Project Dora - Information Sheet

This document is only for those selected to attend Project Dora.

Please take time to read ALL the following information carefully!

You and your child are being invited to take part in a market research study being carried out by PPL Insights, a market research agency, on behalf of a major pain relief product manufacturer. Before deciding whether you and your child will participate in this study, it is important that you read this form. This information sheet and consent form describes the purpose, procedure, benefits, financial payment, risk and potential discomforts of the study. It also describes your right to withdraw yourself and your child from the study at any time. Please ask as many questions as you need to so that you can be sure you and your child want to take part in the study.

What is the purpose of this research?

The purpose of this market research study is to understand differences in taste and parent and children's overall perceptions of pain relief products. Approximately 200 children are expected to participate in this study (alongside 200 parents).

If you and your child qualify for the study, you will both be asked to look at and taste several products over two sessions.

You and your child would only be asked to try a very small amount of carefully measured product and never more than the recommended amount for that session time. The products have the active ingredients of paracetamol and Ibuprofen.

Two of the products you and your child will be trying during the study are currently registered and marketed in Australia, formulated for pain and fever relief in children. Four of the products are yet to be registered although they contain the same ingredients as marketed products apart from the flavour.

The study and products being tested have all be approved by an Australian Ethics Committee as safe to test.

Who can participate?

To qualify for this study your child must meet the following requirements:

• Be aged 9-14 years
• Currently have children's pain relief medicines
• Have no major health problems.
• Be able to swallow medication 

PRECAUTIONS

It is important that you tell the interviewer about past and current medical conditions experienced by yourself and your child, even if it seems to have little to do with the study.

You and your child should not participate if any of the following apply:

- Have a history of or current gastric or duodenal ulceration, history of asthma or are asthmatic.  Have renal, hepatic, thyroid or cardiac impairment

- Have phenylketonuria

- Have high blood pressure (hypertension) or history of an overactive thyroid

-  Have breathing problems such as emphysema, asthma or chronic bronchitis

- Known to have diabetes mellitus or glaucoma or on a sodium-controlled diet or Raynaud's syndrome.

- Have a history of or suffer from epilepsy or seizures.

- Have gastro oesophageal reflux disease (GORD).

- Any acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration as judged by the investigator

- Have taken paracetamol or ibuprofen on the day / days of the test including cold and flu medications. Individuals who have any sensitivity to cold and flu medications containing for example paracetamol, phenylephrine hydrochloride, pheniramine maleate, ascorbic acid, including flavours.

- Have any actual or suspected allergy to Carmosine (E122) or any known or suspected food allergies or food colourants.

- Have any condition or are taking any drug therapy that could affect their sense of smell or the ability to assess the study sample.

- Have any oral symptoms including lesions, sores or inflammation including recent dental work and oral surgery.

You or your child will never be provided with any product to take home, all products must be consumed at the location of the test, all products will be carefully accounted for.

What will you / your child have to do?

If you and your child qualify and you agree for yourself and your child to take part in this study, this will involve the following stages:

1. After completion of this interview, both you and your child will be given time to ask questions and consider your decisions. If you agree to take part, you and your child will be asked to sign an assent form as well as consent form. A date and time will be arranged for you both to attend the first session. You and your child will be asked to attend 2 sessions in total.  Each session should last no longer than 60 minutes.
2. On attending each session you and your child will be amongst other parents and children who are trying the same products. At the first session a nurse and supervisor will introduce you and your child to the study and explain how it will run.
3. During the session both yourself and your child will be asked to look at and then try one or two products and answer a few questions on each product. (If necessary, you may help your child to read the questions and understand any instructions.) You will both be asked simple questions like how much you like the taste of each of the products.  Between each product, yourself and your child will need to cleanse your palates with a cracker/water biscuit and by drinking some room temperature taste neutral mineral water.
4. This form provides you with details of who to contact in the unlikely event that either yourself or your child experience any unusual symptoms after taking part in the test.

Tell the interviewer if your address or phone number changes during the study.

You will be given as much time as you need to make the decision whether to permit yourself or your child to participate or not. If you do agree to yours and your child's participation, we will ask you to sign the attached consent form.

Payment

You will receive compensation of  AUS $110 Eftpos card at the end of the study for the time and effort of taking part. If a parent or child is withdrawn from the study due to feeling unwell or experiencing symptoms (known as an adverse event or AE) then a pro-rata payment may be made if the AE is not a result of the study.  If the AE is as a result of the study then full payment would be made.

Possible side effects and the risks of treatment

You or your child are not expected to experience any side effects whilst using these products. However the following types of reactions (side effects) have been reported for similar products: indigestion, heartburn, nausea, vomiting, loss of appetite, stomach pain, diarrhoea, bloating, gas, constipation; other side effects are dizziness, headache, nervousness; mild itching or rash; or ringing in your ears. There are sometimes signs of an allergic reaction also seen like: sneezing, runny or stuffy nose; wheezing or trouble breathing; urticarial (a type of skin rash); swelling of your face, lips, tongue, or throat.

If you or your child feel unwell or experience symptoms during this research study, full guidance on who to contact is provided below and on the final page of this document which you will be given to take home with you.

If you would like to see this information now, then please ask your interviewer.

In the unlikely event of a medical emergency, seek medical attention immediately.

After seeking medical attention, please call the phone number provided as soon as possible.

Compensation for injury

If you or your child experience any adverse events as a result of your participation in this study, you may be entitled to compensation. There are two avenues that may be available to you to seek compensation.

1)     Sponsors of clinical trials in Australia have agreed that the guidelines developed by their industry body, Medicines Australia, will govern the way in which compensation claims from injured participants are managed by sponsors.

However, as guidelines, they do NOT in any way dictate the pathway you should follow to seek compensation. The sponsor is obliged to follow these guidelines.

These guidelines are available for your inspection on the Medicines Australia Website (www.medicinesaustralia.com.au) under Policy - Clinical Trials - Indemnity and Compensation Guidelines.  Alternatively, your study doctor can provide you with a hard-copy of the guidelines.

2)     You may be able to seek compensation through the courts.

It is the recommendation of the independent ethics committee responsible for the review of this trial that you seek independent legal advice before taking any steps towards compensation for injury.

Study participation / withdrawal

Yours and your child's participation in this study is voluntary. You may withdraw your consent and discontinue yours and/or your child's participation at any time, without penalty or prejudice, no reason need be given. If you should decide to withdraw you and your child's participation, please notify the study site using the contact details provided.

Should you fail to act according to study procedures, you and your child's participation may be terminated.

Participant expenses

You and your child will be required to travel to the location where the test is happening. 

The compensation of AUD $110 is to be given to you at the end of the study is expected to cover this.

Study confidentiality

In signing this form you are confirming your agreement that you and your child will keep the information that you see and any materials or items that you are given about the study, such as information regarding the study product or the type of study being performed confidential. You promise not to copy or photograph any part of the study materials provided. You are of course free to discuss your participation in the study or when discussing your present or future healthcare with your family.

In addition, you confirm that neither you nor anyone else in your household / family are employed in any part of the pharmaceutical industry, healthcare profession, sales and marketing, advertising or the market research industry.

We take this agreement seriously and ask that you do so as well.

To avoid any potential confusion here are some examples of activities that are considered a breach of confidentiality and will result in removal from the study

• Posting of product descriptions or names on chat rooms, bulletin boards, social media or blogs.
• Copying / photographing product ideas.
• Discussing the survey or products with anyone outside of your family.

Will the information provided by me be kept confidential?

Yes. If you consent for you and your child to take part in this study, the information collected during the study will be stored by Your Source in accordance with the Australian Privacy Act and the sponsor in accordance with the UK data protection act.

Participants should note that, some data derived from your participation in this study will be sent overseas; the regulatory regimes governing data access and use in other countries may not be the same as those that are in place in Australia. If you have any questions about this direct them to the Your Source.

The sponsor may also wish to use any comments that you or your child writes in your respective questionnaires (e.g. things you or your child like or dislike about the product you/they are trying) in future marketing materials. However, please be assured that the comments will be anonymous (not attributed to either you or your child) if used. Only Your Source/Chit Chat Research and their staff will know that the information is related to you and your child and this information is kept confidential.

We promise to keep yours and your child's information secure and confidential, and ask that you promise to do the same with the information and product you will see during this test. We value your time and opinions.

New findings

You will be told about any significant new finding about the study products. This information can help you decide if you and your child wish to continue your participation in the study.

Contact during the study

If you agree for you and your child to participate in this study, you will be given contact details for both your interviewer, plus a voicemail where you can leave details should any issues occur during usage.

At the end of this interview, your interviewer will give you the back page of the questionnaire, which contains full information on contact during your participation in the study; however you can read through this information now if you would like

Questions about your participation in this study

If you have questions about this study, please refer to the contact details information sheet for information on contacting your interviewer.

If you do not want to talk to the study staff, if you have concerns or complaints about the research, or want to ask questions about the rights of study participants you may contact Bellberry Limited which has responsibility for scrutinizing proposals for research on humans.

The study was given a favourable ethical opinion for conduct. You are free to contact the Bellberry Limited for any further questions you may have on your rights. Their contact details are provided in the contact sheet, which you will be given.