University guidance on designing a participant information sheet

Text with a coloured background in this document is for guidance only,

and should be deleted from the final ‘Participant Information Sheet’ that is
provided to participants.

The informed consent process

The informed consent process requires that prospective participants are

provided with as much information as possible about a research project in
order that they and / or their legal guardians / advocates can make an
informed decision about whether or not they want to take part in the
project.

Information sheets, which are normally provided in written format - but

can also be spoken, are an important part of the informed consent
process. This document has been produced as guidance for staff and
students designing their information sheets. If you have any questions,
please contact the Research Ethics and Integrity team on 0151 794 8290
or at [email protected].
Guidelines for creating your participant information sheets

Designing your participant information sheets

The design of your information sheet should reflect the nature of the
research study.
Wherever possible, it is important to seek input from your
participant pool, who can help design your form with you for best
practice. For example, for a study which involves children, you may
consult the Young Person’s Advisory Group.

Some information sheets may need to be more detailed than others, or

may use graphics as well as text. You may decide that a word-processed
document is not the best or only way to communicate with your
participants – you should consider exploring other formats such as
video, audio, or leaflets.

Important rules relating to your information sheets

It is important to make sure that even after the information sheet has
been read and consent has been obtained, the participant has the
right to ask any further questions and they should be provided with
details on where to find further appropriate information on the specific
research area.

All protocols, research proposals, and supporting documents (including

information sheets and consent forms) should state the version number
and date of the document, as in the template provided later in this
document. This date indicates when the documentation was finalised.
Version numbers and dates show how a document was developed, help to
identify earlier versions if required, and aid monitoring and audit.

Please note:
 If an amendment to a document is made, the version number and date
must also be amended.
 Failure to include version dates will slow up the approval process as
they will be sent back to the researcher for amendment.
 You must ensure that the information you provide in this
document is consistent with the statements in your consent
form and the information listed in your data management plan.
For example, if your data management plan states anonymised data
will be archived, the consent form must also have a statement
mirroring this, and so on.

It is essential that any logos, project titles, contact details, etc. are
consistent across all documents, and that a record of the changes to
documents is logged through version numbers and dates for each
document.

The first page of the information sheet (and all corresponding documents)
should have the University Crest (found at:
https://www.liverpool.ac.uk/intranet/brand/brand-guidelines/ at the top in
the centre.
Specific considerations for different research populations

You may need to make provision for participants who are not
fluent in the language used in the information sheet and should
consider how to deal with challenges such as illiteracy. For example, you
may choose to have an interpreter / translator to hand for participants
who may not be fluent in the language used; and you will need to consider
appropriate ways to record the participant’s consent.

Information should be displayed in an appropriate format for the

population involved in the research, for example, pictorial / diagram /
oral / video format may be more suitable for some participant groups.

Studies involving children / vulnerable adults: you may need to

consider producing an alternative version of the information sheet which
is more accessible, and which can be discussed with the legal guardian
(e.g., parent / guardian/ caregiver etc.). This alternative version should,
however, conform to the same purpose as other information sheets in that
its aim is to provide enough information and in appropriate detail so that
informed consent can be obtained.
Checklist for your participant information sheet

Before finalising your information sheet using the template on the

following page, please use the checklist below to ensure your information
sheet conforms with good research practice.

Consideration Respons
e
Have you worked with, consulted with, or at least ☐
considered the needs of, the research population when
designing your information sheets?
(Information should be displayed in an appropriate format
for the population involved in the research)
Have you considered different ways to provide information ☐
to your participants?
(For example: explanatory videos, leaflets and visual
media, audio recordings, diagrams etc.)
Do your information sheets have version numbers and ☐
dates?
Is the information in your participant information sheet ☐
consistent with information in other documentation?
(For example, have you described the data management
practices consistently in your information sheet, consent
form, and research ethics application?)
Consideration Respons
e
Have you included clear and consistent contact details for: ☐
 the research study team?
(So that participants can ask any questions about the
study – these should be work phone numbers and email
addresses; you must not include personal contact
details)
 the research ethics team, [email protected] and
0151 794 8290?
(So that participants can raise any complaints or issues
that they do not feel comfortable discussing with the
research study team)
 The Information Commissioner's Office, 0303 123 1113;
or an equivalent body
(So that participants can raise any concerns about the
way their personal data have been processed)
 Any relevant procedures for safeguarding
(So that participants have contact details if they wish to
raise safeguarding issues)

Please see the below pages for the template for the University of
Liverpool participant information sheet, which consists of sections
that apply to each research project. There are also some optional
statements which apply only to specific studies. Please read these
carefully and add any that are appropriate to your research project.
University Participant information sheet template

1. Title of Study

Your study title should be the same on all related documents and should explain the study in simple
English. If you have used a short title, make sure that you quote this as well as the full title on your
ethics application form.

