Participant Information Statement & Consent Form

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[INSERT any other organisational letterhead and the name of the
School/Organisation/Centre]
PARTICIPANT INFORMATION STATEMENT AND CONSENT FORM
[INSERT Participant Group (if applicable)]
[INSERT Title of project]
[INSERT Chief Investigator Name]
The study is being carried out by the following researchers:
Role
Name
Organisation
Chief Investigator
[INSERT name of CI]
[INSERT organisation]
Co-Investigator/s
[INSERTa list of co-investigator/s
[INSERT a list of
name/s]
organisation/s]
Student Investigator/s [INSERTa listof student invesitgator/s
[INSERT a list of
name/s] is conducting this study as the
organisation/s]
basis for the degree of [INSERT degree
undertaken] at The University of New
South Wales. This will take place under
the supervision of [INSERT name and
position of supervisor/s].
Research Funder
This research is being funded by [list the name/s of funding
organisation/s].
What is the research study about?
You are invited to take part in this research study. You have been invited because [INSERT reason
for invitation].
To participate in this project you need to meet the following inclusion criteria:
 [INSERT inclusion/exclusion criteria]
The research study is aiming to [INSERT a brief description of the purpose, aims and significance of
your research study in plain English].
Do I have to take part in this research study?
Participation in this research study is voluntary. If you don’t wish to take part, you don’t have to. Your
decision will not affect your relationship with The University of New South Wales [INSERT any other
organisation/s].
This Participant Information Statement and Consent Form tells you about the research study. It
explains the research tasks involved. Knowing what is involved will help you decide if you want to
take part in the research.
Please read this information carefully. Ask questions about anything that you don’t understand or
want to know more about. Before deciding whether or not to take part, you might want to talk about it
with a relative or friend.
If you decide you want to take part in the research study, you will be asked to:
 Sign the consent form ;
 Keep a copy of this Participant Information Statement;
What does participation in this research require, and are there any risks involved?
If you decide to take part in the research study, you will be asked to [INSERT provide a lay
description of each study task & potential risks. Please ensure they are detailed in chronological
order. Potential risks can include physical, psychological, financial and social risks.]
HC Number:
Version dated: Day Month Year
Page 1 of 8
Participant Group:
[INSERT any other organisational letterhead and the name of the
School/Organisation/Centre]
PARTICIPANT INFORMATION STATEMENT AND CONSENT FORM
[INSERT Participant Group (if applicable)]
[INSERT Title of project]
[INSERT Chief Investigator Name]
[EXAMPLE study tasks & risks]
#[INSERT study tasks name]
Description: [INSERT lay description of the study task]
Risk: [INSERT describe (1) the severity & likelihood (e.g., likely, less likely or rare) for each risk & (2)
how the risk will be managed]
#[INSERT study tasks name]
Description: [INSERT lay description of the study task]
Risk: [INSERT describe (1) the severity & likelihood (e.g., likely, less likely or rare) for each risk & (2)
how the risk will be managed]
[INSERT If no risks aside are anticipated use the following statement: ]
Aside from giving up your time, we do not expect that there will be any risks or costs associated with
taking part in this study.
[EXAMPLE standard wording for common study tasks]
[FOR SCREENING OR BASELINE TESTS]
Before you begin any activities we need to do some tests to understand whether it is ok for you to
take part. In order to do this we will ask you to complete the following tests and/or questionnaires.
The screening and/or baseline tests will involve the following activities:
[INSERT the details of the screening or baseline assessments to be used]
[FOR QUESTIONNAIRE]
You will be asked to complete a number of [INSERT online or paper based] questionnaires, which
will ask you questions about [INSERT the nature of the questions to be asked]. We expect this
activity to take up to [INSERT the time commitment required].
[FOR INTERVIEW]
You will be asked to participate in an interview that would take approximately [INSERT time
commitment required]. During the interview a member of the research team will ask you questions
about the [INSERT the nature of the questions that will be asked]. With your permission we would like
to digitially record the interview using an [INSERT audio tape/videotape/photograph]. The interviews
will take place in the following location:
[INSERT Location Details]
[FOR ACCESS TO PERSONAL RECORDS]
With your permission we would like to gain access to your [INSERT the type of personal records that
will be accessed] to collect information that tells us [INSERT the nature of the information that will be
collected.]
[REMOVE if not applicable - Example study task table]
Visit #
Procedures

HC Number:
Version dated: Day Month Year
Location*
Visit
Length
Screening assessments
Page 2 of 8
Participant Group:
[INSERT any other organisational letterhead and the name of the
School/Organisation/Centre]
PARTICIPANT INFORMATION STATEMENT AND CONSENT FORM
[INSERT Participant Group (if applicable)]
[INSERT Title of project]
[INSERT Chief Investigator Name]
Visit #
Procedures
Visit 1


