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SOCRA 2023 > Miscelanius > Flashcards

Miscelanius Flashcards

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1
Q

Basic ethical principles of the belmont report

A
  • Beneficence
  • Justice
  • Respect for persons
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2
Q

Belmont report: what does “respect for persons” entail?

A
  • Subjects enter the research voluntarily and with adequate information
  • Subjects are treated as autonomous agents and for those with diminished autonomy are entitled to protection

**check for others

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3
Q

Belmont report: what does “beneficence” entail

A

study members should secure the well-being of the subjects by minimizing harm and maximizing benefits

**check for others

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4
Q

Belmont report: properties of “Justice”

A
  • to each person an equal share
  • to each person according to individual need
  • to each person according to individual effort
  • to each person according to societal contribution
  • to each person according to merit
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5
Q

Belmont report: what question does the ethical principle of “justice” beg?

A

Who ought to receive the benefits of research and bear its burden?

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6
Q

How are the Belmont report’s ethical principles applied in clinical research

A
  • Informed consent
  • risk/benefit assessment
  • selection of subjects of research
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7
Q

How many basic principles does the Nuremberg Code entail?

A

10

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8
Q

Which association developed the Declaration of Helsinki

A

The World Medical Association

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9
Q

Declaration of Helsinki: who does the responsibility for protection of research subjects rest with?

A

Physician

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10
Q

Declaration of Helsinki: if potential research subject is incapable of giving informed consent, who should the physician seek informed consent from

A

The legally authorized representative

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11
Q

What does 21 Code of Federal Regulations Part 50 cover?

A

Human Subject Protection

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12
Q

What can the president do under 10 U.S.C. 1107 (f)?

A

Waive the prior consent for a member of the armed forces

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13
Q

Can a clinical investigator ever waive a research participant’s informed consent?

A

Yes - in an emergency situation

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14
Q

What entity is responsible for ensuring that procedures are in place to inform each subject or their LAR the details of the investigation and other information contained in the informed consent document when the clinical investigator waives informed consent?

A

IRB

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15
Q

Requirements for protocols that will include subjects who are unable to consent

A
  • must submit protocol under a separate investigational new drug application (IND) or investigational device exemption (IDE)

*check for more

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16
Q

How many basic elements of consent are there?

A

8

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17
Q

For a short form written consent document, who needs to sign the short form document

A

the subject and the witness

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18
Q

For a short form written consent document, who needs to sign the copy of the summary

A

the person obtaining the consent and the witness

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19
Q

What must the IRB take into account when determining whether children are capable of providing assent

A
  • Age
  • maturity
  • psychological state

**check for more

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20
Q

Adverse Event (AE)

A

Untoward medical occurrence associated with the use of drug whether or not considered drug related

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21
Q

Life-threatening adverse event/suspected adverse reaction

A

AE that puts the subject at immediate risk of death

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22
Q

Serious adverse event/serious suspected adverse reaction

A

Results in the following:
- death
- life threatening AE
- inpatient hospitalization
- significant incapacity
- and/pr congenital anomaly/birth defect

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23
Q

Suspected adverse reaction

A

Reasonable possibility that the drug caused the adverse event

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24
Q

Unexpected adverse event/unexpected suspected adverse reaction

A

untoward medical occurrence associated with the use of drug whether or not considered drug related

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25
Untoward medical occurrence associated with the use of drug whether or not considered drug related
Adverse Event (AE)
26
AE that puts the subject at immediate risk of death
Life-threatening adverse event/suspected adverse reaction
27
Results in the following: - death - life threatening AE - inpatient hospitalization - significant incapacity - and/pr congenital anomaly/birth defect
Serious adverse event/serious suspected adverse reaction
28
Reasonable possibility that the drug caused the adverse event
Suspected adverse reaction
29
untoward medical occurrence associated with the use of drug whether or not considered drug related
Unexpected adverse event/unexpected suspected adverse reaction
30
Within what period of time must WHO notify WHOM in a WHAT of potential serious risks
SPONSOR must notify FDA and ALL PARTICIPATING INVESTIGATORS in an IND SAFETY REPORT within 15 CALENDAR DAYS after the sponsor determines the risks qualify reporting
31
When does the investigator need to update their financial disclosure form?
any time relevant changes occur during the course of the investigation and 1 year following the completion of the study
32
What is 21 Code of Federal Regulations Part 56 concerned with
IRB
33
When must an IRB renew its registration
Every 3 years
34
If an IRB decides to review new types of FDA-regulated products or discontinue reviewing clinical investigations regulated by the FDA, when must the change be reported and to whom?
Within 30 days of the change and to the FDA
35
What must an IRB do if it decides to change its contact information or chairperson information
revise its registration information report it to the FDA within 90 days of the change
36
What must the IRB report to the FDA/appropriate institutional officials
- any unanticipated problems involving risks to human subjects or others - serious or continuing noncompliance - suspension or termination of IRB approval **check for more
37
When can the iRB use expedited review
- for studies involving no more than minimal risk - or studies with minor changes in previously approved research during the period of 1 year or less from approval **check for more
38
Who may disqualify an IRB or the parent institution
The commissioner
39
Phase 1 trials
- designed to determine the metabolism and pharmacologic actions of the drug in humans - side effects associated with increasing doses - number of subjects ranges from 20 to 80 **check for more
40
Phase 2 trials
- study the effectiveness of the drug in patients with the disease or condition under study - determine the common short term risks associated with the drug - number of subjects ?? **check for more
41
Phase 3 trials
- focus on the effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug - provide an adequate basis for physician labelling
42
Enrollment rate calculation
actual enrollment / target enrollment
43
Custom device
device not generally available or used by other physicians or dentists, not generally available for purchase, not offered for commercial distribution, and intended for use by an individual patient
44
Implant
Device placed into a surgically or naturally formed cavity of the human body for more than 30 days
45
Investigational Device
Device that is the object of an investigation
46
Noninvasive
Device that does not by design or intention penetrate or pierce the skin or mucous membranes of the body, go beyond the external auditory canal etc.
47
Significant risk device
investigational device that is intended to be implanted, supporting or sustaining human life, or used for diagnosing, curing or treating disease and presents a potential serious risk to the health safety or welfare of a subject
48
Unanticipated adverse device effect
Serious adverse effect on health or safety or any life threatening problem or death associated with a device
49
Device placed into a surgically or naturally formed cavity of the human body for more than 30 days
Implant
50
Device that is the object of an investigation
Investigational Device
51
Device that does not by design or intention penetrate or pierce the skin or mucous membranes of the body, go beyond the external auditory canal etc.
Noninvasive
52
investigational device that is intended to be implanted, supporting or sustaining human life, or used for diagnosing, curing or treating disease and presents a potential serious risk to the health safety or welfare of a subject
Significant risk device
53
Serious adverse effect on health or safety or any life threatening problem or death associated with a device
Unanticipated adverse device effect
54
Abbreviation: CFR
Code of Federal Regulations
55
Abbreviation: ICH
International Counsel on Harmonization
56
Abbreviation: FD&C
Food Drug and Cosmetics act
57
Abbreviation: OHRP
Office of Human Research Protection
58
Abbreviation: PMA
pre-market approval
59
Record retention: OHRP
3 years minimum: The HHS protection of human subjects regulations require institutions to retain records of IRB activities and certain other records frequently held by investigators for at least three years after completion of the research (45 CFR 46.115(b)).
60
Record retention: PHI
6 years
61
Record retention: minors
7 years after they turn 18
62
Record retention: IVF studies of PG women
25 years
63
Record retention: FDA
2 years minimum

SOCRA 2023 (12 decks)

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