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Belmont Report Flashcards

1
Q

What are the three basic ethical principles?

A
  1. Respect for Persons, 2. Beneficence, 3. Justice
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2
Q

What does the term “practice” refer to?

A

Interventions that are designed solely to enhance the well-being of an individual patient that have a reasonable expectation of success.

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3
Q

What is the purpose of “research”?

A

To designate an activity designed to test an hypothesis, permit conclusions ti be drawn and thereby to develop of contribute to generalizable knowledge

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4
Q

When a procedure is “experimental” (in the sense that it is new, untested or different) is it research?

A

No, it is not automatically placed in the category of research.

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5
Q

Can research and practice be carried out together?

A

Yes, when research is designed to evaluate the safety and efficacy of therapy.

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6
Q

Respect for Persons incorporates what two ethical convictions?

A
  1. Individuals should be treated as autonomous agents and 2. Persons with diminished autonomy are entitled to protection.
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7
Q

Respect for Persons incorporates what two moral requirements separate from the ethical convictions?

A
  1. Required to acknowledge autonomy and 2. Required to protect those with diminished autonomy
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8
Q

Respect for Persons: What is an autonomous person?

A

An individual capable of deliberation about personal goals and of acting under the direction of such deliberation

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9
Q

Beneficence: Persons are treated in an ethical manner not only by…

A

…respecting their decisions and protecting them from harm, but also making efforts to SECURE THEIR WELL-BEING.

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10
Q

Beneficence: What are the two general rules that have been formulated as complementary expressions of beneficent actions?

A
  1. Do not harm and 2. Maximize possible benefits and minimize posible harms.
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11
Q

Respect for Persons: What is a big dilemma while working with prisoners?

A

Whether to allow prisoners to “volunteer” or to “protect” them from subtle coercion

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12
Q

Justice: What is Justice? (2 brief statements)

A

“Fairness in distribution” and “what is deserved”

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13
Q

Justice: When does injustice occur?

A

When some benefit to which a person is entitled is denied without good reasons or when some burden is imposed unduly.

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14
Q

Justice: Name the 5 accepted formulations to distribute burdens and benefits:

A
  1. To each person an equal share, 2. to each person according to individual need, 3. to each P according to individual effort, 4. to each P according to societal contribution, and 5. to each P according to merit.
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15
Q

Applications of the general principles to the conduct of research leads to consideration of what requirements?

A

Informed consent, risk/benefit assessment, and the selection of subjects of research

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16
Q

Applications: The informed consent process can be analyzed as containing what three elements?

A
  1. Information, 2. comprehension, and 3. voluntariness
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17
Q

Informed Consent, Information: What are specific items for disclosure intended to assure that subjects are given sufficient info? (5)

A
  1. The research procedure, 2. their purpose, 3. risks and anticipated benefits, 4. alternative procedures, 5. and a statement offering the subject the opportunity to ask Q’s and withdraw at any time from research.
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18
Q

Risks and Benefits: responsibility of the investigator?

A

Responsible to gather systematic and comprehensive information about the proposed research

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19
Q

Risks and Benefits: responsibility of the review committee?

A

To determine whether the risks that will be presented to subjects are justified

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20
Q

Risks and Benefits: responsibility of the prospective subjects?

A

Determine whether or not to participate

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21
Q

The term risk refers to…

A

A possibility that harm may occur

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22
Q

The terms “small” risk and “large” risks refer almost ambiguously to…

A

both the chance (probability) of experiencing a harm and the severity (magnitude) of the envisioned harm.

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23
Q

Is “benefit” expressed in probabilities?

A

No, unlike risks which are, benefit refers to a positive value related to health or welfare.

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24
Q

Types of potential risks/harms? (5)

A

psychological harm, physical harm, legal harm, social harm, and economic harm.

