79C3C34C52B45572883A05D425EB0F82
Research Ethics Policy Directive, Version No.: 3.1
https://www.sahealth.sa.gov.au/wps/wcm/connect/996102804a9942d8aa46ea7633bbffe0/Directive_Research+Ethics_v3.1_22022018.pdf?MOD=AJPERES&CACHEID=ROOTWORKSPACE-996102804a9942d8aa46ea7633bbffe0-mMy.P7N
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| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Health / Drug Usage
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p.000016:
p.000016: IBC means Institutional Biosafety Committee.
p.000016:
p.000016: ISAAC means the Integrated South Australian Activity Collection (ISAAC), an admitted patient morbidity data collection
p.000016: maintained by SA Health.
p.000016:
p.000016: Lead HREC means the human research ethics committee responsible for the single ethical and scientific review of a
p.000016: research ethics application.
p.000016:
p.000016: National Mutual Acceptance (NMA) means the single scientific and ethical review of human research projects across
p.000016: participating jurisdictions.
p.000016:
p.000016: National Statement means The NHMRC’s National Statement on Ethical Conduct in Human Research (2007).
p.000016:
p.000016: NHMRC means National Health and Medical Research Council.
p.000016:
p.000016: NHMRC Certified HREC means an institution/HREC that has been certified by the NHMRC to undertake the single scientific
p.000016: and ethical review of human research projects.
p.000016:
p.000016: OACIS means an electronic clinical patient information system owned by SA Health.
p.000016:
p.000016: Principal Investigator means the lead investigator responsible for the conduct and management of a research project at
p.000016: a local Institution or Site.
p.000016:
p.000016: RGO means Research Governance Officer.
p.000016:
p.000016: SA Health means the health portfolio of services and agencies responsible to the Minister for Health, Minister for
p.000016: Mental Health and Substance Abuse and the Minister for Ageing.
p.000016:
p.000016: SAE means: Serious Adverse Event.
p.000016:
p.000016: SOP means: Standard Operating Procedure.
p.000016:
p.000016: SSA means: Site Specific Assessment.
p.000016:
p.000016: TGA means: Therapeutic Goods Administration.
p.000016:
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p.000016:
p.000016:
p.000016:
p.000016:
p.000016: INFORMAL COPY WHEN PRINTED Research Ethics Policy Directive
p.000016: Page 15 of 16
p.000016:
p.000016: Public –I1-A1
p.000016:
p.000016: 7. Associated Policy Directives / Policy Guidelines and Resources
p.000016:
p.000016: SA Health Research Governance Policy Directive (2020)
p.000016:
p.000016: SA Health Privacy Policy Directive (2017)
p.000016:
p.000016: General Disposal Schedule No. 28: Clinical and Client-Related Records of Public Health Units in South Australia (2014)
p.000016:
p.000016:
p.000016: 8. Document Ownership & History
p.000016: Document developed by: Office for Research, Department for Health and Wellbeing
p.000016: File / Objective No.: 2018-13236
p.000016: Next review due: 01/07/2023
p.000016: Policy history: Is this a new policy: N
p.000016: Does this policy amend or update and existing policy? Y
p.000016: If so, which version? V3.1
p.000016: Does this policy replace another policy with a different title? N
p.000016: ISBN 978-1-76083-304-6
p.000016:
p.000016:
p.000016: Approval Date
p.000016: 16/07/20
p.000016:
p.000016: 13/11/17
p.000016:
p.000016: 04/01/16
p.000016:
p.000016: 01/07/13
p.000016:
p.000016: Version
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Social / Access to Social Goods
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p.000016: system.
p.000016: • National Mutual Acceptance – for multi-centre human research projects taking place across participating
p.000016: Australian jurisdictions (public health organisations only).
p.000016:
p.000016:
p.000016: 3.2 SA HEALTH SINGLE ETHICAL REVIEW MODEL
p.000016: 1. Every research project which is to be conducted at a site under the jurisdiction of SA Health will be ethically
p.000016: and scientifically reviewed once only by a SA Health HREC or another South Australian based NHMRC certified HREC. The
p.000016: reviewing committee is designated the lead HREC.
p.000016: 2. All sites under the jurisdiction of SA Health that are participating in the proposed research will accept the
p.000016: review of the lead HREC without further ethical or scientific consideration, with appropriate exceptions established by
p.000016: the LHN board and Chief Executive.
p.000016: 3. The research ethics applicant (the Coordinating Principal Investigator or CPI) will select a lead HREC to
p.000016: undertake single review from a register of HRECs on the SA Health ethics website. . The applicant will assume
p.000016: responsibility for submitting all required documentation in accordance with SA Health and local HREC requirements.
p.000016: 4. Lead HRECs must be appropriately constituted in accordance with the requirements of the NHMRC, and fulfil the
p.000016: requirements of the National Statement (section 5.2). Additionally they must have access to the required expertise to
p.000016: undertake a full scientific and ethical review of the type of research which is submitted.
p.000016: 5. Every research application must undergo a separate research governance review at each site where the research is
p.000016: to be conducted to permit consideration and approval of the research governance requirements at that site (a site
p.000016: specific assessment). This is distinct from the scientific and ethical review by the lead HREC.
p.000016: 6. The lead HREC will be responsible for the full scientific and ethical review of the research application. Once
p.000016: completed, the lead HREC will be responsible for notifying the CPI of the outcome of the review. It is the CPIs
p.000016: responsibility to notify the outcome of this review to each of the other sites where the project is proposed to take
p.000016: place, via the Research Governance Officer associated with the site/s.
p.000016: 7. Under this model, HRECs will have the right to refuse to consider a multi-site application only under the
p.000016: following circumstances:
p.000016: i. The HREC Chairperson determines there is insufficient expertise on or available to the HREC to permit an
p.000016: adequate scientific and ethical review of the proposal; or
p.000016: ii. The HREC is not able to review the proposal in a timely manner (e.g. the meeting agenda for the next HREC
p.000016: meeting has reached capacity).
p.000016:
p.000016: 8. In these circumstances (7 [i] and [ii]), the HREC should notify the applicant as soon as practicable in order
p.000016: that they can then submit to another suitable SA Health HREC.
p.000016:
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p.000016: • Where it is proposed to separately identify Aboriginal and Torres Strait Islander people in the results; or
p.000016: • The information has an impact on one or more Aboriginal and Torres Strait Islander communities; or
p.000016: • The geographic location of the research is such that a significant number of the population are likely to be of
p.000016: Aboriginal and Torres Strait Islander origin (based on 4.7.6 of the National Statement, 2007); or
p.000016: • Where terms such as ‘resilience’; ‘well-being’; ‘cultural safely’; ‘cultural health’; and ‘language and culture’
p.000016: are used in the description and design of the project indicating that the project has important health implications; or
p.000016: • Aboriginal and Torres Strait Islander health funds are a source of funding.
p.000016:
p.000016: 10. The CPI should provide the AHREC with a copy of the research application and the lead HRECs ethical determination
p.000016: on the project for consideration as soon as practicable. The AHREC will then provide their evaluation of the project
p.000016: to the lead HREC for consideration prior to providing feedback to the applicant. The AHREC will expedite their review
p.000016: where possible.
p.000016:
p.000016: 11. Ethics applications involving Women’s and Children’s Health Network (WCHN), and where the primary research
p.000016: participants are children and young people, or where the project involves access to paediatric data primarily held by
p.000016: WCHN, must be submitted to the WCHN HREC for review as the lead HREC.
p.000016:
p.000016: 12. Any multi-site project where the primary data being used for the project is held by the Department for Health and
p.000016: Wellbeing should be submitted to the Department for Health and Wellbeing HREC for review as the lead HREC.
p.000016:
p.000016: 13. If a research site is added to an existing project that has HREC approval, it is a requirement that the project is
p.000016: amended to add the new site and this amendment is approved by the lead HREC. The local investigator should then
p.000016: complete and submit the appropriate research governance documents to seek site approval along with a copy of the
p.000016: amendment approval letter issued by the HREC.
p.000016:
p.000016:
p.000016: 3.3 NATIONAL MUTUAL ACCEPTANCE
p.000016: National Mutual Acceptance (NMA) supports the single scientific and ethical review of multi-centre human research
p.000016: projects across participating Australian jurisdictions (public health organisations). The Standard Principles for
p.000016: Operation for NMA, available on the SA Health website provide the overarching framework for NMA and should be referred
p.000016: to by SA Health HRECs, researchers and others who may be involved in seeking approval to undertake research using the
p.000016: NMA system.
p.000016:
p.000016: NMA permits the review of any form of human research, as defined in the National Statement on Ethical Conduct in Human
p.000016: Research (2007) or any replacement of that document published by the National Health and Medical Research Council
p.000016: (NHMRC), for which an application must be made to an HREC for the purpose of research being conducted at a public
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p.000016: in Clinical Practice and Research (NHMRC, 2007).
p.000016:
p.000016:
p.000016: 3.12 IONISING RADIATION
p.000016: All research involving any form of radiation must comply with relevant National and State legislation, organisational
p.000016: policies and procedures, and codes and standards of practice provided by the NHMRC and the Australian Radiation
p.000016: Protection and Nuclear Safety Agency (ARPANSA).
p.000016:
p.000016: SA Health HRECs assessing research proposals involving exposure of participants to ionising radiation must be provided
p.000016: with a written report from an accredited medical physicist.
p.000016:
p.000016: In South Australia, the Environment Protection Authority (EPA) has responsibility for administering the Environmental
p.000016: Protection Act (1993) and Radiation Protection and Control Act (1982). The
p.000016:
p.000016: INFORMAL COPY WHEN PRINTED Research Ethics Policy Directive
p.000016: Page 10 of 16
p.000016:
p.000016: Public –I1-A1
p.000016:
p.000016: Radiation Protection Branch of the EPA must be notified of all research involving exposure of research participants to
p.000016: ionising radiation. This form should be used for notification purposes.
p.000016:
p.000016:
p.000016: 3.13 RESEARCH INVOLVING SA HEALTH DATA
p.000016: For research ethics applications that require access to data or confidential information held by SA Health, it is a
p.000016: requirement that access be granted on the basis of ethical approval from an appropriate Certified HREC and project
p.000016: authorisation by the appropriate Institution/s, following submission of a complete and satisfactory SSA.
p.000016: For projects being undertaken in South Australia only, the CPI should contact the HREC affiliated with their
p.000016: Institution to determine whether it is able to review the ethics application.
p.000016:
p.000016: Any SA based project where the primary data being used for the project is held by the Department for Health and
p.000016: Wellbeing (e.g. ISAAC or Cancer Registry Data) may be submitted to the Department for Health and Wellbeing HREC for
p.000016: ethical review.
p.000016:
p.000016: The data custodian has ultimate responsibility to approve or refuse the release of data for a specific research
p.000016: project, independent of the ethical determination made by the reviewing HREC.
