IRBs have chosen to operate under rela-
in special areas to assist in the review of issues that re- tively rigid rules and procedures, there is actually substan-
quire expertise beyond or in addition to that available tial flexibility in the regulations. OHRP’s Guidance on
on the IRB, but these individuals may not vote with Written IRB Procedures, July 11, 2002, summarizes the ac-
the IRB. tivities IRBs must carry out (the distribution of materials
on research projects to IRB members, initial and continu-
The IRB shall be sufficiently qualified through its ing review of the materials, issuance of approval or disap-
members’ experience, expertise, and diversity, includ- proval of the project, review of changes to the research
ing consideration of race, gender, and cultural back- protocol, and so on) but also says:
grounds and sensitivity to such issues as community
OHRP has not developed a model written IRB proce-
attitudes, to promote respect for its advice and coun-
dures document for institutions to adapt because proce-
sel in safeguarding the rights and welfare of human
dures appropriately can vary significantly among institu-
subjects.
tions as the result of differences in institution size, the
type of research activities, institutional administrative
The IRB shall be able to ascertain the acceptabili-
practices, number of IRBs, and local and state laws and
ty of proposed research in terms of institutional com-
regulations. For each required element, the written IRB
mitments and regulations, applicable law, and stan-
procedures should provide sufficient step-by-step opera-
dards of professional conduct and practice, and shall
tional details so that an independent observer can un-
therefore include persons knowledgeable in these
derstand how an IRB operates and conducts its major
areas.
functions.
If an IRB regularly reviews research that involves a The minimum regulatory requirements for IRB composi-
vulnerable category of subjects, such as children, pris- tion (shown in Box 6) allow IRBs to have as few as five
oners, pregnant women, or handicapped or mentally members and also to incorporate considerable flexibility
disabled persons, consideration shall be given to the into the specification of member qualifications. Thus the
inclusion of one or more individuals who are knowl- specialized IRB—that is, an IRB whose members are cho-
edgeable about and experienced in working with sen to have the expertise needed to review the specific
these subjects. types of research activities usually submitted to that
IRB—is compatible with the regulations.
SPECIAL REPORT / The Ethics of Using QI Methods to Improve Health Care Quality and Safety S27
DHHS regulations altogether, and which do not fall search but does not involve any people who meet the reg-
under the regulations but should nevertheless go to the ulatory definition of human subjects). The organization
QI-IRB because the organization deems them to need the itself sets the boundary between this category and the cat-
kind of review and supervision the QI-IRB provides. It is egory of professional oversight of QI, and it draws what-
not an efficient use of an IRB or QI-IRB to use it to per- ever lines it needs within the category to sort activities and
form this sorting task. The proposal to designate and train direct them to receive appropriate management and su-
one or more specific persons to perform the task is com- pervision.
patible with the DHHS regulations. Specialized QI-IRB review should eliminate some of
the problems in having QI/HuSR activities reviewed by
Separating QI from Research and Defining the Overlap research IRBs; nevertheless, clarifying which QI activities
We have proposed a specialized QI-IRB to review the are subject to the regulatory requirement of IRB review is
QI activities that are also human subjects research and are still important. Dithering over ambiguous classifications
subject to the DHHS regulations. Now we must address wastes time and tends to produce inconsistent decisions
the vexing question of how to determine whether a QI ac- that undermine respect for the review system. Moreover,
tivity falls into this category. if organizations cannot tell which activities are in the
This report has defined QI as “systematic, data-guided QI/HuSR category, they may overload the QI-IRBs with
activities designed to bring about immediate positive activities that don’t need to go there, just to be safe, when
changes in the delivery of health care in particular set- these activities could receive effective management and
tings.” So understood, QI is just a systematic, data-guid- supervision at lower cost within the purely QI oversight
ed form of the clinical and managerial innovation and system.
