Informed consent

Question 1

What are the 4 reasons why research is done on humans?

Answer 1

1. advancing human welfare
2. advancing knowledge
3. advancing understanding
4. examining cultural dynamics

Question 2

What are 3 reasons why we need research ethics?

Answer 2

1. correct past problems and abuses
2. prevent new problems and abuses
3. the law is not enough

Question 3

what 2 major atrocities in the 20th century led to codification of research ethics?

Answer 3

1. nazi science
2. Tuskegee institute

Question 4

1. What was the purpose of Nazi diving suits?
2. T/F: much of the Nazi science was pointless.
3. T/F: the research was known and people knew about it

Answer 4

1. 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
2. T.
3. F. the research was hidden and kept a secret

Question 5

1. what was the Tuskagee study?
2. the purpose was to study in “_______”. what does this mean
3. T/F: The research was hidden and people had no idea

Answer 5

1. 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
2. study in nature = observe the natural course of the disease uninterrupted from inception to its conclusion of when you die from it.
3. F. it was advertised and promoted like a research project

Question 6

Explain how the Tuskagee study was an opportunity?

Answer 6

opportunity to study the untreated syphilitic patient despite there being a treatment

Question 7

what did the nuremberg code say about human research studies?

Answer 7

the voluntary consent of the human being is absolutely essential

Question 8

These human experiments treats people as a _______ to the _____ instead of the _____ of _________

Answer 8

means to the end instead of ends of themselves

Question 9

1. What is the difference in end goals for therapy vs. research?
2. what did the declaration of helsinki ensure (WMA)?

Answer 9

1. 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

2. 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

Question 10

T/F: in research the ENDS matter
T/F: in therapy the ends DO NOT matter

Answer 10

F. research = ends do NOT matter
F. therapy = ends do matter

Question 11

what is standard of care?

Answer 11

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

Question 12

what is the TPS (tri-council policy statement)?

Answer 12

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

Question 13

what are the 4 ethical principles of the TPS?

Answer 13

1. respect for persons (autonomy)
2. non-maleficence
3. beneficence
4. justice

Question 14

what are the 9 guiding ethical principles?
(Hannah Felt Very Peaceful Just Being Never Making Money)

Answer 14

1. Human Dignity
   
   2. Free and Informed Consent
   3. Vulnerable Persons
   4. Privacy and Confidentiality
   5. Justice and Inclusiveness
   6. Balancing Harms and Benefits
   7. Non-Maleficence
   8. Minimizing Harm
2. Maximizing Benefits

Question 15

1. As a patient your consent must be __________
   as a research subject your consent must be __________ (meaning it can be ________ OR __________)
2. What is the difference in informed consent (rights) between medical care and a research subject?
3. T/F: to be a research subject is your free choice and is guaranteed.

Answer 15

1. patient consent must be respected
   research subject consent must be scrutinized meaning it can be accepted or rejected
2. you have the right to medical care. you do or you do not have the right to be a research subject
3. F. it is your free choice but it is NOT guaranteed, they may kick you out.

Question 16

Explain each situation about consent being questionable:
1. experiments on inmates
2. HIV

Answer 16

1. 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
2. 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.

Question 17

____ profile vs. _____ profile was very imbalanced for inmates who gave consent for experiments

Answer 17

risk vs. reward

Question 18

1. what is coercion?
2. how is coercion more common in vulnerable populations?
3. how is coercion different from inducement?

Answer 18

1. 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
2. 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
3. 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

Question 19

What are the 4 qualities of a vulnerable population?

Answer 19

1. institutionalized disparity of power (have less power)
2. cannot respect their own best interests (don’t know any better
3. if they have to consider some sort of punishment or rewards before participating
4. susceptible to power

Question 20

Can inducement be bad?

Answer 20

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

Question 21

1. How is voluntariness an aspect of research participation?
2. voluntariness can be assessed in the case of ___________ or ___________

Answer 21

1. because you choose whether you want to do something or not.
2. coercion or inducement

Question 22

_____ _______ situations is said to make us forced or compelled to choose the offer or to undermine voluntariness

Answer 22

no choice situation

Question 23

T/F: no choice situations mean we are coerced into something

Answer 23

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.

Question 24

what are the 3 additional facts that participants should know if they are invited to participate in research?

Answer 24

1. research contribution = what the study will result in and what benefit in knowledge is going occur from their participation in the future
2. research relationship = gathering knowledge to benefit others
3. research impact = what the study will have on those who participate and what happens to them

Question 25

what are the 2 purposes of informed consent?

Answer 25

1. allows competent individuals to see if the participation in research is compatible with their interests
2. allows individuals to decide for themselves if they want to be involved

Question 26

Participants need to understand the _______ of the study, and the __________ they will have with the investigators

Answer 26

goal/purpose
relationship

Question 27

what is therapeutic misconception in research experiments?

Answer 27

participants suffer this misconception when they do not understand the research relationship. The research relationship is established between the participant and investigator and should indicate the difference between a participant and their clinician. investigators are scientists and are not just responsible for protecting and helping participants (clinician), they also have to gather knowledge from the participants that can benefit others

Question 28

What are the requirements so that investigators can kick people out of a study even though they gave informed consent? (called waived consent)

Answer 28

• when the participant do not have a strong interest relevant to the study
• cannot participate
• cannot fulfill the 3 requirements of research contribution, relationship and impact

Question 29

what is one way to allow participants to better understand their research participation?

Answer 29

shorten consent forms. Because they they will clearly know their participation is directly related to research only