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Publication Details 

Publication title:  

SALHN Ethics Essentials 

Published: 2021 

Publisher: Office for Research 

 

 
Research  

Ethics  
Essentials 



 
 

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Table of Contents    
1. Ethics Overview .......................................................................................................................... 3 

Training resources          4 
Ethics and governance review pathways ........................................................................... 5 

SALHN Office for Research Fees ...................................................................................... 6 

2  Ethical and Scientific review / application types ........................................................................ 6 
Quality assurance / quality improvement / Continuous Improvement ................................. 6 

Low and negligible risk research (LNR)  ............................................................................ 7 

Greater than low risk research ........................................................................................... 7 

Phase 1 clinical trial ........................................................................................................... 7 

Application tips for writing your application ........................................................................ 7 

  General items ........................................................................................................ 8 

  Research personnel ............................................................................................... 8 

  Access to SA Health data ...................................................................................... 8 

3. Writing your application - common ethical considerations ................................................. 9 
Recruitment and consent ................................................................................................... 9 

Dependent and unequal relationships ............................................................................... 9 

Waiver of consent  ........................................................................................................... 10 

Conflicts of interest .......................................................................................................... 10 

Highly dependent, cognitive impairment, intellectual disability or mental illness ............... 10 

Children and young people .............................................................................................  10 

Aboriginal and Torres Strait Islander people .................................................................... 10 

Data linkage and SA/NT data linkage research ............................................................... 11 

Appropriate retention of data ........................................................................................... 12 

Participant information sheets and consent forms ........................................................... 12 

Publications ..................................................................................................................... 12 

Biosafety, Chemical and Radiation Safety ....................................................................... 12 

4.Submitting your application .................................................................................................. 12 

Documents checklist  ....................................................................................................... 13 

Site Specific Assessment (Governance) .......................................................................... 13 

SAC HREC review of multi centre research ..................................................................... 13 

SA Health single ethical review model / National Mutual Acceptance  ............................. 14 

Exemptions ..................................................................................................................... 14 

6 .Post HREC approval monitoring and reporting .................................................................. 15 

Annual reviews, extension requests and discontinuation of research .............................. 15 

Safety reporting and protocol deviations / violations ........................................................ 15 

Notifications ..................................................................................................................... 16 

Amendments ................................................................................................................... 16 



 
 

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7 Reference documents, policies and resources ................................................................... 17 
 

1. Ethics Overview 
 

Human research can involve a wide range of methods and practices: it can be a retrospective audit, 
qualitative, quantitative or mixed; interventional, experimental or observational in nature; and involve 
various degrees of collaboration between researchers and participants. Each research project is shaped 
by the field to which the research question relates the research question itself, the desired outcome, and 
the context in which it is conducted. 

To ensure that all medical research provides adequate protection to the participants involved, and treats 
them in a fair and ethically acceptable manner, all Human Research Ethics Committees (HREC) and 
researchers follow ethical conventions and standards that outline how medical research is designed, 
reviewed and conducted. 

There are 5 guiding ethical principles of research that provide a solid foundation for designing and 
conducting high quality research. Please read section 1 in The National Statement on Ethical Conduct in 
Human Research (2007, updated 2018) on how the below principles relate to your research. 

1. Merit and Integrity 
2. Justice. 
3. Beneficence 
4. Respect 

Research Ethics addresses: 

It is a requirement that all research conducted at South Australian public health institutions, or involving 
clients of South Australian public health institutions, including regional health services, hospitals, 
community health services, public health clinics and associated programs, complies with relevant polices 
and guidelines.  

Every HREC in Australia is required to be properly constituted in accord with section 5.1.30 of the National 
Statement, which prescribes its minimum size and composition, and the expertise necessary to address 
ethical issues. 

The Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC) is registered and 
accredited with the National Health and Medical Research Committee (NHMRC), and has  National 
Mutual Acceptance (NMA) certification which enables the committee to undertake single ethical review 
and multi-site ethical review of research in South Australia, Victoria, New South Wales, Queensland and 
Western Australia. 

As the lead (approving) HREC, the SAC HREC reviews ethics applications, amendments and post 
approval documents within Southern Adelaide Local Health Network (SALHN) SA Health, Country Health, 
DASSA, Southern Mental Health and public health institutions Australia wide. The committee also reviews 
ethics applications for clinical research conducted by Flinders University. 

