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3Moral Identity: Codes of Ethics and Institutional
Ethics Structures
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Learning Objectives
After reading this chapter, you should be able to
1. Understand the importance of identifying and promoting core
principles and values that both
reflect an organization’s moral identity and provide a model to
aspire to.
2. Explain the role of codes of ethics in health care
organizations.
3. Discuss the importance of cultural competence as part of an
institution’s code of ethics.
4. Describe the roles of institutional review boards and ethics
committees.
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Section 3.1Codes of Ethics
Introduction
Codes of ethics, institutional ethics committees, and
institutional review boards play an
important role in shaping and reinforcing a health care
organization’s moral identity. In this
chapter we will discuss how codes of ethics align with and
direct an organization’s moral
identity. We will also explore the parameters of codes of ethics,
as well as how to create and
implement them. Finally, we will examine some of the ethical
dilemmas that led to the cre-
ation of committees designed to deal proactively, as well as
reactively, with ethical issues that
health care organizations face.
3.1 Codes of Ethics
Codifying the behavior of individuals within a community has
ancient roots. The oldest dis-
covered physical evidence of a code of ethics was a rock
fragment containing the Code of
Hammurabi, the edict of King Hammurabi of Babylonia dating
back to around 1772 BCE.
The American Medical Association’s (AMA) first code of
ethics, established in 1847, defined
uniform standards for professional education, training, and
conduct, as well as established
that a physician’s main purpose was to obey the calls of the sick
(Baker & Emanuel, 2000).
The code was created with physicians and medical personnel in
mind and provided strict
guidelines on how these employees should conduct themselves
with patients, with fellow
physicians, with the public, and within their profession in
general (American Medical Asso-
ciation [AMA], 2017).
While an institutional code of ethics, or code of conduct, should
ideally be prescriptive in its
language and precise enough to be followed, it may also paint
an aspirational portrait of a
representative member of the organizational community who
lives by the core values of the
institution and embodies the moral identity the institution is
trying to achieve. For example,
Trinity Health (2017) developed a code of guiding behaviors
that encourages the following
six characteristics:
We support each other in serving our patients and communities.
• Build collaborative relationships within and across boundaries
and levels.
• Demonstrate a passion for understanding how to be of service
to external and internal
customers/constituents, and act accordingly.
• Actions are consistent with words publicly and privately.
• Make decisions in the interest of the larger community (UEM)
[Unified Enterprise
Ministry], not just own function, organization or area.
• Once a decision is made, support it publicly and privately.
• Focus on the things that unite us (Mission, goals, service),
rather than on our
differences.
We communicate openly, honestly, respectfully and directly.
• Listen respectfully to others and value their contribution.
• Willingly express point of view directly “in the meeting, not
in the hall.”
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Section 3.1Codes of Ethics
• Communicate respectfully—whether in agreement or
disagreement.
• Create an environment which values diverse points of view
and experience.
• Foster an environment of openness without fear of reprisal.
We are fully present.
• Set aside distractions to be present.
• Seek first to understand, then be understood.
• Openly appreciate the gifts and contributions of others.
• Create a healthy balance between personal and professional
life.
• Contribute to a positive, optimistic and fun environment.
We are all accountable.
• Focus on finding solutions, not blame.
• Lead by positive, motivating example.
• Accept responsibility for his or her decisions and actions.
• Hold self accountable for the success of the larger
organization—across boundaries.
• Focus on the high payoff items.
• Follow through on commitments.
We trust and assume goodness in intentions.
• Talk directly to an individual when there is a concern or
problem, avoid triangle conver-
sations or hidden agenda.
• Assume positive intentions in one another.
• Act in a way that earns trust and fosters an environment of
trust.
• Listen to people and really hear what they mean without being
dismissive or defensive.
• Build trust through open communication throughout the
organization.
We are continuous learners.
• Consistently demonstrate openness to new possibilities.
• Listen with an open mind.
• Challenge “the way it has always been done.”
• Provide and accept coaching and feedback.
• Encourage new ideas and people to try new ways of getting
the job done.
• Demonstrate genuine curiosity before judging.
Reprinted by permission of Trinity Health, Livonia, Michigan.
Many organizations make an effort to gain their customers’, or
in health care organizations,
their patients’, trust by establishing stringent ethical guidelines
regarding how employees are
expected to act. In the health care industry, elements like the
nature of care and employees’
access to extremely personal information make it especially
important that patients feel con-
fident in their chosen health care facility. Therefore, it is not
only important for health care
organizations to establish and practice proper codes of ethics,
but also to increase transpar-
ency by posting them for anyone to see.
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Section 3.1Codes of Ethics
The principles of medical ethics represent an attempt to balance
the tension between pro-
fessional standards and legal requirements. Therefore, the code
of ethics was created with
three sections: the principles of medical ethics, ethical opinions
of the council on ethical and
judicial affairs, and reports of the council on ethical and
judicial affairs (Riddick, 2003). The
AMA established the Council on Ethical and Judicial Affairs
(CEJA) to “maintain and update
the Code of Medical Ethics and promote adherence to the
Code’s professional and ethical
standards” (AMA, 2018). The principles of medical ethics
established by the AMA and the
opinions of CEJA make up the AMA Code of Medical Ethics.
CEJA’s opinions focus on scenarios
in which ethical issues may arise, such as abortion, capital
punishment, and genetic testing.
Many of these scenarios cover patient-physician relationships,
hospital relations, and profes-
sional rights and responsibilities, and are used to periodically
update the Code of Medical
Ethics (the most recent update having been published in 2017).
These updates occur depend-
ing on the numerous changes in health care over the years, such
as the evolution of medical
technology.
The AMA’s code of ethics covers many
areas and provides important require-
ments for physicians and health care
workers; however, the main focus is
patient welfare. Physicians must keep
patients’ best interests in mind and be
honest when treating patients. They
should also be involved with their com-
munities by serving as many patients as
possible, regardless of their ability to pay.
Physicians must also show they are com-
petent enough to treat and communicate
treatment plans with their patients. Com-
petence is key in developing trust with
patients, and it is important for physicians
to be able to communicate clearly so
patients are well-informed about poten-
tial or ongoing treatment. Even physicians
at the top of their fields will have a tough time gaining patient
trust if they lack skills in com-
petence and communication.
Professional Considerations
Ultimately, the AMA Code of Medical Ethics acts as a guiding
document to help health care
facilities develop their own codes of ethics. Though the AMA’s
code originally focused on
physicians’ treatment of patients, adherence to ethical codes
should be mandatory for reg-
istered nurses, nurse practitioners, administrative personnel,
management personnel, and
even allied health care workers. Indeed, any group that is
involved with patient care should
be held to the same ethical standards as physicians, even health
care workers who are not
clinical, such as those in health information management,
billing, and compliance depart-
ments. The following sections cover in more detail ethical
expectations for different roles in
the health care profession.
iStockphoto/Thinkstock
In shaping an entity’s moral identity, it is
crucial to clearly define and communicate
ethical expectations for all members of the
organization’s staff.
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Section 3.1Codes of Ethics
Physicians
Health care disparities and inequalities are a reality of a
growing population and a daily issue
for health care providers. Regardless, physicians are obligated
to provide care without regard
to race, socioeconomic status, religion, or political affiliation
(Bringedal, Bœrøe, & Feiring,
2011). These expectations should be reflected in all health care
organizations’ codes of ethics.
According to Reiter and Runyan (2013), other ethical dilemmas
such as issues of privacy and
professionalism can occur in primary care settings where
multiple family members receive
care through the same practice. In order to prevent such issues
arising, an organization’s code
of ethics should require all health care providers to follow the
privacy rules under the Health
Information Portability and Accountability Act (HIPAA)
(covered in Chapter 5) by providing
confidentiality to all patients.
Nurses
Nurses typically spend more time with their patients than
physicians do; therefore, it is just
as, if not more, important that nurses follow their organization’s
code of ethics. Nursing care
can include both physical and mental interventions, and nurses
must protect any information
a patient provides during all types of care. According to Mylott
(2005), nurses are account-
able to their patients to make ethically sound health care
decisions, and guidelines for doing
so should be included in all health care organizations’ codes of
ethics. The field of nursing
covers such a broad spectrum that nurses may often work
outside of direct patient care. How-
ever, no matter the capacity in which they work, nurses are
responsible for advocating for
their patients and following a strong code of ethics.
Administrative Personnel
The health care system has evolved over decades into a
multifaceted industry. Advancements
in information technology in particular have not only changed
how patients purchase and
manage their health care, they are also responsible for an
increase in the amount of informa-
tion available to patients prior to visiting their physicians.
Patients can go online and gain
insight into myriad health care issues before ever setting foot in
a doctor’s office. Similarly,
health care facilities are now able to retrieve a patient’s medical
records from anywhere in
the world with the click of a button. However, the growth of
information technology also gives
rise to new risks regarding the privacy and protection of these
records. Therefore, it is critical
that health care workers (regardless of whether they are clinical
or administrative) under-
stand their responsibilities under a code of ethics.
Ongoing education covering the rules and expectations for
adherence to an organization’s
ethical practices can help ensure staff compliance, as can clear
communication of any disci-
plinary actions resulting from instances of noncompliance. As
advances in technology and
other innovations continue to change the health care landscape,
it is important that all health
care workers follow the ethical rules and regulations set by their
organizations. Byrd and
Winkelstein (2014) note that several medical associations, such
as the AMA, American Nurs-
ing Association, and the Medical Library Association, provide
guidelines specific to the roles
of a variety of health care professionals. These guidelines can
be used to assist organizations
with developing codes for ethical decision making at all levels
of service. Figure 3.1 outlines
steps that an organization can take to help develop a successful
code of ethics.
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Section 3.1Codes of Ethics
Figure 3.1: Steps to developing a code of ethics
Employee behaviors often cause headaches for leaders of health
care organizations. However, with a
little planning, addressing inappropriate behaviors can be
handled with a solid code of ethics.
Web Field Trip: Maimonides Medical Center Code of
Mutual Respect
In this web field trip, you will listen to a 2008 episode of The
Brian Lehrer Show, a radio
program on WNYC, in which Brian Lehrer interviews Dr. David
L. Feldman, vice president of
perioperative services at Maimonides Medical Center in
Brooklyn, New York. Feldman talks
about how the Joint Commission, which accredits and certifies
health care organizations in
the United States, has begun to crack down on rude behavior by
health care professionals
and how health care organizations are combating this problem.
Feldman talks about how
Maimonides has instituted its Code of Mutual Respect that all
staff and employees must
abide by. It is firmly grounded in the core principles of the
institution and, together with
its detailed Corporate Compliance Code of Conduct, helps
foster an ethical work environ-
ment that is conducive to quality health care without settling for
the minimal standards
that “compliance” alone may connote.
(continued on next page)
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Section 3.1Codes of Ethics
Cultural Considerations
Since all institutions serve their own unique communities, a
code of ethics should also take
the culture of the community it serves into consideration.
Therefore, many institutions pro-
mote cultural competence, an awareness of and ability to
function “effectively . . . within
the context of the various cultural beliefs, behaviors, and needs
presented by consumers and
communities” (U.S. Department of Health and Human Services,
Office of Minority Health,
2001). Although cultural competence training programs have
become customary in many
health care organizations, the definition of these programs and
terms remains imprecise. The
Department of Health and Human Services’ Office of Minority
Health has defined some of the
terms necessary for a robust implementation of cultural
competence training. While many of
these concepts remain open to debate, for the purposes of our
discussion we will adopt the
Office of Minority Health’s definitions.
Defining Culture and Cultural Competence
The Office of Minority Health makes the following statement
about what culture is and how
it influences health care:
The thoughts, communications, actions, customs, beliefs,
values, and institu-
tions of racial, ethnic, religious, or social groups. Culture
defines how health
care information is received, how rights and protections are
exercised, what
is considered to be a health problem, how symptoms and
concerns about
the problem are expressed, who should provide treatment for the
problem,
and what type of treatment should be given. In sum, because
health care is
a cultural construct, arising from beliefs about the nature of
disease and the
human body, cultural issues are actually central to the delivery
of health ser-
vices treatment and preventive interventions. (U.S. Department
of Health and
Human Services, Office of Minority Health, 2001, p. 4)
Web Field Trip: Maimonides Medical Center Code of
Mutual Respect (continued)
Instructions
1. Listen to “Paging Dr. Jekyll,” a 2008 episode of The Brian
Lehrer Show: https://www
.wnyc.org/story/28252-paging-drjekyll/
2. Read Maimonides Medical Center’s (2018) complete Code of
Mutual Respect: https://
www.maimonidesmed.org/about-us/core-principles/code-of-
mutual-respect
3. Write a short critical paper (less than one page) in which you
critique the Code of
Mutual Respect. Assess whether there are any potential gaps or
missing elements
that might be helpful to include in future versions, and try to
identify any ethical
problems that the code might not be well suited to handle. If
appropriate, come up
with some policy recommendations for revisions to the code
that will cover the
issues you have spotted.
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Section 3.1Codes of Ethics
Culture is of the utmost importance in a
clinical encounter. It is often essential to
appropriate diagnosis and treatment, and
it is always central to caring for the patient
because it is a major determinant of an
individual’s health beliefs, values, percep-
tions, and behaviors. Culture helps deter-
mine how people form interpersonal rela-
tionships (Mattingly & Garro, 2000) and
informs the cultivation of collective as
well as individual identities (Holland,
1998).
The Principles of Cultural
Competence
The essential principles of cultural com-
petence are:
1. acknowledgment of the impor-
tance and prevalence of culture in
people’s lives,
2. respect for cultural differences,
and
3. minimization of the negative
consequences arising from cul-
tural differences (Paasche- Orlow,
2004, pp. 347–348).
Generally, cultural competence promotes two of the four
principles of health care ethics:
respect for patient autonomy and justice. However, in most
cultural competence materials,
the reasons given for its importance are practical; among the
most popular reasons are that
it helps to (a) eliminate health disparities in the population, (b)
meet legislative or regulatory
guidelines, and (c) decrease the likelihood of medical
malpractice claims (Paasche-Orlow,
2004). However, the most important reason to be a culturally
competent professional is the
intrinsic good that arises from having a moral commitment to a
culturally responsive, patient-
centered practice. In this context, cultural competence is not
only characteristic of good health
care professionals and the organizations to which they belong,
but is perfectly aligned with
the goals of practicing medicine.
There are cultural competence guides and programs available
that support students’ aware-
ness of cross-cultural health care and foster an interpretive
method of understanding patients.
These guides state explicitly that any descriptions of cultures
found in cultural competence
materials are never the final word but rather a constructive
starting point for the dialogue
with particular patients and their families. Such materials can
be found, for example, at the
Office of Minority Health website:
http://www.thinkculturalhealth.hhs.gov.
Cusp/SuperStock
Achieving cultural competence can help
diminish health disparities that are
disproportionately faced by minority groups.
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Section 3.1Codes of Ethics
Cultural Competence and the Culture of Health Care
Cultural competence education programs typically emphasize
the importance of patient cul-
tures, but they are silent on a very important dimension of
health care delivery: the cultures
of health care organizations and providers. Historically,
references to culture in health care
applied almost exclusively to the patient. In fact, in some
popular cultural competence books,
culture is defined simply as the patient’s perspective. However,
doctors, nurses, allied health
professionals, and health care administrators are also deeply
imbedded in their diverse
personal cultural backgrounds, the culture of Western
biomedicine, and the culture of their
respective professions or fields (Taylor, 2003). It is therefore
important to understand that
the patient (and often the patient’s family, loved ones,
community, and religious heritage)
and the health care professional (and the practitioner’s
community and culture) meet at the
intersection of both of their cultures, as well as the prevailing
laws, mores, norms, and guide-
lines of the clinical context. (Figure 3.2 shows the levels of
competencies that people possess
in working with other cultures.)
A Peek at Practice: Cultural Competence in Action
Despite its importance, it may not always be clear to
institutions and health care profes-
sionals what they can do on a regular basis to practice cultural
competence. In her arti-
cle “Why More Hospitals Should Prioritize Cultural
Competency,” law professor Olympia
Duhart (2017) suggests that professionals keep the following
practices in mind as they are
providing care:
• Be creative and expansive about addressing language barriers.
• Be alert for, and responsive to, mental health challenges.
• Be mindful of stereotypes.
Visit https://hbr.org/2017/05/why-more-hospitals-should-
prioritize-cultural
-competency to read the full article, then answer the following
questions.
Discussion Questions
1. Based on what you have read in this chapter and the
discussion of competence
training in the article, what types of cultural competence
training do you think
would be effective in the hypothetical case Duhart presents?
2. Now consider patients who come from third-world or non-
English-speaking countries.
What kind(s) of cultural competence training would you
recommend to those providing
care for this group?
3. What cultural competence issues might arise when treating
the following patients?
a. Victims of Hurricane Katrina suffering from PTSD
b. Low-income victims of Hurricane Katrina who lack insurance
and suffer from
mental illness
4. Should health care facilities provide paperwork in languages
other than English? If
they do not, and a patient does not follow their discharge
instructions correctly, is
this an ethical issue?
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Section 3.1Codes of Ethics
Figure 3.2: Cultural competence
Cultural competence is an important factor in health care
service and delivery. Indiana University’s
Equity Project identified six specific levels of cultural
competence, as depicted in this graph.
Source: Whittman, P., & Velde, B. P. (2002). Attaining cultural
competence, critical thinking, and intellectual development: A
challenge for occupational therapists. American Journal of
Occupational Therapy, 56(4), 454–456.
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Section 3.2Institutional Structures That Foster and Support
Moral Identity
Blindness to the culture(s) of modern American health care can
make health care practi-
tioners unaware of embedded prejudices and discriminatory
policies within well-meaning
health care organizations. Cultural competence should thus
foster not only the capacity to
understand patients better and be responsive and respectful of
their desires and needs, but
also awareness of the cultural biases of health care
professionals and their potential discrim-
inatory effects on patients. Blindness to biomedical cultural
perceptions and prejudices in
health care can keep us from seeing how the culture of medicine
is complicit in the cultivation
and transmission of stigma and racial bias as well as other
causes of health disparities in gen-
eral (Betancourt, Green, Carrillo, & Park, 2005; Taylor & Lurie,
2004).
3.2 Institutional Structures That Foster
and Support Moral Identity
In shaping its moral identity, a health care organization must
also organize internal structures
to address medical and administrative ethical issues and
concerns. In addition to establishing
a code of ethics and conduct, officials such as compliance
officers, risk management officers,
and officers of general counsel provide a broad range of
oversight. Working alongside these
officials are institutional committees such as ethics committees
and review boards.
