Consent Talk (17th March 2014)

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Consenting for Planet-2
NHSBT/MRC
Clinical Studies Unit
NHSBT
CTU
NHSBT
Clinical
Trials Unit
Unit
NHSBT/MRC
Clinical Studies
NHSBT
CTU
The GMC says…
7 You must be competent
in all aspects of your work, including management, research and teaching.
11 You must be familiar with guidelines and developments
that affect your work.
12 You must keep up to date with, and follow, the law,
our guidance and other regulations relevant to your work.
67 You must act with honesty and integrity when designing,
organising or carrying out research, and follow national research
governance guidelines and our guidance
NHSBT
Clinical
Trials Unit
Unit
NHSBT/MRC
Clinical Studies
NHSBT
CTU
Respect for autonomy
• Consent should be given freely and voluntarily.
• Sufficient information should be given to make an
informed choice.4
• The understanding of the subject is sufficient to make an
informed choice.
• The person giving consent must be mentally competent.5
• Apply these three principles to neonatal research and the
issues become more complicated because of proxy
consent.
NHSBT/MRC Clinical Studies Unit
GMC also says…
• 33. You must give information about risk in a
balanced way. You should avoid bias, and you
should explain the expected benefits as well as
the potential burdens and risks of any proposed
investigation or treatment.
NHSBT/MRC Clinical Studies Unit
Planet two consenting: the figures!
• Not eligible
NHSBT/MRC Clinical Studies Unit
• Eligible but not approached: 1/3 approach
<50% eligible
NHSBT/MRC Clinical Studies Unit
• Eligible/approached but not consented…
NHSBT/MRC Clinical Studies Unit
Planet 2 consenting: Man of the match!
• Eligible/approached/consented
• 55% consent rate >50%
NHSBT/MRC Clinical Studies Unit
How hard is it to get consent?
• “Recruitment is said to be difficult within
paediatric trials and quoted as being the
single most difficult problem to overcome;
leading to delays, increased costs and
failure to complete drug trials”
NHSBT/MRC Clinical Studies Unit
Why do parents consent?
A study in the Netherlands found the major factors
in parents granting approval were
• 51% contribution to clinical science
• 32% benefit to the child
• 25% felt obliged to participate
• 60% said they would be willing to participate in a
similar study in the future.
NHSBT/MRC Clinical Studies Unit
Baer et al (2007)
NHSBT
Clinical
Trials Unit
Unit
NHSBT/MRC
Clinical Studies
The UK
•
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•
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31% benefit to other children in the future
27% contribution to science,
18% benefit to their own child
15% felt obliged to participate
62% felt there was an advantage to taking part
18% felt there was a disadvantage.
91% of parents said would take part in similar
study, (91% benefit own child, 89% benefit to all
children)
NHSBT/MRC Clinical Studies Unit
Why parents consent
• 84% of parents who did not feel there was an advantage would still
take part in a similar future study.
• Parents who did not feel that 'benefit for other children in the future'
influenced their decision to participate were less likely to participate
again in the future
• If a parent felt that they did not receive enough information or have
enough time to make their decisions they were statistically more likely
to express a wish not to participate in future studies.
NHSBT/MRC Clinical Studies Unit
Reasons for declining consent
• 58% wanted a specific treatment for their child,
• Many parents felt one treatment superior and unwilling to
undergo randomisation.
• 5% did not want to participate in a trial,
• 5% too distressed by child's admission to consider
consenting
• one patient declined consent because of the paragraph on
the consent form saying that the ethics committee would
have access to their child's notes.
NHSBT
Clinical
Trials Unit
Unit
NHSBT/MRC
Clinical Studies
NHSBT
CTU
What about other countries?
• A more recent study in France showed that the possibility of
receiving the most advanced treatments and the confidence
placed in the medical team were their highest motivations for
participation.
Chappuy H, Doz F, Blanche S, Gentet JC, Pons G, Tréluyer JM:
Parental consent in paediatric clinical research.
Arch Dis Child 2006, 91:112-116
NHSBT/MRC
Clinical Studies Unit
NHSBT
CTU
Key points
• Parents want to be involved in the decision to enter a research project
even those who felt significant added stress by the research project
• agree to consent for societal benefit, personal gain, and the
perception of no harm
• refuse consent because of the risk of harm, anti‚Äźexperimentation
beliefs, or clinician approach
• would agree to their baby being in more than one trial
• find some of the concepts of trials difficult to understand
• rely on verbal explanation and information sheets in making decisions
Arch Dis Child Fetal Neonatal Ed. 2006 September; 91(5): F374–F376.
Consent for neonatal research L McKechnie and AB Gill
L
NHSBT/MRC Clinical Studies Unit
Key points
Consent may be improved by
• Clear and well regulated information
• Training of those asking for consent
• Continuing two way communication
NHSBT/MRC Clinical Studies Unit
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