The Southern Adelaide Local Health Network Office for Research (OfR) oversees research Ethics and 
governance and site authorisation of research in line with the SA Health Research Ethics and governance 
Policy Directives available on the SA Health website . 
 






 
 

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Research ethics is concerned with ensuring the research is well-designed and considered, with 
methodology that can meet the research aims and objectives, respect for all participants and that the 
benefits of the research outweigh any risks to participants.  
 
Research governance is concerned with the quality, safety, privacy, risk management, financial 
management and ethical acceptability of research. 
 
Research can only commence when both ethical approval (local or external) and site governance 
authorisation have been granted.  Please refer to the Research Governance Essentials guide for more 
information on governance submissions.  
 
The Office for Research team are:  
 
Simon Windsor 
Manager, Research Governance and Ethics, SALHN 
T: 08 8204 4507 
E: Health.SALHNOfficeforResearch@sa.gov.au 
 
Dani Eley 
Administration Officer   General enquiries 
T: 08 8204 6453  
E: Health.SALHNOfficeforResearch@sa.gov.au 
 
Research Ethics 
Dominic How   Greater than low risk 
applications 
Executive Officer, SALHN  
T: 08 8204 6285 
E: 
Health.SALHNOfficeforResearch@sa.gov.au 

Petrina Kasperski   Low risk applications 
Ethics Officer, SALHN   
T: 08 8204 7433  
E: 
Health.SALHNOfficeforResearch@sa.gov.au 

 
Research Governance 
Karen Saxty 
Research Governance Officer 
T: 8204 6139 
E: 
Health.SALHNOfficeforResearch@sa.gov.au 

Gian Franco Carosi 
Research Governance Admin Officer 
T: 8204 6453 
E: 
Health.SALHNOfficeforResearch@sa.gov.au 

 

Training Resources Page 

The Office for Research has a Training Resources webpage, which provides resources for our staff and 

researchers who are looking to update their skill set.   

  Ethics and Governance   a beginner s guide - 6 steps to get you on your way. 

  A free Good Clinical Practice (GCP) training course - provides a certificate upon completion valid 

for 3 years 

  National Statement training guide and quiz   provides an overview of each section and a quiz at 

the end to test your knowledge. 




 
 

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  Global Health Training Centre   free online courses to help increase your knowledge of research 

processes and methods.  A certificate is issued if an 80% pass mark is reached.  

  Research Governance Essentials   a guide for governance applications at SALHN and what is 

required with the Site Specific Assessment (SSA) form or Low and Negligible Risk (LNR) 

application form. 

Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC) 
The Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC) is a team of 

approximately 40 volunteers with a wide range of medical, clinical and life skills and experience, who work 

together to provide ethical and scientific review for all human research involving human participants and 

tissue. 

 

To ensure that all medical research provides adequate protection to the participants involved,  

and treats them in a fair and ethically acceptable manner, all HRECs follow ethical conventions and 

standards that outline how medical research is designed, reviewed and conducted. In Australia, we use 

the National Statement on Ethical Conduct in Medical Research (2007, updated 2018). This is produced 

by the National Health and Medical Research Council (NHRMC), who are the peak body for supporting 

health and medical research. 

 

The committee is a properly constituted Human Research Ethics Committee under the National Statement 

on Ethical Conduct in Human Research (2007, updated 2018). 

 

Ethics and governance review pathways 
SALHN has five review pathways: 

1. Quality assurance / quality or service improvement / continuous improvement: 
  via Continuous Improvement Pathway 
  reviewed by the SALHN Office for Research 

2. Low and negligible risk (LNR) research  
  Via email using the Ethics and Governance Low and negligible risk application form / 

protocol 
  Reviewed out of session via the Expedited Review Panel 

3. Greater than low risk research 
  Via GEMS using Human Research Ethics Application 
  Reviewed at full committee 
  Site Specific Assessment form 

4. Authorised prescriber 
  Via authorised prescriber form 
  Reviewed at full committee 
  Governance submission not required 
  Please contact the Office for Research if you would like to submit this type of application. 

5. National Mutual Acceptance: 
  via a public health HREC 







 
 

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  Governance at SALHN only 
  Site Specific Assessment form 

Choosing the correct application form for your study can save significant time and will result in a faster 

review. If you are unsure which form to use you are always welcome to contact the SALHN Office for 

Research.  

All applications undergo a quality assurance review, to ensure all appropriate documents have been 

submitted, the application reads well, and all sections have been completed.  

Incomplete applications or password protected documents will be returned. 

