Application Form for Ethical Clearance for Research Involving Human Participants

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Ethical Research Application Form
Application Form for Ethical Clearance for
Research Involving Human Participants
School of Agriculture and Food Sciences
It is the responsibility of the School of Agriculture and Food Sciences, through its Research and Postgraduate
Committees, to assess, and, where appropriate, approve the ‘ethical conduct’ of research activities. This
applies to research involving human subjects conducted by undergraduate, honours, masters and PhD
students (coursework and research). Research on animals and plants requires a different process for ethical
clearance. Note that the School can only assess low risk projects, and may not assess projects where the main
focus of the research is on Indigenous participants. Those projects will be sent to other committees for
assessment.
Working with their course convenors or advisors, students are expected to seek ethical approval for any
research that involves people. Applications for ethical clearance for research including human participants
can be downloaded from the School web site www.uq.edu.au/agriculture and should be forwarded to the
School’s Ethics Committee, via email agriculture@uq.edu.au .
The rationale for ethical approval is to ensure that the process of research is conducted ‘ethically’ and mindful
of courtesy, protection of privacy and not exploitative of participants. This mainly involves establishing
procedures for the informed consent of those subjects involved in the research, as well as appropriate
handling of research findings (e.g. secure storage of data, confidentiality where agreed etc).
Researchers undertaking fieldwork that involves contact with human subjects (or participants) should
complete an application form. This type of research often includes questionnaires and/or interviews for
which the School requires ethical clearance.
Passive observation of human subjects in a public arena, or research involving accessing public documents
does not require ethical approval.
The procedure for obtaining ethical clearance involves:
1. Being familiar with the University’s policy on research ethics (see website:
www.uq.edu.au/research/orps/?id=5064&pid=5256 )
2. Filling out the enclosed application form and submitting this for approval (as a Word document) to the
academic administration officer responsible.
3. Enclosing with the application form a draft Research Information Sheet and Informed Consent Form
(where applicable), and your questions if you intend interviews or a survey (see below).
The application will then be reviewed by at least one member of the Ethics Committee who will, if necessary,
seek clarification of the application with the applicant and their principal advisor, before making a decision.
Further information may be obtained from Mrs Keryn Eaton (agriculture@uq.edu.au, Tel: 07 5460 1691 or
Fax: 07 5460 1324). The Ethics Chair is currently Professor Helen Ross (Tel: 07 5460 1648, 07 336 52062,
0408195324 or helen.ross@uq.edu.au.
Please see advice in the footnotes on this form, to be sure you understand the purpose of each question.
Further information on ethics clearance is at:
www.uq.edu.au/research/services/human
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Ethical Research Application Form
School of Agriculture and Food Sciences
Ethical Research Application Form 1
Project title
Location of research
(e.g. institutions,
communities)
Start/ Finish
date of data
collection
Researcher
Student No.
Contact details
of investigator
Degree enrolled
Phone
Fax
Email
Phone
Fax
Email
Co- Researchers
(if applicable)
Advisor/s
Contact details
principal Advisor
Answer all of the following questions
INTRODUCTION
1. Provide a brief description of your research (what you will do, with whom, where et cetera)
(At least 200 words please)
RECRUITMENT
2a. Who are the participants (research subjects)? (For example, occupation, age range, gender,
male/female ratio if applicable)
2b. How will you contact your participants? (For example, through another organisation, random contact at
shopping centre etc)
1
See final page.
This University requirement for ethical approval is not directly about your research area, methodologies and methods. These are matters for
you to determine with your advisors! This form is about ethical issues that may/will arise from your chosen methodology and methods. In
completing this form, the emphasis must be on ethical issues, and all parts of the form should be completed with this in mind. Your
explanation of methodological approaches and methods should be sufficient for reviewers to clearly understand the ethical issues that might
arise from your chosen area of research.
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Ethical Research Application Form
2c. Does recruitment include disclosure of personal information (for example, mailing list, names, contact
details, et cetera.) from another party or organisation to the researchers?
