Test 10 Flashcards
1
Q
What was the Nuremberg Code?
A
This set of directives established the basic principles that must be observed in order to satisfy moral, ethical, and legal concepts in the conduct of human subject research
2
Q
what are the 3 ethical principles identified in the Belmont Report?
A
- Respect for persons
- Beneficence
- Justice
3
Q
What is an autonomous person?
A
A person capable of deliberation about personal goals and of acting under the direction of such deliberation
4
Q
What do you do when there is diminished autonomy?
A
Give additional protections
5
Q
What is coercion?
A
Influencing an individual’s decision about whether or not to do something by using explicit or implied threats (loss of good standing in a job, poor grades, etc.).
6
Q
What are the two principles of beneficence?
A
- Do no harm
2. Maximize possible benefits and minimize possible harms
7
Q
What are the major principles of justice?
A
The burdens and benefits of research should be fairly distributed among individuals, groups, societies, etc.
8
Q
What is the definition of a human subject?
A
A living individual about whom an investigator conducting research obtains
- Data through intervention or interaction with the individual
- Identifiable private information
9
Q
What is the definition of research?
A
A systematic investigation designed to develop or contribute to generalizable knowledge
10
Q
What subjects require additional protections?
A
Individuals with diminished autonomy
11
Q
What is mean by a vulnerable subject?
A
Pregnant women, Human fetuses and neonates, Prisoners, Children, Mentally disabled, Economically and/or educationally disadvantaged
12
Q
What general questions must be addressed in a research application?
A
- Risk to the subjects
- Adequacy of protection against these risks
- Potential benefits of the research to the subjects and others
- Importance of the knowledge gained or to be gained
13
Q
What is exempt research?
A
Research that is exempt from requirements described in the HHS regulations including IRB oversight
14
Q
What is meant by respect for persons?
A
- Individuals should be treated as autonomous agents
2. Persons with diminished autonomy are entitled to additional protections
15
Q
What are the three fundamental aspects of informed consent?
A
- Voluntariness
- Comprehension
- Discolsure
16
Q
When do you get informed consent?
A
At enrollment and throughout the study
17
Q
what language is used in informed consent?
A
Language that is understandable to the subject
18
Q
What is meant by a waiver of informed consent?
A
The institutional review board (IRB) waives or alters some or all of the required elements of informed consent
19
Q
What is meant by practicability?
A
Not just time and cost restraints
20
Q
How is informed consent documented?
A
Written form that either contains all of the required elements or a short form that states that all of the required elements have been presented orally
21
Q
Can informed consent be waived?
A
Yes
22
Q
What is meant by diminished autonomy?
A
Age, cognitive impairment, illness, and treatments
23
Q
How do you obtain informed consent from someone with diminished autonomy?
A
Legally authorized representatives provide voluntary informed consent for individuals with diminished capacity to participate in research
24
Q
How do you obtain informed consent from a child?
A
You can’t?
25
What is assent?
Affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent
26
Why are prisoners considered vulnerable persons?
They may be under constraints because of their incarceration which could affect their ability to make a truly voluntary and uncoerced decision whether or not to participate as subjects in research
27
What is meant by community consultation?
Obtaining informed consent from a community as a whole through meetings with large groups of community representatives or community leaders
28
What are the 3 guiding practical applications for informed consent?
1. Give their consent freely and voluntarily
2. Have the decisional capacity to understand the information presented to them
3. Be provided with complete information about the study in order to make an informed decision
29
What are the two principles of beneficence?
1. Do no harm
| 2. Maximize possible benefits and minimize possible harms
30
What is the definition of a risk?
The probability that a certain harm will occur
31
What is the definition of minimal risk?
That the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests
32
Who is responsible for protecting participants from risk?
Investigators, Institutional Review Boards, and other members of the research team
33
What is a benefit?
A contribution of generalizable knowledge about diseases disorders, public health concerns, etc., to society
34
What are the 3 requirements that researchers must consider?
