Schedule 1 of the Human Tissue Act 2004 (the Act) sets out ‘performance assessment’ as a ‘scheduled purpose’.
An HTA licence is required if the human cellular material (‘relevant material’) to be stored for performance assessment has been removed from the deceased.
The Act also sets the requirement that consent must be obtained to store and use relevant material from deceased persons for the purpose of performance assessment.
These consent and licensing requirements do not apply if the relevant material has been removed from the living. However, this does not mean that consent to store and use relevant material for this purpose should not be sought where it appropriate and reasonable to do so.
In Vitro Diagnostic Medical Devices
Some companies store and use relevant material to evaluate ‘in vitro diagnostic medical devices’ (IVDs), such as pregnancy test kits, which are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA).
The regulation of IVDs mandates certain types of testing to ensure that they are safe and effective. Where relevant material is stored and used to carry out the mandatory testing of IVDs, this activity is regarded by the HTA as ‘performance assessment’ as set out in the Act.
The activity is therefore exempt from the consent and licensing requirements under the Act, provided that the material has been removed from the living. If the relevant material is obtained from the deceased, then advice from the HTA should be sought.
If an establishment intends to store relevant material for research informing the development of new IVDs, advice from the HTA about consent and licensing requirements should also be sought.
Information on the regulation of human tissue research, including exemptions from HTA licensing, can be found in the HTA’s Code of Practice on Research.
If information on the regulation of IVDs is required, please contact the MHRA.