![NCIG Logo][1] ---------- # Ethics Protocol 2023 ---------- @[toc](Table of Contents) ---------- ### Contact **[Centre Administrator & Board Secretary][2]** National Centre for Indigenous Genomics John Curtin School of Medical Research Australian National University Acton ACT 2601 E: jcsmr.ncig@anu.edu.au P: 1800 100 912 P: 02 6125 9117 W: ncig.anu.edu.au The [ANU Human Research Ethics Committee][3] has approved the ethical aspects of NCIG's work (**Ethics Protocol # 2015/065**) and the following is the protocol. Participants who have concerns or complaints about how NCIG works are advised to contact: **Ethics Manager** The ANU Human Research Ethics Committee The Australian National University T: +61 2 6125 3427 E: Human.Ethics.Officer@anu.edu.au ---------- ## 1. Project information ### 1a. Plain Language Summary NCIG was initially set up in 2013 to implement recommendations of a committee of eminent Indigenous Australians from outside ANU – the ANU Consultative Committee on the Indigenous Collection (CCIC). The CCIC considered a range of options for ANU’s collection of biological samples that had been obtained from Indigenous Australians for scientific research between the 1960s and early 1990s. It recommended that ANU develop the Indigenous Collection into a national resource. In line with the committee’s wishes, NCIG now plays an important role in creating and managing an internationally important resource “for high quality research with substantial beneficial outcomes for the Indigenous people of Australia” and “a model for the conduct of genetic research with Indigenous populations both in Australia and elsewhere in the world”. NCIG was formally established by the *[National Centre for Indigenous Genomics Statute, 2016][4]*, (now replaced by the 2021 statute). The federal statute provides the legal foundation for ANU's management of the [NCIG Collection][5]. Under the Statute, the [ANU Council][6] gives custodianship of the Collection to an [Indigenous-majority Board][7]. The Board makes policies for the management of the Collection. NCIG develops and manages a collection of Indigenous biospecimens, genomic data, and documents/records (the NCIG Collection) to be used by researchers and doctors for the benefit of the people who have donated samples to the Collection, their communities and descendants, the broader Indigenous community, and the general Australian community. Through this statute, and in recognition of the Collection’s immense cultural, historical and scientific importance, ANU commits to ensuring: 1. that the Collection is held and added to under appropriate Indigenous custodianship. 2. that there is proper engagement with Indigenous people and communities from which the samples and records were collected about any use of the Collection for research. 3. that appropriate consents are obtained for any research using material in the Collection. The ANU Council’s purpose in making the Statute is to establish an appropriate framework to ensure Indigenous governance of, and the application of best practice for, the conduct of any research using material held in the Collection. ---------- ### 1b. Location of Data Collection: Australia Data is collected mainly from Indigenous Australians in communities in Western Australia, the Northern Territory and Queensland. Data may be collected from Indigenous Australians in other jurisdictions. Data is maintained on secure servers in Australia. --------- ### 1c. Aims of the project **What are the aims and hypothese of this research?** NCIG's mission is to work with Indigenous communities under Indigenous governance to create an enduring reference resource of genomic information that will improve the individual and population health of Aboriginal and Torres Strait Islander Peoples. NCIG undertakes research as part of the Centre's internal operations (referred to as NCIG Research), which has the primary objective of improving NCIG's ability to fulfil its functions described in the Statute, as determined by the Board. This is described in the [NCIG 5-year strategic plan][8]. **NCIG research aims to** - improve the Centre’s community engagement process; - improve the quality, utility and potential benefits of material in the NCIG Collection including biological material, genomic data, and historical and contemporary records; - improve systems and processes for managing material in the Collection; - address legal, regulatory, governance, policy and/or ethical aspects of NCIG operations; - address social, political and/or cultural aspects of NCIG operations. Current NCIG Research projects are listed [here][9]. Research that fits beyond this scope is referred to as **External research.** **The NCIG Collection** The NCIG Collection consists of: 1. Biological samples collected from Indigenous Australians 2. Genomic and related data associated with these samples 3. Documents and Records associated with these samples and participating communities 4. Social Science and Humanities Research data (e.g. audio-visual materials, interviews, survey results) NCIG continues to develop a comprehensive library of standard operating procedures (SOPs) and protocols and maintains extensive operational records and audit logs in the following areas: - Administration - Biorepository management - Community engagement - Genomic and related data generation and management - Ethical oversight - Records and document management - NCIG research **Methodology** NCIG research projects is multi-disciplinary involving molecular biology, genomics, data science and social science and humanities. The methodologies used for NCIG Research are detailed in descriptions of each [current NCIG Research project][10]. Auditable, version-controlled lab books are maintained for each project, ensuring that the implementation of methods is transparent. NCIG also undertakes software and other development projects that relate to community engagement and to the management and improvement of the Collection. Methodologies used are similarly detailed in descriptions of current projects. **Participants** NCIG is specifically focused on working with Aboriginal and Torres Strait Islander Peoples. Participants are adults. They include people in the following categories: - Healthy members of the community - Members of specific community groups - Members of socially disadvantaged groups - People whose primary language is other than English - Aboriginal and Torres Strait Islander peoples - Donors of human tissue samples - People highly dependent on medical care who may be unable to give consent Potential participants are identified in one of the following ways: 1. The person has previously provided a sample that is in the NCIG Collection. 2. The person has expressed an interest in participating in NCIG. 3. The person has previously provided a sample to another project and has expressed an interest in having that sample and/or data derived from the sample included in the NCIG Collection. 4. The person intends to provide a sample to another project and has expressed an interest in having that sample and/or data derived from the sample included in the NCIG Collection. NCIG has obtained consents from 691 participants from four communities between 2015 and 2023. The exact number of participants will depend on the number of people providing consent and the availability of funds. **Language and Literacy** Research is conducted in English. Some participants do not have a good understanding of English, and some participants have low literacy levels. To ensure that consent is informed, NCIG: - Uses official translation services where these are available. Translators are required to sign confidentiality agreements. - Works with local community organisations to ensure that well informed local community members are able to act as translators and who can answer questions about the project. - Communicates information about the main aspects of the project to potential participants using video animation in addition to providing them with the Information Sheet and answering their questions and addressing their concerns, using translators when necessary. NCIG will translate the information sheet and consent form into local languages when necessary and as funding permits. ---------- ### 1d. Background Review In recent years many large international genome projects, sometimes involving hundreds of thousands of participants, have focused on diseases such as diabetes, schizophrenia, Alzheimer’s disease and cancer. Other large genome studies aim to characterise the nature of genome variation in general populations or in specific population groups in different parts of the world. Most current large genome studies focus mostly on people of European ancestry. Inequity in genomic research, which has arisen for historical reasons, is being addressed through large projects involving some indigenous communities including [The International Genome Sample Resource][11]; [H3 Africa][12], [the Carlos Slim genomics initiative in the Americas][13], [The Saudi Human Genome Project][14]. The principle aim of these projects is to establish reference resources of genomics data to support research and development and clinical practice. They represent the vanguard of a significant shift towards large-scale data-driven genomic approaches to medical research and practice. Indigenous people have the poorest health of any group within Australian society. Despite its potential to contribute to ‘Closing the Gap’ between the health of Indigenous and non-Indigenous Australians, genomic research involving Indigenous Australians has been, to date, extremely limited. However, this is rapidly changing. NCIG, under the leadership and guidance of Indigenous-majority governance board, is building the required reference resources for Indigenous genomics, representing the rich genetic diversity of Indigenous Australians. Reference genomes are essential for accurate analyses and interpretation for the effective use of genomics and Indigenous healthcare benefits. Diversity representative reference genomes are essential because (a) they provide the coordinate system to anchor information about the function, clinical significance, and population variation, and (b) as substrate to align sequence reads. In addition, NCIG is also building a large database of genetic variant profiles for Indigenous Australians. These projects are needed because health and disease are affected by subtle differences in the genomic makeup of different human populations across differing geographical locations. These focused NCIG resources provide a reference against which disease associated genomic variation can be compared and understood in local populations and in populations of mixed ancestry. There are two major initiatives in Australia; CONNECT and [ALIGN][15], which are coordinating efforts for genomics driven healthcare implementation for Indigenous Australians. CONNECT is an NHMRC funded Synergy Grant program titled “Respecting the Gift: Empowering Indigenous communities in genomic medicine” (2021-2026). ALIGN is MRFF funded initiative titled “Pathways to benefit for Indigenous Australians in genomic medicine” (2021-2027). Both these projects involve multi-disciplinary collaborations spanning social science and humanities research, genomics and healthcare research, policy and implementation science. To ensure priorities of Indigenous Australians firmly woven into the genomics revolution, NCIG conducts social science and humanities research to understand the historical context and events leading to the formation of NCIG. It seeks to comprehend both the potential and realized positive and negative outcomes of its research and operations. This understanding will serve as a foundation for continuous reflection and enhancement in NCIG's operational strategies. Beyond the internal mechanics, the research will also explore the wider societal and cultural ramifications of NCIG's activities. Furthermore, one of the key objectives is to document and analyse the insights garnered from NCIG's journey, with a view to sharing these lessons with other Indigenous genomic initiatives, both within Australia and on an international scale. **What NCIG plans to achieve** NCIG provides a framework for