Ethical Review: AHREC

Aboriginal Health Research Ethics Committee

The Aboriginal Health Research Ethics Committee (AHREC) promotes and supports quality research that will benefit Aboriginal people.
The Committee was established in 1986 following concerns by the then Aboriginal Health Organisation of South Australia about the increasing volume of research being conducted in Aboriginal communities in South Australia.
AHREC’s objectives are to monitor and coordinate medical and health research in Aboriginal communities in South Australia, to offer advice to communities on the ethics, methodology and potential benefits of research and to review the research needs of Aboriginal communities in order to determine priorities for research.
Proposals to conduct health-related research involving Aboriginal people or communities in South Australia need to be submitted to AHREC – even if approval has been or will be obtained from the researcher’s institution or SA Health.
AHREC is guided by the principles set out in the National Health and Medical Research Council (NHMRC) ‘National Statement on Ethical Conduct in Human Research’ 2007 (updated May 2015) (the National Statement).
All human research must comply with the:

• National Statement on Ethical Conduct in Human Research (2007) incorporating all updates as at May 2015
• National Health and Medical Research Council (NHMRC) Values and Ethics – Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research
• NHMRC Guidelines Under section 95 and section 95A of the Privacy Act 1988
• Australian Code for the Responsible Conduct of Research 2007

AHREC also takes into account the following companion documents and guidelines during ethical review:

• Keeping Research on Track
• Next Steps for Aboriginal Health Research Final Report 2015
• South Australian Aboriginal Health Research Accord by the Wardliparingga Aboriginal Research Unit, SAHMRI

It is also recommended for researchers to review the following information:

• Guides for Researchers and Supervisors by the Lowitja Institute
• Case Stories for Researchers by the Lowitja Institute
• Research Development and Implementation by the Lowitja Institute

AHREC APPLICATION PROCESS

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 (e.g. total sample level vs. by Aboriginality) and any other information you may deem necessary for a preliminary assessment to Gokhan.Ayturk@ahcsa.org.au . 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 health and well-being 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 well-being of an individual but refers to the social, emotional and cultural well-being of the whole Community in which each individual is able to achieve their full potential as a human being thereby bringing about the total well-being 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 well-being; 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 e.g. 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 well-being;
  • 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 (e.g. no hypotheses) and is an evaluation or audit of projects for reporting purposes or continuous quality improvement activities with no intention to publish in peer-reviewed journals.
  • 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 depending on all of the study characteristics requested above.

AHREC’s 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 well-being 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 (i.e. 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, 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 (e.g. there is a 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 to researchers’ and supervisors’ accountability with regards to the articulation and interpretation of the ethical guidelines and academic standards, and, will notify the relevant parities where required e.g. other HRECs, Head of School, Vice-Chancellor 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 end up taking 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. The relevant guidelines and expected standards to explore challenges and contribute to solutions in the Aboriginal health sector require a high level of scientific rigour, cultural understanding and stakeholder engagement with an aim to yield direct benefit for the community.

PROCEDURE

All researchers are required to submit electronic versions AND paper-based copies of their ethics application as follows:

In short, what you need to submit for ethical review is a single merged and editable PDF document via email, and, 15 hard copies. The study protocol should not be a part of the merged PDF or hard copies, but submitted as a separate attachment via email.

1) Merged and Editable PDF File that is signed (can be a digital signature) and includes 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:

a) must mirror the order of documents provided in hard copies (e.g. cover letter on top, followed by the application form, PIS/Consent form etc). Because some of the AHREC members prefer to work with only digital files and what they receive need to match with the hard copies.

b) must be editable (i.e. 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 do be able to do the review on the merged PDF file itself. If the researcher can’t submit a merged PDF copy utilising a software, they are required to also submit the Word version of all files. The word version of all files is not required if an editable PDF is submitted.

2. A total of 15 hard copies of the application (Please see below, do not attach the study protocol to hard copies). These are the sets that are forwarded to AHREC members as received, please ensure that all sets are identical and all attachments are presented in the order you wish for AHREC to review.

DO NOT attach the study protocol to the MERGED PDF or hard copies. 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 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.

