Participant Information Sheet(Pis)

PARTICIPANT INFORMATION SHEET(PIS)

Full Research Title:

IRAS number:

BLUE TEXT CAN BE DELETED and the PIS is for guidance, please feel to amend but sections will be required therefore please do not delete, you can also add further information/sections if you like.

Please note, if your research involves sensitive issues/questions, please be careful with the tone of the language used; the more sensitive the issue the more empathy will be required in your PIS.

Does your study involve more than one type of participant (NHS service users, staff and healthy volunteers), if yes, Participant Information Sheets (PIS) will be required separately for each type of participant (if it involves observing staff, somewhere in the PIS assure them that the study does not involve assessing the performance of the organisation or any individual members of staff).

Does your study involve children? If yes, what age groups? 16 to 18 years are able to consent for themselves (Gillick Competence). Children under the age of 16, there are PIS required for certain age groups and a information sheet and consent form will be required for the parent/carer as well. Further information is available on or feel free to contact the Research Governance Office via .

These types of studies do not require informing the GP, therefore please do not reference this in any of your documentation.

If you will be recruiting elderly participants, you may want to increase the font size.

Researcher introduction

My name is XXXXXXXXXXXX and I am a Trainee Clinical Psychologist. I would like to invite you to take part in a research study I am completing as part of my Doctorate qualification in Clinical Psychology at the University of Leicester. To help you decide if you would like to participate, I would like you to understand why the research is being done and what it would involve for you.

I will go through the information sheet with you and answer any questions you have and should take about XX minutes.

Brief summary of the research

I am interested in finding out about XXXXXXXXX.

Why have I been invited?

How they were selected, was it by their healthcare professional or you?
Will the health care professional or you discuss the research with them?
You could state how many others will be in the study.

Do I have to take part?

No. Before you decide whether to take part, it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully and discuss it with your relatives/friends if you wish. You are free to decide whether or not to take part in this study. If you choose not to take part, this will not affect your ongoing care. Please feel free to ask any questions or for more information.

What will happen if I decide to take part?

If you do decide to participate ……………………………….

Try and put yourself in the subject’s shoes and should detail the following:

How long the participant will be in the research?
How long the research will last?
If and how often they will need to meet a researcher?
How long these visits will be?
Exactly what will happen
Access to personal information
Questionnaires
Interviews
Discussion groups
Observations
Completing diaries (we will require a template of the Diary, please also ensure this is versioned)
It may help if the information is displayed in a flowchart, table, diagram or photo.
Are there any follow ups?
Are there stages to your research?
How will consent take place?

Participants should be given at least 24 hours to decide if they would like to take part in the study depending on the research as they may want to discuss further with family members/friends.

Meetings:

Will you be arranging a meeting with them?
If yes, how will this be arranged?
Where will you meet them?
How will you decide what time to arrange the meeting at?
Reassure them that the meeting can be arranged around their personal commitments or they will be arranged at the time of their routine appointments.

Does your interview involve questions?

If yes, please create an interview guide (see attached template). State briefly what these questions are.
State that there are no right or wrong answers.
How long will the interviews be?
Let the participant know that they do not have to answer any questions that they do not wish to and that they can provide as much information as they want to.
Confirm how long the interview will take and that they can choose to end the interview at any stage.
Explain that there will some time to talk at the end about the interview.
If you are having more than one interview, please confirm further details about them.
Make it clear that participants do not have to answer all of the questions if they don’t feel comfortable with certain questions.

Expenses

Detail if expenses will be covered or if they will be receiving a voucher for their participation, detail what the voucher is for
How much will this be?
Is there a maximum amount that can be claimed?
Will travel expenses be reimbursed on production of receipts? (REC would expect participants to be reimbursed to attend for research purposes which is not part of routine care).
Is this per study visit, or for their participation as a whole?
Please include that original receipts will be required for all expenses.

Does your research involve audio recording?

Let them know that you will be recording the interview.
That you will ask for their permissions first.
All recording will be anonymised and no personal information will be stored on the audio recordings.
How it will be transferred to the University server
Detail how the data will be transcribed and kept secure.

Will you be using questionnaire?

Are they validated questionnaires and do you have permission to use them or are they available publically via internet
or have you devised your own questionnaires (We will require copies of the questionnaires. if you are devising your own questionnaires, don’t forget to add the research title, IRAS number, logo, page numbering, version number and date).
we will require copies of the questionnaires.
How long will the questionnaires take to fill in
Make it clear that participants do not have to answer all of the questions, if they don’t feel comfortable with certain questions.

Medical Records:

Will you be requesting any information from their medical records?
Who will access the information from the medical records?
Will you be taking demographic details? Will this be using a form created by yourself or taken directly from medical notes?
If you are creating the demographic form yourself, please note the following advice given by the University’s equality office in relation to gender questions:
Question 1 : What is your gender?
Options: Male, Female, Other, Prefer Not to Say.

Question 2: Does your gender identity match the sex you were assigned at birth?
Options: Yes, No, Prefer Not to Say.

Observations:

State what the observations will involve
Will you require permission from anyone to carry out observations for your research in a setting (staff, participants, manager etc)
Consent will be required from each individual person in that setting
For those that do not consent, these observational data will need to be excluded
Re-assure staff that the study does not involve assessing the performance of the organisation or any individual members of staff

Using video recordings

If you will be using a video recording, please contact for further advice.

Withdrawing from the study:

Explain that the participant can withdraw and will not affect their ongoing care

If they withdraw or lose the capacity to consent for themselves, what will you do with the data you have collected up to the date they withdraw? Example ‘If you withdraw from the study, we will need to use the data collected up to your withdrawal.’
It’s OK to keep the data and use it in the study for analysis, you just need to make the participant aware that this is your intention. Is there a point at which you would be unable to remove the data (i.e., for interview studies, this is likely to be once they have been transcribed because all identifiable information will have been removed).

State that participants can receive summary of findings, you can ask them to provide contact details on the consent form by way of an optional Yes/No statement.

For online surveys – how will consent be assumed? Will this be by completion of the survey?

State that they will be able to discuss the study further and ask any questions. They will sign a consent form which demonstrates that they understand what their participation involves and that they have agreed to participate.

Be clear about what will happen if a participant becomes distressed during the interview and where they may be sign posted for further support (depending on the sensitivity or type of study or questions asked).

Are there any benefits or risks to taking part?

Informationthat can be added:

That their opinion will be heard. They will feel positive about contributing to research and find it a rewarding experience. If you are offering gift voucher, state that this is for their time participating. (if you will be giving a gift voucher, please produce a receipt for the participant to sign)
We cannot promise the study will help you but the information we get from this study will help improve the treatment of people with ……
For sensitive matters: state that you understand that some people might find talking about this difficult and distressing. Reassure them that it is ok for feelings to come up within interviews and for them to think carefully about their participation. Let them know that at the end of interview that they can talk about how they feel and about the additional support that may be available to them.

What if I am harmed by the study?

The below is standard text and should not to be removed but blue text can be amended accordingly

It is very unlikely that you would be harmed by taking part in this type of research study. However, if you wish to complain or have any concerns about the way you have been approached or treated in connection with the study, you should ask to speak to myself, XXXXXXXXXXXX as I am the main researcher (my contact details are above or below), or you can speak with my Research Supervisor, XXXXXXXXXXXXXX (their contact details are below) and we will do our best to answer your questions. If you remain unhappy and wish to address your concerns or complaints on a formal basis, you should contact:

[insert local PILS/PALS information here for the NHS Organisation]. (This can be left like this because if your study is multi-site, this information will change for each NHS organisation).

In the event that something does go wrong and you are harmed during the research and this is due to someone’s negligence then you may have grounds for legal action for compensation against the University of Leicester but you may have to pay your legal costs. The normal National Health Service complaints mechanisms will still be available to you (if appropriate).

What will you do with the information I provide and will it be safe

Transparency wording provided by the HRA in relation to GDPR:

The following 1st Paragraph from the HRA webpage is compulsory and is required to be inserted in the Participant Information sheet:

University of Leicester is the sponsor for this study based in the United Kingdom. We will be using information from you in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. University of Leicester will keep identifiable information about you for X years after the study has finished.

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 withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.

You can find out more about how we use your information by contacting .

Then insert transparency wording from section A, B and/or C, whichever is relevant to your study. (Please click this link to access the wording).

We will follow ethical and legal practice and all information about you will be handled in confidence and stored securely and the only people that would have access to your personal information would be myself (XXXXXXX), the main researcher and my Research Supervisor(s) (XXXXXXXX)

How the data will be collected
How paper documentation will stored
How audio files will be transferred and stored
How long it will be retained for and that it will be disposed of securely
That you will be analysing anonymiseddata.
Are you recording interviews? State that the interview will be recorded on a secure encrypted audio-device and then typed up by XXXXXXXXX. All data on the audio files will be pseudonymised and will be only identifiable by a number that is allocated to the participant. The study will be written up and submitted to the University of Leicester.
If you are using an external organisation to transcribe the audio files, state this and that there will be a Confidential Data Agreement in place.
Will the data be published? State that they will not be identifiable in publications.
Will you be using direct quotes? State that they will be used in the final research but care will be taken to remove any personal identifiable information and that they will not be able to be identified from the quotes because a pseudonym will be used and any identifiable information will have been removed already during the transcription of the audio-tapes.
Will you be sharing the results with the participants? If you will, will you take their contact details during consent?
Will it be sent to them by post or email?
or will you be inviting them to a presentation?
How long will you be keeping data for? (this is usually for 5 years after the research has ended) and state that it will then be destroyed.
Basic personal details (this would be their name and contact details for summary finding on the consent forms) will be kept separately from the audio files and securely in a locked filing cabinet within a locked room.
If a healthcare professional or clinical care team identified the participant, let them know that you would not disclose any of the information provided during the interview to them. The only time you would inform them would be when concerns are raised about the safety of the participant or others (if applicable) that you would need to share this information with the relevant professionals.

The below will be required to be inserted:

Your data may be accessed by authorised individuals from the Sponsor (University of Leicester), regulatory authorities and the host NHS organisation for monitoring and audit purposes and will have a duty of confidentiality to you as a research participant and we will do our best to meet this duty.

What will happen with the results of the study?

State it will be anonymised data that will be published
Will you be publishing?
Will you be providing a summary to participants?

Who has reviewed this study?

All research in the NHS is looked at 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 ______Research Ethics Committee.The study has received sponsorship from the University of Leicester and NHS organisations have also been able to review and subsequently approve the study.

What happens now?

If you do not wish to take part in this study, then you can simply destroy all the forms provided and no-one will contact you (your details have not been passed on to me) and that their decision to participate (or not) will not affect the ongoing care that they receive // their working relationships (for staff studies). This is dependent on the design of your research and may not be applicable.

If you have any questions or would like to discuss this further with me, you can contact me on the above or below details. Please be aware that, unfortunately, I am not able to provide support and the contact details can only be used for matters related to the study.