INSTRUCTIONS FOR SUBMITTING ETHICAL CLEARANCE APPLICATIONS
FOR RESEARCH INVOLVING HUMAN PARTICIPANTS
(Applicants should retain this page)
1. Lodge your application with:
Ms Vivienne Balson, UQ Business School Level 2, Colin Clark Building.
Format: Only a single copy of the application is required.
(i) The “CHECK LIST and DECLARATION” page should be submitted in hard copy, and
(ii) Rest of the application can be submitted as “One sided hard copy’ or as an
electronic copy, Word document.
Email the document to v.balson@business.uq.edu.au
2. Sample text for the following documents can be obtained from:
Ms Vivienne Balson or Ms Julie Cooper or on the following link:
http://www.business.uq.edu.au/research_ethical_clearance
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Form E1 – Covering letter to the Chair
Form E2 – Participant Consent form
Form E3 – Participant Information Sheet
Form E4 – Project Consent form (Gatekeeper’s permission) (If required)
3. Additional Information
The NHMRC’s National Statement can be found on the following website:
http://www.nhmrc.gov.au/publications/synopses/e72syn.htm
Aboriginal and Torres Strait Islander Studies Unit website: http://www.uq.edu.au/atsis/ (which
includes links to sites including the Australian Institute of Aboriginal and Torres Strait Islander
Studies Unit under Cool Sites). Enquiries to the Aboriginal and Torres Strait Islander Studies
Unit can be made on: 3365 6714 (ext. 56714).
Full Review of applications submitted to the UQ Business School’s Ethical Review Committee
may take a minimum of four weeks from the time of submission to the issuing of the Chair’s
decision.
Glossary of terms used:
NHMRC: National Health and Medical Research Council
AHEC: Australian Human Ethics Committee
HREC: Human Research Ethics Committee and, for the purposes of this application, means an
AHEC registered committee
Last updated 17 February 2014
UQBS Ethical Review Committee - Application for Ethical Clearance – Instructions for application submission
ETHICAL CLEARANCE APPLICATION: SUBMISSION CHECKLIST & DECLARATION
(Applicants should also submit a hard copy of this page)
Tick (X) the relevant box for each document *
1.
2.
3.
4.
5.
6.
7.
Document Attached?
Yes
No
Form E – Application Form
Form E1 – Covering letter to the Chair, Ethical Review Committee
Form E2 – Participant Consent form
Form E3 – Participant Information Sheet
Form E4 – Project Consent Form (Gatekeeper’s Permission) **
**Note: A ‘gatekeeper’ or ‘permission-giver’ is a person authorised to write a
letter of Authority and Recognition from an organisation of any type
involved with the research, which gives permission to the researcher
for access to the population under the gatekeeper’s or ‘permissiongiver’s’ authority
Form E5 – Sample of Questionnaire/interview protocol
Other documents attached: Please specify the name:
*Please state the reason(s) if any of the above documents have not been
included:
Once clearance is granted, Forms E2, E3 and E4 must be copied on to
UQBS letterhead (available from UQBS Reception) before data collection.
Tick (X) the relevant box for each action completed
1
1a.
1b.
1c.
2
2a.
3
3a
4
4a.
Action completed?
Yes
No
Application form
All questions have been answered
Form endorsed by Principal Investigator
Form endorsed by Principal Advisor
Participant Consent Form
Form is clearly labelled Form E2 -PARTICIPANT CONSENT FORM
Participant Information Sheet
Form is clearly labelled Form E3 - PARTICIPANT INFORMATION FORM
Project Consent Form (If required)
Form is clearly labelled Form E4- PROJECT CONSENT FORM
DECLARATION:
We/I, the undersigned researcher(s) have read The University of Queensland’s Guidelines for Ethical Review
of Research Involving Humans and the NHMRC’s National Statement on Ethical conduct in Human Research,
and agree to abide by them in the conduct of this research. It is understood that this includes the reporting and
monitoring roles associated with the approval by The University of Queensland.
Principal Investigator’s name:
Signature of Principal Investigator:
………………………………………………………….
*Date:
*This should be the date of submission of the ‘complete’ application
Supervisor’s name:
Signature of Supervisor: ………………………………………………………………………..
Date:
UQBS Ethical Review Committee - Application for Ethical Clearance – Submission Checklist
Application Form for Ethical Clearance for Research Involving Human Participants
For review by: UQ Business School Ethical Review Committee
Use Times New Roman font for your answers and do not delete any rows or merge cells in this form
Project Title:
Date of application:
Principal Investigator:
Telephone:
Email:
Student No:
Degree Enrolled:
Supervisor 1:
Supervisor 2:
Project Co-ordinator:
(or authorised contact)
Telephone:
Email:
Co-Investigator/s:
Is the project funded?
NO - Not funded
YES (If yes, provide details of the funding body below.)