2. Version Number and Date

All information sheets should have a version number and date (usually recorded in the document
footer) as a way of determining which version of the documentation participants have received should
any queries arise.

3. Invitation Paragraph

Invite the participant to take part in the study, and make sure that it does not sound as if they are
being pressured or coerced. For example:

You are being invited to participate in a research study. Before you decide whether to participate, it is
important for you to understand why the research is being done and what it will involve. Please take
time to read the following information carefully and feel free to ask us if you would like more
information or if there is anything that you do not understand. Please also feel free to discuss this with
your friends, relatives, and GP if you wish. We would like to stress that you do not have to accept this
invitation and should only agree to take part if you want to.

Thank you for reading this.

4. What is the purpose of the study?

In plain language that can be understood by a non-expert, and with all technical terms and acronyms
defined, you should explain why the study is being done - the background, what is already known,
aims and objectives etc.

If it is not appropriate to inform participants of the purpose of the research at this stage - for example
in the case where this may affect the behaviour of participants - please ensure that participants are
fully debriefed at the end of the research. Please also enclose a debriefing form with your application
for research ethics review.
5. Why have I been chosen to take part?

Briefly explain the reasons why and how you have chosen to invite participants, and how many others
will be taking part and any inclusion or exclusion criteria that may apply.

6. Do I have to take part?

It should be made clear that participation is voluntary and that participants are free to withdraw their
participation at any time, without explanation, and without any disadvantage.

7. What will happen if I take part?

In language that can be understood by a lay reader, you should provide an explanation of exactly
what will be asked of the participant and what will happen during the research. For example, you
should explain clearly:

 what the methods are;

 who the researchers are;
 who will be carrying out the procedure;
 what the duration / frequency of the procedure is, including time for checking processes or taking
part in follow up interviews or multiple processes - a flow chart may be helpful, particularly for
longitudinal studies;
 what the participant’s responsibilities are.

When writing this section, think about what details you would want to know if you were to take part in
a research study.

Participants should be made aware if research involves any audio / visual recording and this should
be made clear in both the information sheet and consent form.

Please note that if there is a possibility that the participant’s GP may need to be contacted (ideally
with the participant’s explicit knowledge – for example, by a copy letter or email), this should also be
made clear in the information sheet and consent form.

8. Are there any risks in taking part?

Please explain any potential disadvantages or risks. Explain that if the participant should experience
any discomfort or disadvantage as part of the research that this should be made known to the
researcher(s) immediately.
Certain areas of research may have the potential for identifying a serious risk to the participant or to
others. This might relate to the identification of a medical condition, financial concerns (e.g., severe
debt), legal concerns, etc. If you believe your research could identify such risks, you should
provide details in your information sheet of advice and resources; and details of any
procedures that will be followed.

For example:

a) in the event of discovering a medical risk, you may advise that information collected may be
referred to an appropriate medical practitioner for professional recommendation on diagnosis
and / or treatment.
b) if you are studying consumer behaviour or spending behaviour, you might include contact details
of the Citizens Advice Bureau so that participants may contact them if they want further advice on
debt.
c) If your research involves studying smoking or alcohol use, you could offer details of local or
national agencies, e.g., Drinkline or Go Smoke Free

In the case of sensitive online studies that are anonymous, if there is a risk of participant distress you
should provide a statement ensuring participants that the researchers will not be able to identify them,
and you should signpost participants to a list of relevant support services.

If the nature of the study means that individuals outside of the research team may need to be
provided with details about the participant’s involvement in the study, this should be stated and
included in the consent form.

9. Are there any benefits in taking part?

Any benefits (at the time of participation or in the future) should be explained. If there is no intended
benefit, this should be made clear; but remember that research can provide benefits in advancing
knowledge and understanding.

10. How will my data be used?

You must inform the participant of the lawful basis for processing their personal data – and if special
category data or criminal offence data will be collected, you will need to outline the condition of
processing as well as the lawful basis (please see the GDPR and research note for further guidance
on the lawful basis for processing). Describe the data you will be collecting - example wording could
be: “specifically we will collect information about your ethnicity and occupation”. You should also state
who will be transcribing the data, if using audio / video recordings.
You should use the following wording to inform participants of the lawful basis on which the University
processes personal data in research; and to inform them of how their data will be used:

“The University processes personal data as part of its research and teaching activities in accordance
with the lawful basis of ‘public task’, and in accordance with the University’s purpose of “advancing
education, learning and research for the public benefit.

Under UK data protection legislation, the University acts as the Data Controller for personal data
collected as part of the University’s research. The [Principal Investigator / Supervisor] acts as the
Data Processor for this study, and any queries relating to the handling of your personal data can be
sent to [Principal Investigator / Supervisor contact details].

