Biobank Donor Information Sheet and Consent Form - STRATUM Template June 2013
1. Background to the Development of Consent Templates within STRATUM
While numerous examples of documentation and consent models exist in relation to the
donation of human biological samples (HBS) and data for biomedical research in the UK,
approaches vary and are not harmonised. This lack of harmonisation results in a lack of
clarity for donors about the types of research their HBS and data may be used for and may
raise barriers to HBS sharing due to differing consent models and related restrictions.
This expanded consent and information template has been developed by the STRATUM
project to address this gap. It is intended to act as a template to inform and guide
professionals developing information and consent materials when HBS are to be collected
for use in research (including in clinical trials and in testing diagnostics). Use of this template
is intended to support a unified approach to the development of information and consent
materials (see benefits below).
To achieve this, the STRATUM project has:
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based the template on current best practice within established and ethically approved
biobanks,
reviewed current examples of biobanking donor information and consent policies,
considered evidence from surveys of public attitudes towards consent and the
donation of HBS for biomedical research,
considered current debate in these areas and relevant publications, and
undertaken a consultation exercise on the template and addressed the resulting
comments.
Benefits from use of the template:
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clarity for donors in relation to the value of using HBS and data in medical research,
and in particular uses of samples and data that may be considered as ‘sensitive’ (for
example research involving animals), and the benefits and risks of biobank research,
greater harmonisation of the contents of information and consent documents will
reduce the consent restrictions that arise due to current variation, and as a result
support the sharing of human biological samples (HBS) and collaboration in
biomedical research, also reducing related costs, and
assisting professionals new to obtaining consent for biobanking, and encouraging
them to consider all possible routes for HBS collection and possibilities with regards
to future use, including sharing samples and including data in databases.
2. An Introduction to the Template
2.1 Key points:
 not all sections are relevant to every project, trial or biobank - only relevant wording
should be selected and used from this template,
 this template supports obtaining ‘Generic’ (broad and enduring) consent, but with
modifications (see the STRATUM Consent Decision Tree document) it can be used
to obtain ‘Tiered’ (Appendix 4) or ‘Specific’ (Appendix 5) consent,
 the template incorporates the donor information sheet and consent form as one
document to:
o ensure the donor has read the information sheet, and
o ensure that the information sheet is stored with the consent form in case what
the donor has consented to must be reviewed later,
 the donor must receive a copy of the full signed document,
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Biobank Donor Information Sheet and Consent Form - STRATUM Template June 2013
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the template provides different options for providing information that depend on the
capabilities, scope of reseach and the role of the biobank,
the template incorporates consent to genetic research as an integral component of
generic consent, and
the template is specifically designed for biobanks operating within the UK legal and
ethical context, and incorporates the differing requirements in Scotland.
2.2 Scope of template
The document is intended to be used to provide template wording for research projects,
biobanks and clinical trials collecting HBS and associated data – where sample collection
and use for research (including development) is either a primary, or secondary, aim.
The template does not cover research involving HBS from pregnant women, embryos,
children, emergency hospital cases, incapacitated persons, healthy volunteers or prisoners
in depth. These areas raise ethical and legal considerations that lead to the need for specific
consideration. However, where relevant we link to other appropriate guidance on these
matters. Collecting HBS and data post-mortem is supported but other relevant guidance is
highlighted.
2.2.1 Existing guidance and templates
In addition, other templates and guidance are available through regulatory bodies and
research funders. The following sources of guidance are generally applicable:
 Human Research Authority guidance on information sheets ; template consent form.
 Human Tissue Authority code of practice on consent ; code of practice on research ;
and related webpages (donating your tissue for research).
 The Medical Research Council Data and Tissues Toolkit and guidance on Human
Tissues and Biological Samples for Use in Research (the latter is currently being
updated).
 Templates from the Public Population Project (P3G) Model Information Pamphlet and
Model Consent Form.
 Examples from many research projects and biobanks including, but not limited to,
Generation Scotland, UKBiobank patient information sheet and Wales Cancer Bank
patient information sheet and consent form.
If you wish to involve children in your research see guidance:
 Medical Research Council Medical Research Involving Children (2007)
 Royal College of Paediatrics and Child Health Ethics of Research in Children (2000)
 Human Tissue Authority Code of Practice on Consent (1), sections 139-145 on
Children.
 Examples of information sheets and consent forms for children from the UK
Children’s Cancer and Leukaemia Group (CCLG).
 Online templates from the World Health Organization – Informed Assent Children
and Informed Parental Consent for Research Involving Children (clinical)
If incapacitated adults might be involved in your research, or research may be conducted in
emergency settings, see guidance:
 Health Research Authority online toolkit on Involving Adults Lacking Capacity in
Research (2010)
 Medical Research Council Medical Research Involving Adults Who Cannot Consent
(2007)
 Mental Capacity Act Code of Practice (2007)
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Biobank Donor Information Sheet and Consent Form - STRATUM Template June 2013
2.3 How to use this template
We suggest you read through the whole document to ensure you have incorporated all
information relevant to you (or use the check-list in Appendix 6). Incorporate relevant text
into your own version of an information sheet and consent form – for an example final
document that includes a minimal set of wording see the two page version (STRATUM
Information and Consent Form Two Page version, June 2013).
This template document uses different coloured text in order to guide the reader. Black text
indicates suggested text, blue italicised text is guidance notes and red prompts the reader to
insert text or choose an option.
