- UniSA Framework for the Responsible Conduct of Research
- Australian Code for the Responsible Conduct of Research
Participant Information Sheet Guidelines
The participant information sheet 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.
- General information
- Email or internet distribution
- Control groups
- Collection of data on audio or videotapes
- Drug therapy
Participant information sheets should be headed with the following information:
- The University of South Australia logo
- The division and school or unit from which the research is being conducted
- The plain English title of the research project
- Researchers' and supervisors' names, highest qualifications and contact telephone numbers/email addresses (students should give their supervisor's name and phone number as the main contact).
All participant information sheets should include:
- If there are no risks beyond those encountered during everyday life, the following statement should be used: "It is not anticipated that there are any risks to participation in this study beyond those encountered during everyday life."
- An invitation to potential participants to participate in the research study, stating that participation is voluntary
- A clear explanation of the purpose of the study.
- A summary of what the participant will be expected to do, or have done to them, during the research
- A statement that the participant may withdraw from the research at any time without affecting their position (or, if appropriate, their treatment or care) now or in the future.
- A statement detailing whether data may be excluded from the study if participants withdraw, and/or the point at which data may be withdrawn (e.g., up until a specified date or a particular stage of data collection).
- The possible benefits or risks to the participant in participating in the research.
- A description of measures which will be taken if the participant suffers adverse events as a result of participating in the research
- A statement informing participants how long all information collected as part of the study will be retained (for example, five years or seven years), and details of where the information will be stored and the form in which it will be stored. Also whether the data will be individually identifiable, re-identifiable (coded) or non-identifiable.
- A statement that all records containing personal information will remain confidential and no information which could lead to identification of any individual will be released, unless required by law OR if individuals will be able to be identified, a statement should be included making them aware of this.
- The following statement: 'This project has been approved by the University of South Australia's Human Research Ethics Committee. If you have any ethical concerns about the project or questions about your rights as a participant please contact the Executive Officer of this Committee, Tel: +61 8 8302 3118; Email: email@example.com'.
- Details about how and when participants will be provided with either a copy of the final research report or summary of the research findings.
- A clear statement outlining the potential and/or actual risks, how these will be minimised and/or managed (for further details refer to Section 2 of the National Statement on Ethical Conduct in Human Research (2007).
- If you are conducting focus groups, your participant information sheet should include the following statement: "Given the public nature of focus groups, confidentiality and anonymity of focus group discussions and participation cannot be guaranteed".
- Details about the complaints process, i.e. participants or third parties who wish to lodge a complaint about either the study or the way it is being conducted should contact the Executive Officer of UniSA HREC in the first instance, email: firstname.lastname@example.org or tel: 8302 3118.
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 responses from any identifying material as early as possible. Likewise individuals' responses will be kept confidential by the researcher and 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.
Where a control group or similar methodology is to be used in your research, you should include a statement that participants may be allocated to either a control or experimental group, and that they may not be told which of these groups they are in.
If audiotapes, videotapes or photographs will be used for data collection, the information sheet should be adapted to ensure that participants are informed that:
- They will be taped or photographed (they should also be reminded of this before data is collected).
- The tape or a certified transcript of the tape is raw data and will be securely retained for five years.
- Their identity can be masked if they request this.
In addition the participant must be informed if another organisation or person
has rights of access to the data collected on tape.
In addition to the usual information, information sheets for protocols involving drug therapy must include:
- name of drug (generic preferred, trade name if necessary to the study design)
- any conditions in which the drug should not be taken (for example during pregnancy)
- whether the drug is meant to treat the disease or to relieve symptoms, and therefore how important it is to take the drug
- how to tell if the drug is working and what to do if it appears not to be working
- when and how to take the drug (for example before or after meals)
- what to do if a dose is missed and the implications of not taking the drug for any length of time
- any interactions with alcohol or other drugs (generic and trade names)
- storage and disposal of the drug
- risks, side effects, discomforts, inconveniences, restrictions, or other negative effects which might occur as a result of taking the drug
- the probability of adverse effects from the test drug compared with other procedures (or drugs) used for the same purpose
- any category of participant to be excluded from the research
- an explanation that randomisation and/or placebos may be used (where relevant)
- a statement that the participant may withdraw from the trial at any
time without prejudice to his or her future treatment (a statement
detailing pro-rata payment for subjects who withdraw should be included
on the information sheet).
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.