Module 5 Presentations

19/07/2024

Consent and Information

• Who may provide consent? Therapy context: English position – Competent adults – Children: • 16 years and over • “Gillick competent” • Under 18 years and incompetent – Proxies:

• Adults – Mental Capacity Act 2005 • Parents/ Guardians for children • NB Consent may be withdrawn at any time

The Organisation for Professionals in Regulatory Affairs

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Who may provide consent?

Clinical trial context: English position – Over age 16: adult regime

– All others (children, incompetent adults): • “legal representatives” can give consent • Non-therapeutic research – Children - “some direct benefit for the group of patients is obtained..” – Adult incompetents – will produce a benefit to the patient outweighing the risks or produce no risk at all – Interests of the patient always prevail over those of science and society - Position of temporarily incapacitated persons - Consider whether requirement for witnessed consent - NB Mental Capacity Act 2005 does not apply to research covered by Clinical Trial Regulations

The Organisation for Professionals in Regulatory Affairs

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