Strand B Flashcards

1
Q

What is a clinical trial?

A

A research study in which one or more human subjects are prospectively assigned to one or more interventions to evaluate those interventions on health-related biomedical or behavioural outcomes

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2
Q

What is a clinical study?

A

A study involving using human volunteers that is intended to add medical knowledge, interventional and observational

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3
Q

What is the difference between a clinical trial and study?

A

Study - interventional and observational
Trial - interventional only

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4
Q

What is the history of clinical trials?

A

562 BCE - ‘first’ clinical trial
1537 - first trial of 2 medical treatments
1747 - one of the earliest controlled clinical trials
1940s - first double blind clinical trial
1948 - first ‘true’ randomised control trial

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5
Q

What are the different types of clinical trials?

A

Mechanistic
Exploratory/development
Pilot/feasibility
Other interventional
Behavioural
Basic experimental (BESH)

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6
Q

What are the differences between experimental and observational studies?

A

Experimental - Randomised control trials (RCTs)
Non-randomised control trials (nRCTs)
Observational - Cohort studies
Case-control studies
Cross-sectional studies
Ecological studies

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7
Q

What are randomised control studies (RCTs)?

A

Used to find effectiveness of new treatment while eliminating as many biases as possible
Randomised to one of two or more groups to test specific drug, treatment, etc (e.g. intervention used vs placebo)
Groups are followed up to see how effective
Outcomes measured at specific times and different responses are assessed statistically

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8
Q

What are non-randomised control studies (nRCTs)?

A

People allocated to different interventions using methods that are not random
Purely observational, non-randomised interventional studies, and single-arm trials with external control

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9
Q

What are cohort studies?

A

Observational study using defined groups while being followed over time
People with similar characteristics

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10
Q

Why are cohort studies used?

A

Examine associations between different interventions received and subsequent outcomes

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11
Q

What is the difference between a prospective and retrospective cohort study?

A

Prospective - recruits participants before
Retrospective - subjects from past records describing interventions received

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12
Q

What are case-control studies?

A

Observational study to find the possible cause of a disease/condition
Researcher looks for aspects of lives that differ to see what has caused the condition

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13
Q

Why are case-controlled studies used?

A

Compares groups of patients who have the disease with a group of people without but with similar characteristics (unrelated from condition)

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14
Q

What is a cross-sectional study?

A

A ‘snap-shot’ observation of a set of people at 1 time
Describe a variable not measuring it

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15
Q

Why are cross-sectional studies used?

A

Public health research uses this to assess exposure and a disease and compare the rates of disease and symptoms of an exposed and unexposed group

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16
Q

What are the advantages and disadvantages of cross-sectional studies?

A

Advantages: cheap, quick, minimal room for error
Disadvantages: Doesn’t help determine cause and effect, report bias is probable (surveys)

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17
Q

What are ecological studies?

A

Used to understand relationship between outcome and exposure at a population level (population with shared characteristics)
Characteristics include geography, ethnicity, socio-economic status of employment

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18
Q

Why are ecological studies used?

A

Ecological vs other studies is the group is the unit analysis studied no assumptions about individual study participants

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19
Q

What are the phases of a clinical trial?

A

Laboratory studies - cell/animal studies
Phase I - Safety of medication on people
Phase II - Safety and effectiveness
Phase III - Safety, effectiveness and dosing
Phase IV - long-term effectiveness vs new treatment to standard treatment

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20
Q

What happens during the laboratory stage of clinical trials?

A

Basic research, accurately model desired biological effect of a drug predicting treatment outcome in patients and predict ant adverse reactions
Testing: in vitro, in vivo and drug profiling using computer models

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21
Q

What happens during phase I of clinical trials?

A

Drug/treatment on small group of people for first time
Safety and side effects
Several months
Success around 52%

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22
Q

What happens during phase II of clinical trials?

A

Larger group of people
Emphasis on effectiveness
Preliminary data whether drug works in people with disease/condition
Last several years (~1-4)
Success around 30%

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23
Q

What happens during phase III of clinical trials?

A

Large groups of people
More information of safety and effectiveness, different populations and dosages and drug-drug interaction
Information for the drug to be used safely
Success around 58%

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24
Q

What is the FDA approval stage during clinical trials?

