protecting participants Flashcards
(16 cards)
Fair participant selection :
-Recruitment strategies must be based on the — , not —
-Minimise – to participants
-Participant selection to enhance – to individuals, groups & social value
-Safeguards for —
1- Recruitment strategy :
Inclusion & exclusion criteria:
-How will initial contact will be made?
-How will information be conveyed?
study goals
convenience
risk
beenfits
vulnerability
Key recruitment questions :
Who will be recruited?
How will participants be identified and recruited?
Will the potential participants be screened?
What is the impact of any relationship between researchers and potential participants on recruitment?
How will the recruitment strategy facilitate obtaining the consent of participants?
How will the recruitment strategy ensure that participants can make an informed decision about participation?
Are there any risks associated with the recruitment strategy for potential participants or for the viability of the project?
Incentives for participation :
Incentives interconnect with – in research relations because they can be used as a tool to – or —.
Incentivising research participation may have the overall — effect of creating a universal expectation of — for research participation and discouraging participants to behave—
power
persuade or coerce
unintended
payment
altruistically
Incentives for participation :
Why is the incentive being used?
Is the incentive tantamount to coercion because it is it is difficult for ‘vulnerable’ persons/ persons in financial need to refuse to participate in the research?
Is the incentive attractive enough to tempt persons to participate in the research study against their better judgement?
If the reason for using the incentive is that it is difficult to recruit research participants?
Are the risks of research participation such that the incentive is being used to account for the increased risk associated with participation? Incentives should not be used to compensate for risks.
informed consent principle of — :
Informed consent is one of the founding principles of —. Its intent is that human participants can enter research freely (voluntarily) with full information about what it means for them to take part, and that they give consent before they enter the research.
-Informed consent may not be necessary in certain circumstances but only where the research does not involve the collecting of — data
-Always check with the research ethics committee
autonomy
research ethics
personal data
informed consent and autonomy:
1. — to consent
-Empowerment to make own —
-capacity to — and question information on which they base their decisions
2. Act —
3. Sufficient — information to make an informed decision.
- info to be discussed:
purpose of the study
nature of the procedure
risk , discomfort , side effects , benefits
incentives
the meaning go relevant research terms , how they can withdraw , what info they receive about the outcome , That the withdrawal will not affect the quality of their health care , any financial conflict of interest of investigator
capacity
decision
understant
voluntarily
comprehensible
its a — not just a form to complete :
Comfortable, private setting
Know your study well
Establish —
Keep it — . Ensure that participants understand
–>why the research is being done
–>why are they being asked to participate
Use — : graphics, pamphlets, videos
Encourage — : “teach back method”: participants asked to say in their own words what has been described
— consent
process
rapport
simple
props
questions
revisit
re-consent:
- seek approval for amendment from REC
- research protocol substantially —
- new safely – has come to light
- — treatment have become available
- child participate reaches —-
- formerly — adult has regained — substaintial
– of time has elapsed since original consent
altered
info
alterative
legal maturity( 16 or 18 )
incapacitated
capacity
period
Confidentiality:
The researcher must ensure that:
Participant’s — is protected, e.g. via anonymisation (removal of identifying information)
Participant is asked for their — for their data to be preserved and/or shared with third parties e.g. for future research
Data is only accessible to appropriate — e.g. named members of the research team
Personal data are stored within the — legal jurisdiction i.e. if using cloud storage, the servers must be located within the EU-GDPR region.
identity
consent
users
GDPR ( general data protection regulation )
Confidentiality: General Data Protection Regulation :
Came into force in May 2018 and applies to any research that uses — data.
Aims toempower EU citizens by providing a —, — set of data — and — rules across Europe.
Individuals whose personal data are used have a fundamental right to — .
GDPR covers most situations in which information about somebody (the ‘personal data’ of a ‘data subject’) is used in some way (‘processed’) by some other person or organisation (the ‘data controller’ and/or ‘data processor’).
personal
modern , single
protection and privacy
privacy
GDPR: 7 accountability principles:
1- — , — and — :- Processing must be lawful, fair, and transparent to the data subject.
2- — limitation :- You must process data for thepurposes specified explicitly to the data subject when you collected it.
3- Data — :-You should collect and process only as much data as absolutely necessary for the purposes specified.
4- —- : You must keep personal data accurate and up to date.
5- — limitation- You may only store personally identifying data for as long as necessary for the specified purpose.
6- — and — : - Processing must be done as to ensure appropriate security, integrity, and confidentiality
7- — : -The data controller is responsible for being able to demonstrate GDPR compliance with these principles.
lawfulness , fairness , transpearency
purpose limitation
data minimisation
accuracy
storage limitation
integrity and confidentiality
accountability
Ethical appraisal of a research article :
Fair — selection
Informed —
— & – protection
Any other —
Examples of protecting (and not protecting) participants individually & collectively:
Research in – income countries
participant
consent
confidentiality and data protection
issues
lower income
informed consent : a process
Respect — decision making fora
Assent/involvement of the community :
–> consultation with — before individuals approached
—> permission from — before research discussed with community or individuals
–> leader of community considered to have — to enrol participants
multiple
community
leader
authority
Incentives for research participation :
In LIC, participants often poor with low literacy levels
May not understand —
Often not in a position to refuse — incentives
Enrol in several studies —
Establish compulsory national databases:
—> Sufficient ‘— periods’ between trials
–> — tracked to not exceed certain levels
risks
financial
sinutanousely
wash out periods
payments
1- Protecting communities :
How are concepts of — & — explained?
Is there a concept of — ?
What role does the — play in decision making?
— and — of results
2- what happens when research is over:
- should effective treatment be given to — or — ?
- is it ethical to conduct research into a treatment that will be too expensive to use after the study finishes ?
health and illness
research
community
dissemination and publication
control groups pr entire community
What happens when the research is over?:
Treatment to be made available to:
? Individuals involved in —
? — community
Responsibility of—/—company
versus
Responsibility of national —
trial
wider community
research / Pharma
national government
