DEAKIN UNIVERSITY HUMAN RESEARCH ETHICS COMMITTEE
REQUEST FOR MODIFICATION FORM
Project ID:
Project Title:
Original approval date:
Date of expiry of approval:
Expected completion date
of data collection:
Other HRECs involved:
Part A
Approval Details
Project approved by:

Deakin University HREC

Faculty of Arts & Education HEAG

Faculty of Business & Law HEAG

Faculty of Health, Medicine, Nursing & Behavioural Sciences HEAG

Faculty of Science, Engineering & Built Environment HEAG
Part B
Researcher Information
Principal investigator (name and title):
Faculty:
School/Centre:
Campus:
Contact phone number:
Email:
Co-researchers (please copy and paste for all additional researchers including students)
Associate investigator (name and title):
Faculty:
School/Centre:
Campus:
DUHREC Request for Modification Form (Version 7)
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Contact phone number:
Email:
Part C
Please provide details of proposed modification(s) to project:
1. Has the membership of the research team changed?
Yes
*
No
2. Are you seeking an extension of time for data collection?
Yes
** No
3. Have any of the funding arrangements and/or intellectual property implications changed?
Yes
No
4. Has the involvement of any external institution in the project changed?
Yes
No
N/A
5. Has the methodology employed in the project changed (including data collection and analysis)?
Yes
No
6. Has the overall number of participants, or the number of participant groups changed?
Yes
No
7. Is it now intended or expected that vulnerable groups will be recruited to the study? (vulnerable
groups include: people whose primary language is other than English, pregnant women or the
human foetus, children and/or young people, people in existing dependent or unequal
relationships, people highly dependent on medical care, people with a cognitive impairment, an
intellectual disability or a mental illness, Aboriginal or Torres Strait Islander people or people
who may be involved in illegal activities).
Yes
No
8. If children or young people are now involved in the study, is their participation essential and has
this been designed to be appropriate for them?
Yes
No
N/A
9. Will participants experience something different to what was originally approved?
Yes
No
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10. Has the recruitment strategy changed (including how participants will be identified, how the
study will be advertised and/or how potential participants will be contacted)?
Yes
No
11. Will participants be screened with a new or altered screening test/has the selection criteria for
participants changed?
Yes
No
12. Has the consent process changed?
Yes
No
13. If a new participant group(s) has been added, do they have the capacity to consent for
themselves (if yes, please include a description of how this capacity will be judged in your
response below)?
Yes
No
N/A
14. If participants do not have the capacity to provide consent for themselves (for example,
children), will someone provide consent on their behalf? (If yes, please include why you believe
that person has a legal right to provide consent in your response below)
Yes
No
N/A
15. If a participant chooses to withdraw, are there any additional or altered consequences of that
decision which they should be made aware of?
Yes
No
16. Does the study now involve an additional or altered incentive/payment for participation?
Yes
No
17. Do you now intend to report information resulting from the study to an additional or different
third party?
Yes
No
18. Do you now intend to disseminate the results of the study in a different way?
Yes
No
19. Have plans for data storage or disposal changed?
Yes
No
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20. Has the form participant information is collected in, used in, or stored in or disseminated in
changed (for example: individually identifiable, re-identifiable, or non-identifiable)?
Yes
No
a. If yes, are you now collecting, using, storing or disseminating:
i. identifiable health information
Yes
No
ii. identifiable sensitive information Yes
No
iii. identifiable personal information Yes
No
21. Do you now intend to collect individually identifiable information from another organisation?
Yes
No
a. If yes, has the person whose information it is, provided their consent for its collection,
use, and/or disclosure?
Yes
No
If no, please provide justification in your response below with reference to sections
2.3.5-2.3.8 of the National Statement on Ethical Conduct in Human Research (2007).
22. Do you now intend to access data from an additional or different database; or has the nature of
the data collected from a database changed?
Yes
No
23. Has the level of confidentiality afforded participant data changed?
Yes
No
24. Have any of the proposed changes to your project increased or decreased the risks to
participants, the research team, or any organisation associated with the research (risks include:
physical, psychological, spiritual, emotional, social, financial, employability or risks to
professional relationships, or to the participants’ communities)?
Yes
No
25. Have any of the proposed changes to your project increased or decreased the expected benefits
