THE GENOMICS PATHWAYS

Guidelines for genomic research involving Aboriginal and Torres Strait Islander peoples of Queensland

DRAFTThis document is a draft version for community consultation

Contents

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Acknowledgement....................................................................................................................................1 Foreword...........................................................................................................................................2 Introduction.......................................................................................................................................

2.1 Rationale for the Genomics Pathway....................................................................................................2.2 Aim and Scope.......................................................................................................................................2.3 Genomic Research in the Australian Indigenous Context......................................................................2.4 Diversity and its Relevance to Genomics...............................................................................................

3 Existing Guidelines.............................................................................................................................3.1 What is Aboriginal and/or Torres Strait Islander Research?..................................................................3.2 National Guides for Ethical Research.....................................................................................................3.3 Six Core Values....................................................................................................................................

4 Engagement with Communities........................................................................................................4.1 Aboriginal and Torres Strait Islander Communities.............................................................................4.2 Working with Community....................................................................................................................4.3 Cultural Awareness, Capability and Competence................................................................................

5 Developing a Research Project.........................................................................................................5.1 Identifying researcher, stakeholder and community priorities............................................................5.2 What if your Research Proposal isn’t a Community Priority?..............................................................5.3 Co-designing Genomic Research Projects............................................................................................5.4 Indigenous Research Methods............................................................................................................5.5 Seeking Agreement.............................................................................................................................5.6 Governance.........................................................................................................................................5.7 Communication Plan...........................................................................................................................5.8 Process Improvement and Reflection..................................................................................................5.9 Research Team....................................................................................................................................

6 Ethical and Social Considerations.....................................................................................................6.1 Informed Consent................................................................................................................................

6.1.1 Community consent.......................................................................................206.1.2 Secondary Use: Extended & Unspecified Consent.........................................20

6.2 Specific Considerations for Risk and Benefit........................................................................................6.2.1 Risk.................................................................................................................216.2.2 Benefit...........................................................................................................226.2.3 Rights and Responsibilities.............................................................................23

6.3 Ethics Application Process...................................................................................................................6.3.1 Ethics approval...............................................................................................236.3.2 Site Specific Approval.....................................................................................24

6.4 When to engage with community.......................................................................................................6.5 Historical data or samples...................................................................................................................

7 Sample Collection and Data Storage.................................................................................................7.1 Collection.............................................................................................................................................7.2 Sample, Data and Research Protocols.................................................................................................7.3 Repatriation.........................................................................................................................................

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7.4 Data Linkage........................................................................................................................................7.5 Sample Size..........................................................................................................................................

8 Reporting Results.............................................................................................................................8.1 Interpretation and Publishing..............................................................................................................8.2 Reporting Outcomes to Community....................................................................................................

Glossary..................................................................................................................................................APPENDIX 1: Development of the Genomics Pathway.............................................................................APPENDIX 2: OTHER RESOURCES.............................................................................................................APPENDIX 3: Health Systems in Queensland...........................................................................................References..............................................................................................................................................

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Abbreviations

ABS Australian Bureau of Statistics

AICCHS Aboriginal and Islander Community Controlled Health Service

HGDP Human Genome Diversity Project

HHS Hospital & Health Services

HREC Human Research Ethics Committee

IP Intellectual Property

IRM Indigenous Research Methods

MOU Memorandum Of Understanding

National Statement National Statement on Ethical Conduct in Human Research (2007 – Updated 2018)

NCIG National Centre for Indigenous Genomics

NHMRC National Health and Medical Research Council

NMA National Mutual Acceptance

NTA Native Title Act 1993

PHA Public Health Act 2005 (QLD)

PHN Primary Health Networks

PSC Project Steering Committee

QAIHC Queensland Aboriginal and Islander Health Council

QGHA Queensland Genomics Health Alliance

RGO Research Governance Office

Road Map 3 Road Map 3: A strategic framework for improving Aboriginal and Torres Strait Islander health through research (2018)

SSA Site Specific Application

The GuidelinesEthical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders (2018)

WES Whole Exome Sequencing

WGS Whole Genome Sequencing

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AcknowledgementWe acknowledge the traditional custodians of Australia, the Aboriginal and Torres Strait Islander peoples. We acknowledge and pay respect to Elders past, present and emerging.

We acknowledge all those who have contributed to the development of The Genomic Pathways: Guidelines for genomic research involving Aboriginal and Torres Strait Islander peoples of Queensland.

Artwork description

Note: A commissioned piece of artwork will adorn the front cover of this document. A description will be included in the final version.

Terminology

The term “Indigenous” is used throughout this document, interchangeably with the terms Aboriginal and/or Torres Strait Islander people and peoples; no disrespect is intended in the use of the aggregate term, intended in this instance (i.e. this document) to reflect groups of peoples “indigenous” to the land with which they identify and with whom they share a connection.

This document uses the term “genomic research” as defined by the National Statement on Ethical Conduct in Human Research [1] – pg 101; “research with the potential for hereditary implications which may range from single gene genetic research to whole genome sequencing and any other ‘omic’ research (e.g. exomic, proteomic, etc.) with potential hereditary implications. Genomic research includes the full scope of ‘genetic’ research.”

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1 ForewordTo be written after completion of the consultation process

2 Introduction

2.1 Rationale for the Genomics Pathway

Genomics is being implemented into the Australian Health system through Federal and State funded initiatives. The Queensland Genomics Health Alliance (QGHA) is a $25 million Queensland Health initiative (2017-2021) with a 5 year mission to “To demonstrate the value of genomic medicine in everyday Queensland healthcare”. At the national level, the National Health and Medical Research Council (NHMRC) funded a $25 million targeted call for research (2016 - 2020) into genomics and in 2018 the Health Minister Greg Hunt announced a national $500 million Australian Genomics Health Futures Mission.

It is widely recognised that there is a significant bias in genomics databases towards people of European ancestry [2, 3]. In contrast, Arab, African, Latin American and Indigenous populations are underrepresented in global genomics databases [3].

The lack of representation has direct implications for healthcare. In order for clinical genomic services to provide meaningful results, there is a need for genomes that represent the Queensland population to be present in databases. This will provide information about the frequency of genomic variants in the Queensland population and knowledge about how they relate to disease profiles.

For many Queenslanders, this data has been made available through domestic and international genomic research and public health initiatives. However, for Aboriginal and Torres Strait Islander peoples there is a lack of this type of research and consequently inequity of access to clinical genomics as it becomes more commonly applied to health care.

Beyond healthcare, genomic research involving Aboriginal and/or Torres Strait Islander peoples has the potential to be used for research that explores ancestry and a person’s connection to country. This can be important to people who have directly experienced or who live with the transgenerational consequences of forced removal from their place of origin.

It is widely recognised that Aboriginal and Torres Strait Islander people have an enduring right of self-determination and ownership of their cultural and intellectual property [4], this includes research pertaining to their life, personal and familial experience. As such, it is not the prerogative of non-Indigenous researchers to dictate how genomic research and associated data is collected and used. Rather researchers need to act as partners, working with Aboriginal and/or Torres Strait Islander peoples to create benefit that reflects the needs and preferences of the community. The practical application of this relationship can be difficult for researchers to negotiate to ensure best research outcomes.

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2.2 Aim and Scope

This document (referred to as the Genomics Pathways Document) is intended for use by researchers to navigate the practicalities of developing, implementing and managing genomics research projects with involving Aboriginal and/or Torres Strait Islander partners. It emphasises issues related to genomic research and provides practical recommendations for genomic research involving the Aboriginal and/or Torres Strait Islander peoples and communities of Queensland. This document was developed through consultation with researchers, clinicians, health providers, policy personnel and community (Appendix 1). It has been written to reflect the context of health research in Queensland. Whilst not an exhaustive source of all published, unpublished and grey literature, the document provides a starting point for genomic research involving Aboriginal and/or Torres Strait Islander peoples of Queensland. Some of the processes in this document may also be applicable to other research.

In creating this, the Genomic Pathways document we aim to provide discipline specific, practical advice for researchers proposing to conduct genomics projects involving Aboriginal and Torres Strait Islander peoples that builds on emphases of the NHMRC documents. NHMRC documents remain the seminal documentation on which the Genomic Pathway document is based and the primary reference for HREC approvals process. The definitions, principles and core values of the NHMRC documents are referenced throughout this document (see section 3.2 National Guides for Ethical Research).

2.3 Genomic Research in the Australian Indigenous Context

Historically, Aboriginal and/or Torres Strait Islander people have tended to be the subjects of research rather than partners and leaders; provided with an opportunity to direct and influence work. This approach to research has extended across all fields, including genomic research.