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Biobank Donor Information Sheet and Consent Form - STRATUM Template June 2013
Donor Information Sheet Template
Donating human tissue and data for biomedical research
Recommended Content
We would like to invite you to donate [a tissue, blood or other human biological sample and
medical information about yourself] 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. Please take time
too to decide whether or not you wish to take part.
Please ask us if there is anything that is not clear to you, or if you would like any further
information, our contact details are on [page x] of this leaflet.
 Part 1 tells you about the purpose of the donation and the scope of use of your samples
and data
 Part 2 answers some of your questions and gives you more detailed information.
PART 1: The purpose of the donation and how it will be used
Why are human tissues and body fluids vital for research?
[General information on why biological samples are needed for research] By studying human
tissue, cells or fluids, scientists can learn about health, how diseases develop and why
individuals respond to treatments differently. They can also test new drugs on tissues to see
whether they are safe and whether they work before trying them in human volunteers. These
studies may lead to the development of new medicines, diagnostic tests and other
treatments.
[If you would like to include more detail about what tissue is, its use in research or potential
uses for education and audit please see Appendix 1 for examples.]
What is the purpose of the [sample collection/research]?
[Insert a brief relevant introduction about the organisation, biobank, study group, etc. the
samples are being collected by. Include information about the main aims and purposes of
the biobank, and the types of research (including development) it supports. For samples
collected for a specific research project, describe this and also include a statement about the
future use of samples for biomedical research. You should provide clear and transparent
information about any intended current and future research and development using the
samples and data.] The [name] Biobank is a project that aims to collect samples of [blood,
bodily fluid, tissues and health data] from [e.g. patients, individuals, healthy volunteers].
Samples and data collected will be used by scientists involved in medical research. This is
an ongoing study that will collect [blood, bodily fluid, tissues and health data] over many
years.
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Biobank Donor Information Sheet and Consent Form - STRATUM Template June 2013
Who has approved the research?
[Include a statement on research ethics or other committee approval required for the
biological sample collection.] The collection and storage of biological samples and [medical
information and/or information on your lifestyle], [and the research we plan to do using
them,] have been [approved by an appropriate research ethics committee and will be
monitored regularly by the committee(s)]. We only release tissue and data to scientists from
the public and private sector if the research they are undertaking [falls within the remit of our
ethical approval or is approved following submission by the researchers to an appropriate
ethics or access committee].
[For a collection for a specific project or clinical trial you may wish to give information on the
main funders.]
Why am I being invited?
[Explain the reason the donor was approached. For example because they are attending a
hospital appointment and you wish to use the leftover tissue.] You are being invited because
you have [previously had, or recently have been invited, to visit hospital for a biopsy, surgical
procedure, or a clinic] that involves the removal of [if appropriate, specify the tissue or other
body samples, e.g. blood or a tumour]. We are asking you to donate [material left over after
diagnosis] removed as part of, or alongside, your routine care or treatment, to the [biobank,
clinical trial or research project].
[If you are asking them to donate an extra sample] We are asking you and other individuals
[attending the clinic, taking part on the clinical trial or research study] to donate an additional
[specify the biological samples, e.g. blood] sample.
[If applicable you may include information about the number of people you are planning to
recruit.]
What will happen if I agree to take part?
[Include a bullet pointed list of what will happen to the donor if he or she agrees to take part.
Address and select the relevant text from these options:]
 You will be asked to give your written permission by signing [a/the attached consent]
form.
 [If the samples will be taken as part of a biopsy or surgical procedure.] If you need to
undergo surgery or a clinical procedure which involves the removal of tissue or body
fluids, these samples will usually be sent to the pathology laboratory in the hospital to
help with your diagnosis. In many cases some of the sample will be left over. Part of
this is normally stored, for example, in case new diagnostic tests become available in
the future, while the rest may be disposed of. With your permission, the hospital will
give some of the tissue or bodily fluid that is not needed for diagnosis to the [biobank,
researchers who have requested samples for approved research, or those
responsible for the clinical trial/research project, etc.].
o [If he or she is asked to allow use of previous samples] We are also asking
you to allow us to transfer some of the material the pathology laboratory has
kept from previous surgery or other procedures to [the biobank, clinical trial or
research project].
o [If he or she is asked for consent to use future samples]
 During your medical care we may wish to take further follow up
samples specifically for research. We ask for your permission now, but
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Biobank Donor Information Sheet and Consent Form - STRATUM Template June 2013
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will confirm that you are happy for this to take place before the
procedure.
 We are also asking you to allow us to ask for samples from any
surplus cells or tissue left over from surgery, biopsy or other
diagnostic tests you may have in the future.
[Explain any tests, examinations or interviews you are planning to conduct in more
detail:
o Will the donor have any blood or other tests?] During your care in hospital,
you will normally give blood samples or urine for tests to be carried out. Either
while this is happening, or at a different time, we would like to ask you to
allow staff to take additional samples so that they can be used for research.
[Outline amount that will be taken, e.g. a sample of blood of around 10ml
(approximately 2 teaspoons)].
o [Will any extra samples be taken during an operation or other clinical
procedure?] If you need to undergo surgery or a clinical procedure,
occasionally we may ask you whether we could take a small extra sample
e.g. an extra biopsy or a piece of fat tissue. This will only happen if it is safe to
do so. [Outline the size of the sample and any implications of removal]
o [If he or she is a healthy volunteer and will be asked to provide samples] If
you agree to join, you will be asked provide a [e.g. blood, saliva]. [Outline
amount that will be taken, e.g. a sample of blood of around 10ml
(approximately 2 teaspoons)] sample.
o [Will the donor need to have a physical examination?] You will be asked to
undergo non-invasive measurements [list them here]. You will be asked by
[staff type] to attend an appointment at [location] which will last approximately
[length of time].
o [Will the donor be interviewed or surveyed about lifestyle or other
information?] You will be asked by [staff] [when? How?] to answer questions
on your [e.g. health, lifestyle, family history].This will take approximately
[length of time].