A

New Drug Application (NDA) for treatment to an organisation e.g. FDA
Review results to determine if approves the drug and allow marketing to public
Continue to monitor effects
Success around 25-30%

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25
What happens during phase IV of clinical trials?
After approved by FDA - post-marketing monitoring stage Available to public Monitored in large diverse populations More information of treatment's benefits and optimal use
26
What are things to consider when setting up and running a clinical trial?
Ethics Consent Controls Randomisation Binding Sample size Statistics
27
What is ethics?
It is moral principles that govern a persons behaviour or the conducting of an activty
28
What are examples of different ethical considerations in research?
Voluntary participation Confidentiality Consent Anonymity Potential for harm
29
What is consent?
Informed consent is one of the founding principles of research ethics, so human participants can enter research freely with full information about what it mean for them to take part Give consent before they enter
30
How can a researcher ensure the participants are fully informed?
By understanding what the research is and what they are consenting to Researcher giving sufficient and appropriate information about the trial (information sheets) Researchers ensures no coercion Time given for the participant to consider choice and discuss if appropriate Participant has the right to withdraw at any time
31
What is bias?
Systematic errors that encourage one outcome over others Investigators then come to wrong conclusions about the beneficial and harmful effects of interventions
32
What is the result of bias?
Over-estimation of the effect of treatments Treatment look better than they really are Make ineffective treatments look as if they work
33
What is a control group?
The standard to which comparisons are made in an experiment Composed of participants who do not receive the experimental treatment
34
Why are controls used?
To effectively test a treatment in the absence of some absolute or relative measure of success
35
What are the parameters of control groups?
Ideally they are identical in every way except that the experimental groups are subjected to treatments or interventions with effect
36
What is randomisation?
It is the process by which treatments are assigned to participants by chance rather than by choice Avoids bias in assigning volunteers to get one treatment or another
37
What are the different types of randomisation?
Simple Block Stratified
38
What is simple randomisation?
Based on a single sequence of random assignments Maintains complete randomness of the assignment of a subject to a particular group Most common and basic
39
What are the advantages and disadvantages of simple randomisation?
Advantages: Simple Easy to implement Disadvantages: Could result in unequal number amongst groups
40
What is block randomisation?
Randomise subjects into groups that result in equal sample sizes Block size decided by researcher, all possible balanced combinations must be calculated Blocks randomly chosen to determine patients' assignment into the groups
41
What are the advantages and disadvantages of block randomisation?
Advantages: Balance in sample size Disadvantages: Can predict blocks Groups may not be comparable in terms of covariates
42
What is stratified randomisation?
Control and balance covariates Generates separate block for each combination of covariates subjects assigned appropriate one After all subjects identified and assigned, simple randomisation is performed within block to assign subjects to group
43
What are the advantages and disadvantages of stratified randomisation?
Advantages: Simple for small trials Takes covariates into consideration Disadvantages: Complicated if many covariates Subjects have to be identified before assignment (bias)
44
What is blinding?
Studies designed to prevent members of research team and study participants from influencing results Allows collection of scientifically accurate data
45
What are single-blinded studies?
Only the researcher knows treatment or intervention the participant is receiving until the trial is over
46
What are double-blind studies?
Neither participants or researcher knows which treatment or intervention participants are receiving until clinical trial is over
47
How can blinding help influence the behaviour of the researchers?
Influence patient management Decision to withdraw patient from trial Decision to adjust drug dose Decision about intensity of therapy Decision about adjacent therapy Decision to discharge patient
48
How can blinding help influence the behaviour of the trial subjects?
Influence compliance with the trial Influence expectations Influence assessment of patient reported outcome Knowledge of treatment group can influence behaviour outcome assessor Influence assessment of outcome
49
What is a placebo?
Treatments that look like the real thing but contain no active ingredient
50
What is the aim of a placebo?
To achieve blinding
51
What is the placebo effect?
When a persons physical or mental health appears to improve after taking a placebo or dummy treatment
52
Why are statistics important in clinical trials?
