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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
consent
entering research freely with full information must: understand premise, info supplied with no coercion, time given for consideration, withdrawal rights at any time
26
bias
systematic errors encouraging one outcome over others > treatment effect over-estimation
27
control group
participants not receiving experimental treatment
28
how are control groups allocated
clinician's choice patient choice consenting vs refused hospital/ consultant differences
29
randomisation
process by which treatments are assigned to participants by chance to avoid bias stratified/ simple/ block
30
simple randomisation
based on single sequence of random assignments :) simple/ easy to implement :( unequal no. among groups
31
block randomisation
equal sample sizes, balanced in random combinations :) sample size balance :( can predict blocks :( may not be comparable in terms of covariates
32
stratified
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
single-blinded
only researcher knows which intervention is being received
34
doubleblinded
neither researcher/ participant know
35
what does blinding affect?
patient management dosage decision therapy intensity discharge decision trial compliance expectations assessment outcome
36
true endpoint
clinically meaningful endpoint directly measuring patients
37
surrogate endpoint
specific outcome measurement used in place of another as a predictor
38
result dissemination
releasing findings to maximise benefit of research without delay - stakeholder engagement - format -context -utilise opportunities
39
1947 Nuremberg trials code of 10 principles
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
1964 Helsinki declaration
guidance for dual role doctors as clinician/ researcher ICH-GCP routed
41
Human participant examples
embryo recently deceased living human foetuses stored tissues/ fluids
42
informed consent stages
1. giving info 2. discussion/ clarification/ review 3. written/ verbal consent 4. process consent
43
informed consent in children
16+ can give consent child's assent / guardians informed consent
44
informed consent in vulnerable adults (temp/ permanent)
mental capacity act 2007 medicine for human use regs 2004 common law
45
HeLa cells (immortal human cells)
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
Alder-hey organ retention scandal
pathologist collecting organs from children without permission
47
human tissue act 2004
storage and use of human tissue regulated from deceased
48
inducement
provision of incentive to entice a person to carry out an action
49
Tuskagee syphilis study
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
GDPR
general data protection regulation
51
7 GDPR principles
1. lawfulness, fairness and transparency 2. purpose limitation 3. data minimisation 4. accuracy 5. storage limitation 6. integrity and confidentiality 7. 'accountability' principle
52
medicines act 1968
- after thalidomide scandal legal standard on supply/ manufacture on 3 classifications of medicine (prescription/ pharmacy/ general
53
Northwick park 2006
healthy males> experimental antibody drug TGN1412 for rheumatoid arthritis/ autoimmune conditions Parexel managed multi-organ failure
54
ontology
philosophical study of entities
55
2 ontologies dominating Western philosophy
mechanistic materialism dualism
56
mechanistic materialism
ontology that reality is formed of components acting in machine-like fashion - no consciousness/ free will - accepts 'determinism' - billiard ball universe
57
determinism
all events determined by causes lacking free will
58
dualism
view that reality is composed of 2 fundamentally distinct things with minds / without
59
panexperientialism
view that mind is a fundamental and ubiquitous feature of reality > differing levels of agency w levels of material and mental complexity
60
speciesism
treating members of one species morally more important than other species
61
example of animal rights philosopher
tom Regan 'view animals as our resources'
62
animal acts 1986
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
alternatives to non-human animal research
micro-dosing observational studies randomised controlled trials use of human tissue computer testinge
64
examples of misconduct in research
falsification fabrication plagiarism self-plagiarism gift authorship
65
4 principles approach for good biomedical research
respect for autonomy beneficence nonmaleficence justice
66
ethical review process 3R's
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
ASPA 1986
animals scientific procedures act 1986 - cost benefit analysis - larger EU legislation - regulation - protected species
68
what does ASPA control?
PPL People researching w PIL in designation certified place
69
PPL
purpose of research via project license
70
PIL
Personal license - required to carry out reg. procedures
71
PPL project license
work programme specification for allowable purpose under license holder control
72
what must a research proposal have
RRR consistent to objectives knowledge outweighs harm sufficient knowledge of applicants clear objectives/ methods
73
EL
establishment license
74
named people involved in animal research
EL holder NVS (Named vet surgeon) NACWO (Named animal care/ welfare officer) NIO (info officer) NTCO (training/ competency officer)
75
AWERB
animal welfare ethics review board - assigned per institute
76
sub-threshold considerations for animal research
less pain than insertion of a hypodermic needle
77
ASPA schedule 1
humane killing methods
78
schedule 2
lab animal supply codes of practice
79

CMB2000 (3 decks)

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