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PPVE
ethics
146
Medical
Undergraduate 4
05/31/2017

Additional Medical Flashcards

 


 

Cards

Term
define research
Definition
generates new information, knowledge, understanding or some other relevant cognitive good.
this is done by means of systematic investigation
Term
what is research NOT?
Definition
it is not audit, experimentation or rx
Term
what is audit?
Definition
it evaluates, assesses and reviews but is not experimental in nature
e.g. pts are receiving drug 'x' which manufacturer claims is effective after 3 days but hospital wants to evaluate the claim so commissions and audit
Term
what is experimentation?
Definition
it focuses on a single individual and tends not to be pre planned.

it is altered to the individuals needs/preferences.
Term
how is research different to rx?
Definition
Rx uses established methods and aim to directly benefit the pt. it is based on individual pts with known parameters and this is not always the case in research.
Term
reasons why research is good?
Definition
intrinsic good: about understanding the world and ourselves

extrinsic good: when we can bring about applicable goods like increasing peoples lives and saving peoples lives

personal benefit: in therapeutic research. participant stands a good chance of directly benefiting from the research

public benefit: in non therapeutic research. the participant is unlikely to benefit directly from research but future pts might.

feel good factor
Term
the difference between therapeutic and non therapeutic research?
Definition
therapeutic: the participant stands to directly benefit from the research

non-therapeutic: in the interest of public good. the participant may not be directly benefitting from the research but future patients might.
Term
examples where research is not good
Definition
Alder Hey where Dick Van Velzen a dutch pathologist order the stripping and keeping of organs of children in which post mortem had been performed

Nuremberg trials and promulgation of Nuremberg Code.
Term
what the Alder Hey report into organ retention called?
Definition
the Redfern report
Term
when can human tissue be used in research w/o gathering consent?
Definition
if research ethics committee has approved use
samples are obtained ethically
research wont harm donors
samples are anonymized
Term
human research is kept ethical by regulance and governance. Give some examples
Definition
Helsinki code
Human Rights Act 1997
EU Clinical Trials Directive
DoH: Research Governance Framework
Research Ethics Committee: national research ethics service and university research ethics committe
Term
what are the reasons for having research ethics?
Definition
protect safety and care of participants
protects researchers ensuring compliance with laws and guidelines
protects reputation of medical research as scandals can damage research
Term
how is animal research kept ethical?
Definition
animal scientific procedures act 1986
Home Office
UK Government
Term
which act lays out the code of practice on Animal research?
Definition
Animal Scientific Procedures Act 1986
Term
which organisation oversees animal research and regulates licenses for animal research?
Definition
Home Office.

you apply for a license to them and they do the harm:benefit analysis.
Term
what stance does the UK Government have on animal research

remember the 3Rs
Definition
It is ok if no practicable alternative exists and suffering is kept to a minimum

3Rs:-
Replacement
Reduction
Refinement
Term
expand on the 3R
Definition
Replacement: non animal methods should be used wherever possible eg computers

Reduction: number of animals used should be the minimum needed to give clear experimental results.

Refinement: smallest degree of pain and distress should be inflicted and for a justifiable purpose
Term
things to consider in ethical research
Definition
comply with the law
respect pt autonomy
protect the research relationship
Term
how should CONSENT be in ethical research?
Definition
INFORMED: clear language, explain risks and benefits
COMPETENT: they must have mental capacity or can conset be given on their behalf?
Voluntary: free from coercion
Term
can deception ever be used in medical research?
Definition
you will need a good case for why it is necessary and why benefits of research outweigh costs of deceiving participants especially if they will cause harm or put them at risk
Term
what does the Helsinki declaration say about participant welfare?
Definition
in medical research on humans, well being to human takes precedence over interests of science and society

human research should only be conducted if importance outweighs inherent risks and burdens particularly when subjects are healthy volunteers
Term
those without capacity can still be included in research but what needs to be done?
Definition
consult and get consent from their legally appointed carers
research must be related to their specific condition
you need to engage in day to day monitoring
harms must be minimal and minimised
Term
top tips for conducting ethical research include?
Definition
validity/rigour of research
balance of risk/benefits arising from research
how is information provided?
processes involved in carrying out research
Term
explain validity/rigour of research
Definition
involves

aims/objectives
no of participants
thematic analysis
Term
explain balance of risks and benefits arising from research?
Definition
this is the vulnerability of the participants versus the long term benefits to society
Term
explain how information can be provided in research?
Definition
written
verbal
diagrammatic
in another language
provided in advance
Term
explain what processes may be involved in carrying out research?
Definition
recruitment
online survey
blinded trial etc
Term
if which 4 conditions apply is the project likely to be research?
Definition
intention is to generate generalizable and new information