For design, conduct, analysis and reporting Researchers form reasonable and accurate inference from collected information No uncertainty Prevent errors and biases in medical research
53
What is a hypothesis?
A proposed assumption for a phenomenon that may or may not be true
54
What is hypothesis testing?
An evaluation done by a researcher to confirm or disprove a hypothesis
55
What are the different types of hypothesis tests?
T-test Chi^2 Z-test
56
What are the 2 different hypothesis the researcher has?
Null and alternative hypothesis
57
What is the null hypothesis (H0)?
Captures what the current situation is
58
What is the alternative hypothesis (H1)?
Captures what we want to show by doing the trial
59
What does hypothesis testing do?
It tests if the hypothesises more probable than the existing hypothesis and assumes the null hypothesis is true until proven that the alternative hypothesis is instead true
60
What happens if there are too little participants?
Real effect may be missed - indistinguishable from chance variation If study does not yield useful results, time and money wasted
61
What happens if there are too many participants?
Smaller trials could reach firm conclusions so no need for participants beyond this Cost implications
62
What is the true endpoint of a clinical trial?
A clinically meaningful endpoint that directly measures patients (has treatment worked?)
63
What is a surrogate endpoint?
A measurement of a specific outcome used in place of another as a predictor to tell if a treatment works Usually occurs before a true endpoint and yields conclusions bout the effect of treatment on a true endpoint
64
What is dissemination of results?
Getting the findings of the research to people that can make use of them, maximise benefit of research
65
What are the principles of good dissemination?
Stakeholder agreement (primary audience, engage with them) Format (produce targeted outputs in an appropriate format) Utilise opportunities (established networks, conferences and events) Context (service context of research) Timing (not limited to end of study)
66
What are things to consider during dissemination of results?
Objective Audience Timeline Resources Strategy
67
What are the nuremberg trials?
In 1947 horrendous medical experimentation in Nazi concentration camps - led to the realisation that there was no generally accepted guidelines for medical research
68
What are the 10 principles of the nuremberg code?
Voluntary consent Research - good of society Based on previous knowledge to justify the experiment Avoids unnecessary physical and mental suffering Research avoided if suspected that death will occur Risk mitigated against and proportionate Adequate facilities Conducted by qualified persons Subjects can end experiments - withdrawal Scientists should not continue if trial is likely to result in injury
69
What is the Helsinki declaration?
1964 - Guidance for doctors operating in a dual role as clinician and researcher Revised multiple times ICH-GCP (international conference for harmonisation - good clinical practice) is routine in the declaration of Helsinki principles
70
How is a human participant defined?
A living human being Human beings who have recently died Foetuses Embryos
71
How can human participants be involved in research?
Directly through physical appearance Indirectly through stored human tissue/bodily fluids or use of human data records
72
What are the 4 steps of giving informed consent?
1 - giving of information 2 - discussion and clarification and review of information 3 - obtaining written and/or verbal consent 4 - process consent
73
How are children able to give consent?
Common law - children are below the age of 18 Generally accepted that whilst children of 16 years and over are minors they can give their own consent Under 16 years often best to gain Childs assent and parent/legal guardian provides informed consent
74
What is Gilicks competence?
It is the measurement of whether a child is mature enough to give their own consent
75
What are the parameters for vulnerable adults?
Temporary: unconsciousness/ some mental illnesses Permanent: genetic/inherited/clinical condition
76
What are the legal constraints of informed consent for vulnerable adults?
The mental capacity act 2007 Medicines for human use regulations 2004 Common law
77
What was the HeLa cells case?
Came from Henrietta Lacks (died 1951) Cells taken from her cervix months before she died
78
What are HeLa cells?
Cervical Adeno-carcinoma cells
79
What was the Alder-Hey organ retention scandal?
Pathologist collected organs from very young children at post-mortem examination (1988-1996) Without asking for permission ~850 body parts collected Not clear how many samples were used
80
What is the human tissue act 2004?
A frame work for regulation of storage and use of human tissue from the living, and the removal, storage and use of the tissue and organs from the deceased for specified purposes
81
What is inducement?
The provision of an incentive to entice a person to carry out an action
82
What is the Tuskegee Syphilis study?
US public health service between 1932-1972 600 low-income black males recruited Free medical care, free meals and burial insurance in return for participation 400 had syphilis Participants monitored for next 40 years
83
What was wrong with the Tuskegee Syphilis study?
