DOCUMENT 4     Formatted: Right
                                                                   Formatted: Font: 12 pt



Author: Richard Palmer, Corporate Compliance Unit

Procedure Approved by:

Responsible Unit: Corporate Compliance Unit (in conjunction with
Research and Commercial Development)

Date issued: November 2007
Review date: December 2007
Version: 1.0

Page 1 of 7
Contents page

   1. Purpose
   2. Scope
   3. Responsible Personnel
   4. Definitions
   5. Procedure
   6. References

Page 2 of 7
1      PURPOSE

The purpose of this Standard Operating Procedure (SOP) is to ensure that staff
involved in research covered by the Human Tissue Act 2004 understand the
procedure and mechanisms for the storage of human tissue.

The purpose of the Human Tissue Act 2004 is to provide a consistent legislative
framework for issues relating to whole body donation and the taking, storage and use
of human organs and tissue. It makes consent the fundamental principle
underpinning the lawful storage and use of human bodies, body parts, organs and
tissue and the removal of material from the bodies of deceased persons. It introduces
regulation of other activities like post mortem examinations, and the storage of
human material for education, training and research. It is intended to achieve a
balance between the rights and expectations of individuals and families, and broader
considerations, such as the importance of research, education, training, pathology
and public health surveillance to the population as a whole.

2      SCOPE

This SOP applies to all Cardiff University staff responsible for the storage of human
tissue for research or teaching purposes.


The Principal Investigator/Research Supervisor is ultimately responsible for ensuring
that this SOP is correctly applied in the conduct of research and each researcher
also has individual responsibility for applying this SOP when required to do so.

The individual member of staff will be responsible for ensuring that this SOP is
correctly applied when storing human tissue.

The Corporate Compliance Unit (in conjunction with the Human Tissue Act Cathays
Park Working Group) is responsible for ensuring that the SOP remains fit for


Human Tissue – Any and all constituent part(s) of the human body formed by cells.
Inclusion of reference to DNA/RNA – definition is per HTA guidance.

Storage – Maintaining the tissue under appropriate controlled conditions.

Relevant Material – Material other than gametes, which consists of or includes
human cells. In the Human Tissue Act, references to relevant material from a human
body do not include:
a) embryo’s outside the human body, or
b) hair and nail from the body of a living person.
c) Cell lines
d) any other human material created outside the human body
e) serum, plasma, DNA and RNA

Page 3 of 7
Designated Individual – means the individual designated in the licence as the
person under whose supervision the licensed activity is authorised to be carried on.
This person is responsible for securing that other persons to whom the licence
applies are suitable persons, that suitable practices are carried out in the course of
carrying-on the licensed activity and for compliance with the conditions of the licence.
The HTA must be satisfied as to the suitability of this person.

Approved Research Ethics Committee – An NRES ethics committee established
or person appointed to advise on, or matters which include, the ethics of research
investigations on relevant material which has come from a human body.

Page 4 of 7
5         PROCEDURE

5.1 General Principles
The giving or withholding of consent to the storage of tissue taken from the living or
the dead are decisions that deserve respect. Human tissue taken from a living
person can be stored provided that consent is obtained from an appropriate person,
unless storage is bound up with the provision of clinical and diagnostic services.

Consent must be sought where tissue is taken from the living for research, unless the
research is ethically approved and the material is anonymised.

Human tissue cannot be stored after death without consent unless for coroner’s or
criminal justice purposes. It is an offence to hold tissue for the analysis of DNA
without consent, subject to exceptions.

Human tissue must be stored securely, in line with health and safety guidelines, and
appropriate records kept.

Long-term storage is acceptable where appropriate and if granted consent. Holdings
must be reviewed on an annual basis.

5.2 Storage of whole bodies

The storage of whole bodies is covered within the University’s Anatomy Licence
(12065). The Designated Individual if Prof Bernard Moxham – BIOSI.

5.3 Existing holdings

It is lawful to store and use, without consent, relevant material and the body of a
deceased person that is already held in storage on 1 September 2006. However,
where the views of the deceased person or of their relatives or friends are known,
those views must be respected.

5.4 Storage of relevant material taken from the living

The Act makes it lawful to store relevant material taken from a living person provided
consent from an ‘appropriate person1’ is obtained. It allows material taken from the
living for any reason to be stored (and used) without consent for the following

         clinical audit
         education or training relating to human health
         performance assessment
         public health monitoring and
         quality assurance

Consent is required to store tissue taken from the living for:

         obtaining scientific or medical information about a person which may be
          relevant to any other person (now or in the future)
         public display

    Cardiff University HTA Standard Operating Procedure ‘Obtaining Informed Consent’

Page 5 of 7
      research into disorders, or the functioning, of the human body and
      transplantation.

Consent should be obtained for the use of tissue removed from the living for
research. Where this is not possible, it is lawful for material taken from a living person
to be stored for research purposes only if:

      the research is ethically approved
      the material is anonymised, and the researcher takes all necessary steps not
       to identify the person from whose body the material has come.

5.5 Unlinked Samples

Although samples are generally unlinked, the linking of samples can be made
through a third party where necessary. In addition, the Act does not prohibit the
persons holding the samples from carrying out the research. When research involves
clinicians who may have access to databases making identification possible, the
sample will still be regarded as non identifiable provided the researcher does not
attempt to link the tissue with the patient. Research in this context is permissible
without consent if approved by a research ethics committee.

Obtaining consent is ordinarily considered best practice, negating the need for
complex systems for keeping samples unlinked.

5.6 Storage of relevant material taken after death

It is an offence under the Human Tissue Act to store relevant material taken after
death without consent, apart from material stored for coroners’ or criminal justice

5.7 Non-consensual analysis of DNA

It is an offence to have human tissue (including hair, nail and gametes in this context)
with the intention of analysing its DNA without consent, subject to exceptions.
Medical diagnosis and treatment, and criminal investigations are excluded from the

5.8 Methods of storage

Tissue should be stored in line with current good practice on:

      security
      traceability, including information about risk. Records should detail the
       location of the materials
      health and safety, including appropriate containment levels for the storage,
       transportation and handling of materials than may pose a risk to others.

Guidelines to be observed for the storing of Human Tissue:

      Human Tissue must be stored using recognised methods as per standard
       practice and guidance and labelled accordingly
      The appropriate label must convey what the specimen is
      Human tissue must be stored in a licensed area that must be locked at all
       times when not in use.

Page 6 of 7
5.9 Appropriate storage period

There is no time limit on the storage or organs and tissue, averting the potential for
the premature loss of useful material, or longer than necessary storage to discharge
a fixed period. Long-term storage in tissue banks may be acceptable to many donors
or their relatives who have given consent for such storage.

The Designated Individual is responsible for ensuring that records are maintained in
the area covered by the licence. Holdings must be reviewed annually and reported
to the DI as per the formal annual review, and any tissue that has not been used in
the previous year must be reviewed and a clear decision made and documented
about whether it should be retained or not.

The Designated Individual must be made aware post review of any tissue in the ‘non-
use’ category.

Page 7 of 7

To top