of the research (including benefits to the participants, the community or group to which the
participants belong, or the wider community)?
Yes
No
26. Are you intending to change any other aspect of the project?
Yes
No
*If you answered YES to question 1, Part C please ensure any researchers who are no longer with the
project but are still at Deakin sign this form.
**If you answered YES to question 2, Part C and you are requesting approval beyond the DUHREC four
year approval limit, please refer to page six for additional requirements.
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Part C
Please provide details of the proposed modification for all the questions to which you answered “YES”
above (please number your responses so they correspond to the applicable questions above):
Please provide a reason for each of the proposed modification listed above (please number your
responses so they correspond to the applicable questions above):
Please include any additional comments required:
Part D
All applications please attach:
All amended participant documents with tracked changes as appropriate (for example: Plain
Language Statements, questionnaires, advertisements).
Part E
Declaration
I/We, the undersigned declare that the information supplied in this form is true and accurate to the
best of my/our knowledge.
I / We the undersigned have read the National Statement on Ethical Conduct in Human Research and
accept responsibility for the conduct of the project detailed in this form in accordance with the
principles contained in the Statement and any other conditions laid down by Deakin University
Human Research Ethics Committee (or the appropriate Faculty HEAG).
Signatures*
Principal investigator
Date:
Associate investigator/s
Date:
Date:
Date:
Head of School/Associate Dean Research**
Date:
*Include the signatures of researchers who have left the project but are still at Deakin.
**Where the HoS is also a member of the research team, the ADR should provide the final sign off on
the project.
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For all DUHREC approved projects, please submit all documents via the Human Research Ethics
lodgement page
For further information contact research-ethics@deakin.edu.au or call (03) 9251 7123
or (03) 5227 2975.
Please note, if you indicated in PART A that the project was approved by a HEAG, all requests for
amendment should be submitted to that HEAG for review.
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Part F
If you answered YES to question 2 of Part C indicating that you are seeking an extension of time for data
collection, please note:
From August 2010, all DUHREC approved projects have been granted an initial four-year approval period.
Up to an additional four years (eight years in total) may be requested at the end of the fourth year.
To apply for additional time beyond the initial four years, please provide:
 A summary of progress to date (see details below)
 A consolidated protocol for the project including all approved modifications and
 Updated copies of all participant information and recruitment documents still in use.
These documents should be submitted along with the completed Request for Modification Form.
Summary of progress to date:
1. How long has the project been underway?
2. What is the number of participants currently enrolled in the study?
3. Is the project proceeding to schedule?
4. Have there been any unexpected adverse events or complaints about the study?
Consolidated protocol:
1.
Please provide a brief description of the project including any aims and/or hypotheses where
appropriate.
2.
Please provide details of the methodology employed in the study.
3.
Please provide participant details including:
i. The total number of participants involved in the study,
ii. The number of participant groups involved in the study,
iii. The relevant characteristics of each participant group.
4.
Please provide details of the recruitment strategy including:
i. How participants are identified,
ii. The initial form of contact made with participants,
iii. Whether potential participants are screened prior to consent and if so, what the screening
process involves.
5.
Please provide details of the consent process including:
i. How all participants are informed about the study,
ii. Whether all participants have the capacity to consent for themselves,
iii. Who provides consent on behalf of any participants who are unable to consent for
themselves,
iv. How consent is recorded.
6.
Please provide details of what each of the participant groups experience in the study.
7.
Please provide details of the form in which the data are collected, used and stored (ie.
individually identifiable, re-identifiable, and/or non-identifiable).
8.
Please provide details of how the data are stored and who has access to them.
9.
Please explain how the confidentiality of participants will be maintained.
10. Please provide details of if, when and how data will be destroyed.
11. Please describe how the results will be disseminated including how participants can obtain a
summary of the results.
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