Yes
No
If YES, please provide details.
Note: disclosure of personal information from another party or organisation to the researchers, even if merely for the
purpose of seeking initial expression of interest in the project, must be authorised by each individual to whom the
information relates (unless it is a completely public database with unrestricted access). For example, an
organisation must not give the researchers a mailing list of members or clients who might be potential participants
for the project, unless those people have previously authorised such use and disclosure of their information to
other parties.
2d. “Gatekeeper” Approvals
Are gatekeeper approval/s required for the research?
Yes
No
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” authority.
For example, if you wish to access staff from a private organisation, then 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.
If YES, who are the gatekeeper/s and how will their approvals be sought and obtained? (If gatekeeper
approval/s has/have already been obtained, then please attach a copy.)
ETHICAL CONSIDERTIONS
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Ethical Research Approval Information
3. Provide a summary of the ethical aspects in this project2. (List possible issues here and remember to include
privacy, confidentiality, informed consent and withdrawal issues.)
4. Provide a summary of methods that will be developed to address each of the ethical concerns
identified in 3. above. (That is, list your solutions to the issues raised under question 3.)
INFORMED PARTICIPATION
5. How will informed consent be obtained from participants? 3
Verbally (for non-literate participants, show how you will record their verbal consent below)
In writing (detail below and include consent form with application)
Other (be specific)
PRIVACY
6. Researchers must ensure that all data, particularly data containing personal information (i.e.
information that can identify the person), are secure both at the point of storage and during transit.
Researchers must be aware of relevant legislation and guidelines governing privacy: Information
Privacy Act (Qld) 2009, Privacy Act (Cth) 1988, and Guidelines under S95 and S95A of the Privacy Act
(Cth).
6a. Will participants be identified in your collected raw data?
Identified by name
Identified by a code (detail your procedure below)
Anonymous
6b. Will participants be identified in the stored data
Identified by name
Identified by a code
Anonymous
6c. Will participants be identified in the contents of your report4
2
A range of ethical issues arise in research, that may be directly related to the research, or hidden, or incidental. We are not interested in
preventing genuine research of a sensitive nature. On the contrary, such research can be a vital part of any agricultural, environmental or
social study. The issue is to ensure that the researcher is fully aware of the possible consequences of their research and develops appropriate
methodologies and mechanisms to address each and every possible ethical situation that might arise. Carefully consider all possible
ramifications of your research, both intended and unintended.
Think about issues of personal distress, topic relevance, cultural appropriateness, gender sensitivity, age related concerns, power relationships and
inequalities, privacy etc. If you are not sure of what should be considered here, go to any methodological text; for example Silverman, D.
(2005) Doing qualitative research: a practical handbook. London: Sage Publications. See also footnote 6.
3
Participants must fully understand the implications of their involvement, acknowledging that for some methods, full disclosure is not appropriate
to the research. Please be sure to attach your information sheet and informed consent recording form, to this application.
4
This usually arises with attribution of quotes or particular points of information: will you name, or avoid naming, individuals who provide
information. Some researchers offer participants the choice of being identified on an acknowledgements page, while their particular
contributions are kept confidential in the body of the report.
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Ethical Research Application Form
Identified by name
Identified by organisation name
Identified by code, or a general description (e.g. male farmer)
Anonymous
6d. Where will data be stored (for example, UQ office of researcher, a secure fieldwork location), and
what measures will be taken to ensure security of data (for example, locked filing cabinets, computer
hard-drive protected by password/encryption/de-identification of data, et cetera)?
6f. Will data be stored on, or taken to, premises other than secure UQ premises (for example,
researcher’s home, a fieldwork location)?
Yes
No
If YES, then what measures will be taken to ensure security of data at these premises?
6g. Will persons other than staff of the research team have access to the data?
Yes
No