p.000016:
p.000016:
p.000016: 3.14 COMPLAINTS PROCESS
p.000016: Each SA Health HREC is responsible for maintaining an appropriate complaints process for health and medical research
p.000016: projects that undergo ethics review and/or ethics approval that should consider:
p.000016: • Complaints made by research participants and/or research (or other) staff concerning the conduct of approved
p.000016: research being undertaken at an Institution;
p.000016: • Complaints made by ethics applicants regarding the ethical review process and/or outcome.
p.000016:
p.000016: The process for dealing with such complaints should be documented in the HREC SOPs, and be published on the local HREC
p.000016: website.
p.000016:
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p.000016: the ongoing conduct of the project.
p.000016:
p.000016: It is recommended that each SA Health HREC has documented processes that outline how breaches of ethical approval will
p.000016: be managed. These processes should be included in the HREC SOPs, and provide a consistent and transparent approach to
p.000016: these issues.
p.000016:
p.000016: All matters concerning possible breaches of research ethics approval should be dealt with in a timely manner, and any
p.000016: decision to either suspend or withdraw ethics approval should be communicated clearly to all key parties involved with
p.000016: the conduct of the project.
p.000016:
p.000016: INFORMAL COPY WHEN PRINTED Research Ethics Policy Directive
p.000016: Page 11 of 16
p.000016:
p.000016: Public –I1-A1
p.000016:
p.000016: 3.16 DATA STORAGE, RETENTION AND DISPOSAL REQUIREMENTS
p.000016:
p.000016: 3.16.1 SA Health records management requirements
p.000016: SA Health organisations are required to comply with the specific organisational requirements that apply to the
p.000016: retention, storage and disposal of HREC related materials, and research material and data specifically outlined in the
p.000016: General Disposal Schedule No. 28: Clinical and Client-Related Records of Public Health Units in South Australia
p.000016: (Section 6: Research and Ethics).
p.000016:
p.000016: 3.16.2 General requirements for researchers
p.000016: Researchers are responsible for ensuring appropriate arrangements with respect to the collection, storage and disposal
p.000016: of research materials including data, in compliance with all applicable requirements. Access to data and information
p.000016: collected during the conduct of research should be limited to those who are directly involved in the conduct of the
p.000016: project, and mechanisms such as use of locked filing cabinets or password protected computers may be warranted.
p.000016: Arrangements should be established for the ongoing handling of research materials in the event the investigator leaves
p.000016: the organisation.
p.000016:
p.000016: The Australian Code (section 2) outlines general requirements for the retention of research data, which should be
p.000016: observed by researchers undertaking approved research across SA Health:
p.000016: • In general, the minimum recommended period for retention of research data is 5 years from the date of
p.000016: publication. However, in any particular case, the period for which data should be retained should be determined by the
p.000016: specific type of research. For example:
p.000016: o For short term research projects, that are for assessment purposes only (e.g. research projects completed by
p.000016: students), retention of research data for 12 months after completion of the project may be sufficient.
p.000016: o For clinical trials, data should be retained for a minimum of 15 years for adult studies or 25 years for paediatric
p.000016: studies after formal notification is received that all study procedures are completed and the study is closed.
p.000016: o For areas such as gene therapy, research data must be retained permanently (e.g. patient records).
p.000016: o If the work has community or heritage value, research data should be kept permanently, preferably within a national
p.000016: collection.
p.000016:
p.000016:
p.000016: 3.17 RESEARCH MONITORING AND REPORTING
p.000016: Each SA Health HREC is required to include the agreed monitoring and safety reporting requirements for ethically
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Social / Child
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p.000016: Page 4 of 16
p.000016:
p.000016: Public –I1-A1
p.000016:
p.000016: • Data collection is explicitly directed at Aboriginal and Torres Strait Islander people; or
p.000016: • Where it is proposed to separately identify Aboriginal and Torres Strait Islander people in the results; or
p.000016: • The information has an impact on one or more Aboriginal and Torres Strait Islander communities; or
p.000016: • The geographic location of the research is such that a significant number of the population are likely to be of
p.000016: Aboriginal and Torres Strait Islander origin (based on 4.7.6 of the National Statement, 2007); or
p.000016: • Where terms such as ‘resilience’; ‘well-being’; ‘cultural safely’; ‘cultural health’; and ‘language and culture’
p.000016: are used in the description and design of the project indicating that the project has important health implications; or
p.000016: • Aboriginal and Torres Strait Islander health funds are a source of funding.
p.000016:
p.000016: 10. The CPI should provide the AHREC with a copy of the research application and the lead HRECs ethical determination
p.000016: on the project for consideration as soon as practicable. The AHREC will then provide their evaluation of the project
p.000016: to the lead HREC for consideration prior to providing feedback to the applicant. The AHREC will expedite their review
p.000016: where possible.
p.000016:
p.000016: 11. Ethics applications involving Women’s and Children’s Health Network (WCHN), and where the primary research
p.000016: participants are children and young people, or where the project involves access to paediatric data primarily held by
p.000016: WCHN, must be submitted to the WCHN HREC for review as the lead HREC.
p.000016:
p.000016: 12. Any multi-site project where the primary data being used for the project is held by the Department for Health and
p.000016: Wellbeing should be submitted to the Department for Health and Wellbeing HREC for review as the lead HREC.
p.000016:
p.000016: 13. If a research site is added to an existing project that has HREC approval, it is a requirement that the project is
p.000016: amended to add the new site and this amendment is approved by the lead HREC. The local investigator should then
p.000016: complete and submit the appropriate research governance documents to seek site approval along with a copy of the
p.000016: amendment approval letter issued by the HREC.
p.000016:
p.000016:
p.000016: 3.3 NATIONAL MUTUAL ACCEPTANCE
p.000016: National Mutual Acceptance (NMA) supports the single scientific and ethical review of multi-centre human research
p.000016: projects across participating Australian jurisdictions (public health organisations). The Standard Principles for
p.000016: Operation for NMA, available on the SA Health website provide the overarching framework for NMA and should be referred
p.000016: to by SA Health HRECs, researchers and others who may be involved in seeking approval to undertake research using the
p.000016: NMA system.
p.000016:
p.000016: NMA permits the review of any form of human research, as defined in the National Statement on Ethical Conduct in Human
p.000016: Research (2007) or any replacement of that document published by the National Health and Medical Research Council
p.000016: (NHMRC), for which an application must be made to an HREC for the purpose of research being conducted at a public
p.000016: health organisation. This includes low and negligible risk research review by a full HREC using the NHMRC’s national
p.000016: ethics form.
p.000016:
p.000016: In accordance with the Standard Principles for Operation, SA Health organisations are required to accept the approval
p.000016: of a NHMRC Certified HREC for a project submitted under NMA without requiring further ethical and scientific review.
p.000016: There are two categories of research that are exempt from being considered under NMA, being Phase 0 (first time in
p.000016: human) and Phase 1 Clinical Trials, and Aboriginal and Torres Strait Islander Projects. For further details on the two
p.000016: exemption areas, refer to section 8 of this Policy Directive.
p.000016:
p.000016: INFORMAL COPY WHEN PRINTED Research Ethics Policy Directive
p.000016: Page 5 of 16
p.000016:
p.000016: Public –I1-A1
p.000016:
p.000016: A list of Certified HRECs can be found here.
p.000016:
p.000016: 3.3.1 SA Health HREC Certification
p.000016: The following SA Health HRECs have been certified by the NHMRC to undertake review in the categories of research
p.000016: outlined.
p.000016:
p.000016: Women’s and Children’s Health Network Human Research Ethics Committee (EC00197)
p.000016: Certification categories:
p.000016: • Clinical trials phase I, II, III, IV.
p.000016: • Clinical trials drugs and devices.
p.000016: • Clinical trials surgery.
p.000016: • Clinical trials other.
p.000016: • Clinical interventional research other than clinical trials.
p.000016: • Population health and/or public health.
p.000016: • Qualitative research.
p.000016: • Mental health.
p.000016: • Paediatric research.
p.000016: • Other health and medical research:
p.000016: o Women’s health.
p.000016: o Genetic studies.
p.000016: o Oncology.
p.000016: o Tissue banking.
p.000016: Southern Adelaide Clinical Human Research Ethics Committee (EC00188)
p.000016: Certification categories:
p.000016: • Clinical trials phase I, II, III, IV.
p.000016: • Qualitative research.
p.000016: • Mental health.
p.000016: • Other health and medical research:
p.000016: o Palliative care.
p.000016: o Oncology.
p.000016: o Intensive care.
p.000016: Central Adelaide Local Health Network Human Research Ethics Committee (EC00192)
p.000016: Certification categories:
p.000016: • Clinical trials phase I, II, III, IV.
p.000016: • Clinical research other than clinical trials.
p.000016: • Population health and/or public health.
p.000016: • Qualitative research.
p.000016: • Mental health.
p.000016:
p.000016: SA Department for Health and Wellbeing Human Research Ethics Committee (EC00304)
p.000016: Certification categories:
p.000016: • Population health and/or public health.
p.000016: • Qualitative research.
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p.000016: that they can then submit to another suitable SA Health HREC.
p.000016:
p.000016: 9. The South Australian Aboriginal Health Research Ethics Committee (AHREC) reviews all research applications where
p.000016: the focus is on a topic or disease/health burden identified as being of specific concern to Aboriginal and Torres
p.000016: Strait Islander people (based on 4.7.6 of the National Statement, 2007). In addition to a research application having
p.000016: been submitted to and reviewed by SA Health HREC, proposals are required to be submitted to the AHREC if:
p.000016: • The experience of Aboriginal and Torres Strait Islander people is an explicit focus of all or part of the research;
p.000016: or
p.000016:
p.000016: INFORMAL COPY WHEN PRINTED Research Ethics Policy Directive
p.000016: Page 4 of 16
p.000016:
p.000016: Public –I1-A1
p.000016:
p.000016: • Data collection is explicitly directed at Aboriginal and Torres Strait Islander people; or
p.000016: • Where it is proposed to separately identify Aboriginal and Torres Strait Islander people in the results; or
p.000016: • The information has an impact on one or more Aboriginal and Torres Strait Islander communities; or
p.000016: • The geographic location of the research is such that a significant number of the population are likely to be of
p.000016: Aboriginal and Torres Strait Islander origin (based on 4.7.6 of the National Statement, 2007); or
p.000016: • Where terms such as ‘resilience’; ‘well-being’; ‘cultural safely’; ‘cultural health’; and ‘language and culture’
p.000016: are used in the description and design of the project indicating that the project has important health implications; or
p.000016: • Aboriginal and Torres Strait Islander health funds are a source of funding.
p.000016:
p.000016: 10. The CPI should provide the AHREC with a copy of the research application and the lead HRECs ethical determination
p.000016: on the project for consideration as soon as practicable. The AHREC will then provide their evaluation of the project
p.000016: to the lead HREC for consideration prior to providing feedback to the applicant. The AHREC will expedite their review
p.000016: where possible.
