NPD89101 Participant Information Sheet V3.0

Study Number: NPD89101

Participant Information Sheet: Final version 3.0 09 Aug 19

Principal Investigator: Dr N Fawkes

Introduction

Before you decide whether you would like to participate, it is important for you to understand why the research is being done and what it will involve. This document describes the purpose of the study, what you will be expected to do if you agree to take part, information on the test product(s) including ingredients and any associated risks, confidentiality and data protection procedures. It also describes your right to withdraw from the study at any time.

This informed consent form consists of:

  • Participant information sheet – to share information about the research with you
  • Consent form – for you to agree electronically to take part

You are free to decide whether to take part in this study.

Key Study Information at a Glance

Study title

An internet mediated research study to assess the quality of life of consumers with self-reported Fungal Nail Infection (onychomycosis) during treatment with Scholl Fungal Nail.

 

Protocol number

NPD89101

Sponsor and data controller

Reckitt Benckiser (Healthcare) Limited (we will refer it as “The Sponsor”, “RB”, “us” or “our”)
Registered offices: 103-105 Bath Road, Slough SL1 3UH, United Kingdom

Study Contact Number

If you wish to discuss the information provided here or any other aspect of the study please call the number below, stating you would like to discuss the Participant Information Sheet for the Scholl Fungal Nail study, quoting study number NPD89101.
01482 326151 (9am-5pm)
Alternatively, you can email the study team via schollimrs@rb.com

Adverse event reporting contact

If you experience any medical problems which are related to use of the product that require immediate medical assistance contact your local GP or A&E. At first opportunity please inform the drug safety officer using the information below and request the UK Drug Safety Officer, alternatively the UK Drug Safety Officer can be directly emailed via UKDSO@rb.com
0333 2005 345

General product complaint

If you have any issues with the product, please contact the customer service number on 0333 2005 345, stating you wish to make a complaint about the Scholl Fungal Nail Treatment. For any website order related complaints please complete the contact us form at https://www.scholl.co.uk/pages/contact-us

Data Privacy Queries

If you have questions on the processing of your personal data by RB, would like to exercise any of your rights, or are unhappy with how we’ve handled your data, you may contact our RB`s group data protection officer`s privacy office via email at PrivacyOffice@rb.com.

Part 1

1.1 What is the purpose of the study?

The purpose of this study is to evaluate the quality of life of consumers with self-reported Fungal Nail Infection (onychomycosis) when using Scholl Fungal Nail Treatment. We will be assessing this over the first 4 weeks of use. We will be asking your opinion on how the nail infection and the treatment impacts your quality of life and how you think the appearance of your nail has improved. We will ask about your feelings including any embarrassment about the appearance of the toenail.

Fungal nail infection usually presents with nail discolouration and nail thickening. Other signs and symptoms include pain, redness and swelling, white zones or streaks, abnormal thickening of the skin and separation of the nail from the toe.

1.2 Why have I been invited?

You are being asked to take part in this research study investigating the Scholl Fungal Nail Treatment because you may have mild fungal nail infection, have purchased a Scholl Fungal Nail treatment via our Scholl.co.uk platform and indicated that you would be happy to participate in some research related to this product. There will be approximately 60 people in this study. You should not take part if you are under 18 years old, have been diagnosed with diabetes (Type I or II) or are a female who is pregnant or breast feeding.

1.3 Do I have to take part?

You are free to decide whether you wish to take part in this study. If you decide to take part, you will be asked to sign the electronic consent form, a copy will be emailed to you, as a personal record of your participation, another copy will be kept by RB as a record of your consent. Once consented, you are still free to withdraw from the study at any time and you do not have to give a reason. By consenting, you are agreeing to provide accurate information, complete all study questionnaires and to follow all study instructions as given to you.

The Investigator or Sponsoring Company may discontinue your participation in the study at any time if in the opinion of the investigator or sponsoring company it is in your best interests.

