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CMB2000 > STRAND B (Ethics) > Flashcards

STRAND B (Ethics) Flashcards

1
Q

clinical trial

A

interventional study with IMP’S

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2
Q

clinical study

A

research with human volunteers/ participants intended to add to medical knowledge, can be observational or interventional.

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3
Q

IMP

A

investigational medicinal products

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4
Q

types of NIH clinical trials

A

mechanistic
exploratory/ development
pilot/ feasibility
behavioural
other interventional
basic experimental

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5
Q

2 types of study design

A

experimental
observational

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6
Q

experimental study

A

researcher intervention and observation
randomised/ non-randomised

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7
Q

observational study

A

observational no action
cohort studies, case-control, cross-sectional, ecological

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8
Q

randomised control trials

A

bias elimination
units randomised to experimental/ comparison group with dummy intervention

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9
Q

non-randomised trials

A

inc. observational/ interventional/ single arm

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10
Q

cohort studies

A

defined group studied over time
observational
associations between interventions received and subsequent outcome
(prospective > recruitment prior to intervention/ retrospective> recruitment from past records)

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11
Q

case control studies

A

observational for possible causes of a disease/ condition
compare similar patients with controls

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12
Q

cross-sectional studies

A

snapshot of set at 1 time
description of variable not measurement > assesses cause and effect and symptom comparison

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13
Q

positives of cross-sectional studies

A

simple
cheap
quick
minimal error margin

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14
Q

negatives of cross-sectional studies

A

bias?
doesn’t determine cause/ effect

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15
Q

ecological studies

A

relationship between outcome and exposure at a population level with same characteristic

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16
Q

phases of a clinical trial

A
  1. pre-clinical research
    phase I
    phase II
    phase III
    phase IV
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17
Q

pre-clinical research

A

model desired bio effect of drug
predict treatment outcome in patients
analyse safety
In vitro/ vivo
computer model drug profile

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18
Q

phase1

A

test in small group of people (safety/ side effects)
months

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19
Q

phase2

A

larger group testing (100-300)
emphasis on efficacy
preliminary data
years

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20
Q

phase3

A

large group testing (1000-3000)
safety/ efficacy/ dosage
FDA approval
NDA submission

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21
Q

phase4

A

post-marketing monitoring
public availability

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22
Q

why did covid vaccines bypass the 10 year journey

A

previous, tested vaccine technology platform
phase 1/2 combined with previous dosage knowledge

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23
Q

clinical trials considerations

A

ethics
consent
controls
randomisation
blinding
sample size
statistics

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24
Q

ethics

A

moral principles governing a person’s behaviour or conducting of an activity

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25
Q

consent

A

entering research freely with full information
must: understand premise, info supplied with no coercion, time given for consideration, withdrawal rights at any time

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26
Q

bias

A

systematic errors encouraging one outcome over others
> treatment effect over-estimation

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27
Q

control group

A

participants not receiving experimental treatment

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28
Q

how are control groups allocated

A

clinician’s choice
patient choice
consenting vs refused
hospital/ consultant differences

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29
Q

randomisation

A

process by which treatments are assigned to participants by chance to avoid bias
stratified/ simple/ block

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30
Q

simple randomisation

A

based on single sequence of random assignments
:) simple/ easy to implement
:( unequal no. among groups

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31
Q

block randomisation

A

equal sample sizes, balanced in random combinations
:) sample size balance
:( can predict blocks
:( may not be comparable in terms of covariates

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32
Q

stratified

A

separate blocks generated for each covariate combo and assigned to appropriate covariate block
simple randomisation within each block
:) simple for small trials/ covariate consideration
:( complicated in large groups/ prior identification of subjects

33
Q

single-blinded

A

only researcher knows which intervention is being received

34
Q

doubleblinded

A

neither researcher/ participant know

35
Q

what does blinding affect?

A

patient management
dosage decision
therapy intensity
discharge decision
trial compliance
expectations
assessment outcome

36
Q

true endpoint

A

clinically meaningful endpoint directly measuring patients

37
Q

surrogate endpoint

A

specific outcome measurement used in place of another as a predictor

38
Q

result dissemination

A

releasing findings to maximise benefit of research without delay
- stakeholder engagement
- format
-context
-utilise opportunities

39
Q

1947 Nuremberg trials code of 10 principles

A
  1. voluntary consent
  2. research for societal good
  3. previous knowledge justification
  4. no unnecessary suffering
  5. avoided if could be fatal
  6. mitigated and proportionate risk
  7. adequate facilities
  8. qualified conductors
  9. subject withdrawal
  10. discharged if injury likely
40
Q