adaptation that has always been an integral part of clinical Developing a clear rule for separating QI from
and managerial practice. The fact that QI is a normal QI/HuSR can be seen as a conceptual task or as a practi-
health care operation focused on improving local care has cal regulatory task, but of course it is both. What should
been critical to our argument that ethical review of QI one look for in a sorting rule? The rule should use easily
should be incorporated into the system of accountability observed aspects of an activity to determine whether it be-
for clinical care. longs to the hybrid category—avoiding, for example, re-
We have noted that in the process of making local im- liance solely on the intent of the person initiating the ac-
provements, QI may produce information that is of use to tivity and focusing on concrete elements in the activity’s
people in other settings. The regulations define research as design or context. The rule should be as consistent as pos-
“a systematic investigation, including research develop- sible with the use of the word “research” in both common
ment, testing and evaluation, designed to develop or con- language and the regulatory definition, while openly ac-
tribute to generalizable knowledge.” Depending on one’s knowledging that some arbitrariness is inevitable in inter-
interpretation of the last clause, one might argue either preting the word to devise a practical rule for regulatory
that nearly all QI or that no QI should count as research. purposes. Finally, the rule’s arbitrary lines should be
We are persuaded that neither extreme is appropriate. QI drawn so as to best serve the end goal of protecting
reports can provide useful insights, just as individual pa- human participants—from both the harm that might be
tient case reports, success stories, and cautionary tales pro- caused by the activity and the harm caused by quality and
vide useful insights. Nevertheless, like these examples, safety deficits in the health care system.
most QI activities are not research as understood by those Some aspects of the history and purpose of human re-
who framed the human subjects protection regulations. search protection shape the possibilities. The origins of
Nevertheless, some QI activities are genuine hybrids: sys- the regulation of research to protect human subjects lie in
tematic investigations designed to bring about local im- risky biomedical research and public outrage over inci-
provement and develop generalizable knowledge simulta- dents in which researchers conducted research on patients
neously. Such activities are an extremely useful and cost- and members of the public without their knowledge or
effective way to deal with quality and safety problems, consent, or wasted public or shared resources, or took un-
and they must be encouraged if we want to make real reasonable risks with little prospect of gain. What was be-
progress in improving the American health care system. fore the National Commission in the late 1970s was a se-
Drawing lines separating categories of activities is a dif- ries of scandals and a growing research enterprise that had
ficult task in a regulatory system. We have tried to shape shown itself to allow, at times, threats to the wellbeing of
our proposals for ethical oversight of QI to minimize the its human subjects. In responding to this situation, the
need for bright lines separating categories of activities National Commission saw as the domain of research not
while remaining in accordance with current DHHS regu- just insights that were “generalizable” in that they would
lations. The category called local management and super- be true of some other situations, but facts that are essen-
vision covers QI that requires oversight but is not human tial to the nature of the human body and its reactions to
subjects research (either because it does not meet the reg- drugs and treatments, as well as other facts that would be
ulatory definition of research or because it qualifies as re- expected to be true for all time and in all places. In its re-
SPECIAL REPORT / The Ethics of Using QI Methods to Improve Health Care Quality and Safety S29
Introducing these changes may require adjustments in back is delayed or altered in order to avoid biasing the
practice over and above what is specifically mentioned in interpretation of data
a description of the new practice, and the adjustments are
likely to differ from one organization to another. QI is Funding from an outside organization with a com-
about “moving fast but checking on progress as you go”— mercial interest in the use of the results
identifying the adjustments that may be required, tracking
what happens as practices change, and being alert for un- As outlined below in the section on strategies for imple-
expected effects—and thus may be the best way to protect mentation, this initial list deserves to be tested in some
patients as the system adjusts to the change. Ensuring that practical settings, aiming to modify it to fit the actual risks
this very specific and local knowledge is developed in a and projects that arise. Organizations with substantial in-
manner that appropriately protects patients is the essence vestment in overlap projects might well be among those
of QI. It is not an activity “designed to develop or con- best situated to develop QI-IRBs, which are described
tribute to generalizable knowledge,” and in fact, the idea above.