p.000016:
p.000016: 11. Ethics applications involving Women’s and Children’s Health Network (WCHN), and where the primary research
p.000016: participants are children and young people, or where the project involves access to paediatric data primarily held by
p.000016: WCHN, must be submitted to the WCHN HREC for review as the lead HREC.
p.000016:
p.000016: 12. Any multi-site project where the primary data being used for the project is held by the Department for Health and
p.000016: Wellbeing should be submitted to the Department for Health and Wellbeing HREC for review as the lead HREC.
p.000016:
p.000016: 13. If a research site is added to an existing project that has HREC approval, it is a requirement that the project is
p.000016: amended to add the new site and this amendment is approved by the lead HREC. The local investigator should then
p.000016: complete and submit the appropriate research governance documents to seek site approval along with a copy of the
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Social / Marital Status
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p.000016: ongoing monitoring of approved projects, in accordance with their Standard Operating Procedures, the requirements of
p.000016: the National Statement of Ethical Conduct in Human Research, and other legislative, policy and operational
p.000016: requirements.
p.000016:
p.000016: Researchers are responsible for undertaking research across SA Health in a safe and ethical manner, in compliance with
p.000016: this Policy Directive and all relevant policies, guidelines and procedures.
p.000016:
p.000016: The Department for Health and Wellbeing Office for Research is responsible for monitoring the implementation of this
p.000016: this Policy Directive and the ongoing review and update of this Policy Directive.
p.000016:
p.000016: 3. Policy Requirements
p.000016:
p.000016: 3.1 STREAMLINED ETHICAL REVIEW
p.000016: SA Health promotes efficiency in the ethical and scientific review of research projects being undertaken across SA
p.000016: Health by ensuring that reviews are sufficiently rigorous, undertaken in accordance with the risk level of the project,
p.000016: and are conducted with reference to the National Statement and other relevant guidelines.
p.000016:
p.000016:
p.000016:
p.000016: INFORMAL COPY WHEN PRINTED Research Ethics Policy Directive
p.000016: Page 3 of 16
p.000016:
p.000016: Public –I1-A1
p.000016:
p.000016: SA Health supports two approaches for streamlined review based upon the mutual recognition of ethical review by
p.000016: properly constituted HRECs. These approaches are complementary, and provide two pathways for researchers conducting
p.000016: research within the South Australian public health system to efficiently gain ethical approval:
p.000016: • The SA Health Single Ethical Review Model – for research taking place within the South Australian public health
p.000016: system.
p.000016: • National Mutual Acceptance – for multi-centre human research projects taking place across participating
p.000016: Australian jurisdictions (public health organisations only).
p.000016:
p.000016:
p.000016: 3.2 SA HEALTH SINGLE ETHICAL REVIEW MODEL
p.000016: 1. Every research project which is to be conducted at a site under the jurisdiction of SA Health will be ethically
p.000016: and scientifically reviewed once only by a SA Health HREC or another South Australian based NHMRC certified HREC. The
p.000016: reviewing committee is designated the lead HREC.
p.000016: 2. All sites under the jurisdiction of SA Health that are participating in the proposed research will accept the
p.000016: review of the lead HREC without further ethical or scientific consideration, with appropriate exceptions established by
p.000016: the LHN board and Chief Executive.
p.000016: 3. The research ethics applicant (the Coordinating Principal Investigator or CPI) will select a lead HREC to
p.000016: undertake single review from a register of HRECs on the SA Health ethics website. . The applicant will assume
p.000016: responsibility for submitting all required documentation in accordance with SA Health and local HREC requirements.
p.000016: 4. Lead HRECs must be appropriately constituted in accordance with the requirements of the NHMRC, and fulfil the
p.000016: requirements of the National Statement (section 5.2). Additionally they must have access to the required expertise to
p.000016: undertake a full scientific and ethical review of the type of research which is submitted.
p.000016: 5. Every research application must undergo a separate research governance review at each site where the research is
p.000016: to be conducted to permit consideration and approval of the research governance requirements at that site (a site
p.000016: specific assessment). This is distinct from the scientific and ethical review by the lead HREC.
p.000016: 6. The lead HREC will be responsible for the full scientific and ethical review of the research application. Once
p.000016: completed, the lead HREC will be responsible for notifying the CPI of the outcome of the review. It is the CPIs
p.000016: responsibility to notify the outcome of this review to each of the other sites where the project is proposed to take
p.000016: place, via the Research Governance Officer associated with the site/s.
p.000016: 7. Under this model, HRECs will have the right to refuse to consider a multi-site application only under the
p.000016: following circumstances:
p.000016: i. The HREC Chairperson determines there is insufficient expertise on or available to the HREC to permit an
p.000016: adequate scientific and ethical review of the proposal; or
...
p.000016:
p.000016: 10. The CPI should provide the AHREC with a copy of the research application and the lead HRECs ethical determination
p.000016: on the project for consideration as soon as practicable. The AHREC will then provide their evaluation of the project
p.000016: to the lead HREC for consideration prior to providing feedback to the applicant. The AHREC will expedite their review
p.000016: where possible.
p.000016:
p.000016: 11. Ethics applications involving Women’s and Children’s Health Network (WCHN), and where the primary research
p.000016: participants are children and young people, or where the project involves access to paediatric data primarily held by
p.000016: WCHN, must be submitted to the WCHN HREC for review as the lead HREC.
p.000016:
p.000016: 12. Any multi-site project where the primary data being used for the project is held by the Department for Health and
p.000016: Wellbeing should be submitted to the Department for Health and Wellbeing HREC for review as the lead HREC.
p.000016:
p.000016: 13. If a research site is added to an existing project that has HREC approval, it is a requirement that the project is
p.000016: amended to add the new site and this amendment is approved by the lead HREC. The local investigator should then
p.000016: complete and submit the appropriate research governance documents to seek site approval along with a copy of the
p.000016: amendment approval letter issued by the HREC.
p.000016:
p.000016:
p.000016: 3.3 NATIONAL MUTUAL ACCEPTANCE
p.000016: National Mutual Acceptance (NMA) supports the single scientific and ethical review of multi-centre human research
p.000016: projects across participating Australian jurisdictions (public health organisations). The Standard Principles for
p.000016: Operation for NMA, available on the SA Health website provide the overarching framework for NMA and should be referred
p.000016: to by SA Health HRECs, researchers and others who may be involved in seeking approval to undertake research using the
p.000016: NMA system.
p.000016:
p.000016: NMA permits the review of any form of human research, as defined in the National Statement on Ethical Conduct in Human
p.000016: Research (2007) or any replacement of that document published by the National Health and Medical Research Council
p.000016: (NHMRC), for which an application must be made to an HREC for the purpose of research being conducted at a public
p.000016: health organisation. This includes low and negligible risk research review by a full HREC using the NHMRC’s national
p.000016: ethics form.
p.000016:
p.000016: In accordance with the Standard Principles for Operation, SA Health organisations are required to accept the approval
p.000016: of a NHMRC Certified HREC for a project submitted under NMA without requiring further ethical and scientific review.
p.000016: There are two categories of research that are exempt from being considered under NMA, being Phase 0 (first time in
p.000016: human) and Phase 1 Clinical Trials, and Aboriginal and Torres Strait Islander Projects. For further details on the two
p.000016: exemption areas, refer to section 8 of this Policy Directive.
p.000016:
p.000016: INFORMAL COPY WHEN PRINTED Research Ethics Policy Directive
p.000016: Page 5 of 16
p.000016:
p.000016: Public –I1-A1
p.000016:
...
p.000016: scientific review.
p.000016: 7. The CPI will be responsible for communicating the outcomes of the ethical and scientific review to all
p.000016: participating research sites through their Principal Investigators.
p.000016: 8. Where a protocol is not approved, the CPI may resubmit the protocol to the lead HREC, providing the grounds for
p.000016: non-approval are remedied.
p.000016: 9. The lead HREC will be responsible for reviewing any amendments to the protocol that are submitted during the life
p.000016: of the research project. In all cases, the CPI is responsible for notifying other participating sites of the outcomes
p.000016: of the review rather than the HREC.
p.000016: 10. The lead HREC will be responsible for reviewing all adverse events that may occur during the life of the research
p.000016: project.
p.000016:
p.000016:
p.000016: 3.4 ETHICS FORM REQUIREMENTS
p.000016: The Human Research Ethics Application (HREA) form has been developed by the NHMRC as a standardised human research
p.000016: ethics application form that may be accepted by Australian research ethics committees. A licensed version of the HREA
p.000016: is available on Online Forms.
p.000016:
p.000016: SA Health supports the use of the HREA and the following guidelines should be observed.
p.000016:
p.000016: 3.4.1 SA Health only research
p.000016: For multi-centre research proposals being conducted across SA Health, SA Health HRECs are encouraged to accept the
p.000016: HREA. Ethics applicants may discuss alternative application forms with the reviewing HREC. For single-site research
p.000016: only, the HREC may choose to accept proposals using a locally developed ethics application form or the HREA.
p.000016:
p.000016: 3.4.2 National Mutual Acceptance
p.000016: Use of the HREA is a requirement for all research ethics proposals submitted under NMA.
p.000016:
p.000016:
p.000016: 3.5 ETHICS APPLICATION SUBMISSION
p.000016: SA Health HRECs are responsible for ensuring human research ethics submission requirements are published appropriately
p.000016: and readily available to applicants.
p.000016:
p.000016: While the electronic submission of HREC applications is preferable, each SA Health HREC is responsible for developing
p.000016: submission guidelines that meet their individual needs.
p.000016:
p.000016:
p.000016:
p.000016: INFORMAL COPY WHEN PRINTED Research Ethics Policy Directive
p.000016: Page 7 of 16
p.000016:
p.000016: Public –I1-A1
p.000016:
p.000016: The ethics applicant is responsible for submitting all required documents to the HREC in accordance with the submission
p.000016: requirements.
p.000016:
p.000016: 3.5.1 Low and Negligible Risk Research
p.000016: The National Statement enables HRECs to adopt processes for expediting the review of low risk projects. Low risk
...
p.000016: 5. National Safety and Quality Health Service Standards
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016: National Standard 1
p.000016: National Standard 2
p.000016: National Standard 3
p.000016: National Standard 4
p.000016: National Standard 5
p.000016: National Standard 6
p.000016: National Standard 7
p.000016: National Standard 8
p.000016: National Standard 9
p.000016: National Standard 10
p.000016:
p.000016:
p.000016: Governance for Safety and Quality in Health Care
p.000016:
p.000016: ☒
p.000016:
p.000016: Partnering with Consumers
p.000016:
p.000016:
p.000016: ☐
p.000016:
p.000016: Preventing & Controlling Healthcare associated infections
p.000016: ☐
p.000016:
p.000016: Medication Safety
p.000016:
p.000016:
p.000016:
p.000016: ☐
p.000016:
p.000016: Patient Identification & Procedure Matching
p.000016:
p.000016:
p.000016: ☐
p.000016:
p.000016: Clinical Handover
p.000016:
p.000016:
p.000016:
p.000016: ☐
p.000016:
p.000016: Blood and Blood Products
p.000016:
p.000016:
p.000016: ☐
p.000016:
p.000016: Preventing
p.000016: & Managing Pressure Injuries
p.000016:
p.000016: ☐
p.000016:
p.000016: Recognising & Responding to Clinical Deterioration
p.000016:
p.000016:
p.000016: ☐
p.000016:
p.000016: Preventing Falls & Harm from Falls
p.000016:
p.000016:
p.000016: ☐
p.000016:
p.000016: 6. Definitions
p.000016:
p.000016: In the context of this document:
p.000016:
p.000016: AHREC means Aboriginal Health Research Ethics Committee.