Applications will not be assigned to the committee until a high-quality application is achieved. 

Please refer to National Statement on Ethical Conduct in Human Research Section 3.1 for guidance on 

the elements of research project design. 

 

All protocol templates, participant information sheet templates and guidance documents can be found on 

our website. 

Our staff are available to discuss your application, please email or ring to arrange a meeting. 

The Office for Research recommend that all researchers obtain their Good Clinical Practice (GCP) 

certificate, to assist in their understanding and practice of conducting a successful and well organised 

research project.  

 
SALHN Office for Research Fees 
The SALHN Office for Research charges fees according to the SA Health Research Ethics and 

Governance Fees Schedule available here. There are three broad categories covered in the SA Health 

fees schedule: 

1. Clinical Trials with Full Commercial Sponsorship 

2. Non-Commercially Sponsored Clinical Trials / Cooperative Research Group (CRG) 

3. Health and medical research projects (non   clinical trials) 

 
To define clinical trials we acknowledge the following the World Health Organisation definition:  

A clinical trial is any research study that prospectively assigns human participants or groups of humans to 

one or more health-related interventions to evaluate the effects on health outcomes.  
 

 

 







 
 

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2. Ethical and Scientific review / application types 
 
1. Quality assurance / quality improvement / continuous improvement 
The Office for Research advises that any projects that are classified as Quality Assurance (QA) / Quality 

Improvement (QI), Service improvement, service design, continuous improvement or negligible risk 

projects may not require ethical review by the Southern Adelaide Clinical Human Research Ethics 

Committee. 

 

An activity whose primary purpose is to monitor or improve the quality of service delivered by an individual 

or an organisation is a QA, QI, audit, service design, negligible risk activity,  

 

A Continuous Improvement activity may involve collection and analysis of information such as 

retrospective audit or process mapping. SALHN uses the 8 Step Problem Solving Framework. 

 

The Continuous Improvement Unit facilitates improvement across the Southern Adelaide Local Health 

Network (SALHN). For support with your Continuous improvement activity, or assistance in completing the 

form, please contact the Continuous Improvement team. 

Ph: 8204 6260 / HEALTH.SALHNContinuousImprovementUnit@sa.gov.au 

 

Further information and the submission template can be found here.  

 

All quality / service improvement projects conducted at SALHN are registered in the SALHN Quality 

Library. To register you project, click here. 
 

3. Low and negligible risk research (LNR) / Retrospective Audit-based Research  
As per the National Statement chapter 2.1.6, low risk research is defined as...the only foreseeable risk is 

one of discomfort. Research in which the risk for participants is more serious than discomfort is not low 
risk. 

 

This type of application is submitted using the Low and Negligible risk application form and protocol, which 

covers both ethical and governance considerations. 

 

As a rule, LNR applications are reviewed out of session and do not go to full committee. The Chair of the 

SAC HREC will refer low risk applications to the full committee if they contain a request for waiver of 

consent involving active participation of participants, a vulnerable participant population, other identified 

issues, or are being submitted under NMA.  

 








 
 

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Triggers to identify your research as greater than low risk are:  

  All interventions 

  Your research involves Aboriginal / Torres Strait Islanders as participants 

  Your research involves participants with mental illness, cognitive or intellectual impairment, 

pregnant women, or their foetus 

  All requests for opt out or waiver of consent (involving active participation) 

  Genetic testing 

  Creating of a databank, biobank, or registry 

  Exploration of sensitive personal or cultural issues 

 

The LNR ethics and governance forms can be found on our website. 

 
4. Greater than low risk research 
Human Research Ethics Form (HREA) form is used for greater than low risk applications and is submitted 

in two separate documents: 

1. The HREA form ensures the project complies with the National Statement on the Ethical 

Conduct in Human Research and created electronically via the GEMS Research Management 

System. 

2. The protocol (project description) provides the HREC with information on the design, 

objectives, methodology, rationale, recruitment, and consent and data management plan for 

the research. The template is located on our website. 

 

Phase 1 clinical trials  
Upon receipt of a phase 1 trial, the application is to be managed and referred by the Office for Research 

to: 

  Drug related: the SALHN Drug and Therapeutic Committee for safety evaluation, prior to being 

listed for review by the SAC HREC or; 

  Device related: the New Health Technology and Clinical Practice Innovation Committee for safety 

evaluation, prior to being listed for review by the SAC HREC or; 

  Any relevant subcommittee of either of these two bodies as advised. 

