IRB Flashcards

1
Q

Who approves and monitors research that involves animals?

A

IACUC

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

Who approves and monitors research that involves Biohazards and Recombinant DNA?

A

Biohazards and Recombinant DNA committee

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

Who approves and monitors research involving a radioisotope?

A

Radiation safety committee

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

Who approves and monitors research involving a controlled substance?

A

University office of Research and Compliance Officer

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

Who approves and monitors research involving humans?

A

The IRB

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

IRB is…?

A

An ethics committee composed of scientists and non-scientists. It is charged with the responsibility of reviewing and overseeing human subjects research conducted under the aegis of the university

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

A project must be both what to require IRB review?

A

BOTH research and involve human subjects

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

Criteria for IRB approval

A
Risks are minimized
Risks are reasonable
Subject selection is equitable
Informed consent is sought and documented
Data monitored
Privacy protected
Safeguards
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

The 3 basic ethical principles that should govern human research

A

Respect for persons

Beneficence

Justice

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

Explain what it means for risks to subjects are minimized

A

Using procedures which are consistent with sound research design and which do not unnecessarily expose to risk

Whenever appropriate by using procedures already being performed on the subjects for diagnostic or treatment purposes

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

What are the 2 aspects of Beneficence?

A

Do no harm

Maximize benefits and minimize possible harms

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

What are the 2 dimensions of risk?

A

Magnitude of harm

Probability of harm

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

What are the 5 types of risk?

A
Physical
Psychological
Social
Legal
Economic
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

Identify aspects of informed consent

A

Legal capacity
Exercise free power of choice
Sufficient knowledge and comprehension

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

What should be made known to the experimental subjects?

A

The nature, duration, purpose, methods, means, inconveniences and hazards

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

The duty and responsibility for ascertaining the quality of consent rests upon who?

A

Each individual who initiates, directs, or engages in the experiment

17
Q

No informed consent, oral or written may include any…?

A

Exculpatory language

18
Q

What legal rights might be infringed by exculpatory language?

A
  • Property rights
  • Right to compensation for injuries
  • Right to sue
19
Q

Simplifying the consent form is known as?

A

Executive summary

20
Q

What is special about case reports?

A

They do not strictly meet the criteria of research

21
Q

Investigations designed to develop or contribute to generalizable knowledge

A

Research