You cannot start data collection until you have received written approval from the relevant Human Research Ethics Panel (HREAP) or Human Research Ethics Committee (HREC). Consultations and literature reviews to determine the scope of your project can occur prior to applying for ethics approval.
If your project involves overseas fieldwork, researchers must establish ethics approval before making and confirming travel arrangements.
The UNSW HREAPs and HRECs do not provide retrospective approval for any research conducted without ethics approval or under an expired ethics project.
All ethics submissions must be supported by a letter or email of support from the head of school*, before it can be accepted for review. Generally this is an email provided by the head of school confirming that they have reviewed the project and are happy for it to proceed.
If the head of school is listed as the Chief Investigator on the ethics application form, then their deputy may sign off on the application.
*Some heads of schools have made arrangements with the Research Ethics and Compliance Support Unit, where a written letter or email of support is not required and the head of school is copied in submission emails. Please check with your supervisor or head of schools for the arrangements specific to your school.
Applications approved by a NHMRC Registered HREC
If you have established ethics approval with a NHMRC-registered Australian HREC a submission to the UNSW HREC for further approval or ratification is not required. You are however required to:
1. Check your site approval: Check with the approving HREC which sites you have approval to conduct your research at. If you are recruiting participants or conducting research procedures (other than data analysis) at a UNSW campus or a site not listed on your ethics approval letter then you will need to ask the approving HREC whether the ethics approval which they issued covers the additional sites. If the approving HREC advises that their approval does not cover these sites you can seek approval from them to add the sites or submit a new application for review by the UNSW HREC.
2. Provide a copy of your ethics approval: You will need to email
(a) a copy of the ethics approval letter
(b) a copy of the ethics application form
(c) a copy of the approved PISCF
(d) copies of all other approved documents to email@example.com
3. Submit annual/final reports: You will also need to ensure that you are following the instructions for reporting to the approving HREC.
For applications approved by an overseas ethics committee
A formal application to the relevant UNSW HREAP (negligible and low risk) or HREC (more than low risk) must be made. Any UNSW researcher undertaking research at UNSW as part of their employment is covered by UNSW insurance policies.
If you are seeking to transfer your project ethics approval from UNSW to another institution you will need to provide the following:
1. Submit an email to the Ethics Office outlining your request to transfer your projects ethics approval. This can only be provided by the Chief Investigator of the project.
2. A letter of support from Head of School approving the transfer of ethical approval and data. The letter should confirm the following:
- Approval that the original project data will be transferred and stored at the new institution.
- A copy of the project data will be maintained with the Head of School.
- The Head of School will be responsible for destroying the copy of the project data after the retention period specified in the original application.
3. Evidence of ethics approval from the new institution HREC for which you intend to transfer data to.
4. A final report to close the project with UNSW.
Once you have submitted all of the above to the Ethics Office, you will be provided with a letter approving your request. You must not transfer any UNSW project data until you have received approval to do so.
A copy of the letter of approval, either from the HREC or HREA Panel, should be retained by the Chief Investigator. A record of the HREC approvals is kept by the Research Ethics and Compliance (RECS) unit and HREA Panel approvals by each Panel administrator.
The Chief Investigator can apply for an extension on the end date of an approved project. The Chief Investigator should detail the reason for requesting an extension in a letter to the HREC or HREA Panel. Requests for extension can only be granted during the approval period. Under no circumstances are retrospective extensions granted.
The HREC provides approval for up to five years and the HREA Panels provide approval for one year. From 1 June 2014 both HREC and HREAP approvals will be for a period of up to five years. The Chief Investigator can apply for an extension before the end date of an approved project. A project modification form must be completed to seek approval for an extension of approval. Please note that:
- Requests for extension can only be granted during the approval period.
- Retrospective extensions will not be granted.
Extensions exceeding 12 months
Extensions for periods of longer than 12 months should be submitted as a new application. The approving HREC/HREAP may grant a 3 month extension to allow the researcher additional time to generate a new application for ethical review.
Extension up to 12 months
A request to extend the approval period for a further 12 months should be submitted as a modification request if recruitment and data collection will cease within a 12 month period. Please note that:
- Additional extensions cannot be requested once an extension has been approved.
- Projects with a high number of modifications submitted during the initial approval period may have to be submitted as a new application.
- Requests for extensions can only be granted if all annual reporting and approval conditions have been met.