Location*
Visit
Length
Interview
Personal Record review
Visit 2
Will I be paid to participate in this project?
[Option 1]
You will be reimbursed for any reasonable travel, parking, meals and other expenses associated with
the research study [INSERT describe the process for how they will be reimbursed].
[OR]
[Option 2]
There are no costs associated with participating in this research study, nor will you be paid.
What are the possible benefits to participation?
We hope to use information we get from this research study to benefit others who [INSERT realistic
potential future benefits. Please do not overstate the benefits]
What will happen to information about me?
By signing the consent form you consent to the research team collecting and using information about
you for the research study. We will keep your data for [INSERT storage period]. We will store
information about you at [INSERT storage location/s]. Your information will only be used for the
purpose of this research study and it will only be disclosed with your permission.
It is anticipated that the results of this research study will be published and/or presented in a variety of
forums. In any publication and/or presentation, information will be published, in a way such that you
will [INSERT one of the options below].
[OPTION 1: where participants will NOT BE IDENTIFIABLE in publications]:
not be individually identifiable.
[OPTION 2: where it is intended to protect participants’ identities but there is a RISK THEY WILL BE
IDENTIFIABLE in publications e.g. studies that focus on a small and specific cohort]:
research findings may be published. Although every effort will be made to protect your identity, there
is a risk that you might be identifiable in publications due to the nature of the study and/or the results.
[OPTION 3: where participants will be given the opportunity to CHOOSE WHETHER THEY ARE
IDENTIFIED in publications]:
research findings may be published, but you will not be identified in these publications unless you
agree to this by [INSERT instructions on how they can indicate their preference].
[OPTION 4: where PARTICIPANTS WILL BE IDENTIFIED in publications e.g. oral history]:
research findings may be published, and you will be identified in these publications if you decide to
participate in this study.
You have the right to request access to the information about you that is collected and stored by the
research team. You also have the right to request that any information with which you disagree be
corrected. You can do this by contacting a member of the research team.
HC Number:
Version dated: Day Month Year
Page 3 of 8
Participant Group:
[INSERT any other organisational letterhead and the name of the
School/Organisation/Centre]
PARTICIPANT INFORMATION STATEMENT AND CONSENT FORM
[INSERT Participant Group (if applicable)]
[INSERT Title of project]
[INSERT Chief Investigator Name]
[OPTION 5: where PARTICIPANTS AUDIOTAPED/VIDEOTAPED/PHOTOGRAPHED:]
The INSERT Audiotaped/Videotaped/Photographed] digital recordings are for the purposes of the
research study. After the INSERT interview/focus group] we will INSERT transcribe OR delete OR
transcribe and then delete] your digital recordings. We will keep your digital recordings in the form of
INSERT transcription OR digital recording and transcription] for [INSERT storage period]. We will
store information about you at [INSERT storage location/s]. Your confidentiality will be ensured by
[INSERT description of how confidentiality will be ensured].
How and when will I find out what the results of the research study are?
You have a right to receive feedback about the overall results of this study. You can tell us that you
wish to receive feedback by [INSERT a description of how participants can indicate they are
interested in receiving feedback].This feedback will be in the form of [INSERT a description of the
feedback that participants will be provided with, ensuring it is appropriate for the audience e.g. a one
page lay summary].You will receive this feedback after the study is finished.
[INSERT, if applicable to your study, a statement about any PERSONALISED FEEDBACK that
participants are entitled to receive concerning their individual results in the study (e.g. diagnostic
procedures, clinical tests, intelligence or aptitude testing). Be sure to distinguish between this type of
feedback and the general group-based results described above. Include any conditions associated
with this feedback (e.g. that participants’ personal results will only be provided to them through a
nominated clinician such as a GP or psychologist) and explain when and how it will be provided.]
What if I want to withdraw from the research study?
If you do consent to participate, you may withdraw at any time. If you do withdraw, you will be asked
to complete and sign the ‘Withdrawal of Consent Form’ which is provided at the end of this document.
Alternatively you can ring the research team and tell them you no longer want to participate.
If you decide to leave the research study, the researchers will not collect additional information from
you.
[INSERT, if applicable to your study – ONE OR MORE of the following statements about study data].
[For INTERVIEWS]
You are free to stop the interview at any time. Unless you say that you want us to keep them, any
recordings will be erased and the information you have provided will not be included in the study
results. You may also refuse to answer any questions that you do not wish to answer during the
interview.
[For NON-ANONYMOUS questionnaire]
Submitting your completed questionnaire is an indication of your consent to participate in the study.
You can withdraw your responses if you change your mind about having them included in the study,
up to the point that we have analysed and published the results.
[For ANONYMOUS questionnaire]
Submitting your completed questionnaire is an indication of your consent to participate in the study.
You can withdraw your responses any time before you have submitted the questionnaire. Once you
HC Number:
Version dated: Day Month Year
Page 4 of 8
Participant Group:
[INSERT any other organisational letterhead and the name of the
School/Organisation/Centre]
PARTICIPANT INFORMATION STATEMENT AND CONSENT FORM
[INSERT Participant Group (if applicable)]
[INSERT Title of project]
[INSERT Chief Investigator Name]
have submitted it, your responses cannot be withdrawn because they are anonymous and therefore
we will not be able to tell which one is yours.
[For FOCUS GROUP]
If you take part in a focus group, you are free to stop participating at any stage or to refuse to answer
any of the questions. However, it will not be possible to withdraw your individual comments from our
records once the group has started, as it is a group discussion.
[For OTHER data that CAN BE WITHDRAWN]
If you decide to withdraw from the study, we will not collect any more information from you. Please let
us know at the time when you withdraw what you would like us to do with the information we have
collected about you up to that point. If you wish your information will be removed from our study
records and will not be included in the study results, up to the point that we have analysed and
published the results.
[For OTHER data that CANNOT BE WITHDRAWN]
If you decide to withdraw from the study, we will not collect any more information from you. Any
information that we have already collected, however, will be kept in our study records and may be
included in the study results.
What should I do if I have further questions about my involvement in the research study?
The person you may need to contact will depend on the nature of your query. If you want any further
information concerning this project or if you have any problems which may be related to your
involvement in the project, you can contact the following member/s of the research team:
Research Team Contact
Name
[INSERT full name]
Position
[INSERT position title]
Telephone [INSERT work telephone number]
Email
[INSERT work email address]
[INSERT if applicable]
If at any stage during the project you become distressed or require additional support from someone
not involved in the research please call:
Contact for feelings of distress
Name/Organisation [INSERT name/organisation]
Position
[INSERT position title]
Telephone
[INSERT work telephone number]
Email
[INSERT work email address]
What if I have a complaint or any concerns about the research study?
If you have any complaints about any aspect of the project, the way it is being conducted, then you
may contact:
HC Number:
Version dated: Day Month Year
Page 5 of 8
Participant Group:
[INSERT any other organisational letterhead and the name of the
School/Organisation/Centre]
PARTICIPANT INFORMATION STATEMENT AND CONSENT FORM
[INSERT Participant Group (if applicable)]
[INSERT Title of project]
[INSERT Chief Investigator Name]
Complaints Contact
Position
Telephone
Email
HC
Reference
Number
HC Number:
Version dated: Day Month Year
Human Research Ethics Coordinator
+ 61 2 9385 6222
humanethics@unsw.edu.au
[INSERT HC reference number]
Page 6 of 8
Participant Group:
[INSERT any other organisational letterhead and the name of the
School/Organisation/Centre]
PARTICIPANT INFORMATION STATEMENT AND CONSENT FORM
[INSERT Participant Group (if applicable)]
[INSERT Title of project]
[INSERT Chief Investigator Name]
Consent Form – Participant providing own consent
Declaration by the participant

