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Template for Patient Information Sheets for CTIMPs Sponsored
by UCL Involving Adults with Capacity.
This template is based up on guidance given by the National Research Ethics Service
(NRES) published May 2009. You are advised to check the NRES guidance on their
website for the most up to date requirements. This template is suitable only for CTIMPs
involving adults with the capacity to give informed consent.
The Patient Information Sheet (PIS) should be written in simple, non-technical terms and
be easily understood by a lay person. Short words, sentences and paragraphs should be
used, with one ‘message’ per sentence. You may wish to estimate the ‘readability’ of
your text by the application of standard formulae. Checks on readability are provided in
most word processing packages. In Microsoft Word, follow these steps:
 Choose Tools from the menu bar
 Click on Spelling and Grammar
 Click on Options at the bottom of this dialogue box
 Check the option on the bottom left to ‘Show readability statistics’ and click on
OK. The statistics will then show at the end of the spelling and grammar check.
Each readability score bases its rating on the average number of syllables per
word and words per sentence. In the Flesch Reading Ease score, aim for 60-70
(100 is the highest) using the Flesch-Kincaid Grade Level score aim for 7 to 8.
Guidance that should be deleted before submission is in red italics. Suggested standard
paragraphs which you should keep or amend to suit your study are given in black
(outside of this box).
To delete this box, right click somewhere within it and choose ‘delete rows’.
Please check that this is the latest version of this template by looking it up on the
JBRU website: http://www.ucl.ac.uk/joint-rd-unit/
Hospital headed paper to be used on the first page of the information sheet only.
The above box containing information about the template should be removed when
developing your information sheet.
Patient Information Sheet OR
Participant Information Sheet
Part 1
This part should allow the participant to decide whether they wish to read and
discuss it further. It should provide clear information on the essential elements of the
specific study: the condition or treatment under study, the voluntary nature of
involvement, what will happen during and after the trial, what treatment may be
withheld, the participant’s responsibilities; the potential risks, inconvenience or
restrictions balanced against any possible benefits and the alternatives.
Study title: Ensure this is consistent with the title on your consent form
Protocol Reference Number:
Use the short title of your study, ensuring that it is comprehensible by lay people. An
appropriate protocol reference should appear on the information sheet and consent
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form, your R&D number will be appropriate. If acronyms are used in the title they
must be spelled out in full the first time they appear. The title should not consist of an
acronym alone.
Invitation paragraph
The invitation is to ask the potential participant to consider the study and then decide
whether to take part. Both must be clearly explained.
We would like to invite you to take part in our research study. Before you decide we
would like you to understand why the research is being done and what it would
involve for you. One of our team will go through the information sheet with you and
answer any questions you have. We‘d suggest this should take about XX minutes
Talk to others about the study if you wish.
Part 1 tells you the purpose of this study and what will happen to you if you take part.
Part 2 gives you more detailed information about the conduct of the study.
Ask us if there is anything that is not clear. Take time to decide whether or not you
wish to take part.
1.
What is the purpose of the study?
Briefly explain the background and aim of the study; you may cover reasons why the
trial is important at this time; evidence from other studies regarding the effectiveness
of the drug to be investigated. If different patients in the trial are to receive different
treatment schedules, a brief overview of what each patient group will receive should
be provided. It should be made clear if the study is being conducted for a student
research project.
2.
Why have I been invited?
Explain why and how the participant was chosen or recruited (i.e. their suitability and
eligibility for the study) and how many others will be in the study.
This section is particularly relevant if the patient was approached by a person other
than the clinician responsible for their care at this hospital.
3.
Do I have to take part?
It is up to you to decide to join the study. We will describe the study and go through
this information sheet. If you agree to take part, we will then ask you to sign a
consent form. You are free to withdraw at any time without giving a reason. This
would not affect the standard of care you receive.
If further explanation is needed of possible implications of withdrawal this should be
given in Part 2.
4.
What will happen to me if I take part?
This section should include:
- how long the participant will be involved in the research;
- how long the research will last (if this is different);
- if and how often they will need to meet a researcher, visit a clinic or their GP;
- how long these visits will be;
- what exactly will happen e.g. access to personal information/samples
questionnaire, interview, discussion group, measurement, sample collection,
blood tests, x-rays, etc. (briefly, further detail can be given in part 2)
- it should be clear which procedures are above standard care and whether any
normal treatment is going to be withheld because they are taking part in the study
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It may help if the information is displayed in a simple flowchart or grid indicating what
will happen at each visit rather than lengthy lists in the text.