involves providing a rx or service

a protocol is used to allocate service or Rx

Participants are randomised.
Term
home office policy on animal research

3Rs
Definition
Replacement: with computers if possible
Reduce: use the minimum number of animals needed to get a clear experimental results
Refinement: smallest degree of pain/distress inflicted for a justifiable purpose
Term
awareness of the lengths people go to achieve claim for ground breaking research

e.g. Paulo Macchiarini
Definition
failure to carry out risk analysis
failure to seek ethical approval
reports showed he persisted with a technique that showed few signs of working

medical institution so attached to start doctor they ignored mounting evidence of his poor judgement
Term
should knowledge gathered by unethical research be put to practical use?
arguments for NO it shouldnt
Definition
numremberg paper argues no
prima facie duty: unethically obtained data should never be used

science as a moral minimum should be sensitive to the emotions of the victims from whom it has pillaged data

researchers must come to a clear understanding that unethical human experimentation in the name of scientific progress is never justifiable

after an atrocity has been committed there should be no use of data. the indignation, emotions and thoughts of the victim must be respected in order to indemnify previous lack of respect
Term
arguments for the use of unethical data
Definition
society could be seen to salvage good from such evil

we may bury cure to AIDS with Nazi data so we should read it and publish it
Term
when faced with unethical research what 3 options does the publisher have?
Definition
publish the unethical research
publish it with explicit condemnation of methods used
reject the article on moral grounds
Term
when should reject an article that is unethical?
Definition
where basic human rights have not been respected
deceit has been practised
consent gained without complete information
Term
in dubious cases of unethical research wehere risk assessment can be doubted or there are suspicions of ethical problems how could the publishers proceed?
Definition
publish the article with serious discussion of ethical problems suspected. this policy allows a rebuttal by authors.
Term
how can government politic influence patient care and provision of services
Definition
Evidence Based Medicine is the official policy for NHS

there may be other stakeholders involved who have different motivations and interests that can affect the provision of services unequally.
Term
define Futile
Definition
from the Latin 'leaky'

no chance of prolonging life
no chance of achieving the pts wishes
will fail to achieve a therapeutic benefit to the pt

futility is in relation to a specified goal so its discussion cannot begin without agreement on the goals.
Term
definition of futile
Definition
no chance of prolonging life or achieve a therapeutic benefit to the patient.

no worthwhile goal can be achieved and the pts QofL would be unacceptable
Term
reasons not to administer futile rx
Definition
may do harm e.g resuscitate into PVS but are we assuming PVS is worse than death?

deprives others of resources: opportunity cost

it may consume disproportionate resources: proportionality

there may be loss of dignity

it may lead to a situation where doctor is being required to administer Rx they deem to be against the interests of their pt.
Term
there is no consensus on definition of futility but there is a classification. what is this?
Definition
quatitative: statistical chances of success are remote. include physiological futily where intervention cannot work

Qualitative futility: intervention would result in an unacceptable situation: unacceptable to whom and by whose standards?...ooo go dr spencer
Term
reality of futility?
Definition
used to justify withdrawal/withholding of medical therapy
represents a shift away from pt autonomy towards paternalism

as there is not clear definition of what constitutes futile therapy it is often a means of presenting an opinion as a fact thereby ending further discussion
Term
passive euthanasia, the definition can have overlaps with futility how?
Definition
intentional hastening of a pts death by withholding or withdrawing rx.

it is common to withdraw life prolonging rx in cases of futility
Term
the Law draws certain distinctions to ensure euthanasia and murder remain illegal while allowing some latitude. this include doctrine of double effect and which other?
Definition
act/omission distinction: is an act to end a life any different to deliberately avoid saving a life?
Term
the negative affect on doctors using futility
Definition
they circumvent ethical discussion by presenting opinion as fact
they make contestable value judgement
they allow paternalism to erode
Term
explain utility as a substitute for futility
Definition
it implies 'usefulness' or ' profitability' so incorporates benefit over cost but it is not the antonym of futility which merely implies the absence of benefit.
Term
what is Mill harms principle?
Definition
puts a limit on autonomy saying that ones choices should not infringe the rights of others
Term
autonomy allows refusal of treatment but does not allow demand of rx. why is this so?
Definition
it would infringe the autonomy of the doctor and potentially compel them to become complicit in what they believe to be a pts self destructive choice
Term
problems in discharge planning
Definition
conflict between pt rights and pressures of managed care.
when confronted by ethical conflicts discharge planners may be tempted to manipulate diagnostic categories in order to prolong hospital stay