If YES, then please specify these persons, state why these persons have access, and what provisions are
in place to ensure the confidentiality of data by these persons.
FEEDBACK
7. Give specific details of whether and/or how feedback will be available to participants.
Feedback via report
5
Via special publication
6
Via visit
Via conference
Via video/audio
Other (e.g. via gatekeeper)
No feedback will be provided (Give justification)
SPECIFIC ISSUES
8. Does the project involve any of the following issues? 7
8a. Special Groups
Certain groups require 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:
pregnant women and the foetus, children and young people; people in dependent or unequal
relationships; people highly dependent on medical care; people with cognitive impairment,
intellectual disability, or mental illness; people involved in illegal activities; Aboriginal and Torres
Strait Islander peoples; people in other countries; other cultural and ethnic groups.
5
For example, a short or full report to: individuals who participated; the community or organisation; or the wider public.
6
Identify the conference, if known
7
Cross-reference to item 3.
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Ethical Research Approval Information
In preparing your research project and application for ethical clearance, you should investigate
thoroughly, through consultation with your Advisors, colleagues in your school and other professional
groups/organizations, how these special groups may or may not be represented in your research and
if participation in this research could have a negative impact on members of any of these groups.
8a1. 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):
Please note: If indigenous participants are the focus of your project, please contact the School ethics
committee chair for advice prior to completing the application. Ethics review may need to be
performed by the UQ central ethics committee.
no participation
some participation possible or likely
focus of the research
Please explain your choice:
If Indigenous Australians may be involved (2nd or 3rd response box above), what strategies will be
used to address their needs and interests?
Please specify your strategies:
Have you consulted anyone with knowledge to provide guidance? Who?
8a2. People in Australia belonging to other cultural or ethnic groups
Are there any ethical considerations that may arise as a result of collection from other cultural or
ethnic groups in Australia? (For example, are there any particular customs, practices, or conditions
which should be taken into account?)
Yes
No
If YES, please provide details:
Have you consulted anyone with knowledge to provide guidance? Who?
8a3. People in overseas countries
Does your project involve data collection in an overseas country?
Yes
No
If YES, what ethical considerations may arise as a result of such data collection, which are different
from those arising from data collection in a general Australian context? (For example, are there any
particular local laws, customs, practices, or conditions which should be taken into account?)
Have you consulted anyone with knowledge to provide guidance? Who?
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Ethical Research Application Form
8a4.Other Special Groups
Participant involvement by any “Vulnerable Groups” (for example, abused, children, et cetera).
Does your project involve any of the other special groups?
Yes
No
If YES, please answer the following:
Specify the group/s:
What is the level of their participation:
a. some participation possible or likely
b. focus of the research
What strategies will be used to address their needs and interests – please specify?
Have you consulted anyone with knowledge to provide guidance? Who?
RISK
9. Indicate what you think the level of risk is for prospective participants against the scale below and
provide a brief justification for your assessment.
Extreme risk 8
High risk
Some risk
Minimal risk
No foreseeable added risk above the risks of everyday life
Provide a brief justification of your assessment (a few sentences)
If ‘no’ briefly give reason 9
Have you also attached?
1. Informed Consent Form
Yes
No
2. Research Information Sheet for Participants
Yes
No
3. Inquiry Instrument (e.g. Sample questionnaire)
Yes
No
8
‘Extreme’ will definitely apply to any legal or community requirement/expectation for privacy (for example, in a health context, medical records
and the high likelihood of obtaining this information purposefully or accidentally). The researcher must have a strategy in place in this
eventuality. Informed consent is only a start to addressing these issues.
9
‘Have not completed as yet’ is not acceptable.
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Ethical Research Approval Information
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Ethical Research Application Form
Statement of Investigator 10
I have reviewed the University’s policy and guidelines on ethical research
Yes
In designing this research, I have paid particular attention to the ethical issues relevant to:
No