p.000016:
p.000016: Certified HREC means a Human Research Ethics Committee that has received certification by the NHMRC to undertake the
p.000016: single scientific and ethical review of a multi-centre research project.
p.000016:
p.000016: Clinical trial means a research study designed to test the safety and/or efficacy of a medical treatment or
p.000016: intervention, often involving a treatment and control arm.
p.000016:
p.000016: CTN means the Clinical Trial Notification scheme developed by the Therapeutic Goods Administration (TGA) to permit
p.000016: unregistered medicines and medical devices to be used in the context of a clinical research trial. For CTN trials, the
p.000016: local HREC is solely responsible for reviewing and determining the safety and appropriateness of the medicine/device in
p.000016: the context of the trial.
p.000016:
p.000016: CTX means the Clinical Trial Exemption scheme developed by the Therapeutic Goods Administration (TGA) to permit
p.000016: unregistered medicines and medical devices to be used in the context of a clinical research trial. For CTX trials, the
p.000016: TGA is also involved in assessing the safety and appropriateness of the medicine/device in the context of the trial.
p.000016:
p.000016: Coordinating Principal Investigator (CPI) means the lead investigator on a research study taking overall responsibility
p.000016: for the conduct of the study at all of the study sites.
p.000016: HREA means the Human Research Ethics Application form developed by the NHMRC.
p.000016:
p.000016:
p.000016: INFORMAL COPY WHEN PRINTED Research Ethics Policy Directive
p.000016: Page 14 of 16
p.000016:
p.000016: Public –I1-A1
p.000016:
p.000016: HREC means Human Research Ethics Committee.
p.000016:
p.000016: IBC means Institutional Biosafety Committee.
p.000016:
p.000016: ISAAC means the Integrated South Australian Activity Collection (ISAAC), an admitted patient morbidity data collection
p.000016: maintained by SA Health.
p.000016:
p.000016: Lead HREC means the human research ethics committee responsible for the single ethical and scientific review of a
p.000016: research ethics application.
p.000016:
p.000016: National Mutual Acceptance (NMA) means the single scientific and ethical review of human research projects across
p.000016: participating jurisdictions.
p.000016:
p.000016: National Statement means The NHMRC’s National Statement on Ethical Conduct in Human Research (2007).
p.000016:
p.000016: NHMRC means National Health and Medical Research Council.
p.000016:
p.000016: NHMRC Certified HREC means an institution/HREC that has been certified by the NHMRC to undertake the single scientific
p.000016: and ethical review of human research projects.
p.000016:
p.000016: OACIS means an electronic clinical patient information system owned by SA Health.
p.000016:
p.000016: Principal Investigator means the lead investigator responsible for the conduct and management of a research project at
p.000016: a local Institution or Site.
p.000016:
p.000016: RGO means Research Governance Officer.
p.000016:
p.000016: SA Health means the health portfolio of services and agencies responsible to the Minister for Health, Minister for
p.000016: Mental Health and Substance Abuse and the Minister for Ageing.
p.000016:
p.000016: SAE means: Serious Adverse Event.
p.000016:
p.000016: SOP means: Standard Operating Procedure.
p.000016:
p.000016: SSA means: Site Specific Assessment.
p.000016:
p.000016: TGA means: Therapeutic Goods Administration.
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016: INFORMAL COPY WHEN PRINTED Research Ethics Policy Directive
p.000016: Page 15 of 16
p.000016:
p.000016: Public –I1-A1
p.000016:
p.000016: 7. Associated Policy Directives / Policy Guidelines and Resources
p.000016:
p.000016: SA Health Research Governance Policy Directive (2020)
p.000016:
p.000016: SA Health Privacy Policy Directive (2017)
p.000016:
p.000016: General Disposal Schedule No. 28: Clinical and Client-Related Records of Public Health Units in South Australia (2014)
p.000016:
p.000016:
p.000016: 8. Document Ownership & History
...
Social / Police Officer
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p.000016: the LHN board and Chief Executive.
p.000016: 3. The research ethics applicant (the Coordinating Principal Investigator or CPI) will select a lead HREC to
p.000016: undertake single review from a register of HRECs on the SA Health ethics website. . The applicant will assume
p.000016: responsibility for submitting all required documentation in accordance with SA Health and local HREC requirements.
p.000016: 4. Lead HRECs must be appropriately constituted in accordance with the requirements of the NHMRC, and fulfil the
p.000016: requirements of the National Statement (section 5.2). Additionally they must have access to the required expertise to
p.000016: undertake a full scientific and ethical review of the type of research which is submitted.
p.000016: 5. Every research application must undergo a separate research governance review at each site where the research is
p.000016: to be conducted to permit consideration and approval of the research governance requirements at that site (a site
p.000016: specific assessment). This is distinct from the scientific and ethical review by the lead HREC.
p.000016: 6. The lead HREC will be responsible for the full scientific and ethical review of the research application. Once
p.000016: completed, the lead HREC will be responsible for notifying the CPI of the outcome of the review. It is the CPIs
p.000016: responsibility to notify the outcome of this review to each of the other sites where the project is proposed to take
p.000016: place, via the Research Governance Officer associated with the site/s.
p.000016: 7. Under this model, HRECs will have the right to refuse to consider a multi-site application only under the
p.000016: following circumstances:
p.000016: i. The HREC Chairperson determines there is insufficient expertise on or available to the HREC to permit an
p.000016: adequate scientific and ethical review of the proposal; or
p.000016: ii. The HREC is not able to review the proposal in a timely manner (e.g. the meeting agenda for the next HREC
p.000016: meeting has reached capacity).
p.000016:
p.000016: 8. In these circumstances (7 [i] and [ii]), the HREC should notify the applicant as soon as practicable in order
p.000016: that they can then submit to another suitable SA Health HREC.
p.000016:
p.000016: 9. The South Australian Aboriginal Health Research Ethics Committee (AHREC) reviews all research applications where
p.000016: the focus is on a topic or disease/health burden identified as being of specific concern to Aboriginal and Torres
p.000016: Strait Islander people (based on 4.7.6 of the National Statement, 2007). In addition to a research application having
p.000016: been submitted to and reviewed by SA Health HREC, proposals are required to be submitted to the AHREC if:
p.000016: • The experience of Aboriginal and Torres Strait Islander people is an explicit focus of all or part of the research;
p.000016: or
p.000016:
p.000016: INFORMAL COPY WHEN PRINTED Research Ethics Policy Directive
p.000016: Page 4 of 16
p.000016:
p.000016: Public –I1-A1
p.000016:
p.000016: • Data collection is explicitly directed at Aboriginal and Torres Strait Islander people; or
...
p.000016: and should be maintained and updated appropriately.
p.000016:
p.000016:
p.000016: 3.8 HREC COMPLAINTS AND APPEALS PROCESS
p.000016: Section 5.1(4) of the National Statement requires institutions to establish processes to handle complaints concerning
p.000016: research. Where a SA public health system HREC rejects a research proposal outright on ethical grounds, makes an
p.000016: unfavourable decision about a component of the research proposal, or fails to reach a decision about the ethics of a
p.000016: research proposal, the investigator has the following rights:
p.000016: INFORMAL COPY WHEN PRINTED Research Ethics Policy Directive
p.000016: Page 8 of 16
p.000016:
p.000016: Public –I1-A1
p.000016:
p.000016: a) Where a proposal has been rejected, the investigator may submit a new application to the HREC, taking due account
p.000016: of the HREC’s concerns. The revised application will be processed and reviewed in accordance with the HREC’s usual
p.000016: processes; or
p.000016: b) Where (a) does not apply, the investigator may lodge a written appeal with the HREC Chairperson specifying the
p.000016: grounds of the appeal. The Chairperson will investigate the appeal, and recommend to the HREC the appropriate course of
p.000016: action within 4 weeks from the date of the appeal being lodged. The HREC will notify the appellant of the course of
p.000016: action and determination in a timely manner.
p.000016:
p.000016: 3.8.1 Appeals Mechanism
p.000016: Following an appeal being lodged to the HREC Chairperson, if the appellant considers that the HREC has not followed due
p.000016: process or remains unsatisfied with the outcome, they may choose to lodge an appeal with the Chief Executive Officer /
p.000016: delegate responsible for the HREC.
p.000016:
p.000016: The following process will be followed:
p.000016: a) The Chairperson will provide the Chief Executive Officer / delegate with all relevant material, including:
p.000016: a. Details of the appeal;
p.000016: b. Material reviewed by the HREC; and
p.000016: c. The outcome/decision of the ethical review process.
p.000016:
p.000016: b) The Chief Executive Officer / delegate will determine if further investigation of the appeal is necessary. If so,
p.000016: a panel will be established to consider the appeal. The panel will include the following members:
p.000016: a. The Chief Executive Officer / delegate;
p.000016: b. Two nominees of the Chief Executive Officer / delegate (not members of the HREC);
p.000016: c. At least one nominee with relevant expertise in human research ethics; and
p.000016: d. Expert(s) in a discipline of research related to the project under consideration.
p.000016:
p.000016: c) The panel will allow the HREC and the appellant the opportunity to make submissions.
p.000016:
p.000016: d) The Chief Executive Officer / delegate will notify the HREC and the appellant of the outcome of the investigation.
p.000016: The possible outcomes include:
p.000016: a. The appeal is dismissed; or
p.000016: b. The appeal is upheld and the panel makes recommendation to resolve the issues based on the findings of the panel.
p.000016: The panel does not have the authority to approve an ethics application, but may choose to refer an ethics application
p.000016: to an independent ethics committee for re-review.
p.000016:
p.000016: If the panel or Chief Executive Officer / delegate requests that a second ethical review is required as a
p.000016: recommendation of the investigation, an alternative SA public health system HREC (where possible) with suitable
p.000016: expertise and no prior involvement in the matter will be invited to undertake this review.
p.000016:
p.000016: The panel or Chief Executive Officer / delegate cannot reverse the final determination of any HREC.
p.000016:
p.000016:
p.000016: 3.9 USE OF APPROVED AND UNAPPROVED MEDICINES AND MEDICAL DEVICES
p.000016: Research that involves the use of approved or unapproved medicines, medical devices, blood, tissues and chemicals must
p.000016: be compliant with the legislation, regulations and guidelines of the Therapeutic Goods Administration (TGA).
