Example PIS
In this part, you can see a complete sample of PIS, some examples are given after each question for reference. On this page, you can learn about the overall framework of PIS, as well as more detailed and rich practical examples.
NB: Sentence highlighted in yellow means you should edit this part in your PIS according to your study. Sentences in normal font indicate template text that does not need to be modified if not necessary. Italic sentences indicate explanations and examples
Participant Information Sheet
| Project title: | enter your project title |
| Principal investigator: | [for student projects, the supervisor is the PI] |
| Researcher collecting data: | enter researcher collecting data |
| Funder (if applicable): | enter funder's name if applicable |
This study was certified according to the Informatics Research Ethics Process, RT number XXXXX [edit accordingly]. Please take time to read the following information carefully. You should keep this page for your records.
Who are the researchers?
Explanation:
Introduce the entire research team who will have access to the data. If you are a student, include your supervisor(s).
Examples:
The research team who will have access to the data collected in this project iIIncludes the principal investigator Dr. Kami Vaniea and the researcher Souven Chen.
What is the purpose of the study?
Explanation:
Summarise research focus and aims
Examples:
We are studying the Unicorn+ app which allows users to create their own images of Unicorns easily and share them online. This study is conducted to evaluate the usability of the app so that we can improve its user interface design and allow people to make awesome Unicorn images with greater ease.
Why have I been asked to take part?
Explanation:
This part needs you to explain specifically why the participant has been invited (e.g. because they have a specific condition, or because they are healthy individuals). It also make sense if you could state how many participants you are intending to involve and their characteristics (e.g. healthy volunteers, people with specific condition).
Examples:
1. We are advertising the study to people who have more than 3 childrens.
2. We are advertising the study to researchers with experience in writing participants information sheets.
3. We are advertising the study to people who are currently at University and are over 18 years old.
4. We are advertising the study to people who are over 20 years old and have long brown hair.
5. We are advertising the study to people who have some motor ability in both hands and can verbally communicate.
Do I have to take part?
No – participation in this study is entirely up to you. You can withdraw from the study at any time, without giving a reason. Your rights will not be affected. If you wish to withdraw, contact the PI. We will stop using your data in any publications or presentations submitted after you have withdrawn consent. However, we will keep copies of your original consent, and of your withdrawal request.
What will happen if I decide to take part?
Explanation: - How often, where, when
In this section, what need to be specifies are:
- Kinds of data being collected (e.g. questions regarding X, Y or Z)
- Means of collection (e.g. questionnaire, interview, focus group)
- Duration of session
- If participant audio/video is being recorded
Examples:
We will ask you to install the Unicorn+ app on your personal Android or iPhone device and use it to generate Unicorn images. You will be provided with several pictures of Unicorns and asked to use the app to generate similar looking Unicorns and then use the app to email your generated Unicorns to the researcher’s email address. At the end of the study we will as you to provide some demographic information including age, gender, and if you are a student. We will also help you uninstall the app from your device.
The study uses a special app version that automatically collects basic information about your device such as its model number the app also records the settings you use to create Unicorns.
With your consent, we will audio and video record the session using an IPhone. If at any point you feel uncomfortable, you can ask me to stop the audio/video recording , or state that you do not want something specific quoted.
Compensation. [only required if applicable]
Explanation:
If you will provide participants with some form of compensation, you need to clearly indicate what the specific compensation is. During the implementation of the project, please ensure that you can deliver on your promises.
Examples:
Pay by voucher: "You will get a £10 voucher from Amazon for participating in this research."
Pay by money: "You will receive £10 in cash for participating in this research."
No compensation: "You will not get any benefit for participating in this study." or you can delete this section directly.
Are there any risks associated with taking part?
Explanation:
In this section include any potential risk or discomforts, and how those risks will be addressed if they arise. If you believe there are no risks involved, since there is never a guarantee, state that there are “no known risks”.
Examples:
No risks: "There are no significant risks associated with participation."
Exist risks: "Whilst all care will be taken to maintain privacy and confidentiality, the researcher cannot guarantee anonymity and confidentiality for group discussions. All group participants will be asked to maintain the confidentiality of group discussions and identity of participants."
Are there any benefits associated with taking part?
Explanation:
If you will provide participants with some form of compensation, you need to clearly indicate what the specific compensation is. During the implementation of the project, please ensure that you can deliver on your promises.
Examples:
No benefits: "You will receive no compensation for participating in this study other than the knowl- edge that you have helped many people have an easier time making Unicorns on their mobile devices."
Exist benefits:"You will get a pizza coupon for participating in this research."
What will happen to the results of this study?
The results of this study may be summarised in published articles, reports and presentations. Quotes or key findings will be anonymized: We will remove any information that could, in our assessment, allow anyone to identify you. With your consent, information can also be used for future research. Your data may be archived for a minimum of X years [typically two, amend where needed. Also specify if you have different retention policies for the consent forms and the collected data].
Data protection and confidentiality.
Your data will be processed in accordance with Data Protection Law. All information collected about you will be kept strictly confidential. Your data will be referred to by a unique participant number rather than by name [amend as appropriate]. Your data will only be viewed by the researcher/research team [name everyone who will access the data here, including any research support staff who have access].
All electronic data will be stored on a password-protected encrypted computer, on the School of Informatics’ secure file servers, or on the University’s secure encrypted cloud storage services (DataShare, ownCloud, or Sharepoint) and all paper records will be stored in a locked filing cabinet in the PI’s office. Your consent information will be kept separately from your responses in order to minimise risk.
What are my data protection rights?
The University of Edinburgh is a Data Controller for the information you provide [amend if student PI]. You have the right to access information held about you. Your right of access can be exercised in accordance Data Protection Law. You also have other rights including rights of correction, erasure and objection. [make restrictions clear if e.g. accessing data would affect outcome of study] For more details, including the right to lodge a complaint with the Information Commissioner’s Office, please visit www.ico.org.uk. Questions, comments and requests about your personal data can also be sent to the University Data Protection Officer at dpo@ed.ac.uk.
Who can I contact?
If you have any further questions about the study, please contact the lead researcher, [name, contact details].
If you wish to make a complaint about the study, please contact inf-ethics@inf.ed.ac.uk. When you contact us, please provide the study title and detail the nature of your complaint.
Updated information.
If the research project changes in any way, an updated Participant Information Sheet will be made available on https://web.inf.ed.ac.uk/infweb/research/study-updates. [NB: the PI should notify the Ethics panel on inf-ethics@ed.ac.uk to upload any updated PIS to the website]
Alternative formats.
To request this document in an alternative format, such as large print or on coloured paper, please contact [insert contact name and contact details such as email].
General information.
For general information about how we use your data, go to: edin.ac/privacy-research.