The Human Genome Diversity Project (HGDP) comprised a consortium of international researchers who collected sample from Indigenous peoples across the globe in an effort to investigate global migration and create a database of first peoples biological samples for health research purposes [5]. Development and design of the HGDP project has been criticised internationally as lacking adequate consultation with Indigenous communities [6]. As a result, Indigenous communities from several countries, including Australia, opted out of and prevented the project from occurring in their respective countries.

In Australia, the HGDP experience had ramifications for genomic research involving Aboriginal and/or Torres Strait Islander people. The decision not to participate in HGDP was seen as an indication that genomic research was not acceptable to Aboriginal and/or Torres Strait Islander people [7]. It is reported that the widespread criticism of HGDP subsequently led to several genomics projects being cancelled and in one case, ethics approval being withdrawn [8, 9].

The stalling of genomic research involving Aboriginal and/or Torres Strait Islander people occurred in the early to mid-2000s. At the time the full extent of genomics and its relevance to healthcare was not yet realised. Currently, there are only a few Aboriginal genomic datasets (Whole genome sequencing (WGS) or whole exome sequencing (WES)) with about 500 participants in total [10-13].

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There are also several genotyping and genome-wide association studies (GWAS) [14-16]. The majority of these participants in these studies are from southern and central Western Australia, and Northern Territory. Of the WGS and WES datasets, the majority are ancestral research project rather than health studies. The National Centre for Indigenous Genomics (NCIG - http://ncig.anu.edu.au/) manages a collection of historical medical research samples from Aboriginal and Torres Strait Islander peoples. It is anticipated that genomic researchers will be able to apply to access data from this collection via the NCIG governance committee.

Key Works

Over the past decade, there have been a number of key works that are important reading for genomics researchers considering working with Aboriginal and/or Torres Strait Islander peoples.

Issues and acceptance of genomic research involving Aboriginal and Torres Strait Islander communities:

Kowal, E., Rouhani, L., Anderson, I. (2011) Genetic Research in Aboriginal and Torres Strait Islander Communities: Beginning the Conversation, The Lowitja Institute, Melbourne. [9]

Kowal, E., Anderson, I. (2012) Genetic Research in Aboriginal and Torres Strait Islander Communities: Continuing the Conversation, The Lowitja Institute, Melbourne. [17]

Kowal, E. (2012) Genetic research in indigenous health: significant progress, substantial challenges. Medical Journal of Australia, 197(1): 19-20. [18]

Case studies of researcher experiences with genomic research involving Aboriginal and Torres Strait Islander people:

McWhirter, R.E., Mununggirritj, D., Marika, D., Dickinson, J.L., Condon, J.R. (2012) Ethical genetic research in Indigenous communities: challenges and successful approaches. Trends in Molecular Medicine, 18(12): 702-708. [19]

Kowal, E., Pearson, G., Rouhani, L., Peacock, C.S., Jamieson, S.E., Blackwell, J.M. (2012) Genetic research and Aboriginal and Torres Strait Islander Australians. Journal of Bioethical Inquiry, 9(4): 419-432. [8]

2.4 Diversity and its Relevance to Genomics

Indigenous Australians are largely referred to as belonging to two overarching groups; Aboriginal people and/or Torres Strait Islander people. While a widely used categorisation, it is also acknowledged that this “grouping” under-represents the breadth of diversity of the Indigenous peoples of Australia. For more sources of information about the cultural diversity of Aboriginal and/or Torres Strait Islander peoples, see Appendix 2. It is estimated that over 500 distinct clan groups existed in Australia prior to European settlement [20]. In a genomic context, it has been estimated that approximately 31,000 years of ancestral separation exist between the Aboriginal peoples of south-west Australia and the peoples of north-east Australia [11]. By comparison, it is estimated that peoples of Europe and East Asia have approximately 43,000 years of ancestral separation [11].

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3 Existing Guidelines

3.1 What is Aboriginal and/or Torres Strait Islander Research?

Indigenous research stands apart from research of Indigenous people in that it engages the Indigenous community as partners and seeks to build knowledge that is significant for the community. Without inclusion of community beyond the role of participants, research runs the risk of continuing the historical wrongs perpetrated on Aboriginal and/or Torres Strait Islander peoples.

3.2 National Guides for Ethical Research

Ethical principles for research involving human participants is directed by international standards. In Australia these standards are translated to a practical framework through guidelines from the National Health and Medical Research Council (NHMRC) – see Key NHMRC Documents box. The NHMRC frameworks and guidelines are used by researchers to develop and conduct ethical research and by Human Research Ethics Committees (HREC) as a basis for assessing ethics applications prior to approval of projects.

Key NHMRC Documents

National Statement on Ethical Conduct in Human Research (2007) - Updated 2018 [1] https://nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-updated-2018

Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders (2018) [21]https://nhmrc.gov.au/about-us/publications/ethical-conduct-research-aboriginal-and-torres-strait-islander-peoples-and-communities

Keeping research on track II: A companion document to Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders (2018) [4]https://nhmrc.gov.au/about-us/publications/keeping-research-track-ii

Road Map 3: A strategic framework for improving Aboriginal and Torres Strait Islander health through research (2018) [22]https://nhmrc.gov.au/road-map-3

To ensure that the ethics of research projects involving Aboriginal and/or Torres Strait Islander peoples reflect the values of the community, the NHMRC has developed specific documents based on consultation. These documents include: Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders (also known as The Guidelines [21]) and an associated companion document Keeping Research on Track II Keeping research on track II: A companion document to Ethical conduct in research with Aboriginal and

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Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders (also know as Keeping research on track II) [4], which are written with a view to support and inform researchers, participants and the community.

3.3 Six Core Values

NHMRC The Guidelines document [21] outlines six core values that reflect the important elements of Aboriginal and Torres Strait Islander culture and identity that should be evident in research. Namely: Spirit and Integrity, Responsibility, Reciprocity, Respect, Equity, and Cultural Continuity (Figure 1). These values form the foundation for a genomic research project that is respectful of Aboriginal and/or Torres Strait Islander peoples as both participants and partners in research. A detailed explanation of these values and their practical application can be found in The Guidelines [21], Keep Research on Track II [4] and Researching Indigenous Health: A Practical Guide for Researchers [23].

[Image to be included once licencing has been granted]

Figure 1: The six core values (Image from Keeping Research on track II: A guide for Aboriginal and Torres Strait Islander peoples about health research ethics (2018) [4])

4 Engagement with Communities

4.1 Aboriginal and Torres Strait Islander Communities

Community means different things to different people. Aboriginal and/or Torres Strait Islander people can feel connected to community on multiple levels depending on their individual circumstances and how they associate with country. Examples of Aboriginal and/or Torres Strait Islander community include:

Extended family and/or kinship group; People who live in a place and may or may not be from a single language group; People associated with an organisation, service or group.

It is important to understand that Aboriginal and/or Torres Strait Islander people who live in the same location, may not necessarily belong to the same traditional group, clan, or family. It may be necessary to consult with multiple groups to gain consent and consensus on a research project.

Aboriginal and/or Torres Strait Islander people have a strong social identity that is linked to culture, kinship and the associated responsibilities that come with being part of a community. Participating in research is not just a choice for the individual but also for community [21]. Few individuals can speak on behalf of a community. Knowing who to speak with and the scope of their responsibilities, is important. Responsibility for decisions made on behalf of a community are often bestowed to a group identified as having expertise in a specific area (e.g. health, research, housing, employment, conservation, the environment, history, lore or tradition).

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It takes time, resources and commitment to developing a meaningful relationship with anyone, community is no exception. Having an existing relationship with an Aboriginal and/or Torres Strait Islander community or organisation is a wonderful starting position, however, this doesn’t always exist. Identifying the representative(s) who a community rely on to act in relation to a particular topic is important when making initial enquires. Beginning a conversation is not a one step process, as it will likely rely on networking with the public, community and private sector. We recommend the following people, entities and organisations as a first point of contact:

Your institution’s Aboriginal and/or Torres Strait Islander program, unit or group; Queensland Aboriginal and Islander Health Council (QAIHC); Clinicians and health personnel working with communities; Other researchers who are Aboriginal and/or Torres Strait Islander people or those who are

advocates for Aboriginal and/or Torres Strait Islander peoples, including those from other disciplines;

People from the community; and People in a community leadership role (i.e. local advocacy groups, councils or government).

In preparing to meet with community representatives, advocates or organisations, researchers should review the NHMRC’s Keeping Research on Track II [4]. This document provides suggestions of questions Aboriginal and/or Torres Strait Islander people and communities should ask of researchers when projects are being proposed.

