Research Services, MBDP: M459
The University of Western Australia
35 Stirling Highway
Crawley WA 6009
Phone: +61 8 6488 4703
Fax: +61 8 6488 8775
Email:
research.uwa.edu.au/staff/human-research
Application for Human Research Ethics Review
Use this form to apply for ethical review of research involving peopleto be carried out at The University of Western Australia. Ethical review of research is a necessary pre-requisite for research involving humans at the University. This includes research that studies data about people and observation of people.
Email the completed form to Human Research Ethics Office:
Email or phone the office for assistance with this form – contact details are in the letterhead above.
- UWA reference no.
Office use, TRIM #
- Project title:
- Chief Investigator, or Supervisor in case of student research:
Name / Click here to enter text.
Title, given name, and family name
School, Centre or Faculty / Click here to enter text. / StaffId #: / Click here to enter text. /
Telephone / Click here to enter text. / Email: / Click here to enter text. /
Additional researchers / co-investigators, including students and non-UWA investigators
Researcher 2 / Click here to enter text.
Title, given name, and family name / Click here to enter text.
School, centre, institution / Click here to enter text.
Staff # or student # / Choose one ...
Co-inv, student, …
Researcher 3 / Click here to enter text.
Title, given name, and family name / Click here to enter text.
School, centre, institution / Click here to enter text.
Staff # or student # / Choose one ...
Co-inv, student, …
Researcher 4 / Click here to enter text.
Title, given name, and family name / Click here to enter text.
School, centre, institution / Click here to enter text.
Staff # or student # / Choose one ...
Co-inv, student, …
Researcher 5 / Click here to enter text.
Title, given name, and family name / Click here to enter text.
School, centre, institution / Click here to enter text.
Staff # or student # / Choose one ...
Co-inv, student, …
[Additional investigators can be noted in the comments section near the end]
- Team Expertise
(clinical research)
NS §3.3.5, NS 4.4.3 Explain how the research team has sufficient skills and experience to conduct the proposed clinical research.
Hyperlinked cross references to the National Statement on Ethical Conduct in Human Research are abbreviated below as NS §section.chapter. If you have any doubt about the meaning or purpose of a question, please use those hyperlinked references to read the definitive explanation.
- Do you seek Exemption from Review?
/ Research that uses only existing collections of data that contain only non-identifiable data about human beings may be exempt from review. NS §5.1.22
Details: / Click here to enter text.
Explain clearly how you meet NS §5.1.22.
To request exemption from ethics review, skip the remaining questions; send in the form.
- Does this project have approval from another Australian ethics committee?
/ If you have Ethics approval from an Australian HREC and the research is to be done at non-UWA research facilities. Complete this question and then submit the formwith a copy of the original applicaition and the HREC approval letter – no further questions need be answered at this time.
HREC and Approval No. / Click here to enter text.
Give the full name of the approving HREC, and, the HREC approval number and attach a copy of the original application, and the approval letter to your application. To request recognition for non-UWA ethics HREC review, you can skip the remaining questions; send in form with attachments.
- Expected project start and end?
- How is the research funded?
Funder, Scheme, reference number (as applicable). Please provide UWA grant reference number if applicable: RA/1/####/###
- Aims of this project.
Describe the purpose of this research in layman’s termsplease. About 300 words recommended.
Attach the research proposal to supply additional detail, background, research design, analysis and procedures where relevant.
- Research design (include analysis & procedures if any)
Explain the research design sufficiently for the reviewers to understand how it will answer the research question(s). Include information about procedures to be carried out and your analytic methodology where appropriate.
- Cost benefit analysis.
Explain the benefits to participants and to humanity, and how it outweighs the costs and potential risks.
- Participant groups / populations.
Define the participant group or demographic so that the review can assess special ethical considerations or burdens. See NS §4 for several groups which may require a more in-depth review.
- Potential harms or risks to participants?
See NS §2.1 - consider illness or injury, potential side-effects; but also include potential embarrassment, economic loss, exposure to prosecution, anything stressful, noxious or unpleasant. Ensure you address these in your Participant Information Sheets (PIS) if you are using those.
- Potential harms or risks to researchers?
Does this work open the research team to direct or indirect risk? Please explain.