[Will the donor be re-contacted at any point in the future to request follow-up
information or to ask about participation in other studies?] We may contact you in the
future, but no more than [e.g. once a year to update this information or invite you to
take part in a new study].
o [Do you expect the donor to keep in touch with you with change of address
details etc.?]
[Access to medical records or other registries
o Will access to the donor’s medical record be required?] We would also like to
access your medical record (which may include records in other hospitals,
disease registries or those held centrally by NHS bodies such as the Health
and Social Care Information Centre). This is because information about your
condition, other disease(s) and your treatment will greatly increase the
usefulness of your donated samples in research. Information from your
medical records that could identify you (such as name, full address, full date
of birth) will not be passed to researchers. [Where this is not the case, explain
that only trusted staff will be able to access this data.] Your notes would be
accessed by the [staff at the hospital, biobank, clinical trial or research project
– describe other security measures you will follow to access medical records].
[For information on the steps we will take to protect your samples and data,
please see the further information section below on How will my samples and
data be stored?]
 [If the project or trial requires access to identifiable information note
this here, and include information on relevant protections in the How
will my samples and data be stored? section]
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Biobank Donor Information Sheet and Consent Form - STRATUM Template June 2013
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[Will access to medical records continue to be required in the future?] We
may need to continue to access your medical record from time to time to
update this information.
o [Will the medical record continue to be accessed after an individual becomes
unwell or dies? Note you may need specific consent for accessing the
medical record after death and should consider including the signature box for
the collection of tissues and/or data after death below] We would like to
access these records even if you become unable to make decisions for
yourself or after your death.
[If not covered elsewhere in the section or information sheet, cover:
o Will the tissue be tested for infectious diseases?] Your tissue samples will be
tested for specific infections [(for example, HIV, Hepatitis B and Hepatitis C)].
 [Outline if you would like to take an extra blood sample from the donor
in order to undertake these tests, or whether they will be done on an
existing blood sample]
o [Whether results from physical examinations or tests for infectious diseases
will be returned, include a link to the section below on Will I find out the
results of the research?).]
o [Will research results be fed back to the biobank?] We request that
researchers give us data from any studies carried out using donated samples
and information from the biobank. This adds to the richness of information
linked to your sample(s). [For information on whether you will find out any of
the research results, please see further information section below on Will I
find out the results of the research?]
o [Outline any envisaged secondary use linked to the data and research results,
for example data sharing or including information in open or limited access
scientific databases] Your information and related research results may be
shared with other biobanks, research groups or institutions or placed in
scientific databases in a way that does not identify you. [For information on
the steps we will take to protect your samples and data, please see the
further information section below on How will my samples and data be
stored?]
o [What happens when researchers wish to use the biological samples and or
data (see section below on Who will access my samples and data?)].
o [You may wish to include information here about donor withdrawal; see
section below.]
[Add a brief statement about maintaining confidentiality in relation to samples and
data.]
o Researchers will not be provided with any identifiable personal information
such as your name, full address or phone number.
Will my sample/s be used in genetic research?
Your [biological samples] may be studied as part of research into genetic disorders, 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 examining all of your genes.
[Consider whether results of any genetic tests may be of individual relevance - see later
section on feedback, for example:] [The biobank, clinical trial or research project will not
disclose information about your genetic make-up to third parties in any way that could affect
you]. Researchers studying genes will not have any information that could be used to identify
you [note this would not be the case if researchers do need to use identifiable information].
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Biobank Donor Information Sheet and Consent Form - STRATUM Template June 2013
Other genetic research may look at characteristics that are not normally inherited, e.g. to
discover ways in which cancer cells have changed compared with healthy cells.
[For further information on risks see the section below on What are the benefits and risks of
taking part?]
[If you would like to include further descriptions of DNA or genes, see Appendix 1 for
examples.]
What are the benefits and risks of taking part?
[You need to give information on the benefits associated with biobanking, as appropriate]
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[Benefits for the individual if they can receive the results of either physical
examinations, incidental findings or individually relevant research results - see
section below on Will I find out results of the research?)]
[Benefits to society] Research carried out today is unlikely to have any direct
medical benefit for you but may help future patients by improving understanding of
how diseases are caused and supporting the development of new diagnostic tests
and treatments. The tests and treatments being used for you were developed with
the help of patients who took part in research years ago.
[Other benefits] In some circumstances, by using human samples there may be less
need to study laboratory animals. [If your research may involve animals you may
wish to direct the donor to the optional section on Will my cells or tissue be used for
research involving animals?]
[You also need to give information on the minimal risks associated with taking part – include
relevant options from the list below] There are minor risks to you as a result of your
participation.
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[Risks associated with sample collection] Taking a [specify the tissue or other body
samples, e.g. blood] sample may cause some [bleeding, bruising, dizziness and/or
discomfort].
[Possible risks associated with data collection] Some of the questions you will be
asked in the questionnaire may be quite personal in nature. If you do not want to
answer any of our questions you do not have to.
