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STANDARD OPERATING PROCEDURE FOR RESEARCH

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					                                                   DOCUMENT 1
CARDIFF UNIVERSITY


STANDARD OPERATING PROCEDURE
FOR THE USE OR STORAGE OF HUMAN
TISSUE FOR THE PURPOSES OF
RESEARCH OR EDUCATION

OBTAINING INFORMED CONSENT



Author: R Robertson, Corporate Compliance Unit

Procedure Approved by:

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


Date issued: August 2007
Review date: December 2007
Version: 2.0




Page 1 of 8
Contents page




   1. Purpose
   2. Scope
   3. Responsible Personnel
   4. Definitions
   5. Procedure
      5.1 Tissue from the living
      5.2 Tissue from the deceased
      5.3 Photographs and Electronic Images of
          Human Tissue
      5.4 The process of consent
      5.5 Withdrawal or refusal to give consent
   6. References




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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 need
and mechanisms for gaining informed consent from the research subjects.

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 collecting, using or
storing human tissue for research or teaching purposes.

NB: Consent is not a statutory requirement for the storage or use of tissue (whether
from living patients or post mortem) from existing holdings for research which also
existed for that purpose on 1st September 2006.


3      RESPONSIBLE PERSONNEL

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 collecting, using or storing human tissue for teaching
purposes.

The Corporate Compliance Unit (in conjunction with the Research and Commercial
Development Division) are responsible for ensuring that the SOP remains fit for
purpose.


4      DEFINITIONS

Anatomical examination – macroscopic examination of the body of a deceased
person, or separated parts of such a body, by dissection for anatomical purposes
(teaching or studying, or researching into the gross structure of the human body).

Human Tissue – Any and all constituent parts of the human body formed by cells.

Informed Consent – there is no statutory definition of informed consent although
there is extensive literature on the subject and the related field of ethics. The Human
Tissue Act Code of Practice on Consent provides further explanation of issues to be
considered in relation to informed consent.


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In relation to consent for use of personal data the Data Protection Act 1998 provides
that valid consent must be fully informed and freely given.

In terms of consent to participate in clinical trials section 1.28 of the International
Conference for Harmonisation Good Clinical Practice (ICH-GCP) guidelines (1996)
states that informed consent is:

 ‘a process by which a subject voluntarily confirms his or her willingness to participate
in a particular trial, after having been informed of all aspects of the trial that are
relevant to the subject's decision to participate. Informed consent is documented by
means of a written, signed and dated informed consent form.’

Principal Investigator (PI) – is the appropriately qualified individual at each project
site who has responsibility for the conduct of the project at that site.


5       PROCEDURE

Any research study carried out using NHS patients or patient
databases/databanks must be conducted following the Standard Operating
Procedure for informed consent applicable to the NHS Trust(s) involved.
Where such a SOP does not exist, the following procedure must be used.

Where human tissue derived from a non-NHS source is used in research or teaching
the following procedure must be followed.


5.1 Tissue from the Living

Under the Human Tissue Act 2004 tissue from the living may be used or stored
without consent for the purposes of education or training relating to human health
(including training for research into disorders, or the functioning of the human body).
However, any health related records which identity the living individual who is the
source of the tissue sample may constitute that individual’s sensitive personal data
and as such the Data Protection Act 1998 will require that consent is sought for the
processing of such data.

Tissue from the living may be stored for use and/or used without consent for
research purposes, provided that:

       the research is ethically approved by a research ethics authority, and

       the tissue is anonymised such that the researcher is not in possession of the
        information identifying the person from whose body the material has come
        and is not likely to come into possession of it. (This does not mean that
        samples must be permanently and irrevocably unlinked.)

In other circumstances informed consent is required before tissue from the living may
be stored or used for research and teaching purposes.




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Authority to Give Consent

Tissue from the Living – Competent Adults

If an adult is competent, only they are permitted to give consent. From October 2007
the Mental Capacity Act 2005 requires that there is a presumption that persons aged
18 have capacity to give consent, unless it is established otherwise.

Tissue from the Living – Adults Lacking Capacity

Where it suspected that an adult lacks capacity the relevant member of staff must
conduct an assessment to establish whether the individual can:
    Understand the nature and purpose of the proposed procedure
    Understand and retain information relevant to the decision
    Weigh the necessary information to arrive at a choice

If the adult is capable of the above then he/she is capable of giving informed consent.

In the absence of explicit consent from an incapable individual, consent may be
deemed to be in place:

      for clinical trials authorised and conducted in accordance with the clinical
       trials Regulations, or
      (from October 2007) where it is consistent with paragraphs 30-34 of the
       Mental Capacity Act 2005, allowing for the storage and use of relevant
       material for research in circumstances provided in that Act.

