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Consenting for Planet-2

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The GMC says…

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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

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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.

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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.

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Planet two consenting: the figures!• Not eligible

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• Eligible but not approached: 1/3 approach <50% eligible

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• Eligible/approached but not consented…

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Planet 2 consenting: Man of the match!

• Eligible/approached/consented • 55% consent rate >50%

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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”

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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.

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Baer et al (2007)

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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)

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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.

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• 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

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• 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?

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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

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Key points

Consent may be improved by• Clear and well regulated information• Training of those asking for consent• Continuing two way communication