[Risks associated with data security] We will take stringent steps to to store your
samples and data securely and maintain your confidentiality. [Describe the security
processes in place further in the section below on How will my data and samples be
stored?] A failure in sample and data security is extremely unlikely, but in the event
this happened there is a risk that you would be identified, which may cause related
medical or genetic information to be revealed
o [Risks associated with re-identification based on rare characteristics.
Concerns are increasing that there may be a possibility of re-identifying
individuals based on genetic information or other rare or unique
characteristics such as an individual having a very rare disease. If relevant,
add this section into the risks associated with data security above, as the
specific risks (e.g. discrimination) are the same.] There is a remote risk that
stored genetic information generated through [research using the biobank, the
clinical trial or research project], or information about a rare diagnosis, could
be linked to genetic or medical information in other databases and used to reidentify you to specialists in your disease area, but not to other organisations.
[Risks associated with returning results of research. Include this if relevant to your
biobank or study, and tailor it depending on the type of results that may be returned.
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Biobank Donor Information Sheet and Consent Form - STRATUM Template June 2013
(For details about how to inform donors about these risks consult the decisionmaking framework being developed by the Wellcome Trust & MRC)].
Who will access my samples and data?
[If this information is not included in the section on What will happen if I agree to take part?,
cover:
(a) When samples may be used and, briefly, what kinds of approvals need to take place
before the research (including development) can begin.]
Your sample(s) and associated information may be used immediately or stored until
released to researchers for use in [ethically and/or scientifically] approved research.
(b) [what types of researchers can access the resource, specifically whether they may
be international or commercial and the implications of this in terms of data protection
and commercial development]
Your samples and the associated health data, with personal identifiers removed, may be
used by researchers in the UK and abroad. [We have put a contract in place (see further
information section below on How will my data and samples be stored?) with all researchers
to ensure that UK legal standards are followed.]
Scientists who use your samples and data may work in universities, hospitals, charities or
commercial companies that do biomedical research, and may be part of large groups of
scientists working together.
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 beneficial new test, treatment or
drug, tested or developed in part using your samples, a commercial company or other
research organisation may then make a profit out of the product they have developed.
However, we regard your sample as a gift and you will not receive any personal financial
reward for your donation or from the results of the research, either now or in the future.
[You may wish to add information here about how you recognise and appreciate the crucial
role donors play in research and in recognition of this will do your best to e.g. make sure
those who wish to know more about the progress of research projects can obtain that
information via websites, see will I find out the results of research? section below.
If you would like to include more detail about governance of the tissue bank/project see
Appendix 2 for examples.]
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Biobank Donor Information Sheet and Consent Form - STRATUM Template June 2013
PART 2: Further information for individuals interested in taking part
How will my samples and data be stored?
[If not already covered, provide information on the data protection, confidentiality and
security mechanisms put in place for the biobank, research project or clinical trial – it can be
bullet-pointed.]
To keep your information and samples confidential, we have put many safeguards in place.
In particular, we will:
 Remove personal identifiers such as your name, full address or full date of birth from
your samples and health information.
 Assign codes to your samples and health information.
 Keep your identifiable personal details separate from your health information and
samples.
 [If applicable] Only provide researchers with the coded information and samples.
 Ensure that relevant agreements and data security measures are in place to protect
your data and samples.
 Ensure that researchers sign a contract ([data and/or material transfer agreement])
with [the Trust/tissue bank/other organisation] that includes provisions on how the
[data and samples] may be stored and used, which applies even if the [data and
samples] are transferred abroad.
 Use stringent data security measures to prevent unauthorized use, including: strict
access controls, computer security and data encryption techniques, confidentiality
agreements and staff training.
 Not allow third parties, such as employers, insurance companies or other family
members, to access any of your information [unless required by law or a court order].
 Not identify you in any resulting publications.
 [If applicable] Be able to re-link your personal details with your samples and
information, should you want to withdraw from the study [if possible for your biobank,
if applicable, or if findings relevant to your treatment come to the biobank’s attention].
 Store samples in a secure facility meeting high security and safety standards. The
same coding and security measures that are in place for your data will also apply to
your samples.
 Ensure that your biological samples and data are stored, used and disposed of in
accordance with legal requirements. In England and Wales, storage of human cells
and tissue for research is governed by the Human Tissue Act (2004) and, where
applicable, licensed by the Human Tissue Authority [or in Scotland governed by
section 45 of the Human Tissue Act and the Human Tissue (Scotland) Act (2006)].
Data confidentiality must meet the requirements of the [Data Protection Act (1998)].
Equivalent law exists in many other countries.
[Inform donors about any data protection rights that are available to them, for example the
right to access and request deletion and rectification.] You have the right to request
information about you held by the [biobank, clinical trial or research project]. You also have
the right to request that any inaccuracies in such data be corrected. If you wish to make a
request, then please contact the [biobank, clinical trial or research project – see the contact
details section below].
How long will my samples and data be stored?
[Inform the donor about how long samples may be stored and how they will be disposed of,
when relevant.] Tissue preservation techniques ensure that tissue and cells remain usable in
research for many years. Your samples and data may be stored [indefinitely, ten years or
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Biobank Donor Information Sheet and Consent Form - STRATUM Template June 2013
more, or if a specific project without consequent tissue banking, give some idea of the length
of the project] unless an ethics committee decides otherwise.
[If you are not storing samples indefinitely, give information about how samples will be
securely disposed of; or information about how samples taken from diagnostic archive will be
returned to the hospital after use. For example:] Samples are carefully disposed of by
[biobank, clinical trial, research project] as detailed in [relevant institution’s] policies on
disposal of human tissue.
