Chapter020

Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins
Chapter 20
Ethical Considerations for
Evidence Implementation and
Evidence Generation

Ethics and EBP
• Some of the motivations underlying the advancement of
EBP are, at their core, ethical issues
− Serious and systemic problems exist with the
delivery of health care
• The Institute of Medicine (IOM) has developed a
conceptual framework to help understand healthcare
quality and how it can be improved practically
− Emphasizes safety, effectiveness, patient-
centeredness, timeliness, equity, and efficiency
• Each consideration is based on an ethical principle

Ethical Conflict and EBQIs
• Evidence-based quality initiatives (EBQIs) can conflict
with ethical principles, e.g.,:
− Attempts to improve quality for some patients that
may cause harm for others
− Strategies intended to improve quality that may turn
out to be ineffective and waste scarce resources
− Activities declared to be quality improvement that
may be more accurately described as clinical
research

EBQIs and Clinical Research
• Both involve human participants and sometimes use
similar methods to evaluate outcomes
• Some believe EBP implementation activities are a form of
clinical research needing the same ethical and regulatory
requirements
• Others claim that EBP implementation is different and
should not be considered clinical research
• Differences exist with regard to generalizability

Controversies
• Should EBQIs require the same standards of patient
consent as clinical research?
• Is it unethical to implement EBP in one setting while
continuing with traditional (substandard?) practice in
another?
• Should informed consent be obtained from the patients
receiving traditional care?

Question
• Tell whether the following statement is true or false.
• There is a lack of agreement regarding the question of
whether ethical principles are relevant in the clinical
application of EBP.

Answer
• False
• Rationale: It is broadly agreed that ethical principles are
an important consideration in the application of EBP. The
debate centers on the question of how stringent or
similar to these requirements should be to the standards
placed on the conduction of clinical research.

Practical Consequences
• The Office for Human Research Protections (OHRP) has
taken a broad view of “research,” often including EBQI
initiatives
• Many journals will not publish articles they deem to be
clinical research if they have not already had IRB review
• Inappropriate classification of an activity as “non-
research” could avoid ethical review, which could have
highlighted ethical problems
• If an ethics process is onerous, practitioners may be
unwilling to make evidence-based changes

Distinguishing Research From Quality
Improvement
• Quality assurance and audit: both terms are designed
to assess how well current practice compares with best
practice
• It can be difficult to distinguish EBQI from clinical
research
− Often a clear dichotomy does not exist
− Generally, research is focused on generating
evidence for practice, whereas EBQI is focused on
implementing evidence in practice

Distinguishing Research From Quality
Improvement (cont’d)
• Research is not an integral part of routine clinical practice
− In contrast, QI is an integral part of the ongoing
management of the system for delivering clinical care
• Research often carries risks for patients
− Risks with EBQI activities are usually very low
− Sometimes the risks may be greater if the EBQI
activities are not implemented

EBQI Versus Clinical Research

Question
• Tell whether the following statement is true or false.
• EBQI initiatives are less likely to be externally funded
than are research activities.

Answer
• True
• Rationale: One of the differences between EBQI and
clinical research is that EBQI initiatives are much more
likely to receive internal funding.

Ethical Principles as Applied to Research
and Evidence-Based Quality
Improvement
• Social or scientific value
− Both research and EBQI activities are only ethical if
they are worth doing
• Scientific validity
− The goal of EBQI is usually local improvement, not
generalizable knowledge, so different methods may
be used

• Fair subject selection
− In both research and EBQI, risks and benefits should
be shared equally
• Favorable risk-benefit ratio
− Sought within both EBQI and research
• Independent review
− Differing standards exist between EBQI and research

• Respect for potential and enrolled subjects
− Differences exist between EBQI and research with
regard to withdrawing participation
• Informed consent
− Significant controversy exists

Question
• The differences in ethical standards and practices
between EBQI and clinical research exist most clearly in
which of the following domains of ethics?
a. Scientific validity
b. Social or scientific value
c. Fair subject selection
d. Independent review

Answer
• d. Independent review
• Rationale: There is significant controversy surrounding
the question of independent review for EBQI, with many
citing a different standard for clinical research than
evidence-based practice change. It is generally agreed
that questions of scientific validity, social or scientific
value, and fair subject selection should be applied to
similar degrees within the two paradigms.

Informed Consent and EBQI
• Obtaining informed consent for each individual action or
intervention aimed at best practice would not be practical
• A question exists whether patients should expect EBQI to
be seen as part of standard healthcare practice
• Some argue there is a responsibility on patients to
participate in such activities
− An appropriate balance between individual autonomy
and group responsibility is necessary
− The responsibility of patients to cooperate in QI
activities is justified by the benefits each patient
receives because of the cooperation of the others in
the collective enterprise

Reviewing Evidence-Based Quality
Improvement Projects
• The majority of EBQI is low risk and could be reviewed
within clinical management and supervision structures
• In some cases, external review may be necessary, e.g.,
when projects involve more risk or seem to become more
like research

Question
• The nurses on a nephrology unit wish to implement an
evidence-based change in the assessment and
management of patients’ arteriovenous fistulas. Which of
the following is the best choice for reviewing the ethics
of this change?
a. The hospital’s ethics review board
b. The state board of nursing’s ethics committee
c. Individual nurses
d. The leadership and management of the unit

Answer
• d. The leadership and management of the unit
• Rationale: Most EBQI initiatives carry a low risk relative
to clinical research. As such, it is sufficient and
appropriate for management and supervisors to critically
examine the ethics of this and other similar changes in
practice.

Chapter020

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