that implementing a new evidence-based guideline in a
local delivery setting is a research project requiring IRB re- Ethical Oversight for Collaborations across Organizations
view seems indefensible.44 This type of activity would not Multi-organization QI activities, such as QI collabora-
require review by a QI-IRB or a research IRB; it would tives, often combine QI activities focused on bringing
generally belong in the category of “local management re- about change in individual organizations into a larger pro-
view and supervision of QI.” ject with an overarching goal of sharing information
Nevertheless, some QI activities really do have a re- about the experience of bringing about positive change.
search component in the sense that they are designed to The collaborative structure may provide for the initial
learn something enduring about the nature and function transfer of technical information about a new practice to a
of human beings and their environment in addition to QI team in each organization, group discussion of how
improving care in the local setting. Perhaps a project is de- best to introduce it using QI methods, and periodic group
signed to improve compliance with guidelines regarding a meetings to boost morale and exchange information
particular treatment, but includes design elements that about failures and successes.
allow the formal testing of a few strategies to gain that The initiators of the collaboration should take the re-
compliance, such as having some sites use QI (while oth- quirements for ethical conduct of QI into account in the
ers use other methods). Perhaps a project employs a new design of the entire enterprise. In deciding whether to par-
treatment that has not yet been fully accepted as the stan- ticipate, each organization should subject the QI activity
dard of care, but embeds that treatment in a QI process at the core of the collaboration to its internal QI account-
aimed at bringing about compliance with other aspects of ability process (assigning it to the appropriate category of
care. Projects like these might well require review as re- review and supervision). The aim is to ensure that the ac-
search, as well as review as QI. tivity is consistent with organizational goals and is de-
What characteristics of projects would make it likely signed so that participants within the organization are
that the project is both QI and research and should be re- properly protected.
viewed by a QI-IRB? Here is a starter set. The main additional issue raised by collaborating with
other organizations concerns the sharing of information
Randomization of patients into different intervention
about the QI activity outside the organization. Care must
groups in order to enhance confidence in differences
be taken to ensure patient confidentiality and conformity
that might be obscured by nonrandom selection (but
to HIPAA rules. The initial transfer of technical informa-
not randomization done to achieve equitable allocation
tion to participants can include assistance in clarifying the
of a scarce resource)
requirements for ethical conduct of the activity, including
the management of protected health information in the
Testing of issues that are beyond current science and
sharing of results. If patient information might sometimes
experience, such as new treatments
be shared, or if follow-back to identify patients is plausi-
ble, then the affected participants should be bound to
The involvement in key project roles of researchers
honor confidentiality through a Business Associate Agree-
who have no ongoing commitment to improvement of
ment or an Organized Health Care Arrangement.45
the local care situation (and who may well have conflicts
Typically, QI collaboratives generate substantial insight
of interest with the patients involved), even if others on
about the effective strategies for QI around a given topic,
the team do have professional commitments
but this does not automatically mean that the collabora-
tive project amounts to research involving human subjects
Delayed or ineffective feedback of data from moni-
and is therefore subject to IRB review. In general, it does
toring the implementation of changes, especially if feed-
not even make it research, since the insights are still tied to
place and time and are acquired while pursuing improve-
SPECIAL REPORT / The Ethics of Using QI Methods to Improve Health Care Quality and Safety S31
projects for which the only significant risk to patients was factor in their choice of provider. This effect is limited,
from a breach of privacy and/or confidentiality. however, since the information available to patients is also
For those QI activities that fall into the QI/HuSR limited, and they rarely have full control over decisions
overlap category, the federal human subject protection about the care that is purchased on their behalf. Market
regulatory system acts as an external accountability mech- forces are most likely to have an effect when they act
anism for the specialized QI-IRBs proposed as part of the through third party purchasers. Health care purchasing
internal accountability structure for the conduct of QI groups and other payers could encourage quality im-
within organizations. provement and its ethical practice by including outcome
Finally, the health care market may enforce a degree of and process standards for the ethical practice of QI in the
accountability through the ability of purchasers to make contracts they make with providers.