[You should also consider informing the donor about what would happen if the biobank
closes.]
Will I find out results of the research?
[You need to consider what type of results may be returned to the donor, and if they will –
when and how? The specific situations that may arise in research using HBS include:

General research results – you should decide whether you will provide study results
via newsletter, email, website and provide information about this] Research projects
that are carried out on tissue that has been gifted to the [biobank, clinical trial or
research project] may be listed [on our website/in our newsletter].The results of the
projects, which often may not be available for several years, may be published in
scientific journals. You will not be identified in any publications. General research
results may be made available to all donors and anyone else who might be interested
through the [name of website /newsletter/email] [If you rely on websites, include
contact details for people without internet access to obtain information.] For those
without internet access, you can contact [contact info]. [If you rely on newsletter or
email updates, you will need to give the donor the opportunity to opt-in or out.] You
will be given the choice of whether you want to receive the [newsletter/email] and can
opt-out of receiving this at any time by contacting [contact info].
[For individual level results, consider results from:
 physical examinations conducted as part of the samples or data collection,
 tests for infectious diseases conducted on the samples, and
 individual results linked or incidental to the research that arise during the course of
the research.
Detailed guidance on issues to consider when deciding to return individual level information
to donors and issues when providing information to donors can be found in the Wellcome
Trust and Medical Research Council recommendations on the feedback of individual health
related findings in research.]
What if I change my mind?
Withdrawal of consent to use of your samples and data in research does not affect your
access to treatment or standard of care. You are free to withdraw consent at any time
without giving a reason by contacting [contact details].
[You need to explain to the donor how they can withdraw from the tissue bank, clinical trial or
research project. Complete withdrawal is usually not possible due to the need to retain
administrative records and because data and samples may already have been used in
research projects, but this needs to be explained to the donor. Choose from these options]:
 No further use option: If you choose to withdraw your consent we will destroy all
tissue [and other] samples we hold that have not been distributed or used. We will
also destroy all information we have collected about you [apart from a small amount of
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Biobank Donor Information Sheet and Consent Form - STRATUM Template June 2013
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data we must hold for archival or audit purposes]. [We will no longer access your
medical records and will not contact you again.] However, if some time has passed
your samples and information may have already been transferred to or used in
research projects. We cannot get these samples back or remove related information
from studies that have already started. This is because scientists need to keep
records of all data and samples they have used to allow their results to be checked or
reproduced. [We will contact the researchers to request disposal of any of your
samples that remain.]
[Alongside the option above you may also offer the donor one or both of the
options below if you have the technical support for this.]
o No further contact: If you choose this option, [biobank/trial name] would no
longer contact you directly, but we would be able to use the samples and data
you provided previously and to obtain and use information from your medical
records.
o No further access: If you choose this option, [biobank/trial name] would no
longer contact you directly or obtain further information from your medical
records in the future, but we would be able to use the samples and data you
provided previously.
[Cannot destroy derivatives option - if you choose not to destroy part of the
derivatives once created, choose an option from above then add a statement about
these exceptions] We will not be able to destroy [cell lines] once they are created,
either by us or by researchers who have received your samples. [Cell lines] that have
been shared with other researchers will not be retrievable.
Contact details for [biobank, clinical trial or research project]
[Include contact details.]
Optional Content
[Public engagement work undertaken as part of STRATUM, as well as many other projects,
indicates that some research areas may be considered by members of the public to be more
sensitive than others. The optional provisions below are intended to provide the donor with
more information about either specific possible areas of sensitivity (e.g. research involving
animals or cell lines) or options not relevant for all biobanks, research projects or trials (e.g.
possibility of compensation).]
Will my cells or tissue be used for research involving animals?
[If the tissue research may involve the use of animals you should inform the donors about
this.] Human cells or tissue are sometimes put into animals for medical research. Such
studies are still considered essential for some medical research, although these are kept to a
minimum. Animal research is strictly regulated by law to ensure that animals are only used
when there is no alternative and to protect their welfare when used. Donated cells and tissue
may occasionally be used in such studies:
 Directly (e.g. cancer cells or tissue is transplanted directly into a mouse in order to test
a treatment without risking harm to patients), or
 Indirectly (e.g. genes taken from human cancer cells are put inside animal cells to
allow researchers to study how they function).
Will my cells or tissue be used to create cell lines?
[If the tissue research may be used to create cell lines you should inform the donors about
this, and explicit information should be provided where possible.] Scientists are able to
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Biobank Donor Information Sheet and Consent Form - STRATUM Template June 2013
separate individual cells from a piece of tissue and keep these alive in the laboratory. These
cells can grow and multiply, creating a cell line. Most cells have a limited lifespan even as
cell lines, but some cells do not and can be kept for research indefinitely. Cell lines are used
to study new drugs, therapies or diagnostic tests without risking any harm to a patient. Your
cells and tissue may be used to create a cell line.
[If the cells and tissue may be used to create stem cell lines you may want to explain these
further, see Appendix 1 for an example. Also see the following guidance on stem cell
research:
- UK Stem Cell Bank / MRC Code of practice for use of human stem cell lines (2010)
- International Society for Stem Cell Research (ISSCR) Guidelines for the conduct of
human embryonic stem cell research (2006)
- National Academies' Guidelines for Human Embryonic Stem Cell Research (US).]
Will my cells or tissue be used for research linked to reproduction?