Instructions and Frequently Asked Questions

• Please address the reviewers in your correspondence e.g. Dear AHREC Chairperson and Members…
• Regarding hard copy sets required, please collate your attachments to each hard copy set. The Secretariat will not collate 15 copies of separate attachments to each hard copy set. It is most efficacious to create a merged PDF first and print 15 double-sided and stapled copies. Otherwise, please create a master hard copy first including all necessary attachments, and, order 15 double-sided and stapled copies through the printer.
• Forms: AHREC no longer accepts previous versions of its forms you may have utilised for your submission, modification or reports. Please check if you are submitting the latest version of the application, modification or annual/final reporting form by downloading the relevant document from the links below.
• Word Count: Applications that do not follow the instructions may be denied review. You are required to follow the word limit of up to 300 words per question, this is no longer negotiable; the Committee requires applications to clearly design appropriate methods to answer study aims, and, articulate and address core ethical issues in a succinct manner. If an application is written or coordinated by a student or an inexperienced researcher, and, AHREC identifies significant issues, the Committee may refer the applicant to the supervisor, research office or the Head of School for further support and require a re-submission.
• Intro Page: You may attach a one-page cover letter e.g. a synopsis about the study addressing AHREC as the first page that will be reviewed before the application form.
• Applications to AHREC must be submitted utilising AHREC’s application form. AHREC does not accept NEAF, HREA or other HRECs’ application forms.
• Where all necessary information is over the word limit, the researchers may attach other documents as required for review e.g. a data de-identification protocol flow chart, distress protocol, a list of variables accessed etc.
• The merged PDF and 15 hard copies must reach the Executive Officer by 5pm on the due date at the address below if they are to be included on the agenda of the scheduled AHREC meeting.
• Depending on the meeting agenda, the Committee may limit the number of new proposals for review, which may mean some proposals may be held until the subsequent AHREC meeting.
• It is advised that researchers should allow at least 3 week days for delivery should they use Express Post. It is the researchers’ responsibility to make necessary arrangements for their application to meet the deadlines. Applications received after the deadlines will be held until the next round.
• If you are based in Adelaide, you may drop your application sets off. The reception at AHCSA, 220 Franklin Street, Adelaide CBD collects the submissions. Please do not request impromptu meetings on the due date when you are dropping your application off.
• Please clearly mark all correspondence with AHREC as ‘CONFIDENTIAL’.
• AHREC requires the signature of only the principal researcher (this may be electronic), and only the contact details of other researchers involved.
• CVs of researchers are not required.
• Please do not change the formatting of the application form or remove page numbers.
• Double-sided printing is recommended.
• Single sided colour printing utilising polished paper is inconsequential. Please do not hesitate to use environmentally friendly paper and use only black ink unless the study materials would need to be reviewed in colour e.g. creative concept trials, promotional posters etc.
• The Committee receives each new proposal set including all associated documents bound with a single bulldog/fold back clip or single staple. Please refrain from using other forms of binding materials such as paper clips as your meeting papers are a part of a much larger set and become detached in-transit.

Paper-based submission address

‘CONFIDENTIAL’
Dr Gokhan Ayturk
Senior Research and Ethics Officer, AHCSA
Executive Officer, AHREC
GPO Box 719, Adelaide SA 5001

Electronic version submission address

• Proposal Application Form – download the form here

• Modification Request Form – download the form here
  • If you are seeking approval for a modification to the research protocol or submitting a minor modification request within original parameters of approval, you are required to use the modification request form.
  • If you are seeking only an extension to the approval duration or providing a personnel update, this can be submitted via email for noting to the file. If, however, the modification request includes an extension request or personnel update AND a modification to the research protocol, then you are required to utilise the modification request form.

• Annual Progress or Final Reporting Template by the Principal Researcher – download the form here

Submission address: Gokhan.Ayturk@ahcsa.org.au

Contacts for Information on a Project and Independent Complaints Procedure

The AHREC monitors all the research projects that it has approved. It important to the Committee that people participating in approved projects have an independent and confidential reporting mechanism which they can use if they have any worries or complaints about that research.
If you have questions or problems associated with the practical aspects of your participation in a research project, or wish to raise a concern or complaint, then you should consult the project coordinator whose details are on the project’s Information Sheet.
If you wish to discuss matters with an independent person, including complaint and concerns as a researcher, you can also contact the Senior Research and Ethics Officer at Gokhan.Ayturk@ahcsa.org.au

•  NHMRC

• Human Research Ethics Committees by focus

• the Lowitja Institute EthicsHub

• National Aboriginal Community Controlled Health Organisation (NACCHO)

• Australian Research Council Codes and Guidelines