A reminder to researchers on using incentives as a means to recruiting research participants. If you are using prizes, rewards or incentives to recruit research participants, keep in mind that these are considered “games of chance” and are subject to NSW Lotteries Act. It is entirely acceptable to run and promote such competitions, for non-commercial purposes (including as an aid to academic research), provided that (a) appropriate ethics approval is obtained, (b) you don’t offer “cash prizes” – prizes must be limited to non-monetary options, such as gift/store vouchers (not redeemable for cash) or goods, (c) any advertising is honest and not misleading – and should include some indication of when the competition will be drawn, and (d) you notify winners promptly (within a day or two) of the prize being drawn. Different types of competitions are subject to different regulations, and can raise additional legal issues. If in doubt, contact the Legal Office on x52701.
Complaints about the conduct of approved research can be submitted directly to the Human Ethics Coordinator. The contact details for the Ethics Coordinator are Phone: 02 9385 6222 and Email firstname.lastname@example.org. Further details on how the complaints are review can be found in the Human Research Ethics Standard Operating Procedures.
Grievances about ethics review and processes by UNSW Australia staff and students should be addressed to the Director Research Ethics & Compliance Support, Dr Ted Rohr. The contact details for Dr Rohr are Phone 9385 4235 and Email email@example.com.
Literature reviews and meta-analyses do not require ethical approval. While meta data per se do not require ethical approval, there are some instances where you will be required to obtain ethical approval prior to accessing the data set. For example, the data custodian may require you to obtain ethical approval to access the data, or ethical approval may be required as part of the data access licencing agreement.
If you are required to establish ethical approval prior to accessing a publically available dataset then you will be required to follow the data extraction process and licensing requirements of the data custodian in order to gain access to the information. In order to gain ethical approval to access publically available datasets, please complete the UNSW Human Ethics Negligible Risk Application Form.
It is common for journals to request for a copy of your data for publication or replication purposes. In such circumstances, it is appropriate to obtain participant consent to do this. The UNSW Human Ethics Participant Information statement template provides standard wording which can be used to obtain participant consent to share or publish the data in a variety of ways that will not identify them.
In circumstances where the appropriate consent was not obtained from participants, and the steps to obtain consent cannot be completed (see attached document), most journals will allow an exemption or allow that data to be provided for the purpose of replication under strict conditions outlined in the agreement between authors and journals.
In order to ensure that the identity and confidentiality of the email recipients is protected, inserting email addresses into the "BCC" field is no longer an acceptable method. As a solution the following methods for emailing research participants are recommended:
Mail Merge Instructions: To create a mail merge using a template email written in Microsoft Word and a list of recipients saved in an excel spreadsheet:
- Start Word. A blank document opens by default. Leave it open. If you close it, the commands in the next step are not available.
- On the Mailings tab, in the Start Mail Merge group, click Start Mail Merge.
- Click Step By Step Mail Merge Wizard. The wizard will guide you through the Mail Merge process and allow you to connect your document to your list of recipients. Emails sent using this process will send to each participant, as opposed to sending to a list of participants which could result in confidentiality breaches. Click here for more information on using mail merge to send e-mails to an address list.
UNSW- Mailman Mailing List Service UNSW IT has a mailing list service which is similar to the above mail merge system. Further instructions on how to access this service can be found by accessing the following link: https://www.it.unsw.edu.au/students/mailman/index.html
If your research involves the use of an unapproved therapeutic good (medicine, medical device or biological not entered on the Australian Register of Therapeutic Goods (ARTG), then the project will need to be reviewed as a clinical trial and notified under the Clinical Trials Notification Scheme (CTN) or the Clinical Trial Exemption Scheme.
Additional guidance on the submission requirements for this type of reserach can be found on the clinical drug or device trials.
At UNSW, portraiture is not deemed to constitute human-research and as such does not require human research ethics approval.
Portraiture is defined here as either:
- The recording and representation of still image, audio and/or moving images recordings of actors or other performers, performing for the purposes of research or course-related work; OR
- The recording and representation of still or moving images of people for the purposes of creative arts practices, where the construction, manipulation and presentation of these portraits images constitutes the primary course-work or research outcome.
Faculty-specific Image Release Agreements (a.k.a. “Model Release Forms”) should be used to provide portrait participants with information about the portrait you are making, the types of situations their image could be shown in, licencing arrangements and limitations on use by (or sale to) third parties, as well as what will happen to this portrait in the event that they no longer wish their portrait to be available for publication/exhibition/circulation. A signed copy of this agreement should be given to portraiture participants for them to keep in the event that they might wish to withdraw their agreement. Faculty-specific Image Release Agreements can be obtained via your supervisor, course-convenor or Head of School.
If you intend to record statements made by the person to be recorded (also referred to as the model / sitter / subject) in which they contribute their personal insights, experiences and/or opinions – this would be considered an interview and would require UNSW human research ethics approval.
If you intend to conduct a survey, an interview or focus group discussion in order to seek feedback about the portrait for a research purpose, this would also be considered human research and therefore ethical approval would be required.