The INFERR trial was designed to understand the benefits and harms of iron therapy in First Nations Australians on haemodialysis with anaemia and hyperferritaemia [13]. The lack of evidence for safe therapy of anaemia using iron in this population was clearly identified and discussed with patients on haemodialysis whose health outcomes were directly affected and who supported the development of the INFERR clinical trial [13, 16]. A key element of ensuring the safe conduct of the INFERR trial was the establishment of the INFERR Indigenous Reference Groups (IRGs) comprising of dialysis patients, one IRG based in the Top End of Australia and one IRG in Central Australia. The need for two IRGs was based on advice from First Nations communities and First Nations researchers/academics on the project regarding cultural differences and approaches to trial conduct which needed to be addressed locally.
A key engagement strategy for the INFERR trial was providing each IRG with the support of a First Nations Research Officer employed on the project and an independent First Nations researcher/academic to assist in explaining research concepts as needed.
Roles and terms of reference (TOR) for IRGs
Purpose
The purpose of the IRGs is to provide high level advice and advocacy for the INFERR study participants, dialysis patients and communities engaged in the trial.
The IRGs function
to provide advice and advocacy on First Nations social, cultural and health issues relevant to research conduct. Key roles include: to facilitate and contribute to the development of health literacy, participant information and consent materials; to advise regarding the conduct and impact of research in participating communities; to advise and direct how to ensure that the study is conducted in a culturally safe manner; to advise regarding knowledge transfer to First Nations communities in the NT; to advise regarding capacity building opportunities for First Nations peoples engaged in the project and to advise regarding dissemination of the study findings and translation of these findings into clinical practice. (see Fig. 1).
The roles, function, relationship of and feedback from the INFERR clinical trial Indigenous Reference Groups (IRGs)
Composition
The INFERR trial IRGs consist of 7–15 members, all of whom are First Nations Australian dialysis patients. Community members related to dialysis patients may attend IRG meetings as support persons but have no voting powers. The membership includes at least two representatives from each dialysis unit across the Northern Territory. Ideally, one is male, and one is female. Additional consideration is given to ensure regional language groups are represented and a mix of age groups. To become a member, dialysis patients can self-nominate or be nominated by or from communities and community-controlled services which are partners in this study. The only non-consumer voting representative is an independent First Nations Academic/researcher. The trial provides each IRG with a First Nations Research Officer to organize, attend the meetings, and provide study progress reports and secretarial support. A quorum is met when there is 50% plus 1 of the members present.
Educational component of the IRG meeting
Most meetings have included an educational component for IRG members on any questions on the research process, health service or any other health related matters; the topic is based on requests from IRG members. The subject matter experts are contacted by the First Nations Research Officer to present information and learnings for members of the IRG. Examples of requested education providers included renal nutritionist, renal transplant coordinators and Health Living NT cardiac education service provider. Each presentation was well received with members engaged and asking questions. This has enabled the trial to provide some reciprocity for members who have kindly agreed to be a member of the IRG. (see Fig. 1).
Chairperson
The IRG chairperson ensures that IRG meetings are conducted in accordance with the agreed terms of reference and focus on priorities identified by IRG members. A representative from each IRG, usually the chair, is a member of the INFERR Trial Management Committee (TMC). The chairperson is the primary contact for information flow between the INFERR TMC, clinical trial manager and the members of the IRGs.
IRG members are encouraged to rotate the chairperson position among members. However, this is at the discretion of the IRGs. (see Fig. 1).
Independent first nations researchers/academics
Two First Nations researchers/academics, one each for the Top End and the Central Australian groups, who are not otherwise involved in the conduct of trial, are members of the IRGs. They fulfil a supporting role within the group and seek to enhance the autonomy and authority of IRG members. They have strong research track records, but do not necessarily have to have dialysis, kidney disease or clinical trials expertise. These independent research/academic members were appointed to the IRGs by the Chair of the INFERR TMC, in consultation with the TMC.
The independent researchers/academics also ensure that key study documents are understood by IRG members and that the IRG members can make informed and independent decisions. Study educational materials and other participant facing documents are simplified and translated with the IRGs. The First Nations research officers and First Nations researchers/academics aid in simplifying many of the complex study documents for the IRG members to better understand. The IRGs are then able to interpret them for renal patients in their language through the creation of simplified study materials. The researchers/academics are voting members of the IRGs. (see Fig. 1).
First Nations research officers
Two First Nations INFERR clinical trial Research Officers (one in the Top End and one in Central Australia) with established connections in the Northern Territory play key roles in consumer and community engagement. The First Nations Research Officers have a thorough understanding of the research process as they have received training, education and induction from the Menzies orientation program which was provided by the project manager and the chief investigators of the trial. They also receive mandatory good clinical practice (GCP) training. (see Fig. 1).
