Samples may be obtained from deceased infants and children in cases of sudden unexpected death in infancy and childhood (SUDIC), in line with national protocols. This practice may take place in Accident and Emergency departments and other areas of a hospital, for example in special care baby units and paediatric wards.
This policy describes the consent and licensing requirements under the Human Tissue Act (HT Act) for removal of relevant material from the deceased, in these cases.
The HT Act requires that removal of relevant material from the body of a deceased person for certain purposes must only take place with appropriate consent or coronial authority and under authority of an HTA licence. Information about offences under the HT Act can be found in HTA Code of Practice B.
In the HT Act, relevant material means material, other than gametes, which consists of or includes human cells. For example, this includes samples of blood, urine, faeces, cerebrospinal fluid and buccal swabs
The removal of relevant material from a deceased person for certain purposes, including determining the cause of death, is a licensable activity under the HT Act. This means that removal of relevant material from deceased infants and children for examination for these purposes must only take place on licensed premises and under the authority of an HTA licence.
It is for establishments to determine whether activity carried out in any area of their premises is licensable under the HT Act and to ensure that the activity is covered by an HTA licence. Establishments should contact the HTA if they require guidance.
The HTA may extend an establishment’s Post Mortem sector licence to include departments where removal of relevant material takes place, if the departments are located on the same premises as those specified on the licence and if the Designated Individual (DI) agrees to oversee the licensed activities. Where the removal activity takes place on other premises, a satellite licence arrangement may be required. Alternatively, an establishment may apply for a stand-alone licence for removal of relevant material at a specific location. Establishments should contact the HTA to apply for any changes to existing licences or where a new licence is required.
It is important to note that the DI named on the HTA licence has statutory responsibility under the HT Act to ensure that the premises are ‘suitable’ and that ‘suitable practices’ take place on those premises. Therefore, the Licence Holder will need to ensure that the DI is content for their remit to be extended to any new areas of responsibility and that they will oversee compliance with the HTA standards. This should be confirmed by the DI in writing to the HTA.
The DI is advised to appoint a Person Designated in relevant areas, to help them oversee licensed activities taking place there.
Under the HT Act, removal of relevant material from the deceased for certain purposes, including determining the cause of death, can only take place with appropriate consent or under the authority of the coroner.
Removal of relevant material from a deceased child without appropriate consent from a parent (or the person with parental responsibility) or coronial authorisation would be unlawful.
It is important that staff ensure there is appropriate consent or coronial authorisation for removing samples from the deceased, before they undertake this activity.