better choice is to change policy at institutional level so preofessionals are not faced with a choice between sacrificing themselves or following ethical standards
Term
how can bed blocking emerge in medical practise?
Definition
loss of long term beds and gaps in community provision
changes in policy and pressures on acute services
means testing
Term
what does the GMC advice on CPR and pt discussion?
Definition
pts who want to know should be informed about risk and benefits and be told if the healthcare team believes the burden would outweigh the benefits.
Term
what are the 2 legal standards for disclosure obligation?
Definition
reasonable doctor and
prudent person
Term
explain the reasonable doctor legal standard
Definition
this is the professional community standard: adequate disclosure in the context of what the relatively trained and experienced physician tells pts
Term
explain the prudent person/ reasonable person standard
Definition
what any person in the pts condition needs to know and the layperson of average sophistication should not be expected to know
Term
of the 2 standards, professional and reasonable person standard which one has emerged as the ethical standard?
Definition
the reasonable person standard.

the doctor should tell pt their diagnosis or condition
tell them of medically reasonable alternatives to diagnoses and mx the pts condition.
they should tell them about short and long term benefits and risks of each alternative.
Term
what can the competent pt do in terms of autonomy?
Definition
they can refuse rx
they cannot demand rx
nor demand rx that doctor believes is dangerous or without therapeutic value.
Term
what is therapeutic privilege?
Definition
recognised by courts as an exemption to the standard of disclosure set by the law, of risks of rx and alternative procedures that should be disclosed to pt.

its provides a justification for withholding such information from competent patients in the interest of pt welfare
Term
the standard of disclosure is set by law and is based on what the reasonable person would want to know. this means that doctors have duty to tell pt of their condition/diagnosis, medically reasonable alternative to diagnosis and to mx the pt condtion. they also should tell them the ST and LT benefits/risks of each alternative.

what is an exception this this disclosure set out by law?
Definition
therapeutic privelage. withholding such information is justified from competent pts in the interest of pt welfare
Term
what is therapeutic privelage?
Definition
refers to withholding information by the clinician during the consent process in the belief that disclosure would lead to harm/suffering of the pt therefore information that a competent pt would ordinarily be told is deliberately withheld for the pts benefit as perceived by the HCP
Term
legal recognition of therapeutic privilege?
Definition
Cantebury V spence

pts occasionally become so ill or distraught on disclosure as to foreclose a rational decision
Term
T/F about therapeutic privilege.

House of Lords have made it clear that information of significant risks may not be brushed aside merely because the pt appaears anxious
Definition
this is true.

anxiousness is not a justified reason to apply therapeutic privilege
Term
what is the consequelist approach to disclosure?
Definition
make a moral judgement if to or not to disclose a diagnosis or risks of a procedure.
by doing this harms and benefits both physical and psychological should be weighed and the option most likely to benefit the pt is selected
Term
long term consequence of withholding information?
Definition
pts may lose trust and feel excluded from full participatory decision making.

they feel they lost autonomy and the ability to make an informed decision because how can they make an informed decision if information has been withheld from them?
Term
what does the welfare approach say about disclosure and therapeutic privilege?
Definition
recognises the need to firmly ground value of autonomy of pt in collective concerns about what is best
Term
what is collaborative autonomy?
Definition
this aims to achieve engagement with the pt to identify what information is important to that pt
Term
complaint of therapeutic privilege?
Definition
failure to tell a pt of their diagnosis seen to undermine respect for pt autonomy
Term
performing a medical exam on a pt without consent may constitute?
Definition
battery

however if doctor fails to adequately warn their pts about risk of a procedure then the case will be dealt through negligence
Term
features of civil battery

medical rx without consent may come under this
Definition
pt may privately sue doctor for damages
they must prove there was touching and it was unauthorised
level of damages may be small or nominal if little harm is caused
Term
what does plaintiff need to prove for a case of negligence
Definition
they were owed duty of care
duty to care was breeched
doctor acted unreasonably
breach caused damage; unreasonable conduct must be cause of harm.

a duty of care is always present in a doctor/pt relationship
Term
explain Bolam and Bolitho
Definition
bolam test: backup from responsible body of medical opinion

Bolitho principle: evidence from responsible body of medical opinion may be rejected if it lacks a logical basis.
Term
in summary of disclosure what must doctors disclose to pt?
Definition
material risks.

this is what a reasonable pt would want to know
Term
describe donation after circulatory death
Definition
the heart beat must cease then donation proceedings can start
Term
describe donors after brain stem death.

why is this method preferred?
Definition
the heart is still beating durng retrieval
organs likely to be viable and there is potential f
Term
describe donors after brain stem death.

why is this method preferred?
Definition
the heart is still beating during retrieval.
organs likely to be viable and there is potential for more organs to be retrieved.
Term
how to assess best interest in relation to a potential organ donor?
Definition
persons known wishes esp any written statements
beleifs/values that would likely influence the persons decision if they had capacity
views of their family or close ones
anyone named by the person to be consulted about such decisions
Term
Human Tissue Act 2004 and if family can over turn a decision of an individual to donate organs
Definition
there is no provision in the Act for family members to overturn an individuals wish to donate organs after death
Term
in terms of organ donation if the wishes of the deceased are unknown then what can be done?
Definition
decision making authority passes to a nominated representative and then to a person in a qualifying relationship to the individual
Term
what does it mean when someone is at the End of Life?
Definition
likely to die within 12 months
Term
can ethical obligations of doctors working in prisons differ?
Definition
no they should not differ
Term
doctors working in prisons have many obligations to who?
Definition
pts
employers
non medical collegues
public
Term
explain the dual obligation doctors working in prison have to their ethics and principles and also their employer
Definition
they have to uphold ethics, principles and duties of a doctor whilst also keeping their employer on board to achieve their common goal of doctor looking after pt whilst prison detains the prisoner
Term
outline rights of confidentiality prisoners have with prison doctors
Definition
their confidentiality must be respected
pts should be made aware at the time they provide information if it will be used for purposes other than their care and they should know what those purposes are likely to be and whether they can opt out.
Term
all pts/prisoners are owed duty of confidentiality but this is not absolute. name a situation when this is so
Definition
forensic examinations
Term
if a doctor sees an inadequacy in the prison that poses a hazard to health what should they do?
Definition
they have a duty to draw attention to this.

they shold be weary of employment contracts that seek to limit their ability to do so
Term
why are pts in detention more vunreble?
Definition
loss of autonomy and choice
Term
when prison governors need information in order to protect the security or safety of other staff or detainees what should the doctor working in the prison do?
Definition
they are obliged to divulge the information but only relevant health information
Term
T/F it is unlawful to give compulsory mental health rx in a setting other than a hospital
Definition
this is true.

if this is the case, the prisoner needs to be transferred to a secure facility
Term
rights of people in police custody, held on remand V convicted prisoners
Definition
people detained in police custody have right to be examined by their own doctor

people held on remand have a right to consult a doctor of their choice

convicted criminals have no general freedom of choice regarding the doctor that they see
Term
how do errors relate to negligence?
Definition
they are considered 'preventable' and not primarily the result of a disease process
Term
define error
Definition
failure to complete a planned action as it was intended
Term
where can negligence be established?
Definition
only in the court of law
Term
effects of not/disclosing a medical error
Definition
further harm to pt: e.g not told that they have been given the wrong drug so they wont know what SE to look for and might deteriorate more

undermines public trust in medicine

pts cannot consent for further rx if they do not know what went wrong

principle of justice: pt/families when harmed should be able to seek appropriate restitution

non disclosure can undermine efforts to improve medical practise e.g if HCP cannot reveal error to pt and family they are unlikely to report it to the relevant authorities
Term
how to prove medical negligence?
Definition
the pt was owed a duty of care
doctor breeched duty of care
that breech caused the damage/injury to pt
Term
features of the National Patient Safety Agency that was established in 2001
Definition
to identify pt safety issues and find appropriate solutions
abolished in 2012 and now called PATIENT SAFETY
Term
define never events
Definition
serious largely preventable patient safety incidents that should not occur if the available preventative measures have been implemented
Term
criteria for never events
Definition
incident has a clear potential for or has cause severe harm/death
it is a known source of risk or has occurred in the past
there is existing national guidance or safety recommendations on how the event can be prevented and support for implementation
event largely preventable if guidance is implemented
occurance can easily be defined, identified and continuously measured
Term
why are never events measured?
Definition
their occurance is an indication of how safe the organisation is and the pt safety culture within that setting
Term
circumstances where doctors can excuse themselves from work
Definition
D&V and condition that spread to others
health problems that would compromise pr safety or that of themselves/other staff
Term
deontological view on deinstitutionalisation
Definition
they find it lacking
Term
utilitarian view on deinstitutionalisation
Definition
policy supported if it results in good consequence to society
they are in support of deinstitutionalisation because research shows mental health pts prefer to live on their own with outreach support available if needed
Term
challenges in schizophrenia reaserch doctors may face
Definition
scientific designs e.g placebo and medicationfree intervals