Following initial review of the report, the HREC and governance process is to proceed simultaneously. 

These applications are also created electronically under the Greater than Low Risk Pathway via the 

GEMS Research Management System and reviewed at the next available full committee meeting. 

 

Application tips for writing your application 
For a timely review and to meet current research ethics and governance requirements, please ensure you 

read through the below information.  These are the most common items that are picked up in the quality 







 
 

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assurance review, and result in the application being returned to the researcher. 

 

General items 
  Please treat your application as a piece of academic writing, taking into careful consideration 

readability, spelling, and grammar. 

  You must provide a literature review, to demonstrate the originality and relevance of your research.  

  Declare the funding source and amount. 

  Fill out all sections of the HREA and protocol in a clear and concise manner, so a lay person 

reading your application will be able to understand what your research project involves. 

  If a section of the HREA or protocol does not apply to your study, rather than write N/A, explain 

why it isn t applicable. 

  Please do not refer to participants as subjects. 

  Please only use SA Health, University, or professional email address in the application. 

  Please ensure additional documents are correctly named and have a version number and date 

in the footer i.e. PICF v2 dated 01.01.17. 

Research Personnel 
  All research activities conducted at SALHN must include a SALHN Principal Investigator 

(PI). The PI must have the experience and training to serve as PI. This means they have 

sufficient authority, relevant scientific knowledge, and the capacity to carry out or 

supervise all aspects of the study at the site. 

  The PI is ultimately responsible for the conduct of the study at the site, and for ensuring all 

annual reviews, amendments and safety reporting is submitted. 

  Students must not be listed as PI. 

  If the PI is not a SALHN employee a SALHN Co-PI must be appointed.  

  The site contact person is the person to liaise with SALHN OFR regarding ethics and 

governance.  

  It is also important to list all non-SA Health staff and students who are working on the 

research at SALHN and to detail their involvement, particularly those having participant 

contact. 

  Additional support staff can be documented on a  Delegation of Responsibilities log . 

Access to SA Health Data 
  Accessing data for clinical purposes is different to accessing data for research purposes. 

Even if you normally have access to this data in a clinical capacity, this does not 

automatically grant you access for research purposes. 

  Data access for research purposes must be in compliant with the SA Health Research 

Governance Policy and have appropriate authorisation before the project commences. 

  Non-SA Health staff should not be granted access to SA Health electronic information 



 
 

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systems that store identifiable patient records / data, without appropriate authorisation via 

Research Governance.  

Students can access patient records as part of their clinical placement agreement 

between SALHN and the University given they are under direct SALHN supervision and 

have undergone all the necessary SALHN requirements to undertake their placement.  

  Where patient and other confidential health data is required for a specific project, the 

preferred mechanism is for SA Health staff to extract and de-identify the data before it is 

provided to the research investigators listed on the application.  

  As part of your Governance application you will be asked to provide approval from the 

relevant data custodian. The SALHN data custodian for hard copy and electronic medical 

records at SALHN is Karen Saxty, Research Governance Officer 

The data custodian reserves the right to refuse a request to supply data if the request cannot be 

met within the required timeframe or has other concerns about the request. 

 

3. Writing your application - common ethical considerations 
 

When reviewing ethics applications, there are a number of items that the committee commonly 

ask to the researchers to amend or add into the submission.  These common items are explained 

below. 

 

Recruitment and consent 
The recruitment method must be compliant with the Health Care Act 2008.  
 

When a researcher is not part of the team directly caring for the patient, there is no legal authority for 

those researchers (or anyone acting on their behalf of those researchers) to access a patient s medical 

records without appropriate consent in order to identify potential participants for clinical trials or other 

research projects. 

 

If you are not part of the patient s clinical care team, and need to access a patient s medical records to pre-
screen for eligible participants, and you do not have prior patient consent to do so, you will need to apply 
for an exemption under 93(3)(f).  

 

Please clearly state in the recruitment section in the protocol:  

  Under s93(3)(f) of the Health Care Act 2008, we wish to apply for an exemption of patient consent 

to access their personal information for research purposes.  In order to identify suitable 

participants for this research project, &lt;specify who or a title i.e. study coordinator&gt; will be required 

to access &lt;specify what is being accessed&gt;, prior to obtaining consent from the patient. 



 
 

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Please consider and address any dependent relationships between participant and researchers in the 
research and use the National Statement chapter 4.3 for guidance on how this will be managed. 