the observance of ethical standards in the conduct of QI a
IV. Implementation
Clarify professional and organizational obligations to-
I
mproving the quality and safety of American health
care is of vital importance. Health professionals, man- ward QI
agers, health care delivery organizations, patients, and Organizations of health professionals (physicians, nurs-
government all have an ethical responsibility to cooperate es, health care managers, and so on) should inform mem-
with one another in pursuing this goal. In this report, we bers about their professional obligation to improve quali-
have discussed the ethical issues raised by the use of QI ty. They should also identify the basic QI skills their
methods to improve health care. Using the principles of members should have, educate members about standards
research ethics that underlie the current human research for ethical conduct of QI, and even incorporate quality
protection system as a point of departure, we have defined improvement into professional codes of ethics. Organiza-
the requirements for ethical conduct of QI activities and tions of health care provider organizations (hospitals,
then considered the institutional arrangements needed to nursing homes, health plans, and so on) should educate
ensure that QI conforms to them. We have discussed the their members about their quality improvement obliga-
use of IRBs for ethical oversight of the conduct of QI and tions, the need to ensure that their employees have basic
concluded that IRBs as currently constituted are not ap- QI skills, and the standards for ethical conduct of QI.
propriate for this purpose. Instead, we argue that ethical Leaders in professional education should press for greater
review of QI activities for purposes of protection of emphasis on the obligations of health professionals toward
human subjects should be integrated into a trustworthy the quality of care and the development of QI skills in ed-
accountability system for managing the quality of clinical ucational curricula.
care.
We recommend that the primary responsibility for the Clarify patients’ obligations toward QI
ethical conduct of QI be lodged in individual organiza- When people seek health care, they should be told
tions, where it should be seen as a normal clinical care about the importance of QI activities for maintaining and
obligation and integrated into supervision and manage- improving the quality of their care and informed that con-
ment, with the organizations’ leaders responsible for over- sent to receive care includes consent to a minimum level
seeing the integration. We call this “internal accountabili- of cooperation with ongoing QI. They should be given
ty” for the ethical conduct of QI, and we distinguish three basic information about the organization’s QI program
broad categories of oversight: professional responsibility and told how they can obtain more information if they
for QI; local management review and supervision of QI; want it.
and QI-IRB review for QI that is also human subjects re- Health care organizations should develop educational
search. We recommend that there also be external ac- materials for their patients on the conduct of QI within
countability for the ethical conduct of QI in the form of an organization and on patient rights and responsibilities
procedures to ensure that individual health care organiza- with respect to QI. Organizations, such as JCAHO and
tions have well-designed, functioning internal practices in the Institute for Healthcare Improvement (IHI), and asso-
place to carry out their QI-related responsibilities. These ciations of organizations, such as the American Hospital
procedures should be part of the overall system of holding Association (AHA), might assist with this by promoting
health care providers accountable for the quality and safe- the development and dissemination of model educational
ty of clinical care. materials that individual organizations could adapt for
We have recommended a variety of specific steps by their own use.
which the ethical conduct of QI might be ensured, but
these recommendations bear summarizing.
SPECIAL REPORT / The Ethics of Using QI Methods to Improve Health Care Quality and Safety S33
the setting in which they were developed, and therefore, QI articles would also promote the development and clar-
dissemination by a variety of means should be encour- ification of QI methodological standards.
