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Ethical research practice (Informed consent (People who lack capacity for…
Ethical research practice
Four principles of NHMRC ethical guidelines
Justice
Regard for human sameness
Types
distributive
fair distribution of benefits and burdens of research
procedural
fair treatment in recruitment of participants
taking into account scope and objectives
process of recruiting participants is fair
no unfair burden of participation of research on certain groups
fair distribution of benefits of research
no exploitation of paritcipants
fair access to benefits of research
Beneficence
assessing and take account of benefits and potential harms of research to participants and wider community
likely benefits must outweigh harms
sensitivity to welfare and interests of people involved
reflecting on social and cultural implications
balance of public and individual benefit
researchers need to take steps to minimise risks
need to clarify and inform participants of potential risks
if there are no likely benefits to participants, risks should be lower than that acceptable normally
where risks are no longer justified based on potential benefits, research should be suspended and reassessed.
Research merit and integrity
Merit
justified by potential benefit to relevant populations affected
designed using methods appropriate to achieving its proposed goal
based on gaps in available literature
designed to ensure that respect is not compromised for participants through methods or results
people conduct research are competent and appropriate
facilities used are appropriate
integrity
searching for knowledge and understanding
following recognised principles of research conduct
conducting research honestly
providing results in a way that permits scrutiny and feedback and contributes to public knowledge
Respect
recognition that each human has value and that this value must inform interaction between people
recognising human autonomy
where unable to, empower where possible and protect where necessary
common thread through all other ethical values
due regard for welfare, perceptions, beliefs, customs and cultural heritage
privacy and confidentiality
Risk
=potential for harm, discomfort or inconvenince
need to assess
likelihood of harm
severity of harm
extent to which risks can be minimised
whether risks are justified by potential benefits
determining how risks can be managed
potential harms in research
physical
injury, illness, pain
psychological
feelings of worthlessness, distress, guilt etc
social
damage to social networks or relationships
economic
costs to particpant
legal
disclosure of criminal activity
discomfort
less serious than harm
when reactions exceed discomfort--> harm
inconvenience
less serious than discomfort
eg filling out form, giving up time to participate
Managing risk
mechanisms to manage risk must be built into design of the research
the greater the risk
more certainty around mechanisms to manage risks
more information provided to participants about risks and how they are being managed,
Informed consent
respect requires informed consent
justice also requires informed consent
research participation a result of informed consent and a choice made by individual
consent must be
voluntary
based on sufficient information given to participant who fully understands information given to them
aim is mutual understanding between researcher and participant
participant must be able to ask questions
no coercion or pressure
People who lack capacity for consent
children and young people
people highly dependant on medical care who may be unable to give consent
people with cognitive impairment, intellectual disability or mental illness
in such cases person with lawful authority should be informed of potential risks and benefits in order to provide consent for the person
decision must not be contrary to that person's best interests
within some communities consent requires input from more than one person
Milgram study application
experimenters gave prompts if teachers objected such as "it is absolutely essential that you continue"
informed consent and deception
researchers must demonstrate that participants will not be harmed by deception
full explanation provided subsequently
no known or likely reason that participants might not have consented if they had not been deceived,
Burger's replication
stopped at 150V point (before shock administered)
debriefing occurred immediately after experiment
Screen process via a psychologist
repeated reminders that subjects could withdraw at any time
experimenter was a psychologist not an actor