 

Participants must be given enough time to read the information sheet, ask questions and provide their 

consent without feeling rushed or coerced into participating in the research. 

 

Appropriate methods are: 

  Letters or emails of invitation sent to patients 

  Posters in the waiting room, that advises they may be approached while waiting  

  Clinician mentions the research during the patient s appointment and gains the patient s consent for 

the researchers to contact them. 

  Flyers and posters in key areas, that invite them to contact the researchers for more information 

 
Consumer engagement 
Researcher are encouraged to consult with Consumer and Community groups with the design of their 

research.  Consumer engagement in research is vital, as it will strengthen the research design and how it 

is conducted. Health care professionals and researchers have the expert knowledge about treatment and 

services, but they do not have the lived experience. By involving consumers in the research design and 

conduct, it can be tailored to suit and support the participants and produce high quality research. 

 

More information on Consumer engagement can be found here. 

 
Waiver of consent 
In some research, requesting a waiver of consent is an appropriate method for researchers to access a 

patient s personal information or personal health information.  Please refer to chapter 2 of the National 

Statement for guidance on this method. 

 

If you are applying for a waiver of consent, you must use section 2.3.9 of the National Statement to justify 

why a waiver of consent is appropriate in the protocol.  All applications requesting a waiver of consent, 

where there is active participation in the research are reviewed at full committee. 

 
Conflicts of interest - researchers 
Please declare all conflicts of interests and how they will be disclosed and managed. The conflicts may 
be actual, potential, or perceived or personal, financial, or professional. It is important the conflicts are 

declared and information on how they will be managed provided to the committee.  Please refer to the 




 
 

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National Statement chapter 5.4 for guidance and to your institutions policies on how to handle a conflict of 

interest. 

 
Highly dependent, cognitive impairment, intellectual disability or a mental illness 
If your research involves any of these patient groups, the committee ask you to read the National 

Statement chapters 4.4 and 4.5 for guidance on how to respectfully include these patients in your 

research. 

 

If the participant is unable to provide consent for themselves, you will need a third-party consent 

participant information sheet and consent form.  A link to the NHMRC PICF is on our website or 

go to the NHRMC website. 

 
Children and young people 
Ethics applications involving multiple sites, including Women s and Children s Health Network 

(WCHN), and where the primary research participants are children and young people, or where 

the project involves access to paediatric data primarily held by WCHN, must be submitted to the 

WCHN HREC for review as the lead HREC.   

 

If the research is to be conducted at SALHN, a Site-Specific Assessment will be required as per 

SALHN governance requirements. 

 

Aboriginal and Torres Strait Islander people 
The South Australian Aboriginal Health Research Ethics Committee (AHREC) reviews all 

research applications where the focus is on a topic or disease/health burden identified as being of 

specific concern to Aboriginal and Torres Strait Islander people (based on 4.7.6 of the National 

Statement, 2007, updated 2018). 

In addition to a research application having been submitted to and reviewed by any SA Health 

HREC, proposals are required to also be submitted to the AHREC if: 

 

  The experience of Aboriginal and Torres Strait Islander people is an explicit focus of all or 

part of the research; or 

  Data collection is explicitly directed at Aboriginal and Torres Strait Islander people; or 

  Where it is proposed to separately identify Aboriginal and Torres Strait Islander people in 

the results; or 

  The information has an impact on one or more Aboriginal and Torres Strait Islander 

communities; or  

  The geographic location of the research is such that a significant number of the population 



 
 

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are likely to be of Aboriginal and Torres Strait Islander origin (based on 4.7.6 of the National 

Statement, 2007, updated 2018); or 

  Where terms such as  resilience ;  well-being ;  cultural safely ;  cultural health ; and 

 language and culture  are used in the description and design of the project indicating that 

the project has important health implications; or 

  Aboriginal and Torres Strait Islander health funds are a source of funding. 

 
Participant information sheets (National Statement 5.2.16   5.2.17) 

  Please use the NHMRC PICF templates, which are found on the Office for Research or NHMRC 

website. 

  Please remove the first two instruction pages  

  Please ensure the formatting is consistent and professional in appearance i.e. check spelling and 

grammar, line spacing, font, text color. 

  Please ensure the participants are provided with clear and concise information on what their 

participation involves. 

  The PICF must be free of any jargon and all acronyms explained. 

  Where the research will involve a variety of cultures then the committee may ask that the PICF be 

translated into the relevant language. 