1. Protections against risk
2. Potential benefits to individual participants
3. Importance of the knowledge to be gained
35
What role does compensation play in research?
Compensation for participants time or effort
36
What are undue inducements?
Offers that are too attractive may blind prospective subjects to the risks or impair their ability to exercise proper judgment and might prompt subjects to lie or conceal information that, if known, would disqualify them from enrolling - or continuing - as participants in a research project
37
What is therapeutic misconception?
The tendency for research participants to: "downplay or ignore the risks posed to their own well-being by participation due to the participant's deeply held and nearly unshakeable conviction that every aspect of their participation in research has been designed for their own individual benefit
38
What is equipoise?
Substantial scientific uncertainty about which treatments will benefit subjects most, or a lack of consensus in the field that one intervention is superior to another
39
What is privacy?
Free from unsanctioned intrusion
40
What is confidentiality?
Holding secret all information relating to an individual, unless the individual gives consent permitting disclosure
41
If you code data on individuals in a study, does that mean this protects privacy?
Yes
42
What is anonymous data?
Data which the investigator cannot ascertain the identity of the individuals and the data was not collected specifically for the currently proposed research project
43
What happened during the Syphilis Study and Tuskegee?
The Syphilis Study at Tuskegee involved approximately 600 African-American men: about 400 with syphilis (cases) and about 200 without syphilis (controls). These men were recruited without informed consent and, in fact, were led to believe that some of the procedures done in the interest of research (e.g., spinal taps) were actually “special free treatment.”
By 1936, it was apparent that many more infected men than controls had developed complications, and 10 years later, reports indicated that the death rate among those with syphilis was about twice as high as it was among the controls. In the 1940s, penicillin was found to be effective in the treatment of syphilis. The Syphilis Study at Tuskegee continued, however, and the men were neither informed about nor treated with the antibiotic.
44
What was the charge of the commission?
To identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles
45
What does "practice" refer to?
Interventions that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success
46
What does "research" refer to?
Designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge
47
How is "experimental" and "research" different?
Experimental refers to new, untested or different
48
What are the three basic ethical principles?
1. Respect for Persons
2. Beneficence
3. Justice
49
What are the 2 basic convictions related to respect of persons?
1. That individuals should be treated as autonomous agents
| 2. That persons with diminished autonomy are entitled to protection
50
1. What are 3 examples to show lack of respect (for autonomy)?
1. 1. To repudiate that person's considered judgments
2. To deny an individual the freedom to act on those considered judgments
3. To withhold information necessary to make a considered judgment, when there are no compelling reasons to do so
51
what are the 2 general rules of beneficence?
1. Do not harm
| 2. Maximize possible benefits and minimize possible harms
52
What is the principle of justice?
Who ought to receive the benefits of research and bear its burdens?????
53
What are 5 formulations of the principle of justice?
To each person an equal share
2. To each person according to individual need
3. To each person according to individual effort
4. To each person according to societal contribution
5. To each person according to merit
54
Why does the selection of research subjects need to be scrutinized?
In order to determine whether some classes are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied
55
What are the information requirements for informed consent?
1. The research procedure
2. Their purpose
3. Risks and anticipated benefits
4. Alternative procedures (where therapy is involved)
5. A statement offering the subject the opportunity to ask questions and to withdraw at any time from the research
56
What is the question that remains regarding informed consent?
What the standard should be for judging how much and what sort of information should be provided
57
What are the 3 criteria to be met when incomplete disclosure is used?
1. Incomplete disclosure is truly necessary to accomplish the goals of the research
2. There are no undisclosed risks to subjects that are more than minimal
3. There is an adequate plan for debriefing subjects, when appropriate, and for dissemination of research results to them
58
How does comprehension impact informed consent?
A.
| The manner and context in which information is conveyed is as important as the information itself
59
What are conditions in which it is necessary to adapt presentation for informed consent?