1.4 What will happen to me if I take part?

Scholl Fungal Nail Treatment is a two-step system comprising of 5 disposable one-sided nail files with an advance nail liquid to treat, hydrate and condition the nail. The regimen involves filing the nail once a week followed by the daily application of the liquid treatment for a period of 4 weeks (the ‘treatment phase’). This is then followed by the application of the liquid formula once weekly (the ‘protection phase’) for a further 9 months (or until the infection has resolved).

Your involvement in the study will last a maximum of 4 weeks from providing your consent to final assessment questionnaire (Treatment phase). However, after you have completed the Treatment phase and finished the study it is important that you continue into the Protection phase described in the product leaflet, this is to ensure you remain protected from reinfection until the nail is fully grown out.

During the study you will be required to photograph your affected toenail(s) and complete a series of question online. A summary of activities is presented below.

 

It is important that you answer all the questions asked, however you should not feel obligated to take part if you believe answering questions on the following areas would cause you any distress.

These questions will focus on;

  • Appearance of your infected toenail
  • Physical symptoms associated with your infected toenail
  • Feelings of embarrassment/self-consciousness about your infected toenail (including in intimate settings)
  • How your infected toenail affects you daily activities (work and social)
  • How you feel your infected toenail affects people’s opinion of you

Prior to receiving the product

Once you have consented to take part in the study, you will be asked some questions to confirm your suitability to continue the study. These questions include your age, whether you are pregnant or breast feeding and if you have diabetes (type I or II) If you are not suitable to continue the study, you will receive notification that you are not suitable, and this will end your involvement in the study. You are advised that if you are suffering from diabetes (type I or II) to seek advice from a healthcare professional since your infection may need treatment from a healthcare professional.

Day 1

  • Before you first use of product

Before beginning treatment, you must first take a digital photograph of your infected toenail. This photograph is intended to be used as your own reference to remind you what your infected toenail looks like before the first use of the product. This photograph is to be stored on your own personal device and does not need uploading to electronic platform. It will not be shared with the people responsible for this study.

Before you use the product for the first time you will complete two short questionnaires assessing the appearance of your infected toenail and your quality of life.

After this please read the instructions on the product leaflet, before you use on your infected toenail.

  • After you first use of product

After you have used the product for the first time you will complete one short questionnaire assessing the appearance of your infected toenail. You will then continue to use the product as per the instructions throughout the 4-week study period.

Day 2, 4, 8, 11, 15 and 22 activities

On each day listed above, you will receive email notification which includes a link to complete a questionnaire assessment on the appearance of your infected toenail. We will ask you to compare your toenail to the picture you took before first use of the product.

You should complete the questionnaire after you have used the product for that day.

You should continue to use the product as per the instructions for use throughout the 4-week study period.

Day 29 activities

On day 29, you will receive email notification which includes a link to complete two questionnaires assessing the appearance of your infected toenail and your quality of life. We will ask you to compare your toenail to the picture you took before first use of the product. This will be the end of your involvement in this study. It is important however, that you continue into the Protection phase described in the product leaflet, to ensure you remain protected from reinfection until the nail is fully grown out. At this point you may wish to delete the picture you took before first use of the product from your personal device.

1.5 Payment

You will receive a study participation fee of £20 in the form of an amazon voucher which will be sent via email once you have completed the study. It is not anticipated that your involvement in this study will cause you to incur out of pocket expenses.

1.6 What will be expected of me?

You will be expected to follow the requirements of the study listed below:

  • You will be expected to complete all study questionnaires on the specified days
  • You will be expected to use the product as per packaged instructions, i.e. during the treatment phase (first four weeks) daily liquid application and filing once per week.
  • Do not let anyone else use your study product.
  • Report any side effects to the contact identified on Page 1 of this document.

1.7 What are the alternative procedures/treatments for fungal toenail?

There are many alternative fungal nail treatments available over the counter or online within the UK.

1.8 What are the possible disadvantages of taking part in this study?

During the study you will be asked to complete some activities which will take up some of your time. This would not be necessary if you were not taking part in this study.

1.9 What are the side effects of any treatment received when taking part?

Although ingredients in Scholl Fungal Nail Treatment are commonly used, rarely they can cause side effects, although not everyone experiences them.

The possible side effects from the use of Scholl Fungal Nail Treatment include:

  • Localised skin irritation

Further details of the side effects can be found on the product information leaflet. There is a risk that unanticipated/unexpected events may occur.

In the unlikely event that you experience a side effect a rare or previously unknown side effect occurs in somebody using this product, you are requested to follow the information in

Section 1.10. If the condition has worsened such that the treatment is no longer effective, we would recommend that you contact your GP and your participation on the study will end.

However, it is anticipated that the no risks associated with participating in this study compared to standard use of the product.

1.10 What if I experience a side effect?

If you experience any medical problems which are related to use of the product that require immediate medical assistance contact your local GP or A&E. At first opportunity please inform the drug safety officer using the information on page 1 of this document.

1.11 What are the possible benefits of taking part?

There are no expected benefits if you take part in this study. Your participation in the study will help us evaluate the quality of life of consumers with self-reported Fungal Nail Infection (onychomycosis) when using Scholl Fungal Nail Treatment.

1.13 What if there is a problem with the product?

If you have any issues with the product itself (for example the product is damaged, missing the package insert, missing components) or your order (for example the order is delayed), please use the contact details provided on page 1

1.14 What if I have a problem with the conduct of the study?

Any complaint about the way you have been dealt with during the study or any possible harm you might suffer will be addressed. If you wish to discuss any issues, please contact the study contact using the information on page 1

1.15 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.

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.

This completes Part 1

Part 2

Further Details

2.1 What will happen if I don’t want to carry on with the study?

You are free to withdraw from participating in this study at any time without providing a reason. All data which does not identify you, which has been collected until the point of withdrawal will be retained by RB. All data will remain the property of the study sponsor.

From the point at which you no longer wish to participate simply ignore any reminder emails to complete the questionnaires.

2.2 Who are we? 

We are RB Healthcare UK Limited of 103-105 Bath Road, Slough, Berkshire, SL1 3UH (“RB” or we”).

We are the sponsor and the data controller of this study which means that we are responsible for looking after your information and using it properly.

We will use your information as further explained in this information sheet.

2.3 Data Protection

What personal data do we collect about you?

When you participate in the study, we will collect certain personal data about you. We will collect the minimum personal data required to complete this study.

By "personal data" (it is also known as "personal information" or "personally identifiable information") we mean any information relating to an identified or identifiable individual. This is broader than just information of a personal or private nature, and also includes information such as your name, date of birth, and e-mail address. Please see the below section for what personal data is obtained from you in relation to this study.

It is important to be aware that whilst we will receive your personal data, we will process this information in a ”de-identified” (it is also known as “pseudonymised”) form meaning that we cannot directly identify you from the information we process – for example, whilst we will receive details of your suitability for the study or physical symptoms  and feelings associated with the infected toenail or the Scholl treatment, this will be in ‘de-identified’ by removing your email address from your survey answers and replacing with a unique number. As result of this de-identification, we cannot directly identify you from the data and your survey responses we process from your participation in the study. 

Due to the nature of this study, we will also receive ‘sensitive’ personal data (also known as special category personal data). The personal data (including the sensitive personal data) we collect include:

  • Age and details concerning your health: once you have consented to take part in the study, you will be asked some questions to confirm your suitability to continue the study. These questions include your age, whether you are pregnant or breast feeding and if you have diabetes (type I or II).
If you are not suitable to continue the study, you will receive notification that you are not suitable, and this will end your involvement in the study. You are advised that if you are suffering from diabetes (type I or II) to seek advice from a healthcare professional since your infection may need treatment from a healthcare professional.
  • Photograph: Before you first use of product and beginning treatment, you must first take a digital photograph of your infected toenail.

This photograph is intended to be used only as your own reference to remind you what your infected toenail looks like before the first use of the product. This photograph is to be stored on your own personal device and does not need uploading to electronic platform. You should not upload or otherwise share this photograph with us. Should this happen, we will delete it immediately.

  • Email address: RB will collect your email address to send you reminder emails on the days that you are required to complete the questionnaires

Your email address will be also used to facilitate payment of your electronic voucher following completion of the study.

  • Information about your use of Scholl Fungal Nail Treatment: these are your answers (which may include information regarding your health), any opinions you express when you give answer to the questions in this study.

As with the other information we collect, this sensitive personal data will be received by us in de-identified form, so we cannot identify you without linking it to identifying information.

We use an electronic platform service (Qualtrics) to enable us to conduct this internet mediated (online) study. All your responses will be de-identified by RB prior to data analysis and/or being shared with other third parties.  Qualtrics, our data processor, stores your de-identified study data in accordance with its own GDPR policy, and RB`s instructions.

At the end of the study your email address together with the key of the unique study numbers will be separately stored from the study data in paper format by RB and will only be accessed in the event of complaints or to confirm your consent to participate. We keep this information separate from all other personal information we receive about in the study. The only people in RB who will have access to information that identifies you will be people who need to contact you for any reason and people that audit the data collection process. The people who analyse the study data will not be able to identify you and will not be able to find out your name or contact details.

Where do we collect personal data about you from?

The personal data we receive about you will be provided by you via online questionnaires.

How and why do we use your personal data?

We use your personal data for the following purposes:

  • to conduct this study (including to check your suitability to participate in this study as mentioned above) to develop and improve RB’s range of Scholl products.
  • to maintain records of this study that RB has sponsored in accordance with legal requirements;
  • to demonstrate to appropriate authorities that the study was conducted in accordance with approval protocols and applicable legal requirements and, where necessary, to permit such authorities to audit the study;
  • to comply with any legal requirements (including reporting adverse event).

We will not use your information for any other purposes unless we are required to do so by law.

How long do we keep your personal data?

We will only retain personal data about you in a form that identifies you for as long as this is necessary for this study. Your personal data will be retained until the completion of the study and for 7 years after the completion, after which we will completely anonymise the personal data we have been provided as part of the study.  Your personal data shall be retained for the period required by applicable regulatory requirements.

Where there are legal or regulatory obligations for us to keep your data, we will process your personal data in de-identified form.

Who do we share your personal data with?

Within the RB Group

Where necessary, your personal data may be shared between the different legal entities within the RB group, for the purposes set out in this information sheet. For more information about the legal entities in your jurisdiction, please contact us.

Our Suppliers

We use third party suppliers to keep your personal data safe and secure and to analyse the data. This includes suppliers that help us with our information security (such as our IT suppliers) and suppliers that help us record and maintain copies of paper documents.  As mentioned above, we use Qualtrics, to enable us to conduct this online study.

Sharing with Regulators

As this type of studies are highly regulated, we may be required to share your personal data with various authorities to ensure that the study was performed properly. Accordingly, we may be required to share your personal data with regulators to approve, assess and audit the results of the studies we undertake and to report any adverse events that may occur during the study.

What legal basis do we have for using your personal data?

When we use your personal data, we are required to have a legal basis for doing so. Health and care research should serve the public interest, which means that we must demonstrate that our research serves the interests of society.

We use personal data to conduct research to improve our health and care products. As a company that produces pharmaceuticals and medical devices, we have a legitimate interest in using information relating to your health and care for research studies when you agree to take part in a research study. This means that we will use your data, collected during the study, in the ways needed to conduct and analyse the research.

We use personal data for our legitimate interests in commissioning studies, engaging with you as a participant (including sending email reminders and the voucher code for your participation in the study), to develop and improve RB’s range of products and to improve our understanding of the market.