  For a multi-site application submit the  master  PICF in a generic format to be used at all sites. The 

site specific will be reviewed in the governance process. 

  Please write the PICF to a readability age of 12 years old. 

  It is acceptable to remove any sections in the template that are not relevant to your study. 

  The Office for Research contact details and a link to the PICF templates can be found on our 

website. 

 

Data linkage and SA/NT data linkage research 
Applicants who are seeking to access SA Health data held by SA NT DataLink or to conduct data linkage 

studies must submit to the SA Department for Health and Wellbeing HREC. 

 

Appropriate retention of data 
General Disposal Schedule No. 28 is for Clinical and Client-Related Records of Public Health Units in 

South Australia. Research and ethics records not only provide evidence of what research is conducted but 

how it is conducted with regards to subject recruitment, treatment and ethical conduct.  The guidance 

recommends data should be destroyed after 15 years and before this occurs, researchers will need to 

seek approval as per Official Records Destruction Agency Process SALHN (SALHN staff only). 
 

 







 
 

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Publications  
As a general principle, the findings of research funded with public money should be made available to the 

wider community to facilitate knowledge and understanding. Publication of research results irrespective of 

whether they are favourable or unfavourable is considered good ethical practice, promoting transparency 

and knowledge, and is supported by SA Health. For these purposes, a  publication  can be a hard copy, 

electronic copy or online (internet) publication.  

 

Project findings should also be appropriately communicated to research participants and the SALHN office 

for Research. 

 
Biosafety, Chemical and Radiation Safety 
All research that involves biosafety or radiation must comply with relevant requirements. If researchers 

are unsure of the biosafety requirements of their study they should contact the Flinders University 

Institutional Biosafety Committee (IBC).  

 

If the study protocol specifies that the study involves radiation beyond what is standard of care a 

radiation report must be provided. If the radiation is not above standard of care the PI must provide a 

letter confirming this. Research involving radiation must be conducted in accordance with the Australian 

Radiation Protection and Nuclear Safety Agency (ARPANSA) Code of Practice for the Exposure of 

Humans to Ionising Radiation for Research Purposes (2005) available here.  

 

The South Australian Environmental Protection Agency (EPA) must also be notified in writing of the 

research before the research commences using the EPA Notification of a Research Study Involving 

Exposure of Humans to Ionising Radiation form found here 
 

4. Submitting your application 
 

Submitting your application 
There are two ways to submit your application. 

1. Greater than low risk applications are created and submitted via GEMS Research Management 

System. 

2. Low and negligible risk applications are submitted via email to the SALHN Office for Research. 

 

Documents checklist 
  HREA. 

  Protocol. 

  LNR application form. 



 
 

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  An Invoicing and Fee form, declaring the funding for the study if applicable. 

  A literature review to support your study. 

  Participant Information/Consent Form (PICF). Download NHMRC template. 

  Victorian or Western Australian specific module for any of these sites that the SAC HREC is 

providing approval for. 

  Project approvals from other HRECs. 

  Aboriginal community approval (if applicable). 

  Protocol and investigator brochure must be submitted for all clinical drug trials. 

  Questionnaires or surveys being used in the study. 

  Data collection tools. 

  Patient facing documents. 

  Recruitment advertisements such as flyers and posters. 

  Relevant Head of Department (HOD) endorsement letter(s). 

  Letter of support from Flinders Medical Centre pharmacy (if applicable). 

  Radiation Safety Report (if applicable).  

  Proof of registration with Australian Register of Therapeutic Goods. 

  HREC indemnity form for multicenter trials. 

 

Site Specific Assessment (Governance) 
For all public health sites listed on your application, a separate Site Specific Assessment (SSA) must also 

be lodged before the research project can begin at any public heath site listed in the application. Your 

research cannot commence until it has been authorised by the Chief Executive/delegate of the public 

health site where the project is to be undertaken. 

 

If the research project is being conducted at a University, please contact the University s Governance 

Officer for institutional requirements. 

 

In the case of SALHN applications, the Office for Research also encourages researchers to submit their 

Site Specific Assessment forms at the same time as the ethics application for concurrent review. This will 

assist in reducing the amount of time it takes for full authorisation to be granted.   

 

The SSA is created via the GEMS Research Management System. 

For low risk applications, the Low and Negligible Risk application form is used. 

 

SAC HREC review of multicenter research 
There are two approaches for multicenter research applications to be submitted and reviewed: 

1. SA Health single ethical review model. 






 
 

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2. National Mutual Acceptance (NMA) model. 