appropriate and respectful Indigenous engagement in genome research in Australia directly or indirectly through nationally collaborative partnerships. It contributes to global efforts to extend opportunities for Indigenous people to participate in genome research without risking (or mitigating the risk) social or cultural harm and to ensure that Indigenous people share in the benefits that may arise from the research. Benefits from research supported by NCIG are long-term and may not make immediate contributions to Indigenous health priorities identified by the [Close the Gap Campaign][16] or the [Council of Australian Governments' National Partnership Agreement on Closing the Gap in Indigenous Health Outcomes][17]. We contend that the principles and practices established by NCIG will serve as best-practice guidelines for funding agencies, governments, and other researchers. NCIG uses genomics and bioinformatics facilities that form part of the [National Collaborative Research Infrastructure][18]. While benefiting from these facilities, NCIG also ensures that national research infrastructure is strengthened by the resources and expertise developed to support its activities. NCIG’s outreach programs helps address the concerns about Indigenous participation in science education identified in the [Report of the Review of Higher Education Access and Outcomes for Aboriginal and Torres Strait Islander Peoples][19]. NCIG can significantly add to existing academic enrichment programs that support Indigenous post-graduates, undergraduates and high school students interested in the sciences. **Ethical oversight of NCIG's operations** Ethical oversight of NCIG's operations presents a number of particular challenges. Some of these are shared with other large biomedical data projects. Others are specific to the purpose of the Centre. *NCIG has an indefinite life span*, similar to many other large data-centric projects. This has a number of consequences that present challenges to reporting and monitoring through standard HREC processes. There is no expected end date to the project. The Centre anticipates that its role and operations may change over time in response to community wishes and expectations, new technologies, changes in legislation and the regulatory environment and the sheer pace of scientific progress. NCIG's approach to ensuring high ethical standards recognises the need for flexibility. An approach has been taken that adds following two key elements to the standard HREC approval process. 1. A number of key features are built into the fabric of the NCIG organisation, which in combination ensure that high ethical standards are maintained over time in the face of change. 2. The NCIG Board's involvement ensures a capacity to innovate, to develop new standards of ethical practice that go beyond current compliance requirements, and to improve processes over time in light of operating experience and in response to community expectations. **ANU HREC approval is required for this protocol and for variation to this protocol.** Institutional features that ensure high ethical standards NCIG, as an organisation, has attributes that combine to ensure the highest ethical standards in all the Centre’s operations. The specific implementation of these principles are detailed in the protocol below. **Good governance** The National Centre for Indigenous Genomics Statute 2021, which has the force of federal law, establishes the foundation of strong Indigenous governance and a legal framework for the ethical conduct of NCIG’s operations. **Close community engagement** NCIG has developed and maintains close and enduring relationships with the Indigenous communities with which it works. **Adherence to strong principles** The NCIG Board has established and oversees the implementation of a set of core principles that govern the conduct of the Centre’s work. **Rigorous planning and reporting** NCIG has a 5-year strategic plan, and statutory requirements to provide an annual operational plan to the ANU Vice Chancellor and an Annual Report to the ANU Council. **High levels of transparency and accountability** NCIG uses international best standards for management and practice, including careful documentation and record keeping. **Application of sound policies and procedures** The NCIG Board has set policies for engagement with communities and management of the Collection that are implemented through well documented procedures. **Implementation of internationally recognised technical and operational standards** NCIG develops or implements international best practice standards to all areas of operation, as detailed in its library of manuals and standard operating procedures. **Research excellence** NCIG is committed to the highest standards of research excellence, backed by sound research planning, careful record keeping, and open, transparent and reproducible research practices. ---------- ### 1e. Methodology **Plain language summary of the methodological approach and minimisation of risk.** The subsidiary documents of the NCIG Governance Framework describe the methods used for community engagement, sample collection, sample storage and maintenance, laboratory analysis, data management, document archive management: - NCIG Community Engagement Protocol - NCIG Sample Collection Protocol - NCIG Biorepository Policy and Manual - NCIG Collection Policy and Manual - NCIG Data Management Policy - NCIG Data Coordination Centre Policy - NCIG Document Archive Policy and Manual ----- P**rovide the survey method, a list of the questions to be asked or an indicative sample of questions. These should give a good sense of the most intrusive/sensitive areas of questioning.** N/A ---------- ### 1f. Participants **Provide details in relation to the potential participant pool, including: - target participant group; - identification of potential participants; - initial contact method, and - recruitment method** NCIG is specifically focused on working with Aboriginal and Torres Strait Islander Peoples. Participants are adults. They include people in the following categories: - Healthy members of the community - Members of specific community groups - Members of socially disadvantaged groups - People whose primary language is other than English - Aboriginal and Torres Strait Islander peoples - Donors of human tissue samples - People highly dependent on medical care who may be unable to give consent Potential participants are identified in one of the following ways - The person has previously provided a sample that is in the NCIG Collection. - The person has expressed an interest in participating in NCIG. - The person has previously provided a sample to another project and has expressed an interest in having that sample and/or data derived from the sample included in the NCIG Collection. - The person intends to provide a sample to another project and has expressed an interest in having that sample and/or data derived from the sample included in the NCIG Collection. **Proposed number of participants** 5000 **Provide details as to why these participants have been chosen?** The participants have been chosen either because there are samples obtained from them or one of their family members in the NCIG Collection or because they have indicated an interest in joining the NCIG Project. ---------- ### 1g. Cultural and Social Considerations/Sensitivities **What cultural and/or social considerations/sensitivities are relevant to the participants in this research project?** There is a need for Indigenous Australians’ participation in genomics research leading to improved health outcomes for all. Despite the pressing need and potential of genomic research to bridge the health disparity between Indigenous and non-Indigenous Australians, such research initiatives remain scant. There is a growing recognition to in Australia for equitable and inclusive genomics research that involves Indigenous Australians. Historically, Indigenous communities have faced oppressive ideologies rooted in scientifically misguided theories of racial inferiority based on genetics. For example, the Human Genome Diversity Project further exacerbated this mistrust. Aimed at cataloguing genetic diversity among the world's Indigenous populations, the project's lack of thorough consultation and meaningful community engagement led to broad concerns. As a result, the Human Genome Diversity Project failed, leaving behind a legacy of scepticism. Indigenous communities have consistently advocated for research initiatives that respect their cultural values and involve them as equal partners. Without these considerations, there is a real concern that such research might not yield meaningful health benefits for them and, in some cases, might even be detrimental. Furthermore, the exclusion of Indigenous Australians from emergent research areas, such as genomics, can prevent them from accessing the potential benefits of cutting-edge health care developments. The current trajectory of human genome research predominantly centres on individuals of European descent. Consequently, the ensuing benefits largely cater to this demographic. Efforts are underway internationally to rectify this imbalance, with significant projects focusing on Indigenous communities in Africa, the Americas, and beyond. To ensure the equitable inclusion of Indigenous Australians in genomic research and its benefits, a national framework is imperative. This framework, under the governance of Indigenous leaders, should prioritize the protection and respect of Indigenous cultures, ensuring their participation without exposing them to potential social or cultural harm. NCIG is collaborating nationally to ensure appropriate inclusion of Indigenous Australians in genomics research. ---------- ### 1h. Incentives **Will participants be paid or any incentives offered? If so, provide justification and details.** Participants will not be paid. The only incentive that will be offered is the opportunity to participate in the Project and contribute to the benefits it delivers. ---------- ### 1i. Benefits **What are the anticipated direct benefits of the research?** The principle benefit from NCIG Research is to maximise the value of its Collection as a resource for research to benefit Aboriginal people. Immediate benefits arising from NCIG research align with NHMRC Indigenous research excellence criteria. **Community engagement** NCIG's Community Engagement Program is central to the Centre's operations. The Program is conducted as described in the [Community Outreach Manual.][20] * NCIG employs a full-time Indigenous Community Engagement Coordinator who leads a team of NCIG staff and actively engages with across Australia * NCIG’s commitment to long-term, ethical engagement with individuals, families and communities ensures: * Community participation in NCIG Operations, including local employment of staff, where possible * A collaborative and equitable approach to research based on shared values * Local relationships that ensure an ongoing shared understanding of NCIG Operations and of how they affect and are affected by local cultural practices and circumstances * Respect for participant and community requirements, wishes and preferences for how engagement with NCIG is conducted, including culturally right ways of decision-making. * NCIG actively seeks to employ Indigenous Australians whenever appropriate, to develop relationships with Indigenous people, and to work with Indigenous organisations at national, regional and local levels. **A high level of Indigenous involvement ensures:** - Knowledge and awareness of the cultures and values of Aboriginal and Torres Strait Islander peoples. * Respect for the principles and values of Aboriginal and Torres Strait Islander cultures. * The knowledge, understanding and expertise needed to maintain long-term ethical relationships with Participants and Indigenous communities. * Indigenous input into the design and conduct of NCIG operations. - Culturally appropriate conduct of NCIG operations. * Outcomes that are valued by Indigenous peoples and that have benefits that are in line with their priorities. * Placing research participants at the centre of medical research in which they are involved – so-called ‘participant-centric research’ – is emerging as a requirement for success in major global research initiatives around the world. In this context, the benefits of NCIG’s ability to achieve long-term continuous engagement with participants and communities extends beyond the Indigenous communities where it is being developed. This is just one important way in which Indigenous research can provide a model for the conduct of research in the broader community. **Sustainability and transferability** * NCIG has established a governance structure and operational model that ensure the persistence of the resources that it creates. * NCIG extends the reach of investigators working in many fields relevant to Indigenous health, enabling them to better incorporate genomic research in their work, thereby enhancing its significance and potential. * NCIG also provides a model of community engagement that may be extendable to other areas of advanced biomedical research, thereby expanding the range of research in which Indigenous Australians can participate and benefit from without risking social or cultural harm. **Building capability** NCIG builds capability in three ways. * NCIG's Outreach Program facilitates co-creation of resources and knowledge about genomic research with Indigenous students and community members. * NCIG's model of continuous engagement provides a means of ongoing engagement between researchers and participants, enabling reciprocal exchange of knowledge and information. * NCIG employs local people as research assistants and to play other roles, who gain an enduring understanding of this field of research as well as experience and expertise that they can pass on to other community members and broaden future employment prospects. * Research translation activities including the development of health promotion approaches that better empower Indigenous Australians to make decisions about engaging in genomics in health and medical research, in health care and in medical practice. * Providing advice on making new knowledge available to Aboriginal people in a culturally safe and meaningful way. Managing and developing health and medical research evidence, including linking with international Indigenous health research. ------- **Potential benefits from External Research Projects** External Research Projects are approved if they meet the criteria established by the NCIG Board. In deciding whether to approve projects, The NCIG Board take advice from the Collection Access and Research Advisory Committee (CARAC). Potential benefits from External research projects include: **1. Health and medical benefits** * NCIG provides reference data about genome variation in Indigenous populations to enable variation associated with health and disease to be appropriately interpreted. * Genomic variation is very similar in most human populations, but there can be important differences, particularly of rare genetic variants. Genes that contribute to specific diseases may differ between populations, sometimes because of exposure to different environmental factors over time. In some genes there are many different rare mutations that make similar contributions to disease with each of the mutations confined to related individuals in specific regions. * The role of genome function and variation in health and disease in Indigenous Australians cannot be understood solely from studies of European populations. Knowledge of genome variation in Indigenous populations is needed. NCIG’s principal objective is to enable that knowledge to be created through the creation of its reference database and through the research that this resource enables. * Researchers will be able to ensure that associations they find between genome variation and disease are due to the disease and are not instead a result of the varying ancestries within the study population. * Indigenous participants and communities may decide that the genomic data in the NCIG Collection is used to: provide information to assist with medical diagnosis and to guide treatment of disease; identify people who are carriers of genetic disorders, or who are at elevated or reduced risk of disease. They may decide that data is used for research aimed at new discoveries about how genetic variation causes or protects against disease and causes people to respond differently to drugs and other forms of therapy. * Research using the NCIG Collection could lead to new discoveries about the way genetic differences between people’s genomes influence how their life history and environment affect their health and cause changes to the structure of their genomes that modify how their genomes function in a way that may affect their health and wellbeing. * Research could also lead to the development of diagnostic, prognostic and predictive medical tests; new strategies for assessing disease risk; new interventions that prevent or reduce the risk of disease; new drugs and other therapies that can be used to treat or cure disease; new approaches and specific devices for monitoring health, and monitoring the effectiveness of preventative and therapeutic health interventions. * In communities where NCIG has commenced engagement activities, family members of original donors and other community members have expressed interest in donating new samples to the NCIG Collection. In this way, the size of the NCIG Collection may be extended to include up to five generations of individual families. * If participants, their families and other community members wish to participate in research that links genomic information to health and medical records, the scope of research aimed at understanding the causes of disease will be further extended. **2. Returning ancestral human remains to country and to family** * Many of the ancestral remains of Indigenous Australians still held in museums, hospitals and other institutions both in Australia and elsewhere cannot be appropriately repatriated because information about their provenance is lacking. * Indigenous communities may wish to use the NCIG Collection to help identify the location and even the family of origin of ancestral human remains that have been removed from Aboriginal and Torres Strait Islander communities, particularly in cases where the origins, or provenance, of the remains cannot otherwise be accurately determined. * Genome data in the NCIG Collection could provide a source of reference data against which genome sequence data from ancestral remains could be compared. By matching genome sequences from specific human remains with those in the different communities represented in the database, it may be possible to identify the geographical origin of the remains. In some cases, where the database is sufficiently complete, it may even be possible to identify living descendants of the people whose remains are being repatriated. In this way the NCIG Collection could help to ensure that ancestral human remains are repatriated to the country where they belong. **3. A richer understanding of Australia’s deep history** * Indigenous communities may wish for material in the NCIG Collection to be used for research aimed at understanding the deep historical connections among Aboriginal peoples from different parts of Australia and between Aboriginal and Torres Strait Islander peoples, complementing traditional knowledge and archeological evidence. * Research could help to reveal the great diversity of peoples who are Indigenous to Australia, complementing traditional knowledge and reflecting the diversity of languages revealed by linguistic research. In this way the NCIG Collection would complement traditional beliefs with new ways of understanding the long history of Australia’s people. * Research could complement traditional knowledge and beliefs about the deep historical connections between Aboriginal and Torres Strait Islander people and people in nearby places like Papua New Guinea and Indonesia and people from other parts of the world. * In these ways, NCIG’s Collection may contribute to a much richer understanding of the richness, depth and dynamic nature of Australia’s long human past. -------- **To whom will the benefits flow?** Benefits will flow to participants, their families, the broader Indigenous community, the broader Australian community and potentially to people receiving health care throughout the world. ------ ### 1j. Potential Risks **Indicate if you consider there are any potential risks associated with the proposed procedures, whether to participants or to researchers. Tick the appropriate risk categories.** Negligible harm - **````Possibly [ ] ````** **````No [x ] ````** Physical harm - **````Possibly [x] ````** **````No [ ] ````** Psychological harm - **````Possibly [x] ````** **````No [ ] ````** Devaluation of personal worth - **````Possibly [x] ````** **````No [ ] ````** Social harm - **````Possibly [x] ````** **````No [ ] ````** Economic harm - **````Possibly [ ] ````** **````No [x ] ````** Legal harm - **````Possibly [x] ````** **````No [ ] ````** Other - **````Possibly [x] ````** **````No [ ] ````** ------- **Provide details of the risks associated with the research.** **1. Physical harm potential risks:** There is no physical risk to providing a saliva sample. There is a small risk of bruising, infection or fainting if participants choose to provide a blood sample. **2. Psychological and social harm potential risks:** Documents and data in the NCIG Collection may reveal sensitive information that may cause participants to feel distress, guilt, anger or embarrassment. Documents and data may reveal information that could cause damage to participants’ social networks or relationships, or that could result in discrimination, social stigmatization, or could reveal previously unknown paternity or other family relationships. Data may also cause psychological harm if they indicate that participants have an untreatable genetic disease. **3. Devaluation of personal worth potential risks:** Research results could be used to support negative views about Aboriginal and Torres Strait Islander peoples. **4. Legal harm potential risks:** NCIG may be required by law to disclose information in the Collection that may be used in evidence against a participant in a court case. For example, police may seek to obtain genetic information from the DNA of a participant to determine whether it matches DNA from a crime scene. ------ **To whom do the risks apply?** Other than the risks to NCIG staff, risks apply to participants and their families and the broader Indigenous communities. ------ **What, if any, strategies will be used to negate, minimise and manage these risks?** **1. Physical harm risk management** Blood is collected by qualified and experienced staff. **2. Psychological and social harm risk management** NCIG only provides information to participants if they initially indicate that they wish to receive it. NCIG ensures that participants who request information are informed about the risk of social harm before the information is released to them. NCIG works with communities to establish appropriate ways to communicate personal and sensitive information and follow the advice it receives. NCIG provides advice and support to participants who request it and ensures that they have access to ongoing local advice and support. For participants who consent to receive medically relevant information, NCIG will provide information about genetic disorders through a doctor. Incidental findings will be assessed by an expert panel before being passed on to a doctor. The doctor will be responsible for deciding how to use the information and provide care to the patient, including clinical genetic tests. **3. Devaluation of personal worth risk management** Indigenous people have a say in the way that research results are described when they are published. Indigenous people are involved in preparing plain language reports to accompany the publication of research findings. NCIG actively counters media reports or public discussions about published research that portray Indigenous people in a negative way. **4. Legal harm risk management** This risk is small because NCIG does not disclose the identities of participants and because it is difficult to conceive of a circumstance in which such information would be sought when it could not be lawfully obtained directly from a participant. NCIG only provides information of this kind when legally required to do so and after it has explored all available legal options to prevent the information from being released. ------ **Management of risks to NCIG staff** NCIG staff incur risks in travelling to visit communities, which are detailed in the Community Outreach Manual, which also details the approach to risk management. NCIG staff travelling to communities report to a base control officer at regular intervals following a set protocol. These reports are logged and incidents are recorded. Risks incurred by NCIG staff in using laboratory and other facilities in the JCSMR building and processes for managing these risks are detailed in the ANU Work Health and Safety Management Arrangements. ------- **Justification. Indicate how the benefits of the research justify the risks.