Institutional Ethics Committees
In 1976, the New Jersey Supreme Court decision regarding
Karen Ann Quinlan paved the
way for the establishment of institutional ethics committees in
hospitals around the country.
Soon after returning home from a party, the 21-year-old Quinlan
experienced two 15-minute
periods of respiratory arrest. She was rushed to a hospital,
where she lapsed into a persis-
tent vegetative state. Her father, Joseph Quinlan, approached
the court with a request to be
appointed Karen’s guardian so that he might consent to remove
her from life support. Karen’s
physicians, the local prosecutor, and the state attorney general
opposed the request. Until
the Quinlan case, the nation’s appellate courts had not decided a
termination-of-life-support
issue. Therefore, this was a case of first impression for the New
Jersey Supreme Court. Quot-
ing Karen Teel’s article from the Baylor Law Review, “The
Physician’s Dilemma: A Doctor’s
View: What the Law Should Be,” the court in its opinion stated:
I suggest that it would be more appropriate to provide a regular
forum for
more input and dialogue in individual situations and to allow
the responsibil-
ity of these judgments to be shared. Many hospitals have
established an Eth-
ics Committee composed of physicians, social workers,
attorneys, and theolo-
gians, which serves to review the individual circumstances of
ethical dilemma
and which has provided much in the way of assistance and
safeguards for
patients and their medical caretakers. Generally, the authority
of these com-
mittees is primarily restricted to the hospital setting and their
official status
is more that of an advisory body than of an enforcing body.
(Teel, 1975, as
quoted in In re Quinlan, 1976)
Today ethics committees, also called bioethics committees, act
in an advisory capacity to
help determine whether to continue life support for patients
with dire prognoses. Ethics
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Section 3.2Institutional Structures That Foster and Support
Moral Identity
committees were rarely found in hospitals in 1976, when Karen
Ann Quinlan collapsed.
Largely due to the recommendation in In re Quinlan, and
subsequent endorsement by other
state appellate courts that hospitals establish institutional ethics
committees, today most
health services organizations—from nursing homes to the
largest academic medical cen-
ters—have some version of an institutional ethics committee.
In 1992, the Joint Commission, an independent, non-profit
organization, provided accredi-
tation and certification to more than 20,000 health care
organizations in the United States.
The Joint Commission required that hospitals institute a
mechanism to resolve ethical issues
such as that of Karen Ann Quinlan and others that had proved so
vexing and contentious in
the 1970s and 1980s. Today this requirement is usually met by
having some variation of an
institutional ethics committee. These committees are designed
to deal proactively, as well
as reactively, to ethical issues that the organization faces. Joint
Commission standards and the
reaccreditation process constitute a form of oversight of such
committees. In many facilities,
the oversight of bioethics committees is the responsibility of the
medical staff.
There are a variety of institutional ethics committees used
today. Some focus on clinical eth-
ics issues (including offering clinical ethics consultation), while
others look at research ethics
(see discussion of institutional review boards later in this
chapter), and still others confront
administrative ethical or legal issues. There are also specialized
committees (or subcommit-
tees) that look at a subset of the issues mentioned above. Some
institutions have multiple
ethics committees, while others have a single general-purpose
one, and still other health care
organizations may have none. When a particular health care
ethics committee is required by
accreditation standards or law, its membership composition is
usually prescribed by mini-
mum standards in order to foster diversity of views and avoid
conflicts of interest.
Activities and Functions
As a best practice, the form of any organiza-
tional structure should follow its function.
Functions of ethics committees can take a
number of forms (e.g., consultation, policy
development, education), and the subject
matter can vary (e.g., clinical, administra-
tive, research-oriented). This section will
discuss these variables. Large and com-
plex health services organizations, such as
acute-care hospitals and academic health
centers, would probably benefit from hav-
ing ethics committees with expertise in
clinical ethics and a separate committee
or committees that deal with administra-
tive ethical issues. This kind of specializa-
tion and division of labor is desirable. The
ethical issues involved in clinical care—
for example, whether life support should
be removed from a patient or whether a
patient who is unable to consent should
have a particular surgery—often depend
Andrew Shurtleff/AP Photo
At the University of Virginia Medical Center,
neurologist Madaline Harrison chairs a
committee of physicians and other hospital
employees that formally reviews ethics policies
and develops regulations that will address a
range of issues. Institutional ethics committees
can be invaluable in resolving ethical issues that
arise in health care organizations.
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Section 3.2Institutional Structures That Foster and Support
Moral Identity
on an understanding of disease processes and physiology. The
issues also generally involve
the patient, the patient’s family, and the nursing and physician
staff. These issues are quite
different than those in health care administration, which take
the form of deciding whether
to purchase certain equipment or end a certain program. The
participants are usually admin-
istrative and management personnel and can include the
governance of, and representatives
from, the public. Unfortunately, it is still relatively rare to see
an administrative ethics com-
mittee that is specifically devoted to meeting regularly and
discussing administrative ethical
issues (Darr, 2011).
Clinical ethics committees may be involved in policy
development, ethics case review and
consultation, and advisory opinions upon request. Their policy
development role can range
from reviewing or developing the informed consent forms and
policies of the institution, to
making large-scale resource allocation policies for emergencies
or natural disasters. As we
will see in Chapter 6, institutional ethics committees have also
been called on to provide over-
sight (along with the institution’s risk-reduction mechanisms)
for cases of medical mistakes
and to establish and maintain a culture of patient safety in an
organization (Meaney, 2004).
A growing concern is that both clinical ethics consultation and
institutional ethics commit-
tees reflect the diversity of modern health care contexts and
develop the competence and
sensitivity to effectively and respectfully deal with cross-
cultural clinical affairs. In 2014, the
American Society for Bioethics and Humanities (ASBH)
published its “Code of Ethics and Pro-
fessional Responsibilities for Healthcare Ethics Consultants”
and is considering a certification
process for clinical ethical consultants, so the role of
institutional ethics committees in clini-
cal ethics consultation may yet again be changing in the near
future (Fox, 2016).
Institutional ethics committees are now largely seen as
necessary and essential components
of ethical health services organizations. Both clinical and
administrative ethical issues are
often better dealt with through committees, rather than through
unilateral decisions made by
executives or directors. However, committees should be
evaluated from time to time to assure
that groupthink or institutional allegiances are not biasing the
committee’s ethics decisions,
and to assure that the institution is continually helping foster an
ethical environment that
helps the organization better achieve its stated goals.
Institutional Review Boards
On the heels of the Nazi medical “research” atrocities of World
War II, the Nuremberg
Code (1947), along with the later Declaration of Helsinki
(World Medical Association,
1964/1975/1983), became the basis for the federal regulations
that govern most medical
research in the United States (Public Welfare Protection of
Human Subjects, 2004). These
regulations also require independent committees to review and
approve research protocols.
In 1978, the National Commission for the Protection of Human
Subjects of Biomedical and
Behavioral Research (1979) issued The Belmont Report: Ethical
Principles and Guidelines for
the Protection of Human Subjects of Research, which identified
the three basic principles for
research involving human subjects:
1. respect for persons
2. beneficence/nonmaleficence
3. justice
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Section 3.2Institutional Structures That Foster and Support
Moral Identity
The Belmont Report, as well as the regulations we now follow
in clinical research in the United
States, differentiates between clinical practice that benefits the
patient and nontherapeutic
research (where the subject is not expected to benefit directly
from the trial). In the latter,
the commission found the need for further regulatory
requirements, such as informed con-
sent, assessment of risks and benefits, and selection of subjects.
These further requirements,
which include the voluntariness of the subjects and the
requirement of informed consent,
also suggest the principles of respect for persons,
nonmaleficence, and the virtues of justice
and honesty. All are integral parts of our regulatory frameworks
(Public Welfare Protection of
Human Subjects, 2004; FDA, 2013).
The Belmont Report and subsequent regulations set the legal
standard for the protection of
subjects involved in clinical research in the United States. To
implement the regulations and
oversee research, an organizational structure called the
institutional review board (IRB)
was established. As a result, to conform to the regulations and
to protect human subjects
in clinical research, health care organizations conducting
research with any level of federal
funding must establish IRBs. IRBs are independent committees
with diverse memberships
that authorize and review most research that falls within the
government’s definition of
research involving human subjects (Public Welfare Protection
of Human Subjects, 2004; FDA,
2013). IRBs must follow processes and guidelines set forth by
the U.S. Department of Health
and Human Services as well as the U.S. Food and Drug
Administration (for trials that are likely
to produce products or drugs meant for public sale). The
processes and guidelines embody
the principles set forth in The Belmont Report, such as informed
consent documentation and
periodic compliance review. IRBs must contain both scientific
and nonscientific members and
at least one representative from the community (Public Welfare
Protection of Human Sub-
jects, 2004). Although the direct effect of the regulations is
limited to government-funded
research, the indirect effect is that such research is so pervasive
that the regulations establish
the standard of practice for civil torts.
As a result, if a drug company, a medical device manufacturer,
or even a college professor
seeks to perform federally funded or FDA-approved research
that involves human subjects,
the research, and particularly the protection of the human
subjects, must be approved and
overseen by an IRB. Although found in other organizations,
IRBs are part of many educational
organizations and health care facilities. An IRB’s mandate is to
ensure ethical clinical research
and minimize risks to subjects. This is done by determining
whether the risks to potential
subjects are reasonable relative to any anticipated benefits to
subjects or society. IRBs must
also make sure that informed consent is obtained from subjects,
or their legally authorized
proxies, as well as monitor the trial’s safety, equity, and
confidentiality. Additional safeguards
are necessary when the proposed subjects are likely to be
especially vulnerable to coercion
or undue influence; in fact, the bulk of the regulations
concerning IRBs are focused on the
requirements for informed consent.
Other Structures
To support its Code of Mutual Respect, Maimonides Medical
Center has established a “respect
hotline” telephone line, along with an e-mail account where
behavior that is inconsistent with
its Code of Mutual Respect can be reported. Maimonides has
other institutional structures to
help organize responses to ethical lapses as well as help foster
and protect the organization’s
moral identity. For example, there is the Medical Staff
Subcommittee on Respect, which moni-
tors physician compliance with the code (Maimonides, 2009).
Committees such as this are a
common way of handling day-to-day ethical issues that may
arise within an institution.
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Chapter Highlights
Chapter Highlights
• A health care organization’s code of ethics should both reflect
and uphold the organi-
zation’s core principles and values.
• Codes of ethics should be applied to all personnel in the field
of health care, including
physicians, nurses, administrative personnel, and anyone else
who comes into contact
with patients and/or patients’ information.
• When creating a code of ethics, institutions should take into
account the culture(s) rep-
resented in the communities they serve. Institutions should
strive to provide cultural
competence training to all health care personnel.
• There are various institutional structures that foster and
support the moral identity
of health care organizations, including the now nearly universal
institutional ethics
committees and review boards that resolve ethical disputes,
ensure compliance,
consult with clinicians, and form ethical policies in health
services organizations.
Case Study: Preventative Ethics
Instructions: Identify the potential ethical dilemma in each of
the scenarios below. Think
about ways in which a change in policy or in the behavior of
staff or employees of the health
care organization could either help avoid the potential ethics
issue or prevent similar dilem-
mas from occurring in the future.
Scenario A: After taking stock of your hospital’s inventory, you
calculate that the number
of working mechanical ventilators, while sufficient for the
regular daily requirements of
a hospital such as yours, are dangerously below the number
suggested to keep on hand
in case of emergencies such as an influenza epidemic. While
some of the costs involved in
stockpiling this kind of equipment are covered by the federal
and state governments, pur-
chasing the additional ventilators would still mean a sizable
investment by your organiza-
tion. You did not plan for this in this year’s budget, which has
already been approved by the
board of directors. If you choose to purchase the ventilators in
the unlikely event that they
will be needed this year, you will have to seek special
permission from the board to amend
the budget. The board, to be sure, will not be pleased by this
seeming oversight, and you
dread thought of having to do this.
1. What is/are the potential ethical dilemma(s)?
2. What is/are your proposed solution(s), and why?
Scenario B: You notice that more of your nursing facility’s
senior citizens are now arriv-
ing at your facility with advanced directives that state their
treatment preferences at the
end-of-life. While you welcome this new development, you also
notice that many of the
advance directives contain boilerplate language that states “no
heroic measures should be
used when there is no longer hope for a meaningful recovery.”
Much of the care that your
patients receive at the end-of-life involves all sorts of medical
procedures and interventions
that would have been seen as “heroic” not so long ago. In
addition, none of the advance
directives you’ve seen recently have specified what sorts of
medical treatments and what
circumstances the patient thinks are “heroic” and which are not.
(continued on next page)
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resale or redistribution.
Chapter Highlights
Critical Thinking and Discussion Questions
1. Why is it necessary for a health care organization to establish
a code of ethics?
2. What role does the Council on Ethical and Judicial Affairs
(CEJA) play in regard to the
American Medical Association’s (AMA) Code of Medical
Ethics?
3. What three elements of the AMA’s Code of Medical Ethics
do you believe are most
important?
4. What institutional structure oversees human subject research
that is at least par-
tially federally funded?
Key Terms
code of ethics A compilation of rules for
ethical conduct for a community or society.
Although the values that codes are aim-
ing to protect, endorse, or foster are often
implied in the language used, codes gener-
ally focus on specific behaviors and actions
that are forbidden or state the minimal
behavior necessary to avoid incurring a
punishment.
cultural competence The ability of a
health care provider to effectively tend to
consumers and communities with particu-
lar cultural beliefs, behaviors, and needs.
institutional ethics committee A group
whose task is to deal proactively and reac-
tively with ethical issues that its organiza-
tion faces. Also called a bioethics committee.
institutional review board (IRB) An
independent committee made up of diverse
organizations and community members
that review the ethics of research involving
human subjects. IRBs are highly regulated
and subject to significant governmental
oversight.
Case Study: Preventative Ethics (continued)
1. What is/are the potential ethical dilemma(s)?
2. What is/are your proposed solution(s), and why?
Scenario C: You have always been proud of the fact that your
clinic’s staff and employees
rarely complain to you or your management team of ethics or
compliance violations or
concerns. However, after reading a journal article on the general
reluctance of staff and
employees to report ethical concerns or even grave problems to
supervisors, you begin to
wonder if your clinic’s “clean record” is true. The research
article suggested that absent
clear policies for non-retaliation toward whistleblowers, many
ethical problems remain
unreported. You wonder how difficult it will be to justify
initiating any new policies if there
is no evidence that the policies are needed to address any
specific problems at your clinic.
1. What is/are the potential ethical dilemma(s)?
2. What is/are your proposed solution(s), and why?
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630
Student Class Registration System Individual Project
Phase 1: Requirements Analysis
1. Problem Definition
ABC University needs a new student registration system for
classes. The current registration method is time consuming and
inefficient for the growing student base. In order to cope with
the demand, ABC university has decided to move forward with
the implementation of a fully automated system for class
registration. The registration system in use now requires
students to meet with their advisors prior to the semester and
decide upon class requirements for the coming term.
Afterwards, the advisors register the student for their classes.
ABC University hopes that this new system will limit the
advisors to an advisory role and students can move forward with
registration on their own.
2. Issues
ABC University currently does not have a portal for students to
register for classes on their own. The current system access is
limited to advisors and it is incumbent upon the advisors to
register students for classes. With a growing student population,
ABC University is not able to respond to the rising need for
advisors during class registration time. In order to provide a
solution to this issue, ABC University is looking to implement a
fully automated online portal system that allows students to
select and register for classes on their own; advisors would
continue to serve in an advisory capacity. The only advantage
currently provided by the existing method is that each student
would get advisor time and the school can maintain a high level
of customer service. The consequence of the current method is
that the school is very limited to how many students they can
have because class registration is a long, drawn out procedure.
The goal of the new system is to automatically provide all
necessary information for students to be able to register on their
own. The system will be connected to the ABC University
database and be able to report on class availability, class
schedules, and professors for the class. The student will still
have the ability to visit their advisor on an as needed basis but
if the need is not there, the student will be able to register on
their own. The benefit of this new system is that the school can
now aggregate data such as:
· Class popularity,
· Wait lists for classes,
· Professor popularity,
· And class descriptions.
Should the new system be successful, university faculty will
experience a rise in time, work, and money. A fully functioning
system can help a student stay on track from the beginning of
their college career to the end. The users of the portal will be
full time and part time students of ABC University. Besides
helping university faculty free up more time, the new system
will also help in increasing student satisfaction by being a great
service to students in ways such as:
· Allow students a better chance to register for desired classes,
· Allow students to register for classes based upon their
schedule,
· And drastically decrease the time spent on the registration
process.
3. Objectives
The creation of a student registration portal for classes would
serve a number of objectives.
The most important objectives are:
· Log in process to ensure security,
· Display of detailed courses required for student’s degree,
· Virtual schedule before registration is finalized,
· Linked to university database to accurately report class
availability,
· Registration confirmation,
· And student advisement report for progress tracking purposes.
It is crucial for the student to be able to access the portal from
any location so they can register at their convenience. Should a
student choose to not visit their advisor in person, the
advisement report will aid in helping a student stay on track in
terms of which classes they need to take and which they have
completed. With the virtual schedule, a student will be able to
get a visual representation of what their semester will look like
so they can have a better foundation for planning their
extracurricular activities.
The advantages of these achieving these objectives for the
university are incredibly practical. Since one of the major
concerns was that the student population was stunted due to
lack of advisors available, this frees up university advisors to
be able to meet with students that need the extra support.
Additionally, it allows the university to track and monitor
students’ progress in their degree.
4. Requirements
The design of the student registration portal for ABC University
has functional, non- functional, hardware, and software
requirements. They are broken down below.
4.1 Functional Requirements
The portal functional requirements are detailed below:
· The system proposes possible schedules to the student during
registration;
· Search function;
· Student degree progression tracking;
· Integration with university database;
· Administrative report generation;
· Administrative override functionality;
· Administrative action tracking;
· Override reversal;
· Course detail display including class capacity, professor,
waitlist, seats remaining, and description;
· Staggered access for registration to prevent overload and
allow priority;
4.2 Non-Functional Requirements
4.2.1 Appearance Requirements
ABC University’s logo and the existing basic design of
university should be displayed. The system should achieve basic
web design standards similar to ones proposed by the US Digital
Service. The design and the color should make users feel
comfortable when using the portal. The design should also
reflect the seriousness of the university environment.
