The participant information sheet is used to explain the purpose of the research and what participants will be required to do /how participants will be involved. It should be in plain English, using language appropriate to the target audience. In some cases it will be appropriate to have the information sheet translated into a language other than English, or to provide an interpreter.
All participants should be given a copy of the participant information sheet, even if they are completing an online questionnaire. Please ensure that the sheet is available for printing from the online site.
A Participant Information Sheet template is available. Details about what to include are below. You are not required to use the outline in the template, but all information is required.
Introduction – What does my participation involve?
What is the purpose of this research?
What does participation in this research involve?
What are the possible benefits of taking part?
What are the possible risks and disadvantages of taking part?
Do I have to take part in this research project?
What will happen to information about me?
What happens when the research project ends?
Who is organising and funding the research?
Who has reviewed the research project?
Further information and who to contact
The purpose of this section is to state the reason the participant is being invited to take part in the research project and to explain the purpose of the form and the nature of informed consent.
Example Text
You are invited to take part in this research project, which is called [Name of research project]. You have been invited because [Explain reason for invitation]. Your contact details were obtained by/from [provide details].
This Participant Information Sheet tells you about the research project. It explains the processes involved with taking part. Knowing what is involved will help you decide if you want to take part in the research.
Please read this information carefully. Ask questions about anything that you don’t understand or want to know more about. Before deciding whether or not to take part, you might want to talk about it with a relative, friend or local health worker/your doctor.
Participation in this research is voluntary. If you don’t wish to take part, you don’t have to.
If you decide you want to take part in the research project, you will be asked to sign the consent section. By signing it you are telling us that you:
Understand what you have read
Consent to take part in the research project
Consent to the use of your information as described.
You will be given a copy of this Participant Information Sheet to keep.
Briefly describe the following aspects of your project in simple terms and in only a couple of sentences for each point:
Include information and clear explanation of the following:
Explain any other relevant information including:
Email or internet distribution
If you will use email or the internet to distribute questionnaires and receive responses, you should include the following statement in the information provided to participants:
The researcher will take every care to remove any identifying material from the responses you provide as early as possible. Likewise individuals' responses will be kept confidential by the researcher and will (or participants will) not be identified in the reporting of the research. However the researcher cannot guarantee the confidentiality or anonymity of material transferred by email or the internet.
Drug therapy
In addition to the usual information, participant information sheets for protocols involving drug therapy must include:
Radiation
In addition to the usual information, participant information sheets for protocols involving radiation must include the following statement
In this project you will be exposed to radiation at a level considered safe for you as long as you have not also been exposed to radiation in other research projects or as a part of investigation (X-Rays) or treatment (Radiotherapy) in the past year. Please advise the researcher if you have had any exposure to radiation for any reason in the last year.
Do not attempt to build up participant hope in this section. Reference to the potential benefit to others in the future may be appropriate, but should not be exaggerated.
Example text
We cannot guarantee or promise that you will receive any benefits from this research; however, possible benefits may include [describe any likely benefits to participants or other people in the future].
If the significant benefits from the research project are to accrue to members of society in the future and NOT to the individuals taking part in the research, this should be made clear.
Example text
There will be no clear benefit to you from your participation in this research.
Provide information on the possible risks with taking part in this research project and strategies the researchers will use to manage and/or minimise the risks.
If there are no foreseeable risks, the following statement should be included:
It is not anticipated that there are any risks to participation in this study beyond those encountered in everyday life.
If data is being collected via Group discussions, this Example text could be included
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.
Explain that taking part in the research is entirely voluntary.
Example text
Participation in any research project is voluntary. If you do not wish to take part, you do not have to. If you decide to take part and later change your mind, you are free to withdraw from the project at any stage.
If you do decide to take part, you will be given this Participant Information and a Consent Form to sign and you will be given a copy to keep.
Your decision whether to take part or not to take part, or to take part and then withdraw, will not affect your routine care, your relationship with professional staff or your relationship with the University of South Australia.
Provide information regarding how participants withdraw and implication for them if they do so. Implications can include
Example text for General statement
If you do consent to participate, you may withdraw at any time. If you decide to withdraw from the project, please notify a member of the research team before you withdraw. A member of the research team will inform you if there are any special requirements linked to withdrawing.
Example text for Anonymous survey
You are free to decline to complete the survey or to withdraw from the study at any point while completing the survey, without affecting your relationship with the researchers or the University of South Australia, either now or in the future. Once you submit your survey, however, we are unable to remove your response as it will be impossible to identify your completed survey.
Information should be provided regarding the following:
Example text
By signing the consent form you consent to the research team collecting and using information about/from you for the research project. Any information obtained in connection with this research project that can identify you will remain confidential. Information collected or used will be stored as [individually identifiable, re-identifiable or non-identifiable. Explain how it will be confidential and, if it is identifiable/re-identifiable, where it will be kept and who will have access to it].
Your information will only be used for the purpose of this research project [and for the future research described]. It will only be disclosed with your written consent, except as required by law.
The information that the research team collect and use is [types of information, e.g. information from questionnaires].
The data will be stored [provide details] in [format] for this period of time [define period of time].
Provide a description of measures which will be taken if the participant suffers adverse events as a result of participating in the research.
Provide information on how, and approximately when, participants will be provided with a summary of the results when the research project is completed.
Example text
A summary of project results will be available [provide date] from [provide details]. Individual results will be provided via [provide details], if possible/applicable.
Provide details about who is organising and funding the research. Include names of any sponsors and any financial benefits that might arise from the conduct of the research.
Example text (include the appropriate information for your research):
This research project is being conducted by [Name of person].
This research is being sponsored by [Name of sponsor]
It is being funded by [Name of funding organisation].
[Company/University] may benefit financially from this research project if, for example, the project assists [Company/University] in any commercial enterprise.
You will not benefit financially from your involvement in this research project even if, for example, knowledge acquired from your information proves to be of commercial value to [Company/University].
In addition, if knowledge acquired through this research leads to discoveries that are of commercial value to [Company/University], the researchers or their institutions, there will be no financial benefit to you or your family from these discoveries.
No member of the research team will receive a personal financial benefit from your involvement in this research project (other than their ordinary wages).
Add any declarations of interest of researchers, sponsors and institutions.
Recommended text:
The ethical aspects of this research project have been approved by the Human Research Ethics Committee (HREC) of the University of South Australia as required by the Australian government research requirements, specified in the National Statement on Ethical Conduct in Human Research (2023). This statement has been developed to protect the interests of people who agree to participate in human research studies.
Recommended text:
The person you may need to contact will depend on the nature of your query. If you want any further information concerning this project or if you have any problems which may be related to your involvement in the project, you can contact the researcher on [Phone number] or any of the following people:
Research contact person
|
Name |
<Name of researcher> |
|
Position |
<Researcher's position> |
|
Telephone |
<Phone> |
|
|
<email address> |
If you have any complaints about any aspect of the project, the way it is being conducted or any questions about being a research participant in general, please contact:
Reviewing HREC approving this research and HREC Executive Officer details
|
Reviewing HREC name |
University of South Australia Human Research Ethics Committee |
|
HREC Executive Officer |
Human Ethics Officer |
|
Telephone |
+618 8302 6330 |
|
|