** The Project is ethically justified because its substantial potential benefits greatly outweigh its relatively minor risks, for which management strategies are in place, as indicated above. ------ ### 1k. Informed Consent **Indicate how informed consent will be obtained from participants. At least one of the following boxes MUST be ticked 'Yes'.** In writing - **````Yes [x] ````** **````No [ ] ````** Return of survey or questionnaire - **````Yes [x] ````** **````No [ ] ````** Orally - **````Yes [ ] ````** **````No [x] ````** Other - **````Yes [ ] ````** **````No [x] ````** ------ **If Oral Consent or Other, provide details.** N/A ------ **Will consent be obtained on behalf of a participant with impaired capacity? If so, advise from whom consent is being sought.** Informed consent is be obtained in writing from participants, using the [Participant Consent Form][21]. NCIG's approach to consent is embedded within the broader community engagement program. It is not treated as a transactional process in isolation. Consent is only sought following extensive community consultation and dialogue with all relevant stakeholders in a community. In addition to participants and their families, this may include community Elders, Traditional Owners, Councils, Health Organisations and Prescribed Bodies Corporate. Consent usually follows several visits to community and sometimes visits by community representatives to NCIG. The initial discussion with communities is about how the community would like NCIG to talk to the community. NCIG's approach is to follow guidance from the community about how to approach and inform people about NCIG's work and their potential to participate. Information is provided through the [Participant Information Sheet][22], [a video animation][23], and lengthy discussion within communities. When participants initially indicate that they wish to participate, they are advised to take time to think further about their decision and to discuss it with their families. ------ **Who can give consent?** Discussions about consent are conducted according to local practice and community protocols. Each community has a different approach, and NCIG is guided by local protocols and the wishes of the community. If the donors of samples already in the NCIG Collection are unable to provide consent due to death or incapacity, or because they cannot be located, NCIG consults with their families and community leaders about the proper community protocol. A community may decide that a surviving descendant relative should make the decision about consent. It may decide that the decision should be made by the head of the family or clan group. Alternatively, it may decide that community elders should make the decision. NCIG follows the protocol specified by the community. NCIG only seeks consent if there is general agreement in the community about the approach to be taken. ------ **Ongoing participant engagement** NCIG continues to visit communities even after all required consents have been obtained to report back progress and findings. Ongoing visits enable participants to tell NCIG if they have changed their mind about consent. Ongoing visits also enable NCIG to discuss what should happen to a participant's sample or data if they have passed away. NCIG follows local community protocols in conducting these discussions. **Will consent be obtained from other interested parties? If so, describe why this is to be done and outline the process to obtain this consent.** As above. ----- ### 1l. Confidentiality For the collection of information, please tick the appropriate categories. At least one of the following boxes MUST be ticked 'Yes'. ------ **In what form will personal information be collected?** Identified information - **````Yes [x] ````** **````No [ ] ````** Re-identifiable / coded information - **````Yes [x] ````** **````No [ ] ````** Non-identifiable - **````Yes [x] ````** **````No [ ] ````** ------- **In what form will personal information be stored?** Identified information - **````Yes [x] ````** **````No [ ] ````** Re-identifiable / coded information - **````Yes [x] ````** **````No [ ] ````** Non-identifiable -**````Yes [x] ````** **````No [ ] ````** ------ **In what form will personal information be stored?** Identified information - **````Yes [] ````** **````No [X] ````** Re-identifiable / coded information -**````Yes [ ] ````** **````No [x] ````** Non-identifiable - **````Yes [x] ````** **````No [ ] ````** ----- **Describe the procedures that will be adopted to ensure confidentiality during the collection phase and in the publication of results.** Personal information that is collected during the project may be: identified; re-identifiable/coded; or non-identifiable. It is stored in all these forms. Recordings of participants are made. Recordings are retained and used beyond the initial transcription/analysis. Personal information is only be published in non-identified form. Measures to preserve confidentiality are described in the Record/Document Management and Data Management Manuals. ----- **If participants are to be identifiable, or potentially identifiable in any publication or report, outline the procedures for participants to authorise the release of their responses / information and to confirm the accuracy of attributed comments.** N/A ----- **Will a recording of participants be made?** **````Yes [X] ````** **````No [ ] ````** ---- **If yes, for what purpose will this recording be used? - Will this be retained and used beyond the initial transcription / analysis or will it be erased following transcription? - How will confidentiality be ensured? - How will specific consent for any subsequent use be obtained?** Recordings of participants will be made. Recordings will be retained and used beyond the initial transcription/analysis. Personal information will only be published in non-identified form. The measures that will be taken to preserve confidentiality are described in the attached NCIG Governance Framework and subsidiary documents. Access to information in the NCIG Collection will be restricted as described in the attached NCIG Collection Policy. ---------- ### 1m. Data Storage Procedures **Provide an overview of the data storage procedures for the research. Include security measures and duration of storage.** * storage procedures, including measures to ensure confidentiality, integrity, privacy, security and protection are described in the Data Management Manual * Data is stored indefinitely. * NCIG’s processes relating to confidentiality, integrity, privacy, security and protection are reviewed on a regular basis to ensure compliance with national and international laws, policies, guidelines and best practice standards. **Location of Data Collection** * Data is collected mainly from Indigenous Australians in communities in Western Australia, the Northern Territory and Queensland. * Data may, in future, be collected from Indigenous Australians in other jurisdictions. * Data is maintained on secure servers in Australia. ----- ### 1n. Debriefing **Will participants be debriefed at the completion of the research? Provide details and include agencies to whom participants may be referred if they have been distressed by the procedures.** * Participants can become distressed when discussing the project if they have unfortunate memories of the time when samples were collected or when they discover that there are samples in the NCIG Collection obtained from relatives or important community members, who have passed away. As detailed in the [Community Engagement Manual][24]: * NCIG staff provide support and advice when participants become distressed during community visits * When working in communities, NCIG staff liaise with local health and other organisations, who can provide additional support and counselling if required * NCIG staff debrief on return from community visits following a set protocol detailed in the Field Trip Base Control protocols. ### 1o. Feedback **Provide details of how the results of the research will be reported / disseminated, including the appropriate provision of results to participants. If appropriate, provide details of any planned debriefing of participants.** On written request, NCIG may provide material to participants who are directly associated with the material, with the exception of information that has implications for their health or healthcare. As part of the consent process, participants will be asked if they wish clinically relevant incidental findings to be reported. Incidental findings will be assessed by an expert panel comprising scientific and clinical experts, who will advise the Board which results are clinically relevant, taking into account evolving evidence from the literature and guidance from national and international clinical genomics bodies. Findings that meet this threshold will be communicated to a doctor, who will decide if further tests are required or if the clinical genetic tests are required. Where appropriate, the participant will be linked to relevant support services. As part of NCIG’s commitment to the highest ethical standards, this process will be monitored and continually evaluated in collaboration with participating communities to ensure we continue to meet the needs of communities and individual participants. When the results relate to genetic diseases, NCIG informs the relevant clinical genetics service. The Board will be notified when this occurs. ----- **Has this work been approved by another Human Research Ethics Committee (HREC)?** **````Yes [] ````** **````No [X] ````** ---- ### 1p. Funding **Is this research supported by external funding?** **````Yes [X] ````** **````No [ ] ````** **Provide the name/s of the external sources of funding. Please include grant number/s if available** Canberra Medical Society. $33,000; 2014 NHMRC Equipment Grant. $32,000; 2014 Bioplatforms Australia. $500,000; 2014 - 2023 Bioplatforms Australia. $30,000; 2014 Australian National Data Service. $200,000; 2014 - 2015 NHMRC Synergy Grant 2021, APP2011277; $5,000,000; 2022 - 2026 NHMRC Ideas Grant 2021; APP2012971; $453,680; 2021 - 2023 Genomics Health Futures Mission; APP2015531; $4,999,987; 2022-2026 Genomics Health Futures Mission; APP2015969; $9,996,894; 2022-2027 Genomics Health Futures Mission; APP2016008; $986,060; 2022-2024 NHMRC Ideas Grant; APP2016149; $975,502; 2022 - 2024 NHMRC Ideas Grant; APP2021172; $2,549,487; 2022 - 2024 **Is the research conducted under the terms of a contract of consultancy agreement between the ANU and the funding source?** **````Yes [X] ````** **````No [ ] ````** **Describe all the contractual rights of the funding source that relate to the ethical consideration of the research.