Long-term monitoring/follow-up should be mentioned. You should inform the
participant if your study will involve video/audio-taping or photography.
Specific consent will be needed if published material identifies the subject.
You should set out simply the research methods you intend to use. The following
simple definitions may help:
Randomised Trial – Sometimes we don‘t know which way of treating patients is best.
To find out, we need to compare different treatments. We put people into groups and
give each group a different treatment. The results are compared to see if one is
better. To try to make sure the groups are the same to start with, each patient is put
into a group by chance (randomly).
You should tell the patients what chance they have of getting the study
drug/treatment, e.g. one in four chance.
Cross-over trial – In a ‘cross-over trial‘ the groups each have the different
treatments in turn. There may be a break between treatments so that the first drugs
are cleared from your body before you start the new treatment.
Blind trial – In a ‘blind trial' you will not know which treatment group you are in. If the
trial is a ’double blind trial‘, neither you nor your doctor will know in which treatment
group you are (although, if your doctor needs to find out he/she can do so).
Placebo – A placebo is a dummy treatment such as a pill which looks like the real
thing but is not. It contains no active ingredient.
5.
Expenses and payments
Explain if expenses (e.g. travel, meals, child-care, compensation for loss of earnings,
etc.) are available and you should consider whether any vouchers, gifts, etc. which
you are intending to give as a ‘thank-you’ for participation, should be detailed in the
information sheet. The arrangements for any other payment, e.g. for Phase I
volunteers, should be given including, if necessary, an explanation of how payments
may be influenced by the duration of involvement in a study or factors such as the
completeness of diaries.
6.
What will I have to do?
Set down briefly and clearly what you will expect of your research subjects.
Include a short description of the drug and give the stage of development. Explain (if
appropriate) that the participants should take the study medication regularly as
directed and whether they can continue to take their regular medication or other
prescribed or over-the-counter drugs.
It should also be explained that they will need to consider whether they should
participate if they are in other drug studies, or have been in the recent past (specify
how long). Explain other essential study requirements, e.g. attendance at all
scheduled visits, keeping diaries, filling questionnaires, etc.
Any lifestyle or dietary restrictions should also be stated, for instance whether they
can drive, drink alcohol, give blood or take part in sports.
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7.
What are the alternatives for diagnosis or treatment?
Explain other possible treatments in therapeutic research, with the important
comparative risks and benefits. For a multi-site study, the Chief Investigator should
check on local variations in alternative treatments, which may need to be reflected in
the information given to the main REC for approval. Relevant information can then
be drawn to the attention of participants at each trial site.
8.
What are the possible disadvantages and risks of taking part?
Risk of the disease/condition/illness and the risk of research should be carefully
separated. Any risks, discomfort or inconvenience should be outlined, for instance if
they are having venepuncture, the risk of bruising, discomfort and fainting should be
mentioned.
Radiation and the Ionising Radiation (Medical Exposure) Regulations –
(IRMER))
If the ionising radiation is part of the research study, then information must be given
to the participant on the radiation involved and dosage, in everyday terms that they
can understand. Since treatments may differ at individual sites in a multi-site study,
expert local advice must be sought for each site. The Chief Investigator should check
on local variations so that the range can be reflected in the information given to the
main REC for approval. Relevant information can then be drawn to the attention of
participants at each trial site.
In designing the information sheet you should consider insurance issues and whether
patients should be informed that their participation may affect insurance cover. If it is
a possibility, the potential participant should be told what would happen if other
conditions were discovered of which he or she was unaware, or example:
Before participating you should consider if this will affect any insurance you have and
seek advice if necessary
9.
What are the side effects of any treatment received when taking part?
For any drug or procedure you should explain the possible side effects. For any new
drug it should be explained that there might be unknown side effects. International
Conference on Harmonisation Good Clinical Practice (ICH GCP) requires
participants to be told about ‘reasonably foreseeable risks’. Side effects should be
listed in terms the participant will clearly understand (e.g. ‘damage to the heart’ rather
than ‘cardiotoxicity’; ‘abnormalities of liver test’s rather than ‘raised liver enzymes’).
The information should be prioritised in terms of seriousness, severity and frequency,
with a simple example of frequency, which a participant would understand.
It should reflect what a reasonable person would expect to be mentioned (i.e. rare
side effects are relevant if they may be serious or permanent). It should include
serious but rare side effects which may influence the patient’s decision to take part –
“if I’d known this might happen I would not have taken part”. The level of detail
should also be influenced by the expected benefit from the treatment and the
underlying prognosis of the condition.
