Application process

The exact timeframe for ethics approval will depend on the type of submission, however applicants should expect the process may take three months.

After submission, applicants will receive a preliminary review of their application within five business days and final submissions responding to this review should be submitted within a further five business days. Applications will then be allocated to a Research Ethics Committee (the Committee) meeting, noting that meetings are held a minimum of eight times per year. Please see a list of current submission deadlines and committee meeting dates here. Following the Committee meetings applicants can expect to be advised of outcomes within ten business days. Depending on the outcome and what, if any, changes are required the applicant has 1-3 months to respond to the Committee’s feedback.

For a breakdown of the application process please see this flowchart.

The AIATSIS Research Ethics Committee (the Committee) will not consider applications unless they are accompanied by evidence of community engagement or support from the relevant peak body (or bodies) and/or community organisation(s). This is an essential element of Aboriginal and Torres Strait Islander research to ensure research aims and outcomes are aligned with community priorities and research needs. This must be demonstrated in the earliest stages of ethics applications to ensure the research is suitable to proceed to review in other areas.

Research applications concerning Aboriginal and Torres Strait Islander peoples require evidence of community engagement and support to demonstrate adherence to the AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander Research. Evidence of engagement and support should demonstrate broad and meaningful engagement in the research planning processes with relevant Aboriginal and Torres Strait Islander groups, communities or organisations. Applicants should consider breadth of engagement including across relevant peak bodies, community organisations and individuals.

Evidence of support may include official emails (from an official email address and with the appropriate signature block), partnership agreement or project sponsorship.

Letters of support, or other evidence, should demonstrate an organisation’s understanding of their role and responsibilities, where there is notable research involvement. Please see section 1.5.3 Evidence of support of A Guide to applying the AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander Research for further information.

Co-design itself is not considered human research and does not require ethics approval. However, if it is intended that the co-design process itself be the subject of research and/or information or data is intended to be recorded and/or is intended for publication, this is human research and requires the appropriate ethics review. Referring to the process of research design (i.e., ‘through co-design’) in a publication does not create a requirement for ethical review while the co-design is not the subject of research. Section 1.8 of the AIATSIS Code of Ethics reiterates this advice on instances where early research design processes may require ethics review.

Aboriginal and Torres Strait Islander research is defined within the AIATSIS Code of Ethics as all research that impacts or is of a particular significance to Aboriginal and Torres Strait Islander peoples, including the planning, collection, analysis and dissemination of information or knowledge, in any format or medium, which is about or may affect Indigenous peoples, either collectively or individually. This research requires ethics review.

For the purposes of this Code, Aboriginal and Torres Strait Islander research should be understood as research that concerns or impacts Aboriginal and Torres Strait Islander peoples in any of the following ways:

• The research is about Aboriginal and Torres Strait Islander peoples, societies, culture and/or knowledge, Aboriginal and Torres Strait Islander policies or experience.
• The target population is Aboriginal and Torres Strait Islander individuals, groups, communities or societies.
• The target population is not explicitly Aboriginal and Torres Strait Islander individuals or communities, but the research population includes a significant number of Aboriginal and Torres Strait Islander people.
• Aboriginal and/or Torres Strait Islander people have been incidentally recruited and researchers wish to do separate analysis of Indigenous-specific data.
• There are Aboriginal and Torres Strait Islander individuals or communities contributing to the research.
• There is new or pre-existing data related to Aboriginal and Torres Strait Islander peoples being used in the research.
• The research concerns Aboriginal and Torres Strait Islander peoples’ lands or waters.

A preliminary review is a review of your application by the Committee Secretariat before the application can proceed to the Committee. This review focuses on the structure and content of the application. The secretariat will highlight any gaps in the application and provide suggestions on where the Committee may seek further information which can be supplied before final submission. Although it is not compulsory to adopt preliminary review feedback, you are strongly encouraged to do so.

When neither explicit consent nor an opt-out approach are appropriate, the requirement for consent may sometimes be justifiably waived. When an HREC or, where appropriate, another review body grants a waiver of consent for research conducted prospectively or retrospectively, research participants will characteristically not know that they, or perhaps their tissue or data, are involved in the research. According to the National Statement, only a HREC may grant a waiver of consent for research using personal information in medical research, or personal health information. Other review bodies may grant waiver of consent for other research.