p.000016:
p.000016:
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p.000016: Page 9 of 16
p.000016:
p.000016: Public –I1-A1
p.000016:
p.000016: Use of medicines or medical devices within the context of an approved research project does not guarantee their use
p.000016: beyond the scope of the research project.
p.000016:
p.000016:
p.000016: 3.10 CLINICAL RESEARCH TRIALS CONDUCTED UNDER THE CTN OR CTX SCHEMES
p.000016: The TGA permits the use of unregistered or unapproved medicines or medical devices to assess their safety and efficacy
p.000016: within the context of a monitored clinical research trial under Sections 18 and 19 of the Therapeutic Goods Act (1989).
p.000016: This is done through either the Clinical Trial Notification (CTN) or Clinical Trial Exemption (CTX) schemes.
p.000016:
p.000016: For the CTN scheme, the reviewing HREC has sole responsibility for reviewing all the data relating to the trial, such
p.000016: as safety data pertaining to the investigative medicine or device. It also has responsibility for making a
p.000016: determination about the scientific and ethical merit of the trial.
p.000016:
p.000016: For the CTX scheme, the TGA has responsibility for reviewing relevant data including preclinical data pertaining to the
p.000016: investigative medicine or device. The TGA’s review of this data is taken into account by the reviewing HREC, who will
...
p.000016: Safety monitoring and reporting in clinical trials involving therapeutic goods.
p.000016:
p.000016:
p.000016: 3.18 MANAGEMENT OF RESEARCH ETHICS APPLICATIONS
p.000016: SA Health requires HRECs to use the approved research management system for all research ethics submissions. HRECs are
p.000016: required to maintain complete records of human research ethics applications, including correspondence and decisions
p.000016: relating to the review of HREC submissions, in accordance with the requirements of Section 5 of the National Statement.
p.000016: SA Health HRECs are also required to record review times for HREC submissions using the approved research management
p.000016: system to enable appropriate monitoring and reporting as required.
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
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p.000016:
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p.000016:
p.000016:
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p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
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p.000016:
p.000016: 4. Implementation & Monitoring
p.000016:
p.000016: Each Local Health Network through the Chief Executive Officer is responsible for implementing the requirements of this
p.000016: Policy Directive.
p.000016:
p.000016: The Department for Health and Wellbeing Office for Research is responsible for monitoring the implementation of this
p.000016: Policy Directive in conjunction with the Local Health Networks.
p.000016:
p.000016: The Local Health Networks will report on key research outputs and performance measures linked to this Policy Directive
p.000016: through their annual research report provided to the Chief Executive, SA Health, as a component of the Service Level
p.000016: Agreements.
p.000016:
p.000016:
p.000016: 5. National Safety and Quality Health Service Standards
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016: National Standard 1
p.000016: National Standard 2
p.000016: National Standard 3
p.000016: National Standard 4
p.000016: National Standard 5
p.000016: National Standard 6
p.000016: National Standard 7
p.000016: National Standard 8
p.000016: National Standard 9
p.000016: National Standard 10
p.000016:
p.000016:
p.000016: Governance for Safety and Quality in Health Care
p.000016:
p.000016: ☒
p.000016:
p.000016: Partnering with Consumers
p.000016:
p.000016:
p.000016: ☐
p.000016:
p.000016: Preventing & Controlling Healthcare associated infections
p.000016: ☐
p.000016:
p.000016: Medication Safety
p.000016:
p.000016:
p.000016:
p.000016: ☐
p.000016:
p.000016: Patient Identification & Procedure Matching
p.000016:
p.000016:
p.000016: ☐
p.000016:
p.000016: Clinical Handover
p.000016:
p.000016:
p.000016:
p.000016: ☐
p.000016:
p.000016: Blood and Blood Products
p.000016:
p.000016:
p.000016: ☐
p.000016:
p.000016: Preventing
p.000016: & Managing Pressure Injuries
p.000016:
p.000016: ☐
p.000016:
p.000016: Recognising & Responding to Clinical Deterioration
p.000016:
p.000016:
p.000016: ☐
p.000016:
...
p.000016: Page 14 of 16
p.000016:
p.000016: Public –I1-A1
p.000016:
p.000016: HREC means Human Research Ethics Committee.
p.000016:
p.000016: IBC means Institutional Biosafety Committee.
p.000016:
p.000016: ISAAC means the Integrated South Australian Activity Collection (ISAAC), an admitted patient morbidity data collection
p.000016: maintained by SA Health.
p.000016:
p.000016: Lead HREC means the human research ethics committee responsible for the single ethical and scientific review of a
p.000016: research ethics application.
p.000016:
p.000016: National Mutual Acceptance (NMA) means the single scientific and ethical review of human research projects across
p.000016: participating jurisdictions.
p.000016:
p.000016: National Statement means The NHMRC’s National Statement on Ethical Conduct in Human Research (2007).
p.000016:
p.000016: NHMRC means National Health and Medical Research Council.
p.000016:
p.000016: NHMRC Certified HREC means an institution/HREC that has been certified by the NHMRC to undertake the single scientific
p.000016: and ethical review of human research projects.
p.000016:
p.000016: OACIS means an electronic clinical patient information system owned by SA Health.
p.000016:
p.000016: Principal Investigator means the lead investigator responsible for the conduct and management of a research project at
p.000016: a local Institution or Site.
p.000016:
p.000016: RGO means Research Governance Officer.
p.000016:
p.000016: SA Health means the health portfolio of services and agencies responsible to the Minister for Health, Minister for
p.000016: Mental Health and Substance Abuse and the Minister for Ageing.
p.000016:
p.000016: SAE means: Serious Adverse Event.
p.000016:
p.000016: SOP means: Standard Operating Procedure.
p.000016:
p.000016: SSA means: Site Specific Assessment.
p.000016:
p.000016: TGA means: Therapeutic Goods Administration.
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016: INFORMAL COPY WHEN PRINTED Research Ethics Policy Directive
p.000016: Page 15 of 16
p.000016:
p.000016: Public –I1-A1
p.000016:
p.000016: 7. Associated Policy Directives / Policy Guidelines and Resources
p.000016:
p.000016: SA Health Research Governance Policy Directive (2020)
p.000016:
p.000016: SA Health Privacy Policy Directive (2017)
p.000016:
p.000016: General Disposal Schedule No. 28: Clinical and Client-Related Records of Public Health Units in South Australia (2014)
p.000016:
p.000016:
p.000016: 8. Document Ownership & History
p.000016: Document developed by: Office for Research, Department for Health and Wellbeing
p.000016: File / Objective No.: 2018-13236
p.000016: Next review due: 01/07/2023
p.000016: Policy history: Is this a new policy: N
p.000016: Does this policy amend or update and existing policy? Y
p.000016: If so, which version? V3.1
p.000016: Does this policy replace another policy with a different title? N
...
Social / Victim of Abuse
Searching for indicator abuse:
(return to top)
p.000016:
p.000016: ISAAC means the Integrated South Australian Activity Collection (ISAAC), an admitted patient morbidity data collection
p.000016: maintained by SA Health.
p.000016:
p.000016: Lead HREC means the human research ethics committee responsible for the single ethical and scientific review of a
p.000016: research ethics application.
p.000016:
p.000016: National Mutual Acceptance (NMA) means the single scientific and ethical review of human research projects across
p.000016: participating jurisdictions.
p.000016:
p.000016: National Statement means The NHMRC’s National Statement on Ethical Conduct in Human Research (2007).
p.000016:
p.000016: NHMRC means National Health and Medical Research Council.
p.000016:
p.000016: NHMRC Certified HREC means an institution/HREC that has been certified by the NHMRC to undertake the single scientific
p.000016: and ethical review of human research projects.
p.000016:
p.000016: OACIS means an electronic clinical patient information system owned by SA Health.
p.000016:
p.000016: Principal Investigator means the lead investigator responsible for the conduct and management of a research project at
p.000016: a local Institution or Site.
p.000016:
p.000016: RGO means Research Governance Officer.
p.000016:
p.000016: SA Health means the health portfolio of services and agencies responsible to the Minister for Health, Minister for
p.000016: Mental Health and Substance Abuse and the Minister for Ageing.
p.000016:
p.000016: SAE means: Serious Adverse Event.
p.000016:
p.000016: SOP means: Standard Operating Procedure.
p.000016:
p.000016: SSA means: Site Specific Assessment.
p.000016:
p.000016: TGA means: Therapeutic Goods Administration.
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016: INFORMAL COPY WHEN PRINTED Research Ethics Policy Directive
p.000016: Page 15 of 16
p.000016:
p.000016: Public –I1-A1
p.000016:
p.000016: 7. Associated Policy Directives / Policy Guidelines and Resources
p.000016:
p.000016: SA Health Research Governance Policy Directive (2020)
p.000016:
p.000016: SA Health Privacy Policy Directive (2017)
p.000016:
p.000016: General Disposal Schedule No. 28: Clinical and Client-Related Records of Public Health Units in South Australia (2014)
p.000016:
p.000016:
p.000016: 8. Document Ownership & History
p.000016: Document developed by: Office for Research, Department for Health and Wellbeing
p.000016: File / Objective No.: 2018-13236
p.000016: Next review due: 01/07/2023
p.000016: Policy history: Is this a new policy: N
p.000016: Does this policy amend or update and existing policy? Y
p.000016: If so, which version? V3.1
p.000016: Does this policy replace another policy with a different title? N
p.000016: ISBN 978-1-76083-304-6
p.000016:
p.000016:
p.000016: Approval Date
p.000016: 16/07/20
p.000016:
p.000016: 13/11/17
p.000016:
p.000016: 04/01/16
p.000016:
p.000016: 01/07/13
p.000016:
p.000016: Version
p.000016:
p.000016: 3.2
p.000016:
p.000016: 3.1
p.000016:
...