[If the tissue research may involve reproduction or you intend to collect gametes or embryos
you should inform the donors about this. Please refer to HFEA guidance for specific
information requirements if you are going to conduct this type of research.
- Human Fertilisation and Embryology Authority Code of practice: Research and
training and specifically information provided to donors.]
Can I donate cells or tissue after death?
[Include this section if your tissue bank has mechanisms to collect tissue or cells after death.
You can ask the donor to sign to an intent to donate statement (see below). The donor
should not be incapacitated at the time of signing the statement. After the donor has died,
the donor’s relatives would also be asked for consent (or authorisation).] Donating tissue and
cells after death can make a significant contribution to our understanding of the causes of
disease and in developing new treatments. [Briefly outline the types of tissue and data your
bank or project is collecting and why.]
If you are interested in donating, you will need to complete and sign a ‘Statement of Intent to
Donate’. If you are interested in becoming a donor, please discuss this with your family and
friends and share your decision with them too. This is important as it will enable them to
carry out your wishes after your death. Unless you have made your wishes known, they may
not be carried out.
[See Appendix 3 for specific points to include on information sheets relating to the collection
of tissue after death.]
Will I receive any compensation for being involved?
[In some cases expenses may be claimed in relation to the donor’s participation in the
research. If so describe these here] Your involvement is on a voluntary basis. There will be
no payment for the donation of [tissue, fluids, data]. However, you will receive [sum] for [type
of visit, e.g. a visit to the clinic or a visit at home] as reimbursement for traveling expenses
and other inconveniences related to taking part.
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Biobank Donor Information Sheet and Consent Form - STRATUM Template June 2013
Consent Form
Optional Content
[We recognise that many consent forms include a list of consent statements for the donor to
initial to signal understanding. We have not taken this approach as the consent form is
intended to appear at the end of, and as an extension to, the information sheet. As such, the
relevant signatures signal agreement to biobanking and research (including development)
described within the whole document. For tiered consent options see Appendix 4.
On signing, the donor should be given a copy of the whole document to keep, and another
complete copy must be kept on file.]
Preferences for Re-contact [only when necessary]
[Recording the donor’s wishes in relation to re-contact will depend on what your tissue bank
or project is capable of offering. Asking donors whether they are happy to be re-contacted is
important if you envisage contacting them to ask for further information, about participation in
new studies, or to provide information relating to your research. If used, accompany with a
choice of two boxes entitled yes or no that the donor, representative or relative can initial.
Possibilities include:]
We may like to re-contact you in the future to ask for further samples or information that may
be of use to researchers, or for further permissions relating to the use of the samples and
information you have already donated:
 I agree that [biobank, clinical trial or research project] may re-contact me in the future
to ask me to provide additional samples or information related to [biobank, clinical
trial or research project] or to invite me to take part in a new study. I understand that
this does not oblige me to provide the samples or take part in further research
We may re-contact with information arising from the study [the options you include here will
depend on the possibilities in relation to feedback of study results, include where relevant:
 Agreement or opt-in/out to receiving general projects results, for example in the form
of a newsletter or email.
 Agreement or opt-in/out to receiving the results of any physical examination
conducted as part of the samples or data collection in which case also briefly explain
the circumstances this may take place and mechanisms by which it would be
achieved].
 Agreement or opt-in/out to receiving the results of any tests for infectious diseases
conducted on the samples, and explain circumstances and mechanisms as above.
 Agreement or opt-in/out to receiving individual level research results or other
incidental results arising from the research. Explain the circumstances and
mechanisms as above – see Will I find out the results of the research?].
[If a re-contact section is included, reassure donors they can re-contact you to change these
choices] If you would like to change any of these options, or withdraw from the research,
please contact [contact details].
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Biobank Donor Information Sheet and Consent Form - STRATUM Template June 2013
Recommended Content
[Please note the consent options below cover circumstances that relate to adults with
capacity. Please include the consent statements required for your biobank or study from the
options below (we use the term consent throughout, but this is also intended to mean
‘authorisation’ in terms of legal requirements in relation to the use of human tissue in
Scotland):
[Donor statement – should always be included]
Donor Statement I have read the information above, had the opportunity to ask questions and
agree to give [tissue, bodily fluid (e.g. blood) and data /allow access to my medical record] for use
in [biomedical] research as described above.
Signed…………………………….Print Name……………………………………Date………………….
[Statement of person seeking consent – always to be included]
[Clinical/Health/Research Practitioner Seeking Consent] Statement I have explained the
information above to the donor [and/or their representative] and have answered all of their
questions.
Signed…………………………….Print Name……………………………………Date………………….
[A statement from an interpreter should be included if it is possible that any of your
donors or their representatives are unable to communicate in English.]
Interpreter Statement I have interpreted the above information to the donor to the best of
my ability in a way which I believe the patient has understood.
Signed…………………………….Print Name……………………………………Date……………
[A witness statement should be included if it is possible that the donor or their
representative is illiterate, blind or may be able to indicate his or her consent but be
unable to sign – but is not mentally incapacitated. The witness should ideally be
chosen by the donor and not linked to the research team.]
Independent Witness Statement I have witnessed the accurate reading of the information sheet
above to the potential donor and the individual has had the opportunity to ask questions. I confirm
that the individual has given consent freely.
Signed…………………………….Print Name……………………………………Date………………….
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Biobank Donor Information Sheet and Consent Form - STRATUM Template June 2013
[Use of tissue and data after death – intent to donate statement. The donor should not
sign the statement if they can be deemed as lacking in capacity. Consent (or
authorisation in Scotland) might be further sought from the relative after death.]