4.2.2 Usage Requirements
The overall design of the portal ensure ease of access, usability
and maintain user efficiency. The portal design should ensure
that the user will have an easy learning curve so the portal can
be seamlessly adopted by the stakeholders. Stakeholders should
have the option of undoing any changes made to their own
records as well as offer redundancies in checking and
confirming their selections.
4.2.3 Accessibility Requirements
The portal should follow national guidelines such as 508
Accessibility requirements to ensure accessibility by all
stakeholders. The portal design should take into consideration
stakeholder disabilities and the design should allow for them to
access as well. In order to maintain accessibility, the portal
design should also be
4.3 Software Requirements
In order to be scalable and user friendly, the proposed system
has the following requirements:
· Responsive in design,
· Browser agnostic,
· Maintain acceptable speed and latency for use;
· Maintain data reliability;
· Allow for access through any device with web access;
· Maintain easy of administration so university IT will have
· Accessibility compliant (example: 508 compliant)
4.4 Hardware Requirements
Since the solution is web based, the hardware requirements will
be limited for the proposed system. However, there are some
needs and they are listed below:
· Function on a minimum of 2GB RAM
· Functional on basic graphics hardware (example: video card,
device display, etc)
· Operating system agnostic
· Device processor compatibility (example: intel i5 chip or
higher)
5. Constraints
In order to have a clear understanding of the design constraints,
it is necessary to understand the environment in which the
system will be implemented. The portal will have to interact
with the university’s current environment. Therefore, it is
important in maintaining
control the adjacent systems such as the university database(s)
and/or the computerized environment. The development of this
portal will not require any increase in physical space. Due to
the need for accessibility, it is important that the portal remain
device and browser agnostic because it is to be expected that
stakeholders will try to access the portal remotely from
anywhere. Lastly, it is important that the solution takes into
consideration user and administrator technical abilities. The
portal should be capable of being updated to follow
standardized compliance regulations and not interfere with
stakeholder performance.
6. Proposed System
To combat the difficulties of student registration at ABC
University, a student registration portal has been presented as a
potential solution. The ultimate goal of this portal is to increase
the efficiency of student class registration and allow ABC
university to grow their student population so it is important
that the solution remains scalable.
Armed with a comprehensive understanding of ABC
University’s environment, the proposed solution is a web-based
portal that pulls data from the university’s database and
displays information for the stakeholder regarding classes, class
details, class schedules, etc. Aside from IT, the two
stakeholders are students and administrators. Both groups of
stakeholders will have their own log in to utilize the portal. The
student will have access to the following information in the
portal:
· Student ID
· Name
· Date of birth
· Password
· Mailing address
· Registration date
· Student status
· Contact information
· Image
As a user, a student can perform the following tasks:
· Registration
· Branch selection
· Scheduling
· Search
· View class details
· Generate advisement reports.
Available to stakeholders is the log in portal. This portal allows
for authentication of user accounts. All stakeholders will have
their own unique credentials for the portal. Once logged in,
stakeholders have the ability to search the university database
for the data they need. Students will be able to search for the
classes they register, see the details for the classes, create a
mock schedule prior to confirmation, and finalize their
selections. Administrators will be able to see class details,
reverse changes to student schedules, and create priority
registration for students
that are allowed that. User management is limited to be used by
administrators such as IT and/or university faculty. Students
will not see or have access to this part of the portal.
6.1 Data Flow Diagram
After the student requests a log in to the registration portal and
access is granted, the student is able to request information
from the portal in terms of class information, class schedule,
and make edits. This information is pulled from the ABC
University database. For administrators, the format is very
similar. The administrator is submits a log in request and once
it is granted, they are able to view the student data, class data,
and make edits to the data in the portal. Similarly, the
information is also retrieved from the ABC University database.
Data input into the registration portal is transferred to the ABC
University database.
Phase 2: System and Database Design
7. User Interface
The user interface design for students and administrators are
shown below.
Student registration portal log in
Each student and administrator will have their own unique
credentials to log into the portal on this interface. Once they log
in, they will be able to view the information available to them
in the next page.
Student portal interface
This is the student class registration portal. This is where a
student will be able to access their class registration by
following the “add/drop class” link. The other options available
to them is their class schedule, their personal information, their
advisor information, an ability to sign up for graduation, and an
advisement tool should they feel they do not need to meet with
an advisor in person.
Administrator portal interface
As an administrator, their main job has been to aid the students
in registering for their classes. Once an administrator logs in,
they will be able to see their own calendar that typically
displays meetings with the student. Since administrators have
no need to add/drop classes for themselves, their registration
portal will be slightly different from a student’s.
Student course search interface
When a student navigates to their add/drop class portal, this is
the interface they are presented with. They will have the ability
to search for a specific school term and search using keywords
or course numbers to find the classes they intend to take.
Student Course Search Results
Once a student searches for the class they would like to take,
the portal than directs them to a results list of the results. These
results include classes that have reached capacity and are
identified with the letter F under status, and classes that have
not reached capacity. Once a student selects the class, they click
“add” to include it in their schedule.
Student Registration Portal Class Registration Completion
Upon completion of registration, the student home interface of
the registration portal will display the class that the student
registered for.
7.1 Logical Model Design
8. System Architecture
The student registration portal is a web-based portal that
interacts with an existing database of information. Once a
stakeholder (student or administrator) accesses the web portal,
the web portal pulls information from the ABC University
database and displays the information requested.
8. Conclusion
With the implementation of a student class registration portal, it
will allow for ABC University to more efficiently process class
registration. The shift from manual registration by student
advisors to a more automated solution has been long awaited.
With the implementation of a student registration portal, the
university can grow their student population and advisors would
have more free time devoted to other tasks. The class
registration process would not take as long and it would become
a more efficient process. The initial roll out of the portal will
have to be monitored but the potential to build upon the student
registration portal will be great.
1The Evolution of Health Care Ethics: Overview, Theories,
and Methods
Travel Pictures Ltd./SuperStock
Learning Objectives
After reading this chapter, you should be able to
1. Summarize major factors that contributed to the interest and
importance of medical ethics in
the mid-20th century.
2. Identify the major factors associated with the rise of
bioethics committees, as well as with
their primary functions.
3. Summarize ethical theory and how it attempts to explain and
guide right action.
4. Discuss principlism, along with its strengths and weaknesses,
as a prime method for
addressing ethical problems.
5. Explain the process for ethical decision making.
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resale or redistribution.
Section 1.1The Rise of Contemporary Health Care Ethics
Introduction
Ethics is a word that is frequently used, heard, and seen in the
media. It generally refers to
what people should do and how they ought to act. However, the
meaning of the term is often
unclear, and people do not always share a common
understanding of what it means to be
ethical or behave ethically. Additionally, what some may see as
an ethical issue, others may
not. Therefore, those going into the field of health care must
learn the theories, principles,
beliefs, and values that guide ethical decision making and
problem-solving in the health care
environment. While there are many concrete laws, rules, and
regulations that must be fol-
lowed to the letter in health care, the application of ethics in
health care is more fluid in that
each situation requires unique considerations and each outcome
may be different as a result
of those considerations.
As an academic study, ethics refers to a systematic analysis of
the rightness and wrongness of
actions, along with the theoretical basis and methods used in
deciding which course of action
to take. Ethics also encompasses a very practical application: It
seeks to provide a guide to
behaviors. How people behave toward one another is based on
their personal morals as well
as on societal ethics. There is some universal agreement about
what is right and wrong; for
example, murder and incest are almost always considered
wrong. However, there is much
variability in what an individual or particular society considers
ethical behavior, depending
on its laws and norms. This is in part due to the fact that
different peoples regard different
situations as posing an ethical dilemma, or a situation in which
they are uncertain about the
correct course of action. The goal of applied ethics is to identify
and resolve such dilemmas.
Given that Western societies, particularly the United States,
comprise many communities,
cultures, and languages, it is not surprising that there is
difficulty formulating concise and
coherent language to describe a comprehensive set of ethical
standards that can be applied to
society at large. Similar challenges arise within organizations.
These challenges are particu-
larly pronounced in health care organizations, where
communities, cultures, and languages
intersect on a daily basis, sometimes under critical and urgent
circumstances. Therefore, the
major question we will explore in the chapters that follow is:
Can health care professionals
and organizational decision makers identify a core set of
fundamental precepts and prin-
ciples that should be considered regardless of location, religion,
and law? We will consider
which principles are to be prioritized, as well as how to address
ethical questions systemati-
cally. First, we will explore the ways in which health care and
ethics have intersected through-
out history.
1.1 The Rise of Contemporary Health Care Ethics
Doing the right thing has long been a tenet of medical
practitioners, with doctrines of ethi-
cal practices such as the Hippocratic oath dating back to the 5th
century BCE. Though other
philosophers have commented on the oath and ethical duties
over the centuries, and some
have recently written contemporary versions, the original
remains foundational to medical
practice. Graduating physicians still swear to uphold the tenets
of the oath, which include
the promises to practice fidelity (faithfulness), observe patients’
confidentiality, and have
respect for those under their care.
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resale or redistribution.
Section 1.1The Rise of Contemporary Health Care Ethics
Until the mid-20th century, health care was delivered without
significant technology or capa-
bility other than simple procedures and a great deal of
compassion. For example, sterile tech-
niques and anesthesia were unknown until the beginning of the
20th century, and antibiotics
were not developed until World War II. In cases where effective
treatments were not readily
available (or not yet invented), paternalism, or the belief that
the doctor knew best, was not
significantly challenged, and, according to Cotler (2013),
“kindness and caring were indeed
the best medicine” (p. 4).
Beginning around the 1950s and 1960s, advents in both
medicine and medical technology
increased choices and costs, which complicated medical
decisions. In the 1960s, the invention
of dialysis, ventilators, and intensive care units vastly improved
patient health; the advent of
dialysis, for example, meant that patients could now be
maintained on machines that essen-
tially function as kidneys by mixing and monitoring the fluid
that removes unwanted waste
products from a patient’s blood. Such advancements in
knowledge and technology were mak-
ing it clear that age-old applications of medical ethics were no
longer sufficient, and with that
realization the field of bioethics was born. Drawn from the
combination of the words biology
and ethics, bioethics became the health care community’s
answer to the question of how to
study ethical issues arising from advances in biology and
medicine.
Coinciding with a rise of technology were social
justice movements calling for increased civil lib-
erties and women’s rights. As part of these move-
ments, individuals and interest groups also agi-
tated for the right to make health care decisions
(Cotler, 2013). On occasion, patients, their fami-
lies, and their physicians disagreed about
whether to continue treatment. In those cases it
was not clear what to do, who should decide, and
what basis to use for decisions. Given the plural-
istic society of the United States and the fact that
the nation lacks a common ethos, these decisions
fell to the courts. New technology also required
capital-intensive hospitals, specialization, and
new financing mechanisms. Specialists who often
did not have any relationship with the patient or
the family replaced the old family doctor who had
the luxury of knowing his or her patients. This
affected the physician-patient relationship, and
new forms of health care delivery developed.
In addition to court decisions that influence prac-
tice, heightened public expectations sometimes
result in malpractice suits. In turn, many physi-
cians practice defensively. Practice is also regu-
lated by third-party payers, including the state
and federal governments and insurance compa-
nies. Many health care organizations incorporate peer review
for their physicians, and many
hospitals are accredited through an independent, non-profit
organization known as The Joint
Commission.
Exactostock/SuperStock
Advancements in medical technology,
especially in life-support systems, have
given rise to new ethical dilemmas for
doctors, patients, and family members.
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Section 1.1The Rise of Contemporary Health Care Ethics
Organizations and Physicians
The relationships of individual physicians to health care
organizations have become increas-
ingly important and complex. These relationships vary by the
particular characteristics of
the organization, which may be integrated vertically, with
facilities that offer either a lower
or higher level of care (such as nursing homes or tertiary care
hospitals), horizontally, with
similar institutions at the same level of care, or both vertically
and horizontally. Hospitals also
differ in their characteristics and feature a wide array of options
and potential arrangements:
Health care organizations might be religious, private,
governmental, for-profit, urban, or com-
munity-based. According to Cotler (2013), the structural
differences among organizations
do not prevent ethical challenges; they simply change some of
the contextual details of the
cases. Individuals and organizations have somewhat different
roles and functions, but they
all share the principal aim of quality patient care. However,
they also may compete for limited
resources and power, which could create conflicts of interest.
Thus, “duties and responsibili-
ties of the board of directors, the CEO, and the administrative
team and their relationships to
individual physicians and medical groups all present potential
ethical pitfalls” (Cotler, 2013,
p. 14). The following are examples of structural differences that
could potentially pose a con-
flict of interest:
• Physicians may work independently of the organization in
their own office, but they
will usually also be a member of the medical staff, which has its
own bylaws. They
are thus constrained by rules with which they may not agree or
which they may not
respect.
• Administrators may have loyalty to their institution, but as
part of a corporation,
they are also required to comply with financial and managerial
demands. Potential
financial and clinical conflicts are part of their daily lives.
• The board of directors has differing power, authority, and
functions, depending on
whether the facility is independent or part of a corporation. Its
philosophy of care
may diverge from the corporation or from administration. In
addition, the boundar-
ies of the board’s authority may not be clear.
Human Subjects Research
Another historical influence on the rise of bioethics was the
realization, which began around
World War II, that persons all over the world had been forced to
become subjects in clini-
cal research; in other cases, research subjects were mistreated
or abused. Perhaps the best
known example in the United States of grievous research
misconduct was the Tuskegee
syphilis study conducted by the U.S. Public Health Service from
the late 1930s until the early
1970s. In that trial, individuals afflicted with the disease were
not given antibiotics, despite
availability and efficacy. Table 1.1 shows the number of
participants who were not treated for
syphilis for research purposes. Many research abuses have been
reported worldwide, and in
response, the international community has developed codes and
regulations that foster ethi-
cal practice.
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Section 1.1The Rise of Contemporary Health Care Ethics
Table 1.1: Participants in the Tuskegee syphilis study
Results of the Tuskegee syphilis study conducted from 1932 to
1972. In 1932 poor Black
sharecroppers from Macon County, Alabama, were recruited to
participate in the study so researchers
could follow the progression of untreated syphilis over time.
The men all believed they were receiving
free health care and did not know they had the disease. The
controversial study led to tight federal
regulations that require informed consent to protect human
research subjects.
Control
participants
Syphilitic
participants
Total
Classification at initial examination 200 411 611
Cases added in 1938–1939 – 14 14
Total—original classification 200 425 625
Controls infected during
observation
–9 +9 –
Controls reclassified as syphilitic
on basis of additional history
–1 +1 –
Controls reclassified as syphilitic
on basis of treponemal tests
–8 +8 –
Total—final classification 182 443 625
Known dead—number 97 276 373
Known dead—percentage 53.3 62.3 59.7
Remainder; examined in
1968—number
36 53 89
Remainder; examined in
1968—percentage
42.4 31.7 35.3
Source: Department of Health, Education, and Welfare. Public
Health Service. Health Services and Mental Health
Administration.
Center for Disease Control. Venereal Disease Branch. (1969).
Tuskegee syphilis study administrative records, 1929–1972.
Retrieved
from https://catalog.archives.gov/id/281642
Indeed, ethics committees in many countries remain concerned
with research rather than
clinical or organizational issues. Clinical trials are heavily
regulated to protect quality and
human safety. According to Cotler (2013)
Major ethical issues, surrounding the protection of human
subjects including
informed consent, confidentiality, conflict of interest, and
justice, are similar
to the clinical concerns. There are essential differences between
the clinic
and the clinical trial. Patients’ rights to refuse recommended
treatments are
well established. In research, the primary ethical goals surround
protection
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Section 1.1The Rise of Contemporary Health Care Ethics
of human subjects . . . This is a soft paternalistic approach
justified by a long
and widespread international history of abuse of human subjects
and by the
complexity of proposed trials which require highly regulated
review by insti-
tutional review boards (IRBs). (p.13)
The true differences between clinical care and research,
however, are in their goals. In clini-
cal care, the goal is to heal and care for; in research, it is to
discover and increase knowledge.
Possible research ethics issues include:
• how research subjects are selected
• access to studies
• use of placebos
• international trials
• compliance
• relationships with outside vendors (Cotler, 2013, p. 14)
Another potential dilemma can occur when patients are asked to
participate in clinical trials
being run by their personal physician. While a patient must give
consent to take part in a clini-
cal trial, even if it is being conducted by their personal
physician, both parties may be wary of
the potential conflict when the researcher and the clinician are
the same person. For instance,
a patient may wonder if the physician is acting as the researcher
or as the treating doctor
who places the patient’s interests above all. Some ethical
dilemmas are not easily resolved by
regulation, and so require extra careful attention from both
professionals and organizations.
Bioethics Committees
According to Cotler (2013), bioethics committees (BECs) “have
grown as a response to
demands raised by exploding medical technology, diversity
among the population, directives
from the courts, and health-care systems attempting to address
ethical conflicts in health-
care organizations” (p. 6). Technology has increased choices
and thus raised questions about
what medical decisions to make, who should make them, and
when they are appropriate.
Ideally, BECs can prevent some of the many ethical dilemmas
posed by these developments.
Preventive ethics implies that the best resolution to a dilemma
is to prevent it from arising
in the first place.
Global diversity means that people of different cultures and
beliefs bring an array of perspec-
tives and values to the table when they make critical health care
decisions. In some countries
religion plays a strong enough role that it provides direction,
and possibly resolution, to ethi-
cal issues through consistent moral authority. Examples include
the Catholic Church’s prohi-
bition of elective abortions and the Islamic prohibition of male
physicians touching female
patients. Most countries lack a single authority, however, and
many developed nations have
various multicultural communities. Thus, particularly in diverse
regions that lack a unified
religion, language, or culture, there is confusion over how to
universally address or resolve
ethical dilemmas.
In an effort to prevent such confusion, most hospitals have
established a mechanism for
addressing bioethical problems such as who has the authority to
give informed consent,
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Section 1.2Theories and Methods of Contemporary Bioethics
whether to continue life support, and how to resolve
disagreements between or among care-
givers and families when patients can no longer represent
themselves. Some larger institu-
tions and university medical centers employ clinical ethicists.