We may be subject to other legal requirements that require the processing of your personal data, including disclosing your personal data to regulators or other official bodies if requested.

Where we process your ‘sensitive’ personal data, we primarily do so based on your explicit consent, but where retaining your personal data in accordance with legal requirements or disclosing your personal data to regulatory authorities as required by law we will do so on the basis of this being in the public interest in the area of public health. We have put in place appropriate and specific measures to protect the personal data that you provide to us as part of the study.

We may also be required to process your sensitive personal data to establish, defend or exercise legal claims that relate to the study.

What happens if you withdraw from the study?

If you withdraw from the study, we will keep the information about you that we have already obtained and will continue to use such data, including for analysing the results of the study. To safeguard your rights, we will de-identify this data so that we cannot directly identify you from the data held by RB.

Do we make automated decisions concerning you?

No, we do not carry out automated decision making or automated profiling using the personal data collected through your participation in the study.

Where do we store your personal data? Do we transfer your personal data outside the EEA?

Where possible, we try to only process your information within the UK and European Economic Area (EEA). If we or any third party transfers your personal data outside of the UK or EEA, we always require that appropriate safeguards are in place to protect the information when it is processed.

We have put in place safeguards to protect personal data processed in or accessed from non-EEA countries. You can obtain a copy of the safeguards in place for such transfers by contacting us.

What rights do you have in relation to the personal data we hold on you?

By law, you have a number of rights when it comes to your personal data.

You have the right to be provided with clear, transparent and easily understandable information about how we use your information and your rights. Therefore, we’re providing you with the information here.

You may also have the right to:

  • request a copy of personal data we hold about you;
  • ask that we restrict the way in which we use your personal data;
  • ask that we update the personal data we hold about you, or correct any personal data that you think is incorrect or incomplete;
  • ask that we delete personal data that we hold about you (the “right to be forgotten”);
  • object to our processing of your personal data;
  • request your personal data be transferred to you or another data controller (the “data portability” right).

However, in the context of the study, your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate.

If you wish for all your data to be deleted at any point during or after the study, you can request this by contacting the study team (see page 1 of the Participant Information Sheet provided as an attachment to the invitation email).

To exercise any of your rights in relation to your personal data, or to ask a question, contact us. We’ll respond as soon as we can. Generally, this will be within one month from when we receive your request but, if the request is going to take longer to deal with, we’ll come back to you and let you know.

We usually act on requests and provide information free of charge, but may charge a reasonable fee to cover our administrative costs of providing the information for:

  • baseless or excessive/repeated requests, or
  • further copies of the same information.

If you are not satisfied with our response or believe we are processing your personal data in a way that is not lawful you can complain to the Information Commissioner’s Office (ICO) https://ico.org.uk/.

If you have questions on the processing of your personal data by RB, please contact the privacy office, refer to the “contact details” section.

2.4 What will happen to the results of the research study?

The results of the study may be published in the medical literature and/or shared with other researchers, but your identity will not be revealed, the results of the study may also inform future product development and research. The Protocol summary and a summary of the study results may be posted on publicly available results register(www.clinicaltrials.gov). If you require a summary of the study results, please inform the study staff and they will be provided once available.

2.5 Who is organising and funding the research?

The sponsoring company for this study is Reckitt Benckiser.

2.6 Who has reviewed the study?

This research has been reviewed by an independent group of people called a Research Ethics Committee to protect your interests. This study has been reviewed and given favourable opinion by Reading Independent Ethics Committee.

2.7 Further information and contact details

For any further information on this study, including questions about your rights as a volunteer, study related injury and about any study procedures, please contact Reckitt Benckiser during normal office hours. Please quote study number NPD89101.

Should you require advice as to whether to participate in this study please feel free to discuss this with your family and friends or your health care professional.

If you require more information about this study, please refer page 1 for contact details to enable you to speak with a member of the study team.

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