Further information on how your data will be used can be found in the table below”.

How will my data be collected?

How will my data be stored?
How long will my data be stored for?
What measures are in place to protect the
security and confidentiality of my data?
Will my data be anonymised?
How will my data be used?
Who will have access to my data?
Will my data be archived for use in other
research projects in the future?
How will my data be destroyed?

Transferring data outside the EU1

If personal data will be transferred outside the European Union, you must explain how this will be
conducted, why this is necessary, and outline the safeguards in place to protect the data.

11. Expenses and / or payments

Detail any expenses that might be available (for travel, refreshments etc.) and any reimbursement
that participants may be eligible for.

12. What will happen to the results of the study?

1
Please note: for the purposes of data protection, the UK is classed as “adequate” and is free to
transfer data within the EU with no additional obligations.
Detail how the results will be made available to the participants and whether the results are to be
published. If the results are to be published, detail how and where they will be accessible. Tell
participants that they will not be identifiable from the results unless they have consented to being so.

If participants are asked to consent to being identifiable through use of their real names or identifiable
quotations, then they should be given the opportunity to review their transcripts and redact them, or
decline to take part after a defined timescale.

13. What will happen if I want to stop taking part?

Participants should be informed that they can withdraw their participation in the study at any time,
without explanation.

Results up to the period of withdrawal may be used, if participants are happy for this to be done.
Otherwise, participants may request that the results are destroyed, and no further use is made of
them. If results are anonymised, you should make clear that results may only be withdrawn prior to
anonymisation; and it is good practice to provide participant with an estimated time for when the
anonymisation will take place.

You should provide details of how participants can withdraw their information, explain who should be
contacted, and explain any limitations on the withdrawal of information (for example, if the data have
been fully anonymised, or if you plan to use the data for future studies).

14. What if I am unhappy or if there is a problem?

All complaints should be handled through the Committee on Research Ethics complaints procedure.
You should use something similar to the following to explain how complaints will be handled:

“If you are unhappy, or if there is a problem, please feel free to let us know by contacting
[Principal Investigator name and number] and we will try to help. If you remain unhappy or
have a complaint which you feel you cannot come to us with then you should contact the
Research Ethics and Integrity Office at [email protected]. When contacting the Research Ethics
and Integrity Office, please provide details of the name or description of the study (so that it can
be identified), the researcher(s) involved, and the details of the complaint you wish to make.

The University strives to maintain the highest standards of rigour in the processing of your data.
However, if you have any concerns about the way in which the University processes your
personal data, it is important that you are aware of your right to lodge a complaint with the
Information Commissioner's Office by calling 0303 123 1113.”
15. Who has reviewed this research?

You should state which bodies have given approval to the research (including any reference numbers
for the study) – this should also include any local ethics committees if the research is taking place
outside the UK.

16. Who can I contact if I have further questions?

You should give the work name, address, and contact telephone number of the Principal
Investigator. Personal contact details and telephone numbers must not be provided.

Principal Investigator Student Investigator

[Name] [Name]
[Work address] [Work address]
[Work telephone] [Work telephone]
[Work email] [Work email]

Accessibility: To request this document in an alternative format, please contact the Principal
Investigator listed above.
Appendix 1: Optional sections (choose as appropriate)

Who is organising and funding the research?

If the research is externally funded, you should state the organisation or

company that is sponsoring or funding the research.

Disclosure Barring Service check (DBS)

If the research involves vulnerable people (e.g., children, the elderly,

those with learning disabilities etc.) you will usually need to obtain a
Disclosure Barring Service (DBS) check. You may therefore want to make
a short statement to explain that the researchers involved have obtained
a DBS check and that research participants may request evidence of the
DBS from the Principal Investigator.

Discussing sensitive or distressing topics

If the research involves the potential disclosure of personal and sensitive

information, you should explain the risk of potential emotional distress,
and you should emphasise that participants can abstain from answering
any questions they may be uncomfortable with.

You should explain the procedure in place to manage a situation where

participant distress occurs (for example, pausing the interview to provide
time for participants to consider whether to continue or withdraw from the
study).
Health related findings in research

Some health-related studies may involve the collection of data which can
reveal significant unexpected abnormalities, which require medical follow-
up, either for further investigation or (more rarely) treatment.

You should explain to participants that the data are being collected for
research purposes, and state whether you propose to review the data for
potential health related findings in research. If so, you should explain the
procedure in the event that a significant health related abnormality is
found, including whether you will send a report to the participant’s GP
(best practice is to copy in the participant). It should be emphasised that
participation in the study is not a substitute for a ‘health check’.

Please note: for studies taking place at Liverpool Magnetic Resonance

Imaging Centre (LiMRIC), please follow the Policy on Incidental Findings.