CASE STUDY:

Research project to determine the genetic role in a cluster of vulvar cancer in Arnhem Land communities [15, 19]

Women in remote communities of Arnhem Land were being diagnosed with rare vulvar cancer at a rate 70 times higher than the national average. A research project was devised to explore possible genetic causes. The study focused on a group of affected communities in a specific region. Researchers consulted with local elders, health boards and health services about the project. This consultation was facilitated by an Indigenous reference group comprised of local women from each community. The reference group also served to provide ongoing advice to the researchers about the project. Reference group members worked with researchers to co-facilitate consultations in their respective communities.

4.2 Working with Community

When working with communities (be it in the city, regional or remote locations), there are practicalities that need to be considered. Engagement with communities and participants can be influenced by a range of circumstances, and it may not be possible to predict which issues will impact a project. However, it is important to appreciate that cultural, social, familial and community responsibilities of Aboriginal and/or Torres Strait Islander people can influence their ability and decision to participate in research. It is important to appreciate these circumstances and responsibilities when visiting, consulting and engaging.

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Individuals who live in a particular community at the time of one visit, may not exclusively reside in that community; they may have shared responsibility to other communities and may not be available at subsequent visits;

The impact of weather or emergency events, especially during the wet season; Cultural events, festivals and celebrations and the responsibility of community to those

events, can impact the availability of community; Support service availability (i.e. opening hours of health centres, workers can be Fly-in/Fly-out

or Drive-in/Drive out); Sorry business; that is the passing, illness or ill health of a person of significance to the

individual, their family or their community; The people who grant permission for a research project to proceed in a particular community

can change; Key personnel and people working in partner organisations might change roles or move on to

pursue new employment opportunities.

When working with communities there may be protocols that you as a visitor are expected to follow. These will vary depending on the people, organisations and communities with whom you are working. It is important to be flexible in your research schedule and to respect the expectations, wishes and needs of the community; to communicate with all stakeholders across the life of a project.

4.3 Cultural Awareness, Capability and Competence

When engaging in research involving Aboriginal and/or Torres Strait Islander people, a researcher should aspire to be aware and competent in the conduct of research that serves to benefit, empower, and partner with Aboriginal and/or Torres Strait Islander communities. Cultural awareness training is a good place to start a partnership with Aboriginal and/or Torres Strait Islander communities. This training is offered through a variety of providers and the length of the course which you choose to undertake will differ depending on the depth of understanding you wish to develop (see Appendix 2).

It should be noted that funding bodies (such as NHMRC) and HRECs are increasingly requiring individual applicants and/or research teams to demonstrate capacity for culturally sensitive research when applying to undertake projects involving Aboriginal and/or Torres Strait Islander people. The requirement for experience in Aboriginal and/or Torres Strait Islander research does not exclude inexperienced researchers from entering into this type of research. Keeping Research on Track II [4] acknowledges the benefit for both communities and inexperienced researchers when mutual two-way sharing of knowledge, skills and experience occurs. In these circumstances mentoring and partnership become particularly important to support learning in the context of the researcher’s activities. A mentor can be someone in the community participating in the research or an experienced Aboriginal and/or Torres Strait Islander researcher.

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5 Developing a Research Project

5.1 Identifying researcher, stakeholder and community priorities

A researcher’s decision to develop a proposal is influenced by various factors; including the perceived impact of the work, their personal interest and expertise, access to resources, the power of their partnerships, and the potential of receiving funding. For projects involving Aboriginal and/or Torres Strait Islander people, there are additional factors that need to be considered prior to developing a research proposal. Aboriginal and/or Torres Strait Islander people have been over-researched. Some communities who have a history of welcoming research, report feeling overwhelmed and burdened with requests to participate in research. Many communities report feeling that research proposals do not reflect their priorities, needs and concerns. Being able to identify individual and community benefits early in a conversation helps to inform the development of a research proposal. Deliberate, respectful and mutually beneficial engagement increases the likelihood of developing a proposal that translates to shared benefit for everyone involved.

5.2 What if your Research Proposal isn’t a Community Priority?

It is reasonable that an Aboriginal and/or Torres Strait Islander community might choose not to participate in a research project. This can be for a variety of reasons and doesn’t reflect the merit of a proposal or the researcher/s. It could be that:

A proposal doesn’t align with a communities’ priorities; The community do not have the requisite resources to commit to the proposed work; and/or The community has had negative experiences with research in the past.

A preference for one community not to be involved in a project doesn’t mean that another community won’t be interested in a proposal. Consider if a proposal is better suited to another community, and seek advice from those with expertise, networks and connections to aid a review of the proposal and consider the potential for a different community to be involved. While you may not always receive feedback, it is important to appreciate the factors that influence a decision not to partner in research.

5.3 Co-designing Genomic Research Projects

Co-design is a process whereby community that is intended to benefit or participate in research is involved in the process of developing the project. It is considered best practice when working with Aboriginal and Torres Strait Islander peoples. Using co-design principles ensures that community views, beliefs and culture are at the forefront of the research project, and that community are empowered partners in the research process. Numerous and varied examples of co-design with Aboriginal and Torres Strait Islander peoples in different fields. There are few clearly articulated examples of co-design available in the Aboriginal and Torres Strait Islander genomics context. See the box below Co-design of genomics research with Indigenous peoples for some key international examples.

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Key document

Co-design of genomics research with Indigenous peoples

Claw, K.G., et al., (2018) A framework for enhancing ethical genomic research with Indigenous communities. Nature Communications. 9(1): p. 295. [24]

5.4 Indigenous Research Methods

Aboriginal and/or Torres Strait Islander peoples have a rich knowledge and history of research. This knowledge has been communicated across thousands of generations through the narrative that is language, dance and story. When developing a genomic research project involving Aboriginal and/or Torres Strait Islander peoples, consider the inclusion of Indigenous Research Methods (IRM).

IRM emphasise the importance of impact, community benefit and knowledge sharing. In some instances, IRM will exist that are comparable to non-indigenous methods (i.e. group interview method versus yarning circles method). Both approaches might yield similar results and the opportunity to include IRM should be considered especially if requested by community. For suggested reading see Appendix 2.

5.5 Seeking Agreement

For practical reasons, it is not enough to have a verbal agreement that a community is willing to participate in a research project. There needs to be documentation that a project is agreed upon. Whilst this is necessary for administrative reasons, it is also necessary from the perspective of building respectful and reciprocal relationship with other researchers, research partners, participants and the community. It is important that there is clear understanding of each person’s roles and responsibilities for the project. The types of documents needed will depend on the project, but might include:

Letter(s) of support from community, community partner and/or representatives of the community;

Research agreement; Memorandum of understanding (MOU). Communication plan

In circumstances where there is the possibility of commercially relevant intellectual property (IP) or financial gains arising from the research, this needs to be communicated with participants and community. Agreements about compensation and ownership of IP need to be made early in the process even when a project is unlikely to yield these outcomes.

Agreement documents may need to be drafted specifically for a project or adjusted from templates already available through the community partner, research entity and/or based on past research projects – see Appendix 2 for examples.

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5.6 Governance

Governance in the context of research, is the process of assuring rigorous scientific methodology and alignment of activities with evidence-based protocol which are conducted in an ethical manner. Indigenous governance in a research project serves to contribute to the cultural and social integrity of research. It can also explore more general themes of ethics and scientific rigour from the Aboriginal and/or Torres Strait Islander perspective. Involvement in governance can come in many forms. How it is applied to a project will depend on the size and scope of the project, plus the preferences of community. It can include Aboriginal and/or Torres Strait Islander membership within leadership groups or the creation of a specialist Indigenous advisory position on the project. Some examples of governance structures that serve to recruit Indigenous expertise to project governance, include:

Project steering committee (PSC); Indigenous reference group; and or Project team membership.

It might be possible to access existing governance structures for community partners. Some Aboriginal and Islander Community Controlled Health Services (AICCHS) have research review committees who serve to review and provide input to research involving their community.

CASE STUDY

A research project into the genetic contribution to rheumatic heart disease in Aboriginal people [14]

A state-wide genomic project was established to look at genetic risk factors associated with rheumatic heart disease in Aboriginal people of the Northern Territory. The project involved Aboriginal people from remote, rural, peri-urban and urban areas across the Northern Territory. A project steering committee was established to oversee the project. In addition to the PSC, three subcommittees were established: the Aboriginal governance committee, a clinical committee and a scientific committee. The Aboriginal governance committee had oversight of the study protocol and changes that occurred throughout the course of the project. They also established a protocol for data and sample sharing with project collaborators. The Aboriginal governance committee was in addition to community engagement, gaining permission for research within communities, and individual consent.

