Participant Information Leaflet - Template - Arthritis New Zealand

Participant Information Leaflet - Template

The School of Linguistic, Speech & Communication Sciences has prepared a Participant Information Leaflet
template (based on guidance from Trinity College Dublin Research Ethics Committee) to aid researchers
prepare the participant information leaflet for their own research studies.

The form provided is a template only: researchers will need to tailor this template to their own research
studies.
• The template includes sections which typically apply to ALL research with human participants
• Additional sections which apply to some types of projects with our School (e.g. research in clinical
   contexts), appear at the end of the forms and should be either integrated or deleted if not relevant to
   the study
• In some cases, your project may require additional information, this should be included

Researchers should pay attention to:
• The content of the leaflet particularly the importance of using plain English.
• The appearance of the leaflet particularly the font and font size used.
• Whether a communication-accessible leaflet may be appropriate (for certain groups of people with
   communication disabilities, cognitive impairments or intellectual disability for example). A separate
   sample of a communication-accessible leaflet is available on the REC website for the School of Linguistic,
   Speech & Communication Sciences and should be appropriately tailored.
• The National Adult Literacy Agency have provided useful advice on how to ensure the leaflet is suitable
   for your target audience and is available at www.simplyput.ie.

It is critical that the contents of the Participant Information Leaflet match the details provided in the
Application Form.

TRINITY COLLEGE DUBLIN
             SCHOOL OF LINGUISTIC, SPEECH AND COMMUNICATION SCIENCES

                            Participant Information Leaflet

Surveying the Prevalence and Nature of Oropharyngeal Dysphagia
       experienced by adults presenting with Fibromyalgia
 Principal Investigator(s) and Co-Investigator(s)   Catherine Costello: Student, costelc5@tcd.ie
 (insert names, titles and contact details. Where   Dr. Órla Gilheaney: Supervisor, OGILHEAN@tcd.ie
 relevant, give the name of academic supervisor
  Study Organiser/ Funder (if applicable – remove
  row if not applicable)
  Data Controllers                                    Trinity College Dublin

  Data Protection Officer                             Data Protection Officer
                                                      Secretary’s Office
                                                      Trinity College Dublin
                                                      Dublin 2

You are being invited to take part in a research study that is being done by Catherine Costello in an online
survey.
Before you decide whether or not you wish to take part, please read this information sheet carefully. You
should understand the risks and benefits of taking part in this study so that you can make a decision that is
right for you. You may wish to discuss it with others. Ask us if there is anything that is not clear or if you would
like more information. Take time to decide whether or not you wish to take part. Thank you for reading this.

This leaflet has five main parts:
          Part 1 – Information about the Study
          Part 2 – Information on how your data will be used and stored
          Part 3 – Information about Costs, Funding and Approval
          Part 4 – Future Research
          Part 5 – Further Information

Part 1 - The Study
 Why is this study being done?
My name is Catherine Costello, and I am an undergraduate student in the Department of Clinical Speech and
Language Studies, Trinity College Dublin. I am conducting research on the characteristics and frequency of
eating, drinking and swallowing problems associated with Fibromyalgia. Fibromyalgia is a chronic pain
syndrome characterised by chronic widespread pain, stiffness, fatigue, and sleep disorders. It affects 2-4%
of the general population. However, little is known about the presentation of an eating, drinking and
swallowing difficulty associated with fibromyalgia and even less is known on how many people are affected
in this way by Fibromyalgia. If researchers and clinicians understood how many people experience these
difficulties and how these problems present, then more person-centred and appropriate treatments could
be developed and more adequate training could be provided to those working with patients with
Fibromyalgia. I am researching this topic to understand how common and severe eating, drinking and
swallowing difficulties are in people with Fibromyalgia and to investigate how these difficulties present. I
would like to invite you to take part in this research.

 Why have I been invited to take part?
We are inviting all adults with fibromyalgia to participate in this study. You are eligible to participate if you
are:
    o Over the age of 18 years
    o Enduring a specific chronic pain condition called Fibromyalgia
    o Experiencing painful or uncomfortable sensations when you eat, drink and swallow
We aim to have 100 people involved in this study.