Disclosure of criminal activity and duty to disclose

If you are carrying out research where you may collect information with
the potential for disclosure of serious criminal activity (e.g., research with
young offenders and / or prisoners) you should inform participants
that confidentiality may not always be assured. Example wording
could be as follows: “if during the study, you disclose information about
any current or future illegal activities, we have a legal obligation to report
this and will therefore need to inform the relevant authorities.”
Please also ensure that you have discussed with the Prison or Young
Offender Institution an appropriate reporting procedure to follow if such
information is disclosed.

If the nature of the study means that individuals outside of the research
team may need to be provided with details about the participant’s
involvement in the study, this should be stated and included in the
consent form. Examples include:

If, during the study, we have concerns about your safety or the safety of
others, we will inform your GP/care team/family member.

If, during the study, you disclose information about misconduct/poor

practice, we have a professional obligation to report this and will therefore
need to inform your employer/professional body.

Individuals from the University, the site where the research is taking place
and regulatory authorities may need to review the study information for
auditing and monitoring purposes or in the event of an incident.

A court can in exceptional circumstances order researchers to disclose

confidential information that they have collected as part of research
projects. If a court orders disclosure of information collected from you,
confidentiality can no longer be maintained.
Audio/Visual activities

For audio/video recordings you must explicitly state whether participants

are free to decline the recording or whether it is essential to their
participation in the study. You must also state that participants should be
comfortable with the recording process at all times, and they are free to
stop recording at any time.

For audio/video recordings you should tell participants what the

recordings/photographs will consist of (e.g., voice only, facial features, full
body, surrounding environment, other individuals, etc.) and how they are
obtained (e.g., during a focus group discussion, asking participants to take
images or recordings of their lives)
Example: Recordings of your voice during the focus group discussion
Example: Pictures that you take of your local community including the
residents, buildings and any community events that are taking place.

Projects involving Human Tissue

For projects where the researchers are collecting Human Tissue the
participant should be informed of: the samples to be collected; how, when
and by whom; where samples will be stored and for how long; and
whether they are able to ask for the samples to be destroyed at any point.

They should be informed whether there will be DNA analysis; whether you
are seeking generic consent, i.e., to retain the samples (including DNA) for
use in future, ethically approved, research studies, which may include
DNA analysis; how you will dispose of the samples; whether any samples
in this study or future studies will be used in other countries such as the
U.S.A; whether it will involve commercial organizations or the use of
laboratory animals.
Appendix 2: Other example participant information sheets

Examples of participant information sheets can be accessed through the

following links:

 Health Research Authority

 UK Data Service

Examples of age-appropriate information sheets for children can be found

using the below resources:

 Health Research Authority

 Global Kids Online

Utilising different PIS formats may be helpful participants for whom a

traditional participant information sheet may be inaccessible. An example
would be researchers providing some information on their study via
YouTube. The study advertisement can provide a link to the video and
this may supplement the paper version of the participant information
sheet provided. Video link provided courtesy of Ms Tsai Ping-Chen.

https://www.youtube.com/watch?v=hAeNhA8oRAk

When presenting an alternative participant information sheet, captions or

alt-text and other appropriate accessible alternative should be used for
images or graphics. Where video is proposed, a transcript should be
provided with the research ethics application. All videos should be
subtitled.
Appendix 3: University of Liverpool example child participant information
sheet

“Breakfast, lunch and feeling full”

Hello, my name is [A] and I’m from the University of Liverpool. I

am visiting your school today and I am interested in finding out
what kind of breakfast, snack and lunch makes you feel more full.
Please have a look at this leaflet which tells you about this study.

Information sheet for you!

What is the study about? This study is to find out what kind of
breakfast, snack and lunch makes you
feel more full!

Why have I been chosen? You are very important and with your
help I can learn more about this!

1. I will visit you four times at school.

Each time I will ask you to eat a
What will happen if I take different kind of breakfast, snack and
lunch and I will ask you how full you
part? feel and if you liked what you ate.
2. I’ll also ask you to fill in a few short
questionnaires (I will explain what to
do before each one and can help if
you get stuck).
3. The last time I visit I will see how tall
you are and what you weigh (no-one
else will see this).
Yes, you can stop at any point if
Can I stop if I don’t want to do you don’t want to take part
the study anymore? anymore. You don’t have to say
why.

Yes, we will put a number on it

but not your name. No-one will
Will the things I write be
know who you are when we
kept secret?
write about this study.

If you have any questions,

please ask me!

Thank you for reading about

my study 
Appendix 4: Example of a project poster used as a child appropriate participant information
sheet used in a University of Liverpool approved study (courtesy of Dr Ataa Alsalloum,
School of the Arts).

Utilising different formats for the PIS might be appropriate. Leaflets or posters for children
can accompany a parental/guardian PIS. An example of this is shown below used for a
workshop involving children: