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NHSBT CTU. Consenting for Planet-2. NHSBT Clinical Trials Unit. NHSBT CTU. NHSBT Clinical Trials Unit. 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 - PowerPoint PPT Presentation
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NHSBT/MRC Clinical Studies Unit
The GMC says…
NHSBT Clinical Trials UnitNHSBT CTU
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/MRC Clinical Studies Unit
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
• 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
The UK• 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
• 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.
Reasons for declining consent
NHSBT Clinical Trials UnitNHSBT CTU
NHSBT/MRC Clinical Studies Unit
• 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
What about other countries?
NHSBT CTU
NHSBT/MRC Clinical Studies Unit
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‐experimentation
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