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Participant information sheet guidelines

The participant information sheet should be in plain English, avoiding technical terminology and using language appropriate to those being invited to be participants. In some cases it will be appropriate to have the information sheet translated into a language other than English.


General information

Participant information sheets should be headed with the following information:

  • University of South Australia
  • the division and school or unit from which the research is being conducted
  • the plain English title of the research project
  • the names, highest qualifications and contact telephone number of the researchers (undergraduate students should give their supervisor's name and phone number as the contact person).

All participant information sheets should include:

  • 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
  • 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 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: vicki.allen@unisa.edu.au'
  • 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) - Updated December 2013  
  • If you are conducting focus groups, your participant information sheet should include the following statement: “Given the nature of focus groups, confidentiality of focus group discussions and participation cannot be guaranteed.”

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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 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.
 

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Control groups

Where a control group or similar methodology is to be used in your research, you should include a statement that subjects may be allocated to either a control or experimental group, and that they may not be told which of these groups they are in.
 

Collection of data on audio or videotapes

If audio or videotapes will be used for data collection the information sheet should be adapted to ensure that participants are informed that:

  • information will be taped. 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.
 

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Drug therapy

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).
     

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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.

 

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