 Do I have to take part? Can I withdraw?
You have volunteered to participate in this study. You can change your mind about taking part and opt out
at any time even if the study has commenced. If you decide not to participate or opt out, it will not affect
your current or future medical care. You do not have to give a reason for not taking part or for opting out
and you can opt out at any point during the survey.

 What happens if I change my mind?

You can change your mind at any time by leaving the survey. If you choose not to continue to take par your
medical care will not be affected in any way. Accessing your data will not be possible as this survey is
anonymous and there will be no collection of any personally identifying information.

What will happen to me if I decide to take part? What will I need to do?

This study involves the completion of a 5-10 minute anonymous survey about your symptoms of
discomfort when eating, drinking or swallowing. Accessing your data will not be possible as all information
collected will be anonymised. You will also be asked on how severe these symptoms are and how regularly
they occur.
To begin you will be asked for your consent. You may consent by clicking the box on screen. The survey will not
commence until the consent box has been ticked.
The survey consists of three sections- a demographics section, a section on oral symptoms of fibromyalgia and a section
on symptoms relating to eating, drinking, and swallowing difficulties.
In the first section, the survey will ask for your age, sex and country location. This section will not ask for any personal,
sensitive, or identifiable data.

The second section will contain a list of oral symptoms relating to Fibromyalgia. Here you will be asked if you experience
these symptoms, how often the symptoms occur and how severe you experience these symptoms when they do occur.

 Finally, there are a list of sentences that describe symptoms of eating, drinking and swallowing difficulties. Here you
will be asked to select the severity of each of the sentences. You will be asked to mark each of the sentences from a
scale of 0-4. ‘0’ meaning you experience no problems and ‘4’ meaning it is a severe problem for you.

 Are there any benefits to taking part in this research?
Taking part in this study will not directly benefit you. However, it is intended that results from this study will reflect the
burden of eating, drinking and swallowing difficulties associated with fibromyalgia internationally.

Other possible benefits that may arise from this study include:
   • Raised awareness:
           o This study can help raise awareness and provide guidelines towards better training for clinicians and
                others who work with people living with Fibromyalgia.
           o Informed clinicians is vital for good practice procedures.
           o If results from this study indicate a high occurrence of eating drinking and swallowing difficulties in people
                living with fibromyalgia, a diagnosis may be reached quicker and more easily and appropriate assessment
                and management procedures could be created which may improve their overall quality of life.
   • Informed Therapies:
   • The data collected from this study could also inform the assessment of therapies which could guide developers
       of therapies and policy makers on the burden of eating, drinking and swallowing difficulties presenting in
       Fibromyalgia.
   • It may also support the identification of recognising priorities in healthcare, prevention and policy.

Overall, it is hoped that this study will help inform better care pathways in Ireland and internationally.
  Are there any risks to me or others if I take part? What will happen if something goes wrong?
There are very low risks to participating in this study. There is also a very low risk of something going wrong for
research
The studyparticipants
           may also bein this
                          thethis study. of creating appropriate treatments for these difficulties and providing
                              beginning
information to develop adequate training for staff working these difficulties associated with Fibromyalgia.
 However, inconvenient outcomes may include:

    •    Time Constraints- the survey will take approximately 2-5 minutes to complete
    •    Emotional Distress- please contact the necessary local assistances if emotional distress occurs.

You are not eligible to participate if you:

    •    Do not have Fibromyalgia
    •    Are under the age of 18

Part 2 - Data Protection
  How will my data be used?
Data from this research project may be published in future in scientific journals. You will not be able to be
identified in any reports or publications as the data collected is anonymous. Your privacy is important to us.
We take many steps to make sure that we protect your confidentiality and keep your data safe. Here are
some examples of how we do this:

   o You will not be asked for personal, sensitive or identifiable information to hide your identity.
   o All the data collected will be stored on the researcher’s laptop in an encrypted and password
     protected file in accordance to Trinity College Dublin’s GDPR guidelines.
   o All files will be encrypted and transferred to a secure folder in the Trinity College Dublin computer
     network
   o All files will accessible only by Catherine Costello & Dr.Órla Gilheaney.
   o All individual researchers involved in this project have been trained in data protection law and are
     bound by professional code to maintain confidentiality.