None of participants were treated for syphilis and none were told they had it (effective cure of penicillin found in 1940s) Prevented participants from accessing syphilis treatment programs available to others in the area Victims included numerous men in program who died of syphilis and partners contracted disease and children born with congenital syphilis
84
Why is confidentiality important in clinical trials?
Goes with anonymity when dealing with participant information Participant in research study has to have confidentiality maintained unless specifically consented to personal details being disclosed
85
What is general data protection regulation (GDPR)?
Governs protection and control of personal data Anyone processing personal data must comply
86
What are the GDPR principles?
Lawfulness, fairness and transparency Purpose limitation - not used for anything else Data minimisation Accuracy - checks in place Storage limitation - time held Integrity and confidentiality - safe and secure The 'accountability' principle - principles are followed
87
What is personal data?
Identifiable data Confidential information Sensitive information Coded data Linked anonymised Unlinked anonymised Data that relates to an individual
88
Who does GDPR apply to?
Everyone processing personal data
89
Why is GDPR important?
As it is part of the research process Carefully considered in advance of a research study, processes in place at stages and after the end of the study to ensure compliance Recognised that personal data is handled and managing it within the law ICO now applies large fines to those not complying
90
What were the regulations of drugs in research before 1960s?
Not necessary to show that drug actually worked against what it worked against Bring a drug to market if you had a good theory that it might work against a disease
91
What was the thalidomide scandal?
Developed as sickness tablet Given for morning sickness during first trimester of pregnancy in 1950s and early 60s Resulted in thousands of children being born with severe congenital abnormalities Highlighted insufficient safe guards in relations to ways efficacy and toxicity of drugs were accessed before they were put on the market
92
What is the medicines act?
Developed in 1968 Merged a number of pervious medical regulations Provides a broad legal standard on the manufacture and supply of medicines related to general practice Necessity of clinical trials and scientific evidence to inform on the safety and efficacy of medication Looks at the effects of drugs or possible toxicity of drugs in relations to females who are pregnant and the foetus and the future development of the child
93
What are the 3 main classifications of the medicines act?
Prescription only, pharmacy and general medication
94
Who is the clinical trials legislation under?
Medicines for human use regulations 2004
95
What is the UK policy framework for health and social care research?
Developed in 2018 Designed to set principles of good practice across all areas of health and social care research in the UK Applies to organisation and individuals that have responsibilities for health and social care research Includes funders, sponsors, researchers and employers, research sites and care providers
96
What are the principles that apply to all health and social care research?
Safety Competence Scientific and ethical conduct Patient, service user and public involvement Integrity, quality and transparency Protocol Legality Benefits and risks Approval Information about the research Accessible findings Choice Insurance and indemnity Respect for privacy Compliance
97
What are the principles that apply to interventional health and social care research?
Justified intervention Ongoing provision of treatment Integrity of the care record Duty of care
98
What is the Northwick Park incident?
London 2006 Healthy male volunteers Antibody drug TGN 1412 Would be used in rheumatoid arthritis and other autoimmune disorders First human trial to test for safety Managed by TeGenero of Wurzburg, Germany
99
What was the response to TGN 1412?
1 hour - Excruciating headaches, shivering, back pain, gut pain, diarrhoea, swelling and nausea 4 hours - fevers, flushed, BP drops dangerously low, hearts race, blood tests show lymphocytes and monocytes vanishing fast 5 hours - one fighting for breath, lung pain, steroids and others to ease inflammation 12 hours - ICU on ventilator, all taken to ICU 24 hours - 2 ventilators, 4 need support 48 hours - 4 start to recover 6 begin to suffer multi-organ failure and attached to kidney machines
100
What are UK research ethics committees for?
Ensure dignity, rights, safety and well-being are protected Reducing risk associated with research Patient participants - UK research ethics committee Non-patient participants - university ethics committee
101
What are the different meta-ethical theories?
Moral absolutism/dogmatism - I know that X is right or wrong (anyone disagreeing is wrong) Moral relativism - Statement X is right or wrong is synonymous with the statement that an agent approves or disapproves of X Pyrrhonian moral scepticism - I believe that X is right or wrong
102
What are tools of the ethics trade?
Logic Analogies Avoiding slippery slope arguments
103
Why is ethics needed subjectively?
