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The removal of relevant material from the body of a deceased person and its subsequent storage for use for a scheduled purpose can only take place on premises licensed by the HTA. However, there are some exemptions.
The LH has the right to vary a licence. This enables them to substitute another person as the Designated Individual (DI) and allows the establishment to cover circumstances where the DI is unable or incapable of overseeing the licensable activities. Consequently, the HTA requires individual LH...
The brain bank organising the donation will contact you to ask you to perform the retrieval, they will inform you of the way they wish the brain to be removed and stored until collection and they will provide you with a copy of the consent form.
You will need the third party agreements with anyone who:carries on a licensed activity (other than import or storage), on behalf of the licensed establishment or supplies to the licensed establishment any goods or services which may affect the quality or safety of tissue or cells.
Those establishments who intend to conduct the activities specified above. The applicant for the Licence Holder could be the Designated Individual (DI) who has responsibilities under the Human Tissue to ensure good practice is followed and licence conditions are complied with.
The HTA will appoint individuals to perform site visits. Our aim is to work collaboratively with other regulators and we may seek to delegate the inspection function or work together with another inspectorate.
If a serious adverse event or reaction has implications for other tissue establishments - for example, because of a shared donor - the tissue establishment should also notify those other tissue establishments as appropriate without delay.
The specialist laboratory should be made aware if the family has requested that relevant material be returned to them, in order that it can be sent back to the licensed establishment for the family’s wishes to be acted upon.
The HTA has a statutory responsibility to make decisions on all cases of bone marrow and PBSC donation where the donor is a child who lacks competence to consent or the donor is an adult lacking capacity to consent.
According to the stillbirth and neonatal death charity Sands, around 15 babies a day die before, during, or soon after birth (ref - Baby death: current picture (2016)).