Human Tissue Authority

The regulator for human tissue and organs

List of materials considered to be ‘relevant material’ under the Human Tissue Act 2004

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 might be considered relevant material. The HTA will review the list periodically and update it as required.

Where a material is not included within the following list, stakeholders should use the information on our website to make their own assessment about whether it is relevant material, seeking advice from us where necessary.

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:

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

Although cell damage can be minimised by controlling the rate of temperature change and/or by adding one or more ‘cryoprotective’ agents, freezing/thawing can cause cell damage such that no whole cells remain. Centrifugation can be used to remove residual platelets from plasma, rendering it acellular, but the effectiveness is dependent on the protocol used. In either case, sufficient validation data (either in-house or published research) should be provided if the techniques are to be relied on to render samples acellular.

Antibodies

No

Nail (from deceased person)

Yes

Bile

Yes

Nail (from living person)

No

Blood

Yes

Nasal and bronchial lavage

Yes

Bone marrow

Yes

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

Yes

Bones/skeletons

Yes

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

Yes

 

Brain

Yes

Breast milk

Yes

Organs

Yes

Breath condensates and exhaled gases

No

Pericardial fluid

Yes

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

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

Cell lines

No

Cells that have divided in culture

No

Platelets

Yes

CSF (cerebrospinal fluid)

Yes

Pleural fluid

Yes

Cystic fluid

Yes

Primary cell cultures (whole explant/biopsy present)

Yes

DNA

No

Pus

Yes

Eggs (ova)*

No

RNA

No

Embryonic stem cells (cells derived from an embryo)

No

Saliva

Yes

Embryos (outside the body)*

No

Sebum

No

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

No

Serum No

Skin

Yes

Faeces

Yes

Sperm cells (spermatozoa)*

No

Fetal tissue

Yes

Sputum (or phlegm)

Yes

Fluid from cystic lesions

Yes

Stomach contents

Yes

Gametes*

No

Sweat

No

Hair (from deceased person)

Yes

Teeth

Yes

Hair (from living person)

No

Tumour tissue samples

Yes

Joint aspirates

Yes

Umbilical cord blood stem cells

Yes

Lysed cells

No

Urine

Yes

Mucus

Yes

 

 

 

Notes

* While outside the definition of relevant material for the purposes of the Human Tissue Act 2004, these materials fall within the remit of the Human Fertilisation and Embryology Act 1990, and are regulated by the Human Fertilisation and Embryology Authority (HFEA).

Download this list as a PDF - for easier/clearer printing.

Updated May 2014

Audience: