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The list is not intended as exhaustive or exclusive, but is intended to provide guidance to stakeholders in respect of a number of materials that guidance on the status of, as relevant material or otherwise, has previously been sought. The HTA will review and update the list periodically. The list currently refers solely to which human body parts, tissues and cells are defined as ‘relevant materials’ for the purposes of the Human Tissue Act 2004, in line with the statutory definition above. The HTA intends to expand the list in the future to also provide guidance to the human application sector on which ‘tissues and cells’ are regulated under the Human Tissue (Quality and Safety for Human Application) Regulations 2007. Where a material is not included within the following list stakeholders should refer to the policy framework to formulate their own assessment of the material’s status in line with the guidance provided in the framework. Materials classified in the following list as relevant material are done so subject to the following general caveat that they are relevant material except where:

  • They have divided or been created outside the human body
  • They have been treated, processed or lysed through a process intended to render them acellular within 7 days of reciept. This would include the freezing or thawing of cells only where that process is intended to render the material acellular.

This list is correct as of November 2017 - the most current list is available from the HTA website here

Material

Relevant Materials for the purpose of the HTA 2004

Antibodies

No

Artificially created stem cells*

No

Bile

Yes

Blood

Yes

Bone marrow

Yes

Bones/Skeletons

Yes

Brain

Yes

Breast Milk***

Yes

Breath condensates and exhaled gases

No

Buffy coat layer (interface layer between plasma and blood cells when blood is separated)

Yes

Cell lines**

No

Cells that have divided in culture

No

CSF (Cerebrospinal fluid)

Yes

Cystic fluid

Yes

DNA

No

Eggs*

No

Embryonic stem cells (cells derived from an embryo)**

No

Embryos (outside the body)*

No

Extracted material from cells, e.g. nucleic acids, cytoplasmic fractions, cell lysates, organelles, proteins, carbohydrates and lipids.

No

Faeces

Yes

Fetal Tissue

Yes

Fluid from cystic lesions

Yes

Gametes

No

Hair from decesased person

Yes

Hair from living person

No

Joint aspirates

Yes

Lysed cells

No

Mucus

Yes

Nails from the deceased

Yes

Nails from the living

No

Nasal and bronchial lavage

Yes

Non blood derived stem cells (i.e. derived from the body.)

Yes

Non foetal products of conception ( i.e. the amniotic fluid, umbilical cord, placenta and membranes)

Yes

Organs

Yes

Pericardial fluid

Yes

Plasma

(Please note: Depending on how plasma is prepared and processed, it may contain small numbers of platelets and other blood cells. If any of these cells are present then the plasma must be regarded as relevant material.)

No

Platelets

Yes

Pleural fluid

Yes

Primary cell cultures (whole explant/biopsy present)

Yes

Pus

Yes

RNA

No

Saliva

Yes

Serum

No

Skin

Yes

Sperm*

No

Sputum (or Phlegm)

Yes

Stomach contents

Yes

Teeth

Yes

Tumour tissue samples

Yes

Umbilical cord blood stem cells

Yes

Urine

Yes

* While outside the definition of relevant material for the purposes of the HT Act, these materials fall under the remit of the Human Fertilisation and Embryology Act 1990, and are regulated by the Human Fertilisation and Embryology Authority (HFEA)

** Cell lines and embryonic stem cell lines fall within the regulatory remit of the HTA by virtue of the Human Tissue (Quality and Safety for Human Application) Regulations 2007, which regulates the processing, storage and distribution of stem cell lines for human application. Both the HFEA and the Medicines and Healthcare products Regulatory Agency (MHRA) also have a regulatory remit in respect of cell lines and embryonic stem cell lines. A joint position statement issued by the HTA, HFEA and MHRA provides guidance on the relevant regulatory remits

*** Breast milk does not constitute tissue or cells for human application under the (Quality and Safety for Human Application) Regulations 2007, but is classified as relevant material for the purposes of the Human Tissue Act 2004 where stored or used for scheduled purposes.