19/11/2023 Version 0.

Participant Information Sheet

Study title

“Investigating the Prevalence of Work-related Stress in Frontline Pre-hospital Paramedics compared with S

Version number and date

Version 0.1 19/11/2023

Researcher’s name

Dee Mencarini

Supervisor: Dr Denise Bӓckstrӧm

QMERC Participant Information Sheet template; Version 2.0 – 05 July 2022

DSREC reference number:

[Insert reference number allocated to your study by the DSREC secretary]

Invitation paragraph

You are being invited to participate in a research study. Before you decide whether

or not you wish to participate in this study, 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 others if you wish. Ask us

questions if there is anything that is not clear or if you would like more information.

Your participation is entirely voluntary, you do not need a reason to refuse, and your

refusal will not affect your rights. If you consent to take part, your answers will be

completely anonymous.

What is the purpose of the study and what would taking part involve?

It has been well documented in recent years that paramedics have a higher

prevalence of stress related illnesses compared to the general population. This study

aims to explore whether there is a difference in stress related illness depending on

the division of prehospital care. Specifically, exploring whether there is a difference

on stress levels across specialist provisions such as air operations; Critical Care

QMERC Participant Information Sheet template; Version 2.0 – 05 July 2022

Paramedics, Special Operations and Resilience; Hazardous Area Response Team

Paramedics and Accident and Emergency Operations; Frontline Paramedics.

If you opt to participate in this study, you will be required to complete an anonymous

questionnaire which will ask about your personal demographics such as age,

gender, number of years since registration as a paramedic and time served within

your current job role. The questions will then investigate your individual emotional

stress using Goldberg’s General Health Questionnaire (GHQ-28); 28 questions

which explore how your health has been over the last few weeks using a four-point

Likert scale ranging from 0-3. Each individual can score between 0-84, with higher

scores suggesting a higher level of emotional stress.

The aim of this research is to investigate if there are any differences in stress levels

depending on which division or role of prehospital care a Paramedic may work

within.

 The questionnaire should take no longer than 10 minutes and there is no

requirement for you to meet the researcher.

 Once your data has been collected the results will be analysed to determine if

there are any differences in levels of stress, depending on your job role.

 The questions may suggest some level of emotional stress that was

unrealised previously. As the questionnaire is completely anonymous, there is

no way for the researcher to follow up with after care. If you consent to take

part in this research project, there will be options to self-refer to various

pathways and charities in order to access support and further advice.

QMERC Participant Information Sheet template; Version 2.0 – 05 July 2022

 Are there any plans for follow up?

 What types of information will you be collecting?

 What methods will you be using to collect data?

Where it is not appropriate to fully inform participants of the research purpose at this

stage, you should ensure that participants are fully debriefed at the end of the

research. A debriefing form should be included to your research ethics application

form.

The potential impact of research success should be cautiously stated, with care

taken not to use language or content that is overly persuasive.

Why am I being invited?

You are being invited as a qualified, HCPC registered paramedic with a minimum of

2 years’ experience to share the results of your questionnaire to explore whether

your job role has an impact of the stress you may or may not experience.

If you are not a registered HCPC paramedic, or have fewer than 2 years’ experience,

are currently seconded in an administrative role, on maternity leave, or long term

sick, you should not take part in this study.

QMERC Participant Information Sheet template; Version 2.0 – 05 July 2022

Do I have to take part?

It is entirely your choice whether to take part in this research. You can withdraw at

any point during the completion of the questionnaire, though due to the anonymity of

the research questionnaire, once you submit your data, there is no possibility of

withdrawal, your anonymised data will be gathered by the researcher and included in

the study. Refusal to participate requires no reason and will not affect the individual

or their rights.

You can choose not to answer individual questions within the questionnaire

For studies involving questionnaires/ surveys/ interviews, it is expected that the

participant can choose not to answer any individual question(s) and move on to the

next with impunity, without question and without explanation. If the researcher

believes that forced answers are necessary, this will need to be justified to the Ethics

Committee via application (with a clear indication of how any potential harms would

be mitigated) and to the participant in the PIS.

Example text;

This participant information sheet has been written to help you decide if you

would like to take part. It is up to you whether you wish to take part. If you do

decide to take part you will be free to withdraw at any time without needing to

provide a reason, and with no penalties or detrimental effects.

QMERC Participant Information Sheet template; Version 2.0 – 05 July 2022

What are the possible benefits of taking part?

You should state any potential benefits that may be gained by the research

participant through taking part in the research, either now or in the future.

Research outcomes can benefit the individual participant directly (for example, by

having access to new interventions or treatments that are not currently available or

by providing a voice for vulnerable groups of participants). Research can also benefit

the community in which the individual resides and the society as a result of finding

an answer to the research.