** NCIG is supported by funds from institutional, government and philanthropic sources ANU has made a substantial strategic financial investment in NCIG ANU, through NCIG, does not currently generate revenue through the provision of services or the sale of goods, or the licensing or sale of intellectual property Commercial gain from research undertaken on the NCIG Collection is possible but unlikely at this stage. Profits generated in this way will be shared with participating Indigenous communities (see below) NCIG obtains advice and support, pro bono, from outside agencies. NCIG, through the ANU, agrees to terms in contracts or agreements with external agencies only when these are consistent with ANU Policies and with the NCIG Statute and Policy Framework. A list of NCIG Funding Sources can be found [here][25]. **Use of funds** Funds received by NCIG are used to: - pay for the direct costs and expenses of NCIG’s operations - acquire physical assets, such as laboratory equipment, required to conduct NCIG operations. - pay the indirect costs that ANU incurs in supporting and administering NCIG’s operations, as determined by ANU Policy. **Financial reporting** - Under 20(2)(a) of The Statute the NCIG Board must include in its annual Operational Plans submitted to the ANU Vice Chancellor, the projected revenue and expenses for the Centre and the Board for at least the plan year. - The Director provides quarterly statements on revenue and expenditure to the NCIG Board, which are included in Board minutes - The Board provides annual statements of revenues and expenditure as part of the annual reports it provides to the ANU Vice Chancellor for presentation to the ANU Council. ----- ## 2. Clinical Trials **Is this a clinical trial?** **````Yes [ ] ````** **````No [X] ````** ------- ## 3. Aboriginal and/or Torres Strait Islander Peoples **Does this research involve the intentional recruitment or issues involving Aboriginal and / or Torres Strait Islander Peoples?** For research fitting the above description, researchers must consult Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Research (NHMRC 2003) In undertaking research that involves the intentional recruitment of Aboriginal and Torres Strait Islander peoples, or issues of significance to Aboriginal or Torres Strait Islander Peoples, ensure your answers reflect considerations outlined in Chapter 4.7 of the NATIONAL STATEMENT, in particular: - Research Merit & Integrity - Justice - Beneficence - Respect **````Yes [X] ````** **````No [ ] ````** ----- **Cleared by another HREC, listed procedure or renewal application?:** **````Yes [ ] ````** **````No [X] ````** Provide details: N/A **Has there been a broad and extensive process of consultation and negotiation between Aboriginal and Torres Strait Islander peoples and the researcher, regarding the proposed research?** You must provide clear evidence of consultation prior to the committee review of your research protocol as per chapter 4.7 of the National Statement of Ethical Conduct in Human Research. **````Yes [X] ````** **````No [ ] ````** ----- **Describe this process or if there has been NO process of consultation, explain why** Since the project began in 2015, and even before that, community engagement and consultations have been a constant feature and focus of NCIGs work. NCIGs Community engagement processes are long term, consistent and embedded at every stage of the project. Our engagement is informed by community led and appropriate processes. During 2015, in the initial phase of the project, discussions with ethics boards, community organisations and Elders throughout Kimberley, Queensland and Northern Territory communities were held to seek guidance and establish community focused processes for undertaking further engagement. As previously outlined, the NCIG board guides NCIGs work and ensures the capacity to ensure ethical practice that goes beyond current compliance requirements and improves over time and in response to community expectations. Local HREC approval is sought where needed alongside Land Council, community and organisational approval. NCIGs consent process is an extended, respectful, tailored consent processes guided by local research partners. This process can take up to 2 years, and consent is never taken in initial visits. Effectiveness of the community engagement and consultations processes led to [repatriation of samples to Galiwin’ku Community][26]. NCIG reports back to communities about the progress of research, publications and other developments on a regular basis (minimum once a year). Documentation of these processes is contained within our Community Outreach Manual, community reports and our [Annual reports][27]. Demonstrated outcomes of this work include dozens of visits, over 600 consents obtained for participation in the project, and a number of publications (often written collaboratively with representatives for the communities) focusing on the perspectives of the communities with which we work to inform and enhance engagement practices within this area and promote the voices of the community (for examples, [Hermes et al., 2021][28]). NCIGs role in the CONNECT and ALIGN research networks nationally contributes to ensuring a national impact for the work we do and a concerted effort to promote the research priorities of the many Indigenous organisations, Nations and communities involved, and deliver benefit. Long term trusted relationships with organisations such as the Anindilyaka Land Council, Yalu Aboriginal Corporation, KALLAC, the MJD Foundation amidst many others are also testament to NCIGs approach to fostering and maintaining meaningful relationships that ensures effective and appropriate consultation. ----- **Have the benefits of the research been discussed and agreed to by the research stakeholders?** **````Yes [X] ````** **````No [ ] ````** ----- **How do the research outcomes advance the interests of the participants?** **1) Improving health and wellbeing of Indigenous Australians** The science of genomics is at the heart of extraordinary new discoveries and technologies that are transforming medical practice. Genomics enables information about a person’s DNA to be used for diagnosis and treatment of disease. It also allows the effects of environmental and lifestyle factors to be monitored. For this to happen a person’s genome must be examined together with the genomes of many other people. Currently we know a great deal about the genomes of people of European ancestry but much less about the genomes of people from other parts of the world, and almost nothing at all about the genomes of Indigenous Australians. Without this knowledge, Aboriginal and Torres Strait Islander peoples will be excluded from many of the benefits that flow from human genomics research. Rather than helping to close the health gap, these developments in medical science may actually cause it to open up even further.  NCIGs work with Indigenous communities, governance and leadership and participation in National Indigenous Governance initiatives will ensure that as medical science advances, Indigenous Australians are not left behind. It is creating the framework needed to ensure that Indigenous Australians are included, in ways that they decide, in the health, economic, educational and social benefits of advances in genome science. In addition to adhering to the National Statement on Ethical Conduct in Human Research, the Australian Code for the Responsible Conduct of Research, 2018, the research that NCIG enables must, at a minimum, conform to the six values identified in the NHMRCs Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholder’s. The value of NCIGs contribution to Indigenous health can be considered in terms of how well it will uphold these values.  **2) Spirit and Integrity** NCIGs Indigenous leadership and Governance ensure that respect for the cultural inheritance of past, current and future generations is embedded within our processes and interactions with those people and communities represented in the collection. NCIGs Governance Framework sets out the essential role of integrity, trust and respect within the Centres approach. The Centres efforts to embed Indigenous ways of being, doing and knowing into our processes, and essentially, reflect these ways into the management of and research on the collection are testament to the commitment to Spirit and Integrity within the Centre. NCIGs community engagement is guided and led by the Deputy Director and actively engages with a number of specific communities in The Northern Territory, Queensland and Western Australia. NCIGs commitment to long-term, ethical engagement with individuals, families and communities ensures: Community participation in NCIG Operations, including local employment of staff, where possible.  A collaborative and equitable approach to research based on shared values.  Local relationships that ensure an ongoing shared understanding of NCIG Operations and of how they affect and are affected by local cultural practices and circumstances.  Respect for participant and community requirements, wishes and preferences for how engagement with NCIG is conducted, including culturally right ways of decision making.  NCIGs community engagement is reinforced by strong Indigenous governance and leadership NCIG has an Indigenous-majority Governance Board, under the leadership of an Indigenous Chair, who alongside the CARAC Committee advise on the appropriateness of external research projects considering the benefit to Aboriginal and Torres Strait Islander peoples. Indigenous Australians played key roles in the establishment of NCIG and continue to be involved in all phases and levels of NCIGs Operations. NCIG actively seeks to employ Indigenous Australians whenever appropriate, to develop relationships with Indigenous people, and to work with Indigenous organisations at national, regional and local levels. This high level of Indigenous involvement ensures: Knowledge and awareness of the cultures and values of Aboriginal and Torres Strait Islander peoples. Respect for the principles and values of Aboriginal and Torres Strait Islander cultures. The knowledge, understanding and expertise needed to maintain long-term ethical relationships with Participants and Indigenous Communities. Indigenous input into the design and conduct of NCIG Operations. Culturally appropriate conduct of NCIG Operations Outcomes that are valued by Indigenous peoples and that have benefits that are in line with their priorities. **3) Cultural Continuity** As outlined above the ongoing and respectful relationship between the Centre and communities as well as the central role of Indigenous governance and leadership at the Centre, ensures the culturally informed operations of NCIGs work. The extent to which NCIGs research is undertaken using Aboriginal and Torres Strait Islander methodologies is increasing within the Centre. In addition, the Centre has undertaken to return ancestral human remains to Country and family. The Centre respects and actions the requests of families and Communities to repatriate biological samples from the Collection or in some cases, could support the identification and return of remains. **4) Equity** In recent years many large international genome projects, sometimes involving hundreds of thousands of participants, have focused on diseases such as diabetes, schizophrenia, Alzheimer’s disease and cancer. Other large genome studies aim to characterise the nature of genome variation in general populations or in specific population groups in different parts of the world. Most current large genome studies focus mostly on people of European ancestry. Inequity in genomic research, which has arisen for historical reasons, is being addressed through large projects involving some indigenous communities including The International Genome Sample Resource;  H3 Africa, the Carlos Slim genomics initiative in the Americas, The Saudi Human Genome Project. The principle aim of these projects is to establish reference resources of genomics data to support research and development and clinical practice. They represent the vanguard of a significant shift towards large-scale data-driven genomic approaches to medical research and practice.  