Subjective aspect: To justify behaviours Explain why behaviour is (un)acceptable - relate actions to principles theory account of which principles should be followed and how to balance
104
Why is ethics needed objectively?
Objective aspect: Many (or all) things deserve moral consideration
105
What are formal ethical theories?
About the sorts of abstract principles and values that should matter
106
What are material ethical theories (axiologies)?
About the concrete things/entities that should matter
107
What are examples of formal ethical theories?
Principlism - autonomy (e.g. biomedical research), beneficence (doing good), non-maleficence (doing some harm, trying to prevent it), justice Consequentialism - can be bad if ill intention Deontology - blind eye to consequence (careless) Virtue ethics - cultivate virtues (high moral standard) and right actions follow Care ethics - caring personalities
108
What is the connection between axiologies and ontologies?
Which things deserve moral consideration, how much moral significance we should attribute to them related to actions How we value things (ontologies)
109
What are examples of axiologies?
Strong speciesism - only human beings matter Weak speciesism - other entities matter Animal egalitarianism - treat animals the same Radical biocentrism - all living things treat the same Ecocentrism - kill humans to make the ecosystem better
110
Which ontologies has western philosophy been dominated by?
Mechanistic materialism Dualism
111
What is mechanistic materialism?
Ontology that realist is composed of bits of stuff that act in a machine-like fashion
112
What happens in mechanistic materialism?
Mental phenomena should be explained entirely in terms of the material components that constitute them Material components do not possess any mental properties
113
What views does mechanistic materialism accept?
Determinism - the view that all events are determined by causes that lack free will
114
How can mechanistic behaviour be determined?
Externally by the Great Builder of the machine By aimless forces
115
What is dualism?
The view that reality is composed of two fundamentally distinct things: things with minds and things that lack minds
116
What is panexperientialism?
The ideology that all real individuals collect an experience and there is a mindfulness of molecules and atoms
117
What are aggregates or true/compound individuals?
Individuals that are not experiencing subjects but they have experiencing subjects within it
118
When was the rise of animal ethics?
1966 - moral philosophers started questioning the use of animals in research
119
Who started questioning animal ethics and why?
Tom Regan, 1985 - viewing animals as resources Marti Kheel, 1989 - feelings of connection with other forms of life Peter Singer, 1990 - equal consideration of interests, speciesism
120
What is speciesism?
It regards the way people treat different species and the values or rights to beings on the basis of their biological species
121
What were different researchers' opinions on speciesism?
Nathan Nobis 2011 - Biological humanity has nothing to do with morals Richard Haynes 2008 - Benefits of animal used outweighs costs to animal Mary Midgley 1983 - Relative disregard of other creatures and emotional preference for own species over others
122
Why is it problematic for the legal and advisory documents of the use of animals in research to be drawn up by scientists?
As they are primarily using the animals Many prefer self-regulation, forecloses external scrutiny Are they experts in ethical relevance of animal welfare
123
What is the law on using nonhuman animals for biomedical science?
Animal Act 1986 - applied to any living vertebrate other than man and any living cephalopod from the stage of development when: Mammal, bird/reptile 2/3 of gestation/incubation period Capable of independent feeding
124
What does the Animal Act 1986 apply to?
Scientific procedures - cause harm, suffering, pain or distress more than the insertion of a hypodermic needle
125
What are the 3 R's that laws defend?
Replacement, reduction and refinement
126
What do the 3 R's mean?
Replacement - substitution for conscious living higher animals of insentient material Reduction - reduction in numbers of animals used to obtain information Refinement - decrease in incidence and severity of inhumane procedures applied to animals still being used
127
What is required by the ASPA to conduct animal research?
Obtains personal licence Project licence is obtained for projects Place of research has certificate, minimum of 3 named people: Certificate holder Veterinary surgeon Animal welfare and care officer Licences from home office and visits for inspection
128
What are AWERBs?
Animal welfare and ethical review body
129
What are alternatives to nonhuman animal research?
Micro-dosing (nano-range) Observational studies Randomised controlled trials Use of human tissues, cells and genes Computer testing
130
What are the methods of biomedical research?
Using (parts of) biological organisms to identify the causes of health and illness
131
What is clinical equipoise?
It is the balance of interest e.g. uncertainty which trial is better or just as good as the other
132
What is the Freedom of Information Act?
