Materials considered ‘relevant material’ under the Human Tissue Act

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.

Material considered to be 'relevant material'

  • Nail (from deceased person)
  • Bile
  • Blood
  • Nasal and bronchial lavage
  • Bone marrow
  • Non-blood, derived stem cells (i.e. derived from the body)
  • Bones/skeletons
  • Non-fetal products of conception ( i.e. the amniotic fluid, umbilical cord, placenta and membranes)
  • Brain
  • Breast milk
  • Organs
  • Pericardial fluid
  • Buffy coat layer (interface layer between plasma and blood cells when blood is separated
  • Platelets
  • CSF (cerebrospinal fluid)
  • Pleural fluid
  • Cystic fluid
  • Primary cell cultures (whole explant/biopsy present)
  • Pus
  • Saliva
  • Skin
  • Faeces
  • Material relating to early pregnancy loss or termination
  • Sputum (or phlegm)
  • Fluid from cystic lesions
  • Stomach contents
  • Hair (from deceased person)
  • Teeth
  • Tumour tissue samples
  • Joint aspirates
  • Umbilical cord blood stem cells
  • Urine
  • Mucus

Material not considered to be 'relevant material'

  • Antibodies
  • Nail (from living person)
  • Breath condensates and exhaled gases
  • 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)
  • Cell lines
  • Cells that have divided in culture
  • DNA
  • Eggs (ova)
  • RNA
  • Embryonic stem cells (cells derived from an embryo)
  • Embryos (created outside the body)
  • Sebum
  • Extracted material from cells e.g. nucleic acids, cytoplasmic fractions, cell lysates, organelles, proteins, carbohydrates and lipids.
  • Serum
  • Sperm cells (spermatozoa)
  • Gametes
  • Sweat
  • Hair (from living person)
  • Lysed cells