Tissue from the Living – Children

Children may consent to the storage and use of their tissue if they are competent to
do so. A child who has sufficient intelligence and understanding to enable them fully
to understand what is involved is considered to be competent to give consent.

It is recommended as good practice that parents of children who are competent to
give consent in their own right are still involved in a supportive role in the decision-
making process. See Department of Health’s guidance Seeking Consent: working
with children

Where a child is not competent to give consent a person with parental responsibility
(as defined in the Children Act 1989 as amended) may give consent on his/her
behalf.


5.2 Tissue from the Deceased

Consent is needed for the removal, storage and use of human tissue for educational
and research purposes, unless it is part of an investigation under the authority of the
coroner or in connection with a criminal investigation or following a criminal
conviction.

Authority to give consent




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Tissue from the Deceased – adults

Where an adult has, whilst alive and competent, given consent for the use or storage
of tissue for research or teaching purposes, then that consent is sufficient for the
activity to be lawful. The consent required for anatomical examination of a deceased
person’s body must be written down and witnessed.

Tissue from the deceased – nominated representatives

If a deceased adult has neither consented to nor specifically refused any particular
donation or removal, storage or use of their body or tissue those close to them
should be asked whether a nominated representative was appointed to take those
decisions.

A nominated representative cannot give consent for anatomical examination, but may
consent to other teaching or research purposes.

More information on nominated representatives and other persons with ‘qualifying
relationships’ and the power to give consent can be found in the Human Tissue
Authority - Code of Practice on Consent.

Tissue from the deceased – children

As with adults, where a child has, whilst alive and competent, given consent for the
use or storage of tissue for research or teaching purposes, then that consent is
sufficient for the activity to be lawful. The consent required for anatomical
examination of a deceased child’s body must be written down and witnessed.

It will however still be essential to discuss this with the child’s family and to take their
views and wishes into account before deciding how to proceed.

If a child did not make a decision, or was not competent to make a decision, the Act
makes it clear that the appropriate consent will be that of the person with parental
responsibility for the child (as defined by the Children Act 1989 as amended).

For more information on consent from others in respect of deceased children see the
Human Tissue Authority - Code of Practice on Consent.

Fetal tissue

The law does not distinguish between fetal tissue and other tissue from the living –
fetal tissue is regarded as the mother’s tissue, however, it is recommended that
consent is always gained (from the mother) for the examination, storage of use of
fetal tissue.

It is considered good practice that wherever practicable, consent should also be
obtained for the use in research of non-fetal products of conception. Research
Ethics Committee approval is always required for the use of fetal tissue and products
of conception in research.




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5.3 Photographs and Electronic Images of Human Tissue

These are not covered by the Human Tissue Act 2004, however, they will constitute
personal data if linked to information about a living identifiable individual or
individuals. In such cases the Data Protection Act 1998 will require that consent is
given by the living individuals for their use for research or teaching purposes.


5.4 The Process of Consent

Consent should be seen as part of a continuing process in which individuals, their
relatives and friends can discuss the issue fully, ask questions and make an informed
choice.

Valid consent can only be given if proper communication has taken place. Particular
consideration should be given to the needs of individuals and families whose first
language is not English. Where consent forms are used, these should on be
available in English and any other relevant language depending on the sample
population’s language profile.

The person responsible for seeking consent must know enough about the proposed
use of the tissue and the risks involved (if any) to adequately brief the person.
Individuals should be told whether the consent for research is generic or specific, i.e.
whether it is consent for use in any future research project which has ethical
approval).

Anyone seeking consent in respect of a deceased person must have received
appropriate training/experience in dealing with the bereaved. The Human Tissue
Authority’s Code of Practice on Post Mortem Examinations1 gives more detail.

Any applicable ethical guidelines relating to the process of gaining consent should be
followed as far as practicable.

5.5 Withdrawal or Refusal to Give Consent

Where consent is a legal requirement for the intended purpose and it is refused then
that tissue may not be used/stored for that purpose lawfully. No-one should be co-
erced into giving consent as that consent will not be ‘valid’.

Where consent is a legal requirement and is given but later withdrawn then this must
be respected. No further use may be made of the tissue and the sample must be
destroyed/disposed of or returned to the individual.


6      REFERENCES

Human Tissue Authority: Code of Practice – Consent Code 1 July 2006
http://www.hta.gov.uk/_db/_documents/2006-07-04_Approved_by_Parliament_–
_Code_of_Practice_1_–_Consent.pdf

Human Tissue Authority: Code of Practice – Post Mortem Examination Code 3 July
2006




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http://www.hta.gov.uk/_db/_documents/2006-07-04_Approved_by_Parliament_-
_Code_of_Practice_3_-_Post_Mortem.pdf




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