Social / Women
Searching for indicator women:
(return to top)
p.000016: or
p.000016:
p.000016: INFORMAL COPY WHEN PRINTED Research Ethics Policy Directive
p.000016: Page 4 of 16
p.000016:
p.000016: Public –I1-A1
p.000016:
p.000016: • Data collection is explicitly directed at Aboriginal and Torres Strait Islander people; or
p.000016: • Where it is proposed to separately identify Aboriginal and Torres Strait Islander people in the results; or
p.000016: • The information has an impact on one or more Aboriginal and Torres Strait Islander communities; or
p.000016: • The geographic location of the research is such that a significant number of the population are likely to be of
p.000016: Aboriginal and Torres Strait Islander origin (based on 4.7.6 of the National Statement, 2007); or
p.000016: • Where terms such as ‘resilience’; ‘well-being’; ‘cultural safely’; ‘cultural health’; and ‘language and culture’
p.000016: are used in the description and design of the project indicating that the project has important health implications; or
p.000016: • Aboriginal and Torres Strait Islander health funds are a source of funding.
p.000016:
p.000016: 10. The CPI should provide the AHREC with a copy of the research application and the lead HRECs ethical determination
p.000016: on the project for consideration as soon as practicable. The AHREC will then provide their evaluation of the project
p.000016: to the lead HREC for consideration prior to providing feedback to the applicant. The AHREC will expedite their review
p.000016: where possible.
p.000016:
p.000016: 11. Ethics applications involving Women’s and Children’s Health Network (WCHN), and where the primary research
p.000016: participants are children and young people, or where the project involves access to paediatric data primarily held by
p.000016: WCHN, must be submitted to the WCHN HREC for review as the lead HREC.
p.000016:
p.000016: 12. Any multi-site project where the primary data being used for the project is held by the Department for Health and
p.000016: Wellbeing should be submitted to the Department for Health and Wellbeing HREC for review as the lead HREC.
p.000016:
p.000016: 13. If a research site is added to an existing project that has HREC approval, it is a requirement that the project is
p.000016: amended to add the new site and this amendment is approved by the lead HREC. The local investigator should then
p.000016: complete and submit the appropriate research governance documents to seek site approval along with a copy of the
p.000016: amendment approval letter issued by the HREC.
p.000016:
p.000016:
p.000016: 3.3 NATIONAL MUTUAL ACCEPTANCE
p.000016: National Mutual Acceptance (NMA) supports the single scientific and ethical review of multi-centre human research
p.000016: projects across participating Australian jurisdictions (public health organisations). The Standard Principles for
p.000016: Operation for NMA, available on the SA Health website provide the overarching framework for NMA and should be referred
p.000016: to by SA Health HRECs, researchers and others who may be involved in seeking approval to undertake research using the
p.000016: NMA system.
p.000016:
p.000016: NMA permits the review of any form of human research, as defined in the National Statement on Ethical Conduct in Human
p.000016: Research (2007) or any replacement of that document published by the National Health and Medical Research Council
p.000016: (NHMRC), for which an application must be made to an HREC for the purpose of research being conducted at a public
p.000016: health organisation. This includes low and negligible risk research review by a full HREC using the NHMRC’s national
p.000016: ethics form.
p.000016:
p.000016: In accordance with the Standard Principles for Operation, SA Health organisations are required to accept the approval
p.000016: of a NHMRC Certified HREC for a project submitted under NMA without requiring further ethical and scientific review.
p.000016: There are two categories of research that are exempt from being considered under NMA, being Phase 0 (first time in
p.000016: human) and Phase 1 Clinical Trials, and Aboriginal and Torres Strait Islander Projects. For further details on the two
p.000016: exemption areas, refer to section 8 of this Policy Directive.
p.000016:
p.000016: INFORMAL COPY WHEN PRINTED Research Ethics Policy Directive
p.000016: Page 5 of 16
p.000016:
p.000016: Public –I1-A1
p.000016:
p.000016: A list of Certified HRECs can be found here.
p.000016:
p.000016: 3.3.1 SA Health HREC Certification
p.000016: The following SA Health HRECs have been certified by the NHMRC to undertake review in the categories of research
p.000016: outlined.
p.000016:
p.000016: Women’s and Children’s Health Network Human Research Ethics Committee (EC00197)
p.000016: Certification categories:
p.000016: • Clinical trials phase I, II, III, IV.
p.000016: • Clinical trials drugs and devices.
p.000016: • Clinical trials surgery.
p.000016: • Clinical trials other.
p.000016: • Clinical interventional research other than clinical trials.
p.000016: • Population health and/or public health.
p.000016: • Qualitative research.
p.000016: • Mental health.
p.000016: • Paediatric research.
p.000016: • Other health and medical research:
p.000016: o Women’s health.
p.000016: o Genetic studies.
p.000016: o Oncology.
p.000016: o Tissue banking.
p.000016: Southern Adelaide Clinical Human Research Ethics Committee (EC00188)
p.000016: Certification categories:
p.000016: • Clinical trials phase I, II, III, IV.
p.000016: • Qualitative research.
p.000016: • Mental health.
p.000016: • Other health and medical research:
p.000016: o Palliative care.
p.000016: o Oncology.
p.000016: o Intensive care.
p.000016: Central Adelaide Local Health Network Human Research Ethics Committee (EC00192)
p.000016: Certification categories:
p.000016: • Clinical trials phase I, II, III, IV.
p.000016: • Clinical research other than clinical trials.
p.000016: • Population health and/or public health.
p.000016: • Qualitative research.
p.000016: • Mental health.
p.000016:
p.000016: SA Department for Health and Wellbeing Human Research Ethics Committee (EC00304)
p.000016: Certification categories:
p.000016: • Population health and/or public health.
p.000016: • Qualitative research.
p.000016: • Mental health.
p.000016: • Other health and medical research:
p.000016: o Data linkage research.
p.000016:
p.000016:
p.000016:
p.000016:
p.000016: INFORMAL COPY WHEN PRINTED Research Ethics Policy Directive
p.000016: Page 6 of 16
p.000016:
p.000016: Public –I1-A1
p.000016:
p.000016: 3.3.2 Procedures for SA Health HRECs acting as the ‘lead’ HREC for NMA
p.000016: 1. South Australian researchers who wish to undertake a new research project eligible for review under NMA should
p.000016: identify an appropriate Certified SA Health HREC (the ‘lead’ HREC).
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000016: delegate responsible for the HREC.
p.000016:
p.000016: The following process will be followed:
p.000016: a) The Chairperson will provide the Chief Executive Officer / delegate with all relevant material, including:
p.000016: a. Details of the appeal;
p.000016: b. Material reviewed by the HREC; and
p.000016: c. The outcome/decision of the ethical review process.
p.000016:
p.000016: b) The Chief Executive Officer / delegate will determine if further investigation of the appeal is necessary. If so,
p.000016: a panel will be established to consider the appeal. The panel will include the following members:
p.000016: a. The Chief Executive Officer / delegate;
p.000016: b. Two nominees of the Chief Executive Officer / delegate (not members of the HREC);
p.000016: c. At least one nominee with relevant expertise in human research ethics; and
p.000016: d. Expert(s) in a discipline of research related to the project under consideration.
p.000016:
p.000016: c) The panel will allow the HREC and the appellant the opportunity to make submissions.
p.000016:
p.000016: d) The Chief Executive Officer / delegate will notify the HREC and the appellant of the outcome of the investigation.
p.000016: The possible outcomes include:
p.000016: a. The appeal is dismissed; or
p.000016: b. The appeal is upheld and the panel makes recommendation to resolve the issues based on the findings of the panel.
p.000016: The panel does not have the authority to approve an ethics application, but may choose to refer an ethics application
p.000016: to an independent ethics committee for re-review.
p.000016:
p.000016: If the panel or Chief Executive Officer / delegate requests that a second ethical review is required as a
p.000016: recommendation of the investigation, an alternative SA public health system HREC (where possible) with suitable
p.000016: expertise and no prior involvement in the matter will be invited to undertake this review.
p.000016:
p.000016: The panel or Chief Executive Officer / delegate cannot reverse the final determination of any HREC.
p.000016:
p.000016:
p.000016: 3.9 USE OF APPROVED AND UNAPPROVED MEDICINES AND MEDICAL DEVICES
p.000016: Research that involves the use of approved or unapproved medicines, medical devices, blood, tissues and chemicals must
p.000016: be compliant with the legislation, regulations and guidelines of the Therapeutic Goods Administration (TGA).
p.000016:
p.000016:
p.000016: INFORMAL COPY WHEN PRINTED Research Ethics Policy Directive
p.000016: Page 9 of 16
p.000016:
p.000016: Public –I1-A1
p.000016:
p.000016: Use of medicines or medical devices within the context of an approved research project does not guarantee their use
p.000016: beyond the scope of the research project.
p.000016:
p.000016:
p.000016: 3.10 CLINICAL RESEARCH TRIALS CONDUCTED UNDER THE CTN OR CTX SCHEMES
p.000016: The TGA permits the use of unregistered or unapproved medicines or medical devices to assess their safety and efficacy
p.000016: within the context of a monitored clinical research trial under Sections 18 and 19 of the Therapeutic Goods Act (1989).
p.000016: This is done through either the Clinical Trial Notification (CTN) or Clinical Trial Exemption (CTX) schemes.
p.000016:
p.000016: For the CTN scheme, the reviewing HREC has sole responsibility for reviewing all the data relating to the trial, such
p.000016: as safety data pertaining to the investigative medicine or device. It also has responsibility for making a
p.000016: determination about the scientific and ethical merit of the trial.
p.000016:
p.000016: For the CTX scheme, the TGA has responsibility for reviewing relevant data including preclinical data pertaining to the
p.000016: investigative medicine or device. The TGA’s review of this data is taken into account by the reviewing HREC, who will
p.000016: then make a determination about the scientific and ethical merit of the trial as a whole.
p.000016:
p.000016: Under both schemes, the reviewing HREC has the authority to approve (or reject) the trial based on the scientific and
p.000016: ethical merit of the trial.
p.000016:
p.000016:
p.000016: 3.11 REGULATION OF GENE TECHNOLOGIES AND RELATED THERAPIES
p.000016: Health and medical researchers in South Australia are legally required to comply with the Gene Technology Act (2001)
p.000016: and the Gene Technology Regulations (2002) for research involving Genetically Modified Organisms.
p.000016:
p.000016: SA Health facilities in which researchers are using gene technology must be accredited and maintain, or have an
p.000016: established link with, a properly constituted Institutional Biosafety Committee (IBC) within a collaborating
p.000016: organisation.
p.000016:
p.000016: Any formal review provided by an IBC should be given to the lead HREC by the applicant upon submission of a new
p.000016: application for review.
p.000016:
p.000016: All research protocols involving gene therapy and related gene technologies including xenotransplantation must be
p.000016: submitted to a HREC for review.
p.000016:
p.000016: Research involving embryos must comply with the Prohibition of Human Cloning for Reproduction and the Regulation of
p.000016: Human Embryos Research Amendment Act (2006), and the Ethical Guidelines on the Use of Assisted Reproductive Technology
p.000016: in Clinical Practice and Research (NHMRC, 2007).
p.000016:
p.000016:
p.000016: 3.12 IONISING RADIATION
p.000016: All research involving any form of radiation must comply with relevant National and State legislation, organisational
p.000016: policies and procedures, and codes and standards of practice provided by the NHMRC and the Australian Radiation
p.000016: Protection and Nuclear Safety Agency (ARPANSA).
p.000016:
p.000016: SA Health HRECs assessing research proposals involving exposure of participants to ionising radiation must be provided
p.000016: with a written report from an accredited medical physicist.
p.000016:
p.000016: In South Australia, the Environment Protection Authority (EPA) has responsibility for administering the Environmental
p.000016: Protection Act (1993) and Radiation Protection and Control Act (1982). The
p.000016:
p.000016: INFORMAL COPY WHEN PRINTED Research Ethics Policy Directive
p.000016: Page 10 of 16
p.000016:
p.000016: Public –I1-A1
p.000016:
p.000016: Radiation Protection Branch of the EPA must be notified of all research involving exposure of research participants to
p.000016: ionising radiation. This form should be used for notification purposes.
p.000016:
p.000016:
p.000016: 3.13 RESEARCH INVOLVING SA HEALTH DATA
p.000016: For research ethics applications that require access to data or confidential information held by SA Health, it is a
p.000016: requirement that access be granted on the basis of ethical approval from an appropriate Certified HREC and project
p.000016: authorisation by the appropriate Institution/s, following submission of a complete and satisfactory SSA.
p.000016: For projects being undertaken in South Australia only, the CPI should contact the HREC affiliated with their
p.000016: Institution to determine whether it is able to review the ethics application.
p.000016:
p.000016: Any SA based project where the primary data being used for the project is held by the Department for Health and
p.000016: Wellbeing (e.g. ISAAC or Cancer Registry Data) may be submitted to the Department for Health and Wellbeing HREC for
p.000016: ethical review.
p.000016:
...