  What information about me (personal data) will be used as part of this study?
  Will my medical records be accessed?

  No identifiable, personal or sensitive data will be collected in this study and your medical records will
  not be accessed. All data collected will be anonymous.

 Who will have access my personal data? What will happen to my personal data?
All the personal data that we collect about you during the research study will be kept strictly confidential
and will only be accessible to members of the research team, Catherine Costello and Dr. Órla Gilheaney. All
information collected will be anonymously coded and no identifiable information will be collected. All of
your anonymous personal data will be stored on OneDrive with a password protected lock that only the
above members of the research team can access. The data is anonymised and will be kept until the data is
no longer in use. You will not have access to your data as it is anonymised. After a period of 7 years the data
will be destroyed by Dr. Órla Gilheaney.

Will my personal data be kept confidential? How will my data be kept safe?

Your privacy is important to us. We will take many steps to make sure that we protect your confidentiality
and keep your data safe. Here are some examples of how we do this:

      o All information collected will be anonymously coded and no identifiable information will be
        collected.
      o Anonymous data will be used to hide your identity
      o All the data collected will be stored on the researcher’s laptop in an encrypted and password
        protected file
      o All original files will be encrypted and transferred to a secure folder in the Trinity College Dublin
        computer network
      o All files will accessible only by Catherine Costello & Dr.Órla Gilheaney.

All individual researchers involved in this project have been trained in data protection law and are bound by
professional code to maintain confidentiality.

    What is the lawful basis to use my personal data?
According to data protection legislation, we are required to inform you of the legal basis for using your
personal data.
The tasks we are performing are considered to be in the public interest

As data collected from this survey contains no identifiable information and data from surveys completed will
be anonymous, you will not have access to your data once you have given your consent and have completed
the survey

    What are my rights?
As data collected from this survey contains no identifiable information and data from surveys completed
will be anonymous, you will not have access to your data once you have given your consent and have
completed the survey

1
  The European General Data Protection Regulation ( GDPR)
2
  Article 6(1)(e)
3
  Article 9(2)(j)

Part 3 - Costs, Funding and Approval
 Has this study been approved by a research ethics committee?

Yes, this study has been approved by the Research Ethics Committee of the School of Linguistic, Speech &
Communication Sciences on 13/07/2021.

 Who is organising and funding this study?

This study is not funded.

 Is there any payment for taking part? Will it cost me anything if I agree to take part?

No. We are not paying participants to take part in the study.

 Part 4 - Future Research
Due to the nature of this research, it is very likely that other researchers may find the data collected to be
useful in answering future research questions about the eating, drinking and swallowing difficulties in Fibromyalgia.
Future research will only take place if it has research ethics approval.

Part 5 - Future Information
 Who should I contact for information or complaints?
If you have any concerns or questions, you can contact Catherine Costello or Dr. Órla Gilheaney whose
details are listed below. If the researcher learns of important new information that might affect your
desire to remain in the study she will let you know.

Principal Investigator: Catherine Costello costelc5@tcd.ie
Supervising Co-Investigator: Dr. Órla Gilheaney
Data Protection Officer, Trinity College Dublin: Data Protection Officer, Secretary’s Office, Trinity College
Dublin, Dublin 2, Ireland. Email: dataprotection@tcd.ie Website: www.tcd.ie/privacy
Under GDPR, if you are not satisfied with how your data is being processed, you have the right to lodge
a complaint with the Office of the Data Protection Commission, 21 Fitzwilliam Square South, Dublin 2,
Ireland. Website: www.dataprotection.ie

Will I be contacted again?
If you would like to take part in this study, you will be asked to tick the agree box to consent on the front
page of the survey. If you consent, you can complete the survey at a time that suits you. The survey will
approximately take 2-5 minutes to complete. You will not be contacted again following completion of the
survey.