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Why is the Belmont report such named? - ✔✔✔ Correct Answer >
The Commission created by the National Research Act held its
deliberations at the Belmont Conference Center of the Smithsonian.
How does a non-therapeutic trial differ from a therapeutic trial? -
✔✔✔ Correct Answer > There is no anticipated benefit for the
subject. This makes it less appealing to participate. It should be an
autonomous person's decision to participate in a non-therapeutic trial.
Whenever possible, LARs should not enroll their dependents in such
trials because there is no expected benefit. (THERE ARE EXPECTATIONS)
Please name the 3 Broad Sections of the Belmont Report - ✔✔✔
Correct Answer > 1. Boundaries between Practice and Research
2. Basic Ethical Principles (there are 3)
3. Applications (there are 3)
,What are the 3 basic ethical principles outlined in the belmont report?
- ✔✔✔ Correct Answer > Respect for Persons, Beneficence, and
Justice
What are the 3 "Applications" Outlined in the Belmont report? - ✔✔✔
Correct Answer > Informed Consent
Assessment of Risk and Benefits
Selection of Subjects
How does the Belmont report distinguish between Practice and
Research? - ✔✔✔ Correct Answer > Practice: Interventions SOLELY
designed to benefit and individual, already have a reasonable
expectation of success.
Research: an activity to test a hypothesis, develop generalizable
knowledge. Formal protocol and procedures defined.
respect for persons - ✔✔✔ Correct Answer > treating persons as
autonomous agents and protecting those with diminished autonomy
(relates to children, prisoners, mental disability, respect for peoples
opinions and judgements)
Beneficence (Definition) - ✔✔✔ Correct Answer > Maximize possible
benefits and minimize possible harms.
,Belmont Report: Justice - ✔✔✔ Correct Answer > fair balance
between those who participate and those who benefit. (good
distribution of BURDENS vs. Benefits)
you can't study prisoners to benefit larger society (and other examples)
What are the 3 important elements of informed consent, as outlined in
the Belmont Report applications? - ✔✔✔ Correct Answer >
Information, Comprehension, Voluntariness
Describe the differences in information, comprehension, voluntariness
- ✔✔✔ Correct Answer > Information is WHAT is presented.
Comprehension is HOW it is presented (time, organization, layman's
terms, simple english). Voluntariness is freedom from coercion and
influence (like from powerful people/power imbalance/threats)
How should selection of subjects be systematically approached? -
✔✔✔ Correct Answer > Adults before children, capable before
incapable, free before unfree etc. Free from social, racial cultural
biases.
Why is the Nuremburg Code such named? - ✔✔✔ Correct Answer >
Came about from the trials held in Nuremburg Germany to prosecute
unethical human experimentation in concentration camps
, Describe (in brief) the 10 principles set forth by the Nuremburg Code -
✔✔✔ Correct Answer > 1. Voluntary Consent of the subject
2. Fruitful results unprocurable by other methods
3. Based on animal results and natural history
4. Avoid ALL unnecessary suffering
5. Cannot conduct study in which death or disability will reasonably
occur
6. Degree of risk should NEVER outweigh societal benefit
7. Proper preparations and adequate facilities to protect subjects
8. Only conducted by scientifically qualified persons with the highest
skill and care
9. Human subjects must be at liberty to bring the experimentation on
them to an end
10. Investigator must terminate any experiment when he has probably
cause to believe death, injury, or disability is likely
Please order dec of helsinki, belmont report, and nuremburg code in
chronological order - ✔✔✔ Correct Answer > 1. Nuremburg code
(40s)
2. Dec of Helsinki (60s)
3. Belmont report (70s)
Who is the target audience of the Declaration of Helsinki? - ✔✔✔
Correct Answer > Physicians