5.7 Communication Plan

Communication plans describe the way that information will be shared to participants, to community and to stakeholders during the life of a project. It is also a way of articulating how participants, stakeholders, partners and the general community can provide feedback to the research team. Contact details should be provided for the team member(s) that can provide assistance with complaints or concerns, general information, or recruitment. There should also be a plan in place for responding to feedback. This is important to build trust and ensuring open

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pathways for communication. Detail included in a communication plan will differ depending on: community, partner and stakeholder needs; the resources and preferences for the dissemination of information; and the nature of the project. The plan should be developed with and agreed upon by the participating community as part of project agreements.

A well-structured communication plan identifies:

The type of communication activities; The goal of each communication activity; The intended audience; The frequency of each communication activity; and Detail how others can provide feedback to the research team.

Communication with the public, stakeholders and partners is important throughout the life of the project and key to recruiting participants, interim reporting and return of final results to the community (see section on 8.2 Reporting Outcomes to Community). Communication during a project serves to benefit recruitment by keeping lines of communication open. Examples of strategies that researchers can use to sustain engagement across the life of a project include:

Regular reports to governance committees; Email updates; Printed newsletters; Posters or infographics on research topics; Presentations at public forums, council and/or community meetings; Information stalls at community events; Newspaper or radio advertisements; Radio, television and/or newspaper interviews; Web based social media promotions; or Development and update of a project website/webpage.

Better Communication: Beginning a Conversation with Community.

Make it a discussion, not a presentation - allow people an opportunity to respond and tell their story

Look for meaningful analogies or use narratives that are appropriate and relatable for the community

Invite participants to tell their story of participating in the research Consider doing several presentations to small groups rather than a large, one-off presentation Use diagrams and illustrations Be prepared to present without the use of PowerPoint Avoid jargon or technical terms (spoken or written) Have access to interpreters, if necessary Prioritise information that will engage people and community when communicating results

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5.8 Process Improvement and Reflection

Learning from experiences helps with continued refinement of the research process and can help to strengthen the development of meaningful relationships by acknowledging the experience, expertise and roles of partners, participants and the community. Across the life of a research project, it is important for both researchers and community to examine both positive and negative experiences. These reflective activities are an important part risk assessment and mitigation for any project. For genomic research projects that require collection of biological samples and/or re-consenting for future projects, maintaining relationships is crucial to sustained participant and community engagement. For more information see the Learning from Experience section in Keep Research on track II [4].

5.9 Research Team

Research that aims to benefit Aboriginal and/or Torres Strait Islander people must demonstrate inclusion and/or engagement with Indigenous expertise. There are presently few Aboriginal and/or Torres Strait Islander researchers with technical expertise and experience in genomics and bioinformatics. Depending on the focus of a project, consider partnering with researchers from other, complementary research disciplines (i.e. social or health sciences), clinical experts or policy experts.

The inclusion of Aboriginal and/or Torres Strait Islander researchers on the team and mechanisms to support workforce development and capacity building of Aboriginal and/or Torres Strait Islander people are encouraged. Queensland anti-discrimination legislation supports targeted recruitment where it is a genuine occupational requirement that a role be filled by a person of Aboriginal and/or Torres Strait Islander descent (Anti-Discrimination Act (1991), s105) - for more information see the Australian Human Rights Commission’s guidelines [25].

While identified recruitment is one way to involve more Aboriginal and/or Torres Strait Islander people in projects of relevance to Indigenous health, such a strategy will not always yield suitably qualified applicants. Therefore, opportunities to support workforce development and capacity building of an Aboriginal and/or Torres Strait Islander health researchers should be considered. These could include;

Providing paid undergraduate traineeships for Indigenous students; Providing placements for Indigenous research higher degree students; Provide or sourcing scholarships for Indigenous students; Up-skilling existing staff of hospital and health services (HHS) or AICCHS to take on research roles; Funding research positions in HHS/AICCHS; and/or Identifying community representatives who can be upskilled to take on liaison and engagement

officer positions to facilitate research in the community.

Many research organisations have initiatives that support equal employment opportunities for Aboriginal and/or Torres Strait Islander people. Assistance, advice and expertise can be sought from the human resources department or the Aboriginal and/or Torres Strait Islander unit of your organisation.

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Key Works

Laycock, A., Walker, D., Harrison, N., Brands, J. (2009) Supporting Indigenous Researchers: A Practical Guide for Supervisors. Cooperative Research Centre for Aboriginal Health, Darwin. [26]

Laycock, A., Walker, D., Harrison, N., Brands, J. (2011) Researching Indigenous Health: A Practical Guide for Researchers, The Lowitja Institute, Melbourne. [23]

Both available at [https://www.lowitja.org.au/resources-researchers]

6 Ethical and Social Considerations

6.1 Informed Consent

Consent is focused on an individual’s autonomy in making an informed decision about joining a research study and ensuring participant care through risk management [1, 27]. One of the central covenants of consent is that it is informed consent. Participant Informed Consent Forms (PICF) and associated Participant Information materials are the most widely accepted form of consent documentation for Human Research Ethics Committees to review. Research consent is more than just a signature on a piece of paper. The process of informing a participant about a research project; whether it is done verbally, in writing and/or through multimedia presentation, is as much a part of the consent process as the final signature.

When undertaking the process of consent with a concept as complex as genomics, both technically and ethically, the development of a consent process that suits the project and its participants is critical. Key areas that need to be considered when developing genomic consent for Aboriginal and/or Torres Strait Islander peoples are as follows.

Language: Where participant information and consent documentation is written in English, researchers should aim for a Grade 8 readability level, this rule of thumb applies to all people, not only Aboriginal and/or Torres Strait Islander peoples. This can be checked by readability apps that are freely available online.

Alternative consent strategies: For some Aboriginal and/or Torres Strait Islander people and communities, English is not the primary or even a routinely used language. It may be the case that a local language or dialect doesn’t include a written form. In these cases, the researcher needs to develop patient information and consent documentation in the languages of the community and use a combination of non-written media. For example:

Spoken consent process (with permission these could be recorded); Audio or video presentations; and/or Diagrammatic or pictorial representations.

Using storytelling and metaphors can be helpful when explaining complex topics such as genomics. Working with a community to develop these resources is important. It aids communication of technical concepts, promoting community ownership and involvement along with sharing responsibility for the appropriateness and effectiveness of resources. It is increasingly common to have a suite of consent resources available, supporting adaptive consenting that appreciates an

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individual’s communication preferences. The development of these materials is a phase of research development where co-design can be utilised to engage and empower community in the research process.

Consent personnel: The person taking the potential participant through the consent process needs to be familiar with; the study, potential implications for the participant or family members, and the consent process. The participant and the community research partner may prefer that this role be filled or supported by a local community member or medical service staff (rather than researchers).

Reduce external influences: In a health care setting there needs to be a clear delineation between clinical care and research to ensure that participation is informed and voluntary. Creating a consent process that separates the two is important. This can be achieved by;

having staff specifically responsible for the consent process, separation of the research consent process from clinical consultations by either time or location

When seeking consent, it is important to understand that social norms and societal structures can cause a participant to feel pressured to consent. Researchers should be aware of the influence that external factors can have on voluntary consent. In particular:

Community approval being seen by individuals as consent on their behalf; The position/standing/role of the person involved in the consent process; Views on authority (for example, are doctors being viewed as authorities who cannot be

questioned?).

External factors will vary from person to person and community to community. Awareness of potential issues help the researcher to work with community and its representatives to develop a consent process that respects the preferences of the community.

Case Study:

Consent process for a research project to determine the genetic role in a cluster of vulvar cancer in Arnhem Land communities [19]

In Arnhem Land a project was developed to explore potential genetic causes of vulvar cancer. Before the project started the researchers first worked with community to gain group consent to allow research to be conducted within communities of the region.

For individual consent researchers then worked with community representatives to develop a consent process that was customised to the project and region. Participants were provided an illustrated book that present concepts round genetics and inheritance along with an explanation to accompany the book recorded in a widely used dialect of the region. The consent process was conducted in the presence of an interpreter. Once consent the consent discussion was completed participant gave written informed consent.

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6.1.1 Community consent

When undertaking research it is important to recognise that permission to conduct research may need to be given by the individual and community. Community level permission will vary depending on who is responsible for providing permission for research in a community (for example; elders, council of community representatives, AICCHS). The difference between individual and community consent lays in how community communicates its consent to participate. For administrative purposes, Human Research Ethics Committees require evidence that an individual is consenting to the research, and that community is aware of the project and have demonstrated a willingness to participate, such as letter(s) of support (see section 5.5 Seeking Agreement).

Community consent comes from mutual discussions that cover:

Needs and expectations of the community; Rights and responsibilities of the community; Rights and responsibilities of the researchers; Benefits that researchers gain from being part of the research project; Practicalities of the research protocol and methods - what community requests can or cannot be

accommodated; Realistic discussion of expected outcomes, benefits and risks to the community and for

individual participants.