In the United States and other
Western nations, most bioethics committees are part of the
medical staff, although some are
part of administrative departments. Though many other
countries rely on ethics committees
to also review proposed clinical trials and other institutional
research, there is increasing
interest in the Western model, which features a BEC that
focuses on clinical concerns and
an IRB that manages ethical concerns in research. The function
of bioethics committees and
institutional review boards will be discussed in greater detail in
Chapter 3.
Prior to the mid-20th century, theology and philosophy provided
the foundation for bioeth-
ics scholarship. However, it was soon clear that the questions
generated by new technology,
which included life-sustaining equipment and complex
organizational structures, required
ethical study and explicit practice standards. Thus, in the
United States, the 1960s and 1970s
saw the birth of freestanding and university-affiliated entities
devoted to the study and reflec-
tion of bioethics. Early prominent examples are the Hastings
Center, which is freestanding,
and the Kennedy Institute of Ethics, which is affiliated with
Georgetown University. Several
professional organizations (now largely subsumed under the
American Society for Bioeth-
ics and Humanities) also developed within philosophy, law, and
medicine. The field is still
very new, and it continues to struggle with creating an identity,
determining its own code
and structural requirements, forming a unified theory and
method, and determining whether
such a multidisciplinary field should even have a unified theory
or method.
1.2 Theories and Methods of Contemporary Bioethics
Before turning to the specific ethical issues health care
practitioners face, an introduction to
ethical theory is helpful. The goal of this section is to discuss
ways to think about the rightness
or wrongness of actions that have been historically important.
In particular, we will focus on
principlism, an approach commonly used in health care, and
how it is applied by practitioners
to resolve bioethical problems.
Ethical Theory
Traditionally, ethical theory has been the purview of
philosophers, including Immanuel Kant,
John Rawls, and John Stuart Mill. Today, ethics, or moral
philosophy, is a major branch of aca-
demic philosophy. Moral philosophers ask questions such as,
“What features of an action or
event make it right or good?” “What are the sources of our
moral obligations?” and “Do out-
comes matter when determining the rightness of an action? If
so, are they all that matter or, at
least, the most important factor?” Philosophers then attempt to
systematize their answers to
arrive at an explanation of the rightness or goodness of actions
and events in general. These
explanations are ethical theories. In essence, an ethical theory is
a view about what makes
actions or events right or good; an ethical theory gives general
criteria for rightness and iden-
tifies the right-making features of actions and events—in other
words, that which we should
take into account when judging whether an act is right or
wrong. To see what philosophers
mean by “right-making features,” consider the case study
Rationing the Antidote.
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Section 1.2Theories and Methods of Contemporary Bioethics
Principlism
There are several methods for “doing ethics.” Whatever
methods, or combination of methods,
apply to the individual case or problem, it is helpful to
remember that, basically, ethics is
about respect for persons, truthfulness, and fidelity. Primarily
in the 1970s and 1980s, courts
and philosophers emphasized principlist ethics, which stresses
the application of general
principles, in a top-down fashion, to serve as the basis for rules
or guides to action. These
general principles include autonomy, nonmaleficence,
beneficence, and justice. The princi-
plist approach has mainly been associated with Tom Beauchamp
and James Childress (2009),
the authors of the canonical text on principlism, Principles of
Biomedical Ethics. Figure 1.1
provides a diagram to help visualize the four principles.
Case Study: Rationing the Antidote
You are a hospital administrator. One afternoon, the director of
your emergency department
notifies you that six patients have been brought to your
emergency room, all of whom are
dying after ingesting a rare poison. Unfortunately, your facility
does not have a large enough
supply of the antidote on hand to save the lives of all six
patients. There is also no way to
acquire more antidote in time to save all the patients. The
patients must be treated within
one hour of ingestion of the poison for the antidote to be
effective, and time is already run-
ning out. The director informs you that one of the patients has
ingested a much larger dose
of the poison than the others. If the antidote on hand is divided
five ways, there will be
enough antidote to save the five who ingested a small dose. In
order to save the patient who
ingested the large dose, however, all the antidote on hand would
have to be administered.
How should the emergency department staff distribute the
antidote?
The answer probably seems clear. Of course, the antidote should
be divided among the five
patients who require a smaller dose. Given that the hospital has
a choice between saving
one life or saving five lives, the hospital should save the greater
number. This requires the
assumption that there are no other factors that should influence
the decision about whom
to save. If, to give an extreme example, the five patients were
violent criminals who escaped
from prison and the one patient was the president of the United
States, some might think
the hospital should act differently. Or what if the patient who
took the larger dose was a
major donor to the hospital and the other five patients were just
members of the com-
munity? While many may feel that a person’s social standing or
ability to financially invest
in a certain institution should not be considered in a case like
this, ethical dilemmas like
these can come into play. The antidote case study is, of course,
imaginative and unrealistic.
However, it highlights an important moral intuition that many
people share. In fact, in 1960
when dialysis units were first developed in Seattle, Washington,
there were not enough for
everyone who needed them. The question of how to distribute
them was real, and a process
for deciding had to be developed prior to selecting patients.
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Section 1.2Theories and Methods of Contemporary Bioethics
Figure 1.1: Venn diagram of ethical principles in health care
A useful way to imagine the four ethical principles is as a Venn
diagram, or a group of overlapping
areas of concepts. These areas overlap because often the
concerns and questions associated with the
principles occupy more than one area. For example, “respecting
a patient’s choices” falls under
autonomy, but it can also fairly be described as observing the
principle of nonmaleficence, since
disrespecting a person is a form of harm. It might also be
described as falling into the category of
beneficence if respecting a patient’s wishes fosters autonomy or
a sense of control that may itself be
therapeutic or beneficial.
Dan Bustillos
Autonomy
Court decisions in a variety of landmark cases have established
autonomy as the dominant
ethical principle. Literally meaning “self-determination,”
autonomy grants patients the right
to be left alone and not be touched without permission, and it
forms the basis for our laws
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Section 1.2Theories and Methods of Contemporary Bioethics
against battery. However, no one is entirely self-determining.
Everyone has aspirations and
dreams, and yet everyone encounters reality. In health care, for
example, providing what the
patient wants must be contrasted with what he or she gets; this
is limited by the physician,
who is responsible for clinical judgment and determining
medical necessity.
According to Cotler (2013), the autonomy maxim “Do not do
unto others that which they
would not have you do, and keep your promises” has been such
a misunderstood concept
that Englehardt (1996) renamed it the principle of permission.
Autonomy forms the rationale
for informed consent. If one may not touch another without
permission, informed consent
provides a mechanism to obtain the permission by declaring
risks, potential benefits, and
alternatives. Note that the maxim includes the mandate to keep
promises. Autonomy is par-
ticularly confusing to providers and patients in that the
principle grants the right to accept
or reject recommended treatments, but decisions about
appropriateness and effectiveness
are the domain of the physician. Many cultures value
community over individual choice, and
autonomy may not be the most important value for such
communities. It may not even be
considered. In all cases practitioners need to discuss decisions
with the patient to discern the
relative value he or she places on autonomous choice. Does the
patient want information?
Does the patient want to be involved in decisions, or does he or
she delegate to family? These
are autonomous choices, and health care practitioners have a
duty to assure they are stable
and authentic.
As noted above, informed consent derives from the principle of
autonomy, and it is discussed
in detail in Chapter 2. However, note that informed consent
requires a conversation between
the physician and the patient or surrogate engaged in shared
decision making. Informed con-
sent requires that the patient be an active participant in the
process, necessitating well-docu-
mented notes in the medical records. It is much more than a
signature on a form.
Though court decisions tend to favor patient autonomy, “the
repeated lack of a clear mech-
anism to resolve conflicts between and among the principles at
the bedside demonstrates
weakness in the principalist approach” (Cotler, 2013, p. 6). For
example, consider a case in
which, based on medical necessity and the physician’s clinical
judgment, surgery is recom-
mended for a particular patient. However, the patient refuses
based on his or her own com-
plex reasons, preferences, and values. This collision between
the patient’s choices or refusals
causes dilemmas at the bedside and in setting policy. Before
life-sustaining technology, such
dilemmas were precluded by old paternalistic methods in which
the physician decided. Crit-
ics ask how principles help resolve conflicts in a given case.
Beauchamp and Childress address
the question in their later editions by recommending specifying
and balancing approaches in
specific cases.
Nonmaleficence
The ethical principle of nonmaleficence is based on the age-old
medical precept “first, do no
harm,” or the Latin primum non nocere. Nonmaleficence is the
general duty to avoid causing
harm to others, either directly or indirectly. It sometimes is
necessary to risk harm in order to
achieve a greater good or prevent a worse harm. For example,
performing a difficult gastric
surgery on a patient with heart or organ failure jeopardizes the
weak organ, but it may be
necessary to save the life. The decision about what to do is not
primarily a medical one; there
is a choice to make and values are at stake. Life-saving
technology has sometimes made it
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Section 1.2Theories and Methods of Contemporary Bioethics
difficult to know what is a harm and what
is a benefit. For example, consider a dying
patient who is on a ventilator. Is continu-
ing aggressive support saving the life or
prolonging the death? These questions
require more information and much
greater understanding of the case.
In clinical health care it is easy to think of
the myriad ways in which a patient can be
harmed through incompetence, error, or
systems failure, or ways in which a phy-
sician can inadvertently cause pain, dis-
ability, or even death. Preventing harm to
patients is the responsibility of the admin-
istrator, in collaboration with the medical
staff. In addition to the physical, psycho-
logical, and economic ways that health
care managers can affect patients or staff, those in leadership
roles also have the ability to
affect the culture of the organization in critical ways. The duty
of nonmaleficence not only
involves not causing harm, but also actively choosing the least
harmful alternatives. Nonma-
leficence requires that managers actively minimize or eliminate
workplace hazards and risks
that could harm employees and patients. It is prudential as well
as practical for administrators
to regularly review relevant policies, make rounds, meet with
practitioners and employees,
and attend meetings in which the topic is preventing or
responding to error and other harms.
Beneficence
Beneficence is the principle that guides health care
professionals to do good. It provides
the grounding for charitable duty to others. At the bedside,
patients define their own good;
this may present a conflict with a health care provider’s
recommendations, which are based
on the physician’s clinical judgment about the best medical
good. Problems may occur when
patients refuse recommended treatments. Conversely, they may
occur when patients or their
surrogates demand care that physicians deem inappropriate or
nonbeneficial. Misunder-
standings about patient and provider rights lead to many of the
requests for bioethics con-
sultation. In the case of refusal, autonomy usually trumps.
However, it is critical to evaluate
the patient’s capacity to make rational and authentic decisions.
Capacity goes beyond being
oriented to time, person, and place. It is the ability to
understand the context, meaning, and
implications of choices. If the patient is incapable of making his
or her own decisions, it is
necessary to evaluate whether the surrogate is acting in a way
that is consistent with the
patients’ directives and interests.
Health care professionals are not obligated to participate in acts
about which they have a con-
scientious objection. Organizations are also protected. For
example, Catholic hospitals are not
required to perform elective abortions or participate in assisted
reproductive technologies
that compromise their ethical and religious doctrine. The
positive duty imposed by the prin-
ciple of beneficence requires that health care managers do
everything they can to reasonably
care for and benefit patients, employees, and others for whom
the organization is or may be
iStockphoto/Thinkstock
Health care providers have an ethical obligation
to bring no harm to their patients. However,
sometimes harm must be risked in order to
prevent a greater detriment.
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Section 1.2Theories and Methods of Contemporary Bioethics
responsible. How this duty is put into practice depends upon the
nature of the organization
and its mission. For example, if a practitioner’s organization
has an explicit mission to serve
the health needs of a particular population or community, then
those commitments should
give shape and substance to the practitioner’s duty of
beneficence.
Justice
The justice principle can be broadly defined as “fairness.” It is
exemplified by the Aristotelian
ideal that people in similar situations ought to be treated
similarly, and people in different
situations should be treated differently. A distinction is
sometimes made between distribu-
tive justice, which refers to the allocation of resources, and
procedural justice, the fair-
ness and transparency of processes by which decisions are
made. The Belmont Report: Ethical
Principles and Guidelines for the Protection of Human Subjects
of Research, prepared by the
National Commission for the Protection of Human Subjects of
Biomedical and Behavioral
Research (1979), offers guidelines on ethical principles; it
states that “[a]n injustice occurs
when some benefit to which a person is entitled is denied
without good reason or when some
burden is imposed unduly” (p. 5). This may occur in the clinic
or in research. For example,
there is some evidence that persons who are poor and thus have
less access to care and infor-
mation about options may also have less access to clinical
trials. They also have less access to
the benefits of findings and to drugs that are approved as a
result of such studies. Charges of
injustice regarding access to research involving women have
also been made (Mastroianni,
1998); women have proportionately been less often represented
as research subjects. Data
also indicate that persons belonging to some racial groups are
treated differently when they
appear at an emergency department (James et al., 2005; Selassie
et al., 2003). Statistics have
consistently shown differences in life expectancy by
socioeconomic status (National Center
for Health Statistics, 2012).
In 1971, the leading American political philosopher of the 20th
century, John Rawls (1921–
2002), wrote A Theory of Justice, a highly influential book that
advances the idea that the best
principles of justice are those that we would all agree to if we
were all impartially situated
as equals. This he arrives at through his famous thought
experiment “the veil of ignorance,”
in which we are asked to imagine an “original position” from
which no one was better situ-
ated than anyone else (or at least that we’d be ignorant of any
inequalities in such a utopian
state-of-affairs).
A Rawlsian approach to distributive justice and health care
ethics is one based on fairness.
Therefore, even in cases where not everyone will have access to
a certain good because it is
scarce, there needs to be fair opportunity of access to the
benefit. For Rawls, fair access was
ensured by formal procedures that were themselves required to
be fair. This leads us to the
concept of procedural justice.
In order for the justice principle’s requirements to be met, any
formal procedures or mecha-
nisms by which people attempt to decide dilemmas must be fair
and just, or equitable. Pro-
cedural justice requires that policy makers craft regulations,
laws, and formal procedures that
are free from bias that would render them inaccessible to some,
or that would unduly restrict
the chances of fair treatment for others. For example, a policy
that recognizes employees’
rights to opt out of procedures when they have a strong
conscientious objection states that
employees must provide documentation in writing to the
supervisor at least two weeks prior
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Section 1.2Theories and Methods of Contemporary Bioethics
to the event. But given the nature of acute care, in which the
unexpected happens routinely,
how can a nurse know in advance that something will be
demanded of her that strongly vio-
lates her conscience? When this issue came up in a local
hospital, human resources had the
policy rewritten to accommodate reality. Hospitals and nursing
homes have to be clear about
nurses’ rights and duties. For example, a policy might state that
a nurse who has a strong
moral objection to terminal extubations could be transferred to a
unit where this procedure
will not likely occur. Other policies might call for less
supportive measures such as unpaid
leave; such options could trigger a union dispute.
Justice is a fundamental principle for health care administrators
and practitioners—particu-
larly in their responsibilities to make resource allocation
decisions—and among those who
work toward eliminating health inequities. The justice principle
impacts many other day-to-
day decisions that health care managers make. Examples include
policies regarding unioniza-
tion, working conditions, and staffing patterns for employees;
hiring and promoting staff;
decisions about where and to whom the institution should be
marketed; and determining
whether promotion should be by merit, seniority, or favoritism.
In addition, hospitals that
undergo purchase or mergers often have to make choices about
their mission and values.
Strengths and Weaknesses of Principlism
Scholars continue to refine the principlist approach; with each
new edition, Beauchamp and
Childress refine the text to accommodate legitimate criticism.
Some bioethicist academics
turn to casuistry, a case-based method of resolving ethical
issues. Most practitioners use a
combined approach from different methods, depending
somewhat on the particulars of the
case. The several methods reflect the necessity of an
interdisciplinary approach. According
to Cotler (2013), “no single method has been successful in
addressing the varied and com-
plex dilemmas that arise in the clinic, the institution, or the
community” (p. 7). Principles
provide fundamental guidelines, but when they conflict with one
another, there is a lack of
clear instructions on how to prioritize. The courts have
consistently favored autonomy, but
that does not always seem correct in an acute health care
setting. It is also not always clear
whether a choice is consistent and authentic; in other words,
will the decision be the same
later today or tomorrow? Is it an accurate reflection of the
person’s narrative and the other
choices he or she has made?
Some argue that principlism fails to consider the complexities
of real-world situations, or
that it is too rigid in following prescribed formulas for making
ethical decisions (Pellegrino
& Thomasma, 1993). Other critics posit that principlism pays
too little attention to the char-
acter of the agent, opting instead to focus on actions that typify
the principle in question;
for example, asking if the decision was autonomous rather than
also looking at precedent
or important context (Bulger & Reiser, 1990). Does the way the
four principles are selected,
prioritized, and applied to ethical dilemmas depend on who gets
to do the selecting, prioritiz-
ing, and applying? Given that along with their great strengths,
principles have weaknesses in
application, leading proponents of principlism—especially
Beauchamp and Childress—con-
tinue to refine their text to include the necessity to specify and
balance in individual cases.
Whether in management, at the bedside, or in the community, it
has become clear that princi-
ples are important, but they are not to serve as a blind mantra.
They work when they are aptly
applied, usually along with other methods, and always in
conjunction with good judgment.
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Section 1.3Practical, Ethical Decision Making in Health Care
Administration
1.3 Practical, Ethical Decision Making in Health Care
Administration
The complicated nature of the work of modern health
care administrators and leaders often means that they
have to take into consideration a multitude of factors
and facts when making a well-reasoned, ethical deci-
sion. Typically we experience an ethical dilemma
because one (or more) ethically relevant factor of the
situation is pulling us to act one way while one (or more)
ethically relevant factor is pulling us to act in a different
or even opposing way. Ethically relevant factors
(ERFs) are goods or values, rights, or any other factor to
which we ought to be sensitive in determining the ethi-
cally correct way to respond to the situation. Issues
involving mergers with institutions at the same level of
care or above or below the acuity level, changes in
financing, relationships with the community, and profit
status are only a few of the ethical challenges. Without
an organization’s clearly defined moral identity, often
made apparent through mission and vision statements,
or without a well-articulated moral identity statement
of his or her own, the modern health care leader may
lack direction and base decisions on ill-defined or unde-
veloped personal ethics. These types of decisions run
the risk of being unfair, inconsistent over time, or easily swayed
by factors that seem the most
urgent, instead of those that are most important to the primary
goals of the institution or
practice.
The bulk of this textbook is devoted to helping cultivate in the
student the characteristics of
a moral leader capable of leading a moral organization. In this
section we will consider the
value of a flowchart method of resolving ethical dilemmas.
