Leeds University GIFT Research Tissue Project
Research Tissue Donation
The Leeds GIFT project was created in response to the changes made in law which regulate
the uses of human tissues, in research, Human tissue Act 2004, and that the demand for
lawful tissues for research has increased but the availability of these has reduced.
Research into cancers, other diseases, injuries, early diagnosis and treatments as well as the
teaching and training of surgeons requires the use of human tissue. Where possible artificial
equivalents and simulations are used but in most cases there is no substitute available that
mimics or behaves the same way as human tissue does.
The Leeds GIFT Project retrieves consented tissues and bones from people who have died and
issues them to researchers. By law consent needs to be given, the same as people have to
give before having an operation, but for donation after death consent has to be given by the
donors “Next of Kin”.
All tissues that are used for research, including blood, have to be consented for research use
and if consent is not given then tissues will not be retrieved or used under any circumstances.
The rules and regulations regarding consent and donation are governed by the Human Tissue
Authority and the Human Tissue Act with very stiff penalties if anybody is found to have
contravened them.
Consent for research donation is taken on behalf of the GIFT Project by the National Health
Service Blood and Transplant, Tissue Service (NHSBTTS). This organisation looks after all
transplants and blood donations in the United Kingdom. The specially trained staff at
NHSBTTS will interview the Next of Kin by telephone at a pre arraigned time on a telephone
number of their choice. The interview and giving of consent is digitally recorded and kept in a
secure archive. Access to the recording is restricted to essential staff only and the recorded
details are not released to anyone other than to senior GIFT staff. All tissues retrieved by
GIFT are given a unique identification number. This is to anonimise all tissues to protect the
privacy of the donor and their family but still allows the tissues to be linked to the donor.
Only very senior GIFT Project staff has access to this link or to any identifiable information.
The GIFT Project number is allocated by a senior member of GIFT and linked information is
not held on any electronic record but as a paper record kept in locked cabinets, within a
locked room which is located in a secure building on St James’s Hospital premises. This is all
in compliance with the Human Tissue Act 2006 and relevant codes of practice including Data
Protection.
Staff recording relatives consent will ask them questions about the donor, will ask for
permission to look at their hospital records or “case notes”, and also to contact their GP. This
is to obtain information about the donors’ health and treatments, both recent and previous.
This helps researchers understand the donors conditions better and also means that we can
make sure that researchers receive the most appropriate tissues for their research. This
information is supplied in a totally anonymised way and no information is given which could
Leeds University GIFT Research Project
1
identify the donor or their family. All tissues and samples that are used by researchers are
identified by the unique code number only. Again this is done so it is not possible for
researchers, or anybody else, to identify the donor.
All information about the donor and there family is confidential and is protected by the Data
Protection Act. This information is not released. The only people with access to identifiable
information held by GIFT are selected senior GIFT Project staff only. The confidentiality of
information about our donors and their family’s information is of paramount importance to us
and we take all steps necessary to ensure its protection at all times. All GIFT staff has either
an NHS contract or a joint University and NHS contract. The GIFT staff are a combination of
Doctors, Pathologists, Nurses or NHS trained Technicians.
If a donors family change their mind
When tissues are donated for research use this does not mean that the GIFT Project “owns”
the tissue and we do not have any proprietary rights over any donated tissues. All tissues
remain the property of the donor or there family. GIFT Tissue Project acts as custodian of the
donated tissues and ensures that they are used both in the most appropriate manner and in
full accordance with the consent given. This includes honouring any restrictions recorded
during the donor family interview.
Even after consent has been given it can be withdrawn at any time and all tissues or samples
held will be destroyed. This is not always possible if researchers have already used the
tissues, however we make every effort to recall all the donated tissues or samples as
possible. Recalled tissues or samples are disposed of by GIFT as detailed in Leeds Hospitals
Trust policies on disposal of human tissue.
Withdrawing consent will in no way affect a family’s future care in any way. GIFT keeps a
record of the withdrawal of consent but destroys all other records which relate to the donor or
there family. This information is not accessible except to senior designated GIFT Project staff
only.
GIFT has a 28 day “cooling off” period where tissues are held prior to issue to allow the family
to change their mind. During this period we can guarantee that all retrieved material will be
destroyed.
