Chapter020

Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins

Chapter 20Ethical 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


Ethical Principles as Applied to Research and Evidence-Based Quality Improvement (cont’d)

• 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


Ethical Principles as Applied to Research and Evidence-Based Quality Improvement (cont’d)

• 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.

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