They work closely with all stakeholders, which include government and non-government health service providers, to determine and implement activities that facilitate communication between consumers, researchers, and health services. They are responsible for operational aspects of this engagement including assisting in the development of culturally safe and appropriate resources. They also facilitate the informed consent process for potential participants. Their role involves co-design processes such as development of all study participant facing documents with IRG patient members; for example, consent forms and participant information sheets. They inform and assist with implementation of the clinical trial, including assistance with stakeholder engagement and approvals, and ensure research activities are conducted in a culturally safe manner.
The Research Officers are responsible for the establishment and ongoing function of each IRG. On behalf of the IRG, the research officer arranges meetings, including working with the IRG Chair to develop the agenda, meeting location, invitation of educational subject matter expert, catering, and research team members updates for each meeting. The research officer writes the minutes and distributes the key findings including any concerns identified at the meetings. They are not voting members of the IRGs but are vital in helping facilitate and support the IRG members.
Authority of the IRGs
The INFERR trial IRGs function independently of other INFERR trial committees or teams. The IRG is part of the INFERR governance framework and provides recommendations to the TMC. The IRGs provide expert advice to research staff on critical issues relating to engaging renal patients within the dialysis clinics. This advice has addressed issues such as culturally safe communication and appropriate consenting processes, reviewing in their meetings how the project continues to involve the community and other stakeholders, interpretation and advice on dissemination of emerging findings from this research project for example sharing of information regarding the high prevalence of markers of liver disease. f. Renal patients participate as active members of the IRG and recruitment as a participant in the actual study is not required. A member from each IRG is nominated by the group as a representative (usually the chair) to sit on the Trial Management Committee. Their role on the TMC is to talk to the recommendations made during the IRG meetings. The TMC will consider these recommendations with final approval resting with the TMC. The IRG representative and the First Nations Research Officers provide feedback of TMC meeting at the subsequent IRG meeting. Although their primary role is related to the clinical trial, the IRGs also provide general feedback to renal services across the NT and other research projects.
Custodianship of data
The TMC, operating in accordance with the relevant institutional polices of Menzies School of Health Research, are the custodians of the INFERR trial data. The TMC recognizes the important role of the INFERR trial IRGs in data governance and INFERR trial committees recognize the collective benefit, authority, responsibility, and ethics. (CARE) principles of Indigenous data sovereignty. The INFERR trial IRGs continue to provide guidance regarding acceptable and appropriate data usage and interpretation and dissemination of findings. The INFERR study will establish an Editorial Sub-Committee to oversee relevant data governance issues. The IRGs will provide a member to the Editorial Committee.
Time commitments
The INFERR trial IRGs meet at least three times per year and whenever the need arises. The meetings are a mix of face-to-face meetings in Darwin or Alice Springs and teleconference/videoconference for those unable to travel. Face-to-face meetings constitute a half day, including allocated time for education. As required, additional teleconferences or other face-to-face meetings can be called.
As well as extending an invitation to individuals to participate in the INFERR IRGs, upon acceptance, letters are written to members’ employers and/or representative organisations to seek their support and acknowledge their contribution to the project through the release of the INFERR trial IRG member for reference group activities and meetings.
Costs
Travel, meals and accommodation costs are covered by the INFERR study. Bookings are made and travel arranged by the First Nations Research Officer.
Payments
Where an IRG member is employed, support is sought for members to be paid by their employer to attend the IRGs meetings as part of their professional development and/or regular employment. In the case of an IRG member being self-employed or unemployed, the IRG members are compensated for their time in attendance at an IRG meeting. All members are paid according to the per Menzies School of Health Research Enterprise Bargaining Agreement (EBA) 2018 for the time they attend meetings. The members are paid A$50.40 per hour for a minimum of 3 h. On the day of the meeting, transport to and from the meeting is provided, as well as morning tea and lunch.
Meeting processes
The agenda for the IRG meetings follows a standard format in keeping with the agreed purposes of the IRG (Additional document 1). Each meeting consists of the option to have a closed session with voting members and the First Nations Research Officer present.
Members are asked at each meeting if they consent to the recording of the meeting. All recordings are kept and stored by the First Nations Research Officer at Menzies School of Health Research (Darwin) to assist with drafting minutes. Once the minutes are circulated to the group and accepted, the recordings are deleted. All recordings are private and confidential and only accessed by the IRG Chair and the secretarial and administrative support. The minutes including any action items are circulated within one week of the meeting. The agenda and any required reading materials are provided to the IRG at least two weeks prior to each meeting. A brief project progress report is tabled at each meeting by the Clinical Trial Manager or Principal Investigator. Additional meetings of the IRG or meetings with a TMC chair or delegate can be requested at any time. There is continuation of engagement with members between meetings via newsletters and face-to-face catch ups at the renal clinics.
Review of IRG TOR or membership
The IRG can review and amend the TOR and the membership of the IRG as needed. Any amendments or modifications to IRG TOR or membership will need to be communicated through the First Nations Research Officers and Clinical Trial Manager to the TMC Chair as soon as possible and be tabled and ratified at the next TMC meeting. (Additional document 2)
Figure 1 provides an outline of the roles including some examples of the feedback provided by the IRGs and the relationship of the IRGs, First Nations research officer, First nations academics and other teams and committees within the INFERR clinical trial.
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