Introduction to the Sample Framework
Flowcharts, or decision-tree diagrams, such as the one seen in
Figure 1.2, help demonstrate
some of the important factors and norms that should be a part of
any thoughtful ethical deci-
sion. However, it is also important to remember that these
guides, when misused or relied
on too strictly, can serve as a crutch for bureaucrats and can
impede the kind of rigorous
and nuanced analysis that usually needs to happen in modern
health care ethics. Once you
become confident in applying the rules and norms covered in
this text, and become adept at
identifying the most important stakeholders and factors that
need to be addressed, then you
can use the diagram as a reference. It can be stored in a file
cabinet or on a computer so that it
is accessible when you need to make sure nothing important has
been overlooked. It can also
be used as a reminder of important questions to raise in an
ethics committee meeting.
Creatas/Thinkstock
Administrators routinely
face ethical dilemmas at the
institutional level.
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3Moral Identity Codes of Ethics and Institutional Ethics .docx

  • 1. 3Moral Identity: Codes of Ethics and Institutional Ethics Structures iStockphoto/Thinkstock Learning Objectives After reading this chapter, you should be able to 1. Understand the importance of identifying and promoting core principles and values that both reflect an organization’s moral identity and provide a model to aspire to. 2. Explain the role of codes of ethics in health care organizations. 3. Discuss the importance of cultural competence as part of an institution’s code of ethics. 4. Describe the roles of institutional review boards and ethics committees. © 2019 Bridgepoint Education, Inc. All rights reserved. Not for resale or redistribution. Section 3.1Codes of Ethics Introduction Codes of ethics, institutional ethics committees, and
  • 2. institutional review boards play an important role in shaping and reinforcing a health care organization’s moral identity. In this chapter we will discuss how codes of ethics align with and direct an organization’s moral identity. We will also explore the parameters of codes of ethics, as well as how to create and implement them. Finally, we will examine some of the ethical dilemmas that led to the cre- ation of committees designed to deal proactively, as well as reactively, with ethical issues that health care organizations face. 3.1 Codes of Ethics Codifying the behavior of individuals within a community has ancient roots. The oldest dis- covered physical evidence of a code of ethics was a rock fragment containing the Code of Hammurabi, the edict of King Hammurabi of Babylonia dating back to around 1772 BCE. The American Medical Association’s (AMA) first code of ethics, established in 1847, defined uniform standards for professional education, training, and conduct, as well as established that a physician’s main purpose was to obey the calls of the sick (Baker & Emanuel, 2000). The code was created with physicians and medical personnel in mind and provided strict guidelines on how these employees should conduct themselves with patients, with fellow physicians, with the public, and within their profession in general (American Medical Asso- ciation [AMA], 2017). While an institutional code of ethics, or code of conduct, should ideally be prescriptive in its
  • 3. language and precise enough to be followed, it may also paint an aspirational portrait of a representative member of the organizational community who lives by the core values of the institution and embodies the moral identity the institution is trying to achieve. For example, Trinity Health (2017) developed a code of guiding behaviors that encourages the following six characteristics: We support each other in serving our patients and communities. • Build collaborative relationships within and across boundaries and levels. • Demonstrate a passion for understanding how to be of service to external and internal customers/constituents, and act accordingly. • Actions are consistent with words publicly and privately. • Make decisions in the interest of the larger community (UEM) [Unified Enterprise Ministry], not just own function, organization or area. • Once a decision is made, support it publicly and privately. • Focus on the things that unite us (Mission, goals, service), rather than on our differences. We communicate openly, honestly, respectfully and directly. • Listen respectfully to others and value their contribution. • Willingly express point of view directly “in the meeting, not in the hall.” © 2019 Bridgepoint Education, Inc. All rights reserved. Not for
  • 4. resale or redistribution. Section 3.1Codes of Ethics • Communicate respectfully—whether in agreement or disagreement. • Create an environment which values diverse points of view and experience. • Foster an environment of openness without fear of reprisal. We are fully present. • Set aside distractions to be present. • Seek first to understand, then be understood. • Openly appreciate the gifts and contributions of others. • Create a healthy balance between personal and professional life. • Contribute to a positive, optimistic and fun environment. We are all accountable. • Focus on finding solutions, not blame. • Lead by positive, motivating example. • Accept responsibility for his or her decisions and actions. • Hold self accountable for the success of the larger organization—across boundaries. • Focus on the high payoff items. • Follow through on commitments. We trust and assume goodness in intentions. • Talk directly to an individual when there is a concern or problem, avoid triangle conver- sations or hidden agenda.
  • 5. • Assume positive intentions in one another. • Act in a way that earns trust and fosters an environment of trust. • Listen to people and really hear what they mean without being dismissive or defensive. • Build trust through open communication throughout the organization. We are continuous learners. • Consistently demonstrate openness to new possibilities. • Listen with an open mind. • Challenge “the way it has always been done.” • Provide and accept coaching and feedback. • Encourage new ideas and people to try new ways of getting the job done. • Demonstrate genuine curiosity before judging. Reprinted by permission of Trinity Health, Livonia, Michigan. Many organizations make an effort to gain their customers’, or in health care organizations, their patients’, trust by establishing stringent ethical guidelines regarding how employees are expected to act. In the health care industry, elements like the nature of care and employees’ access to extremely personal information make it especially important that patients feel con- fident in their chosen health care facility. Therefore, it is not only important for health care organizations to establish and practice proper codes of ethics, but also to increase transpar- ency by posting them for anyone to see. © 2019 Bridgepoint Education, Inc. All rights reserved. Not for
  • 6. resale or redistribution. Section 3.1Codes of Ethics The principles of medical ethics represent an attempt to balance the tension between pro- fessional standards and legal requirements. Therefore, the code of ethics was created with three sections: the principles of medical ethics, ethical opinions of the council on ethical and judicial affairs, and reports of the council on ethical and judicial affairs (Riddick, 2003). The AMA established the Council on Ethical and Judicial Affairs (CEJA) to “maintain and update the Code of Medical Ethics and promote adherence to the Code’s professional and ethical standards” (AMA, 2018). The principles of medical ethics established by the AMA and the opinions of CEJA make up the AMA Code of Medical Ethics. CEJA’s opinions focus on scenarios in which ethical issues may arise, such as abortion, capital punishment, and genetic testing. Many of these scenarios cover patient-physician relationships, hospital relations, and profes- sional rights and responsibilities, and are used to periodically update the Code of Medical Ethics (the most recent update having been published in 2017). These updates occur depend- ing on the numerous changes in health care over the years, such as the evolution of medical technology. The AMA’s code of ethics covers many areas and provides important require-
  • 7. ments for physicians and health care workers; however, the main focus is patient welfare. Physicians must keep patients’ best interests in mind and be honest when treating patients. They should also be involved with their com- munities by serving as many patients as possible, regardless of their ability to pay. Physicians must also show they are com- petent enough to treat and communicate treatment plans with their patients. Com- petence is key in developing trust with patients, and it is important for physicians to be able to communicate clearly so patients are well-informed about poten- tial or ongoing treatment. Even physicians at the top of their fields will have a tough time gaining patient trust if they lack skills in com- petence and communication. Professional Considerations Ultimately, the AMA Code of Medical Ethics acts as a guiding document to help health care facilities develop their own codes of ethics. Though the AMA’s code originally focused on physicians’ treatment of patients, adherence to ethical codes should be mandatory for reg- istered nurses, nurse practitioners, administrative personnel, management personnel, and even allied health care workers. Indeed, any group that is involved with patient care should be held to the same ethical standards as physicians, even health care workers who are not clinical, such as those in health information management, billing, and compliance depart- ments. The following sections cover in more detail ethical
  • 8. expectations for different roles in the health care profession. iStockphoto/Thinkstock In shaping an entity’s moral identity, it is crucial to clearly define and communicate ethical expectations for all members of the organization’s staff. © 2019 Bridgepoint Education, Inc. All rights reserved. Not for resale or redistribution. Section 3.1Codes of Ethics Physicians Health care disparities and inequalities are a reality of a growing population and a daily issue for health care providers. Regardless, physicians are obligated to provide care without regard to race, socioeconomic status, religion, or political affiliation (Bringedal, Bœrøe, & Feiring, 2011). These expectations should be reflected in all health care organizations’ codes of ethics. According to Reiter and Runyan (2013), other ethical dilemmas such as issues of privacy and professionalism can occur in primary care settings where multiple family members receive care through the same practice. In order to prevent such issues arising, an organization’s code of ethics should require all health care providers to follow the privacy rules under the Health Information Portability and Accountability Act (HIPAA) (covered in Chapter 5) by providing confidentiality to all patients.
  • 9. Nurses Nurses typically spend more time with their patients than physicians do; therefore, it is just as, if not more, important that nurses follow their organization’s code of ethics. Nursing care can include both physical and mental interventions, and nurses must protect any information a patient provides during all types of care. According to Mylott (2005), nurses are account- able to their patients to make ethically sound health care decisions, and guidelines for doing so should be included in all health care organizations’ codes of ethics. The field of nursing covers such a broad spectrum that nurses may often work outside of direct patient care. How- ever, no matter the capacity in which they work, nurses are responsible for advocating for their patients and following a strong code of ethics. Administrative Personnel The health care system has evolved over decades into a multifaceted industry. Advancements in information technology in particular have not only changed how patients purchase and manage their health care, they are also responsible for an increase in the amount of informa- tion available to patients prior to visiting their physicians. Patients can go online and gain insight into myriad health care issues before ever setting foot in a doctor’s office. Similarly, health care facilities are now able to retrieve a patient’s medical records from anywhere in the world with the click of a button. However, the growth of information technology also gives rise to new risks regarding the privacy and protection of these
  • 10. records. Therefore, it is critical that health care workers (regardless of whether they are clinical or administrative) under- stand their responsibilities under a code of ethics. Ongoing education covering the rules and expectations for adherence to an organization’s ethical practices can help ensure staff compliance, as can clear communication of any disci- plinary actions resulting from instances of noncompliance. As advances in technology and other innovations continue to change the health care landscape, it is important that all health care workers follow the ethical rules and regulations set by their organizations. Byrd and Winkelstein (2014) note that several medical associations, such as the AMA, American Nurs- ing Association, and the Medical Library Association, provide guidelines specific to the roles of a variety of health care professionals. These guidelines can be used to assist organizations with developing codes for ethical decision making at all levels of service. Figure 3.1 outlines steps that an organization can take to help develop a successful code of ethics. © 2019 Bridgepoint Education, Inc. All rights reserved. Not for resale or redistribution. Section 3.1Codes of Ethics Figure 3.1: Steps to developing a code of ethics Employee behaviors often cause headaches for leaders of health
  • 11. care organizations. However, with a little planning, addressing inappropriate behaviors can be handled with a solid code of ethics. Web Field Trip: Maimonides Medical Center Code of Mutual Respect In this web field trip, you will listen to a 2008 episode of The Brian Lehrer Show, a radio program on WNYC, in which Brian Lehrer interviews Dr. David L. Feldman, vice president of perioperative services at Maimonides Medical Center in Brooklyn, New York. Feldman talks about how the Joint Commission, which accredits and certifies health care organizations in the United States, has begun to crack down on rude behavior by health care professionals and how health care organizations are combating this problem. Feldman talks about how Maimonides has instituted its Code of Mutual Respect that all staff and employees must abide by. It is firmly grounded in the core principles of the institution and, together with its detailed Corporate Compliance Code of Conduct, helps foster an ethical work environ- ment that is conducive to quality health care without settling for the minimal standards that “compliance” alone may connote. (continued on next page) © 2019 Bridgepoint Education, Inc. All rights reserved. Not for resale or redistribution.
  • 12. Section 3.1Codes of Ethics Cultural Considerations Since all institutions serve their own unique communities, a code of ethics should also take the culture of the community it serves into consideration. Therefore, many institutions pro- mote cultural competence, an awareness of and ability to function “effectively . . . within the context of the various cultural beliefs, behaviors, and needs presented by consumers and communities” (U.S. Department of Health and Human Services, Office of Minority Health, 2001). Although cultural competence training programs have become customary in many health care organizations, the definition of these programs and terms remains imprecise. The Department of Health and Human Services’ Office of Minority Health has defined some of the terms necessary for a robust implementation of cultural competence training. While many of these concepts remain open to debate, for the purposes of our discussion we will adopt the Office of Minority Health’s definitions. Defining Culture and Cultural Competence The Office of Minority Health makes the following statement about what culture is and how it influences health care: The thoughts, communications, actions, customs, beliefs, values, and institu- tions of racial, ethnic, religious, or social groups. Culture defines how health care information is received, how rights and protections are exercised, what
  • 13. is considered to be a health problem, how symptoms and concerns about the problem are expressed, who should provide treatment for the problem, and what type of treatment should be given. In sum, because health care is a cultural construct, arising from beliefs about the nature of disease and the human body, cultural issues are actually central to the delivery of health ser- vices treatment and preventive interventions. (U.S. Department of Health and Human Services, Office of Minority Health, 2001, p. 4) Web Field Trip: Maimonides Medical Center Code of Mutual Respect (continued) Instructions 1. Listen to “Paging Dr. Jekyll,” a 2008 episode of The Brian Lehrer Show: https://www .wnyc.org/story/28252-paging-drjekyll/ 2. Read Maimonides Medical Center’s (2018) complete Code of Mutual Respect: https:// www.maimonidesmed.org/about-us/core-principles/code-of- mutual-respect 3. Write a short critical paper (less than one page) in which you critique the Code of Mutual Respect. Assess whether there are any potential gaps or missing elements that might be helpful to include in future versions, and try to identify any ethical problems that the code might not be well suited to handle. If appropriate, come up
  • 14. with some policy recommendations for revisions to the code that will cover the issues you have spotted. © 2019 Bridgepoint Education, Inc. All rights reserved. Not for resale or redistribution. Section 3.1Codes of Ethics Culture is of the utmost importance in a clinical encounter. It is often essential to appropriate diagnosis and treatment, and it is always central to caring for the patient because it is a major determinant of an individual’s health beliefs, values, percep- tions, and behaviors. Culture helps deter- mine how people form interpersonal rela- tionships (Mattingly & Garro, 2000) and informs the cultivation of collective as well as individual identities (Holland, 1998). The Principles of Cultural Competence The essential principles of cultural com- petence are: 1. acknowledgment of the impor- tance and prevalence of culture in people’s lives, 2. respect for cultural differences, and
  • 15. 3. minimization of the negative consequences arising from cul- tural differences (Paasche- Orlow, 2004, pp. 347–348). Generally, cultural competence promotes two of the four principles of health care ethics: respect for patient autonomy and justice. However, in most cultural competence materials, the reasons given for its importance are practical; among the most popular reasons are that it helps to (a) eliminate health disparities in the population, (b) meet legislative or regulatory guidelines, and (c) decrease the likelihood of medical malpractice claims (Paasche-Orlow, 2004). However, the most important reason to be a culturally competent professional is the intrinsic good that arises from having a moral commitment to a culturally responsive, patient- centered practice. In this context, cultural competence is not only characteristic of good health care professionals and the organizations to which they belong, but is perfectly aligned with the goals of practicing medicine. There are cultural competence guides and programs available that support students’ aware- ness of cross-cultural health care and foster an interpretive method of understanding patients. These guides state explicitly that any descriptions of cultures found in cultural competence materials are never the final word but rather a constructive starting point for the dialogue with particular patients and their families. Such materials can be found, for example, at the Office of Minority Health website:
  • 16. http://www.thinkculturalhealth.hhs.gov. Cusp/SuperStock Achieving cultural competence can help diminish health disparities that are disproportionately faced by minority groups. © 2019 Bridgepoint Education, Inc. All rights reserved. Not for resale or redistribution. Section 3.1Codes of Ethics Cultural Competence and the Culture of Health Care Cultural competence education programs typically emphasize the importance of patient cul- tures, but they are silent on a very important dimension of health care delivery: the cultures of health care organizations and providers. Historically, references to culture in health care applied almost exclusively to the patient. In fact, in some popular cultural competence books, culture is defined simply as the patient’s perspective. However, doctors, nurses, allied health professionals, and health care administrators are also deeply imbedded in their diverse personal cultural backgrounds, the culture of Western biomedicine, and the culture of their respective professions or fields (Taylor, 2003). It is therefore important to understand that the patient (and often the patient’s family, loved ones, community, and religious heritage) and the health care professional (and the practitioner’s community and culture) meet at the intersection of both of their cultures, as well as the prevailing
  • 17. laws, mores, norms, and guide- lines of the clinical context. (Figure 3.2 shows the levels of competencies that people possess in working with other cultures.) A Peek at Practice: Cultural Competence in Action Despite its importance, it may not always be clear to institutions and health care profes- sionals what they can do on a regular basis to practice cultural competence. In her arti- cle “Why More Hospitals Should Prioritize Cultural Competency,” law professor Olympia Duhart (2017) suggests that professionals keep the following practices in mind as they are providing care: • Be creative and expansive about addressing language barriers. • Be alert for, and responsive to, mental health challenges. • Be mindful of stereotypes. Visit https://hbr.org/2017/05/why-more-hospitals-should- prioritize-cultural -competency to read the full article, then answer the following questions. Discussion Questions 1. Based on what you have read in this chapter and the discussion of competence training in the article, what types of cultural competence training do you think would be effective in the hypothetical case Duhart presents? 2. Now consider patients who come from third-world or non- English-speaking countries.
  • 18. What kind(s) of cultural competence training would you recommend to those providing care for this group? 3. What cultural competence issues might arise when treating the following patients? a. Victims of Hurricane Katrina suffering from PTSD b. Low-income victims of Hurricane Katrina who lack insurance and suffer from mental illness 4. Should health care facilities provide paperwork in languages other than English? If they do not, and a patient does not follow their discharge instructions correctly, is this an ethical issue? © 2019 Bridgepoint Education, Inc. All rights reserved. Not for resale or redistribution. Section 3.1Codes of Ethics Figure 3.2: Cultural competence Cultural competence is an important factor in health care service and delivery. Indiana University’s Equity Project identified six specific levels of cultural competence, as depicted in this graph. Source: Whittman, P., & Velde, B. P. (2002). Attaining cultural competence, critical thinking, and intellectual development: A challenge for occupational therapists. American Journal of Occupational Therapy, 56(4), 454–456.
