Key principles of ethical research Flashcards
what are the five key principles
respect beneficence non-maleficence justice fidelity
beneficence
research must ‘do good’. Benefits can be direct or indirect
direct benefit
immediate benefit for the participants
indirect benefit
benefit society by changing policy, practice and attitudes, or increasing knowledge and understanding
respect
research must respect the autonomy of people, and ensure that people with diminished autonomy are protected.
-respect religious belief and practice- how this may affect their choice to participate
autonomy
people can make their own decisions of it and how they take part in research
Respect for people: in practice
- informed consent
- vulnerable populations- supported and protected through research
- privacy, anonymity and confidentiality- when you share findings
justice
research should not exploit participants or perpetuate problematic relationships. Need to think critically at when ebenfits from research and who bears the risk
justice: in practice
- ensure that a diverse range of participants are included
- avoid targeting certain groups e.g. Tuskegee
- avoid deception: no bullying or offering incentives
- share findings with participants and the wider community
- patient and public involvement
target groups to avoid
- if they are illiterate
- if they cant read
- if they cant understand
- if they cant access care any other way
- if they cant afford healthcare
there is a real push to
share data for secondary research- so work doesn’t need to be repeated
patient and public involvement is importnant
to make sure that the research is actually useful- used at every stage of research
shift in research language e.g.
people are not called subject anymore- participants. Research is done with real people, in partnership
Non-maleficence
research must not do harm. Harm can be direct or indirect
direct harm
immediate risk to participant
indirect harm
risk to society by changing policy, practice and attitudes, or promoting misinformation
example of indirect harm within non-maleficence
Wakefield claimed there was a link between autism and the MMR vaccine- caused a decrease in the % vaccinated, though that some conditions could be eradicated if it wasn’t for him .
how can non-maleficence be insured
provide participants and ethics committee with fun info about risk and benefits
privacy: respect
-research shouldn’t unnecessarily intrude into participants private lives e.g. not asking irrelevant questions
anonymity: respect
participants identities should not be revealed in the publication and dissemination of results or the sharing of data
example of where anonymity was not kept in research
Phones Gage- aggregate data- don’t focus on one person
confidentiality : respect
participants inf should only be shared to the extent necessary for the research or as required by legal/ethical obligations
privacy, anonymity , confidentiality in relation to respect : in practice
- only measure what is necessary
- de-identified data
- pseudonyms
- reporting aggregate data without talking about participants
- reporting of pertinent quotes (rather than whole transcripts)
vulnerable populations: respect
- people living in institutions (care home, prison etc)
- people who lack the capacity to consent
- marginalised/disadvantaged stigmatised groups, ethnic minorities
- people living in dangerous environments
- people engaging in high risk behaviour e.g. prostitution
vulnerable groups should be
supported to participate in research, but also be protected from abuse and eploitation
research with vulnerable groups is only justified if:
1) the research is addressing a need or priority for this group e.g. sickle cell mainly affects black people
2) the research cannot be conducted with a non-vulnerable group e.g. child health, impact of assault in prisons
3) the group will benefit fro the results in the research
vulnerable populations must also be protected from
gate keepers- those who allow the research on their charges–> what if they have ulterior motives
informed consent: respect
people must consent to being invade in research and their consent must be based o complete information about the study
three components of informed consent
(1) information voluntary
(2) procedures- risks and benefits
(2) comprehension- simple language- primary school level
informed consent in practice
- information sheets
- consent forms- kept by researcher- conns can be withdrawn at any time
- provide material in other languages
- test comprehension
what if a person lacks the capacity to consent?
can be provided by authorised representatives e.g. next of kin, parent, legal guardian
even if consent is give for a person wh lacks the ability to consent, what must be given
assent
assent is
a physical or verbal expression of willingness to participate e.g. wear an arm thermometer in dementia patients, if they try to take it off they have not shown assent
dissent is
a physical or verbal expression of an unwillingness to participate
assent is……, but not ………
necessary, sufficient
consent does not overrule
dissent e.g. if a parent has given permission, but the child dissents (runs out of the room), the researcher should not continue
who decides capacity
a lack of capacity to consent, does not mean research should not be done e..g if the study is to d with a pattern of children behaviour
risk- non-maleficence
risk is the possibility that harm will occur/ the severity of that harm
harms can be
physical, psychological, financial, social or legal
who else can be at risk of harm
researchers e.g. they will usually not go to homes alone e.g. marie curie
adverse events
any untoward medical occurrence experience by a participant during the research- regardless of whether it is causal of not
adverse events simple
new or worsening symptoms
serious adverse events
death, life-threatening, requiring hospital treatment, persistent or significant disability, birth defect
example of an adverse event
thalidomide - babies born without limbs
adverse events must be
documents and reported in the publication of findings
researchers have an obligation
to terminate research thats leading to serious adverse events
deception- justice
in some some situations providing complete information would invalidate the research . in these situations it may be necessary to temporarily deceive participants e.g placebo
deception is different to
covert research
covert research
research done without consnet
deception is only justified if
- incomplete disclosure is truly necessary to accomplish the goals of the research
- any undisclosed risk are minimal
- participants are debriefed as soon as possible and ar provided with research results
example of when deception was not justified
pilgrims experiment- didn’t debrief
Coercion- justice
consent is only valid when given voluntarily. Participants must not be coerced or unduly influenced
coercion is
an overt threat f harm
coercion includes undue influence
offer of excessive, unwarranted, inappropriate, or improper reward
coercion reduction in practice
- incentives must be reasonable e.g. payment of travel, lunch
- care must not be affected by choice to participate- control group will be given the gold standard treatment already on offer
fidelity
researchers should be honest, trustworthy and act with integrity- unethical research destroys that trust
top five most trusted jobs
nurses doctors teachers professors scientists
fidelity in practice
- provide complete and accurate info to prospective participants
- avoid plagiarism, mis-representation, and intellectual property theft
- do not fake data or misuse research funds
- declare conflicts of interest
- stop research that cases adverse effects and act in the best interest of participants
- identify and punish unethical research practices
’ as a researcher..
my intellectual property is all i have’
how is misuse of research funds monitored
use of funding must be declared and justified
punishments for unethical research practices
retraction
financial penalty
people lose their job
legal
data management- fidelity
how data is collected, stored, analysed, shared and destroyed is an ethical issue. It has become particularly important in the digital age
appropriate management of data is a
legal requirement in the UK
give an example of funfairs who have specific principles for the management of research data and require researchers to plan data management in advance
ESRC
when researcher is funded or supported by a third part who may or may not have an interest in positive finding
conflict of interest
how to avoid conflicts of interest
- declare sources of sport in informed consent material nd published research
- seek independence in all arrangements
- research shouldn’t be used for lobbying e.g. asking for money from the government
what shouldn’t research be used for
lobbying- e.g. asking for money from the government
