Belmont Principles Flashcards
(15 cards)
Belmont Report - Date of Occurrence
1978
Belmont Report - The Three Principles
Respect for Persons;
Beneficence;
Justice;
Belmont Report - Respect for Persons
Voluntary Consent (no coercion or taking advantage of people) + Protection for the vulnerable + Protection of Privacy and Confidentiality + The right to Withdraw without penalty
Belmont Report - Beneficence
Maximize benefits and minimize harm for each individual subject
Belmont Report - Justice
Fair distribution of the benefits and burdens of research (subject selection is equitable and no group is unfairly burdened or excluded from potential benefits without justification)
Substituted Judgement
When someone consents/makes a decision on behalf of someone, typically when they are of diminished capacity.
What federal regulation incorporates the Belmont Principles as foundational ethical guidance?
The Common Rule (45 CFR 46, Subpart A) is based on the ethical principles outlined in the Belmont Report.
Which Belmont principle is most directly tied to requiring informed consent in human subjects research?
Respect for Persons — because it requires honoring individual autonomy and ensuring voluntary, informed participation.
How do the Belmont Principles help guide IRB decisions during protocol review?
They provide an ethical framework for evaluating risk-benefit balance (Beneficence), consent and autonomy (Respect for Persons), and equitable subject selection (Justice).
What does “diminished autonomy” mean under the Belmont Principle of Respect for Persons?
It refers to individuals who are not fully capable of making informed decisions (e.g., children, prisoners, those with cognitive impairments) and therefore require additional protections.
What are examples of minimizing risk under the Belmont Principle of Beneficence?
Using the least risky procedures, monitoring for adverse events, and ensuring confidentiality of data.
How can the principle of Justice be violated in research design?
By targeting vulnerable populations for risky research without direct benefit, or excluding certain groups from beneficial research without scientific justification.
Which Belmont principle is most concerned with equitable subject selection?
Justice — it requires that the selection of research subjects be fair and not exploitative.
Why is the Belmont Report still relevant today?
It provides the foundational ethical principles for human subjects research and continues to guide IRB review and federal research regulations.
Which Belmont principle is most directly concerned with assessing the risk-benefit ratio of a study?
Beneficence — it requires minimizing potential harms and maximizing anticipated benefits for research participants.