- Sampling
Sample size: / Click here to enter text.
If using a sample, explain how the size and profile of the sample to be recruited is adequate to answer the research question.
- Recruitment methods:
Please attach copies of advertisements, flyers, posters, emails, etc.
- Data management and publication plan:
How and where will you record, store, share, transmit, and archive your data? How will you publish / disseminate your work.
Does the research use any of the following research methods or fields?
- Qualitative methods
- Databanks
- Interventions, therapies, trials
- Human tissue
- Human genetics
Please attach your research proposal and ensure you have addressed the special ethical considerations of these methods or fields.
Does the research focus on any of the following groups of people?
- Pregnant women, or Human ovum, embryo, or foetus
- Children or young people (< 18 y.o.)
- Dependent or unequal relationships
- Highly dependent on medical care
- Cognitive impairment, intellectual disability, or mental illness
- Potential exposure of illegal activities
- Aboriginal or Torres Strait People
Please attach your research proposal and ensure you have addressed the special ethical considerations of these groups in that proposal.
- Are any participants outside Australia?
/ NS §4.8explains specifics of working outside Australia.
Countries and approvals: / Click here to enter text.
NS §4.8Explain the ethical review process of the countries where overseas participants reside.Note: Australian and overseas ethics approval will probably be required.
- Relationshipsor dependencies between researchers and participants?
/ NS §4.3 e.g. patients, students,employees, refugees, prisoners ….
NS §4.4 e.g. too ill or disabled to consent in person, …
NS §4.5 e.g. people with intellectual disability, mental illness
Describe: / Click here to enter text.
Declare any relationship between the researcher and potential participants, for example private clients, relatives, colleagues, students of researcher. Also any dependent relationships or perceived relationships with an organisation which could influence participation or responses, see for example NS §4.3, NS §4.4, NS §4.5.How will you deal with these relationships and dependencies in your research design?
- Are drugs, biological agents or therapeutic devices to be used?
/ NS §3.3 Please read this section of the Statement.
Attach full protocol. / Attach a copy of the full protocol.
For new drugs or devices a Clinical Trials Notification (CTN) or Clinical Trial Exemption (CTX) from Therapeutic Goods Administration (TGA) may be required.
- Will blood, or tissue, (incl. bone, fluids, hair, teeth, DNA)be collected?
/ NS §3.4 Please read this section of the Statement.
Please describe: / Click here to enter text.
Include explanation of biobank use, and if samples are an ongoing part of the research, or merely to assess entry criteria.
- Will invasive procedures be used?
/ NS §3.3 Please read this section of the Statement.
Please describe: / Click here to enter text.
- Will (ionising) radiation be used?
/ Review the ARPANZA guidelines.
You need to additionally obtain approval from UWA Health and Safety for this work.
Please describe: / Click here to enter text.
Address radiological protection of participants involved exposed to x rays, CT-scan, DEXA, radiopharmaceuticals, fluoroscopy, radiation for cancer or benign lesions. Information at the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) will assist here.
- Will you make video, photograph, or audio recordings?
/ NS §3.1 provides guidance on recording.
Please describe: / Click here to enter text.
Address cultural issues if applicable. Ensure you explain storage of this material in your data management plan (above). Ensure you advise of this in your Participant Information and Consent forms.
- Will the research use deception, concealment or incomplete disclosure?
/ NS §2.3 discusses use of deception, covert observation, concealment, and incomplete disclosure.
Please describe: / Click here to enter text.
How will participants be de-briefed after the experiment? Explain why this essential to the research aims.
- Will participants be given financial or non-financial incentives?
/ NS §2.2.10-11 concerns inducements.
Please describe: / Click here to enter text.
NS §2.2.10 - payment that is disproportionate to the time involved, or any other inducement that is likely to encourage participants to take risks, is ethically unacceptable.
- Will all participants provide written informed consent?
/ NS §2.2 concerns issues of consent.
NS §2.3 concerns potential waiver of consent.
NS §3.2 concerns use of databanks.
NS §4.44.5 concern consent of impaired or unconscious people.
How will you obtain consent, or justify a waiver? / Click here to enter text.
