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CPSY 641 > Human participants Protections Education For Research Teams > Flashcards

Human participants Protections Education For Research Teams 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 reserach

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2
Q

What happened during the Syphilis Study and Tuskegee?

A

400 Men with syphilis were studied without informed consent to observe the natural progression of Syphilis and were not given treatment

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3
Q

What are the 3 ethical principles identified in the Belmont Report?

A
  1. Respect for persons
  2. Beneficence
  3. Justice
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4
Q

What is an autonomous person?

A

A person capable of deliberation about personal goals and of acting under the direction of such deliberation

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5
Q

What do you do when there is diminished autonomy?

A

Give additional protections

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6
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.).

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7
Q

What are the two principles of beneficence?

A
  1. Do no harm

2. Maximize possible benefits and minimize possible harms

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8
Q

What are the major principles of justice?

A

The burdens and benefits of research should be fairly distributed among individuals, groups, societies, etc.

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9
Q

What is the definition of a human subject?

A

A living individual about whom an investigator conducting research obtains

  1. Data through intervention or interaction with the individual
  2. Identifiable private information
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10
Q

What is the definition of research?

A

A systematic investigation designed to develop or contribute to generalizable knowledge

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11
Q

What subjects require additional protections?

A

Individuals with diminished autonomy

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12
Q

What is mean by a vulnerable subject?

A

Pregnant women, Human fetuses and neonates, Prisoners, Children, Mentally disabled, Economically and/or educationally disadvantaged

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13
Q

What general questions must be addressed in a research application?

A
  1. Risk to the subjects
  2. Adequacy of protection against these risks
  3. Potential benefits of the research to the subjects and others
  4. Importance of the knowledge gained or to be gained
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14
Q

What is exempt research?

A

Research that is exempt from requirements described in the HHS regulations including IRB oversight

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15
Q

What is meant by respect for persons?

A
  1. Individuals should be treated as autonomous agents

2. Persons with diminished autonomy are entitled to additional protections

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16
Q

What are the three fundamental aspects of informed consent?

A
  1. Voluntariness
  2. Comprehension
  3. Discolsure
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17
Q

What are the three fundamental aspects of informed consent?

A
  1. Voluntariness
  2. Comprehension
  3. Disclosure
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18
Q

When do you get informed consent?

A

At enrollment and throughout the study

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19
Q

What language is used in informed consent?

A

Language that is understandable to the subject

20
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

21
Q

What is meant by practicability?

A

Not just time and cost restraints

22
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

23
Q

Can informed consent be waived?

A

yes

24
Q

What is meant by diminished autonomy?

A

Age, cognitive impairment, illness, and treatments

25
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

26
Q

How do you obtain informed consent from a child?

A

You cannot

27
Q

What is assent?

A

Affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent

28
Q

Why are prisoners considered vulnerable persons?

A

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

29
Q

Why are prisoners considered vulnerable persons?

A

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

30
Q

What is meant by community consultation?

A

Obtaining informed consent from a community as a whole through meetings with large groups of community representatives or community leaders

31
Q

What are the 3 guiding practical applications for informed consent?

A
  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
32
Q

What are the two principles of beneficence?

A
  1. Do no harm

2. Maximize possible benefits and minimize possible harms

33
Q

What is the definition of a risk?

A

The probability that a certain harm will occur

34
Q

What is the definition of minimal risk?

A

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

35
Q

Who is responsible for protecting participants from risk?

A

Investigators, Institutional Review Boards, and other members of the research team

36
Q

What is a benefit?

A

A contribution of generalizable knowledge about diseases disorders, public health concerns, etc., to society

37
Q

What are the 3 requirements that researchers must consider?

A
  1. Protections against risk
  2. Potential benefits to individual participants
  3. Importance of the knowledge to be gained
38
Q

What role does compensation play in research?

A

Compensation for participants time or effort

39
Q

What are undue inducements?

A

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

40
Q

What is therapeutic misconception?

A

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

41
Q

What is equipoise?

A

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

42
Q

What is privacy?

A

Free from unsanctioned intrusion

43
Q

What is confidentiality?

A

Holding secret all information relating to an individual, unless the individual gives consent permitting disclosure

44
Q

If you code data on individuals in a study, does that mean this protects privacy?

A

yes

45
Q

What is anonymous data?

A

Data which the investigator cannot ascertain the identity of the individuals and the data was not collected specifically for the currently proposed research project

CPSY 641 (3 decks)

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