aged. There has been considerable confusion in the past Editors of medical and other health care-related jour-
about the relationship of publication to IRB review and nals could adopt a standardized format for the reporting
the designation of QI as research; however, at this point, of QI activities for publication, encourage the submission
OHRP and others now seem to be in agreement with of articles on QI methods and results, and become edu-
these conclusions.48 cated about what falls outside of the QI/HuSR range so
The next step is to develop strategies that facilitate the that they do not reject articles that report QI activities just
sharing of QI results. For example, publication of QI re- because they were conducted without informed consent
sults should be encouraged, and the results should be pub- or IRB review. AHRQ, CMS, and other federal agencies
lished in a standardized format so that it is easier to com- could develop and implement ways of providing financial
pare different QI activities and evaluate the extent to support for the conduct of QI, the dissemination of re-
which the conduct of the activities met ethical require- sults, and the development of QI methods, and provide
ments.49 By allowing wider scrutiny of the methods used ongoing guidance on the application of HIPAA privacy
in QI, removal of the current bias against publication of rules to QI activities that involve collaboration across or-
ganizations.
V. Conclusion
A
lthough the findings and conclusions we have ar-
rived at during the course of our research on ethi- research involving human subjects and should meet the
cal issues and health care quality improvement are requirements for review of protection of human subjects
complex and nuanced, they can be summarized as follows: in research.
QI is any systematic, data-guided activity that is de-
Meeting those requirements might be more readily
signed to bring about the immediate improvement of
accomplished with a QI-IRB that met regulations, but
care in a local setting.
whose policies and procedures were also tailored to the
needs and expectations of QI.
QI is both appropriate and vital to health care.
Certain issues might trigger the requirement for for-
QI is marked most distinctly by the prompt feedback
mal review of a proposed QI project: randomized de-
of the effects of deliberate changes to the same care de-
signs, novel treatments, involvement of researchers, de-
livery setting that is making the changes.
layed feedback of monitoring, or external funding.
QI is intrinsic to health care delivery and obligatory
Federal agencies and voluntary organizations should
for both professionals and patients.
cooperate in further developing and implementing these
ideas.
Though QI is often driven by a priori evidence that
suggests substantial benefits are likely for the patients
Resolving the uncertainty about what is ethically and
and/or staff involved, QI can pose some risks to some
legally required to safeguard participants in QI activities is
patients.
essential if QI methods are to be available to help trans-
form the culture of American health care delivery into a
Not undertaking QI in the face of recognized quality
culture committed to continuous quality improvement.
deficiencies also puts patients at risk.
In this report, we have outlined what must be done to
protect patients’ and staff members’ rights to privacy, in-
QI should itself be implemented ethically.
formed consent, and justice when carrying out QI activi-
ties. The challenge now is for the regulatory community
Low-risk QI should generally have the same review
and health care management and professionals to put the
and standards as routine health care delivery.
appropriate standards and practices for QI in place. The
goal—a better and safer health care system—is worth the
Higher-risk QI should undergo routine and orderly
effort.
review within the usual arrangements for clinical super-
vision or by an advisory group.
SPECIAL REPORT / The Ethics of Using QI Methods to Improve Health Care Quality and Safety S35
Grady, “What Makes Clinical Research Eth- “receive and review reports of local, on-site Subjects Regulations Decision Charts,” Sep-
ical?” 2701-2711. adverse events and unanticipated problems tember 24, 2004, http://www.hhs.gov/
29. See F. Davidoff, “Publication and the involving risks to subjects or others and any ohrp/humansubjects/guidance/decision-
Ethics of Quality Improvement Projects,” other information needed to ensure that its charts.htm.
background paper prepared for The Hast- continuing review is substantive and mean- 43. The National Commission for the
ings Center project, “The Ethics of Improv- ingful. In addition, institutions and IRBs Protection of Human Subjects of Biomed-
ing Health Care Quality and Safety.” may require additional information for con- ical and Behavioral Research, Ethical Guide-
30. For an entertaining discussion related tinuing review at their discretion.” See Of- lines for the Delivery of Health Services by
to this point, see the satirical article by fice for Human Research Protections, DHEW: Report and Recommendations
G.C.S. Smith and J.P. Pell, “Parachute Use “Guidance on Continuing Review,” July 11, (Washington, D.C.: U.S. Government
to Prevent Death and Major Trauma Relat- 2002, http://www.hhs.gov/ohrp/human- Printing Office, 1978).
ed to Gravitational Challenge: Systematic subjects/guidance/contrev2002.htm. 44. Note, however, the survey in P.K.