the methods and protocols to be used for this research
No

the questionnaire/s to be used for this research
No
Not applicable
Yes

the interview questions to be used for this research
No
Not applicable
Yes

the process of obtaining informed consent from participants
Yes
No

the procedure for maintaining confidentiality and protecting privacy
Yes
No

the approach to providing feedback to participants
No
Yes

other matters relevant to the ethical conduct of this research
Specify
Yes
Not applicable
Yes
No
I confirm that the proposed research meets the ethical requirements of the University of Queensland and
that I have fully considered all foreseeable ethical ramifications of my research both intended and
unintended.
Signature of investigator: ………………………………………………………….
Date:
Statement of Principal Advisor 11
I have reviewed

the University’s policy and guidelines on ethical research
Yes
No

the methods and protocols to be used for this research
Yes
No

the questionnaire/s to be used for this research
Yes
No

the interview questions to be used for this research
Yes
No

the process of obtaining informed consent from participants
Yes
No

the procedure for maintaining confidentiality and protecting privacy
Yes
No

the approach to providing feedback to participants
Yes
No

other matters relevant to the ethical conduct of this research
Yes
No
Not applicable
Not applicable
Specify
I confirm that the proposed research meets the ethical requirements of the University of Queensland and
that this application adequately describes actual and potential ethical issues that might arise and how it is
planned to address these issues.
Signature of Advisor: ………………………………………………………….
10
Your role, and the purpose of this form, is to clearly indicate to the Ethics Committee that you are aware of your ethical obligations.
11
Ultimately, you will be held responsible for any breaches of the University’s ethical protocols. The Ethics Committee relies on your judgement.
You must consider the ethical requirements assiduously and honestly.
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Ethical Research Approval Information
Date:
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Ethical Research Application Form
Ethics Committee Review
Reviewer 1
Reviewer 2
Name
Comment
Recommendation
Ethical clearance
The School of Agriculture and Food sciences Research Committee has reviewed the ethical issues relating
to this research against The University of Queensland’s policy and guidelines on such matters.
The Committee confirms that the research meets University requirements.
Ethical clearance is granted subject to (mark as necessary)
additional independent review of the inquiry instruments
sighting of the inquiry instruments by the research committee
sighting of the informed consent form by the research committee
sighting of the research information sheet by the research committee
other special requirements or clarifications as listed below
……………………………………………………………………………………………………….……
…………………………………………………………………………………………………………..……………
………………………………………………………………………………………………………….………..……
…………………………………………………….…….
…………………………………………………….…….
Ethics Coordinator
Date
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Ethical Research Application Form
Informed Consent Process
Information
To give ‘informed consent’ participants must be given sufficient information about the research to make an
informed decision on whether to participate. Usually this will require information on the nature of the
research (its purpose), how data will be used and secured to ensure confidentiality, and the time or other
commitment required. In most cases it is useful to provide your research subjects with an information sheet
describing the project and ethical steps you are taking to protect their interests.
Consent
Consent represents a ‘contract’ between the researcher and the participant. You, as the researcher, have an
obligation to the participant and the University to fulfil any commitment made when providing information
to the potential participant and meet University ethical requirements.
Consent may be given verbally or formalised by the participant with their signature on a consent form. Verbal
consent is often appropriate, for example, when undertaking questionnaire surveys where voluntary
participation is indicated simply by participation. Formal signed consent is usually appropriate, for example,
where in-depth interviews are conducted with individuals.
So, while signed consent is preferred, it may be waived where this is considered culturally inappropriate, where
participants are illiterate, or for certain forms of data collection (e.g. street polls). In addition, some potential
participants may feel threatened/disempowered by an excessively formal Informed Consent process. The best
approach for your research should be discussed with your Advisors.
Note that it is possible to combine the information sheet and consent form into a single document,
provided you leave one copy with the participant for future reference. It is also useful to provide a means
of reporting back to participants as a gesture of good-will.
Research Project Information Sheet
At a minimum, the basic elements of informed consent require the researcher to provide the participant with
a Research Project Information Sheet which provides the research subject or informant with information on:
1.
2.
3.
4.
5.
6.
the title of the project
the purpose of the proposed study
the expected duration of their participation in the study
a clear and precise description of procedures for their involvement
a clear and precise description of any foreseeable risks due to their involvement in the study
the method used to maintain their confidentiality and privacy, along with the security of the data once
collected and stored
7. a statement that their participation is voluntary and that they may withdraw at anytime without
prejudice
8. the name and contact details of the appropriate person to answer any further questions they may have
concerning their participation in the project
9. a statement on gaining feedback or results concerning either their individual involvement in the project
or the completed study.
The information sheet must be written for your research participants, and in a style and language which
they will easily understand.
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Ethical Research Application Form
The Research Project Information Sheet should also contain the following paragraph.
This study adheres to the Guidelines of the ethical review process of The University of
Queensland. While you are free to discuss your participation in this study with the researcher
(contactable on .......................), if you would like to speak to an officer of the University not
involved in the study, you may contact Prof. Helen Ross (ph. 0408-195324) or
Helen.Ross@uq.edu.au).
Example of acceptable Informed Consent Form
School letterhead at top
Name of Project
Investigator
I agree to be involved in the above research project as a respondent. I have read the relevant research
information sheet and understand the nature of the research and my role in it.
I would/would not like my name acknowledged in the acknowledgments page of reports
……………………………………
Signature of research subject.
Date:
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