  • 19. © 2019 Bridgepoint Education, Inc. All rights reserved. Not for resale or redistribution. Section 3.2Institutional Structures That Foster and Support Moral Identity Blindness to the culture(s) of modern American health care can make health care practi- tioners unaware of embedded prejudices and discriminatory policies within well-meaning health care organizations. Cultural competence should thus foster not only the capacity to understand patients better and be responsive and respectful of their desires and needs, but also awareness of the cultural biases of health care professionals and their potential discrim- inatory effects on patients. Blindness to biomedical cultural perceptions and prejudices in health care can keep us from seeing how the culture of medicine is complicit in the cultivation and transmission of stigma and racial bias as well as other causes of health disparities in gen- eral (Betancourt, Green, Carrillo, & Park, 2005; Taylor & Lurie, 2004). 3.2 Institutional Structures That Foster and Support Moral Identity In shaping its moral identity, a health care organization must also organize internal structures to address medical and administrative ethical issues and concerns. In addition to establishing a code of ethics and conduct, officials such as compliance
  • 20. officers, risk management officers, and officers of general counsel provide a broad range of oversight. Working alongside these officials are institutional committees such as ethics committees and review boards. Institutional Ethics Committees In 1976, the New Jersey Supreme Court decision regarding Karen Ann Quinlan paved the way for the establishment of institutional ethics committees in hospitals around the country. Soon after returning home from a party, the 21-year-old Quinlan experienced two 15-minute periods of respiratory arrest. She was rushed to a hospital, where she lapsed into a persis- tent vegetative state. Her father, Joseph Quinlan, approached the court with a request to be appointed Karen’s guardian so that he might consent to remove her from life support. Karen’s physicians, the local prosecutor, and the state attorney general opposed the request. Until the Quinlan case, the nation’s appellate courts had not decided a termination-of-life-support issue. Therefore, this was a case of first impression for the New Jersey Supreme Court. Quot- ing Karen Teel’s article from the Baylor Law Review, “The Physician’s Dilemma: A Doctor’s View: What the Law Should Be,” the court in its opinion stated: I suggest that it would be more appropriate to provide a regular forum for more input and dialogue in individual situations and to allow the responsibil- ity of these judgments to be shared. Many hospitals have established an Eth- ics Committee composed of physicians, social workers,
  • 21. attorneys, and theolo- gians, which serves to review the individual circumstances of ethical dilemma and which has provided much in the way of assistance and safeguards for patients and their medical caretakers. Generally, the authority of these com- mittees is primarily restricted to the hospital setting and their official status is more that of an advisory body than of an enforcing body. (Teel, 1975, as quoted in In re Quinlan, 1976) Today ethics committees, also called bioethics committees, act in an advisory capacity to help determine whether to continue life support for patients with dire prognoses. Ethics © 2019 Bridgepoint Education, Inc. All rights reserved. Not for resale or redistribution. Section 3.2Institutional Structures That Foster and Support Moral Identity committees were rarely found in hospitals in 1976, when Karen Ann Quinlan collapsed. Largely due to the recommendation in In re Quinlan, and subsequent endorsement by other state appellate courts that hospitals establish institutional ethics committees, today most health services organizations—from nursing homes to the largest academic medical cen- ters—have some version of an institutional ethics committee.
  • 22. In 1992, the Joint Commission, an independent, non-profit organization, provided accredi- tation and certification to more than 20,000 health care organizations in the United States. The Joint Commission required that hospitals institute a mechanism to resolve ethical issues such as that of Karen Ann Quinlan and others that had proved so vexing and contentious in the 1970s and 1980s. Today this requirement is usually met by having some variation of an institutional ethics committee. These committees are designed to deal proactively, as well as reactively, to ethical issues that the organization faces. Joint Commission standards and the reaccreditation process constitute a form of oversight of such committees. In many facilities, the oversight of bioethics committees is the responsibility of the medical staff. There are a variety of institutional ethics committees used today. Some focus on clinical eth- ics issues (including offering clinical ethics consultation), while others look at research ethics (see discussion of institutional review boards later in this chapter), and still others confront administrative ethical or legal issues. There are also specialized committees (or subcommit- tees) that look at a subset of the issues mentioned above. Some institutions have multiple ethics committees, while others have a single general-purpose one, and still other health care organizations may have none. When a particular health care ethics committee is required by accreditation standards or law, its membership composition is usually prescribed by mini- mum standards in order to foster diversity of views and avoid
  • 23. conflicts of interest. Activities and Functions As a best practice, the form of any organiza- tional structure should follow its function. Functions of ethics committees can take a number of forms (e.g., consultation, policy development, education), and the subject matter can vary (e.g., clinical, administra- tive, research-oriented). This section will discuss these variables. Large and com- plex health services organizations, such as acute-care hospitals and academic health centers, would probably benefit from hav- ing ethics committees with expertise in clinical ethics and a separate committee or committees that deal with administra- tive ethical issues. This kind of specializa- tion and division of labor is desirable. The ethical issues involved in clinical care— for example, whether life support should be removed from a patient or whether a patient who is unable to consent should have a particular surgery—often depend Andrew Shurtleff/AP Photo At the University of Virginia Medical Center, neurologist Madaline Harrison chairs a committee of physicians and other hospital employees that formally reviews ethics policies and develops regulations that will address a range of issues. Institutional ethics committees can be invaluable in resolving ethical issues that arise in health care organizations. © 2019 Bridgepoint Education, Inc. All rights reserved. Not for
  • 24. resale or redistribution. Section 3.2Institutional Structures That Foster and Support Moral Identity on an understanding of disease processes and physiology. The issues also generally involve the patient, the patient’s family, and the nursing and physician staff. These issues are quite different than those in health care administration, which take the form of deciding whether to purchase certain equipment or end a certain program. The participants are usually admin- istrative and management personnel and can include the governance of, and representatives from, the public. Unfortunately, it is still relatively rare to see an administrative ethics com- mittee that is specifically devoted to meeting regularly and discussing administrative ethical issues (Darr, 2011). Clinical ethics committees may be involved in policy development, ethics case review and consultation, and advisory opinions upon request. Their policy development role can range from reviewing or developing the informed consent forms and policies of the institution, to making large-scale resource allocation policies for emergencies or natural disasters. As we will see in Chapter 6, institutional ethics committees have also been called on to provide over- sight (along with the institution’s risk-reduction mechanisms) for cases of medical mistakes and to establish and maintain a culture of patient safety in an
  • 25. organization (Meaney, 2004). A growing concern is that both clinical ethics consultation and institutional ethics commit- tees reflect the diversity of modern health care contexts and develop the competence and sensitivity to effectively and respectfully deal with cross- cultural clinical affairs. In 2014, the American Society for Bioethics and Humanities (ASBH) published its “Code of Ethics and Pro- fessional Responsibilities for Healthcare Ethics Consultants” and is considering a certification process for clinical ethical consultants, so the role of institutional ethics committees in clini- cal ethics consultation may yet again be changing in the near future (Fox, 2016). Institutional ethics committees are now largely seen as necessary and essential components of ethical health services organizations. Both clinical and administrative ethical issues are often better dealt with through committees, rather than through unilateral decisions made by executives or directors. However, committees should be evaluated from time to time to assure that groupthink or institutional allegiances are not biasing the committee’s ethics decisions, and to assure that the institution is continually helping foster an ethical environment that helps the organization better achieve its stated goals. Institutional Review Boards On the heels of the Nazi medical “research” atrocities of World War II, the Nuremberg Code (1947), along with the later Declaration of Helsinki (World Medical Association,
  • 26. 1964/1975/1983), became the basis for the federal regulations that govern most medical research in the United States (Public Welfare Protection of Human Subjects, 2004). These regulations also require independent committees to review and approve research protocols. In 1978, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979) issued The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, which identified the three basic principles for research involving human subjects: 1. respect for persons 2. beneficence/nonmaleficence 3. justice © 2019 Bridgepoint Education, Inc. All rights reserved. Not for resale or redistribution. Section 3.2Institutional Structures That Foster and Support Moral Identity The Belmont Report, as well as the regulations we now follow in clinical research in the United States, differentiates between clinical practice that benefits the patient and nontherapeutic research (where the subject is not expected to benefit directly from the trial). In the latter, the commission found the need for further regulatory requirements, such as informed con- sent, assessment of risks and benefits, and selection of subjects. These further requirements,
  • 27. which include the voluntariness of the subjects and the requirement of informed consent, also suggest the principles of respect for persons, nonmaleficence, and the virtues of justice and honesty. All are integral parts of our regulatory frameworks (Public Welfare Protection of Human Subjects, 2004; FDA, 2013). The Belmont Report and subsequent regulations set the legal standard for the protection of subjects involved in clinical research in the United States. To implement the regulations and oversee research, an organizational structure called the institutional review board (IRB) was established. As a result, to conform to the regulations and to protect human subjects in clinical research, health care organizations conducting research with any level of federal funding must establish IRBs. IRBs are independent committees with diverse memberships that authorize and review most research that falls within the government’s definition of research involving human subjects (Public Welfare Protection of Human Subjects, 2004; FDA, 2013). IRBs must follow processes and guidelines set forth by the U.S. Department of Health and Human Services as well as the U.S. Food and Drug Administration (for trials that are likely to produce products or drugs meant for public sale). The processes and guidelines embody the principles set forth in The Belmont Report, such as informed consent documentation and periodic compliance review. IRBs must contain both scientific and nonscientific members and at least one representative from the community (Public Welfare Protection of Human Sub-
  • 28. jects, 2004). Although the direct effect of the regulations is limited to government-funded research, the indirect effect is that such research is so pervasive that the regulations establish the standard of practice for civil torts. As a result, if a drug company, a medical device manufacturer, or even a college professor seeks to perform federally funded or FDA-approved research that involves human subjects, the research, and particularly the protection of the human subjects, must be approved and overseen by an IRB. Although found in other organizations, IRBs are part of many educational organizations and health care facilities. An IRB’s mandate is to ensure ethical clinical research and minimize risks to subjects. This is done by determining whether the risks to potential subjects are reasonable relative to any anticipated benefits to subjects or society. IRBs must also make sure that informed consent is obtained from subjects, or their legally authorized proxies, as well as monitor the trial’s safety, equity, and confidentiality. Additional safeguards are necessary when the proposed subjects are likely to be especially vulnerable to coercion or undue influence; in fact, the bulk of the regulations concerning IRBs are focused on the requirements for informed consent. Other Structures To support its Code of Mutual Respect, Maimonides Medical Center has established a “respect hotline” telephone line, along with an e-mail account where behavior that is inconsistent with its Code of Mutual Respect can be reported. Maimonides has
  • 29. other institutional structures to help organize responses to ethical lapses as well as help foster and protect the organization’s moral identity. For example, there is the Medical Staff Subcommittee on Respect, which moni- tors physician compliance with the code (Maimonides, 2009). Committees such as this are a common way of handling day-to-day ethical issues that may arise within an institution. © 2019 Bridgepoint Education, Inc. All rights reserved. Not for resale or redistribution. Chapter Highlights Chapter Highlights • A health care organization’s code of ethics should both reflect and uphold the organi- zation’s core principles and values. • Codes of ethics should be applied to all personnel in the field of health care, including physicians, nurses, administrative personnel, and anyone else who comes into contact with patients and/or patients’ information. • When creating a code of ethics, institutions should take into account the culture(s) rep- resented in the communities they serve. Institutions should strive to provide cultural competence training to all health care personnel. • There are various institutional structures that foster and
  • 30. support the moral identity of health care organizations, including the now nearly universal institutional ethics committees and review boards that resolve ethical disputes, ensure compliance, consult with clinicians, and form ethical policies in health services organizations. Case Study: Preventative Ethics Instructions: Identify the potential ethical dilemma in each of the scenarios below. Think about ways in which a change in policy or in the behavior of staff or employees of the health care organization could either help avoid the potential ethics issue or prevent similar dilem- mas from occurring in the future. Scenario A: After taking stock of your hospital’s inventory, you calculate that the number of working mechanical ventilators, while sufficient for the regular daily requirements of a hospital such as yours, are dangerously below the number suggested to keep on hand in case of emergencies such as an influenza epidemic. While some of the costs involved in stockpiling this kind of equipment are covered by the federal and state governments, pur- chasing the additional ventilators would still mean a sizable investment by your organiza- tion. You did not plan for this in this year’s budget, which has already been approved by the board of directors. If you choose to purchase the ventilators in the unlikely event that they will be needed this year, you will have to seek special permission from the board to amend
  • 31. the budget. The board, to be sure, will not be pleased by this seeming oversight, and you dread thought of having to do this. 1. What is/are the potential ethical dilemma(s)? 2. What is/are your proposed solution(s), and why? Scenario B: You notice that more of your nursing facility’s senior citizens are now arriv- ing at your facility with advanced directives that state their treatment preferences at the end-of-life. While you welcome this new development, you also notice that many of the advance directives contain boilerplate language that states “no heroic measures should be used when there is no longer hope for a meaningful recovery.” Much of the care that your patients receive at the end-of-life involves all sorts of medical procedures and interventions that would have been seen as “heroic” not so long ago. In addition, none of the advance directives you’ve seen recently have specified what sorts of medical treatments and what circumstances the patient thinks are “heroic” and which are not. (continued on next page) © 2019 Bridgepoint Education, Inc. All rights reserved. Not for resale or redistribution. Chapter Highlights Critical Thinking and Discussion Questions
  • 32. 1. Why is it necessary for a health care organization to establish a code of ethics? 2. What role does the Council on Ethical and Judicial Affairs (CEJA) play in regard to the American Medical Association’s (AMA) Code of Medical Ethics? 3. What three elements of the AMA’s Code of Medical Ethics do you believe are most important? 4. What institutional structure oversees human subject research that is at least par- tially federally funded? Key Terms code of ethics A compilation of rules for ethical conduct for a community or society. Although the values that codes are aim- ing to protect, endorse, or foster are often implied in the language used, codes gener- ally focus on specific behaviors and actions that are forbidden or state the minimal behavior necessary to avoid incurring a punishment. cultural competence The ability of a health care provider to effectively tend to consumers and communities with particu- lar cultural beliefs, behaviors, and needs. institutional ethics committee A group whose task is to deal proactively and reac- tively with ethical issues that its organiza- tion faces. Also called a bioethics committee.
  • 33. institutional review board (IRB) An independent committee made up of diverse organizations and community members that review the ethics of research involving human subjects. IRBs are highly regulated and subject to significant governmental oversight. Case Study: Preventative Ethics (continued) 1. What is/are the potential ethical dilemma(s)? 2. What is/are your proposed solution(s), and why? Scenario C: You have always been proud of the fact that your clinic’s staff and employees rarely complain to you or your management team of ethics or compliance violations or concerns. However, after reading a journal article on the general reluctance of staff and employees to report ethical concerns or even grave problems to supervisors, you begin to wonder if your clinic’s “clean record” is true. The research article suggested that absent clear policies for non-retaliation toward whistleblowers, many ethical problems remain unreported. You wonder how difficult it will be to justify initiating any new policies if there is no evidence that the policies are needed to address any specific problems at your clinic. 1. What is/are the potential ethical dilemma(s)? 2. What is/are your proposed solution(s), and why? © 2019 Bridgepoint Education, Inc. All rights reserved. Not for resale or redistribution.
