Evidence-Based Practice – Final
Examination: Research into Action
Define four core ethical principles that guide healthcare practice
1. Beneficence
2. Nonmaleficence
3. Autonomy
4. Justice
Beneficence
Captures the importance of doing good for patients
Nonmaleficence
Addresses the importance of not harming patients
Autonomy
Acknowledges that patients have the right to make decisions about their health, lives, and bodies
Justice
Declares that resources should be distributed fairly among people and without prejudice
Describe how the four core ethical principles can be seen as the foundation for the Institute of
Medicine's (IOM's) core dimensions of quality
Safety: nonmaleficence
Effectiveness: Benefience
Patient-centeredness: Autonomy
Timeliness: Beneficence and nonmaleficence
,Equity: Justice
Efficiency: Beneficence and nonmaleficence
IOM Quality Dimensions
Safety
Effectiveness
Patient-centeredness
Timeliness
Equity
Efficiency
Three examples of how EBP quality improvement initiatives could conflict with ethical principles
1. Attempts to improve quality for some patients and may cause harm to others.
2. Strategies intended to improve quality that may turn out to be ineffective and waste scarce resources
3. Activities declared to be quality improvement that may be more accurately described as clinical
research
Clinical research
Activities involving direct interaction by investigators with human subjects or material of human origin;
generates knowledge on which practice should be based
Patient participation viewed as optional. Aim is to generalize findings to a population wider than
research subjects. Aim to disseminate findings for use outside of the organization.
Evidence-based quality improvement (EBQI) initiatives
Systematic, evidence-based activities designed to immediately improve healthcare delivery in specific
settings
All patients receive the same evidence-based intervention as part of routine care. Aim is to improve care
of patients in a specific organization/setting. Aim is to provide internal data to practitioners to guide
further practice changes.
Similarities between EBQI and clinical research
Involve human participants
May use similar data collection procedures to evaluate outcomes (e.g., surveys and physiological
measurements)
Both may use the same data analysis methods to manage and process data
Ethical implications with EBQI and clinical research
If efforts are not made to improve quality through EBQI, principles of beneficence and nonmaleficence
may be violated
, If EBQI does not offer the same treatment strategies to all patients, then the principle of justice and
autonomy may be violated, especially if patient consent is not obtained.
Three ethical controversies related to EBQI initiatives
1. Should EBQIs require the same standards of patient consent as clinical research?
2. Is it ethical to implement EBP in one setting while continuing with traditional (and possibly
substandard) practice in another?
3. Should informed consent be obtained from the patients receiving traditional care?
Similarities and differences among research, EBP, and QI that have implcations for human subjects
review
1. research is not an integral part of routine clinical practice
2. EBQI is an integral part of the ongoing management of clinical care delivery (EBP)
3. Research often carries risks for patients
4. Risks with EBQI activities are usually very low; sometimes the risks may be greater if the EBQI
activities are not implemented.
5. Generally, research is focused on generating evidence for practice, whereas EBQI is focused on
implementing evidence in practice
Seven ethical requirements that have been proposed as the ethical foundations upon which clinical
research should be based.
1. Social or scientific value
2. Scientific validity
3. Discuss the concept of patients having some ethical responsibility in the process of improving health
care
4. Fair subject selection
5. Favorable risk-benefit ration
6. Independent review
7. Respect for potential and enrolled subjects
8. Informed consent
Social or scientific value
For research, EBP, or EBQI to be ethical, it should be worth doing
Scientific validity
Research projects must be methodologically sound enough to ensure valid and generalizable findings;
poorly designed or implemented EBP or EBQI projects waste resources and the time of those involved
Fair subject selection
Inclusion and exclusion criteria for recruiting study participants should be based on scientific rationale,
not convenience or vulnerability
Patients involved in EBP or EBQI project should be determined by the population of patients served by
the organization rather than the ability to generalize outcome findings
Examination: Research into Action
Define four core ethical principles that guide healthcare practice
1. Beneficence
2. Nonmaleficence
3. Autonomy
4. Justice
Beneficence
Captures the importance of doing good for patients
Nonmaleficence
Addresses the importance of not harming patients
Autonomy
Acknowledges that patients have the right to make decisions about their health, lives, and bodies
Justice
Declares that resources should be distributed fairly among people and without prejudice
Describe how the four core ethical principles can be seen as the foundation for the Institute of
Medicine's (IOM's) core dimensions of quality
Safety: nonmaleficence
Effectiveness: Benefience
Patient-centeredness: Autonomy
Timeliness: Beneficence and nonmaleficence
,Equity: Justice
Efficiency: Beneficence and nonmaleficence
IOM Quality Dimensions
Safety
Effectiveness
Patient-centeredness
Timeliness
Equity
Efficiency
Three examples of how EBP quality improvement initiatives could conflict with ethical principles
1. Attempts to improve quality for some patients and may cause harm to others.
2. Strategies intended to improve quality that may turn out to be ineffective and waste scarce resources
3. Activities declared to be quality improvement that may be more accurately described as clinical
research
Clinical research
Activities involving direct interaction by investigators with human subjects or material of human origin;
generates knowledge on which practice should be based
Patient participation viewed as optional. Aim is to generalize findings to a population wider than
research subjects. Aim to disseminate findings for use outside of the organization.
Evidence-based quality improvement (EBQI) initiatives
Systematic, evidence-based activities designed to immediately improve healthcare delivery in specific
settings
All patients receive the same evidence-based intervention as part of routine care. Aim is to improve care
of patients in a specific organization/setting. Aim is to provide internal data to practitioners to guide
further practice changes.
Similarities between EBQI and clinical research
Involve human participants
May use similar data collection procedures to evaluate outcomes (e.g., surveys and physiological
measurements)
Both may use the same data analysis methods to manage and process data
Ethical implications with EBQI and clinical research
If efforts are not made to improve quality through EBQI, principles of beneficence and nonmaleficence
may be violated
, If EBQI does not offer the same treatment strategies to all patients, then the principle of justice and
autonomy may be violated, especially if patient consent is not obtained.
Three ethical controversies related to EBQI initiatives
1. Should EBQIs require the same standards of patient consent as clinical research?
2. Is it ethical to implement EBP in one setting while continuing with traditional (and possibly
substandard) practice in another?
3. Should informed consent be obtained from the patients receiving traditional care?
Similarities and differences among research, EBP, and QI that have implcations for human subjects
review
1. research is not an integral part of routine clinical practice
2. EBQI is an integral part of the ongoing management of clinical care delivery (EBP)
3. Research often carries risks for patients
4. Risks with EBQI activities are usually very low; sometimes the risks may be greater if the EBQI
activities are not implemented.
5. Generally, research is focused on generating evidence for practice, whereas EBQI is focused on
implementing evidence in practice
Seven ethical requirements that have been proposed as the ethical foundations upon which clinical
research should be based.
1. Social or scientific value
2. Scientific validity
3. Discuss the concept of patients having some ethical responsibility in the process of improving health
care
4. Fair subject selection
5. Favorable risk-benefit ration
6. Independent review
7. Respect for potential and enrolled subjects
8. Informed consent
Social or scientific value
For research, EBP, or EBQI to be ethical, it should be worth doing
Scientific validity
Research projects must be methodologically sound enough to ensure valid and generalizable findings;
poorly designed or implemented EBP or EBQI projects waste resources and the time of those involved
Fair subject selection
Inclusion and exclusion criteria for recruiting study participants should be based on scientific rationale,
not convenience or vulnerability
Patients involved in EBP or EBQI project should be determined by the population of patients served by
the organization rather than the ability to generalize outcome findings