 
SA Health single ethical review model 

The Single Review Model applies to all multi-site research taking place within SA public health 

system. This model enables researchers to seek ethical and scientific approval through one HREC 

only (referred to as the lead committee). This approval will be accepted by all SA Health HRECs and 

institutions. The SAC HREC will accept ethics approval of the lead SA Health HREC for all research 

taking place within the SA Health public health system. 

 

As a rule the lead committee will be located at the institution of the CPI. The applicant will assume 

responsibility for submitting all required documentation in accordance with SA Health and local HREC 

requirements. 

The SAC HREC is responsible for notifying the CPI of the outcome of the review. It is the CPIs 

responsibility to notify the outcome of this review to each of the other sites where the project is 

proposed to take place, via the Research Governance Officer associated with the site/s. For further 

information, please refer to the SA Health Research Ethics Operational Policy. 

 
National Mutual Acceptance 
National Mutual Acceptance (NMA) is the system of single scientific and ethical review of multi-centre 

human research projects across Australian jurisdictions (public health organisations only). New South 

Wales, Queensland, Victoria, the ACT, Western Australia and South Australia are current NMA 

participants. 

 

SALHN accepts (subject to NHMRC HREC research category certification) SA Health HREC reviews and 

National Mutual Acceptance (NMA) single ethical review and Private HREC review. This means that you 

may be able to rely on ethics review from another site if they are under NMA or another accredited public 

health HREC in South Australia.  

All research must have ethical approval prior to site authorisation.  

 

SALHN accepts ethics review for commercially sponsored clinical trials from the Belberry HREC.  

 

In SA, the ethics application and SSA must be completed via the GEMS Research Management 

System and be submitted to a lead HREC (NMA Certified) for review.   
 

Exemptions 
The following research proposals are excluded from consideration under these two review pathways in 

South Australia in accordance with Standard Principles for Operation: 

  Phase 0 (first time in human) and Phase 1 clinical trials. 






 
 

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o SALHN have specific Phase 1 requirements, click here for further information. 
  Human research proposals involving South Australian Aboriginal and Torres Strait Islander 

participants or which have an Aboriginal health focus, for which applications will need to be 

reviewed by the SA Aboriginal Human Research Ethics Committee (AHREC) in addition to a NMA 

certified HREC. 
 

6. Post approval monitoring and reporting  

 
The SALHN Office for Research has a responsibility to monitor all research authorised to be conducted at 

a SALHN site. SALHN has produced monitoring and reporting guidelines to assist researchers in 

understanding their obligations.  

 
Once you have received ethics and governance authorisation for your research project, there are 

mandatory reporting requirements you must adhere to Failure to do is a breach of a breach of the NHRMC 

Australian Code for the Responsible Conduct of Research R17, R22, the National Statement chapter 5.5 

and the terms and conditions of the ethical approval for this study.    

 

Failure to submit the required report may result in the ethics approval being withdrawn and the application 

closed. 

 

Annual reviews, extension requests, Discontinuation of research projects and final reports 
It is the Chief Investigator s responsibility to ensure that all reports and amendments are submitted to the 

Office for Research. Reporting is an important part of your research project, as it provides the SAC HREC 

with an overview of the study progress and that it is progressing as approved. 

  Annual review  is required annually for the life of the study, on the anniversary of the approval 

date. 

  Extension request   is required 1 month before the ethics expiry date. 

  Discontinuation of research projects   this must be communicated via the Withdrawal of Research 

form as soon as possible. 

  Final report   this is required to be submitted on completion of the research project. Copies of all 

publications or posters are to be provided to the SAC HREC when available. 

 

If the research application was submitted via GEMS, researchers will receive a reminder email to submit 

the report through the Research Management System. 

 

These templates can also be found our website and the competed report emailed to 

Health.SALHNofficeforresearch@sa.gov.au 






 
 

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The Office for Research also has a Research Integrity webpage, which provides the channels in which all 

SALHN approved studies are monitored, plus self-monitoring tools for our researchers. 

 

 
Safety reporting and protocol deviations / violations 
The Monitoring and Reporting Guidelines and reporting templates are on our website. 

 

Depending on nature of your research project, you may need to submit Serious Adverse Event reports, 

protocol violations or Development Safety reports.  These can be submitted via GEMS or via email on the 

appropriate template. 