Funding Body:
Industry funds
Name of funding body:
Year funded:
Reference no. if available:
UQBS funds (annual funding round for confirmed RHD students)
Other funds:
Please provide details
Project Location:
Project Duration:
(For how long is the ethics approval required)
Is this application being re-submitted for approval at the request of the UQBS
Ethical Review Committee? (Mark (X) in the most appropriate box):
NO
YES
If YES, date of submission of revised application:
Is the application being submitted for expedited review?
(Mark (X) in the most appropriate box):
NO
Is this submission identical or very similar to a previously approved
protocol?
(If yes, provide details below):
NO
Does this submission hold ethical clearance from other agencies?
(If yes, attach copies from other AHEC fully registered ethics committees.)
NO
Last updated: 17/02/2014
YES
YES
YES
UQBS Ethical Review Committee - Application for Ethical Clearance – Page 1/9
INFORMATION ABOUT THE PROPOSED RESEARCH
Q1.
Who are the participants or informants?
(e.g., Children, University students, or other persons)
Note: Details of approximate number, age range, and male/female ratios are required.
The Committee needs to have adequate information on the composition of the sample of
participants so that (i) the potential risk to each type of participant and (ii) the ethical obligations of
the applicant to each type of participant, are better understood by the Ethics Committee members
for assessing the application.
Q2.
The NHMRC’s National Statement has identified certain groups as vulnerable or with specific
ethical considerations. Researchers must take special care to protect the interests of these
groups if they are in any way involved in the project. Those groups include:
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pregnant women and the foetus (Ch. 4.1);
children and young people (Ch. 4.2);
people in dependent or unequal relationships (Ch. 4.3);
people highly dependent on medical care (Ch. 4.4);
people with cognitive impairment, intellectual disability, or mental illness (Ch. 4.5); people
involved in illegal activities (Ch. 4.6);
Aboriginal and Torres Strait Islander peoples (Ch. 4.7) and
people in other countries (Ch. 4.8).
In preparing your research project and application for ethical clearance, you should investigate
thoroughly, through consultation with supervisors, colleagues in your school and other professional
groups/organizations, how these vulnerable groups may or may not be represented in your
research.
Note: If participation of vulnerable groups is a focus of the research, the protocol cannot qualify
for expedited review (unless other current HREC clearance is held and a copy provided).
Q2a. Aboriginal and Torres Strait Islanders Group
Specify the level of participation that Indigenous Australians will have in this research
(as members of the research team, or as members of the group to be researched):
Note: If the applicant indicates that some participation is likely (second response), and a
clear and careful explanation is not provided, assessment of the application will be delayed.
(A) My study does not focus on indigenous Australians. Their
participation is unlikely.
Very rarely applications are likely to fall in this category.
(B) My study does not focus on indigenous Australians. However,
some participation is likely.
This is likely to be the option for most applications.
(C) Focus of the study is on indigenous Australians
If you chose Option B or Option C above for Q2a:
(i) Please explain your choice,
(ii) Please specify your strategies to address their needs and interests:
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UQBS Ethical Review Committee - Application for Ethical Clearance – Page 2/9
Q2b. Other Vulnerable Groups
Specify the name and level of participation that any of the other vulnerable groups
above will have in this research (as members of the group to be researched).
Note: If the applicant indicates that some participation is likely (second response), and a
clear and careful explanation is not provided, assessment of the application will be delayed.
Specify the group/s:
(A) My study does not focus on other vulnerable groups. Their
participation is unlikely.
Very rarely applications are likely to fall in this category.
(B) My study does not focus on other vulnerable groups. However,
some participation is likely.
This is likely to be the option for most applications.
(C) Focus of the study is on other vulnerable groups.
If you chose Option B or C above for Q2b:
(i) Please explain your choice:
(ii) Please specify your strategies to address their needs and interests:
Q3.
Participant recruitment details: (Please provide exact details of contact.)
Q4.
In EVERY-DAY or LAY LANGUAGE please provide a summary of the project – including
aims and benefit: This section MUST be completed in LAY LANGUAGE.
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Q5.
Give details of the research plan:
Note: The Committee needs sufficient information to put into context the ethical considerations
listed in later questions.
Note: This section should be completed in LAY LANGUAGE as much as possible so that it can be
understood and appreciated by all Committee members and administration staff.
(Provide your reply below.)
Q6.
Give details of the ethical considerations attached to the proposed project:
Tell us how participants’ anonymity, rights (to withdraw) will be ensured. Other things to consider
include potential risk(s) involved.
Q7.
How will informed consent be obtained from participants or informants?
Note: “Gatekeeper” Approvals
A “gatekeeper” or “permission-giver” is a person authorised to write a Letter of Authority and
Recognition from an organisation of any type involved with the research, which gives permission to
the researcher for access to the population under the “gatekeeper’s” or “permission-giver’s”
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UQBS Ethical Review Committee - Application for Ethical Clearance – Page 4/9
authority.
[For example, if you wish to conduct research in schools and the participants are the school
teachers, then gatekeeper approval will need obtained from the relevant education authority (e.g.,
Education Queensland) and the School Principals before you may approach those school teachers
in recruitment.