Review of Randomised Controlled Trials,” 39. One might object that a review car- Lindenauer et al., “The Role of the Institu-
British Medical Journal 327 (2003): 1459- ried out by the organization doing the QI is tional Review Board in Quality Improve-
61, and responses by M. Diaz and D. not an independent review. Note, however, ment: A Survey of Quality Officers, Institu-
Neuhauser, “Pasteur & Parachutes,” Quality that the research ethics requirement is for tional Review Board Chairs, and Journal
& Safety in Health Care 14 (2005): 140-43. review by individuals unaffiliated with the Editors,” The American Journal of Medicine
31. Emanuel, Wendler, and Grady, research project, not review by individuals 113 (2002): 575-77, showing that many
“What Makes Clinical Research Ethical?” unaffiliated with the organization in which chairs of IRBs thought such an activity
2705. the research is carried out. Under current should receive IRB review.
rules, IRBs must have at least one member 45. See K. Lawlor, “OHCAs and Collab-
32. In practice, the DHHS regulations unaffiliated with the organization, but the
allow informed consent to be waived for orative Quality Improvement Projects,”
rest can be affiliated. Moreover, the name background paper prepared for The Hast-
minimal risk research provided that several “institutional review board” reflects the
other stringent requirements are met. Such ings Center project, “The Ethics of Improv-
original concept of IRBs as entities responsi- ing Health Care Quality and Safety.”
waivers are considered incompatible with ble for carrying out an institution’s obliga-
ethical principles by some ethicists, howev- tion to protect the human subjects in the re- 46. Bottrell, “Accountability for the Con-
er. search conducted under its auspices. duct of Quality Improvement Projects.”
33. See Dubler et al., “Informed Partici- Human subjects protection was deliberately 47. See American Nurses Association,
pation in the QI Process.” located at the institutional level so that re- Code of Ethics for Nurses with Interpretative
34. See discussion of “notification” in viewers would have knowledge of local con- Statements, June 30, 2001, http://www.
Levine, Ethics and Regulation of Clinical Re- ditions and the opportunity for ongoing nursingworld.org/ethics/chcode.htm;
search, 178-81. oversight (limited though it is). In other American Medical Association Council on
35. See K. Maschke, “Health Care Qual- words, locating primary responsibility for Ethics and Judicial Affairs, Code of Medical
ity Improvement Activities and the HIPAA the protection of human participants in QI Ethics (Chicago, Ill.: American Medical As-
Privacy Rule,” background paper prepared within the organization doing the QI is not sociation, 2004-2005).
for The Hastings Center project, “The a significant departure from independent 48. Statement by Michael Carome, page
Ethics of Improving Health Care Quality review as it currently occurs in research. 158 of transcript, Secretary’s Advisory Com-
and Safety.” 40. A. Gauthier and M. Serber, A Need to mittee on Human Research Protections
36. See J. Lynn, “When Does Quality Transform the U.S. Health Care System: Im- (SACHRP) Meeting, October 5, 2004,
Improvement Count as Research?” Quality proving Access, Quality, and Efficiency (New h t t p : / / w w w. h h s . g o v / o h r p / s a c h r p /
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and R.J. Levine, “Institutional Review 41. M. Bottrell, “Accountability for the 49. See Davidoff, “Publication and the
Boards: A Crisis in Confidence,” Annals of Conduct of Quality Improvement Pro- Ethics of Quality Improvement Projects,”
Internal Medicine 134 (2001): 161-63. jects,” background paper prepared for The and F. Davidoff and P. Batalden, “Toward
37. See Institute of Medicine, Responsible Hastings Center project, “The Ethics of Im- Stronger Evidence on Quality Improve-
Research: A Systems Approach to Protecting proving Health Care Quality and Safety.” ment. Draft Publication Guidelines: The
Research Participants (Washington D.C.: 42. The regulations are complicated and Beginning of a Consensus Project,” Quality
National Academy Press, 2002). difficult to summarize briefly or reduce to a & Safety in Health Care 14 (2005): 319-25.
