Participant Information Sheets
In this post we will explore best practices for providing further information to participants after they have applied to your research study.
This post is part of a series covering ethical issues relating to researcher participation and consent, the full series is linked at the end of this post and we recommend you read the full series in order.
In this post we will be looking at providing potential participants with more detailed information about the study so they can decide if they wish to take part.
Providing information after initial contact
Once potential participants respond to your advertisement and express an interest in taking part, you need to provide them with more specific information about what the study involves. This is done through the use of a participant information sheet (PIS).
A good PIS is comprehensive, yet concise and written in lay language that members of the general public will be able to easily understand. You want to avoid participants needing to read a lengthy, complex document as this may result in them losing interest, and hindering recruitment to your study.
If detailed, supplementary information needs to be made available to participants, such as the Research Privacy Notice, you can provide a hyperlink to the relevant digital document or have paper copies available upon request.
The PIS serves an important purpose as it’s your opportunity to outline your research and specifically what you’d like the participant to do. Potential participants then need to have the opportunity to consider this information before deciding whether or not they want to take part. For this reason, the PIS should be given to participants at least 24 hours before any activities are due to begin (e.g. interviews).
Components of a good PIS
In order to ensure that the Participant Information Sheet has all of the essential information needed for the participant to make an informed decision about participating, it should include the following key sections:
1. About the Research
- Who will conduct the study?
- What is the purpose of the research or what does it hope to highlight or achieve?
2. What would my involvement be?
- What will the participant be asked to do?
- How long will it take?
- Is participation a one off event or part of a series?
- Will they be compensated for their time?
- What happens if they change their mind part way through?
3. Data protection and confidentiality
- What data will be collected about the participant?
- What is the legal basis for processing this data?
- What are the rights of the participant in relation to their data?
- Will their participation be confidential or will data be shared with others?
- What happens if something is revealed during the study that means the researcher needs to alert another person or group of people or provide support via charities or other organisations?
The last question in the list is often one of the most difficult to plan for.
‘If you’re conducting interviews with members of the general public about their experiences during the COVID pandemic lockdown and they express concerns about their current state of mental health and well-being, you may need to provide them with support via mental health charities or encourage them to speak with their GP.
If they become very upset during the interview, you may need to call a family member or friend to come and meet with them or contact another professional organization for additional support.’
Another example involves disclosures and needing to report these to the relevant organisation or authority.
If during the course of an interview a participant reveals child safeguarding concerns, you must report these following the University’s Child Protection Policy and note this requirement in the PIS.
4. What if I have a complaint?
- Contact details of the supervisor or first point of contact.
- Contact details of the Research Governance, Ethics and Integrity Team (if not satisfied with response from first point of contact).
- Contact details of the Data Protection Office and Information Commissioner’s Office (if complaint is in relation to UK GDPR).
5. Researcher contact details
- Should be the telephone number and or email address of the student.
6. Version number and date
- Version numbers and dates should appear in the header, footer or just below the title of all supporting documents and is required under UK GDPR.
7. Ethics committee and reference number
- The name of the ethics committee that granted approval (if applicable) and the reference number of your study
8. Additional sections that may be applicable
- Will the research project be published?
- Is the research project being funded?
- Disclosure and Barring Service (DBS) Check
Constructing your PIS
Having all of these essential sections will help to ensure that your participants have detailed information about your research and can therefore make an informed decision about whether or not they want to take part.
Some other useful advice to remember when constructing your PIS is:
- Always use a UK GDPR compliant template, which can be downloaded from the research ethics website.
- Ensure that any other essential sections are also included. For example, if working with children or young people you should also include the section relating to a DBS check.
- If any information in the template is not relevant to your study (e.g. if you’re not planning on sharing data with others) then ensure it is removed to avoid potential confusion.
- The template contains words in red that need to be changed to the specifics for your study. It also contains guidance notes (e.g. in the header) that should be removed in your final version.
- Ensure you update the footer with a correct version number and date for your document. This will help to ensure that your participants are receiving the most up to date version, should you choose to make changes in future.
- Ensure you write the PIS in lay language. You should also consider the average reading age of your potential participants as you may need to simplify this further. For example if you are planning on recruiting those with significant learning difficulties or those recovering from a stroke, you may wish to consider presenting your PIS in a more simplified format and even using pictures.
- You may need to have different PIS documents if you are recruiting more than one group of participants (e.g. teachers and parents)
In this post we explored best practice for providing information to participants after they express an interest in taking part in your research study. We recommend you now look at the next post in this series ‘Obtaining Informed Consent’. Further support posts linked below or go back to the full list of posts in this series here.