Consent Update同意更新.pptVIP

Consent Update Gail Jenner CCLG Tissue Bank Support and Education 6/7/2011 Human Tissue Act Became law in Sept 2006 Detailed statutory framework, codes of practice (UK Human Tissue Authority) Storage and use of tissue predominantly regulated by HTA Tissue stored for research must have a HTA licence * Codes of Practice Practical guidance for professionals ‘Consent’ ‘Research’ (September 2009) Human Tissue Authority * Surgical consent covers storage of samples for diagnostic purposes Tissue can be held indefinitely as part of the consent to treatment/procedure Scheduled purposes (Schedule 1 HTA) Surgical removal and pathology handling of tissue * Clinical audit Education and training Performance Assessment Public Health Monitoring Quality Assurance Consent Exception * Researcher must not obtain information that identifies the patient The material is used for a specific project with ethical approval Research without Consent * Consent and the Law Treatment and examination covered by ‘common law’ Consent for ‘scheduled purposes’ under HT Act Consent can be combined, principles the same * HTA and provision for ‘competent’ children Child defined as under 18 years old,16 in Scotland (HTA) The child’s consent is sufficient to make lawful removal of tissue for scheduled purposes Age and level of understanding must be taken into account Discuss with family * Who may seek consent Healthcare professional Procedures in place outlining responsibilities Training and support Good understanding of processes. Enduring consent recommended * Withdrawal of consent Right to withdraw at any time Cannot be effective where tissue has already been used Samples do not need to be destroyed Information and research data remain for existing projects. Existing Holdings HT Act not retrospective (1 Sept 2006) Ethical consideration Licensing requirements remain Consent Forms To remain in banking centre Signed confirmation at CCLG Regular audit to comply with HTA inspections CCLG