  • 34. 630 Student Class Registration System Individual Project Phase 1: Requirements Analysis 1. Problem Definition ABC University needs a new student registration system for classes. The current registration method is time consuming and inefficient for the growing student base. In order to cope with the demand, ABC university has decided to move forward with the implementation of a fully automated system for class registration. The registration system in use now requires students to meet with their advisors prior to the semester and decide upon class requirements for the coming term. Afterwards, the advisors register the student for their classes. ABC University hopes that this new system will limit the advisors to an advisory role and students can move forward with registration on their own. 2. Issues
  • 35. ABC University currently does not have a portal for students to register for classes on their own. The current system access is limited to advisors and it is incumbent upon the advisors to register students for classes. With a growing student population, ABC University is not able to respond to the rising need for advisors during class registration time. In order to provide a solution to this issue, ABC University is looking to implement a fully automated online portal system that allows students to select and register for classes on their own; advisors would continue to serve in an advisory capacity. The only advantage currently provided by the existing method is that each student would get advisor time and the school can maintain a high level of customer service. The consequence of the current method is that the school is very limited to how many students they can have because class registration is a long, drawn out procedure. The goal of the new system is to automatically provide all necessary information for students to be able to register on their own. The system will be connected to the ABC University database and be able to report on class availability, class schedules, and professors for the class. The student will still have the ability to visit their advisor on an as needed basis but if the need is not there, the student will be able to register on their own. The benefit of this new system is that the school can now aggregate data such as: · Class popularity, · Wait lists for classes, · Professor popularity, · And class descriptions. Should the new system be successful, university faculty will experience a rise in time, work, and money. A fully functioning system can help a student stay on track from the beginning of their college career to the end. The users of the portal will be full time and part time students of ABC University. Besides helping university faculty free up more time, the new system will also help in increasing student satisfaction by being a great service to students in ways such as:
  • 36. · Allow students a better chance to register for desired classes, · Allow students to register for classes based upon their schedule, · And drastically decrease the time spent on the registration process. 3. Objectives The creation of a student registration portal for classes would serve a number of objectives. The most important objectives are: · Log in process to ensure security, · Display of detailed courses required for student’s degree, · Virtual schedule before registration is finalized, · Linked to university database to accurately report class availability, · Registration confirmation, · And student advisement report for progress tracking purposes. It is crucial for the student to be able to access the portal from any location so they can register at their convenience. Should a student choose to not visit their advisor in person, the advisement report will aid in helping a student stay on track in terms of which classes they need to take and which they have completed. With the virtual schedule, a student will be able to get a visual representation of what their semester will look like so they can have a better foundation for planning their extracurricular activities. The advantages of these achieving these objectives for the university are incredibly practical. Since one of the major concerns was that the student population was stunted due to lack of advisors available, this frees up university advisors to be able to meet with students that need the extra support. Additionally, it allows the university to track and monitor
  • 37. students’ progress in their degree. 4. Requirements The design of the student registration portal for ABC University has functional, non- functional, hardware, and software requirements. They are broken down below. 4.1 Functional Requirements The portal functional requirements are detailed below: · The system proposes possible schedules to the student during registration; · Search function; · Student degree progression tracking; · Integration with university database; · Administrative report generation; · Administrative override functionality; · Administrative action tracking; · Override reversal; · Course detail display including class capacity, professor, waitlist, seats remaining, and description; · Staggered access for registration to prevent overload and allow priority; 4.2 Non-Functional Requirements 4.2.1 Appearance Requirements ABC University’s logo and the existing basic design of university should be displayed. The system should achieve basic web design standards similar to ones proposed by the US Digital Service. The design and the color should make users feel comfortable when using the portal. The design should also reflect the seriousness of the university environment. 4.2.2 Usage Requirements The overall design of the portal ensure ease of access, usability and maintain user efficiency. The portal design should ensure that the user will have an easy learning curve so the portal can be seamlessly adopted by the stakeholders. Stakeholders should have the option of undoing any changes made to their own
  • 38. records as well as offer redundancies in checking and confirming their selections. 4.2.3 Accessibility Requirements The portal should follow national guidelines such as 508 Accessibility requirements to ensure accessibility by all stakeholders. The portal design should take into consideration stakeholder disabilities and the design should allow for them to access as well. In order to maintain accessibility, the portal design should also be 4.3 Software Requirements In order to be scalable and user friendly, the proposed system has the following requirements: · Responsive in design, · Browser agnostic, · Maintain acceptable speed and latency for use; · Maintain data reliability; · Allow for access through any device with web access; · Maintain easy of administration so university IT will have · Accessibility compliant (example: 508 compliant) 4.4 Hardware Requirements Since the solution is web based, the hardware requirements will be limited for the proposed system. However, there are some needs and they are listed below: · Function on a minimum of 2GB RAM · Functional on basic graphics hardware (example: video card, device display, etc) · Operating system agnostic · Device processor compatibility (example: intel i5 chip or higher) 5. Constraints In order to have a clear understanding of the design constraints, it is necessary to understand the environment in which the system will be implemented. The portal will have to interact with the university’s current environment. Therefore, it is important in maintaining
  • 39. control the adjacent systems such as the university database(s) and/or the computerized environment. The development of this portal will not require any increase in physical space. Due to the need for accessibility, it is important that the portal remain device and browser agnostic because it is to be expected that stakeholders will try to access the portal remotely from anywhere. Lastly, it is important that the solution takes into consideration user and administrator technical abilities. The portal should be capable of being updated to follow standardized compliance regulations and not interfere with stakeholder performance. 6. Proposed System To combat the difficulties of student registration at ABC University, a student registration portal has been presented as a potential solution. The ultimate goal of this portal is to increase the efficiency of student class registration and allow ABC university to grow their student population so it is important that the solution remains scalable. Armed with a comprehensive understanding of ABC University’s environment, the proposed solution is a web-based portal that pulls data from the university’s database and displays information for the stakeholder regarding classes, class details, class schedules, etc. Aside from IT, the two stakeholders are students and administrators. Both groups of stakeholders will have their own log in to utilize the portal. The student will have access to the following information in the portal: · Student ID · Name · Date of birth · Password · Mailing address · Registration date · Student status
  • 40. · Contact information · Image As a user, a student can perform the following tasks: · Registration · Branch selection · Scheduling · Search · View class details · Generate advisement reports. Available to stakeholders is the log in portal. This portal allows for authentication of user accounts. All stakeholders will have their own unique credentials for the portal. Once logged in, stakeholders have the ability to search the university database for the data they need. Students will be able to search for the classes they register, see the details for the classes, create a mock schedule prior to confirmation, and finalize their selections. Administrators will be able to see class details, reverse changes to student schedules, and create priority registration for students that are allowed that. User management is limited to be used by administrators such as IT and/or university faculty. Students will not see or have access to this part of the portal. 6.1 Data Flow Diagram After the student requests a log in to the registration portal and access is granted, the student is able to request information from the portal in terms of class information, class schedule, and make edits. This information is pulled from the ABC
  • 41. University database. For administrators, the format is very similar. The administrator is submits a log in request and once it is granted, they are able to view the student data, class data, and make edits to the data in the portal. Similarly, the information is also retrieved from the ABC University database. Data input into the registration portal is transferred to the ABC University database. Phase 2: System and Database Design 7. User Interface The user interface design for students and administrators are shown below. Student registration portal log in Each student and administrator will have their own unique credentials to log into the portal on this interface. Once they log in, they will be able to view the information available to them in the next page. Student portal interface This is the student class registration portal. This is where a student will be able to access their class registration by following the “add/drop class” link. The other options available to them is their class schedule, their personal information, their advisor information, an ability to sign up for graduation, and an advisement tool should they feel they do not need to meet with an advisor in person.
  • 42. Administrator portal interface As an administrator, their main job has been to aid the students in registering for their classes. Once an administrator logs in, they will be able to see their own calendar that typically displays meetings with the student. Since administrators have no need to add/drop classes for themselves, their registration portal will be slightly different from a student’s. Student course search interface When a student navigates to their add/drop class portal, this is the interface they are presented with. They will have the ability to search for a specific school term and search using keywords or course numbers to find the classes they intend to take. Student Course Search Results Once a student searches for the class they would like to take, the portal than directs them to a results list of the results. These results include classes that have reached capacity and are identified with the letter F under status, and classes that have not reached capacity. Once a student selects the class, they click “add” to include it in their schedule. Student Registration Portal Class Registration Completion Upon completion of registration, the student home interface of the registration portal will display the class that the student registered for. 7.1 Logical Model Design 8. System Architecture
  • 43. The student registration portal is a web-based portal that interacts with an existing database of information. Once a stakeholder (student or administrator) accesses the web portal, the web portal pulls information from the ABC University database and displays the information requested. 8. Conclusion With the implementation of a student class registration portal, it will allow for ABC University to more efficiently process class registration. The shift from manual registration by student advisors to a more automated solution has been long awaited. With the implementation of a student registration portal, the university can grow their student population and advisors would have more free time devoted to other tasks. The class registration process would not take as long and it would become a more efficient process. The initial roll out of the portal will have to be monitored but the potential to build upon the student registration portal will be great. 1The Evolution of Health Care Ethics: Overview, Theories, and Methods Travel Pictures Ltd./SuperStock Learning Objectives After reading this chapter, you should be able to 1. Summarize major factors that contributed to the interest and importance of medical ethics in the mid-20th century. 2. Identify the major factors associated with the rise of
  • 44. bioethics committees, as well as with their primary functions. 3. Summarize ethical theory and how it attempts to explain and guide right action. 4. Discuss principlism, along with its strengths and weaknesses, as a prime method for addressing ethical problems. 5. Explain the process for ethical decision making. © 2019 Bridgepoint Education, Inc. All rights reserved. Not for resale or redistribution. Section 1.1The Rise of Contemporary Health Care Ethics Introduction Ethics is a word that is frequently used, heard, and seen in the media. It generally refers to what people should do and how they ought to act. However, the meaning of the term is often unclear, and people do not always share a common understanding of what it means to be ethical or behave ethically. Additionally, what some may see as an ethical issue, others may not. Therefore, those going into the field of health care must learn the theories, principles, beliefs, and values that guide ethical decision making and problem-solving in the health care environment. While there are many concrete laws, rules, and regulations that must be fol- lowed to the letter in health care, the application of ethics in health care is more fluid in that
  • 45. each situation requires unique considerations and each outcome may be different as a result of those considerations. As an academic study, ethics refers to a systematic analysis of the rightness and wrongness of actions, along with the theoretical basis and methods used in deciding which course of action to take. Ethics also encompasses a very practical application: It seeks to provide a guide to behaviors. How people behave toward one another is based on their personal morals as well as on societal ethics. There is some universal agreement about what is right and wrong; for example, murder and incest are almost always considered wrong. However, there is much variability in what an individual or particular society considers ethical behavior, depending on its laws and norms. This is in part due to the fact that different peoples regard different situations as posing an ethical dilemma, or a situation in which they are uncertain about the correct course of action. The goal of applied ethics is to identify and resolve such dilemmas. Given that Western societies, particularly the United States, comprise many communities, cultures, and languages, it is not surprising that there is difficulty formulating concise and coherent language to describe a comprehensive set of ethical standards that can be applied to society at large. Similar challenges arise within organizations. These challenges are particu- larly pronounced in health care organizations, where communities, cultures, and languages intersect on a daily basis, sometimes under critical and urgent
  • 46. circumstances. Therefore, the major question we will explore in the chapters that follow is: Can health care professionals and organizational decision makers identify a core set of fundamental precepts and prin- ciples that should be considered regardless of location, religion, and law? We will consider which principles are to be prioritized, as well as how to address ethical questions systemati- cally. First, we will explore the ways in which health care and ethics have intersected through- out history. 1.1 The Rise of Contemporary Health Care Ethics Doing the right thing has long been a tenet of medical practitioners, with doctrines of ethi- cal practices such as the Hippocratic oath dating back to the 5th century BCE. Though other philosophers have commented on the oath and ethical duties over the centuries, and some have recently written contemporary versions, the original remains foundational to medical practice. Graduating physicians still swear to uphold the tenets of the oath, which include the promises to practice fidelity (faithfulness), observe patients’ confidentiality, and have respect for those under their care. © 2019 Bridgepoint Education, Inc. All rights reserved. Not for resale or redistribution. Section 1.1The Rise of Contemporary Health Care Ethics Until the mid-20th century, health care was delivered without
  • 47. significant technology or capa- bility other than simple procedures and a great deal of compassion. For example, sterile tech- niques and anesthesia were unknown until the beginning of the 20th century, and antibiotics were not developed until World War II. In cases where effective treatments were not readily available (or not yet invented), paternalism, or the belief that the doctor knew best, was not significantly challenged, and, according to Cotler (2013), “kindness and caring were indeed the best medicine” (p. 4). Beginning around the 1950s and 1960s, advents in both medicine and medical technology increased choices and costs, which complicated medical decisions. In the 1960s, the invention of dialysis, ventilators, and intensive care units vastly improved patient health; the advent of dialysis, for example, meant that patients could now be maintained on machines that essen- tially function as kidneys by mixing and monitoring the fluid that removes unwanted waste products from a patient’s blood. Such advancements in knowledge and technology were mak- ing it clear that age-old applications of medical ethics were no longer sufficient, and with that realization the field of bioethics was born. Drawn from the combination of the words biology and ethics, bioethics became the health care community’s answer to the question of how to study ethical issues arising from advances in biology and medicine. Coinciding with a rise of technology were social justice movements calling for increased civil lib-
  • 48. erties and women’s rights. As part of these move- ments, individuals and interest groups also agi- tated for the right to make health care decisions (Cotler, 2013). On occasion, patients, their fami- lies, and their physicians disagreed about whether to continue treatment. In those cases it was not clear what to do, who should decide, and what basis to use for decisions. Given the plural- istic society of the United States and the fact that the nation lacks a common ethos, these decisions fell to the courts. New technology also required capital-intensive hospitals, specialization, and new financing mechanisms. Specialists who often did not have any relationship with the patient or the family replaced the old family doctor who had the luxury of knowing his or her patients. This affected the physician-patient relationship, and new forms of health care delivery developed. In addition to court decisions that influence prac- tice, heightened public expectations sometimes result in malpractice suits. In turn, many physi- cians practice defensively. Practice is also regu- lated by third-party payers, including the state and federal governments and insurance compa- nies. Many health care organizations incorporate peer review for their physicians, and many hospitals are accredited through an independent, non-profit organization known as The Joint Commission. Exactostock/SuperStock Advancements in medical technology, especially in life-support systems, have given rise to new ethical dilemmas for doctors, patients, and family members.
  • 49. © 2019 Bridgepoint Education, Inc. All rights reserved. Not for resale or redistribution. Section 1.1The Rise of Contemporary Health Care Ethics Organizations and Physicians The relationships of individual physicians to health care organizations have become increas- ingly important and complex. These relationships vary by the particular characteristics of the organization, which may be integrated vertically, with facilities that offer either a lower or higher level of care (such as nursing homes or tertiary care hospitals), horizontally, with similar institutions at the same level of care, or both vertically and horizontally. Hospitals also differ in their characteristics and feature a wide array of options and potential arrangements: Health care organizations might be religious, private, governmental, for-profit, urban, or com- munity-based. According to Cotler (2013), the structural differences among organizations do not prevent ethical challenges; they simply change some of the contextual details of the cases. Individuals and organizations have somewhat different roles and functions, but they all share the principal aim of quality patient care. However, they also may compete for limited resources and power, which could create conflicts of interest. Thus, “duties and responsibili- ties of the board of directors, the CEO, and the administrative team and their relationships to individual physicians and medical groups all present potential
  • 50. ethical pitfalls” (Cotler, 2013, p. 14). The following are examples of structural differences that could potentially pose a con- flict of interest: • Physicians may work independently of the organization in their own office, but they will usually also be a member of the medical staff, which has its own bylaws. They are thus constrained by rules with which they may not agree or which they may not respect. • Administrators may have loyalty to their institution, but as part of a corporation, they are also required to comply with financial and managerial demands. Potential financial and clinical conflicts are part of their daily lives. • The board of directors has differing power, authority, and functions, depending on whether the facility is independent or part of a corporation. Its philosophy of care may diverge from the corporation or from administration. In addition, the boundar- ies of the board’s authority may not be clear. Human Subjects Research Another historical influence on the rise of bioethics was the realization, which began around World War II, that persons all over the world had been forced to become subjects in clini- cal research; in other cases, research subjects were mistreated or abused. Perhaps the best known example in the United States of grievous research misconduct was the Tuskegee
  • 51. syphilis study conducted by the U.S. Public Health Service from the late 1930s until the early 1970s. In that trial, individuals afflicted with the disease were not given antibiotics, despite availability and efficacy. Table 1.1 shows the number of participants who were not treated for syphilis for research purposes. Many research abuses have been reported worldwide, and in response, the international community has developed codes and regulations that foster ethi- cal practice. © 2019 Bridgepoint Education, Inc. All rights reserved. Not for resale or redistribution. Section 1.1The Rise of Contemporary Health Care Ethics Table 1.1: Participants in the Tuskegee syphilis study Results of the Tuskegee syphilis study conducted from 1932 to 1972. In 1932 poor Black sharecroppers from Macon County, Alabama, were recruited to participate in the study so researchers could follow the progression of untreated syphilis over time. The men all believed they were receiving free health care and did not know they had the disease. The controversial study led to tight federal regulations that require informed consent to protect human research subjects. Control participants Syphilitic participants
  • 52. Total Classification at initial examination 200 411 611 Cases added in 1938–1939 – 14 14 Total—original classification 200 425 625 Controls infected during observation –9 +9 – Controls reclassified as syphilitic on basis of additional history –1 +1 – Controls reclassified as syphilitic on basis of treponemal tests –8 +8 – Total—final classification 182 443 625 Known dead—number 97 276 373 Known dead—percentage 53.3 62.3 59.7 Remainder; examined in 1968—number 36 53 89
  • 53. Remainder; examined in 1968—percentage 42.4 31.7 35.3 Source: Department of Health, Education, and Welfare. Public Health Service. Health Services and Mental Health Administration. Center for Disease Control. Venereal Disease Branch. (1969). Tuskegee syphilis study administrative records, 1929–1972. Retrieved from https://catalog.archives.gov/id/281642 Indeed, ethics committees in many countries remain concerned with research rather than clinical or organizational issues. Clinical trials are heavily regulated to protect quality and human safety. According to Cotler (2013) Major ethical issues, surrounding the protection of human subjects including informed consent, confidentiality, conflict of interest, and justice, are similar to the clinical concerns. There are essential differences between the clinic and the clinical trial. Patients’ rights to refuse recommended treatments are well established. In research, the primary ethical goals surround protection © 2019 Bridgepoint Education, Inc. All rights reserved. Not for resale or redistribution. Section 1.1The Rise of Contemporary Health Care Ethics
  • 54. of human subjects . . . This is a soft paternalistic approach justified by a long and widespread international history of abuse of human subjects and by the complexity of proposed trials which require highly regulated review by insti- tutional review boards (IRBs). (p.13) The true differences between clinical care and research, however, are in their goals. In clini- cal care, the goal is to heal and care for; in research, it is to discover and increase knowledge. Possible research ethics issues include: • how research subjects are selected • access to studies • use of placebos • international trials • compliance • relationships with outside vendors (Cotler, 2013, p. 14) Another potential dilemma can occur when patients are asked to participate in clinical trials being run by their personal physician. While a patient must give consent to take part in a clini- cal trial, even if it is being conducted by their personal physician, both parties may be wary of the potential conflict when the researcher and the clinician are the same person. For instance, a patient may wonder if the physician is acting as the researcher or as the treating doctor who places the patient’s interests above all. Some ethical dilemmas are not easily resolved by regulation, and so require extra careful attention from both
  • 55. professionals and organizations. Bioethics Committees According to Cotler (2013), bioethics committees (BECs) “have grown as a response to demands raised by exploding medical technology, diversity among the population, directives from the courts, and health-care systems attempting to address ethical conflicts in health- care organizations” (p. 6). Technology has increased choices and thus raised questions about what medical decisions to make, who should make them, and when they are appropriate. Ideally, BECs can prevent some of the many ethical dilemmas posed by these developments. Preventive ethics implies that the best resolution to a dilemma is to prevent it from arising in the first place. Global diversity means that people of different cultures and beliefs bring an array of perspec- tives and values to the table when they make critical health care decisions. In some countries religion plays a strong enough role that it provides direction, and possibly resolution, to ethi- cal issues through consistent moral authority. Examples include the Catholic Church’s prohi- bition of elective abortions and the Islamic prohibition of male physicians touching female patients. Most countries lack a single authority, however, and many developed nations have various multicultural communities. Thus, particularly in diverse regions that lack a unified religion, language, or culture, there is confusion over how to universally address or resolve ethical dilemmas.