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25
What the most likely types of harms to come to research subjects? (2)
psychological or physical pain/injury - but others are still possible.
26
21CFR11
Electronic records; electronic signatures
27
21CFR50
Protection of human subjects
28
21CFR50.20
General requirements for informed consent
29
21CRF50.23
Exception from general requirements of IC
30
21CFR50.24
Exception from IC requirements for emergency research
31
21CFR50.25
Elements of IC
32
21CFR50.27
Documentation of IC
33
21CFR50.50
Children involved in clinical research IRB duties
34
21CRF50.51
Studies w/ C NOT involving > minimal risk
35
21CFR50.52
Studies w/ C involving > min risk but with potential benefit to subject
36
21CFR50.1
Scope of Research
37
21CRF50.53
Studies w/ C involving > min risk, no potential benefit, but yield generalizable knowledge about the subject
38
21CFR50.54
Studies w/ C not otherwise approvable, present opportunity to understand, prevent, or alleviate serious problem
39
21CRF50.55
Requirements for permission by P or G and for assent by C
40
21CFR50.56
Wards
41
21CFR56
Institutional Review Boards
42
21CFR56.103
Circumstances in which IRB review is required
43
21CFR56.104
Exemptions from IRB requirement
44
21CFR56.105
Waiver of IRB requirement
45
21CFR56.106
IRB registration
46
21CFR56.107
IRB Membership
47
How many members should each IRB have?
Five
48
21CFR56.108
IRB Functions and Operations
49
21CFR56.109
IRB review of research
50
21CFR56.115
IRB Records
51
21CFR56.120
Lesser administrative actions
52
21CFR56.121
Disqualification of an IRB or institution
53
What is the Nuremberg Code?
A set of research ethics principles for human experimentation set as a result of the Nuremberg Trials @ the end of WWII
54
When were the Nuremberg Trials?
1946-1949
55
What does Act mean?
Act means the Federal Food, Drug, and Cosmetic Act
56
What are the categories that are exempt from IRB requirements? (3)
1. any investigation that commenced before 7/27/1981. 2. Emergency use of a test article - provided EU reported to IRB within 5 working days. 3. Safe taste and food quality evaluations and consumer acceptance studies
57
Can the FDA waive any requirements from IRB approvals?
Yes, the FDA may waive any requirements contained within regulations
58
What IRB's must register?
Each IRB (in the US) that reviews clinical investigations regulated by FDA (sections 505i & 520g) and each IRB that reviews clinical studies intended to support applications for research or marketing permits for FDA regulated products.
59
What is the research permit under section 505i?
An investigational new drug application (IND).
60
What is the research permit under section 520g?
An investigational device exemption (IDE)
61
What info must an IRB register?
1. Name & address of institution operating IRB. 2. Name, address, phone#, email, fax of the senior officer overseeing IRB, the IRB itself, each IRB chairperson,and the contact person providing registration information. 3. Approx. # of active protocols involving FDA regulated products. 4. A description of the types of FDA-regulated products involved in the protocols that the IRB reviews
62
What is an "active protocol"?
Is any protocol for which the IRB conducted an initial review or CR at a convened meeting or under an expedited review procedure during the preceding 12 months.
63
When must an IRB register?
Each IRB must submit an initial registration, this must be before the IRB begins to review studies.
64
How often must an IRB renew its registration?
Each IRB must renew its registration every 3 years.
65
When does an IRB registration become effective?
After review and acceptance by HHS.
66
Where can an IRB register?
Each IRB can register electronically or if they do not hace access to register electronically - they must send this info in writing.
67
How many days does the IRB have to submit changes to their registration information to the FDA?
within 90 days of the change
68
How many days does the IRB have to send the FDA information about discontinuing review of clinical investigations regulated by the FDA?
within 30 working days of IRB cessation.
69
Can an IRB consist entirely of one member of sex?
No, it must have males and females
70
What type of individuals must each IRB have? (3)
1. at least 1 member whose primary concerns are in the scientific area. 2. at least 1 member whose primary concerns are in the non-scientific area. 3. at least 1 member who is not affiliated with the university and who is not part of the immediate family of a person who is affiliated with the institution.