38. The IRB is required to regularly simple diagram. For more details, see Office
monitor the research. For example, it must of Human Research Protections, “Human
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Healthcare Quality Report (Rockville, Md.: U.S. Department tion 284 (2000): 1786-88.
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Acknowledgments
This project had its origins in an exploratory confer- Two “field trips” taken by the project’s principal in-
ence initiated by Joanne Lynn and Melissa Bottrell. With vestigator, Mary Ann Baily, helped to deepen our under-
Bruce Jennings, they developed a proposal to commis- standing of the issues. One was a trip to Dartmouth-
sion four background papers, convene an interdiscipli- Hitchcock Medical Center, made at the invitation of Paul
nary group of experts, and use the papers as the basis Batalden, who thought it would be a good way to learn
for group discussion of the ethical and policy issues more about the range of QI projects. We would like to
raised by the use of quality improvement methods in thank Polly Campion for organizing a day packed full of
health care. The Agency for Healthcare Research and fascinating give-and-take with people engaged in QI;
Quality (AHRQ) funded the proposal, and the conference there were too many to name individually, but we are
took place in December 2001 in conjunction with the In- grateful to all of them. The second was a trip to M.D. An-
stitute for Healthcare Improvement (IHI) Annual Quality derson Cancer Center, where Mary Ann Baily made pre-
Forum. Intense discussions over two days, in breakout sentations about the project to several different groups.
sessions and plenary sessions, clarified the issues but The trip was a wonderful opportunity to engage in in-
made it clear that further work was needed. This gave tense discussion with people about the issues they faced
rise to The Ethics of Improving Health Care Quality and doing QI activities in the context of specialized cancer
Safety Project, which was also funded by AHRQ and by treatment. We are grateful to all the participants and
in-kind contributions by The Hastings Center. would especially like to thank Mano Selvan and Mar-
We deeply appreciate the hard work of the project garet Holm for organizing the visit.
participants (listed by name at the front of this report) We are grateful to AHRQ for providing funds for the
and the authors of the background papers (referred to in project, and we appreciate the assistance of our project
footnotes to this report). The papers, the meeting dis- officers: Elinor Walker, Marge Keyes, and finally, Robert
cussions, the comments on drafts of the report, and the Borotkanics. We thank the RAND Corporation for provid-
many one-on-one conversations we had with partici- ing us with meeting space for our final project meeting,
pants and authors were critical to the development of and the RAND staff for administrative support for the
this document. We would also like to acknowledge the meeting. Finally, we appreciate the efforts of the various
contributions of several people not listed who shared members of The Hastings Center staff who have provid-
their expertise at individual project meetings: Andrea ed support throughout the project. We thank Mary Ann
Kabcenell, Jenny Kitsen, Charles Bosk, and Jason Kar- Hasbrouck, Ann Mellor, Jay Camp, and Vicki Peyton for
lawish. In addition, we had many stimulating discussions their work on meeting arrangements and project admin-
of the issues with others interested in the project, in- istration, Michael Khair and Stacy Sanders for research
cluding Louis Diamond, Paul Palevsky, Michael Rie, and assistance, and Greg Kaebnick, Joyce Griffin, and Nora
Andrew Kofke. Porter for editorial and design assistance for this Special
Report.
SPECIAL REPORT / The Ethics of Using QI Methods to Improve Health Care Quality and Safety S39
ABOUT ABOUT
THE HASTINGS CENTER THE AUTHORS
On the cover: Arrow Up & Down, by Alexander Calder, 1972, gouache on paper, 74.9 cm x 110 cm.
© Artists Rights Society, New York. Photo courtesy Art Gallery of Ontario.