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									                              PARTICIPANT INFORMATION STATEMENT
                                      AND CONSENT FORM


HREC Project Number:           30XYZ


Research Project Title:        Does CHOCA-11 stop allergic reactions to chocolate?


Principal Researcher:          Associate Professor Henny Penny, Consultant, Allergy department



Thank you for taking the time to read this Information Statement. This Information Statement and Consent
Form is 7 pages long. Please make sure you have all the pages.

You are invited to participate in a research project that is explained below.

What is an Information Statement?
These pages tell you about the research project. It explains to you clearly and openly all the steps and
procedures of the project. The information is to help you to decide whether or not you would like to take part
in the research.

Please read this Information Statement carefully. You can ask us questions about anything in it. You may
want to talk about the project with your family, friends or health care worker.

Participation in this research project is voluntary. If you don’t want to take part, you don’t have to. You can
withdraw from the project at any time without explanation and this will not affect your access to the best
available treatment options and care from The Royal Children’s Hospital.

Once you have understood what the project is about, if you would like to take part please sign the consent
form at the end of this information statement. You will be given a copy of this information and consent form
to keep.



1. What is the research project about?
There has been a sharp increase in chocolate and cocoa allergy in recent years. The cause of this is
unknown. Because so much processed food contains cocoa, it is difficult for people to avoid eating these
products. Trying to avoid products that contain cocoa is very hard because product labels are confusing.
However, the number of people experiencing allergic reactions has significantly increased.
A new medicine, called CHOCA-11, has been developed to treat people with chocolate/cocoa allergy.
CHOCA-11 contains small traces of natural cocoa and is an immunotherapy treatment. Immunotherapy
treatment is where an increasing amount of an allergen is given to desensitise a person. Use of the medicine
for up to 3 months should help desensitise people with a mild cocoa allergy and allow them to consume
cocoa products in the future.
Medications have to be approved for use by the Therapeutic Goods Administration (TGA), Australia.
CHOCA-11 is an experimental treatment. This means that it is not an approved treatment for chocolate or
cocoa allergy in Australia.

This study is taking place in five hospitals around Australia and aims to enrol 90 children. The Royal
Children’s Hospital hopes to enrol 10 children aged 13-17 years.


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2. Who is funding this research project?
This project is sponsored by the Sweet Tooth Pharma Inc, an Australian pharmaceutical company.
The study drug will be made available to you at no charge while you are on the study. You will not have to pay
for any study tests or procedures.

3. Why am I being asked to be in this research project?
We are asking you to take part because you are 13-17 years old and have an allergy to chocolate/cocoa
products.

4. What do I need to do to be in this research project?
If you are suitable to be in the study and agree to participate, you will need to come to 6 study visits over 12
months. You will take the study medication for 12 weeks.
All of the visits will take place in the Allergy department at The Royal Children’s Hospital.
Screening assessment
To check that the study is suitable for you, we need to do some tests. These include:
      Collecting personal information such as name, date of birth, address and medical history
      Medical check-up: height, weight, waist measurement, blood pressure, stage of puberty
      Blood test
      Urine test including pregnancy test for females
      Skin prick test
      Food challenge
      Questionnaire about your recent health
Randomisation
If you are suitable to take part, we will place you into one of two groups:
           Treatment group. In this group you will receive CHOCA-11
           Placebo group. In this group you will receive placebo. A placebo is a medicine with no active
            ingredients. It looks like the real thing but is not.
The group you are place in will be done by chance, similar to tossing a coin, so you have an equal chance of
being in either group. For the duration of the study neither you nor your doctors will know which group you
are in, however if we need to find out, we can.
Study medication
Whichever group you are placed in, you will need to take 3 x 50mg tablets each day for 12 weeks. This is the
treatment phase of the study. The tablets must be taken with a meal each day and should be taken at the
same time each day for example, if you are taking the tablets with lunch, you must take them at lunch every
day.
Hospital visits
The table below details the number of visits that are needed as part of this project and what will happen at
each visit.
                            Screening     1 month visit      2 month visit   3 month visit   6 month visit      12 month
                                                                                                                  visit
                               visit
    Personal details            X
    Medical check-up            X               X                 X               X                X               X
    Blood test (mls)            10             10                 10              10              10              10
    Urine test                  X               X                 X               X                X               X
    Skin prick test             X                                                                  X               X
    Food challenge              X


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    Questionnaires                X               X               X         X                 X              X
    Randomisation                 X
    Diary                                         X               X         X
    Visit length               4 hours         30 mins          30 mins   30 mins          1 hour          1 hour


