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SOCRA 2023 > Miscelanius > Flashcards

Miscelanius Flashcards

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
Q

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

A

Adverse Event (AE)

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26
Q

AE that puts the subject at immediate risk of death

A

Life-threatening adverse event/suspected adverse reaction

27
Q

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

A

Serious adverse event/serious suspected adverse reaction

28
Q

Reasonable possibility that the drug caused the adverse event

A

Suspected adverse reaction

29
Q

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

A

Unexpected adverse event/unexpected suspected adverse reaction

30
Q

Within what period of time must WHO notify WHOM in a WHAT of potential serious risks

A

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
Q

When does the investigator need to update their financial disclosure form?

A

any time relevant changes occur during the course of the investigation and 1 year following the completion of the study

32
Q

What is 21 Code of Federal Regulations Part 56 concerned with

A

IRB

33
Q

When must an IRB renew its registration

A

Every 3 years

34
Q

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?

A

Within 30 days of the change and to the FDA

35
Q

What must an IRB do if it decides to change its contact information or chairperson information

A

revise its registration information

report it to the FDA within 90 days of the change

36
Q

What must the IRB report to the FDA/appropriate institutional officials

A
  • any unanticipated problems involving risks to human subjects or others
  • serious or continuing noncompliance
  • suspension or termination of IRB approval

**check for more

37
Q

When can the iRB use expedited review

A
  • 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
Q

Who may disqualify an IRB or the parent institution

A

The commissioner

39
Q

Phase 1 trials

A
  • 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
Q

Phase 2 trials

A
  • 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
Q

Phase 3 trials

A
  • 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
Q

Enrollment rate calculation

A

actual enrollment / target enrollment

43
Q

Custom device

A

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
Q

Implant

A

Device placed into a surgically or naturally formed cavity of the human body for more than 30 days

45
Q

Investigational Device

A

Device that is the object of an investigation

46
Q

Noninvasive

A

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
Q

Significant risk device

A

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
Q

Unanticipated adverse device effect

A

Serious adverse effect on health or safety or any life threatening problem or death associated with a device

49
Q

Device placed into a surgically or naturally formed cavity of the human body for more than 30 days

A

Implant

50
Q

Device that is the object of an investigation

A

Investigational Device

51
Q

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.

A

Noninvasive

52
Q

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

A

Significant risk device

53
Q

Serious adverse effect on health or safety or any life threatening problem or death associated with a device

A

Unanticipated adverse device effect

54
Q

Abbreviation: CFR

A

Code of Federal Regulations

55
Q

Abbreviation: ICH

A

International Counsel on Harmonization

56
Q

Abbreviation: FD&C

A

Food Drug and Cosmetics act

57
Q

Abbreviation: OHRP

A

Office of Human Research Protection

58
Q

Abbreviation: PMA

A

pre-market approval

59
Q

Record retention: OHRP

A

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
Q

Record retention: PHI

A

6 years

61
Q

Record retention: minors

A

7 years after they turn 18

62
Q

Record retention: IVF studies of PG women

A

25 years

63
Q

Record retention: FDA

A

2 years minimum

SOCRA 2023 (12 decks)

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