For a very new or very potent investigational drug, a fuller list of suspected sideeffects may be appropriate.
Adverse events that have been noted with an equal rate in active and control groups
and that are most likely due to the underlying condition should not usually be listed
as likely side effects. If participants suffer these or any other symptoms they
should be given clear guidance on when, how and to whom to report them.
Contact numbers should be given clearly and boldly.
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Harm to the unborn child: therapeutic studies
Complete this section carefully. In certain circumstances, for instance in patients who
are involuntarily infertile, its use would be inappropriate.
For women A clear warning must be given in studies where there could be harm to
an unborn child or there was risk in breast-feeding. The information should include
the need for pregnancy testing, contraceptive requirements, and reporting of a
pregnancy during the trial. If any pregnancy were to be monitored, this needs to be
made clear, particularly if the mother’s notes or child’s notes are going to be
accessed. If the baby will be followed up or examined post-natally, this should also
be explained.
It is possible that if the treatment is given to a pregnant woman it will harm the
unborn child. Pregnant women must not therefore take part in this study,
neither should women who plan to become pregnant during the study.
Women who are at risk of pregnancy may be asked to have a pregnancy test
before taking part to exclude the possibility of pregnancy. Women who could
become pregnant must use an effective contraceptive during the course of this
study. Any woman who finds that she has become pregnant while taking part
in the study should immediately tell her research doctor.
For men There should also be an appropriate warning and advice for men if the
treatment could damage sperm and consequently the foetus. Information concerning
the importance of careful contraception and what to do if their partner becomes
pregnant is essential. Specific advice for pregnant partners may be needed,
including information on any compensation arrangements
10.
What are the possible benefits of taking part?
Explain these, but where there is no intended clinical benefit, this should be stated
clearly. It is important not to exaggerate the possible benefits as this may be seen as
coercive.
We cannot promise the study will help you but the information we get from this study
will help improve the treatment of people with [name of condition].
11.
What happens when the research study stops?
The arrangements after a therapeutic trial must be given, particularly if this differs
from that normally expected for their medical condition. It must be clear whether the
participant will have continued access to any benefits or intervention they may have
obtained during the research. If the treatment will not be available after the research
finishes, this should be explained to the participant with information on what
treatment will be available instead. You should consider whether and when it may be
possible to tell participants which arm of the study they were in.
12.
What if there is a problem?
Any complaint about the way you have been dealt with during the clinical trial or any
possible harm you might suffer will be addressed. The detailed information
concerning this is given in Part 2 of this information sheet. If you have any concerns
or complaints you should contact your study doctor in the first instance.
13.
Will my taking part in the study be kept confidential?
Yes. We will follow ethical and legal practice and all information about you will be
handled in confidence. The details are included in Part 2.
14.
Contact Details
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Your Doctor
Name add name
Tel. Number: add Tel. number
Your Research/Specialist Nurse/Research Fellow delete as appropriate
Name add name
Tel. Number: add Tel. number
This completes Part 1 of the Information Sheet.
If the information in Part 1 has interested you and you are considering participation,
please read the additional information in Part 2 before making any decision.
Part 2
15.
What if relevant new information becomes available?
You will need to tell the participant about this. The following is an example:
Sometimes we get new information about the treatment being studied. If this
happens, we will tell you about it and discuss whether you want to or should continue
in the study. If you decide not to carry on, we will make arrangements for your care to
continue. If you decide to continue in the study we will ask you to sign an updated
consent form. OR On receiving new information, we might consider it to be in your
best interests to withdraw you from the study. If so, we will explain the reasons and
arrange for your care to continue.
OR If the study is stopped for any other reason, we will tell you why and arrange your
continuing care.
16.
What will happen if I don’t want to carry on with the study?
Explain what the subject can and can’t expect if he or she withdraws. It may not be
possible or desirable for data to be extracted and destroyed. In a clinical trial, the
participant may wish to withdraw entirely or may wish to withdraw from treatment but
be willing to continue to be followed up. If there are any restrictions on withdrawal,
e.g. a single intervention will take place but they may withdraw from any further data
collection, this should be made clear. If continuing follow-up is genuinely in the
participant’s own interests or an exit check up will be needed, then this should be
stated. The participant, however, retains the right to decide if data from this visit can
be used.