Medical check-up
We will complete a physical examination at each visit including a check of your whole body. We will measure
your height and weight and check your blood pressure, heart rate, oxygen saturation of the blood (by clipping
a monitor on your finger), temperature, and how fast you breathe (respiratory rate).
Blood tests
A total of 6 blood samples will be taken during the course of the project. The total amount of blood taken
during the project will be 60 mls (approx 3 tablespoons). The blood will be taken using a needle from a vein
in the arm. The samples will be sent to Sweet Tooth Pharma Inc for testing.
Urine samples
We will get a urine sample to check your kidney function and general health. If you are a girl and have started
your periods, we will do a pregnancy test. Girls who are pregnant are unable to take part in the study.
Skin prick test (SPT)
Skin prick tests are a form of allergy testing which you may be familiar with. They are done by placing drops
of allergens onto the skin of your forearm and making a small prick through the drop using a lancet (a small
metal instrument with a sharp point). In most cases this does not go all the way through the skin and does not
draw any blood. We can tell whether you are allergic to the allergens if a small red lump develops after about
15 minutes. We can give you the results of these tests right away. At the screening visit, if you have a
positive skin prick test to cocoa then you will be able to participate in this study and we will continue with the
rest of the visit.
Food Challenge
We need you to do a food challenge so we are able to determine how sensitive you are to cocoa. This will be
done by getting you to eat small amounts of chocolate over a period of time.
Questionnaires
So we can follow your progress through the study and have a look at your quality of life we will also ask you
to fill in some questionnaires. There will be 2 questionnaires and each will take about 10 minutes to fill in at
the start of each visit.
Diary
During the treatment phase of the study, you will need to write in a diary each day the following information:
what time you took the tablets, what you were eating when you took the tablets, if you had any skin reactions
after you took the tablets eg rash or itch, if you felt sick after taking the tablets or if you had any diarrhoea.
Optional consent
We would like you to consider letting us store any leftover blood samples collected as part of this study, for
use in future ethically-approved research studies related to food allergy. The samples will be stored at Sweet
Tooth Pharma Inc laboratories in Queensland. You will not be contacted if the samples are used in future
research.
Withdrawal from study treatment
We may decide to take you off the study treatment under the following circumstances:
      if we believe that it is in your best interest
      if you have side effects from the treatment that are considered too severe

5. What are my alternatives to taking part in this project?
You do not have to take part in this project if you do not want to.
If you take part and change your mind, you can stop at any time without telling us why. If you withdraw
from the project we will use any information collected from you unless you tell us not to.

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Your decision will not affect any treatment or care you get, or your relationship with The Royal
Children’s Hospital.

6. What are the possible benefits for me?
We cannot promise that you will get any benefits from this project. It is possible you may be able to eat small
amounts of chocolate/cocoa without getting an allergic reaction after treatment with CHOCA-11.
If you take placebo you are unlikely to get a direct benefit from this study.

7. What are the benefits to other people in the future?
The information from this study will help us find out if CHOCA-11 is safe to use in adolescents. If it is, we
may be able to use it as a treatment for chocolate/cocoa allergy in the future.

8. What are the possible risks, side-effects and/or discomforts?
Side-effects
Medical treatments often cause side-effects. You may have none, some or all of the effects listed. They may
be mild, moderate or severe. You should tell us immediately if you experience any side-effects. Sweet Tooth
Pharma Inc has completed two clinical trials of CHOCA-11 in adults. The reported side-effects of CHOCA-11
from these studies include:
              Common                              Uncommon                                      Rare
      Diarrhoea and/or tummy pain         Rash/itchy skin                        Difficulty swallowing
      Constipation                        Headache                               Swelling in the lips, face,
      Nausea/vomiting                                                              mouth and neck
                                                                                   Severe allergic reaction
                                                                                   Anaphylaxis


CHOCA-11 does contain small traces of cocoa product and although the risk of anaphylaxis is rare based on
previous studies, depending on the severity of your allergy, you may be at higher risk for this. Anaphylaxis is
life-threatening. We will supply you with an EpiPen®, and you must agree to keep this with you at all times
during the treatment phase of the study.
Blood tests
There are no major risks associated with a blood test. It is possible you may feel some discomfort during the
blood test. You may feel a sting when the needle is put in you arm to take the blood. We can use a cream to
numb the skin before the blood is taken. It is possible there may be some bruising, swelling or bleeding
where the needle enters the skin. Some people can feel a little light-headed when blood is taken.
Skin Prick Test
The skin prick test is not painful, but it can cause a bump that is itchy for about the first 15 minutes. These
bumps go down within an hour or two. We will tell you how to manage the itch if it causes distress. Skin
prick tests are very safe, but there is a small risk (about 1 in 10,000) of a serious allergic reaction. If this
happens we will immediately treat the reaction with the appropriate medicines.
Food Challenge
You may be at risk of an allergic reaction during the food challenge, however, the risk of anaphylaxis during a
controlled food challenge is low (less than 1 in 100 amongst children presenting to clinics with food allergies).
We will watch you very closely throughout the food challenge and treat any reactions immediately if it
happens.
Reproductive risks
If you are of child-bearing age, it is important to be aware that the drug treatment in this project can
affect an unborn baby.
You should not become pregnant or father a baby while in this project. You should not breastfeed if
you are in this project.
We can advise whether you need to use contraception, what kind of contraceptive methods to use,
and how long to use them.