informed consent and decision making capacity

understanding and perceptions of risk and benefit

influences of research participation (voluntary, altruism, other motivatin)

key participant safeguards
Term
reasons not to tell a person of their diagnosis of schizophrenia?
Definition
do no harm: harm is adding to pts despair by increasing anxiety

being labelled: stigma that comes with diagnosis

uncertainty principle: dr isn't sure about diagnosis

people don't want to be told

pt with schizophrenia lack insight: they may not accept the diagnosis, not acknowledge or it may add to thir paranoia
Term
reasons to tell someone about their diagnosis of schizophrenia
Definition
moral: their right to know
clinical:explain reason for behaviour and acceptance by family for behaviour
practical: pt may find out eventually; at least control the environment in which they are told
Term
what does article 8 of HRA says?
Definition
right to privacy and family life. these rights need to be upheld during rx of people with mental health conditions
Term
define dignity in care
Definition
care which supports and promotes, does not undermine a persons self respect regardless of any difference
Term
define privacy
define dignity
Definition
privacy: freedom from intrusion
dignity: being worthy of respect
Term
freezing eggs, sperm and embryos
positives
Definition
eliminates dilemma of discarding as they are stored
freezing seen as practionner acting in best interest of women trying to conceive
benefit women physically, emotionally and financially
Term
negatives of freezing sperm embryos and
Definition
emotional attachment, women coming to visit their eggs, asking for their petri dish, preparing themselves for success
divorce: what happens to embryos if they cant agree?
failure of freezing equipment: power cut etc
Term
who provides license to fertility clinics carrying out fertility rx?
Definition
Human Fertilization and Embryology Authority

it also overseas the use of gametes and embryos in fertility and research
Term
which report lay the foundations for the Human Fertilisation and Embry Authority?
Definition
The Wornock Committee Report in July 1984

it was appointed in 1982 to consider recent and potential developments in medicine and science related to human fertilization and embryology
Term
how often are fertility clinics inspected?
Definition
every 2 years
Term
T/F the HFEA has a register of every cycle of IVF in the UK?
Definition
True
Term
how is reproductive autonomy important to womens welfare?
Definition
childbearing takes place in the womens body and because they are generally expected to take primary responsibility for child rearing
Term
storage and destruction of embryos
Definition
if one party withdraws consent the other party is notified.
storage can cx for upto 12 months
if no decision is made then embryos are destroyed
Term
valid consent from labouring women
Definition
birth plan and other pre labour directives can serve as a Ulysses contract in labour

despite reduced communication capacity a labouring womens choice when clear should supercede decisions made before labour
Term
whats the name given to a women who serves another women during childbirth?
Definition
A doula
Term
reasons why a mother might want a doula at birth
Definition
she is unsure of her choices
she feels the HCP are not listening to her

they provide psychological support to birthing families who have enlisted them to uphold their wishes
Term
why are doulas criticised?
Definition
they work for a 'fee'
some organisations offer a volunteer doula

some overstep boundaries and cause conflict with HCP
Term
how to preserve dignity during labour?
Definition
give women their preferred level of control
nursing behaviour that demonstrates valuing and respect of childbearing women are essential in preserving the quality of the birthing experience
Term
things that affect dignity of women in labour
Definition
not being given a choice of where to give birth
not feeling in control of their birthing experience
unhappy with choice of pain relief
not being given a choice of position during labour
HCP not always introducing themselves or listening to them
Term
when was the Royal College of Midwives established?
Definition
1881.

established as the Matron's Aid or Trained Midwives Registration Society

it has existed under the current name
Term
baby born dead after 24 weeks gestation is known as stillbirth. before this it is known as a miscarriage

How long do stillborn babies need to be registered within?
Definition
42 days

professionals may pass details of your still birth to National Congenital Anomaly and Rare Diseases Registration Service. this helps scientist to understand more about this complication but you can opt out of the register anytime
Term
explain doctrine of double effect
Definition
HCP will not be seen as committing a crime if they intend no harm but none the less the rx administered in the pts best interest simultaneously hastens the death of that pt
Term
example of double effect
Definition
pt in severe intractable pain. attending physician may increase the dose of analgesia thus potentially shortening the pts life or leave them to suffer.

