What are the 4 reasons why research is done on humans?
- advancing human welfare
- advancing knowledge
- advancing understanding
- examining cultural dynamics
What are 3 reasons why we need research ethics?
- correct past problems and abuses
- prevent new problems and abuses
- the law is not enough
what 2 major atrocities in the 20th century led to codification of research ethics?
- nazi science
- Tuskegee institute
- What was the purpose of Nazi diving suits?
- T/F: much of the Nazi science was pointless.
- T/F: the research was known and people knew about it
- create diving suits to allow the military to work under water and see the temperatures they could operate in. They performed experiments on the prisoners to test the data which led to many people dying
- T.
- F. the research was hidden and kept a secret
- what was the Tuskagee study?
- the purpose was to study in “_______”. what does this mean
- T/F: The research was hidden and people had no idea
- they took untreated black men with syphilis and observed the progression of the disease from inception to when they died. They did everything in their power to prevent these men from getting treated even when it was available- essentially just let them die
- study in nature = observe the natural course of the disease uninterrupted from inception to its conclusion of when you die from it.
- F. it was advertised and promoted like a research project
Explain how the Tuskagee study was an opportunity?
opportunity to study the untreated syphilitic patient despite there being a treatment
what did the nuremberg code say about human research studies?
the voluntary consent of the human being is absolutely essential
These human experiments treats people as a _______ to the _____ instead of the _____ of _________
means to the end instead of ends of themselves
- What is the difference in end goals for therapy vs. research?
- what did the declaration of helsinki ensure (WMA)?
- research end goal = creating scientific data overrules the patient’s welfare. Trying to gather data from some sort of treatment
therapy end goal = restoring the patient at the highest level possible to help them
- ensured there was a distinction between research vs therapeutic experiments, that doctors were giving the standard of care, every patient should be given the best diagnostic and therapeutic method
T/F: in research the ENDS matter
T/F: in therapy the ends DO NOT matter
F. research = ends do NOT matter
F. therapy = ends do matter
what is standard of care?
standard of care = doctors agree given that the patient has stage 4 lymphatic cancer that here is what they should do. They should not turn and say nothing can be done and that the patient is going to be used for experimental research since there is no hope for them.
ensures care up until their lives end
what is the TPS (tri-council policy statement)?
ensures that if there is public money attached to research, it must go through TPS to make sure stuff is not going unchecked
-see if research is ethical
what are the 4 ethical principles of the TPS?
- respect for persons (autonomy)
- non-maleficence
- beneficence
- justice
what are the 9 guiding ethical principles?
(Hannah Felt Very Peaceful Just Being Never Making Money)
- Human Dignity
- Free and Informed Consent
- Vulnerable Persons
- Privacy and Confidentiality
- Justice and Inclusiveness
- Balancing Harms and Benefits
- Non-Maleficence
- Minimizing Harm
- Maximizing Benefits
- As a patient your consent must be __________
as a research subject your consent must be __________ (meaning it can be ________ OR __________) - What is the difference in informed consent (rights) between medical care and a research subject?
- T/F: to be a research subject is your free choice and is guaranteed.
- patient consent must be respected
research subject consent must be scrutinized meaning it can be accepted or rejected - you have the right to medical care. you do or you do not have the right to be a research subject
- F. it is your free choice but it is NOT guaranteed, they may kick you out.
Explain each situation about consent being questionable:
1. experiments on inmates
2. HIV
- inmates would line up for sketchy experiments because they wanted to be seen as cooperative and they thought if they participated, then they would have been let out easier or granted for parole
- researchers went to where HIV was most common and cheaper to get subjects- in prostitutes. Subjects were not coming by free choice and were told it was an occupational requirement.
____ profile vs. _____ profile was very imbalanced for inmates who gave consent for experiments
risk vs. reward
- what is coercion?
- how is coercion more common in vulnerable populations?
- how is coercion different from inducement?
- coercion = threatening someone with something bad and making the decision not because you want to but because you do not want something negative to occur if you were to do otherwise
- because they already have structural and systemic vulnerability so they do not want anything else bad to happen to them, don’t know any better
- inducement = some sort of reward can be given and ultimately your choice. Coercion = forcibly against your will and the result if you do otherwise is normally negative
What are the 4 qualities of a vulnerable population?
- institutionalized disparity of power (have less power)
- cannot respect their own best interests (don’t know any better
- if they have to consider some sort of punishment or rewards before participating
- susceptible to power
Can inducement be bad?
yes because although it is ultimately your choice and some sort of reward is given, you may have to participate in a risky situation that is unethical, however it is still your decision. Many people do it because of the reward
- How is voluntariness an aspect of research participation?
- voluntariness can be assessed in the case of ___________ or ___________
- because you choose whether you want to do something or not.
- coercion or inducement
_____ _______ situations is said to make us forced or compelled to choose the offer or to undermine voluntariness
no choice situation
T/F: no choice situations mean we are coerced into something
F. it means that we have a choice, but there is significant better results on one side that essentially we would never choose the bad one. Ex: if you have a choice between being pushed into fire where it is guaranteed you will die or having to complete your homework, you will probably choose your homework.
what are the 3 additional facts that participants should know if they are invited to participate in research?
- research contribution = what the study will result in and what benefit in knowledge is going occur from their participation in the future
- research relationship = gathering knowledge to benefit others
- research impact = what the study will have on those who participate and what happens to them