1964 Helsinki declaration

A

guidance for dual role doctors as clinician/ researcher
ICH-GCP routed

41
Q

Human participant examples

A

embryo
recently deceased
living human
foetuses
stored tissues/ fluids

42
Q

informed consent stages

A
  1. giving info
  2. discussion/ clarification/ review
  3. written/ verbal consent
  4. process consent
43
Q

informed consent in children

A

16+ can give consent
child’s assent / guardians informed consent

44
Q

informed consent in vulnerable adults (temp/ permanent)

A

mental capacity act 2007
medicine for human use regs 2004
common law

45
Q

HeLa cells (immortal human cells)

A

helped polio vaccine/ chemo/ cloning/ IVF/ gene mapping
mimicked living human experimentation
Henrietta Lacks (d. 1951) prior to adeno-carcinoma death
no benefit to fam despite commercial billions

46
Q

Alder-hey organ retention scandal

A

pathologist collecting organs from children without permission

47
Q

human tissue act 2004

A

storage and use of human tissue regulated from deceased

48
Q

inducement

A

provision of incentive to entice a person to carry out an action

49
Q

Tuskagee syphilis study

A

US public health service
600 poor black males offered free healthcare/ meals/ burial insurance
400 w syphilis and monitored for 40 years
no treatment despite penicillin cure

50
Q

GDPR

A

general data protection regulation

51
Q

7 GDPR principles

A
  1. lawfulness, fairness and transparency
  2. purpose limitation
  3. data minimisation
  4. accuracy
  5. storage limitation
  6. integrity and confidentiality
  7. ‘accountability’ principle
52
Q

medicines act 1968

A
  • after thalidomide scandal
    legal standard on supply/ manufacture on 3 classifications of medicine (prescription/ pharmacy/ general
53
Q

Northwick park 2006

A

healthy males> experimental antibody drug TGN1412 for rheumatoid arthritis/ autoimmune conditions
Parexel managed
multi-organ failure

54
Q

ontology

A

philosophical study of entities

55
Q

2 ontologies dominating Western philosophy

A

mechanistic materialism
dualism

56
Q

mechanistic materialism

A

ontology that reality is formed of components acting in machine-like fashion
- no consciousness/ free will
- accepts ‘determinism’
- billiard ball universe

57
Q

determinism

A

all events determined by causes lacking free will

58
Q

dualism

A

view that reality is composed of 2 fundamentally distinct things with minds / without

59
Q

panexperientialism

A

view that mind is a fundamental and ubiquitous feature of reality
> differing levels of agency w levels of material and mental complexity

60
Q

speciesism

A

treating members of one species morally more important than other species

61
Q

example of animal rights philosopher

A

tom Regan
‘view animals as our resources’

62
Q

animal acts 1986

A

demands some forms of protection should be applied to ‘any living vertebrate other than man when gestation/ incubation period has elapsed and capable of independent feeding

63
Q

alternatives to non-human animal research

A

micro-dosing
observational studies
randomised controlled trials
use of human tissue
computer testinge

64
Q

examples of misconduct in research

A

falsification
fabrication
plagiarism
self-plagiarism
gift authorship

65
Q

4 principles approach for good biomedical research

A

respect for autonomy
beneficence
nonmaleficence
justice

66
Q

ethical review process 3R’s

A

replacement (of sentient w non-sentient)
reduction (no. animals to minimum w/o compromising precision/ value)
refinement (decreasing incidence/ severity of inhumane procedures, suffering evaluation)

67
Q

ASPA 1986

A

animals scientific procedures act 1986
- cost benefit analysis
- larger EU legislation
- regulation
- protected species

68
Q

what does ASPA control?

A

PPL
People researching w PIL in designation certified place

69
Q

PPL

A

purpose of research via project license

70
Q

PIL

A

Personal license
- required to carry out reg. procedures

71
Q

PPL project license

A

work programme specification for allowable purpose under license holder control

72
Q

what must a research proposal have

A

RRR consistent to objectives
knowledge outweighs harm
sufficient knowledge of applicants
clear objectives/ methods

73
Q

EL

A

establishment license

74
Q

named people involved in animal research

A

EL holder
NVS (Named vet surgeon)
NACWO (Named animal care/ welfare officer)
NIO (info officer)
NTCO (training/ competency officer)

75
Q

AWERB

A

animal welfare ethics review board
- assigned per institute

76
Q

sub-threshold considerations for animal research

A

less pain than insertion of a hypodermic needle

77
Q

ASPA schedule 1

A

humane killing methods

78
Q

schedule 2

A

lab animal supply codes of practice

79
Q
A

CMB2000 (3 decks)

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