Indigenous people have the poorest health of any group within Australian society. Despite its potential to contribute to ‘Closing the Gap’ between the health of Indigenous and non-Indigenous Australians, genomic research involving Indigenous Australians has been, to date, extremely limited. However, this is rapidly changing with the guidance and leadership from Aboriginal and Torres Strait Islander people, including those at the Centre. NCIG, under the leadership and guidance of Indigenous-majority governance board, is building the required reference resources for Indigenous genomics, representing the rich genetic diversity of Indigenous Australians. Reference genomes are essential for accurate analyses and interpretation for the effective use of genomics and Indigenous healthcare benefits. Diversity representative reference genomes are essential because (a) they provide the coordinate system to anchor information about the function, clinical significance, and population variation, and (b) as substrate to align sequence reads. In addition, NCIG is also building a large database of genetic variant profiles for Indigenous Australians. These projects are needed because health and disease are affected by subtle differences in the genomic makeup of different human populations across differing geographical locations. These focused NCIG resources provide a reference against which disease associated genomic variation can be compared and understood in local populations and in populations of mixed ancestry.  There are two major initiatives in Australia; CONNECT and ALIGN, which are coordinating efforts for genomics driven healthcare implementation for Indigenous Australians. CONNECT is an NHMRC funded Synergy Grant program titled “Respecting the Gift: Empowering Indigenous communities in genomic medicine” (2021-2026). ALIGN is MRFF funded initiative titled “Pathways to benefit for Indigenous Australians in genomic medicine” (2021-2027). Both these projects involve multi-disciplinary collaborations spanning social science and humanities research, genomics and healthcare research, policy and implementation science.   These initiatives are needed to progress beyond equity to sovereignty. One element of NCIGs efforts to progress in this direction includes the building of capacity of Aboriginal and Torres Strait Islander peoples to be involved in all elements of the Centres scope, including leading community engagement, developing resources that support patient/participant capacity, working towards education and guidance for the health system to improve services and supporting Aboriginal and Torres Strait Islander secondary and higher education students to engage with the topic. **5) Reciprocity** NCIG recognises that the benefits from to health from this research are not immediate. This is a key part of discussions with communities and during discussions for informed consent. NCIGs principle objective is to enable knowledge to be created through the establishment of its reference database and through the research that this resource enables.  Researchers will be able to ensure that associations they find between genome variation and disease are due to the disease and are not instead a result of the varying ancestries within the study population. Indigenous participants and communities may decide that the genomic data in the NCIG Collection will be used to: Provide information to assist with medical diagnosis and to guide treatment of disease. Identify people who are carriers of genetic disorders, or who are at elevated or reduced risk of disease. They may decide that will be used for research aimed at new discoveries about how genetic variation causes or protects against disease and causes people to respond differently to drugs and other forms of therapy. Research using the NCIG Collection could lead to new discoveries about the way genetic differences between peoples genomes influence how their life history and environment affect their health and cause epigenetic changes to the structure of their genomes that modify how their genomes function in a way that may affect their health and wellbeing.  Research could also lead to the development of diagnostic, prognostic and predictive medical tests; new strategies for assessing disease risk; new interventions that pre-vent or reduce the risk of disease; new drugs and other therapies that can be used to treat or cure disease; new approaches and specific devices for monitoring health, and monitoring the effectiveness of preventative and therapeutic health interventions.  The embedded nature of Indigenous leadership, the ongoing engagement with communities and the responsiveness to community decisions embedded within the NCIG model ensure that the priorities of communities are central to NCIGs functions. As described above, NCIG invests in capacity building in a holistic way, including payed roles, educational efforts and two-way knowledge exchange. **6) Respect** NCIG demonstrates respect for Aboriginal and Torres Strait Islander peoples ways of knowing, doing and being in all elements of our research, governance and community engagement. The Centre demonstrates this commitment through: Processes that emphasise the perspectives of Aboriginal and or Torres Strait Islander peoples, throughout the Centres operations, including through approval of external projects through the NCIG board. Ongoing and trusting relationships with communities beyond the life of any single research project. Long term, extensive and multilayered consent gathering processes that respect the unique decision making processes of that community, including seeking Land Council, organisational, family and individual levels of consent and permission for activities. Maintaining communication about the project through regular visits to communities and through the development of resources that engage and expand the community level knowledge of genomics more broadly. Ensuring appropriate acknowledgment and authorship of community research assistants in publications. Establishing models of respectful engagement with communities that could be transferable to other research in the community or to research with Aboriginal and Torrres Strait Islander people more broadly. **7) Responsibility** NCIGs core purpose is to ensure that the harms caused by research in the past are not perpetuated. NCIG embeds and responds to the specific requests of the communities with which we work in relation to, how the engagement is undertaken; the way that consent and other decisions are made in the collection (including the potential layers of collective consent processes); the kinds of research that are undertaken by external research. NCIG seeks approval and guidance from local Land Councils, communities, and organisations around the appropriate conduct of research in the communities and follows local ways of doing business. There is dedicated consideration of the potential harms of this research and this informs the Centres models of Governance and Community Engagement. Extensive and considered engagement occurs for years before NCIG staff address the question of consent. This ensures that the project proceeds at the pace of trust, avoids pressuring decisions, and ensures informed consent for participation in the project. NCIG has gone to great efforts to establish a governance structure and operational model that will ensure the persistence of the resources that it creates. NCIG will extend the reach of investigators working in many fields relevant to Indigenous health, enabling them to better incorporate genomic research in their work, thereby enhancing its significance and potential.  NCIG will also provide a model of community engagement that may be extendable to other areas of advanced biomedical research, thereby expanding the range of research in which Indigenous Australians can participate and benefit from without risking social or cultural harm. ----- **What role have Aboriginal or Torres Strait Islander peoples played in the development and implementation of the research proposal? Describe their role.** NCIG is established by the [*National Centre for Indigenous Genomics Statute, 2016*][29]. Under the Statute, NCIG has the following functions: - To hold the Collection, and add to it, in accordance with international standards - To engage with Indigenous communities, organisations and people in relation to the Collection, particularly those associated with material in the Collection - To promote the use of the Collection, including by engaging with researchers and research institutions outside the University - To support research using the Collection - To do anything incidental or conducive to the exercise of any of its other functions. [The NCIG Board][30] has 10 members, a majority of whom must be Indigenous Australians, and an Indigenous Chair. A Board meeting quorum is a majority of Indigenous members present. The primary function of the Board is to act as the custodian of the NCIG Collection. As custodian of the Collection, the Board is responsible for its management and use, and for the appropriate addition of material, in accordance with international standards. The Board's functions under the Statute are to: 1. Oversee the operations of the Centre 2. Approve policies for the Centre 3. Provide advice to the Council and the Vice-Chancellor about the Collection 4. Promote the Collection as a national and international resource 5. Seek funding for the purposes of the Centre, including for research and community engagement 6. Encourage the Centre to promote the use of the Collection, including by engaging with researchers and research institutions outside the University 7. Exercise any other function given to it under this instrument 8. Do anything incidental or conducive to the exercise of any of its other functions. ---------- ![enter image description here][31] **Figure 1. The NCIG governance framework.** --------- ### Implementation of the Statute The Board: - holds quarterly meetings - has a [5-year Strategic Plan][32] to guide the operations of the Centre - submits to the ANU Vice Chancellor: - an [Operational Plan][33] at the beginning of each year, - an [Annual Report][34] at the end of each year, for presentation to the ANU Council. The Director and the Deputy Director: - provide the Board with quarterly reports against the Operational Plan, which are included in Board minutes. ---------- ### Governing Principles The following principles, established by the NCIG Board, govern the operations of the Centre: **Integrity, Trust and Respect** NCIG acts with integrity, builds trust and behaves ethically. NCIG gives respect and strives to earn it in return. **Transparency** Transparent and accountable processes and clear lines of responsibility, accountability, reporting and communication are integral to NCIG operations. **Indigenous Governance** Indigenous Australians play the central role in NCIG’s governance and decision making. **Indigenous Engagement** NCIG is committed to long-term engagement with individuals, families, communities and organisations based on respect for the principles and values of Aboriginal and Torres Strait Islander cultures. **International Best Practice** NCIG is committed to the development and implementation of international best practice in all its operations to ensure outcomes of the highest quality and value. **Research Excellence** NCIG is committed to conducting and enabling research of the highest quality. **Confidentiality, Privacy and Security** NCIG protects the privacy of participants and the confidentiality and security of data and information about participants. ---------- ### Policy Framework Under Section 8 of the Statute, NCIG must comply with Commonwealth laws that apply to the University and statutes, rules, orders and policies of the University. In accordance with Section 12(3)(b) of the Statute, the NCIG Board has made [additional policies][35]described in the NCIG Governance Framework, in relation to: 1. Indigenous Community Engagement 2. Ethical Oversight 3. Additions to the Collection 4. Access to the Collection for Research 5. Media and Communication 6. Publication 7. Conflict of Interest ---------- ### The NCIG Board's Role in Ethical Oversight Under the NCIG Board Policy on Ethical Oversight: - The NCIG Board approves an ethics protocol for NCIG Research which is also approved by the ANU and other relevant Human Research Ethics Committees (HRECs) - The NCIG Director reports to the NCIG Board on ethical aspects of NCIG Research - Proposed variations to the ethics protocol are approved by the NCIG Board - NCIG does not report or apply for variations to the ethics protocol directly to the ANU and other relevant HRECs. - Rather, the Chair and Secretary of the ANU and other relevant HRECs have access to relevant NCIG Board papers, which must include reports on ethical aspects of NCIG Research, applications for variations to the Protocol, and Board responses, including questions and concerns raised and the responses to these. ![Ethics approval and reporting][36] **Figure 2. NCIG ethics protocol approval and reporting arrangements.