Once again, the potential impact of benefits to the individual or other parties should

be cautiously stated, with care taken not to use language or content that is overly

persuasive.

What are the possible disadvantages and risks of taking part?

However unlikely the possibility, it is important to disclose potential disadvantages

and risks of taking part in the research for potential participants to consider. These

might include physical harm; risks to confidentiality; risks to anonymity; psychological

risk etc. Where potential disadvantages are identified you should also describe the

QMERC Participant Information Sheet template; Version 2.0 – 05 July 2022

procedures in place to minimise or mitigate risks, and provide referral to relevant

support services for those in distress.

What information about me will you be collecting?

Describe what personal data you will be collecting. Take guidance from the research

ethics application form about what details to include.

How will my data be stored and who will have access to it?

Describe the measures to protect security and confidentiality of data. Provide a lay

summary description of the anonymisation and data management plans as

described in section 12 (Anonymity and Confidentiality) and section 13 (Data

management plan) of your research ethics application form.

Please refer to relevant University data policies when writing this section:

 Data Protection Policy

 Information/Data Governance Policy – DG14 – Storage of information

Example text;

 Your data will be stored in fully anonymised format in [insert location], and

only [insert individual] will be able to access it.

or

QMERC Participant Information Sheet template; Version 2.0 – 05 July 2022

 Your data will be stored in de-identified format. Your name and other

identifiers will be replaced by a unique code. To reduce the risk of disclosure,

personal identifiers will be stored separately from the research data in [insert

location] and will only be accessible to [insert individual]. There will be a key

document which will link your unique code to your real identity. This will be

kept in [insert location] and only [insert individual] will be able to access this

and link your data to you.

or

 Your data will be stored in identifiable format in [insert location], and only

[insert individual] will be able to access it.

When and how will my data be destroyed?

Provide a lay language summary of your retention and data destruction plans which

are described in section 13 (Data management plan) of your research ethics

application form.

Please refer to key University data policies and guidelines for writing this section:

 Queen Mary Records Retention Schedule

 Information/Data Governance Policy – DG16 – Disposal of information

How will my data be used and shared?

QMERC Participant Information Sheet template; Version 2.0 – 05 July 2022

Explain how participants’ data will be used and published (i.e. dissertation report/

thesis/ peer reviewed journals/ conferences) and in what format (anonymised/

pseudonymised/ identifiable). Also clarify if data will be stored in a database

accessible by others (open access).

Provide a lay summary of what is described in section 13 (Data management plan)

of your research ethics application form.

Please refer to key University data policies for writing this section:

 Research Data Access and Management Policy

Under what legal basis are you collecting this information?

Do not amend or delete the following text as this is required to comply with Queen

Mary’s legal obligations.

Queen Mary University of London processes personal data for research purposes in

accordance with the lawful basis of ‘public task’.

Please read Queen Mary’s privacy notice for research participants containing

important information about your personal data and your rights in this respect. If you

have any questions relating to data protection, please contact Queen Mary’s Data

QMERC Participant Information Sheet template; Version 2.0 – 05 July 2022

Protection Officer, Queens’ Building, Mile End Road, London, E1 4NS or data-

[email protected] or 020 7882 7596.

What will happen if I want to withdraw from this study?

Participants should be informed that they can withdraw their participation in the study

at any time without providing a reason.

Explain what will happen to the data in the event that a participant wishes to stop

taking part in the study. Clarify if you will retain and analyse already-collected data

relating to the participant up to the time of participant withdrawal or if you will

confidentially destroy the participant’s data. Be realistic about stages at which

complete, or only partial withdrawal of information is possible.

For example, participants can ask for access to the information they provide and can

request the destruction of that information if they wish at any time prior to [specified

point: i.e. anonymisation/submission of dissertation/a time frame, i.e. - 1 month]

following which they will not be able to request access to or withdrawal of the

information they have provided.

What should I do if I have any concerns about this study?

QMERC Participant Information Sheet template; Version 2.0 – 05 July 2022

You must include a way for the participants to contact someone if they have any

complaints. Do not amend or delete the following text.

If you have any concerns about the manner in which the study was conducted, in the

first instance, please contact the researcher(s) responsible for the study [Supervisor

if you are a student]. If you have a complaint which you feel you cannot discuss with

the researchers then you should contact the DSREC by e-mail: TS-EM-

[email protected]

Please provide details of the study title, description of the study and DSREC

reference number (where possible), the researcher(s) involved, and details of the

complaint you wish to make.

Who can I contact if I have any questions about this study?

[insert Investigator’s name]

[insert Investigator’s Queen Mary email address]

[insert Investigator’s Queen Mary telephone number]

QMERC Participant Information Sheet template; Version 2.0 – 05 July 2022