6.1.2 Secondary Use: Extended & Unspecified Consent

The value of genomic data is its potential to be used to investigate a broad range of research topics that are secondary to the original project. National Statement [1] defined three broad categories for consent – specific, extended and unspecified.

During the workshops to develop the Genomics Pathways Document, there was general agreement that unspecified consent for undefined future work was not a preferred option for Aboriginal and /or Torres Strait Islander peoples. Participants in the workshops noted that these types of consent were unacceptable because they reduced autonomy for individuals and the community to make informed decisions about and to be in control of their right to be involved in research.

An alternative strategy for enabling extended or unspecified consent to secondary research projects with Aboriginal and Torres Strait Islander peoples, is establishing data custodians with governance structure to approve secondary use of genomic data. This approvals process would be separate to human research ethics approval process.

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EXAMPLE

Havasupai Tribe lawsuit after secondary use of DNA samples

In the late 1980s, a research partnership between Arizona State University and the Havasupai Tribe was established to look at genetic links to Type II diabetes. The consent process included broad consent to other projects but the consent process was only available in English. A second language for most participants. By 2003 the Havasupai became aware that the samples had been used for additional studies including mental health, migration and rates of consanguinities, which are taboo subjects for this tribe. A lawsuit was filed citing issues with consent, mishandling of blood samples, unapproved use of data and breach of medical confidentiality. The lawsuit resulted in an out of court settlement and the repatriation of the samples.

6.2 Specific Considerations for Risk and Benefit

6.2.1 Risk

When considering participant risks in genomic research consent there are standard considerations that apply to any person or participant cohort.

Incidental findings Return of results Genetic discrimination

In addition to these general considerations, there are also additional risk factors for Aboriginal and Torres Strait Islander peoples. Their relevance of each risk will depend on the topic of the genomic research and the community involved. The following are risk factors identified through the consultation process that led to the development of the Genomics Pathway document. There may be additional risks that researchers need to consider.

Identification or re-identification of individuals and communities: there are circumstances where communicating the study site or the name of the community involved can contribute to identification of individual study participants due to small community size. There needs to be agreement with community if location or name of community will be made publically available. If community or study site is to be communicated publically individual participants need to be informed of the risk of re-identification, especially in small communities or when studying rare diseases.

Self-determination of cultural identity - Genomics has the potential to create conflict between the scientific narratives of ancestry versus the views and beliefs of an individual or community. Aboriginal and Torres Strait Islander peoples have the right to have their cultural identity, views and beliefs reflected in the public narrative that is created by research. Genomics projects that have the potential to provide an alternative narrative on local beliefs should discuss this issue with community and participants.

Self-determination of Aboriginality – Some people with Aboriginal and Torres Strait Islander ancestry do not identify as Indigenous, or do not know about their ancestral links to country. In

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assessing participant risks of a project consideration must be made of the potential for an individual’s or a community’s identity to be challenged by the results.

Social stigma and Taboo subjects – For Aboriginal and Torres Strait Islander people some topics could be taboo or have a social stigma associated with them. There are also topics that are considered the purview of a specific group (example being topics related to women’s business and men’s business). There needs to be consideration of the potential for discrimination or social stigma in the context and internal to community (local views and norms) and external to community (wider societal views and norms).

Land rights – In Australia, the Native Title Act 1993 (NTA) recognises the traditional rights and interests of Aboriginal and Torres Strait Islander people. Whilst the NTA does not require proof of ancestry through DNA testing there are concerns voiced through community consultation that genomics could be used for this purposes in the future. Whilst it may not be a current risk it is a current concern for participants and communities as such it should, therefore, be addressed in conversations especially for projects that explore ancestry or are seeking unspecified consent.

Family – Familial risk from genomic research can be applicable to anyone. Depending on the risk associated with the project this factor may need to be considered in the context of cultural protocol observed by the study participant and their family.

6.2.2 Benefit

The NHMRC Guidelines [21] emphasise the importance of research involving Aboriginal and/or Torres Strait Islander peoples benefiting the community and the individual. The benefit of participating in research should be explicitly and realistically explained. These discussions should include explanations of the benefit that a researcher gains from conducting research. This is so communities can decide if the benefit to both parties is balanced. An individual’s or community’s perception of what constitutes benefit will vary greatly. Some people and communities will accept benefit that is derived from altruistic participation as acceptable whilst others won’t.

The need for research to articulate individual and community benefit was a consistent theme that came up in the consultation process that informed the development of this document. During consultations, two potential reasons for the emphasis of benefit in research involving Aboriginal and/or Torres Strait Islander participants emerged:

1) Aboriginal and/or Torres Strait Islander people have a societal structure that values social relationships and reciprocity, and

2) Continued experience of non-Indigenous people taking and misappropriating knowledge and culture from Aboriginal and/or Torres Strait Islander people without acknowledgement or benefit to their community.

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6.2.3 Rights and Responsibilities

Keeping Research on Track II [4] has an in-depth exploration of the rights of Aboriginal and Torres Strait Islander peoples when participating in research. It is researcher’s responsibility to uphold and facilitate the realisation of these rights during a genomic research project. Practical guidance on how researchers responsibilities can be demonstrated are provided Guidelines [21].

As stated in the NHMRC’s Guidelines (2018) “Aboriginal and Torres Strait Islander Peoples have a right to assert and retain ownership of the cultural and intellectual property related to the information that is provided for research projects” [21]. While the NHMRC’s Guidelines refer directly to spoken and created objects [21] there is an expectation among international Indigenous communities that this also incorporates data [28, 29], including genomic sequences. Discussion and negotiations should be held to define ownership and co-ownership of knowledge that provides adequate recognition and shared benefit, especially when traditional knowledge (including genomic and genetic information and biological samples) are used for or may be used for commercial purposes [4].

6.3 Ethics Application Process

6.3.1 Ethics approval

There are additional criteria for assessing ethics applications for human research involving Aboriginal and/or Torres Strait Islander peoples [21]. These guidelines have been developed with a view to improve the way researchers develop research proposals, conduct and report projects and to ensure that the work serves to support Aboriginal and/or Torres Strait Islander rights and capacity in research.

In practice, compliance with the NHMRC guidelines is evidenced as part of a researcher’s application for ethics approval. The requirement to provide evidence of consultation and agreement for community participation can vary between HREC. It is worth consulting with your intended HREC during the planning phase so as to avoid delays in their processing of your application. Additional requirements that a HREC may require of a researcher for projects involving Aboriginal and/or Torres Strait Islander peoples, include:

Specific questions relating to how a researcher has involved Aboriginal and/or Torres Strait Islander people at different levels of the proposed project (i.e. as stakeholders, participants, partners and/or co-lead investigators);

Supporting documentation that evidences that the project team has consulted with the community and that they are aware of the project (see 5.5 Seeking Agreement section of this document);

Evidence of cultural competency and experience of the proposed research team and in the area of Aboriginal and/or Torres Strait Islander research; and/or

Evidence or explanation of how the six core values (Section 3.3) will be incorporated into the project.

In most cases, a research project will be assessed by the HREC at the site of research or by the researcher’s organisation. Most human research ethics applications require only one ethical and

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scientific review. There are circumstances where multiple ethics approvals are required. This usually occurs when:

1) A single ethics committee does not have the necessary expertise to consider either the scientific and/or ethical issues relating to specific participants (see section 4 of National Statement [1] for details); such as Aboriginal and/or Torres Strait Islander people, or

2) An expressed preference by a community for the researcher to use an Aboriginal and/or Torres Strait Islander specific committee.

Outside of Queensland, there are HREC that specialises in the review of applications for research involving Aboriginal and/or Torres Strait Islander people. No equivalent HREC exists in Queensland at this time, however, some of these specialist inter-state HREC may consider reviewing an application for research that is principally focused on recruitment of people from outside of their state (fees may apply). When talking with the HREC with whom you intend to lodge an application, you should ask about their ability to assess your application.

EXAMPLE

A research team is applying for HREC approval for a project involving Aboriginal and/or Torres Strait Islander people in genomic research; they have been advised that their local HREC does not have the capacity to assess the ethics application.

What should the researchers do?

Understanding local policy is key to resolving this issue is understanding local policy. There are a number of options available to HREC and which a researcher may suggest:

Use of an external expert panel member(s) with specialist advice; Engagement of a specialist HREC to assess the elements of the application not within the scope

of the principal HREC (while the principal HREC provide assessment of the elements of the application within scope); or

Support the researcher to access another HREC who are able to assess the full application.