** ---------- ### The Scope of the NCIG Ethics Protocol - This ethics protocol applies only to **NCIG Research**, which is undertaken as part of NCIG’s internal operations that has the primary objective of improving NCIG's ability to fulfil its functions as described in the Statute. - External collaborators on NCIG Research (Figure 3) must agree in writing to comply with the NCIG Statute and NCIG policies, including the policy on ethical oversight. - For researchers outside the ANU, formal agreements between ANU and their host institutes are required to ensure full accountability to the NCIG Board. - NCIG applies to jurisdictional Aboriginal and Torres Strait Islander Health Ethics Committees for ethics protocol approval for NCIG research, as required. - The NCIG ethics protocol does not apply to **External Research Projects**, which address specific research questions through access and use of material in the NCIG Collection. ---------- ![enter image description here][37] **Figure 3. Preparation, approval and reporting requirements for NCIG Research** ---------- ### Management **The NCIG Director** is a member of ANU staff and cannot be a member of the Board. The Director is responsible for: 1. Supporting the Board as the custodian of the Collection and in the exercise of its other functions under the Statute 2. Managing the operations of the Centre in accordance with Commonwealth laws that apply to the University; statutes, rules, orders and policies of the University; the operational plan prepared and varied, from time to time, by the Board; and policies approved by the Board in relation to the Collection. The NCIG Director provides quarterly reports to the NCIG Board on progress in implementing the Board's Operational Plan. NCIG staff report to the Director. **Does the research team include Aboriginal or Torres Strait Islander people?** **````Yes [X] ````** **````No [ ] ````** **Does this proposal involve health research involving Aboriginal and Torres Strait Islander peoples?** For reporting purposes to National Health and Medical Research Council **````Yes [X] ````** **````No [ ] ````** ----- ## 4. Human Research Ethics Committee (HREC) **Does this research involve Human Genetics?** In such research there are particular ethical issues to consider (e.g revealing information that may have implications or generate sensitivities for the individual participant, his or her family or community **Cleared by another HREC, listed procedure or renewal application?** **````Yes [ ] ````** **````No [X] ````** **Provide details** Renewal application. **Does this research involve Human Stem Cells?** Note that research involving derivation of embryonic stem cell lines is also governed by the Research Involving Human Embryos Act 2002 and the NHMRC 'Ethical guidelines on the use of assisted reproductive technology in clinical practice and research'. **````Yes [ ] ````** **````No [X] ````** **Does this research involve Women who are pregnant and the Human Foetus?** This provides for research involving women who are pregnant, the human foetus ex utero, and human foetal tissue after the separation of the foetus from the women. **````Yes [ ] ````** **````No [X] ````** **Does the research involve people highly dependent on medical care who may be unable to give consent?** **````Yes [ ] ````** **````No [X] ````** **Does the research involve people with a cognitive impairment, an intellectual disability or a mental illness?** **````Yes [ ] ````** **````No [X] ````** **Does this research involve an intention to study or expose or is likely to discover illegal activity?** Research may in some instances discover illegal activity by participants or others, or may discover information indicating future illegal activity. In such research there may be particular issues regarding both ethical and legal ramifications. **````Yes [ ] ````** **````No [X] ````** **Does this research involve human gametes (eggs or sperm)?** Note that research involving human embryos and gametes is also governed by the Research Involving Human Embryos Act 2002 and the NHMRC 'Ethical guidelines on the use of assisted reproductive technology in clinical practice and research' (2017). **````Yes [ ] ````** **````No [X] ````** **Does this research involve excess ART embryos?** Note that research involving human embryos is also governed by the Research Involving Human Embryos Act 2002 and the NHMRC 'Ethical guidelines on the use of assisted reproductive technology in clinical practice and research' (2017). **````Yes [ ] ````** **````No [X] ````** ------- ### Expedited Review Questions Please read the list carefully and tick 'Yes' to any of the below that relates to your research. **Third Party Identification. Is it possible for third parties to identify participants, and would this identification have a negative impact on the participant?** **````Yes [] ````** **````No [x ] ````** **Children or young people. Does the research involve the participation of children or young people?** **````Yes [] ````** **````No [x ] ````** **Dependent or Unequal Relationship Does a pre-existing relationship exist between participants and researchers or between participants and others involved in facilitating or implementing the research?** **````Yes [] ````** **````No [x ] ````** **Membership of a Group, or Related Issues** Does the research involve the recruitment of members of a group, a significant coincidental recruitment of members of a group, and/or issues likely to be considered significant to the group? **````Yes [X] ````** **````No [ ] ````** **Has there been full consultation with the community?** Such consultation might involve discussions with elders, community leaders or representative organizations. **````Yes [X] ````** **````No [ ] ````** **Does the research team include member(s) of a group?** Such inclusion is considered useful from both an ethical and methodological point of view and is encouraged. **````Yes [X] ````** **````No [ ] ````** **Will there be appropriate reporting back to the group and/or a direct flow of benefits to the community?** Historically there has been a poor flow of direct benefits back to communities in which the research has been conducted. Increasingly there is an expectation that the community will be provided with the results of the research. **````Yes [X] ````** **````No [ ] ````** **Are the risks easily negate, minimised or managed?** **````Yes [X] ````** **````No [ ] ````** **In 200 words or less, outline the measures which will be taken to address the risks: Physical harm** The above protocol details the extensive measures taken to ensure the prevention, mitigation and minimisation of risks to participants including:  Extensive community engagement and involvement at all phases of the project Considered, careful and culturally responsive consent processes Strong and multi-layered governance Community partnerships Compliant systems to protect privacy, and security of data ***Physical Harm*** Does the research involve a risk of physical harm, which may include injury, illness or pain? This may include being humiliated, manipulated or in other ways treated disrespectfully or unjustly. **````Yes [X] ````** **````No [ ] ````** *Is prior warning given?* Such a warning would normally be provided in plain language in the context of the recruitment materials and / or the informed consent procedure. **````Yes [X] ````** **````No [ ] ````** *Does the protocol allow many opportunities for the participant to seek relief and/or withdraw?* Participants should be afforded the opportunity to take breaks and/or withdraw their consent to participate. Withdrawing participation must also include the opportunity to withdraw their data from the research. **````Yes [X] ````** **````No [ ] ````** *Are the risks easily negated, minimised or managed?* **````Yes [X] ````** **````No [ ] ````** **In 200 words or less, outline the measures which will be taken to address the risks: Psychological Harm** Blood is collected by qualified and experienced staff. ***Psychological Harm (includes Devaluation of Personal Worth)*** Does the research involve a risk of psychological harm, which may include feelings of worthlessness, distress, guilt, anger or fear related? **````Yes [X] ````** **````No [ ] ````** *Is prior warning given?* **````Yes [X] ````** **````No [ ] ````** *Will potential participants be screened on the basis of complicating mental health factors?* Participants with complicating mental health factors may be more-than-usually vulnerable to various forms of discomfort and stress. **````Yes [X] ````** **````No [ ] ````** *Can the research team guarantee that a reasonable person would not find the stress significant?* The question of significance should be based upon impact upon quality of life, enduring implications and stigma. **````Yes [X] ````** **````No [ ] ````** *Will participants be provided with an appropriate contact if they become distressed?* The counselling participant is referred to should be a free service. For example, Lifeline, ANU counselling, etc. **````Yes [X] ````** **````No [ ] ````** *Are the risks easily negated, minimised or managed?* **````Yes [X] ````** **````No [ ] ````** **In 200 words or less, outline the measures which will be taken to address the risks: Psychological and social harm risk management** NCIG only provides information to participants if they initially indicate that they wish to receive it. NCIG ensures that participants who request information are informed about the risk of social harm before the information is released to them. NCIG works with communities to establish appropriate ways to communicate personal and sensitive information and follow the advice it receives. NCIG provides advice and support to participants who request it and ensures that they have access to ongoing local advice and support. For participants who consent to receive medically relevant information, NCIG will provide information about genetic disorders through a doctor. Incidental findings will be assessed by an expert panel before being passed on to a doctor. The doctor will be responsible for deciding how to use the information and provide care to the patient, including clinical genetic tests. Devaluation of personal worth risk management Indigenous people have a say in the way that research results are described when they are published. Indigenous people are involved in preparing plain language reports to accompany the publication of research findings. NCIG actively counters media reports or public discussions about published research that portray Indigenous people in a negative way. ***Social Harm*** *Could the research result in a significant negative impact upon personal relations? For example, could the research damage the relationship between a participant and another family member?* **````Yes [X] ````** **````No [ ] ````** *Does the protocol ensure that there are no anticipated duty of care, or duty of disclosure issues which might warrant the reporting of identified data to third parties?* **````Yes [X] ````** **````No [ ] ````** *Is prior warning given?* **````Yes [X] ````** **````No [ ] ````** *Are the risks easily negated, minimised or managed?* **````Yes [X] ````** **````No [ ] ````** *In 200 words or less, outline the measures which will be taken to address the risks of Social Harm* NCIG only provides information to participants if they initially indicate that they wish to receive it. NCIG ensures that participants who request information are informed about the risk of social harm before the information is released to them. NCIG works with communities to establish appropriate ways to communicate personal and sensitive information and follow the advice it receives. NCIG provides advice and support to participants who request it and ensures that they have access to ongoing local advice and support. For participants who consent to receive medically relevant information, NCIG will provide information about genetic disorders through a doctor. Incidental findings will be assessed by an expert panel before being passed on to a doctor. The doctor will be responsible for deciding how to use the information and provide care to the patient, including clinical genetic tests. ***Economic Harm*** *These are harms which may have direct or indirect costs on participants, such as, potential loss of professional reputation, market standing, health insurance, or employability.