HUMAN TISSUE ACT 2004
The Human Tissue Act 2004 regulates the removal, storage, use and disposal of
human bodies, organs and tissues for a number of Scheduled Purposes, including
research, education and training. Researchers using any of these materials must be
aware of and comply with the Act.
How does the Act affect medical research?
The Act defines ‘relevant material’ and outlines the ‘scheduled purposes’ for which
‘appropriate consent’ must be sought. The two groups of purposes are:
 ‘research in connection with disorders or the functioning of the human body’ for
which consent is required for storage and use of tissue from either living or
deceased persons
 audit, training and education for which consent is required for storage and use
solely for tissue from deceased persons.
The categories of relevant material are:
 Specifically identified relevant material which includes material such as bodily
organs and tissues, consisting largely or entirely of cells, and clearly identifiable
and regarded as such. This category includes human bodies, internal organs and
tissues, skin and bone; and specifically the following:
 stem cells created inside the human body
 embryonic stem cells
 non-blood derived stem cells
 umbilical cord blood stem cells
 bone marrow
 primary human cell cultures
but not:
 cultured cells which have divided outside the human body
 artificially created embryonic stem cells
 cell lines
 extracted DNA
 plasma extracted DNA

Processed material. Where it is generally agreed that a processed material is
left either cellular or acellular as a result of the process, then it should be
presumed that examples should always be regarded as such. The Human Tissue
Authority relies on the researchers’ assurance that the process in question has
been carried out.
Under this category plastinated tissue and plastinated body parts (where the
cellular structure is retained by the plastination process) are to be regarded
generically as relevant material; while plasma or serum, for example, will be
regarded as not.

Bodily waste products, including excretions and secretions. The Act
stipulates that even a single cell can be subject to research; therefore bodily
waste should normally be regarded as relevant material. However, in cases
where a researcher believes that material intended for a scheduled purpose is
actually acellular, s/he should contact the Human Tissue Authority who will refer
the case to a members’ panel for advice if necessary.
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Consent
Consent is not always required for the use of tissue in research.

Existing holdings of human tissue from the living or the deceased which was
already held in storage for a scheduled purpose on the date the requirement for
consent took effect (April 2006) can be used without obtaining consent.

Tissue from the living. Consent is not needed for the use of surplus or ‘residual’
tissue taken from living patients that is left over from diagnostic or surgical
procedures for audit, education or training.
Consent is not needed for the use of residual tissue in research where the project
has ethical approval and the researcher cannot identify the tissue donor and is
not likely to be able to do so in the future. This allows for linking with medical
records provided that patient-identifying information is not obtained.

Tissue from the living and the deceased. Consent is not required for tissue
that has been imported or comes from a body that has been imported, nor for
tissue that is or comes from the body of a person who died before the consent
regime was brought into force, and at least 100 years have passed since the date
of death.

Appropriate consent. The Act identifies the person who can give ‘appropriate
consent’ for the lawful storage or use of human tissue for scheduled purposes in
different circumstances, as set out in the table below.
Living competent adult, or competent
child willing to make a decision
His / her consent
Living child (incompetent, or
competent but unwilling to make a
decision)
Consent of a person with parental
responsibility
Deceased adult
i His / her consent before death
ii If no prior consent, consent of a
nominated representative
iii If no representative, the consent of a
qualifying relative
Qualifying relatives
Spouse or partner
Civil partner
Parent or child
Brother or sister
Grandparent or grandchild
Child of a brother or sister
Stepfather or stepmother
Half brother or half sister
Friend of longstanding
These ‘qualifying relative’ relationships
should be ranked in order when seeking
consent to use tissues or organs from
deceased persons for scheduled
purposes
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Licenses for human tissue storage and use
The Human Tissue Act stipulates that certain activities can only be carried out under
the authority of a licence granted by the Human Tissue Authority. The licence will
allow research to take place at specified premises under the supervision of a
designated individual who is named on the licence.
A licence is not required to store and use human tissue for research in a specific
research ethics committee approved project and is not retained after that project for
unspecified future use.
If you believe you may be carrying out activities that are licensable by the Human
Tissue Authority please contact the Research Ethics and Governance Officer.
Penalties
The Human Tissue Act incorporates several existing offences under the Anatomy Act
1984 and the Human Organ Transplants Act 1989, with increased maximum
penalties. The Act also contains several new offences with penalties ranging from a
fine to up to three years’ imprisonment, or both.
These offences include:
 removing, storing or using human tissue for scheduled purposes without
appropriate consent
 storing or using human tissue donated for a scheduled purpose for
another purpose
 trafficking in human tissue for transplantation purposes
 carrying out licensable activities without holding a licence from the Human
Tissue Authority (with lower penalties for related lesser offences such as
failing to produce records or obstructing the Human Tissue Authority in
carrying out its power or responsibilities)
 having human tissue, including hair, nail and gametes, with the intention
of its DNA being analysed without the consent of the person from whom
the tissue came or of those close to them if they have died.
These main new offences are triable in a magistrate’s court or a Crown court and
penalties range from a fine, to imprisonment for up to three years, or both.
‘Reasonable belief’ defences are provided in relation to these offences.
The HTA Code of Practice on consent is available at:
http://www.hta.gov.uk/_db/_documents/2006-07-04_Approved_by_Parliament__Code_of_Practice_1_-_Consent.pdf
Sources
The Human Tissue Act 2004: New legislation on human organs and tissue.
Department of Health, 2004.
The Human Tissue Authority:
http://www.hta.gov.uk/
Medical Research Council policy and guidance on use of human tissue:
http://www.mrc.ac.uk/PolicyGuidance/EthicsAndGovernance/UseofHumanTissue/ind
ex.htm
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