2000 - promote openness by public authorities, public have statutory right of access to information held by public authorities Anonymised information disclosed
133
What are different examples of scientific misconduct?
Falsification - changing data Fabrication - making up results Plagiarism Self-plagiarism - extracts from own previous work Gift authorship - recognised as author/co-author in spite of making minor contributions
134
Why is the opinion of ethics concerning animals important?
For: Ethical concerns (public concern and animal welfare concerns) Scientific concerns Institutional/professional requirements Legal requirements
135
What is absolute dominion?
It is the belief that all animal experiments are justified and humans have a higher status than animals so it is okay to use them
136
What is the absolute dominion view for why animals are necessary for research?
Animals are good models Fundamental for research as they are used as a legal requirement before drugs are released Needed to model complex organisation and processes Alternatives are currently insufficient
137
How does drug safety govern the use of animals?
It is needed to identify any problems or side effects Involves: in-vitro and in-vivo screens and a relatively small number of animals (100s) Only then are they given to many people and animals (could be unwell and/or taking other drugs)
138
What is abolition?
Animal experiments are morally wrong
139
What is the abolition view for why animals are unnecessary for research?
Medical advances using: human-based research public health measures population studies Viable alternatives useful: computer models & analysis use of non-animal tests alternative medicine Money better spent on prevention not cures
140
How can misleading experiments be detrimental?
If tested in these species that would they be used in humans penicillin is lethal in guinea pigs paracetamol is lethal in cats Damaging in humans: thalidomide Tested in rodents which are tetragenic (has no effect)
141
What is the 'troubled' middle of animal experiments?
Some animal experiments are justified Reduce pain and suffering experienced
142
Why are the 3 R's important?
Because it forms a basis for all legislation covering experimental animals requires alternatives to be considered and evidence provided forms heart of Ethical Review Process
143
When will an animal procedure be regulated?
If it causes: death, disease and injury physiological and psychological stress discomfort and disturbance to normal health anaesthetic or analgesic admin for scientific purpose
144
What is the animal regulation threshold?
A procedure that causes pain, suffering or lasting harm equivalent to or higher than that caused by insertion of a hypodermic needle for the purpose of research
145
What are the protected species?
Living vertebrates and cephalopods Foetal, larval and embryonic forms included: mammals, birds and reptiles (2/3 through gestation) fish, amphibians and cephalopods (independent feeding) Special protection: dogs, cats, horses and non-human primates
146
What are the ASPA controls?
Purpose of research via project licence (PPL) People conducting research via personal licence (PPL) Places that research is done via establishment licence (EL) Consider licence applications, give advice and provides codes of practice Enforcement via inspectorate
147
What are named people required for animal research?
Establishment licence holder (ELh) - responsibility for compliance with ASPA Veterinary surgeon (NVS) - advises welfare, health and vet medicines Animal care and welfare officer (NACWO) - care and welfare of all animals Information officer (NIO) - PILs and PPLs have access to current information Training and competency officer (NTCO) - PILs properly trained, supervised and competent and record it
148
What is AWERB?
Animal Welfare Ethics Review Body
149
What do AWERB do?
Review applications before submission (cost/benefit and justification, 3 R's, non-animal approaches used first) Full implementation of ASPA Provide advice and guidance on animal health and welfare Support NACWOs and NVS
150
What is the utilitarian principle?
Greatest good for the least harm assuming animal research is justified Benefits of research must be greater than the costs
151
How do cost/benefit analysis's work in theory?
Assigns values to costs (animal interests) and a value to the benefits (research value)
152
What are the 5 pillars?
Honesty, fairness, accountability, transparency and responsibility
153
What is auto plagiarism?
Using the same piece of work previously submitted and submitting it again to get 2 lots of credit
154
What is a main example of scientific fraud?
Like Andrew Wakefield and his claims on the MMR vaccine causing autism which was then taken down as there was insufficient evidence towards the claims
155
What is retraction?
Removal of a paper from the 'system' after fraud or honest error has been detected
156
What is social capital?
Form of economic and cultural capital in which social networks are central, transactions marked by reciprocity, trust and cooperation, market agents produce goods and services not for themselves but for common good
157
What are the pros and cons to open science?
Pros: open, funders and public see what you are doing, peer reviewed Cons: ownership, early data, risk of scoop, funders see what you are doing, not peer review