With each of these options, the researchers need to talk with their local HREC chair or, if the role exists, HREC co-ordinator. For Queensland Health HHS’, the researcher also needs to consult with the Research Governance Office (RGO) to confirm local policies for their acceptance of external HREC approvals. These conversations should occur in the planning stages of the project rather than after the application has been submitted to avoid delays.

6.3.2 Site Specific Approval

In addition to ethics approval for research, Queensland Health HHS and AICCHS require site specific approval by research governance before research can begin (Figure 2). This is to ensure that the health service is appropriately covered for research activities, including adequate and appropriate staffing, resourcing, budgeting, insurance cover and/or the development of IP agreements. The process for site specific approval varies considerably and researchers need to consult with service partners to determine the site’s process.

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Figure 2: Flow chart of ethics process for research.

6.4 When to engage with community

Anyone who has applied for human research ethics approval will be aware of questions about the involvement of Aboriginal and/or Torres Strait Islander people in their research. When considering this question there are three types of research that involve Aboriginal and/or Torres Strait Islander peoples;

Specific: research explicitly speaks to the experience of Aboriginal and/or Torres Strait Islander peoples

Non-specific: research that explores experiences of the wider population but relevant to the experiences of Aboriginal and Torres Strait Islander people within this broad context.

Incidental recruitment: Participation in research projects by a person that identifies as Aboriginal and/or Torres Strait Islander where identity or ancestry does not inform the research analysis or discussions.

For projects that propose to recruitment to Aboriginal and/or Torres Strait Islander people as all of the research cohort, it is clear that the research falls under the category of specific research, and requires the engagement outlined in this and other documents [4, 21]. This requires targeted recruitment of Aboriginal and/or Torres Strait Islander peoples can be categories as a research project that;

Aboriginal and/or Torres Strait Islander people are a focus of all or part of the research; Data collection is from Aboriginal and/or Torres Strait Islander peoples; As a group, Aboriginal and/or Torres Strait Islander peoples are to be examined in analysis

and/or commented on in the results;

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Funding for research was obtained through Aboriginal and/or Torres Strait Islander specific grant.

Non-specific research and incidental recruitment of Aboriginal and/or Torres Strait Islander in the context of community engagement is a grey area. Neither topic is clearly articulated in the National Statement [1] or the Guidelines [21]. For NHMRC grants that fund research for Aboriginal and/or Torres Strait Islander people, there is an expectation that a minimum of 20% of participants identifies as Indigenous [30]. This is a cut-off for funding allocations and is not a suitable benchmark for defining incidental, or even targeted, research recruitment. In community consultations for the Genomics Pathways Document, we came to formulate the following advice for researchers regarding non-specific and incidental recruitment.

Non-specific research of Aboriginal and/or Torres Strait Islander peoples can be defined as any research;

Aboriginal and /or Torres Strait Islander people are known, or are likely, to be significantly over-represented in the group being studied (for example, compared to the 4.0% of the total Queensland population as shown in the 2016 Census); or

The Aboriginal and/or Torres Strait Islander experience being studied is known, or is likely, to be different from the overall population; or

There are Aboriginal people who use the services being studied in distinctive ways, or who have distinctive barriers that limit their access to the services; or

It is proposed to separately identify data relating to Aboriginal people in the results.

When a project meets these criteria for non-specific research of Aboriginal and/or Torres Strait Islander peoples the process of community consultation outlined in this document need to be applied. Incidental recruitment of participants that identify as Aboriginal and/or Torres Strait Islander but where this information is not relevant to the study or study outcomes is the only circumstance where community consultation is optional.

An Aboriginal and/or Torres Strait Islander person wants to participate in a genomic research project. Is community engagement needed for the project?

If the participants Aboriginal and/or Torres Strait Islander ancestry is relevant to analysis and reporting of the research, then both individual and community consent are required.

If the researcher intends to report results in relation to the family, language group, or community, then community consultation is required.

If the researcher intends to make statements about Aboriginal and/or Torres Strait Islander people in general, then community consultation is required.

If the participant’s Aboriginal and/or Torres Strait Islander ancestry is not relevant to the analyses and won’t be reported, then only individual consent is required; however, the individual may want to consult with their family prior to their making a decision to participate.

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EXAMPLE

A researcher is studying the genomic factors influencing diabetes for people accessing the Townsville Hospital. The only selection criteria is that the participants need to be diagnosed with diabetes. It is researcher’s opinion that the study applies to everyone with diabetes.

Is the researcher doing Aboriginal and Torres Strait Islander research?

Yes

Why?

The researcher looked at Queensland Health reports and found that Aboriginal people are known to be over-represented in diabetes patient cohorts. This research then made an application through the relevant data custodian channels at Queensland Health. Using patient summary data, the researcher determined that Aboriginal and Torres Strait Islander people access the Townville Hospital diabetes clinic at a higher rate than the regions general population.

EXAMPLE

A researcher is studying the genomic factors that predispose people to skin cancer in Queensland.

Is the researcher doing Aboriginal and Torres Strait Islander research?

Maybe

Why?

Literature and health data indicate that Aboriginal and Torres Strait Islander people have a low incidence of skin cancer cases in Queensland. However, the survey forms collect demographic information from participants, also it enquired about ancestry and included amongst the many options is “Aboriginal or Torres Strait Islander ancestry.”

If the researcher is not publishing or presenting results that relate to Aboriginal and Torres Strait Islander participants, then this is not Aboriginal and Torres Strait Islander research.

If the researcher is publishing or presenting the data and drawing conclusions about Aboriginal and/or Torres Strait Islander people, then this is Aboriginal and/or Torres Strait Islander research.

6.5 Historical data or samples

For any new project, the focus should on assessing the need for community consultation and engagement, as outlined in section 6.4 When to engage with community, and working with the concepts outlined in the Genomic Pathways document where appropriate. Through the consultation process the question was raised by researchers about how to manage situations were findings relevant to Aboriginal and/or Torres Strait Islander people have been identified from research but when consulted and engaged with the community has not been done.

It was outlined during the workshops that, when practical, publish the component of the research that doesn’t comment about the implications of the research for Aboriginal and/or Torres Strait

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Islander people separately. Then to publish research that draws conclusions about Aboriginal and/or Torres Strait Islander people, it is recommended that the researcher either:

Develop a project that extends on the unpublished findings using recommendations in this document, or

Consult and engage with community on the publication of the existing data - this may require re-consenting individuals, ethics amendments and/or community engagement.

When managing historical data and samples collected from Aboriginal and/or Torres Strait Islander peoples where there are questions over the validity of consent it is always best, err on the side of caution. These samples and data can potentially be used for research but there must first be engagement and consultation about the research and re-consenting.

CASE STUDY

The National Centre for Indigenous Genomics

The National Centre for Indigenous Genomics (NCIG) based at the Australian National University is an organisation who serve as custodians for a collection of historical samples and data from Aboriginal and Torres Strait Islander people. There are acknowledged issues around the validity of consent for samples in this collection. As such, NCIG is working towards seeking consent from individual owners or their descendants for the use of these samples in research. Central to the management of NCIG is the Board and a Collection Access Committee that both have majority Indigenous membership. This committee assesses review applications by researchers to access the NCIG collection. (For more details see http://ncig.anu.edu.au/)

7 Sample Collection and Data Storage

7.1 Collection

The human body and all parts of the person including its excretions and evidence of being, (including but not exclusively, blood, tissue, hair, faeces, sweat, and saliva) are considered sacred by Aboriginal and Torres Strait Islander peoples and serve to evidence a connection to the environment, personal, family and community (past, present and future). The way in which this connection is emphasised, perceived and respected (through ceremony and cultural practice) will differ between communities, families and their members. For this reason, the specific methods and type of samples collected is an important point to discuss with communities and participants. During the workshops to develop the Genomics Pathways Document, it was noted that:

A recommended source of DNA for genomic testing is saliva (rather than blood) for studies that do not require specific tissues.

All researchers, scientists and project personnel should treat samples (regardless of their origin or type) as precious and significant for the people from whom they were collected.

The person from whom a sample has been collected should be aware of the intended use of their sample and the process of repatriation or disposal once data has been extracted.

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7.2 Sample, Data and Research Protocols

Protocols and practises for the handling and long-term management of data and samples need to reflects communities expectations, customs and beliefs. Sometimes community expectations or understanding of research processes may not align with current genomic research practices in Australia. For example, many participants in the workshops, without life sciences background, were surprises that sequencing and data storage could involve commercial companies based overseas, and that human genomic data was routinely stored in databases not managed by the researchers conducting the study.