 

  Serious adverse events (SAE s) only need to be reported if they are definitely, probably or possibly 

related to the study, within 72 hours of the occurrence, unless the Principal Investigator considers 

immediate notification is necessary. 

  SAE s occurring where there is no impact or relationship to the clinical trial does not need to be 

reported to the SAC HREC. 

  Other safety reports required by the committee are Serious Unexpected Suspected Adverse 

Reactions (SUSARs), Adverse Events (AEs), Adverse Device Events (ADEs) and Data 

Monitoring Committee (DMC/IDMC) reports. 

o These are to be reported immediately if they have an impact on the safety of the study 
within SALHN or patients involved in SAC HREC approved research at other 

institutions, otherwise they are to be reported at least every six months. 

  Protocol Violations or Deviations are only reported, where there is an impact on the participant s 

safety within 72 hours of the occurrence.  The PI should acknowledge the Violation or Deviation 

and corrective action should be outlined. 

o If there is no site impact, the violation / deviation does not need to be reported. 
 
Notifications 
Any other items, such as letters, insurance certificates and minor communications from sponsors or 

researchers can be submitted via email or GEMS for review by the Office for Research. 

 

Amendments 
Studies can change overtime and no matter how small the change is, and amendment is required to be 

submitted for review. 

 






 
 

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The amendment notification process is a requirement of continuing ethics approval and institutional 

authorisation and aims to eliminate immediate risks to participants or to assist in the viability of recruitment 

or other research administration.  

 

Amendments can be submitted via email or via GEMS for review by the Office for Research. 
  All relevant application documents will need to be updated, to reflect the current status of the 

research. 

  Please use track changes to make all edits, so the committee can clearly see what has been 

changed. 

  Investigator brochure and protocols: 

o Will need to be submitted with a clean and tracked version. 
o Will require a summary of changes. 

  Please update the version number and date of all submitted documents in the document footer. 

  Sub studies or significant changes to the study design will need to be submitted as a new application. 

 

Amendments requiring SAC HREC approval and SALHN research governance acknowledgement will be 

reviewed at the same time.   The amendment cannot be incorporated into the study until the ethical 

approval has been granted by the committee, which will be a communicated in a formal letter via email. 
 

6. Reference Documents, policies and Resources 
 

Polices and guidance documents to assist in your submission are:  

  SA Health Research Ethics Operational Policy (2017)  
  SA Heath Ethics Policy (2020) 
  SA Health Research Governance Policy (2020) 

  Access to Data for Research Purposes policy (2019) 
  National Statement on Ethical Conduct in Human Research (NHMRC) (2007   updated 2018) 

  Australian Code for the Responsible Conduct of Research (2018)  

  Clinical Trials Toolkit - australianclinicaltrials.gov.au/clinical-trials-toolkit 

  Access to Unapproved Therapeutic Goods  - Clinical Trials in Australia (TGA) 

  International Conference on Harmonisation / Good Clinical Practice  Guidelines (ICHGCP Guidelines) 

  NHMRC AHEC Position Statement, Monitoring and Reporting of Safety for Clinical Trials involving 

therapeutic products (2009) 

  Framework for Monitoring: Guidance for the National Approach to single ethical review of multi-centre 

research (NHMRC, 2012) 

  SA Health Intellectual Property Policy (2017) 

  Department of the Premier and Cabinet (2016), Information Privacy Principles 

  SA Health Privacy Policy Directive (2017) 

  SA Health Privacy Policy Framework (2017) 



















 
 

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  Terms of Reference dated July 2017 
 

 

 

 

Document History  

Custodian  SALHN Office for Research 
Document status  New document  
Key words  Research, Research Governance, Ethics, Human Research Ethics 

Committee (HREC), Clinical Trials, Audit Based Research, Monitoring, 
Education.  

Version control Amendment details Start Date 
V1.0 Initial targeted launch for consultation December 2018 

V2.0 Final document incorporating consultation outcomes pending SALHN Authorisation April 2019 

2.1 Update to incorporate recent changes to submission documentation Jan 2020 

2.2 Update to incorporate introduction of GEMS May 2021 

3.0 Update to incorporate changes to audit applications and addition of new webpages. Aug 2021 

.31 Update to incorporate training resources Nov 2021 
 

Print Name: Simon Windsor, Manager, Research Governance &amp; Ethics 

Signature: 

Date:   

The signed version is retained by SALHN Office for Research. 



	Training Resources Page
	Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC)
	Ethics and governance review pathways
	SALHN Office for Research Fees

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