Donor Statement of Intent to Donate Tissues and Cells After Death In the event of my death I
wish to donate my [tissues, organs or fluids] and allow access to my medical records for
[biomedical] research purposes as described above. I have made this decision at a time when I
am in sound mind and wish it to be followed wherever possible.
Signed…………………………….Print Name……………………………………Date………………….
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Biobank Donor Information Sheet and Consent Form - STRATUM Template June 2013
Appendices
Appendix 1 – Detailed Explanations of Tissue, Cells and DNA
Human cells and tissue
Cells are the basic units from which our bodies are made. They perform all of the functions
we need. Cells can work as single units or combine to make tissue. Good examples of cells
working as single units are red and white blood cells, which we often investigate when
carrying out blood tests. Body fluids, such as blood and urine also contain cells.
However, most cells in our bodies are organised into tissue. In tissue, a mixture of cell types
exist together to carry out a particular job for your body. Most tissues within your body are
organised into organs – for example, your skin, breast, lung, throat, stomach or prostate.
Other tissues do not form organs, for example teeth and bone.
DNA and genes
Cells in your body contain a type of molecule called deoxyribonucleic acid, or DNA for short.
DNA is what your genes are made of. Genes are inherited and direct growth, development,
and how the body functions. For example, some genes control the colour of your hair or
eyes. Scientists have learned a lot about how genes work. There are many differences, or
variations, in DNA from one person to another. These variations may affect a person’s
chance of suffering from a particular disease or the way a person responds to a particular
drug.
How cells and tissue are collected
Cells and tissue are collected from people during a range of procedures. For example:
 blood tests,
 brushings or gentle scrapes from inside of cheeks ,
 operations, and
 biopsies (removing a small tissue sample for examination).
This is done as a normal part of investigating and treating illness. Cells and tissues are
examined by a pathologist to help make a diagnosis. [You may include further information
about the ways you are collecting samples.]
The use of human tissue and fluids for medical education and audit
As well as providing care and treatment, the NHS is responsible for making sure that
medical students, nurses, doctors and other care providers get the training they need and
that NHS processes are monitored (audited). Your tissue can help support these activities.
[You should include further information about how you would use the samples for education
or audit.]
Specific types of tissues or donors
[If your research involves the use of specific types of tissues, including normal tissue, you
may want to give more information about this
Normal tissue needed] An important part of our work is to look at both normal and abnormal
(diseased) tissue samples from patients.
[well donors] Healthy tissue donation is essential in order to enable scientists to compare
diseased and healthy tissue, to find out what goes wrong in disease, why and how diseases
may be treated.
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Biobank Donor Information Sheet and Consent Form - STRATUM Template June 2013
[stem cells] The purpose of this research is to create, use, and share stem cells that can be
converted into many different kinds of cell types, such as muscle, nerve, and liver cells. They
can be kept alive and stored indefinitely in the laboratory and in stem cell banks. There are
different kinds of stem cells. All tissues contain some types of stem cell that are responsible
for renewing that tissue; for example in bone marrow, for making blood, or in the skin. [If
making iPS you may wish to elaborate.] Stem cells can also now be made from normal cells,
for example hormones can be added to skin cells to turn them into nerve cells in the
laboratory. This is very useful as it enables scientists to study different types of tissue that
may otherwise be difficult to obtain. Stem cells can also be obtained from embryos; however,
the creation of stem cells from tissues such as skin raises fewer ethical questions. [see
guidance referred to in optional content section on - Will my cells or tissue be used to create
cell lines?]
Appendix 2 – Detailed Information on Biobank Governance
[Include sections below if your project or tissue bank feels that it must include in-depth
information on governance procedures].
Applications from researchers are evaluated by an [independent access/scientific/ethics
committee] consisting of [health professionals/lay persons/researchers/external specialists].
All organisations wishing to use the tissues or data must enter into a contract ([data and/or
material transfer agreement]) with [the Trust/tissue bank/other organisation] which outlines
what the tissue and data can be used for and how it must be looked after.
[If it is the case that researchers must act in partnership with local researchers add details of
this here.]
Appendix 3 – Detailed Information for Post-Mortem Donors
[Please note, this information suggested is for the donor, also refer to:]
 Human Tissue Authority Code of Practice on Consent Part 2: Tissue from the
deceased and Code of Practice on Research, section on consent.
o Human Tissue Authority model post-mortem examination consent form 2011
 An example of an information sheet is the Leeds GIFT Tissue Bank
Particular points to address with the potential post-mortem donors include, but are not
limited to:
 What will happen when the donor is alive (e.g. will they receive a donor card, need to
complete questionnaires etc.)
 How the donor should keep the biobank staff or research team updated with their
address/GP information.
 Describe the need for the donor to discuss their intention with their relative and
ensure they understand what they will need to do in the event of the donor’s death]
Your relative will need to telephone the [name of biobank, clinical trial or research
project] as soon as possible after your death to arrange for the consent interview and
retrieval of the tissue. The telephone number is [contact details and information about
the hours of service]. A [who e.g. nurse] will answer their call.