To ensure agreement between researchers and community, in-depth discussions about research protocols need to occur when making a research agreement. Further, there needs to be agreement on how a protocol changes that occur during the project lifecycle are communicated and agreed upon. Having governance structures that are willing and able to assess protocols would be beneficial for both parties, see section 5.6 Governance.

It is important to note that sometimes researchers may not be able to change their protocols to suit a community’s expectations. This does not mean a community need to accept the research protocol as given. There will be times when researchers and community reach an impasse over research protocol and the project will not continue. In these circumstances two-way discussion and negotiation that clearly seeks to present both perspectives become critical to ensure a positive relationship can be maintained.

Each community will have their own areas of interest in the research protocol. Points for data, sample and protocol discussion that were identified during consultation included:

Location(s) where samples are being stored; Location(s) where samples are being processed; How samples will be stored and for how long; How samples will be disposed of when requested/required; How samples will be repatriated when requested/required; Who will have access to the sample; Who will have access to the data; What commercial companies will handle the samples and associated data; Will the government have access to the samples or data; and Who will have access to the samples and data, can this change over time.

CASE STUDY

Maori kaitiaki (guardianship) & karakia (blessing) of biological samples

In response to the increased interest of genomics as a health care and research tool, the Maori people of New Zealand developed guidelines that reflected their cultural beliefs. The two document outline expectations for genomic research and biobanking [31, 32]. The application of these guidelines in research has seen the Maori community have an active involvement in the use of their biological samples and data.

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When samples are no longer needed Christchurch Tissue Bank provided participants with the option of specimen disposal with a Maori karakia (blessing) [7].

To ensure culturally appropriate manage of sample a genetic research project formed a kaitiaki (guardianship) group of Maori people. The group’s task was to ensure the research benefited the community. Additionally, the project employed two elder to act as “spiritual guardians” for the samples [7].

7.3 Repatriation

Due to the connection between an Aboriginal and/or Torres Strait Islander person’s physical body, spirit and country, there may be circumstances were participants or communities want samples returned. During project development, the topic of repatriation of samples should be discussed. Important points to clarify:

Local belief of the individuals within the community (as there may be more than one point of view);

What materials repatriation processes refer to, including but not limited to, sample and/or products extracted from samples (e.g. DNA);

Timeframes for the return or disposal of samples; Process for returning samples (to whom, how and through consultation with whom); and How these preferences are to be recorded (for example individual consent document and/or

community agreement).

7.4 Data Linkage

Genomic data can be made more informative by combining data collected through a research project with other studies or through linkage with other government health records. For example, data stored on the Commonwealth government’s My Health Record, Medicare Benefits Scheme and Pharmaceutical Benefits Scheme or via state managed electronic medical records. As the role of genomics in health care increases, it is anticipated that there will be an increase in the number of genomes sequenced for diagnostic purposes. This Queensland Health genomic data may be released for research purposes via Public Health Act (PHA) applications (under section 280 of the Public Health Act 2005) - see Appendix 2 for more information on accessing Queensland Public Health data.

It is important to note that not all medical records are held in government databases or repositories. AICCHS, privately run health services and medical centres may be custodians of medical records for individuals. In these circumstances, researchers need to determine the relevant organisation’s process for access and release of medical records for research purposes. This may include;

Patient or record owner’s consent to share information with a third party; or Approval by the organisation for the researcher(s) to access patient records that they hold (i.e.

board of directors, governance, etc.).

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7.5 Sample Size

While the Aboriginals and/or Torres Strait Islander people are referred to broadly as belonging to one of two cultural groups; there is a vast genetic diversity between the different Indigenous peoples of Australia [11]. This raises the question of how representative variants of interest may be when applied to the collective. Genomic research relies on a genomic reference for the population and an understanding of the genomic variance in the population, such that the researcher needs to consider:

Ability to recruit sufficient numbers of participants for statistically significant analysis; How relevant a variant is likely to be within a population; How a community came to be formed (traditional country or forced relocation to a geographical

location); and Whether data and/or samples from other collections be used to increase sample size.

8 Reporting Results

8.1 Interpretation and Publishing

When publishing or presenting research involving Aboriginal and/or Torres Strait Islander peoples, non-Indigenous researchers should avoid speaking about or on behalf of Aboriginal and/or Torres Strait Islander community. Researchers should work with community partners and their project governance committee to develop publications that respect and empower Aboriginal and/or Torres Strait Islander voice, as self-determining and entitled to represent itself [4]. Examples of how a researcher might promote self-determination and empowerment of Aboriginal and Torres Strait Islander voice in a research project, include:

Interpretation of results in the community context to aid development of the discussion; Using language that is inclusive of community’s culture, values and beliefs; Identify results that can cause harm to participants or community, i.e. promote negative

stereotypes or health disparity.

To ensure the community’s voice is represented in scientific reports, community members should be able to contribute directly to scientific journals articles and presentations. This can be through proofing or advising on documents and presentations. Alternatively, general advice on preferences for how results are reported can be gained through;

Individual or group interviews with community members; and/or Meetings with community representatives, project governance or Indigenous Reference

group.

For projects that do not have a direct link to a specific community, inclusion of an Indigenous perspective can be achieved through consultation with or seeking advice from;

Team members or leaders that are able to represent the community perspective; Project Indigenous governance committee; Aboriginal and/or Torres Strait Islander partner organisations; and/or

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Your organisation’s Aboriginal and/or Torres Strait Islander unit.

These organisations may not be able to give ‘permission’ to make statements about Aboriginal and/or Torres Strait Islander peoples or communities. Rather, they will be in a position to provide general advice on the language used in documents, provide cultural or social perspective, or provide suggestions of other people to approach for specific advice.

EXAMPLE

Media misrepresentation of the MAOA gene research findings [33]

In 2006, it was reported at a conference that genetic variant in the X chromosome linked Monoamine oxidase A (MAOA) gene had a higher prevalence in Maori males than males with European ancestry. The gene had previously been described as the ‘Warrior Gene’ due to link with aggression, risk taking and addiction. This lead to mis-reporting in the media that current variants were evidence of genetic predisposition for criminality and addiction in Maori. This resulted in an outcry from the Maori community that saw the research as promoting negative stereotypes and criticism of the researchers.

8.2 Reporting Outcomes to Community

An important part of finalising a research project is reporting outcomes to community. This is separate to publishing results in scientific journals or presentations at conferences, and returning research results to participants. Even if the project had null results, researchers should still return to the community to discuss why there were no results. As partners in the project, community and participating individuals have a right to be informed of the project outcomes. This information can help community and community based research partners to inform decision making processes when approached about future research projects. It can also help to strengthen relationships between community and researchers through promoting open two-way discussions.

When returning results to the community there needs to be a focus on:

Translating findings into community benefit, Avoiding jargon and technical terminology, and Use of a dissemination strategy that suits community needs.

For strategies to report outcomes to community, see section 5.7 Communication Plan. For projects that do not have an easily definable community (for example, those in metropolitan areas) a more general outcome dissemination strategy may be required;

Reporting to partner organisations; Working with partner organisations to produce communications suitable for their members; Developing media releases (traditional or social) with a specific focus on engaging health

organisations and community media (for example, local radio or newspaper); Writing articles for industry publications (for example, Australian Indigenous Health Bulletin or

Australian Medical Journal); or Reporting directly to participants through newsletter, project website or social media.

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GlossaryBiocolonisation taking of knowledge or biological resources from an Indigenous person or community without compensation

Community as defined by The Guidelines [21] “is recognised as a complex notion incorporating cultural groups, geographic groups or groups and organisations sharing common interests. Communities are not always geographically based, and can include non-discrete or disperse groups. ‘Community’ is also a term that can be used to describe a shared view amongst Aboriginal and Torres Strait Islander Peoples.” - pg. 2

Country as defined by The Guidelines [21] “ Aboriginal and Torres Strait Islander Peoples have spiritual, physical and cultural connections to their land. Aboriginal lore and spirituality are intertwined with the land, the people and creation and this forms their cultural identity and sovereignty. Country takes in everything within the landscape – landforms, waters, air, trees, rocks, plants, animals, foods, medicines, minerals, stories and special places. Community connections include cultural practices, knowledge, songs, stories and art, as well as all people: past, present and future.”

Cultural Protocol Refers to the code of conduct that guides behaviours of a particular cultural group. This code of conduct can be in the forms of customs, lore or codes. Using cultural protocols is a way of demonstrating respect for the cultural traditions and peoples of the community.

Extended consent paraphrased from the National Statement [1]- gives consent for use of data or biological samples for any future research (also referred to as broad consent)

Genomic research as defined by the National Statement [1] as “research with the potential for hereditary implications which may range from single gene genetic research to whole genome sequencing and any other ‘omic’ research (e.g. exomic, proteomic, etc) with potential hereditary implications. Genomic research includes the full scope of ‘genetic’ research.” – pg. 101.

