Scope of Review
If you are unsure whether you are required to submit an application to AHREC or not, please review AHREC’s application form first, and submit a synopsis including the scope, methods, target group, risks, form of data accessed/collected, intended analysis (eg total sample level vs. by Aboriginality) and any other information you may deem necessary for a preliminary assessment to Manager, Research and Ethics [email protected]. Any calls regarding whether you need to submit an application or not will be referred back to this instruction. AHREC’s scope of review is as follows:
- AHREC reviews studies that are directly related to the health and wellbeing of Aboriginal people. Health and well-being are defined as per the National Aboriginal Community Controlled Health Organisation’s definition, where it is stated that:
Aboriginal health means not just the physical wellbeing of an individual but refers to the social, emotional and cultural wellbeing of the whole Community in which each individual is able to achieve their full potential as a human being, thereby bringing about the total wellbeing of their Community. It is a whole of life view and includes the cyclical concept of life-death-life.
- The researchers are required to seek AHREC’s approval based on the following:
- the primary research goals and questions of study are directly related to health research and wellbeing; and
- the experience of Aboriginal and/or Torres Strait Islander people (hereafter referred to as Aboriginal) is an explicit focus of all or part of the research; or
- data collection is explicitly directed at Aboriginal people; or
- it is proposed to conduct sub-group analyses and separately analyse Aboriginal people in the results; or
- the information, potential over-representation in the dataset or geographic location has an impact on one or more Aboriginal communities;
- Governmental Aboriginal health funds are a source of funding eg if it is a review of governmental services that may impact on the Aboriginal Community or organisations and there is an intention to disseminate key findings or recommendations in a public report.
- The researchers may not be required to also acquire AHREC’s approval (Researcher is required to justify the reasoning in relation to the below)
- if the study is not directly related to health and wellbeing;
- if it is a mainstream study with coincidental recruitment of Aboriginal people in a low-risk scope AND its proposed references to Aboriginal people are only in terms of demographics at the total sample level with no sub-group analysis; or
- if the proposed study does not hold research characteristics (eg no hypotheses) and is an evaluation or audit of projects for reporting purposes or continuous quality improvement activities.
- if it is a scoping review of publicly available information/services or systematic literature review.
If a researcher is seeking advice regarding whether they need to submit or not, they need to present their arguments and justify why the study may not require AHREC’s review. The final decision regarding whether a study/project also requires AHREC’s approval is determined on a case-by-case basis depending on all of the study parameters requested above.
Standard of Review
AHREC is guided by the AHCSA Constitution and operates in accordance with the NHMRC National Statement on Ethical Conduct in Human Research and other relevant federal and state legislation and regulations. The Committee reviews studies also with respect to Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research, the Australian Code for the Responsible Conduct of Research 2007 and the South Australian Aboriginal Health Research Accord. AHREC’s deliberations take into account AHCSA’s priorities and commitment to develop and assess culturally appropriate methods of research for the benefit of the South Australian Aboriginal Community.
All research submitted to AHREC must place the needs, priorities and wellbeing of the South Australian Aboriginal Community before the needs of the study and present a partnership approach at all phases with a feasible knowledge translation strategy involving relevant Aboriginal organisations.
All research submitted to AHREC must meet with good research practice and present a rigorous methodology in terms of quantitative representativeness and qualitative data saturation. The methodology should be designed to adequately answer the study’s research questions and achieve meaningful research outcomes for the South Australian Aboriginal Community.
If an application does not meet the requisite research and ethical standards (ie inadequate sample size, community consultation, governance structure, lack of understanding of research methods, inability to articulate or respond to the Committee’s concerns), it is at AHREC’s discretion to not further review the study and advise its re-submission at least 3 months after the initial review or progression without the Aboriginal component.
In view of the above, in order to ensure that student applicants are properly and adequately supervised, and the students’ well-being is protected, the Committee requires supervisors of all students wishing to conduct research in the Aboriginal health sector to thoroughly assess the feasibility of achieving the scope with respect to the student’s timeframes, capabilities and academic level. All applicants, regardless of their academic or professional level, must be aware of the ethical and research standards they need to meet.
If the Committee assesses that a submission by a student or any researcher is sub-standard and under- or inadequately-supervised (eg there is significant room for improvement in all aspects of the application), it may refer the student or the researcher to their research office and/or other relevant parties for support and review of guidelines ahead of any further correspondence with the Committee. AHREC will not be a substitute for researchers’ and supervisors’ accountability with regard to the articulation and interpretation of the ethical guidelines and academic standards, and, will notify the relevant parties where required eg other HRECs, Head of School, Vice-Chancellor, Research Integrity Office, funder etc.
AHREC requires supervisors of students to directly engage with the Committee in place of, and for, students with due diligence regarding AHREC’s scope and standard of review as well as the procedures/instructions below. Students are advised to ensure supervisors’ inclusion of any, and all, engagement with AHREC.
Due to prior experience and in order to ensure that potential applicants will not take up AHREC’s or other Aboriginal stakeholders’ or families’ time excessively, the Committee strongly urges supervisors and study teams to thoroughly and objectively assess their timeframes, capabilities and academic level ahead of any correspondence with the Committee.
Research conducted in the Aboriginal health sector requires a high level of scientific rigour, cultural understanding and stakeholder engagement. In line with the relevant guidelines and standards, the studies must aim to produce benefit for the Aboriginal communities in SA.
Paper-based copies are no longer required. All researchers are required to submit electronic versions of ALL NEW PROPOSALS AND MODIFICATIONS AND REPORTS as a single merged pdf file. Please bear in mind that your application is part of a much larger set of meeting papers, and it is not possible for reviewers to open and close 10-20 different electronic files per agenda item.
In short, what you need to submit for ethical review is a single merged and editable PDF document via email. The study protocol should not be part of the merged PDF but submitted as a separate attachment via email.
The merged and editable pdf file must be signed (can be a digital signature) and should include all associated attachments. Please consult with your IT department regarding how to merge all files into a single PDF document before submission in the order you wish to present. This is the document that is kept for the database for future reference and has to be searchable. If the size of the document is over 20MB, you may submit it via a secure Dropbox link.
This merged PDF document must be editable (ie not locked, not password protected, not submitted as a jpeg file, not be the scanned version of a hard copy set). This is to enable members to be able to, for example, search for words in the application form.
If the researchers submit individual files rather than a single merged pdf file, the new proposal or modification will not be included in the agenda.
Please email a copy of the protocol as a separate attachment. The Committee advises that researchers should include all details necessary for review on the application form and attachments. AHREC meetings run at capacity and the Committee will not cross-reference details included in the application form vs the study protocol. Please ensure that your AHREC application is not a simple copy-paste exercise and that the most critical information is included and that you respond to questions directly. For example, please do not leave the table/list of variables you wish to access in a data linkage study, an interview schedule in a qualitative study, or the survey itself in a quantitative study back in the protocol. These, and such other information that can be deemed critical, should be included in the application form or as attachments.