Intelligence, rationality, maturity and language
60
What are the criteria used to select third parties for informed consent?
The third parties chosen should be those who are most likely to understand the incompetent subject's situation and to act in that person's best interest
61
What is Voluntariness?
An agreement to participate in research constitutes a valid consent only if voluntarily given
62
What are the two components of Voluntary consent?
1. Free of coercion
| 2. Free of undue influence
63
What is meant by the nature and scope of risks and benefits?
The requirement that research be justified on the basis of a favorable risk/benefit assessment
64
What is meant by "risk"?
A possibility that harm may occur
65
What is meant by "benefit"?
Something of positive value related to health or welfare
66
What types of harm should be considered?
1. Psychological
2. Physical
3. Legal
4. Social
5. Economic
67
How does the principle of beneficence apply to risk of harm?
Beneficence requires that we protect against risk of harm to subjects and also tat we be concerned about the loss of the substantial benefits that might be gained from research
68
What is meant by the systematic assessment of risks and benefits?
This ideal requires those making decisions about teh justifiability of research to be thorough in the accumulation and assessment of information about all aspects of the research, and to consider alternatives systematically.
Benefits and risks must be "balanced" and shown to be "in a favorable ratio"
69
What are the five considerations for the justifiability of research?
1. Brutal or inhumane treatment of human subjects is never morally justified
2. Risks should be reduced to those necessary to achieve the research objective
3. When research involves significant risk of serious impairment, review committees should be extraordinarily insistent on the justification of the risk
4. When vulnerable populations are involved in research, the appropriateness of involving them should itself be demonstrated
5. Relevant risks and benefits must be thoroughly arrayed in documents and procedures used in the informed consent process
70
How does the principle of justice impact the selection of subjects?
It gives rise to moral requirements that there be fair procedures and outcomes in the selection of research subjects
71
What sources of injustice are there?
1. Social
2. Racial
3. Sexual
4. Cultural
72
What is the definition of vulnerable subjects?
Subjects that are dependent or have frequently compromised capacity for free consent
Such as racial minorities, economically disadvantaged, the very sick and the institutionalized
73
What is the definition of Medical research?
To understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions
74
What is the duty of the physician?
To promote and safeguard the health, well-being and rights of patients, including those who are involved in medical research
75
What should take precedence in medical research?
The rights and interests of individual research subjects
76
What research populations are considered vulnerable and need special protection?
1. Pregnant Women
2. Human fetuses and neonates
3. Prisoners
4. Children
5. Mentally disabled
6. Economically and/or educationally disadvantaged
77
To whom should the experimental protocol be submitted?
1. The concerned research ethics committee
| 2. The committee must be transparent, independent
78
Who is responsible for the human subject?
The physician and never the research subject
79
What is the role of risk and benefits to the subject?
If the importance of the objective outweighs the risks and burdens to the research subjects
80
When is medical research justified?
if the research is responsive to the health needs or priorities of this group and the research cannot be carried out in a non-vulnerable group. In addition, this group should stand to benefit from the knowledge, practices or interventions that result from the research.
81
What safeguards must be provided to research subjects?
the health, well-being and rights of patients, including those who are involved in medical research. The physician’s knowledge and conscience are dedicated to the fulfilment of this duty.
82
What requirements are there for “informed”?
1. Informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, post-study provision
2. Informed of the right to refuse to participate
83
For persons who are unable to give consent, what 2 requirements must be met?
1. The physician must seek informed consent from the legally authorized representative
2. If no such representative is available and if the research cannot be delayed, the study may proceed without informed consent provided that the specific reasons for involving subjects with a condition that renders them unable to give informed consent have been stated in the research protocol and the study has been approved by a research ethics committee
84
At the conclusion of the study, what must be assured to every patient?
Post-trial access for all participants who still need an intervention identified as beneficial in the trial