Specific consent paraphrased from the National Statement [1] - limited to the specific study under consideration

Unspecified consent paraphrased from the National Statement [1] - as gives consent to use data or biological samples in future projects that are either (1) an extension or closely related to the primary project, or (2) is in the same general area of research.

Women’s or Men’s Business Traditionally, customs and practises that are performed by women or men only. In the modern context of health and community, when discussing topics that are considered women’s or men’s business there is usually a splitting of genders to discuss issues.

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APPENDIX 1: Development of the Genomics Pathway

Consultation

This section is to be completed once consultation is finished

This document, to be referred to as the pathways document, comprises advice and recommendations for genomic researchers working with the Aboriginal and/or Torres Strait Islander peoples of Queensland. It has been developed in collaboration with researchers, clinicians, health providers, policy personnel and community leaders. Consultation to inform the development of the pathways document began in March 2018 and asked stakeholders to consider:

Whether Aboriginal and/or Torres Strait Islander people of Queensland are interested in exploring participating in genomic research;

What is important for genomic researchers to appreciate when developing research partnerships;

Priority and possible content for inclusion in the pathways document; and Issues that impact genomic research and partnership including those specific to Queensland.

The process of consultation and engagement comprised four parts:

1. Workshops involving people from the research community, health service, ethics, and health policy sector;

2. Public forums introducing the concept of genomic research and precision medicine;3. Written input and/or feedback about the experience of the workshops; and4. Written input and/or feedback on draft pathways document as it moved from draft to final

versions.

Workshops were held at five locations across Queensland, with public forums held at seven locations. A total of 52 people attended the first round of workshops, with 51 people attending the public forums (Figure 3). xx people attended a second-round of workshops facilitated across Queensland and serving to introduce the penultimate version of the document back to those involved in its development. xx people provided electronic feedback that served to inform the development of the pathways document. Reports on the process used develop the pathways document, are available, <link to be added>.

Figure 3: Workshop and public forum locations and participant numbers (example image)

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Project Steering Committee

In addition to the consultation and engagement process outlined above, development of the pathways document was overseen by a Project Steering Committee (PSC). Committee membership comprised of highly respected experts from the Aboriginal and/or Torres Strait Islander health research sector and genomic research community.

https://www.qimrberghofer.edu.au/genetiqs-project

Mr Greg Pratt (Chair)Manager

Aboriginal and Torres Strait Islander Health ResearchQIMR Berghofer Medical Research Institute

Prof Roxanne BainbridgeDirectorCentre for Indigenous Health Equity ResearchCQ University

Dr Nic WaddellGroup LeaderMedical GenomicsQIMR Berghofer Medical Research Institute

Prof Emma KowalPrinciple Research FellowInstitute for Citizenship and GlobalisationDeakin University

Ms Raelene WardSenior LecturerSchool of Nursing and MidwiferyUniversity of Southern Queensland

Prof Adrian MillerPro-Vice ChancellorIndigenous EngagementCQ University

Dr Felicia WatkinsTheme LeaderIndigenous Futures - The Cairns InstituteJames Cook University

Dr Sean TaylorExecutive DirectorAboriginal and Torres Strait Islander Health PractitionersTop End Health Services

Dr Daniel WilliamsManager (Performance)Aboriginal and Torres Strait Islander Health BranchQueensland Health

Dr Maree ToombsDirectorIndigenous HealthFaculty of MedicineThe University of Queensland

Ms Angela YoungGeneral ManagerPolicy & ResearchQueensland Aboriginal and Islander Health Council

Mr Paul Stephenson, Chief Executive OfficerApunipima Cape York Council

Prof Yvonne Cadet-JamesIndigenous Education & Research CentreJames Cook University

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APPENDIX 2: OTHER RESOURCESSources of information

The following list serves as a starting point for researchers looking to explore diseases and health conditions of significance for Aboriginal and/or Torres Strait Islander peoples. Sources of health data that are relevant to Queensland:

Australian Bureau of Statistics (ABS)http://abs.gov.au/Aboriginal-and-Torres-Strait-Islander-Peoples or http://abs.gov.au/census

Queensland Government Statistician’s Office (QGSO) http://www.qgso.qld.gov.au/

Queensland Health’s Aboriginal and Torres Strait Islander Health Branch – Burden of Diseases Reports https://www.health.qld.gov.au/atsihealth/burden_of_disease

Queensland Primary Health Networks (PHN) – This has web links to the seven PHNs Queensland. On each of the PHN’s website there are relevant documents (i.e. needs assessment reports).http://www.health.gov.au/internet/main/publishing.nsf/content/phn-maps-qld

Australian government’s Aboriginal and Torres Strait Islander Health Evidence and Data Collectionshttp://www.health.gov.au/internet/main/publishing.nsf/Content/PHN-Aboriginal_Data

Queensland Chief Health Officers Report- 2018 https://www.health.qld.gov.au/research-reports/reports/public-health/cho-report/current/full

State Health Resources

Access to health records (Qld) via the Public Health Act (2005)https://www.health.qld.gov.au/hiiro/html/regu/aces_conf_hth_info

How to access data from the Statistical Services Branch for your research projecthttps://www.health.qld.gov.au/hsu/how-to-access-data-from-ssb

The Queensland Hospital Admitted Patient Data Collection (QHAPDC) collects demographic data and clinical information on all admitted patients separated from both public and licensed private hospitals and private day surgeries in Queensland. https://www.health.qld.gov.au/hsu/collections/qhapdc

Cultural Diversity

Families and cultural diversity in Australia: Aboriginal families in Australia https://aifs.gov.au/publications/families-and-cultural-diversity-australia/3-aboriginal-families-australia

Indigenous languages map of Queensland http://www.slq.qld.gov.au/resources/atsi/languages/indigenous-languages-map

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Aboriginal and Torres Strait Islander histories and cultures resources: https://www.qcaa.qld.edu.au/downloads/aust_curric/ac_ccp_atsi_cultures_history.pdf

Indigenous Research Methods

Wilson, S. (2011) What is Indigenous research methodology? Canadian Journal of Native Education, 25:2. 175-179.

Chilisa, B (2012) Indigenous research methodologies. Thousand Oaks. California. Wilson, S. (2008) Research is Ceremony: Indigenous Research Methods. Fernwood Publishing Co

Ltd; Point Black. Walter, M., Andersen C. (2013) Indigenous Statistics: A Quantitative Research Methodology. Left

Coast Press Inc.; Walnut Creek. Alison Laycock, A., Walker, D., Harrison, N., Brands, J. (2011) Researching Indigenous Health: A

Practical Guide for Researchers. The Lowitja Institute, Melbourne. https://www.lowitja.org.au/resources-researchers

Research Agreements

Kowal, E., Pearson, G., Rouhani, L., Peacock, C.S., Jamieson, S. E., Blackwell, J.M. (2012) Genetic Research and Aboriginal and Torres Strait Islander Australians. Journal of Bioethical Inquiry, 2012. 9(4): p. 419-32. (Example Memorandum of Understanding)

Aboriginal Health and Medical Research Council of New South Wales Ethics Committee Model Consent Form- Aboriginal Community organisationshttp://www.ahmrc.org.au/ethics.html

Cultural Capability Resources

Cultural capabilities training providers list in Queensland:

https://www.datsip.qld.gov.au/people-communities/cultural-capability/training-providers

Cultural capability training strategy

https://www.datsip.qld.gov.au/resources/datsima/involved/cultural-capability-training-strategy.pdf

RACGP Cultural Awareness and Cultural Safety Traininghttps://www.racgp.org.au/the-racgp/faculties/aboriginal-and-torres-strait-islander-health/education/post-fellowship/cultural-awareness-and-cultural-safety-training

APPENDIX 3: Health Systems in QueenslandThe health system of Queensland extends across the public, private and community-controlled sector (Figure 4). Access to patients and the general public for genomic research may require

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researchers to develop relationships with people or organisations in the public, private and community-controlled health sector.

Queensland Health is responsible for state wide delivery of public health services. The Aboriginal and Islander Community Controlled Health Services (AICCHS) are providers of primary health care services for Aboriginal and/or Torres Strait Islander people. Engagement with the AICCHS is important in developing a research team for work involving Aboriginal and/or Torres Strait Islander Queenslanders. For research that proposes to work with the Hospital and Health Services of Queensland Health, it is recommended that researchers also consult with AICCHS, QAIHC and other community organisations to determine community priorities and ensure that knowledge arising from research is communicated for public/community benefit.

Figure 4: Summary of health service providers in Queensland that are relevant to Aboriginal and Torres Strait Islander people and genomics .

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