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Protecting Patients: Research Governance in Practice

Protecting Patients: Research Governance in Practice. Mental Incapacity & The EU Directive. Directive 2001/20/EC.

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Protecting Patients: Research Governance in Practice

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  1. Protecting Patients: Research Governance in Practice Mental Incapacity & The EU Directive

  2. Directive 2001/20/EC ‘Persons who are incapable of giving legal consent should be given special protection….in cases such as persons with dementia, psychiatric patients, etc….the written consent of the persons legal representative, given in cooperation with the treating doctor, is necessary before participation in any such trial’

  3. Issues? • Who is incapable of giving legal consent? • Who is the patient’s legal representative? • What mechanism for obtaining prior written consent?

  4. Legal View ‘A person lacks capacity if some impairment or disturbance of mental functioning renders the person unable to make a decision whether to consent to or refuse treatment’ Re MB (Medical Treatment) [1997] 2 FLR 426, at 437

  5. Inability to make a decision (give consent) will occur When ‘The patient is unable to comprehend and retain the information which is material to the decision, especially as to the likely consequences of having or not having the treatment in question;’

  6. Inability to make a decision (give consent) will occur and ‘the patient is unable to use the information and weigh it in the balance as part of the process of arriving at the decision’ Re MB (Medical Treatment) [1997] 2 FLR 426, at 437

  7. Mental Incapacity Generally May be: • Transient – children • Temporary • Permanent • Fluctuating • Anticipated/Unexpected

  8. Children EU Directive encourages child research ‘Medicinal products, including vaccines, for children need to be tested scientifically before widespread use. This can only be achieved by ensuring that medicinal products which are likely to be of significant value for children are fully studied.’

  9. Children Current legal/ethical approach • Parents consent – best interests • Gillick competence • Assent

  10. Adults with Incapacity • EU Directive is restrictive: ‘Medicinal products for trial may be administered to all such individuals only when there are grounds for assuming that the direct benefit to the patient outweighs the risks.’

  11. Adults with Incapacity And, introduces new regulation: ‘Moreover, in such cases the written consent of the patient’s legal representative, given in cooperation with the treating doctor, is necessary before participation in any such trial’ Directive 2001/20/EC

  12. Legal Representative? ‘The notion of legal representative refers back to existing national law and consequently may include natural or legal persons, an authority and/or body provided for by national law.’ Directive 2001/20/EC

  13. Adults Legal Representative? BUT • Not recognised under current law (England & Wales) - yet • Adults with Incapacity (Scotland) Act 2000 • Draft Mental Incapacity Bill

  14. Real Practical Problems • Appointment of Legal Representative – who, when, how? • Time delays • Emergency research • Dissemination of information • etc

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