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Unknown risks
There may be unforeseen or unknown risks. During the research project, new information about the risks
and benefits of this project may become known to us. If this happens, we will tell you about this new
information and how it affects you. This new information may mean that you can no longer participate in this
research. If this happens, we will stop your participation.

9. What are the possible inconveniences?
The main inconvenience is the number of visits to the hospital. We will try to organise these visits for when
you have a regular clinic appointment. We will pay for parking/travel costs to the hospital for visits that are
specifically for this project.

10. What will be done to make sure my information is confidential?
Any information we collect for this research project that can identify you will be treated as confidential. We
can disclose the information only with your permission, except as required by law.
All information will be stored securely in the Allergy department at The Royal Children’s Hospital.
The information will be re-identifiable. This means that we will remove your name and give the information a
special code number. Only the research team can match your name to your code number, if it is necessary
to do so.
We will keep the information until the youngest participant turns 25 years old or for 15 years following the
closure of the study – whichever date is latest. After this time, it will be destroyed.
In accordance with relevant Australian and/or Victorian privacy and other relevant laws, you have the right to
access and correct the information we collect and store about you. Please contact us if you would like to
access your information.
The re-identifiable information from this study will be sent to the sponsor, Sweet Tooth Pharma Inc. The
sponsor will make sure that any information it receives or discloses is kept as confidential as possible. The
sponsor may request to review your hospital medical record.
The following people may access information collected as part of this research project:
               the research team involved with this project
               The Royal Children’s Hospital Human Research Ethics Committee
               Sweet Tooth Pharma Inc
               Therapeutic Goods Administration, Australia
These groups may need to inspect and/or copy your research records for data analysis or to check that study
procedures are followed correctly. Your name and personal details will not be released unless required by
law.
Any blood samples collected as part of this study will be destroyed at the end of the study, unless you have
given your consent for the storage and future use of these samples.
At the end of the study, results will be presented at conferences or published in medical journals. This will be
done in such a way that you cannot be identified.

11. Will I be informed of the results when the research project is finished?
We will send you a summary of the overall project results at the end of the study in 2012. The summary will
be of the whole group of participants, not your individual results.

12. What happens if I am injured during the project?
In the unlikely event that you suffer an injury because of participating in this project, the public health service
will provide hospital care and treatment at no cost to you.

13. Will I be able to claim any compensation if injured?
There are two avenues that may be available to you for seeking compensation if you suffer an injury as a
result of your participation in this research project:

    The pharmaceutical industry has set up a compensation process, with which the Sponsor, Sweet Tooth
     Pharma Inc, of this research project has agreed to comply. Details of the process and conditions are set
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     out in the Medicines Australia Guidelines for Compensation for Injury Resulting from Participation in a
     Company-Sponsored Clinical Trial. In accordance with these Guidelines, the sponsor will determine
     whether to pay compensation to you, and if so, how much. A copy of the Guidelines is available to you
     from the research staff on request. If you have any questions about the Guidelines, please contact
     Director of Ethics & Research on (03) 9345 5044.
    You may be able to seek compensation through the courts.




If you would like more information about the project or if you need to speak to a member of the research
team in an emergency please contact:

Name:                     Henny Penny
Contact telephone:        (03) 9345 0000




If you have any concerns about the project or the way it is being conducted, and would like to speak to
someone independent of the project, please contact:

Director, Ethics & Research, The Royal Children’s Hospital on telephone: (03) 9345 5044.




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                                                  CONSENT FORM


HREC Project Number:              30XYZ


Research Project Title:           Does CHOCA-11 stop allergic reactions to chocolate?


Version Number:                   1                     Version Date:                    31/12/2010



    I voluntarily consent to take part in this research project.
    I believe I understand the purpose, extent and possible risks of my involvement in this project.
    I have had an opportunity to ask questions and I am satisfied with the answers I have received.
    I understand that this project has been approved by The Royal Children’s Hospital Human Research
     Ethics Committee and will be carried out in line with the National Statement on Ethical Conduct in Human
     Research (2007).
    I understand I will receive a copy of this Participant Information Statement and Consent Form.


OPTIONAL CONSENT

    I do             I do not          consent to the storage of my blood samples for use in future ethically
                                       approved research related to food allergy




Participant Name                                      Participant Signature                                      Date




Name of Witness to Participant’s                      Witness Signature                                          Date
Signature


I have explained the project to the participant who has signed above, and believe that they understand the
purpose, extent and possible risks of their involvement in this project.



Research Team Member Name                             Research Team Member Signature                             Date


                          Note: All parties signing the Consent Form must date their own signature.




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