For example, if you wish to access staff from a private organisation, then similarly, gatekeeper
approval will usually be required from senior personnel or an appropriate manager who is able to
grant such access to approach that organisation’s staff in recruitment.]
(Provide your reply in the box below.)
Q7a. Is gatekeeper approval required for the research?
NO
You may need permission from someone (e.g. a participating
organisation) to collect the data from participants.
YES
If you answer Yes - go to Question 7(b),
Otherwise go to Question 8.
Q7b. If YES, who are the gatekeepers and how will their approvals be sought and obtained?
(If gatekeeper approval/s have already been obtained, please attach a copy-Form E4)
Q8.
Provide details of procedures for establishing confidentiality and protecting privacy of
participants or informants:
Q9.
Provide details of data security and storage:
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Q10.
In what form will the data be collected: (Select (X) the most appropriate response below.)
Identified
Potentially Identifiable
De-Identified
Please explain your choice
Q11.
In what form will the data be stored and/or accessed:
(Select (X) the most appropriate response below.)
Identified
Potentially Identifiable
De-Identified
Please explain your choice
Q12.
Q13.
Will feedback be available to participants or informants?
NO
(If yes, provide details below):
YES
Does the project involve any of the following possibilities?
Q13a. The possibility of physical stress/distress, or discomfort to the
participants.
(If yes, provide details below):
Q13b. The possibility of physical stress/distress, or discomfort to the
researchers/data collectors.
(If yes, provide details below):
Q13c. The possibility of psychological/mental stress/distress, or
discomfort to the participants.
(If yes, provide details below):
Last updated: 17/02/2014
NO
YES
NO
YES
NO
YES
UQBS Ethical Review Committee - Application for Ethical Clearance – Page 6/9
Q13d. The possibility of psychological/mental stress/distress, or
discomfort to the researchers/data collectors.
NO
YES
(If yes, provide details below):
Q13e. Deception of/or withholding information from, participant at
ANY stage of the project.
NO
YES
(If yes, provide details below):
Q13f. Access to data held by a Commonwealth Department or
Agency. (Please also specify the number of records to be accessed)
NO
YES
(If yes, provide details below):
Q13g. Access to data by bodies or people other than the investigators
(e.g. Medical Records).
NO
YES
(If yes, provide details below):
Q13h. Use of questionnaires, interviews, or focus groups with
questions or topics which are sensitive, have potential to cause
distress, or may reveal illegal activity.
NO
YES
(If yes, provide details below):
Q14.
Please indicate what you think is the level of risk for prospective participants.
(e.g. Harm; Physical, emotional, psychological, social, confidentiality and legal risks; discomfort
and inconvenience)
•
The expression ‘low risk research’ (minimal risk) describes research in which the only
foreseeable risk is one of discomfort.
•
Research in which the risk for participants is more serious than discomfort is not low risk.
•
The expression ‘negligible risk research’ describes research in which there is no foreseeable
risk of harm or discomfort; and any foreseeable risk is no more than inconvenience.
(Select the most appropriate response below.)
Extreme Risk
High Risk
Some risk
Minimal Risk
No foreseeable added risk above the risks of everyday living
Q15.
Please provide details to assist the committee as to why you indicated the level of risk to
prospective participants or informants in the Question 14.
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Q16.
How has the possibility of participant withdrawal from the project been addressed?
Note: Ensure that details and effects of withdrawal without prejudice AT ANY TIME have been
considered and explained. Refer to the NHMRC’s National Statement section 2.2.19 – 2.2.20.
Q17.
Please note that this section must be completed for funded research or the application will
not be processed.
Q17a. Is this project receiving financial support to conduct the
research?
NO
YES
Q17b. If YES, please provide the name of the source(s):
Q17c. Who will be administering the budget?
Q17d. Please provide details of the budget distribution.
(Or attach a copy of the budget statement.)
Q18.
Provide details of any other “in kind” support for the project or direct or indirect
payment to any investigator:
Q19.
Please provide details of participant reimbursement for their involvement in the
Project, if any:
Note: This could be cash payment, food vouchers, free services, movie passes….
Q20.
In undertaking this research do any “conflict of interest” issues arise?
Note: Conflict of Interest may arise, for example, because a researcher, or
someone close to the researcher, stands to benefit financially from the
research or the carrying out of the project or because inconsistent or
incompatible obligations exist. Refer to section 5.4 of the NHMRC’s National
Statement:
NO
YES
(If yes, provide details below):
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Q21.
Is the project a multi-centre or site project?
(i.e., is this research carried out at more than one location?)
NO
YES
(If yes, provide the name of the principal ethics committee. Please provide
copies of any conditions or requirements placed by other AHEC registered
Human Ethics Committees.)
Note: The Principal Ethics Committee is the Institutional Ethics Committee
where the budget is to be administered.
Q22.
I am happy for this application to be made available to future
applicants.
NO
YES
End of UQBS application form for ethical clearance
1. Please make sure you have answered all the questions. Incomplete applications
delay the processing
2. Please check the application and the supporting documents for typos and
grammatical errors.
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