Researchers who receive tissues from GIFT are obliged to use samples only for the research
they state in their application and are bound by a strict legal agreement to ensure this. If
anybody is found to be in breach of this agreement they will be reported to the Human Tissue
Authority, Medical Research Council and may be the subject of legal proceedings.
Researchers who wish to use tissues from the GIFT Project must have approval from an “NHS
Ethics Committee”. An Ethics Committee is comprised of medical experts, legal
representatives, local Health Authority representatives and lay people. There job is to
examine proposals submitted by researchers. These proposals outline what they want to do,
how they want to do it and what they want to achieve. The committee then decides if this can
be done, is it legal, is it the right thing to do and does it have the best chance of success, this
is what is meant by Ethical. There are several of these committees around the UK.
The Leeds GIFT Research Tissue Project also has an Access Committee which is similar to an
Ethics Committee but its main job is to ensure that our donors wishes are always respected
and that requested samples are used in the best possible way. Our Access Committee is a
combination of medical and scientific experts from the Trust, the University, lay members,
representatives of the legal profession and members of the Trust/University Multi faith
Chaplaincy service. Details of our selection criteria and advisory committee are available on
Leeds University GIFT Research Project
2
the GIFT Project website, www.gift.leeds.ac.uk or please contact the GIFT team, see end of
leaflet.
All applications for tissues or samples are screened by this committee and only
valid, approved researchers are given access to the project.
Donated tissues will only be used for medical research or education and will not be provided
for any other purposes. No tissues or samples will be provided for research into cloning or for
cosmetic testing. Medical research is not always about cancer but can be about other
diseases, for example Arthritis, Rheumatoid Arthritis, Osteoporosis. We also currently supply
tissues to help train ENT (Ear Nose and Throat) Surgeons and Orthopaedic Surgeons.
While tissues are only supplied to UK researchers they may also be subject to testing or
examination by overseas researchers who are collaborating with UK researchers. These
researchers also have to be approved by our Access Committee as well as an NHS Ethics
Committee and must also provide us with a copy of their equivalent to our ethics committee
approval. Collaboration with acknowledged experts is an important part of some research but
if families do not wish tissues to go outside the United Kingdom then they can state this at
the time of giving consent and GIFT will ensure this is adhered to, to the best of our ability.
GIFT is partially funded by research grants but also asks researchers to pay fees to help cover
our costs (cost recovery) but this is not to make a profit. This fee is based on the costs
involved in retrieving and processing tissues and is a proportion of the total cost. All fees are
reinvested back into the GIFT Project to enable us to continue providing the highest
standards of safety and professionalism for donors, their families and also to
researchers/educators. We will never sell your tissue gift for a profit. Your family will also not
receive any personal financial reward for making your gift.
GIFT accepts donors with a wide variety of conditions not just cancer and we also accept
people who do not have any diseases as normal tissues are just as important to researchers.
GIFT Tissue Project donors can donate many tissues, bones and joints for research and these
are retrieved by specially trained staff. All GIFT donors are returned to a pre donation
appearance and any incisions made, where possible, are unobtrusive. Donors can be viewed
after retrieval has taken place.
Any incisions to be made and locations are discussed as part of the consent interview and
families can place limits if they wish. All restrictions will be strictly followed.
Unlike a donation to medical science for the training of new Doctors where the Anatomy
department pays for the funeral, typically this can be in 3 to 4 years time, GIFT returns the
donor to the family for burial or cremation. We do not intend to cause any delays to funerals
and normally a donor is returned to the family within 3 days. GIFT will pay all other expenses
incurred including transferring the donor to St James’s Hospital in Leeds for the retrieval and
then returning them to a place of the families choice.
All transfers are by qualified and experienced funeral directors in an appropriate, sensitive
manner.
If you have any further questions or queries, please contact the GIFT team on 0113 343
38508. If necessary please leave a message and we will contact you as soon as possible.
We can also be contacted by e mail on www.gift.leeds.ac.uk.
Alternatively you can contact the National Blood Service Tissue Services on 0800 432 0559
Leeds University GIFT Research Project
3