I have read the Participant Information Sheet or someone has read it to me in a language that I
understand;

I understand the purposes, study tasks and risks of the research described in the project;

I have had an opportunity to ask questions and I am satisfied with the answers I have received;

I freely agree to participate in this research study as described and understand that I am free to
withdraw at any time during the project and withdrawal will not affect my relationship with any of the
named organisations and/or research team members;

I understand that I will be given a signed copy of this document to keep;
Participant Signature
Name of Participant (please
print)
Signature of Research
Participant
Date
Declaration by Researcher*
 I have given a verbal explanation of the research study, its study activities and risks and I believe that
the participant has understood that explanation.
Researcher Signature*
Name of Researcher (please
print)
Signature of Researcher
Date
+
An appropriately qualified member of the research team must provide the explanation of, and
information concerning the research study.
Note: All parties signing the consent section must date their own signature.
HC Number:
Version dated: Day Month Year
Page 7 of 8
Participant Group:
[INSERT any other organisational letterhead and the name of the
School/Organisation/Centre]
PARTICIPANT INFORMATION STATEMENT AND CONSENT FORM
[INSERT Participant Group (if applicable)]
[INSERT Title of project]
[INSERT Chief Investigator Name]
Form for Withdrawal of Participation
I wish to WITHDRAW my consent to participate in the research proposal described above and
understand that such withdrawal WILL NOT affect my relationship with The University of New South
Wales, [other participating organisation[s] or other professional(s)].
Participant Signature
Name of Participant
(please print)
Signature of Research
Participant
Date
The section for Withdrawal of Participation should be forwarded to:
CI Name: [insert CI name]
Email: [insert work email address]
Phone: [insert work mobile number]
Postal Address: [insert work postal address]
HC Number:
Version dated: Day Month Year
Page 8 of 8
Participant Group:
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