A review body may also grant a mature minor waiver of parental consent. At times, parental consent may not be required for mature minors to participate in research. According to the National Statement, the two circumstances in which this may occur include when a) the young person is mature enough to understand and consent and not vulnerable through immaturity in ways that would warrant additional consent from a parent or guardian (See 4.2.8), or b) the young person is of developing maturity, the research involved no more than low risk, the aim is to benefit young people, and there are additional good reasons not to involve parents (see 4.2.9).

If you are collecting data from human participants, you must have a Participant Information Sheet. It should be brief, written in plain English, and provide sufficient detail to allow an informed decision by the participant on whether to take part in the research project or not. It is important that the information participants receive before giving consent to participant is clear and accurate.

An expression of informed consent is also required for every research project. In most cases this means a written consent form or some record of oral consent (e.g. audio recording, witness signature). In online surveys, clicking the 'submit' button can constitute consent. An example of a participant information sheet and informed consent form is available here: Participant Information Sheet and Informed Consent Form

Approval will be automatically granted for three years. If you need more time, you can request extensions.

If you need to change something about your research from the approved protocol, you need to submit a variation request via the AIATSIS Portal. This includes changes to research method, research team members, locations for research, research end dates and others. If you are unsure whether the changes you are making require the submission of a variation, please get in touch with the Secretariat at ethics@aiatsis.gov.au

The variation request will be reviewed out-of-session by the Committee.

Less than 10% of all applications are approved as submitted. In instances where an application is not approved in the first instance, the Committee may apply the status of ‘approved with conditions’ or ‘resubmission’. This will allow the research team time to update the project with the feedback from the committee.

The National Statement on Ethical Conduct in Human Research (2023) allows for fair reimbursement for participating in research and proposed payments should not be such as to impair voluntary participation. Incentive payments present more of an issue and, as with unduly large payments, would not be justified if it means that the research and related risks are not fully appreciated. It should be noted that the National Statement makes no allowance for rewards or bonuses for participating in research and there can be no penalty imposed for participating in research or not.

Where participants are invited to enter into a prize draw as a thank you for taking part in research, the prizes should not be an inducement that impairs voluntary informed consent. Where a prize draw is proposed for implementation in Victoria, Victorian gaming regulations may apply, in particular the current terms and conditions for a Trade Promotion Lottery.

In proposing the use of a prize draw, the arrangements need to be sufficiently disclosed both in the ethics application and in information being issued to participants, including:

• that entry into the prize draw is voluntary (note that some may object to gaming)
• how the participant can enter and by what date (in some cases, a quite separate procedure may need to be arranged and spelt out to ensure anonymity of research participation)
• on what date names will be drawn for the prize
• how and when winners will be notified in writing (if they have won a prize and the value of the prize is above $1,000 then further notification requirements are likely to apply)
• contingency for non-collection or non-acceptance of a prize
• what the minimum period is for retaining records for administering the lottery.

Importantly, the arrangements for the prize draw should be fully consistent with applicable regulatory and ethical standards, including arrangements to respect and ensure anonymity and/or confidentiality. For example: it would be problematic to say to participants that their participation would be anonymous even to the researchers, then require a participant to collect a prize from the researchers.

Any concerns or complaints about AIATSIS Ethics approved research projects should be forward to AIATSIS:

I know that I can complain to:

• The Executive Director of Research Education Group, AIATSIS, 51 Lawson Crescent, Acton ACT 2601, (e) ethics@aiatsis.gov.au
• The Chair of the AIATSIS Research Ethics Committee, AIATSIS, 51 Lawson Crescent, Acton ACT 2601, (e) ethics@aiatsis.gov.au

If you think there has been a breach of your privacy you can write to the Office of the Australian Information Commissioner, GPO Box 5218 Sydney NSW 2001 or call 1300 363 992.

The AIATSIS Research Ethics Committee meets at least eight times per year. Dates for meetings and submission deadlines can be found on our website: https://aiatsis.gov.au/research/ethical-research/application-process

Consider if the addition of new team member(s) impacts on the Research Team’s ability to continue to meet the four principles of the AIATSIS Code of Ethics, in particular, 1 Indigenous Self-Determination and 2 indigenous Leadership.

The AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander Research can be found here:

https://aiatsis.gov.au/sites/default/files/2022-02/aiatsis-code-ethics-jan22.pdf

The AIATSIS guide to applying the code can be found here:

https://aiatsis.gov.au/sites/default/files/2020-10/aiatsis-guide-applying-code-ethics_0.pdf

In line with the Australian Code of Responsible Conduct of Research, data should be stored securely and retained for a minimum of 5 years. The code can be found here: https://www.nhmrc.gov.au/about-us/publications/australian-code-responsible-conduct-research-2018

While data or information may be collected, aggregated and stored for an initial purpose or activity, it is common for researchers to ‘bank’ their data or information for possible use in future research projects or to otherwise share it with other researchers. It is also increasingly common for funding agencies to require the sharing of research data either via open access arrangements or via forms of mediated access controlled by licenses.

To this end, data or information may be deposited in an open or mediated access repository or data warehouse, similar to an archive or library, and aggregated over time. Archived data or information can then be made available for later analysis, unless access is constrained by restrictions imposed by the depositor/s, the original data custodian/s or the ethics review body.

Please ensure that you include in your application how you intend to share your research and that your participant information sheet also contains this detail.

More information is contained in Chapter 3 of the National Statement on Ethical Conduct in Human Research 2023.

What is needed to satisfy consent depends on the nature of the project, and may be affected by the requirements of the codes, laws, ethics and cultural sensitivities of the community in which the research is to be conducted.

Information on consent is contained in Chapter 2.2 of the National Statement on Ethical Conduct in Human Research 2023.

Researchers must respect the developing capacity of children and young people to be involved in decisions about participation in research. The child or young person’s particular level of maturity has implications for whether their consent or ascent is necessary and/or sufficient to authorise participation. There are times when it may be necessary to seek consent from a parent or guardian.

Information on children and young people is contained in Chapter 4.2 of the National Statement on Ethical Conduct in Human Research 2023.

You should respond to the Committee’s feedback by:

1. Providing responses to the AIATSIS REC Feedback in the document sent to you and add to the portal.
2. Update the electronic Ethics Application form in track changes and add to the portal.
3. Add any relevant supporting documents requested by the Committee to the portal.
4. Upload all attachments to the portal (please ensure that any attachments that have been revised, include tracked changes).

You will need:

• Lettter/s of support
• PICFs
• Data collection tools
• Risk management plan and distress protocol
• Data management plan

You can provide other documentation which you consider relevant, however, all critical information needs to be contained in the application form, rather than in lengthy attachments.

The AIATSIS Secretariat undertake a preliminary review when the application is submitted – we usually complete this within 2 working days of receipt, which leaves you 8 working days to respond. If you overcome all matters necessary from the preliminary review, the application proceeds to the next available committee meeting.

The committee reviews and issues a decision of not approved, unable to assess, resubmission, approved with conditions or approved.

Not approved or unable to assess – the application doesn’t meet the basic requirements of the National Statement and the AIATSIS Code of Ethics, reasons will be provided

Resubmission - The application doesn’t meet the basic requirements and requires substantial reworking. A resubmission letter is sent out with correspondence containing questions and/or suggested modifications. The applicant will need to resubmit the application to the entire committee. Applicants are allowed three months to resubmit applications, otherwise the application is considered withdrawn.

Approved with conditions - the application meets the basic requirements of the National Statement and the AIATSIS Code of Ethics. Modifications and/or clarifications are required prior to full approval being granted by the REC. The Applicant has one month to provide a response and the response is reviewed out of session.

Approved - The application meets the expectations of the REC and the applicant is sent a letter of approval.

In your application, please ensure that you detail: How the Research Team will promote ongoing Indigenous governance, such as the right to “…manage the creation, collection, analysis, interpretation, management, storage, dissemination, access, reuse, disposal off and access to their data”?

How the Research Team will undertake honest and transparent project reporting and compliance, so all parties (specifically Indigenous partners and contributors) are kept abreast of the progress and (if applicable) any changes to the project?