  • 56. In an effort to prevent such confusion, most hospitals have established a mechanism for addressing bioethical problems such as who has the authority to give informed consent, © 2019 Bridgepoint Education, Inc. All rights reserved. Not for resale or redistribution. Section 1.2Theories and Methods of Contemporary Bioethics whether to continue life support, and how to resolve disagreements between or among care- givers and families when patients can no longer represent themselves. Some larger institu- tions and university medical centers employ clinical ethicists. In the United States and other Western nations, most bioethics committees are part of the medical staff, although some are part of administrative departments. Though many other countries rely on ethics committees to also review proposed clinical trials and other institutional research, there is increasing interest in the Western model, which features a BEC that focuses on clinical concerns and an IRB that manages ethical concerns in research. The function of bioethics committees and institutional review boards will be discussed in greater detail in Chapter 3. Prior to the mid-20th century, theology and philosophy provided the foundation for bioeth- ics scholarship. However, it was soon clear that the questions generated by new technology,
  • 57. which included life-sustaining equipment and complex organizational structures, required ethical study and explicit practice standards. Thus, in the United States, the 1960s and 1970s saw the birth of freestanding and university-affiliated entities devoted to the study and reflec- tion of bioethics. Early prominent examples are the Hastings Center, which is freestanding, and the Kennedy Institute of Ethics, which is affiliated with Georgetown University. Several professional organizations (now largely subsumed under the American Society for Bioeth- ics and Humanities) also developed within philosophy, law, and medicine. The field is still very new, and it continues to struggle with creating an identity, determining its own code and structural requirements, forming a unified theory and method, and determining whether such a multidisciplinary field should even have a unified theory or method. 1.2 Theories and Methods of Contemporary Bioethics Before turning to the specific ethical issues health care practitioners face, an introduction to ethical theory is helpful. The goal of this section is to discuss ways to think about the rightness or wrongness of actions that have been historically important. In particular, we will focus on principlism, an approach commonly used in health care, and how it is applied by practitioners to resolve bioethical problems. Ethical Theory Traditionally, ethical theory has been the purview of philosophers, including Immanuel Kant, John Rawls, and John Stuart Mill. Today, ethics, or moral
  • 58. philosophy, is a major branch of aca- demic philosophy. Moral philosophers ask questions such as, “What features of an action or event make it right or good?” “What are the sources of our moral obligations?” and “Do out- comes matter when determining the rightness of an action? If so, are they all that matter or, at least, the most important factor?” Philosophers then attempt to systematize their answers to arrive at an explanation of the rightness or goodness of actions and events in general. These explanations are ethical theories. In essence, an ethical theory is a view about what makes actions or events right or good; an ethical theory gives general criteria for rightness and iden- tifies the right-making features of actions and events—in other words, that which we should take into account when judging whether an act is right or wrong. To see what philosophers mean by “right-making features,” consider the case study Rationing the Antidote. © 2019 Bridgepoint Education, Inc. All rights reserved. Not for resale or redistribution. Section 1.2Theories and Methods of Contemporary Bioethics Principlism There are several methods for “doing ethics.” Whatever methods, or combination of methods, apply to the individual case or problem, it is helpful to remember that, basically, ethics is about respect for persons, truthfulness, and fidelity. Primarily in the 1970s and 1980s, courts
  • 59. and philosophers emphasized principlist ethics, which stresses the application of general principles, in a top-down fashion, to serve as the basis for rules or guides to action. These general principles include autonomy, nonmaleficence, beneficence, and justice. The princi- plist approach has mainly been associated with Tom Beauchamp and James Childress (2009), the authors of the canonical text on principlism, Principles of Biomedical Ethics. Figure 1.1 provides a diagram to help visualize the four principles. Case Study: Rationing the Antidote You are a hospital administrator. One afternoon, the director of your emergency department notifies you that six patients have been brought to your emergency room, all of whom are dying after ingesting a rare poison. Unfortunately, your facility does not have a large enough supply of the antidote on hand to save the lives of all six patients. There is also no way to acquire more antidote in time to save all the patients. The patients must be treated within one hour of ingestion of the poison for the antidote to be effective, and time is already run- ning out. The director informs you that one of the patients has ingested a much larger dose of the poison than the others. If the antidote on hand is divided five ways, there will be enough antidote to save the five who ingested a small dose. In order to save the patient who ingested the large dose, however, all the antidote on hand would have to be administered. How should the emergency department staff distribute the antidote?
  • 60. The answer probably seems clear. Of course, the antidote should be divided among the five patients who require a smaller dose. Given that the hospital has a choice between saving one life or saving five lives, the hospital should save the greater number. This requires the assumption that there are no other factors that should influence the decision about whom to save. If, to give an extreme example, the five patients were violent criminals who escaped from prison and the one patient was the president of the United States, some might think the hospital should act differently. Or what if the patient who took the larger dose was a major donor to the hospital and the other five patients were just members of the com- munity? While many may feel that a person’s social standing or ability to financially invest in a certain institution should not be considered in a case like this, ethical dilemmas like these can come into play. The antidote case study is, of course, imaginative and unrealistic. However, it highlights an important moral intuition that many people share. In fact, in 1960 when dialysis units were first developed in Seattle, Washington, there were not enough for everyone who needed them. The question of how to distribute them was real, and a process for deciding had to be developed prior to selecting patients. © 2019 Bridgepoint Education, Inc. All rights reserved. Not for resale or redistribution.
  • 61. Section 1.2Theories and Methods of Contemporary Bioethics Figure 1.1: Venn diagram of ethical principles in health care A useful way to imagine the four ethical principles is as a Venn diagram, or a group of overlapping areas of concepts. These areas overlap because often the concerns and questions associated with the principles occupy more than one area. For example, “respecting a patient’s choices” falls under autonomy, but it can also fairly be described as observing the principle of nonmaleficence, since disrespecting a person is a form of harm. It might also be described as falling into the category of beneficence if respecting a patient’s wishes fosters autonomy or a sense of control that may itself be therapeutic or beneficial. Dan Bustillos Autonomy Court decisions in a variety of landmark cases have established autonomy as the dominant ethical principle. Literally meaning “self-determination,” autonomy grants patients the right to be left alone and not be touched without permission, and it forms the basis for our laws © 2019 Bridgepoint Education, Inc. All rights reserved. Not for resale or redistribution. Section 1.2Theories and Methods of Contemporary Bioethics against battery. However, no one is entirely self-determining.
  • 62. Everyone has aspirations and dreams, and yet everyone encounters reality. In health care, for example, providing what the patient wants must be contrasted with what he or she gets; this is limited by the physician, who is responsible for clinical judgment and determining medical necessity. According to Cotler (2013), the autonomy maxim “Do not do unto others that which they would not have you do, and keep your promises” has been such a misunderstood concept that Englehardt (1996) renamed it the principle of permission. Autonomy forms the rationale for informed consent. If one may not touch another without permission, informed consent provides a mechanism to obtain the permission by declaring risks, potential benefits, and alternatives. Note that the maxim includes the mandate to keep promises. Autonomy is par- ticularly confusing to providers and patients in that the principle grants the right to accept or reject recommended treatments, but decisions about appropriateness and effectiveness are the domain of the physician. Many cultures value community over individual choice, and autonomy may not be the most important value for such communities. It may not even be considered. In all cases practitioners need to discuss decisions with the patient to discern the relative value he or she places on autonomous choice. Does the patient want information? Does the patient want to be involved in decisions, or does he or she delegate to family? These are autonomous choices, and health care practitioners have a duty to assure they are stable
  • 63. and authentic. As noted above, informed consent derives from the principle of autonomy, and it is discussed in detail in Chapter 2. However, note that informed consent requires a conversation between the physician and the patient or surrogate engaged in shared decision making. Informed con- sent requires that the patient be an active participant in the process, necessitating well-docu- mented notes in the medical records. It is much more than a signature on a form. Though court decisions tend to favor patient autonomy, “the repeated lack of a clear mech- anism to resolve conflicts between and among the principles at the bedside demonstrates weakness in the principalist approach” (Cotler, 2013, p. 6). For example, consider a case in which, based on medical necessity and the physician’s clinical judgment, surgery is recom- mended for a particular patient. However, the patient refuses based on his or her own com- plex reasons, preferences, and values. This collision between the patient’s choices or refusals causes dilemmas at the bedside and in setting policy. Before life-sustaining technology, such dilemmas were precluded by old paternalistic methods in which the physician decided. Crit- ics ask how principles help resolve conflicts in a given case. Beauchamp and Childress address the question in their later editions by recommending specifying and balancing approaches in specific cases. Nonmaleficence
  • 64. The ethical principle of nonmaleficence is based on the age-old medical precept “first, do no harm,” or the Latin primum non nocere. Nonmaleficence is the general duty to avoid causing harm to others, either directly or indirectly. It sometimes is necessary to risk harm in order to achieve a greater good or prevent a worse harm. For example, performing a difficult gastric surgery on a patient with heart or organ failure jeopardizes the weak organ, but it may be necessary to save the life. The decision about what to do is not primarily a medical one; there is a choice to make and values are at stake. Life-saving technology has sometimes made it © 2019 Bridgepoint Education, Inc. All rights reserved. Not for resale or redistribution. Section 1.2Theories and Methods of Contemporary Bioethics difficult to know what is a harm and what is a benefit. For example, consider a dying patient who is on a ventilator. Is continu- ing aggressive support saving the life or prolonging the death? These questions require more information and much greater understanding of the case. In clinical health care it is easy to think of the myriad ways in which a patient can be harmed through incompetence, error, or systems failure, or ways in which a phy- sician can inadvertently cause pain, dis- ability, or even death. Preventing harm to
  • 65. patients is the responsibility of the admin- istrator, in collaboration with the medical staff. In addition to the physical, psycho- logical, and economic ways that health care managers can affect patients or staff, those in leadership roles also have the ability to affect the culture of the organization in critical ways. The duty of nonmaleficence not only involves not causing harm, but also actively choosing the least harmful alternatives. Nonma- leficence requires that managers actively minimize or eliminate workplace hazards and risks that could harm employees and patients. It is prudential as well as practical for administrators to regularly review relevant policies, make rounds, meet with practitioners and employees, and attend meetings in which the topic is preventing or responding to error and other harms. Beneficence Beneficence is the principle that guides health care professionals to do good. It provides the grounding for charitable duty to others. At the bedside, patients define their own good; this may present a conflict with a health care provider’s recommendations, which are based on the physician’s clinical judgment about the best medical good. Problems may occur when patients refuse recommended treatments. Conversely, they may occur when patients or their surrogates demand care that physicians deem inappropriate or nonbeneficial. Misunder- standings about patient and provider rights lead to many of the requests for bioethics con- sultation. In the case of refusal, autonomy usually trumps. However, it is critical to evaluate
  • 66. the patient’s capacity to make rational and authentic decisions. Capacity goes beyond being oriented to time, person, and place. It is the ability to understand the context, meaning, and implications of choices. If the patient is incapable of making his or her own decisions, it is necessary to evaluate whether the surrogate is acting in a way that is consistent with the patients’ directives and interests. Health care professionals are not obligated to participate in acts about which they have a con- scientious objection. Organizations are also protected. For example, Catholic hospitals are not required to perform elective abortions or participate in assisted reproductive technologies that compromise their ethical and religious doctrine. The positive duty imposed by the prin- ciple of beneficence requires that health care managers do everything they can to reasonably care for and benefit patients, employees, and others for whom the organization is or may be iStockphoto/Thinkstock Health care providers have an ethical obligation to bring no harm to their patients. However, sometimes harm must be risked in order to prevent a greater detriment. © 2019 Bridgepoint Education, Inc. All rights reserved. Not for resale or redistribution. Section 1.2Theories and Methods of Contemporary Bioethics
  • 67. responsible. How this duty is put into practice depends upon the nature of the organization and its mission. For example, if a practitioner’s organization has an explicit mission to serve the health needs of a particular population or community, then those commitments should give shape and substance to the practitioner’s duty of beneficence. Justice The justice principle can be broadly defined as “fairness.” It is exemplified by the Aristotelian ideal that people in similar situations ought to be treated similarly, and people in different situations should be treated differently. A distinction is sometimes made between distribu- tive justice, which refers to the allocation of resources, and procedural justice, the fair- ness and transparency of processes by which decisions are made. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, prepared by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979), offers guidelines on ethical principles; it states that “[a]n injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly” (p. 5). This may occur in the clinic or in research. For example, there is some evidence that persons who are poor and thus have less access to care and infor- mation about options may also have less access to clinical trials. They also have less access to the benefits of findings and to drugs that are approved as a result of such studies. Charges of
  • 68. injustice regarding access to research involving women have also been made (Mastroianni, 1998); women have proportionately been less often represented as research subjects. Data also indicate that persons belonging to some racial groups are treated differently when they appear at an emergency department (James et al., 2005; Selassie et al., 2003). Statistics have consistently shown differences in life expectancy by socioeconomic status (National Center for Health Statistics, 2012). In 1971, the leading American political philosopher of the 20th century, John Rawls (1921– 2002), wrote A Theory of Justice, a highly influential book that advances the idea that the best principles of justice are those that we would all agree to if we were all impartially situated as equals. This he arrives at through his famous thought experiment “the veil of ignorance,” in which we are asked to imagine an “original position” from which no one was better situ- ated than anyone else (or at least that we’d be ignorant of any inequalities in such a utopian state-of-affairs). A Rawlsian approach to distributive justice and health care ethics is one based on fairness. Therefore, even in cases where not everyone will have access to a certain good because it is scarce, there needs to be fair opportunity of access to the benefit. For Rawls, fair access was ensured by formal procedures that were themselves required to be fair. This leads us to the concept of procedural justice.
  • 69. In order for the justice principle’s requirements to be met, any formal procedures or mecha- nisms by which people attempt to decide dilemmas must be fair and just, or equitable. Pro- cedural justice requires that policy makers craft regulations, laws, and formal procedures that are free from bias that would render them inaccessible to some, or that would unduly restrict the chances of fair treatment for others. For example, a policy that recognizes employees’ rights to opt out of procedures when they have a strong conscientious objection states that employees must provide documentation in writing to the supervisor at least two weeks prior © 2019 Bridgepoint Education, Inc. All rights reserved. Not for resale or redistribution. Section 1.2Theories and Methods of Contemporary Bioethics to the event. But given the nature of acute care, in which the unexpected happens routinely, how can a nurse know in advance that something will be demanded of her that strongly vio- lates her conscience? When this issue came up in a local hospital, human resources had the policy rewritten to accommodate reality. Hospitals and nursing homes have to be clear about nurses’ rights and duties. For example, a policy might state that a nurse who has a strong moral objection to terminal extubations could be transferred to a unit where this procedure will not likely occur. Other policies might call for less supportive measures such as unpaid
  • 70. leave; such options could trigger a union dispute. Justice is a fundamental principle for health care administrators and practitioners—particu- larly in their responsibilities to make resource allocation decisions—and among those who work toward eliminating health inequities. The justice principle impacts many other day-to- day decisions that health care managers make. Examples include policies regarding unioniza- tion, working conditions, and staffing patterns for employees; hiring and promoting staff; decisions about where and to whom the institution should be marketed; and determining whether promotion should be by merit, seniority, or favoritism. In addition, hospitals that undergo purchase or mergers often have to make choices about their mission and values. Strengths and Weaknesses of Principlism Scholars continue to refine the principlist approach; with each new edition, Beauchamp and Childress refine the text to accommodate legitimate criticism. Some bioethicist academics turn to casuistry, a case-based method of resolving ethical issues. Most practitioners use a combined approach from different methods, depending somewhat on the particulars of the case. The several methods reflect the necessity of an interdisciplinary approach. According to Cotler (2013), “no single method has been successful in addressing the varied and com- plex dilemmas that arise in the clinic, the institution, or the community” (p. 7). Principles provide fundamental guidelines, but when they conflict with one another, there is a lack of
  • 71. clear instructions on how to prioritize. The courts have consistently favored autonomy, but that does not always seem correct in an acute health care setting. It is also not always clear whether a choice is consistent and authentic; in other words, will the decision be the same later today or tomorrow? Is it an accurate reflection of the person’s narrative and the other choices he or she has made? Some argue that principlism fails to consider the complexities of real-world situations, or that it is too rigid in following prescribed formulas for making ethical decisions (Pellegrino & Thomasma, 1993). Other critics posit that principlism pays too little attention to the char- acter of the agent, opting instead to focus on actions that typify the principle in question; for example, asking if the decision was autonomous rather than also looking at precedent or important context (Bulger & Reiser, 1990). Does the way the four principles are selected, prioritized, and applied to ethical dilemmas depend on who gets to do the selecting, prioritiz- ing, and applying? Given that along with their great strengths, principles have weaknesses in application, leading proponents of principlism—especially Beauchamp and Childress—con- tinue to refine their text to include the necessity to specify and balance in individual cases. Whether in management, at the bedside, or in the community, it has become clear that princi- ples are important, but they are not to serve as a blind mantra. They work when they are aptly applied, usually along with other methods, and always in conjunction with good judgment.
  • 72. © 2019 Bridgepoint Education, Inc. All rights reserved. Not for resale or redistribution. Section 1.3Practical, Ethical Decision Making in Health Care Administration 1.3 Practical, Ethical Decision Making in Health Care Administration The complicated nature of the work of modern health care administrators and leaders often means that they have to take into consideration a multitude of factors and facts when making a well-reasoned, ethical deci- sion. Typically we experience an ethical dilemma because one (or more) ethically relevant factor of the situation is pulling us to act one way while one (or more) ethically relevant factor is pulling us to act in a different or even opposing way. Ethically relevant factors (ERFs) are goods or values, rights, or any other factor to which we ought to be sensitive in determining the ethi- cally correct way to respond to the situation. Issues involving mergers with institutions at the same level of care or above or below the acuity level, changes in financing, relationships with the community, and profit status are only a few of the ethical challenges. Without an organization’s clearly defined moral identity, often made apparent through mission and vision statements, or without a well-articulated moral identity statement of his or her own, the modern health care leader may lack direction and base decisions on ill-defined or unde- veloped personal ethics. These types of decisions run the risk of being unfair, inconsistent over time, or easily swayed by factors that seem the most
  • 73. urgent, instead of those that are most important to the primary goals of the institution or practice. The bulk of this textbook is devoted to helping cultivate in the student the characteristics of a moral leader capable of leading a moral organization. In this section we will consider the value of a flowchart method of resolving ethical dilemmas. Introduction to the Sample Framework Flowcharts, or decision-tree diagrams, such as the one seen in Figure 1.2, help demonstrate some of the important factors and norms that should be a part of any thoughtful ethical deci- sion. However, it is also important to remember that these guides, when misused or relied on too strictly, can serve as a crutch for bureaucrats and can impede the kind of rigorous and nuanced analysis that usually needs to happen in modern health care ethics. Once you become confident in applying the rules and norms covered in this text, and become adept at identifying the most important stakeholders and factors that need to be addressed, then you can use the diagram as a reference. It can be stored in a file cabinet or on a computer so that it is accessible when you need to make sure nothing important has been overlooked. It can also be used as a reminder of important questions to raise in an ethics committee meeting. Creatas/Thinkstock Administrators routinely face ethical dilemmas at the institutional level.