71
Can and IRB member participated in an initial or CR of a project that they have a conflicting intrest in?
No, but they may provide information if requested by the IRB.
72
Can an IRB use individuals from special areas to assist in review of complex issues?
Yes, if the review requires expertise beyond the available IRB, but these individuals may not vote with the IRB.
73
When a study includes children what must the IRB determine that the study is in compliance with?
21CFR Part 50 Subpart D
74
When can an IRB use expedited review? (2)
1. Some or all of the research involves no more than minimal risk. 2. Minor changes in previously approved research during the period (1 year or less) for which approval has been authorized.
75
Who can carry out an expedited review?
An IRB chairperson or one or more experienced reviewers designated by the IRB chairperson.
76
Can the reviewer in an expedited review disapprove the research?
No, but they have all other authorities. A research activity can only be disapproved after a non-expedited review procedure has taken place.
77
Can the FDA restrict, suspend, or terminate an IRB's use of expedited review procedures?
Yes, if it is necessary to protect the rights or welfare of subjects.
78
What populations are apart of Phase 1 studies?
Patients or normal volunteers
79
Number of subjects involved in phase 1 studies:
20 to 80
80
What are phase 1 studies trying to achieve? (3 points)
1. Designed to determine the metabolism and pharmacologic actions of the drug in humans 2. Side effects associate with increasing doses and 3. If possible to gain early evidence on pharmacological effectiveness.
81
What are phase 2 studies trying to achieve? (2)
1. Evaluate the effectiveness of the drug for a particular indication in patients w/ the disease or condition under study, and 2. to determine the common short-term side effects and risks assoc. with the drug.
82
Number of subjects involved in phase 2 studies:
Relatively small, no more than several hundred subjects.
83
Are phase 1 studies controlled or uncontrolled?
controlled - closely monitored
84
Are phase 2 studies controlled or uncontrolled?
controlled - closely monitored
85
Are phase 3 studies controlled or uncontrolled?
Both controlled and uncontrolled
86
When are phase 3 studies performed?
After preliminary evidence suggesting effectiveness of the drug has been obtained.
87
What are phase 3 studies trying achieve?
1. To gather additional info about effectiveness and safety that is needed to evaluate the overal benefit-risk relationships of the drug to provide adequate basis for physician labeling.
88
How many subjects are involved in phase 3 studies?
several hundred to several thousand subjects.
89
What are the FDA's primary objectives in reviewing an IND in all phases?
To assure the safety and rights of the subjects.
90
What are the FDA's other primary objectives in reviewing an IND in phase 2 and 3?
To help assure that the quality of the scientific evaluation of rugs is adequate to permit an evaluation of the drug's effectiveness and safety.
91
In an IND application, what must be included in the general statement (312.23)? (7)
1. Name of the drug. 2. Active ingredients in the drug. 3. pharmacological class 4. structural formula 5. formulation of the dosage form to be used 6. route of administration and 7. broad objectives and planned duration of the proposed investigation.
92
What should be included in the overall plan for the upcoming year in an IND (312.23)? (6)
1. Rationale for the drug/research study 2. indications to be studied 3. general approach to evaluate drug 4. kinds of clinical trials to be conducted in the first year 5. est. # of patients to be given drug in those studies 6. any risks or severity or seriousness anticipated based on toxicology in animals or prior human studies with drug or related drugs.
93
What should be included in the overall plan for the upcoming year in an IND (312.23)? (6)
1. Rationale for the drug/research study 2. indications to be studied 3. general approach to evaluate drug 4. kinds of clinical trials to be conducted in the first year 5. est. # of patients to be given drug in those studies 6. any risks or severity or seriousness anticipated based on toxicology in animals or prior human studies with drug or related drugs.

My SOCRA Exam Flash Cards (3 decks)

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