the doctor will not be legally sanctioned so long as their primary intention is to relieve pain despite foreknowledge that the action may shorten the pts life
Term
what does the principle of double effect allow doctors to do?
Definition
to give medical rx that has both bad and good effects as long as the intention is to provide an overall good effect
Term
explain the moral distinction between intending and forseeing the harm
Definition
intention of drugs is to relieve pain. the harmful but unintended effect is risk of shortening life, which the doctor may forsee but not intend.
Term
CTO which section of MHA?
Definition
17A

you need to be on section 3, 37 or 47

2 conditions attached to your CTO
if it is going to be renewed you need to make yourself available to see your RC
if you are asked to then you must see the SOAD
Term
can you challenge a CTO?
Definition
yes you can

you have the right to see an independent mental health advocate
Term
what does the Family Law Reform Act 1969 classify a child as?
Definition
any person who has not reached their 18th birthday
Term
MHA 1983 classes children as those under 16.

what are 16 and 17 year olds classed as?
Definition
young person
Term
what are the different definition for child and young person according to Family Law Reform Act and MHA?
Definition
family Law Reform Act 1969 - Child is someone who has not reached their 18th birthday

MHA 1983 - Child is under 16

aged 16 and 17 is 'young person'
Term
a parent can consent/refuse a procedure for their child. for most things consent from only 1 parent is needed. name 2 things where consent from both is needed?
Definition
non therapeutic circumcision
cosmetic purposes
Term
a school teacher can give consent for a pupil to get surgery for a broken arm without parents there. which act does this come under?
Definition
Section 3(5) of Children Act 1989. this allows a person with care of a child to 'do what is reasonable in all the circumstances of the case for the purpose of safeguarding or promoting the child's welfare.'
Term
T/F
anyone caring for a child who does not seek essential medical rx may be criminally laible
Definition
This is TRUE
Term
What does the Family Law Reform Act 1969 say about children and consent to rx?
Definition
consent to any surgical, medical or dental rx shall be as effective as it would be if they were of full age
Term
what do under 16 year olds need to be able to consent for rx?
Definition
capacity

if 16-17 then use MCA 2005
under 16? cant use MCA, it doesn't apply, use gillick competence
Term
children under 16 and consent
Definition
gillick competent

they understand medical issue
don't want to inform parents
mature enough to be presenting their own views and not just repeating someone else
competence is reasonably secure. if fluctuating then they lack capacity
if there decision is not the same as yours this does not mean they lack capacity!
Term
gillick competence
Definition
they understand medical issues
cant be persuaded to involve parents
mature enough to reach a decision not just presenting the views of someone else
competence must be reasonably secure. if it is fluctuating they lack capacity
you cannot reason that because their decision is not the same as yours that they lack capacity
Term
a child needs to be how old to be able to apply MCA 2005 ?
Definition
16-17

if they are under 16 then MCA doesn't apply
Term
fraser guidelines are different to Gillick. when might they be used?
Definition
if a 15 year old wants contraception

understands doctors advice
cant be persuaded to involve parents
likely to start or cx sexual intercourse
without contraception her physical/ mental health will suffer
it is in her best interest to get contraception
Term
can refusal of rx by a child who is gillick competent be over riden by parents?
Definition
yes. also it can be overridden by a court order where rx is intended to prevent death or serious irreversible harm
Term
what are specific issue order or prohibited steps order?
Definition
they come under Children Act 1989
it is when parents disagree on consent between them e.g. one says no.

it permits rx without both parents where this would be normally required.

it also can prevent a procedure taking place without prior court authorisation
Term
if a parent is present but refuses to give consent, under which circumstances can rx still be administered?
Definition
emergency rx to save the childs life. this is done under the defence of 'necessity' even if parent refuses.

also anyone caring for a child who does not seek essential medical rx may be criminally liable
Term
what is consent and assent?
Definition
consent: permission that could otherwise be withheld
assent: general agreement to go along with something therefore has a lower threshold
Term
whats the difference between competence and capacity?
Definition
competence is under 16 year old
capacity in 16 years and over
Term
what are professional and legal considerations with children in clinical research?
Definition
researchers need to make it clear how they will judge capacity and vunrebility
parental consent not always needed if child has capacity
Term
what is assent ?
Definition
it is an affirmative agreement to participate. there is no need for a signature.

assent is not sufficient to authorise participation in research and should not be confused with informed consent.

child assent should only be used in conjunction with parental consent
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