Orphaned Trigger Words
p.000016: research within the South Australian public health system to efficiently gain ethical approval:
p.000016: • The SA Health Single Ethical Review Model – for research taking place within the South Australian public health
p.000016: system.
p.000016: • National Mutual Acceptance – for multi-centre human research projects taking place across participating
p.000016: Australian jurisdictions (public health organisations only).
p.000016:
p.000016:
p.000016: 3.2 SA HEALTH SINGLE ETHICAL REVIEW MODEL
p.000016: 1. Every research project which is to be conducted at a site under the jurisdiction of SA Health will be ethically
p.000016: and scientifically reviewed once only by a SA Health HREC or another South Australian based NHMRC certified HREC. The
p.000016: reviewing committee is designated the lead HREC.
p.000016: 2. All sites under the jurisdiction of SA Health that are participating in the proposed research will accept the
p.000016: review of the lead HREC without further ethical or scientific consideration, with appropriate exceptions established by
p.000016: the LHN board and Chief Executive.
p.000016: 3. The research ethics applicant (the Coordinating Principal Investigator or CPI) will select a lead HREC to
p.000016: undertake single review from a register of HRECs on the SA Health ethics website. . The applicant will assume
p.000016: responsibility for submitting all required documentation in accordance with SA Health and local HREC requirements.
p.000016: 4. Lead HRECs must be appropriately constituted in accordance with the requirements of the NHMRC, and fulfil the
p.000016: requirements of the National Statement (section 5.2). Additionally they must have access to the required expertise to
p.000016: undertake a full scientific and ethical review of the type of research which is submitted.
p.000016: 5. Every research application must undergo a separate research governance review at each site where the research is
p.000016: to be conducted to permit consideration and approval of the research governance requirements at that site (a site
p.000016: specific assessment). This is distinct from the scientific and ethical review by the lead HREC.
p.000016: 6. The lead HREC will be responsible for the full scientific and ethical review of the research application. Once
p.000016: completed, the lead HREC will be responsible for notifying the CPI of the outcome of the review. It is the CPIs
p.000016: responsibility to notify the outcome of this review to each of the other sites where the project is proposed to take
p.000016: place, via the Research Governance Officer associated with the site/s.
p.000016: 7. Under this model, HRECs will have the right to refuse to consider a multi-site application only under the
p.000016: following circumstances:
p.000016: i. The HREC Chairperson determines there is insufficient expertise on or available to the HREC to permit an
p.000016: adequate scientific and ethical review of the proposal; or
p.000016: ii. The HREC is not able to review the proposal in a timely manner (e.g. the meeting agenda for the next HREC
p.000016: meeting has reached capacity).
p.000016:
p.000016: 8. In these circumstances (7 [i] and [ii]), the HREC should notify the applicant as soon as practicable in order
p.000016: that they can then submit to another suitable SA Health HREC.
p.000016:
p.000016: 9. The South Australian Aboriginal Health Research Ethics Committee (AHREC) reviews all research applications where
p.000016: the focus is on a topic or disease/health burden identified as being of specific concern to Aboriginal and Torres
p.000016: Strait Islander people (based on 4.7.6 of the National Statement, 2007). In addition to a research application having
p.000016: been submitted to and reviewed by SA Health HREC, proposals are required to be submitted to the AHREC if:
p.000016: • The experience of Aboriginal and Torres Strait Islander people is an explicit focus of all or part of the research;
p.000016: or
p.000016:
p.000016: INFORMAL COPY WHEN PRINTED Research Ethics Policy Directive
p.000016: Page 4 of 16
p.000016:
p.000016: Public –I1-A1
p.000016:
p.000016: • Data collection is explicitly directed at Aboriginal and Torres Strait Islander people; or
p.000016: • Where it is proposed to separately identify Aboriginal and Torres Strait Islander people in the results; or
p.000016: • The information has an impact on one or more Aboriginal and Torres Strait Islander communities; or
p.000016: • The geographic location of the research is such that a significant number of the population are likely to be of
p.000016: Aboriginal and Torres Strait Islander origin (based on 4.7.6 of the National Statement, 2007); or
p.000016: • Where terms such as ‘resilience’; ‘well-being’; ‘cultural safely’; ‘cultural health’; and ‘language and culture’
p.000016: are used in the description and design of the project indicating that the project has important health implications; or
p.000016: • Aboriginal and Torres Strait Islander health funds are a source of funding.
p.000016:
p.000016: 10. The CPI should provide the AHREC with a copy of the research application and the lead HRECs ethical determination
p.000016: on the project for consideration as soon as practicable. The AHREC will then provide their evaluation of the project
p.000016: to the lead HREC for consideration prior to providing feedback to the applicant. The AHREC will expedite their review
p.000016: where possible.
p.000016:
p.000016: 11. Ethics applications involving Women’s and Children’s Health Network (WCHN), and where the primary research
p.000016: participants are children and young people, or where the project involves access to paediatric data primarily held by
p.000016: WCHN, must be submitted to the WCHN HREC for review as the lead HREC.
p.000016:
p.000016: 12. Any multi-site project where the primary data being used for the project is held by the Department for Health and
p.000016: Wellbeing should be submitted to the Department for Health and Wellbeing HREC for review as the lead HREC.
p.000016:
p.000016: 13. If a research site is added to an existing project that has HREC approval, it is a requirement that the project is
p.000016: amended to add the new site and this amendment is approved by the lead HREC. The local investigator should then
p.000016: complete and submit the appropriate research governance documents to seek site approval along with a copy of the
p.000016: amendment approval letter issued by the HREC.
p.000016:
p.000016:
p.000016: 3.3 NATIONAL MUTUAL ACCEPTANCE
p.000016: National Mutual Acceptance (NMA) supports the single scientific and ethical review of multi-centre human research
p.000016: projects across participating Australian jurisdictions (public health organisations). The Standard Principles for
p.000016: Operation for NMA, available on the SA Health website provide the overarching framework for NMA and should be referred
p.000016: to by SA Health HRECs, researchers and others who may be involved in seeking approval to undertake research using the
p.000016: NMA system.
p.000016:
p.000016: NMA permits the review of any form of human research, as defined in the National Statement on Ethical Conduct in Human
p.000016: Research (2007) or any replacement of that document published by the National Health and Medical Research Council
p.000016: (NHMRC), for which an application must be made to an HREC for the purpose of research being conducted at a public
p.000016: health organisation. This includes low and negligible risk research review by a full HREC using the NHMRC’s national
p.000016: ethics form.
p.000016:
p.000016: In accordance with the Standard Principles for Operation, SA Health organisations are required to accept the approval
p.000016: of a NHMRC Certified HREC for a project submitted under NMA without requiring further ethical and scientific review.
p.000016: There are two categories of research that are exempt from being considered under NMA, being Phase 0 (first time in
p.000016: human) and Phase 1 Clinical Trials, and Aboriginal and Torres Strait Islander Projects. For further details on the two
p.000016: exemption areas, refer to section 8 of this Policy Directive.
p.000016:
p.000016: INFORMAL COPY WHEN PRINTED Research Ethics Policy Directive
p.000016: Page 5 of 16
p.000016:
p.000016: Public –I1-A1
p.000016:
p.000016: A list of Certified HRECs can be found here.
p.000016:
p.000016: 3.3.1 SA Health HREC Certification
p.000016: The following SA Health HRECs have been certified by the NHMRC to undertake review in the categories of research
p.000016: outlined.
p.000016:
p.000016: Women’s and Children’s Health Network Human Research Ethics Committee (EC00197)
p.000016: Certification categories:
p.000016: • Clinical trials phase I, II, III, IV.
p.000016: • Clinical trials drugs and devices.
p.000016: • Clinical trials surgery.
p.000016: • Clinical trials other.
p.000016: • Clinical interventional research other than clinical trials.
p.000016: • Population health and/or public health.
p.000016: • Qualitative research.
p.000016: • Mental health.
p.000016: • Paediatric research.
p.000016: • Other health and medical research:
...
p.000016: HREA. Ethics applicants may discuss alternative application forms with the reviewing HREC. For single-site research
...
p.000016:
p.000016: 3.8.1 Appeals Mechanism
p.000016: Following an appeal being lodged to the HREC Chairperson, if the appellant considers that the HREC has not followed due
p.000016: process or remains unsatisfied with the outcome, they may choose to lodge an appeal with the Chief Executive Officer /
p.000016: delegate responsible for the HREC.
p.000016:
p.000016: The following process will be followed:
p.000016: a) The Chairperson will provide the Chief Executive Officer / delegate with all relevant material, including:
p.000016: a. Details of the appeal;
p.000016: b. Material reviewed by the HREC; and
p.000016: c. The outcome/decision of the ethical review process.
p.000016:
p.000016: b) The Chief Executive Officer / delegate will determine if further investigation of the appeal is necessary. If so,
p.000016: a panel will be established to consider the appeal. The panel will include the following members:
p.000016: a. The Chief Executive Officer / delegate;
p.000016: b. Two nominees of the Chief Executive Officer / delegate (not members of the HREC);
p.000016: c. At least one nominee with relevant expertise in human research ethics; and
p.000016: d. Expert(s) in a discipline of research related to the project under consideration.
p.000016:
p.000016: c) The panel will allow the HREC and the appellant the opportunity to make submissions.
p.000016:
p.000016: d) The Chief Executive Officer / delegate will notify the HREC and the appellant of the outcome of the investigation.
p.000016: The possible outcomes include:
p.000016: a. The appeal is dismissed; or
p.000016: b. The appeal is upheld and the panel makes recommendation to resolve the issues based on the findings of the panel.
p.000016: The panel does not have the authority to approve an ethics application, but may choose to refer an ethics application
p.000016: to an independent ethics committee for re-review.
p.000016:
p.000016: If the panel or Chief Executive Officer / delegate requests that a second ethical review is required as a
p.000016: recommendation of the investigation, an alternative SA public health system HREC (where possible) with suitable
p.000016: expertise and no prior involvement in the matter will be invited to undertake this review.
p.000016:
p.000016: The panel or Chief Executive Officer / delegate cannot reverse the final determination of any HREC.