* **````Yes [ ] ````** **````No [X] ````** ***Legal Harm*** *Could the research expose participants to potential litigation or has the possibility for documents to subpoenaed?* **````Yes [ ] ````** **````No [X] ````** **Covert Observation** Will the research involve the observation of others without their knowledge? This does not apply to the observation of legal behavior in a public place **````Yes [ ] ````** **````No [X] ````** **Deception** Does the research involve active concealment or planned deception? **````Yes [ ] ````** **````No [X] ````** **Sensitive Personal Information** **````Yes [X] ````** **````No [ ] ````** **Is prior warning given and is the participant reminded occasionally that they can withdraw?** Such a warning would normally be provided in plain language in the context of the recruitment materials and / or the informed consent mechanism. **````Yes [X] ````** **````No [ ] ````** **Collection, use or disclosure of personal information WITHOUT the consent of the participant** Before deciding to waive the requirement for consent, an HREC must be satisfied with regard to a number of conditions. Please refer to the National Statement Chapter 2.3.6. **````Yes [ ] ````** **````No [X] ````** **Overseas Research** Will the research be conducted overseas? **````Yes [ ] ````** **````No [X] ````** **Secondary Data** Secondary data or information is data or information that was originally generated or collected for previous research or for nonresearch purposes. **````Yes [ ] ````** **````No [X] ````** **Is this publicly available data?** **````Yes [ ] ````** **````No [X] ````** -------- ---------- ## 5. Definitions **Access Agreement** means a legally binding agreement between an external party and the ANU that specifies the terms and conditions for access to, and use of, material in the NCIG Collection. **the Centre** means National Centre for Indigenous Genomics. **Closed Collection** is the part of the NCIG Collection containing containing private, confidential or proprietary information that cannot be accessed for research purposes. **the Collection** (also **the NCIG Collection**) means biological samples, documents/records and data held by NCIG, as specified in Part 2. 5 of the Statute. **Controlled material** means material in the NCIG Collection that is private or confidential, and accessible for specific use only under an Access Agreement following approval by the NCIG Board. **Cultural competence** means the ability to interact effectively with people across different cultures. **External Research Project** means a research project that addresses a specific research question through access and use of the NCIG Collection. The NCIG Ethics Protocol does not apply to external projects. External Research Projects must be approved by the NCIG Board. They are not covered by the NCIG Ethics Protocol and require separate ethics approval. **Human Research Ethics Committees (HRECs)** are established by organisations in Australia to review research proposals involving human participants to ensure that they are ethically acceptable and in accordance with relevant standards and guidelines. **Jurisdictional ethics committee** means an HREC that has the role of assessing research proposals affecting the health and wellbeing of Aboriginal people and communities in an Australian jurisdiction, and which is registered with the NHMRC. NHMRC registration means that the institution(s) that established the HREC notifies NHMRC of the HREC’s existence and provides a signed declaration that the HREC will comply with the National Statement on Ethical Conduct in Human Research, 2007 (National Statement) and any revisions made to it. **Material** means biological samples, documents and data. **NCIG Research** means research undertaken as part of NCIG’s internal operations that has the primary objective of improving NCIG's ability to fulfil its functions as described in the Statute. **NCIG Personnel** means NCIG Board members, NCIG staff, members of NCIG Board committees, and students, interns, volunteers, consultants and collaborators working with NCIG. **NCIG Statute** (also **the Statute**) means the *National Centre for Indigenous Genomics Statute 2016*. **Research** means "work of direct relevance to the needs of commerce, industry, and to the public and voluntary sectors; scholarship; the invention and generation of ideas, images, performances, artifacts including design, where these lead to new or substantially improved insights; and the use of existing knowledge in experimental development to produce new or substantially improved materials, devices, products and processes, including design and construction". *[This definition of research is used in The British Research Assessment Exercise and quoted in the National Statement on Ethical Conduct in Human Research 2007].* **Sample** means biological material taken from a person’s body for a research or medical purpose, such as solid tissue, blood or cells contained in saliva and any separated component (such as red blood cells, white blood cells and plasma in the case of blood) and any derived component such as protein, DNA or RNA. ------ ## 6. Historical Variations No historical variations were added. ---------- ## 7. Supporting Documentation ### 7a. Informed Consent 1. [Participant information sheet][38] 2. [Information video animation][39] 2. [Participant consent form][40] 3. [Online Participant consent form][41] 3. [Participant details form][42] 3. [Translator confidentiality form][43] ---------- ### 7b. Governance, Policy, Planning and Reporting 1. [NCIG Statute][50] 6. [NCIG Governance Framework][51] 7. [NCIG Strategic Plan (2017-2020)][52] 8. [Annual Report (2017)][53] ---------- Contact **The Centre Administrator & Board Secretary** National Centre for Indigenous Genomics John Curtin School of Medical Research Australian National University Acton ACT 2601 E: jcsmr.ncig@anu.edu.au P: 1800 100 912 P: 02 6125 9117 W: ncig.anu.edu.au to request access to the following additional documents: 1. Biorepository Manual 8. Biorepository Management 'Lab Book' 2. Board Agendas 2. Board Minutes 2. Board Handbook 3. Community Engagement Manual 12. Community Engagement Reports 3. Current NCIG Research Projects 14. Current External Research Projects 2. Data Management Manual 10. Data Management 'Lab Book' 11. Ethics Incidents Reports 10. Induction Manual 8. Operational Plan 8. Record/Document Management Manual 9. Record/Document Management 'Lab Book' 12. Standard Operating Procedure Library ---------- ### 7c. Related ethics resources 15. [National Statement on Ethical Conduct in Human Research (2007)][58] 16. [Australian Privacy Principles][59] 17. [Australian Code for the Responsible Conduct of Research, 2018][60] [1]: https://mfr.osf.io/export?url=https://osf.io/fut35/?action=download%26direct%26mode=render%26view_only=b246a90956584b0ca6cf764678f9b45c%26public_file=False&initialWidth=848&childId=mfrIframe&parentTitle=OSF+%7C+NCIG_logo.png&parentUrl=https://osf.io/fut35/?view_only=b246a90956584b0ca6cf764678f9b45c&format=1000x1000.jpeg [2]: https://osf.io/ykhrp/wiki/Administrator%20%26%20Board%20Secretary/?view_only=5e1e82f2effb4ff4ae9d53cb5b135981 [3]: https://services.anu.edu.au/planning-governance/governance/human-research-ethics-committee [4]: https://www.legislation.gov.au/Details/F2016L01873/Html/Text#primary-content [5]: http://ncig.anu.edu.au/about [6]: https://www.anu.edu.au/about/governance/council [7]: https://ncig.anu.edu.au/about/indigenous-leadership [8]: https://osf.io/m8k6u [9]: https://osf.io/m6w8z/wiki/Projects/ [10]: https://osf.io/m6w8z/wiki/Projects/ [11]: https://www.internationalgenome.org/ [12]: https://h3africa.org/ [13]: https://www.broadinstitute.org/sigma [14]: http://shgp.kacst.edu.sa/site/ [15]: https://indigenousgenomics.com.au/ [16]: https://www.humanrights.gov.au/our-work/aboriginal-and-torres-strait-islander-social-justice/projects/close-gap-indigenous-health [17]: https://federalfinancialrelations.gov.au/sites/federalfinancialrelations.gov.au/files/2021-01/all_states_ip_closinggap_indig_health_outcomes_cwth_pdf.pdf [18]: https://www.education.gov.au/ncris [19]: https://www.dese.gov.au/higher-education-publications/resources/review-higher-education-access-and-outcomes-aboriginal-and-torres-strait-islander-people [20]: https://osf.io/e8hxp/wiki/home/?view_only=5e1e82f2effb4ff4ae9d53cb5b135981 [21]: https://osf.io/m6w8z/wiki/Ethics%20Consent%20form [22]: https://osf.io/m6w8z/wiki/Participant%20information%20sheet/ [23]: https://youtu.be/wftujBV2LPs?feature=shared [24]: https://osf.io/e8hxp/wiki/home/?view_only=5e1e82f2effb4ff4ae9d53cb5b135981 [25]: https://osf.io/m6w8z/wiki/Funding%20sources [26]: https://www.abc.net.au/news/2021-05-27/blood-samples-stored-at-anu-returned-to-indigenous-community/100164322 [27]: https://jcsmr.anu.edu.au/research/centres/ncig/about [28]: https://onlinelibrary.wiley.com/doi/10.1111/imj.15223 [29]: https://www.legislation.gov.au/Details/F2021L00183 [30]: https://osf.io/m6w8z/wiki/NCIG%20Governance%20Board/ [31]: https://files.osf.io/v1/resources/m6w8z/providers/osfstorage/656436bc932b9f37827607fb?mode=render [32]: https://osf.io/m8k6u [33]: https://osf.io/f4cdm [34]: https://jcsmr.anu.edu.au/research/centres/ncig/about [35]: https://ncig.anu.edu.au/about/governance-framework [36]: https://mfr.osf.io/export?url=https://osf.io/7294z/?action=download%26direct%26mode=render%26view_only=b246a90956584b0ca6cf764678f9b45c%26public_file=False&initialWidth=848&childId=mfrIframe&parentTitle=OSF+%7C+NCIG+ethical+oversight.png&parentUrl=https://osf.io/7294z/?view_only=b246a90956584b0ca6cf764678f9b45c&format=1000x1000.jpeg [37]: https://files.osf.io/v1/resources/m6w8z/providers/osfstorage/65643beef0b8e2370ea9d6a7?mode=render [38]: https://osf.io/m6w8z/wiki/Participant%20information%20sheet%20%28draft%29/?view_only=b246a90956584b0ca6cf764678f9b45c [39]: https://osf.io/m6w8z/wiki/Contact/?view_only=5e1e82f2effb4ff4ae9d53cb5b135981 [40]: https://osf.io/m6w8z/wiki/Contact/?view_only=5e1e82f2effb4ff4ae9d53cb5b135981 [41]: https://osf.io/m6w8z/wiki/Contact/?view_only=5e1e82f2effb4ff4ae9d53cb5b135981 [42]: https://osf.io/m6w8z/wiki/Participant%20details%20form/?view_only=5e1e82f2effb4ff4ae9d53cb5b135981 [43]: https://osf.io/e8hxp/wiki/home/?view_only=5e1e82f2effb4ff4ae9d53cb5b135981 [44]: https://osf.io/m6w8z/wiki/Participant%20details%20form/?view_only=5e1e82f2effb4ff4ae9d53cb5b135981 [45]: http://ncig.anu.edu.au/ [46]: https://osf.io/m6w8z/wiki/Revised%20consent%20form/?view_only=5e1e82f2effb4ff4ae9d53cb5b135981 [47]: https://osf.io/m6w8z/wiki/Contact/?view_only=5e1e82f2effb4ff4ae9d53cb5b135981 [48]: https://osf.io/m6w8z/wiki/Participant%20details%20form/?view_only=5e1e82f2effb4ff4ae9d53cb5b135981 [49]: https://osf.io/m6w8z/wiki/Revised%20translator%20confidentiality%20form/?view_only=5e1e82f2effb4ff4ae9d53cb5b135981 [50]: https://osf.io/m6w8z/wiki/Contact/?view_only=5e1e82f2effb4ff4ae9d53cb5b135981 [51]: https://osf.io/m6w8z/wiki/Contact/?view_only=5e1e82f2effb4ff4ae9d53cb5b135981 [52]: https://osf.io/m6w8z/wiki/Contact/?view_only=5e1e82f2effb4ff4ae9d53cb5b135981 [53]: https://osf.io/m6w8z/wiki/Contact/?view_only=5e1e82f2effb4ff4ae9d53cb5b135981 [54]: https://www.legislation.gov.au/Details/F2016L01873/Html/Text#primary-content [55]: http://ncig.anu.edu.au/governance-framework [56]: http://ncig.anu.edu.au/governance-framework [57]: http://ncig.anu.edu.au/ [58]: https://osf.io/m6w8z/wiki/Contact/?view_only=5e1e82f2effb4ff4ae9d53cb5b135981 [59]: https://policies.anu.edu.au/ppl/document/ANUP_000397 [60]: http://ncig.anu.edu.au/governance-framework [61]: https://www.nhmrc.gov.au/guidelines-publications/e72 [62]: https://www.oaic.gov.au/privacy-law/privacy-act/australian-privacy-principles [63]: https://www.nhmrc.gov.au/guidelines-publications/r41