The informed consent process requires researchers to disclose all information necessary to allow potential participants to make an informed decision about consent. This information is normally presented to participants in written form: Plain Language Information Statement - PLIS (docx, 77kb)
The PLIS needs to be written and presented in a style and format appropriate to the age and educational standard of the potential participants. It needs to be welcoming, and composed using plain, not technical, language. If conveying complex information, you may wish to include headings and diagrams.
The PLIS is to be retained by the participant for their ongoing reference. Researchers may combine the PLIS and consent form into one document in instances when consent is to be implied by participation in an on-line survey or return of a paper based survey, to maintain anonymity of participants.
The PLIS should contain the following information, if relevant to your project:
- Identifying details of the Federation University Australia (download the PLIS template)
- Identifying details of the School / Faculty in which the research is being conducted
- The title of the project
- The level and discipline of all researchers (e.g. 3rd year Bachelor of Nursing student)
- A welcoming invitation to participate
- Advice that if the sample size is small this may have implications for privacy/anonymity.
- A description in lay terms of the nature and purpose of the project
- Details of what will be involved in participation (e.g., telephone interview to take approximately 15 minutes; questionnaire to take approximately one hour to complete; travel to a specific place)
- Information on relevant researcher training or expertise in specific techniques
- Identification of any funding bodies and sponsors of the research
- Details of any remuneration or compensation offered to participants
- A statement to explain if the completion of a survey indicates implied consent to participate.
- A statement that participation is voluntary, that refusal to participate requires no explanation, that participants are entitled to withdraw their consent to participate and discontinue participation at any time without consequence.
- Should (potential) consequences arise from withdrawal, participants must be clearly advised of these before their consent to involvement is obtained
- Advise that if consent is withdrawn after data has been aggregated and processed it will not be possible to withdraw non-identifiable data, although consent can still be withdrawn.
- A statement that participants are free to choose not to answer questions on the questionnaire or during interview without consequence
- An objective statement of any likely risks or discomforts AND contact details for Lifeline and other support agencies as applicable to your type of research risk
- Methods of data collection, storage and dissemination, and an assurance that collected data will be confidential and that no identifying information will be used in any publication arising from the research
- A statement regarding any interview questions or questionnaire items which may be seen as personal and private
- A statement that there will be an opportunity for participants to preview results and transcripts and to withdraw or amend (if appropriate) any data during or at the end of the interview or any unprocessed data previously supplied (this opportunity will not exist for participants where data has been collected anonymously because data will not be able to be matched with specific individuals).
- A description of how and for how long data will be stored, and if, how and when specific items (e.g., audiotapes, videotapes, photographs) will be destroyed
- A description of how data confidentiality will be maintained, and who will have access to the data
- If there is a possibility you or other researchers may wish to use the collected data in future research projects, include wording in the PLIS and consent forms like: 'Be aware that in participating in this research, your de-identified data may be used to inform future research' rather than '...only researchers named on this project will have access to this data...'
- Include a statement of what the research will be used for, how the results will be disseminated, and to whom they will be made available
- A statement that disseminated results will not include information that identifies individual participants (unless specific permission has been obtained)
- Information on the provision, availability and contact details for follow-up support
- An invitation to contact the researchers (provide FedUni email addresses only and FedUni phone numbers whenever possible) if potential participants require any additional explanation of the project
- A statement that if participants wish to make a complaint regarding the conduct of the research they should direct these to the Ethics Officer for attention (this information is contained in the footer of the PLIS template - no further info needs to be added).