p.000016:
p.000016:
p.000016: 3.9 USE OF APPROVED AND UNAPPROVED MEDICINES AND MEDICAL DEVICES
p.000016: Research that involves the use of approved or unapproved medicines, medical devices, blood, tissues and chemicals must
p.000016: be compliant with the legislation, regulations and guidelines of the Therapeutic Goods Administration (TGA).
p.000016:
p.000016:
p.000016: INFORMAL COPY WHEN PRINTED Research Ethics Policy Directive
p.000016: Page 9 of 16
p.000016:
p.000016: Public –I1-A1
p.000016:
p.000016: Use of medicines or medical devices within the context of an approved research project does not guarantee their use
p.000016: beyond the scope of the research project.
p.000016:
p.000016:
p.000016: 3.10 CLINICAL RESEARCH TRIALS CONDUCTED UNDER THE CTN OR CTX SCHEMES
p.000016: The TGA permits the use of unregistered or unapproved medicines or medical devices to assess their safety and efficacy
p.000016: within the context of a monitored clinical research trial under Sections 18 and 19 of the Therapeutic Goods Act (1989).
p.000016: This is done through either the Clinical Trial Notification (CTN) or Clinical Trial Exemption (CTX) schemes.
p.000016:
p.000016: For the CTN scheme, the reviewing HREC has sole responsibility for reviewing all the data relating to the trial, such
p.000016: as safety data pertaining to the investigative medicine or device. It also has responsibility for making a
p.000016: determination about the scientific and ethical merit of the trial.
p.000016:
p.000016: For the CTX scheme, the TGA has responsibility for reviewing relevant data including preclinical data pertaining to the
p.000016: investigative medicine or device. The TGA’s review of this data is taken into account by the reviewing HREC, who will
p.000016: then make a determination about the scientific and ethical merit of the trial as a whole.
p.000016:
p.000016: Under both schemes, the reviewing HREC has the authority to approve (or reject) the trial based on the scientific and
p.000016: ethical merit of the trial.
p.000016:
p.000016:
p.000016: 3.11 REGULATION OF GENE TECHNOLOGIES AND RELATED THERAPIES
p.000016: Health and medical researchers in South Australia are legally required to comply with the Gene Technology Act (2001)
p.000016: and the Gene Technology Regulations (2002) for research involving Genetically Modified Organisms.
p.000016:
p.000016: SA Health facilities in which researchers are using gene technology must be accredited and maintain, or have an
p.000016: established link with, a properly constituted Institutional Biosafety Committee (IBC) within a collaborating
p.000016: organisation.
p.000016:
p.000016: Any formal review provided by an IBC should be given to the lead HREC by the applicant upon submission of a new
p.000016: application for review.
p.000016:
p.000016: All research protocols involving gene therapy and related gene technologies including xenotransplantation must be
p.000016: submitted to a HREC for review.
p.000016:
p.000016: Research involving embryos must comply with the Prohibition of Human Cloning for Reproduction and the Regulation of
p.000016: Human Embryos Research Amendment Act (2006), and the Ethical Guidelines on the Use of Assisted Reproductive Technology
p.000016: in Clinical Practice and Research (NHMRC, 2007).
p.000016:
p.000016:
p.000016: 3.12 IONISING RADIATION
p.000016: All research involving any form of radiation must comply with relevant National and State legislation, organisational
p.000016: policies and procedures, and codes and standards of practice provided by the NHMRC and the Australian Radiation
p.000016: Protection and Nuclear Safety Agency (ARPANSA).
p.000016:
p.000016: SA Health HRECs assessing research proposals involving exposure of participants to ionising radiation must be provided
p.000016: with a written report from an accredited medical physicist.
p.000016:
p.000016: In South Australia, the Environment Protection Authority (EPA) has responsibility for administering the Environmental
p.000016: Protection Act (1993) and Radiation Protection and Control Act (1982). The
p.000016:
p.000016: INFORMAL COPY WHEN PRINTED Research Ethics Policy Directive
p.000016: Page 10 of 16
p.000016:
p.000016: Public –I1-A1
p.000016:
p.000016: Radiation Protection Branch of the EPA must be notified of all research involving exposure of research participants to
p.000016: ionising radiation. This form should be used for notification purposes.
p.000016:
p.000016:
p.000016: 3.13 RESEARCH INVOLVING SA HEALTH DATA
p.000016: For research ethics applications that require access to data or confidential information held by SA Health, it is a
p.000016: requirement that access be granted on the basis of ethical approval from an appropriate Certified HREC and project
p.000016: authorisation by the appropriate Institution/s, following submission of a complete and satisfactory SSA.
...
p.000016: of research materials including data, in compliance with all applicable requirements. Access to data and information
p.000016: collected during the conduct of research should be limited to those who are directly involved in the conduct of the
p.000016: project, and mechanisms such as use of locked filing cabinets or password protected computers may be warranted.
...
p.000016: 4. Implementation & Monitoring
p.000016:
p.000016: Each Local Health Network through the Chief Executive Officer is responsible for implementing the requirements of this
p.000016: Policy Directive.
p.000016:
p.000016: The Department for Health and Wellbeing Office for Research is responsible for monitoring the implementation of this
p.000016: Policy Directive in conjunction with the Local Health Networks.
p.000016:
p.000016: The Local Health Networks will report on key research outputs and performance measures linked to this Policy Directive
p.000016: through their annual research report provided to the Chief Executive, SA Health, as a component of the Service Level
p.000016: Agreements.
p.000016:
p.000016:
p.000016: 5. National Safety and Quality Health Service Standards
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016: National Standard 1
p.000016: National Standard 2
p.000016: National Standard 3
p.000016: National Standard 4
p.000016: National Standard 5
p.000016: National Standard 6
p.000016: National Standard 7
p.000016: National Standard 8
p.000016: National Standard 9
p.000016: National Standard 10
p.000016:
p.000016:
p.000016: Governance for Safety and Quality in Health Care
p.000016:
p.000016: ☒
p.000016:
p.000016: Partnering with Consumers
p.000016:
p.000016:
p.000016: ☐
p.000016:
p.000016: Preventing & Controlling Healthcare associated infections
p.000016: ☐
p.000016:
p.000016: Medication Safety
p.000016:
p.000016:
p.000016:
p.000016: ☐
p.000016:
p.000016: Patient Identification & Procedure Matching
p.000016:
p.000016:
p.000016: ☐
p.000016:
p.000016: Clinical Handover
p.000016:
p.000016:
p.000016:
p.000016: ☐
p.000016:
p.000016: Blood and Blood Products
p.000016:
p.000016:
p.000016: ☐
p.000016:
p.000016: Preventing
p.000016: & Managing Pressure Injuries
p.000016:
p.000016: ☐
p.000016:
p.000016: Recognising & Responding to Clinical Deterioration
p.000016:
p.000016:
p.000016: ☐
p.000016:
p.000016: Preventing Falls & Harm from Falls
p.000016:
p.000016:
p.000016: ☐
p.000016:
p.000016: 6. Definitions
p.000016:
p.000016: In the context of this document:
p.000016:
p.000016: AHREC means Aboriginal Health Research Ethics Committee.
p.000016:
p.000016: Certified HREC means a Human Research Ethics Committee that has received certification by the NHMRC to undertake the
p.000016: single scientific and ethical review of a multi-centre research project.
p.000016:
p.000016: Clinical trial means a research study designed to test the safety and/or efficacy of a medical treatment or
p.000016: intervention, often involving a treatment and control arm.
p.000016:
p.000016: CTN means the Clinical Trial Notification scheme developed by the Therapeutic Goods Administration (TGA) to permit
p.000016: unregistered medicines and medical devices to be used in the context of a clinical research trial. For CTN trials, the
p.000016: local HREC is solely responsible for reviewing and determining the safety and appropriateness of the medicine/device in
p.000016: the context of the trial.
p.000016:
p.000016: CTX means the Clinical Trial Exemption scheme developed by the Therapeutic Goods Administration (TGA) to permit
p.000016: unregistered medicines and medical devices to be used in the context of a clinical research trial. For CTX trials, the
p.000016: TGA is also involved in assessing the safety and appropriateness of the medicine/device in the context of the trial.
p.000016:
p.000016: Coordinating Principal Investigator (CPI) means the lead investigator on a research study taking overall responsibility
p.000016: for the conduct of the study at all of the study sites.
p.000016: HREA means the Human Research Ethics Application form developed by the NHMRC.
p.000016:
p.000016:
p.000016: INFORMAL COPY WHEN PRINTED Research Ethics Policy Directive
p.000016: Page 14 of 16
p.000016:
p.000016: Public –I1-A1
p.000016:
p.000016: HREC means Human Research Ethics Committee.
p.000016:
p.000016: IBC means Institutional Biosafety Committee.
p.000016:
p.000016: ISAAC means the Integrated South Australian Activity Collection (ISAAC), an admitted patient morbidity data collection
p.000016: maintained by SA Health.
p.000016:
p.000016: Lead HREC means the human research ethics committee responsible for the single ethical and scientific review of a
p.000016: research ethics application.
p.000016:
p.000016: National Mutual Acceptance (NMA) means the single scientific and ethical review of human research projects across
p.000016: participating jurisdictions.
p.000016:
p.000016: National Statement means The NHMRC’s National Statement on Ethical Conduct in Human Research (2007).
p.000016:
p.000016: NHMRC means National Health and Medical Research Council.
p.000016:
p.000016: NHMRC Certified HREC means an institution/HREC that has been certified by the NHMRC to undertake the single scientific
p.000016: and ethical review of human research projects.
p.000016:
p.000016: OACIS means an electronic clinical patient information system owned by SA Health.
p.000016:
p.000016: Principal Investigator means the lead investigator responsible for the conduct and management of a research project at
p.000016: a local Institution or Site.
p.000016:
p.000016: RGO means Research Governance Officer.
p.000016:
p.000016: SA Health means the health portfolio of services and agencies responsible to the Minister for Health, Minister for
p.000016: Mental Health and Substance Abuse and the Minister for Ageing.
p.000016:
p.000016: SAE means: Serious Adverse Event.
p.000016:
p.000016: SOP means: Standard Operating Procedure.
p.000016:
p.000016: SSA means: Site Specific Assessment.
p.000016:
p.000016: TGA means: Therapeutic Goods Administration.
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016: INFORMAL COPY WHEN PRINTED Research Ethics Policy Directive
p.000016: Page 15 of 16
p.000016:
p.000016: Public –I1-A1
p.000016:
p.000016: 7. Associated Policy Directives / Policy Guidelines and Resources
p.000016:
p.000016: SA Health Research Governance Policy Directive (2020)
p.000016:
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| abuse | Victim of Abuse |
| access | Access to Social Goods |
| authority | Relationship to Authority |
| children | Child |
| language | Linguistic Proficiency |
| officer | Police Officer |
| single | Marital Status |
| substance | Drug Usage |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
capacity
consent
cultural
developing
ethics
harm
protection
risk
sensitive
Applicable Type / Vulnerability / Indicator Overlay for this Input