![NCIG Logo][1] ---------- # Ethical oversight framework ---------- @[toc] ---------- ## Ethics protocol [2018 Ethics Protocol][2] (ANU Human Research Ethics Committee Protocol # 2015/065). Variations approved: August 2018. ---------- ## NCIG operations and ethical compliance ANU's Human Research Ethics Committee (HREC), which is registered with the National Health and Medical Research Council (NHMRC), ensures compliance with the National Statement on Ethical Conduct in Human Research through oversight of research protocols. Some features of NCIG's activities are not well suited to the standard HREC approval process 1. NCIG does not conduct a defined research project in the normal sense. Activities, which include research, are aimed at developing a data resource to be used for research purposes, as distinct from research aimed at addressing specific scientific questions. 2. NCIG's activities have no specific end date - the intent is to create an enduring and continually improving resource that remains in use indefinitely. 3. Only broad consent is obtained for inclusion of samples and data in the NCIG Collection. Use of material in the NCIG Collection for specific research purposes is controlled by NCIG's Indigenous Majority Board. 4. NCIG is a community-driven initiative, meaning that NCIG is committed to implementing the wishes and priorities of participants and their communities. Specific research objectives and processes cannot, therefore be specified up front and may change substantially over time. 5. The ANU Council’s purpose in making the NCIG 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 in the collection." 6. This purpose is achieved under the Statute through the appointment of an Indigenous-majority Board. The Indigenous governance provided by the Board extends to ethical oversight. Indigenous governance by the Board is reconciled with compliance through the HREC by an arrangement detailed in the [NCIG Board Ethical Oversight Policy][3] ---------- ## Policy 1. The NCIG Board approves an ethics protocol for NCIG Research which is also approved by the ANU Human Research Ethics Committee. This ethics protocol applies only to NCIG Research. It does not apply to External Research Projects. 3. The NCIG Director reports to the NCIG Board on ethical aspects of NCIG Research. 4. Proposed variations to the ethics protocol are approved by the NCIG Board. 2. NCIG does not report or apply for variations to the ethics protocol directly to the ANU HREC. Rather, the Chair and Secretary of the ANU HREC 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. 6. NCIG applies to jurisdictional Aboriginal and Torres Strait Islander Health Ethics Committees for ethics protocol approval for NCIG research, as required. 7. External collaborators on NCIG Research must agree in writing to comply with the NCIG Statute and NCIG policies. 8. For researchers outside the ANU, formal agreements between ANU and their host institutes are required to ensure full accountability to the NCIG Board. ---------- ![enter image description here][4] Figure 1. NCIG ethics protocol approval and reporting arrangements. ---------- ## Ethics committees relevant to NCIG **ACT** [Australian National University Human Research Ethics Committee][5] **Northern Territory** [Human Research Ethics Committee for the Northern Territory Department of Health and Menzies School of Health Research][6] [Central Australian Human Research Ethics Committee][7] **Western Australia** [Western Australian Aboriginal Health Ethics Committee][8] ---------- ## Other Indigenous health ethics committees **ACT** Australian Institute of Aboriginal and Torres Strait Islander Studies Research Ethics Committee **New South Wales** Aboriginal Health and Medical Research Council Ethics Committee **South Australia** Aboriginal Health Research Ethics Committee ---------- ## Useful ethics resources ### International [WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects][9] [World Economic Forum Code of Ethics for Researchers][10] ### Australia [National Statement of Ethical Conduct in Human Research][11] [Australian Code for the Responsible Conduct of Research, 2018][12] [Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders][13] [Researching Right Way. Aboriginal and Torres Strait Islander Health Research Ethics: A Domestic and International Review][14] [Centre for Genetics Education: Life Insurance Products and Genetic Testing in Australia][15] [Australian Genomics Health Alliance Legal Advice][16] [ANU Policy: Responsible Conduct of Research][17] [ANU Policy: Code of Research Conduct][18] ### Other countries **Canada** [Tri-Council Policy Statement: Ethical Conduct for Research Involving Humand, 2014][19] [CIHR Guidelines for Health Research Involving Aboriginal People (2007-2010)][20] **Europe** [European Network of Research Ethics Committees][21] **New Zealand** [Te Ara Tika][22]. Guidelines for Māori research ethics: A framework for researchers and ethics committee members. [Guidelines for Researchers on Health Research Involving Māori][23] [He Tangata Kei Tua. Guidelines for Biobanking with Māori][24] **USA** [Federal Policy for the Protection of Human Subjects ('Common Rule')][25] [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/m6w8z/wiki/1.%20NCIG%20Ethics%20Protocol/?view_only=5e1e82f2effb4ff4ae9d53cb5b135981 [3]: https://osf.io/e4mf5/wiki/home/?view_only=5e1e82f2effb4ff4ae9d53cb5b135981 [4]: 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 [5]: https://services.anu.edu.au/planning-governance/governance/human-research-ethics-committee [6]: https://www.menzies.edu.au/page/About_Us/Menzies_committees/Human_research_ethics_committee/ [7]: https://health.nt.gov.au/health-governance/department-of-health/committees-regulations-advisory-groups/human-research-ethics-committee [8]: https://www.ahcwa.org.au/ethics [9]: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/ [10]: https://widgets.weforum.org/coe/ [11]: https://nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-updated-2018 [12]: https://www.nhmrc.gov.au/guidelines-publications/r41 [13]: https://nhmrc.gov.au/about-us/publications/ethical-conduct-research-aboriginal-and-torres-strait-islander-peoples-and-communities [14]: https://nhmrc.gov.au/sites/default/files/documents/Indigenous%20guidelines/evaluation-literature-review-atsi-research-ethics.pdf [15]: https://osf.io/hduxg/?view_only=5e1e82f2effb4ff4ae9d53cb5b135981 [16]: https://osf.io/hdybt/?view_only=5e1e82f2effb4ff4ae9d53cb5b135981 [17]: https://policies.anu.edu.au/ppl/document/ANUP_007402 [18]: https://policies.anu.edu.au/ppl/document/ANUP_007403 [19]: http://www.pre.ethics.gc.ca/pdf/eng/tcps2-2014/TCPS_2_FINAL_Web.pdf [20]: http://www.cihr-irsc.gc.ca/e/29134.html [21]: http://www.eurecnet.org/index.html [22]: http://www.hrc.govt.nz/sites/default/files/Te%20Ara%20Tika%20Guidelines%20for%20Maori%20Research%20Ethics.pdf [23]: http://www.hrc.govt.nz/sites/default/files/Guidelines%20for%20HR%20on%20Maori-%20Jul10%20revised%20for%20Te%20Ara%20Tika%20v2%20FINAL%5B1%5D.pdf [24]: https://www.waikato.ac.nz/__data/assets/pdf_file/0019/321535/He-Tangata-Kei-Tua-Biobanking-Guidelines.pdf [25]: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html