The position on retention/destruction of data/samples on withdrawal must be made
clear. In a clinical trial it is usually important to retain data already collected, and may
be important to collect further outcome data on an intention to treat basis. It is
important to make your intentions clear to the participant, and ask for the relevant
consent, for example:
If you withdraw from the study, we will destroy all your identifiable samples, but we
will need to use the data collected up to your withdrawal. OR You can withdraw from
treatment but keep in contact with us to let us know your progress. Information
collected may still be used. Any stored blood or tissue samples that can still be
identified as yours will be destroyed if you wish.
17.
What if there is a problem?
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You should inform patients how complaints will be handled and what redress may be
available. This must be applicable, as appropriate, to NHS and private settings for
the research.
Distinguish between complaints from subjects regarding their treatment by members
of staff and something happening during or following their participation in the trial i.e.
a reportable serious adverse event.
Complaints
A contact number should be given. This may be the researcher, who can try to solve
the problem in the first instance. However, a participant may not wish to complain to
the researcher if he/she is the object of the complaint, and may wish to make a more
formal complaint.
If you have a concern about any aspect of this study, you should ask to speak to the
researchers who will do their best to answer your questions [contact number]. If you
remain unhappy and wish to complain formally, you can do this [insert details e.g.
NHS Complaints Procedure]. Details can be obtained from [insert details]
Harm Appropriate redress and/or compensation should be available and details of
insurance/indemnity schemes should be given.
NHS based research NHS bodies are liable for clinical negligence and other
negligent harm to individuals covered by their duty of care. NHS Institutions
employing researchers are liable for negligent harm caused by the design of studies
they initiate. The provision of such indemnity for negligent harm should be stated to
the participant.
Every care will be taken in the course of this clinical trial. However in the unlikely
event that you are injured by taking part, compensation may be available.
If you suspect that the injury is the result of the Sponsor’s (University College London)
or the hospital's negligence then you may be able to claim compensation. After
discussing with your study doctor, please make the claim in writing to the [add name
of Chief Investigator for the trial] who is the Chief Investigator for the clinical trial and
is based at [add location name for Chief Investigator or ‘care of’ and use UCL name].
The Chief Investigator will then pass the claim to the Sponsor’s Insurers, via the
Sponsor’s office. You may have to bear the costs of the legal action initially, and you
should consult a lawyer about this.
Participants may also be able to claim compensation for injury caused by
participation in this clinical trial without the need to prove negligence on the part of
University College London or another party. You should discuss this possibility with
your study doctor in the same way as above.
Regardless of this, if you wish to complain, or have any concerns about any aspect of
the way you have been approached or treated by members of staff or about any side
effects (adverse events) you may have experienced due to your participation in the
clinical trial, the normal National Health Service complaints mechanisms are
available to you. Please ask your study doctor if you would like more information on
this. Details can also be obtained from the Department of Health website:
http://www.dh.gov.uk.
18.
Will my taking part in this study be kept confidential?
You should tell the participant how their confidentiality will be safeguarded during and
after the study. You may wish to tell the participants how your procedures for
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handling, processing, storage and destruction of their data match the Caldecott
principles and/or appropriate legislation.
The participant should be told:
- how their data will be collected;
- that it will be stored securely, giving the custodian and level of identifiably (e.g.
coded, anonymous, etc.);
- what it will be used for. It must be clear if the data is to be retained for use in
future studies and whether further REC approval will be sought;
- who will have access to view identifiable data (authorised persons such as
researchers, sponsors, regulatory authorities & R&D audit (for monitoring of the
quality of the research) etc;
- how long it will be retained and that it will be disposed of securely.
A suggested form of words is given below, however this must be tailored to your
individual study, so please read the text and ensure it applies in your case, it should
be amended if not.
If you consent to take part in this study, the records obtained while you are in this
study as well as related health records will remain strictly confidential at all times.
The information will be held securely on paper and electronically at your treating
hospital and the main hospital site managing this research under the provisions of
the 1998 Data Protection Act. Your name will not be passed to anyone else outside
the research team or the Sponsor (UCL), who is not involved in the trial. You will be
allocated a trial number, which will be used as a code to identify you on all trial forms.
Any information about you which leaves the hospital/surgery will have your name and
address removed so that you cannot be recognised (if it is applicable to your
research).
Your records will be available to people authorised to work on the trial but may also
need to be made available to people authorised by the Sponsor, which is the
organisation responsible for ensuring that the study is carried out correctly. By
signing the consent form you agree to this access for the current study and any
further research that may be conducted in relation to it, even if you withdraw from the
current study.
The information collected about you may also be shown to authorised people from
the UK Regulatory Authority (the Medicines and Healthcare Products Regulatory
Authority); this is to ensure that the study is carried out to the highest possible
scientific standards. All will have a duty of confidentiality to you as a research
participant.
