Information Sheet and Consent Form:
Donation of human biological samples and data for
medical research
We would like to invite you to donate a biological
sample (tissue, blood or other fluid), or samples,
for medical research purposes.
Before you decide whether to take part, it is
important for you to know why the research is
being done and what it will involve. Please take
time to read the following information carefully
and to decide whether or not you wish to donate.
Why am I being invited?
You are being invited because you have
previously had, or have recently been invited, to
visit the hospital to attend a clinic, or for a biopsy,
surgical procedure or other treatment.
Participation is voluntary and any treatment you
receive will not be affected by your decision.
What will happen if I agree?
Why are human tissues and body fluids vital
for research?
By studying biological samples, scientists can
learn about health, how diseases develop and
why individuals respond to treatments differently.
Scientists can also develop better ways of testing
for diseases, as well as testing new treatments on
biological samples to see whether they might
work and are safe before trying them in human
volunteers.
What is the purpose of the sample collection?
The [name] Biobank stores biological samples
and health data collected from patients. The
samples and data will be used by scientists
involved in medical research, now and in the
future.
Who has approved the research?
The collection and storage of the biological
samples and data have been approved by a
research ethics committee (REC) and will be
monitored regularly. We only release tissue and
data to scientists for research approved by [an
REC or by the Biobank’s access committee, as
appropriate].
Will genetic research be conducted?
Donated biological samples may be studied as
part of research into genetic disorders and
diseases (such as some cancers) that may be
influenced by genes, or characteristics that could
be inherited. This research may range from
looking at one gene to many genes. [Please
consider whether results of any genetic tests may be
of individual relevance-see later section on feedback.]
We are either asking you to donate tissue or fluid
left over after your diagnosis is complete, or an
extra tissue or fluid sample removed alongside
your routine care, surgery or other treatment. [Edit
and provide more information about how you will
collect the samples.]
We would also like to access your medical
records, which include health-related records held
centrally by the NHS. This is because
information about your condition, other disease(s)
and your treatment will greatly increase the
usefulness of your donated samples in research.
What if I change my mind?
You are free to contact us to withdraw consent at
any time without giving a reason. If you choose
to withdraw we will destroy all of your samples
that have not been distributed or used. We will
destroy all information we have collected about
you, apart from a small amount of data we must
hold for audit purposes.
However, your samples and data may have
already been used in research projects. We
cannot get these samples back or remove the
results from studies that have already started.
[For a selection of withdrawal options, see the longer
template.]
What are the benefits and risks of taking part?
The tests and treatments you are receiving were
developed with the help of patients who
previously took part in research. Research
carried out today is unlikely to have any direct
medical benefit for you, but may help future
patients by improving our understanding of how
diseases are caused, and support the
development of new tests or treatments for
disease.

1
There are minor risks to you as a result of your
participation. If we take an extra tissue or fluid
sample this may cause some bleeding, bruising,
dizziness and/or discomfort. A failure in sample
and data security is extremely unlikely, but in the
event this happened there is a risk that you would
be re-identified, which may cause related medical
or genetic information to be revealed.
organisation may then make a profit out of the
product they have developed.
However, you will not receive any financial
reward for donating your samples or data, or from
the results of the research, either now or in the
future.
Who will access my samples and data?
How will my samples and data be stored and
kept confidential?
To keep your information and samples
confidential, we have put numerous safeguards in
place. In particular, we will replace personal
identifiers such as your name and full address
with a code before we distribute your samples or
data. Scientists sign a contract with us that
covers how samples and data may be stored and
used. This contract applies even when samples
and data are transferred abroad.
We will also use stringent security measures to
prevent unauthorised access to your samples or
data. We will not allow third parties such as
employers, insurance companies or family
members to access your samples or data unless
required by law or court order. You will not be
identified in any publications.
Will anyone make money from my samples or
data?
We may charge researchers a fee for access to
your samples and data to cover the costs of
collection, storage and transportation.
If scientists develop a new test, treatment or drug
using your biological samples and data, a
commercial company or other research
Scientists who use your biological samples may
work in universities, hospitals, charities or
commercial companies. They may also work
abroad. After removing personal identifiers, your
health information and related research results
may also be shared with other biobanks, research
groups or placed in scientific databases.
How long will my samples and data be
stored?
Your sample(s) and associated data may be used
immediately or stored, potentially for many years,
until released to researchers for use in approved
research.
Will I find out the results of the research?
[Provide more information about whether and how
results will be returned, in particular see the MRC &
Wellcome Trust document on feedback of healthrelated findings arising from research. If you are able
to provide general information about the research, for
example, through a website, this should also be
mentioned here.]
Further information
[Provide contact details]
Consent Section
Donor
 I agree that the biobank may re-contact me in the future to ask me to provide additional
samples or information or to invite me to take part in further research. I understand that this
does not oblige me to provide any more samples or take part in further research.
Y/N
I have read the information sheet and had the opportunity to ask questions. I agree to donate samples
and allow access to my medical record for use in the medical research, as described above.
Signed……………………….……….Print Name……………………………………Date………………….
Professional seeking consent
I have explained the information above to the donor and have answered all of their questions.
Signed…………………………….….Print Name……………………………………Date………………….
2
STRATUM two-page information/generic consent template for biobanks. Please refer to longer template for
more in-depth text on different recruitment pathways and further optional content that relates to research
involving cell lines, animals or post-mortem samples http://stratumbiobanking.org/