Step 3: Attach supporting documentation
The HREC must examine all supporting documentation relevant to your research project to ensure they meet compliance requirements of the National Statement.
Typical supporting documentation may include:
- Plain Language Information Statement (PLIS)
- Consent form
- Letters of approval from external agencies
- Recruitment advertisements: advertisements, flyers, email, Facebook, Twitter etc
- Data-gathering instruments:questionnaires, interview questions, etc.
- Interview schedules
- Debriefing material
Plain language information statement
The informed consent process requires researchers to disclose all information necessary that will 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, 73kb).
The Plain Language Information Statement (PLIS) needs to be written and presented in a style and format appropriate to the age and educational standard of the potential participants and, as its name suggests, it should be composed using plain. not technical language. It can be useful to include headings and diagrams, especially when conveying complex information, and it is sometimes appropriate to present the information in the form of a letter to participants.
The PLIS should always be retained by the participant. Researchers may combine the PLIS and Consent form into one document in instances when consent is to be implied by return of a survey, to maintain anonymity of participants.
The Plain Language Information Statement should contain the following information, if relevant to your project:
- Identifying details of the Federation University (download the University 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)
- An invitation to participate
- Advise 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.
- 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
- 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
- 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).
Download the Informed Consent form (docx, 66kb).
When designing a project, researchers should take into account the following issues when planning how to obtain consent to participate from potential participants:
- Consent must not be subject to any coercion, or to any inducement or influence which could impair its voluntary character.
- An individual's choice not to participate in research should be respected, whether the individual has reasons or not. The freedom to decide not to participate is clearly presented. Participants must be assured that they are free to refuse to participate, and that such a refusal can be made without reason or justification.
- Participants should also be assured that they are free to withdraw their consent to further involvement in the research at any time. If any consequences arise from withdrawal, participants must be advised of these before their consent to involvement is obtained.
Researchers must plan how they will establish and document participant consent; for example, a signed form, the return of a survey, or recorded agreement for interview. Participants can record their consent to participate in a project through the use of a separate consent form, or a separate section of the PLIS can be designed for the participant to complete, sign and return. The consent form/section should record an acknowledgement that the participant:
- Has read the information provided
- Agrees to participate
- Has received answers to their satisfaction to any questions asked of researcher
- Knows they may change their mind and stop at any time without prejudice
understands that all information provided is confidential and will not be released by the investigator unless required to do so by law
- Agrees to audio-/video-recording of interviews (where relevant)
- Agrees that collected data may be published (without identifying information)
In some instance, it is not necessary to obtain signed consent statements of agreement to participate. Such instances include routine procedures such as educational assessments, mass distribution questionnaires that do not collect identifying data, research with no direct contact with participants (e.g., telephone surveys), and research where individuals are reluctant to agree to participate if identifying information is collected (e.g. illegal or socially stigmatised activities).
While written consent is not required in these cases, consent should still be obtained, and researchers must identify the process and documentation of such consent. It is still necessary to provide these potential participants with plain language information about the research and their rights. Verbal consent should be obtained if possible (e.g., at the beginning of an audio or videotape recording). Participants involved in the completion of anonymous questionnaires should be specifically informed that return of the questionnaire will be regarded as consent to use the information for research purposes. Other situations may require alternative specific and creative strategies.
Approvals from external agencies or organisations
Many research projects involve or will impact on participants within other agencies or organisations. In such instances, researchers must supply the HREC with documented approval from the authorised officer or committee of the relevant agency or organisation for the specified project: e.g., Department of Education, School Principal, companies, Elders (Aboriginal communities); or representative bodies for collectives.
When applying for HREC approval, you must supply all approval letters obtained from the external agencies or organisations. If you are in the process of, but have not yet obtained this approval, you must include with your application the following information:
- Names of external agencies or organisations you are applying to for
- Copies of all relevant correspondence with these external agencies to date.
Some institutions/authorities may decline to provide permission letters until ethics approval has been granted.In such cases, you should submit your HREC application, to obtain 'Provisional Approval - pending receipt of the documentation from the external body'. HREC approval will be granted on receipt of all outstanding documents.
Things to consider when preparing supporting documentation
- Ensure all recruitment documents include the FedUni logo
- Use FedUni email details at all times - no personal email contact details should be distributed
- Use FedUni phone details whenever possible - only use personal mobile when necessary
- Remember to prepare documents with the intended audience in mind
- Ensure spelling and grammar are correct for all participant documents
- Include interview schedule information in the PLIS for participants to keep
- Use FedUni templates whenever possible - consent form & PLIS
- Refer back to relevent sections of your application to ensure you have prepared all necessary supplementary documents
- Where supporting documentation is submitted in draft form, the final version must be submitted to the HREC for assessment as soon as it is available.
- Final approval cannot be given by the HREC for any project with outstanding documentation.