If you withdraw consent from further study treatment, unless you object, your data
and samples will remain on file and will be included in the final study analysis.
In line with the regulations, at the end of the study your data will be securely archived
for a minimum of 20 years. Arrangements for confidential destruction will then be
made.
Participants have the right to check the accuracy of data held about them and
correct any errors. Participants should be informed of any transfer of their identifiable
data to countries having a lower standard of data protection than the UK. The
following or similar words could be used:
Data collected during the study may be transferred for the purpose of (processing,
analysis, etc) to associated researchers within/outside the European Economic Area.
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Some countries outside Europe may not have laws which protect your privacy to the
same extent as the Data Protection Act in the UK or European Law. The Sponsor of
the trial will take all reasonable steps to protect your privacy.
19.
Will my GP be informed of my involvement?
You should explain if the participants GP (or other health care practitioner) needs to
be notified of their participation, and seek consent for this.
With your permission, your GP, and other doctors who may be treating you, will be
notified that you are taking part in this study.
You should explain what information will be exchanged, for instance the results of
any tests you perform. There may be circumstances in which informing the GP may
not be necessary, acceptable or possible.
20.
What will happen to any samples I give?
Explain whether:
- new samples will be taken (e.g. blood, tissue, specifically for this study);
- samples excess to a clinical procedure will be asked for;
- access to existing stored samples will be asked for.
Include the following details:
- the secure procedures for collecting, using and storing samples;
- any possible intended use in the future for research that cannot yet be
specified. A separated or two part consent form is recommended if future use
is intended, and it should be clear if further REC approval will be sought;
- who will have access to the samples;
- the level of identifiability (for this study and for storage for future studies);
- provision for destruction;
- procedures for possible feedback of individually significant information from
their use;
- whether samples will be transferred outside the UK.
If there is a any possibility that samples may be used in future research, NRES
strongly advise prospective consent is obtained.
21.
Will any genetic tests be done?
A separate consent form for genetic studies should be used to allow participants to
take part in the main study alone without joining a genetic sub-study, unless this is a
necessary condition of trial entry.
22.
What will happen to the results of the research study?
The results of the study will be available after it finishes and will usually be published
in a medical journal or be presented at a scientific conference. The data will be
anonymous and none of the patients involved in the trial will be identified in any
report or publication.
Should you wish to see the results, or the publication, please ask your study doctor.
Participants often want to know results of a study they have been in. The results
could be separated into ’broad scientific results of a trial’ and ‘results with relevance
to the individual’. Consider both as appropriate but they may need different
management.
23.
Who is organising and funding the research?
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The answer should include the organisation or company sponsoring the research and
funding the research if these are different. The patient should be told whether the
doctor conducting the research is being paid for including and looking after the
patients in the study and has any conflicts of interests. These must be declared to the
REC and participant. The following is an example: Your doctor will be paid for
including you in this study.
24.
Who has reviewed the study?
All research in the NHS is looked at by independent group of people, called a
Research Ethics Committee, to protect your interests. This study has been reviewed
and given favourable opinion by ______________Research Ethics Committee.
The information sheet MUST be dated and given a version number (referring to a
protocol number if necessary) in the footer, and the information sheet should state
that the participant will be given a copy and a signed consent form to keep.
25.
Further information and contact details
You are encouraged to ask any questions you wish, before, during or after your
treatment. If you have any questions about the study, please speak to your study
nurse or doctor, who will be able to provide you with up to date information about the
drug(s)/procedure(s) involved. If you wish to read the research on which this study is
based, please ask your study nurse or doctor. If you require any further information
or have any concerns while taking part in the study please contact one of the
following people:
Your Doctor
Name add name
Tel. Number: add Tel. number
Your Research/Specialist Nurse/Research Fellow delete as appropriate
Name add name
Tel. Number: add Tel. number
For some studies an emergency contact number (which will be manned out-of-hours),
should be given and clearly displayed. In a multi-site trial, the numbers must be
appropriate for each site.
Alternatively if you or your relatives have any questions about this study you may
wish to contact one of the following organisations that are independent of the hospital
at which you are being treated:
Add in any disease specific support groups which may provide advice about taking
part in trials.
If you decide you would like to take part then please read and sign the consent form.
You will be given a copy of this information sheet and the consent form to keep. A
copy of the consent form will be filed in your patient notes, one will be filed with the
study records and one may be sent to the Research Sponsor.
You can have more time to think this over if you are at all unsure.
Thank you for taking the time to read this information sheet and to consider this study.
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