Major principles Flashcards
(25 cards)
What are the four principles of Principlism?
Respect for autonomy, beneficence, nonmaleficence, and justice
Why are the four principles of Principlism used instead of others?
They appeal to a ‘common morality’
What does the Belmont Report emphasize regarding respect for persons?
Recognizing and respecting the human capacity for self-determination by honoring an individual’s autonomous decisions
What are the three main ideas under respect for autonomy?
- Protecting autonomy of a patient
- Protecting patients with diminished autonomy (e.g., children, mental disorders, critical illness)
- Being truthful and conduct - no deception
Respect for persons
What is informed consent?
The process through which we ensure respect for persons (preserving autonomy)
Respect for persons
What is beneficence?
Doing ‘good’ to the individual (a positive obligation)
What is nonmaleficence?
Not doing harm to the individual (a negative constraint)
What is the most commonly recognized principle in bioethics?
Nonmaleficence: ‘Above all, do no harm’
How does beneficence differ from nonmaleficence?
Beneficence focuses on maximizing benefits while nonmaleficence is limited to avoiding harm
What is the role of IRB in the context of respect for persons, beneficence, and justice?
IRB assessment of benefits and risks, informed consent, and distribution of the burden of research
What is the principle of justice in research ethics?
Fair and equitable distribution of burden of research and anticipated benefits
What is a moral requirement concerning the selection of research participants?
Fair procedures and outcomes in the selection of research participants
Can’t only select disadvantaged for risky research, or beneficial research for groups a researcher favors
Fill in the blank: The principle of ________ emphasizes maximizing benefits while minimizing harms.
beneficence
True or False: Nonmaleficence is broader in scope than beneficence.
False
If only people who have failed multiple (costly) therapies or ndergone some specialized diagnostic test are eligible for enrollment, then _______ is a concern because it is not equitable enrollment
Justice
What is equipoise?
Treatment possibilities must be equally acceptable given current knowledge.
i.e. reasonable clinician would not have a clear preference for one treatment approach under investigation
Placebo is not allowed if there is a preventive treatment.
Equipoise is essential for ethical clinical trials to ensure that no participant is knowingly placed in a worse position than they would be outside of the trial.
What must be ensured regarding patient enrollment in research protocols?
We cannot enroll a patient in a research protocol that would make them worse off compared with not enrolling
This principle is crucial for maintaining ethical standards in clinical research.
What must be sufficient in a clinical trial to address concerns with beneficence?
The comparator in a clinical trial must be sufficient
Insufficient comparators can lead to ethical issues regarding the well-being of participants.
When is it inappropriate to use a placebo comparator in a clinical trial?
When an active therapy is considered standard care
Using a placebo in such cases can deny participants access to effective treatment.
What does it mean to deny a participant standard care treatment in a trial?
If we are denying a participant a standard care treatment then we have not achieved equipoise (equally acceptable treatment possibilities)
Achieving equipoise is crucial for ethical justification of clinical trials.
What is therapeutic misconception?
Where a (potential) research subject incorrectly perceives the purpose of participation in a research study is to improve their own care
This misconception can lead to ethical issues in informed consent.
How do subjects typically perceive the purpose of research participation?
Subjects expect some therapeutic benefit from their participation in the study
This expectation can cloud their understanding of the research’s true purpose.
Fill in the blank: The phrase ‘The purpose of this research is to _______’ reflects therapeutic misconception.
[benefit me]
This phrase illustrates how participants may misinterpret the intent of research.
If we are denying a participant a standard care treatment then we have not achieved _______________
equipoise