 [What kinds of things may happen after death:
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Biobank Donor Information Sheet and Consent Form - STRATUM Template June 2013
o
o



What type of tissue(s) may be taken and how and where they may be stored]
[Blood sample taken & tested for communicable diseases] A blood sample
may be taken from you (after death) to test for communicable diseases. [If
this testing is to be undertaken, explain whether positive results will be fed
back to the relatives]
o [Medical record accessed]
o [Relative asked about donor’s social and medical history]
[How the donor will appear after the tissue is removed.] The procedure used for
removing the tissue will leave your body entirely suitable for viewing at an open
casket funeral.
[How and when the donor will be transported to the funeral home and the fact that no
costs will be incurred by the relatives for this donation] As the tissues are removed as
soon as possible after death, your donation to [the tissue bank, clinical trial or
research project] will not delay funeral arrangements. We will organise for your body
to be transported from the hospital where the tissues will be removed to the
undertakers responsible for the funeral. No extra costs will be incurred by your
relatives, carers or estate as a result of these procedures.
o [Outline what may happen if donor dies at home but wishes to donate]
[How tissue may be disposed of] When your tissue has been used for research or it
is no longer suitable for research, it will be disposed of in an ethical and respectful
manner.
Appendix 4 – Tiered Consent
[If tiered consent is offered, provision must be made for tracking donor preferences, and the
samples and data must only be used in agreement with the donor’s wishes.
There are two possible approaches to tiered consent, the first gives the donor an explicit
choice about whether to opt-in or out, and the second asks the donor to agree to a negative
or positive statement, see the examples below taken from existing consent forms.
Opt-in or out:
-
Transfer of HBS or data abroad]
o Do you give permission for samples to be sent to centres outside the UK?
[Experiments involving animals]
o Do you give permission for your samples to be used in experiments using
[animal type e.g. rodents (rats or mice)]?
[Positive or negative statements that must be initialled or ticked in order to agree/give
permission:
-
-
Creation of cell-lines from the tissue]
o These samples may be used to create cell lines
[Use of HBS and data by commercial researchers]
o I understand that some of these projects may be carried out by commercial
organisations and that I will not benefit financially if this research leads to
new treatments or medical tests.
[Use of HBS for genetic research]
o These samples may be used for genetic research
[Access to medical records]
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Biobank Donor Information Sheet and Consent Form - STRATUM Template June 2013
o
-
I give permission for information about me, provided by me or found in my
medical and other health-related records, to be supplied to and stored by
[biobank, research project or clinical trial] for research purposes.
[Contacting GP for information if they stop attending the hospital]
o My GP can be contacted for information relevant to my condition and ongoing
treatment in the event that I stop attending [the hospital or Trust].
Appendix 5 – Specific Consent
[This template can still be used to support specific consent in one of two situations:
1. when HBS and data are initially collected for a specific research project, with generic
(or tiered) consent being sought for the HBS that are left-over after the specific
research project has been conducted,
2. when HBS and data are solely being collected for a specific research project.
In situation 1, you will need to provide both information specific to your “project” and the
“biobank” under headings: “What is the purpose of the sample collection?”, for example ]
The purpose of asking you to donate your samples with [medical/lifestyle] information is to
enable research into your [disease/condition]. With your agreement, leftover samples and
related information will be transferred to [name] Biobank for future research into related
[diseases/conditions], and other [diseases/conditions] with a genetic basis.
[You will also need to amend sections on: “Who has approved the research”, “Will my [tissue
or body fluid] sample be used in genetic research?”, “How will ...” and “How long will my
samples and data be stored?”, “Will I find out the results of the research?”, “What if I change
my mind?”, “Contact details..”, the optional content (e.g. on animals, cell lines and
reproductive research). In “What will happen if I agree?” add a paragraph on the optional
transfer to the biobank after the sample has been used in the research project. “Who will
access..” should mainly refer to the biobank.
In relation to consent options, the re-contact section should contain separate statements on
the research project and biobank as applicable. The general consent options should include
one statement the donor agrees to in relation to the project, and another for further
biobanking. If using tiered consent, refer to Appendix 4 for more details on additional
consent options.
In situation 2 consider removing the section on “who will access my samples and data, and
how is this decided?”. The other options should be selected as relevant.]
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Biobank Donor Information Sheet and Consent Form - STRATUM Template June 2013
Appendix 6 – Check-list for Designing Information Sheets and Consent Forms
Section
Why are human tissues and body fluids vital for
research?
What is the purpose of the [sample
collection/research]?
Who has approved the research?
Why am I being invited?
What will happen if I agree to take part?
Will my sample/s be used in genetic research?
What are the benefits and risks of taking part?
Who will access my samples and data?
How will my samples and data be stored?
How long will my samples and data be stored?
Will I find out results of the research?
What if I change my mind?
Contact details for [biobank, clinical trial or
research project]
Will my cells or tissue be used for research
involving animals?
Will my cells or tissue be used to create cell
lines?
Will my cells or tissue be used for research linked
to reproduction?
Can I donate cells or tissues after death?
Will I receive any compensation for being
involved?
Preferences for Re-contact
Consent Statements
Appendix 1 – Detailed Explanations on Tissue,
Cells and DNA
Appendix 2 – Detailed Information on Biobank
Governance
Appendix 3 – Detailed Information for PostMortem Donors
Appendix 4 – Tiered Consent
Appendix 5 – Specific Consent
Mandatory or Optional? Covered?
Mandatory
Mandatory
Mandatory
Mandatory
Mandatory
Mandatory
Mandatory
Mandatory
Mandatory
Mandatory
Mandatory
Mandatory
Mandatory
Optional
Optional
Optional
Optional
Optional
Optional
Mandatory
Optional
Optional
Optional
Optional
Optional
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