Describe how you will deal with §2.2, §2.3§3.2 of the National Statementregarding consent. If you request waiver of consent you need to address NS§2.3.For a waiver, please also see the following section regarding the Privacy Act.
Privacy Act 1998, Sections
§95 and §95A / If you do not have written informed consent and you are requesting a waiver of consent to access Commonwealth or private-sector data, you will need to justify how the public interest value of your research relevant to public health or public safetyout-weight the public interest in the protection of privacy. There are guidelines to assist you with this and you need to use them to make your case to the HREC. To use health information from a Commonwealth Government agency, see: Guidelines Under Section 95 of the Privacy Act 1988 available at: use health information from a private sector source, see: Guidelines approved under Section 95A of the Privacy Act 1988 available at:
Do you need health data from Commonwealth Agencies (§95)? / ☐Yes
Do you need Health data from Private sector sources(§95A)? / ☐Yes
- Will there be a placebo or non-treatment group?
/ NS §3.3 See 3.3.10 in particular.
Please describe: / Click here to enter text.
If a placebo is to be used, explain why it is the best comparator.
- Is there a potential conflict of interest?
Please describe: / Click here to enter text.
For example: are there any private, personal, or financial connections between funder and researcher? Actual or perceived? See: NS§5.4.
- Other comments?
Are there other issues you believe to be relevant to the ethical review of this research?
[If there are more than 6 co-investigators, please list additional researchers here].
Attachments Checklist - Please ensure you attach the following if applicable:
Ethics approval from non-UWA HREC / ☐Research proposal and/or full research protocol (if requested above) / ☐
Recruitment material
(e.g. advertisements, posters, flyers) / ☐
Participant Information Sheet (PIS) / ☐
Participant Consent Form (PCF) / ☐
Additional PIS and PCF for parent, teacher, school, as needed / ☐
Questionnaire / survey instrument / ☐
Other docs (e.g. contracts, agreements, focus group docs, detailed procedure info) / ☐
Translations, where languages other than English are used above. / ☐
Certification/ signatures
NOTE: UWA policy deems this document as signed, if you send it attached to an email from your UWA email address. Alternatively you can sign the signature page, scan that page and send it with the application documents.Chief Investigator
or Supervisor of Higher Degree Research Student: / I declare that:
- The information provided in this application is truthful and as complete as possible.
- I undertake to conduct the research in accordance with the approved protocol, the National Statement on Ethical Conduct in Human Research, 2007, relevant legislation and the policies and procedures of The University of Western Australia.
- Where I am the Project Supervisor for research described to be conducted by a student of The University of Western Australia, I declare that I have provided guidance to the student in the design, methodology and consideration of ethical issues of the proposed research; that the student has received the relevant research and ethics training for this project; and, that I will monitor the project during data collection.
- I make this application on the basis that the information it contains is confidential and will be used by The University of Western Australia for the purposes of ethical review and monitoring of the research project described herein, and to satisfy reporting requirements to regulatory bodies. The information will not be used for any other purpose without my prior consent.
Signed:
(see comment below about using UWA email instead of ink signatures)
Name:Click here to enter text. Date: Click here to enter a date.
Head of School Declaration: / (Where the Head of School or nominee has a conflict of interest with the proposed research, e.g. an investigator on the project, a member of the research group, or a personal relationship to any member of the research team, this Declaration is to be completed by the Deputy Head of School.)
I declare that:
- I am satisfied that an adequate peer review has been conducted and that the research proposal is ready for submission for ethics approval.
- The resources required to undertake this project are available.
- The researchers have the skill and expertise to undertake this project appropriately.
Signed:
(see comment below about using UWA email instead of ink signatures)
Name:Click here to enter text. Date:Click here to enter a date.
UWA policy deems this document as signed, if you send it attached to an email from your UWA email address. Alternatively you can sign the signature page, scan that page and send it with the application documents.
For example, the form can be filled out by the CI, emailed as an attachment to the Head of School, and then Forwarded (to ensure all attachments and email from/to/date lines are carried forward) to the Human Research Ethics Office (HREO) at – this method avoids the need for ink signatures, preserves the best available viewing and search quality, saves paper and saves time.
Email form to . Please do not submit paper copies.
Page 1 of 7UWA Ethics Review Application for Research With Human Subjects – V9a (Sept-13)