< back
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.
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, treatment or care
- 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 that all information collected as part of the study
will be retained for five 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 OR if individuals will be able to be identified, a statement should
be included making them aware of this
- the name and telephone number of the Executive Officer of the
ethics committee (UniSA HREC or DEC as
applicable),
stating they will be available to discuss any ethical concerns about the
project or answer questions about the rights of participants
- 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
top^
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.
top^
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.
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.
top^
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).
top^
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.
top^
