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<pre>
 
 

Policy No.: D0262 

 

 
 
 

 

Research Ethics 
Policy Directive 

 
Version No.:  3.2 
Approval date:  16/07/20   



 
 

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Contents  
 
1. Policy Statement .................................................................................................................. 3 
2. Roles and Responsibilities .................................................................................................. 3 
3. Policy Requirements............................................................................................................ 3 
4. Implementation &amp; Monitoring ............................................................................................. 14 
5. National Safety and Quality Health Service Standards ..................................................... 14 
6. Definitions .......................................................................................................................... 14 
7. Associated Policy Directives / Policy Guidelines and Resources ..................................... 16 
8. Document Ownership &amp; History ........................................................................................ 16 
  



 
 

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Research Ethics Policy Directive 
 
1. Policy Statement 
 
SA Health is committed to supporting the conduct of high quality health and medical research 
across the South Australian public health system.  
 
It is important that research involving human participants is conducted in a manner that respects 
and protects all involved, including the researcher, the research participants and the Institution. 
Obtaining research ethics approval helps to ensure that the research is carried out professionally 
and takes into account relevant legal, ethical, organisational and cultural standards. 
 
SA Health has an obligation to ensure that research being conducted within the South Australian 
public health system by staff or external researchers is of a high standard and observes all ethical 
requirements in accordance with applicable guidelines and standards, including the NHMRC s 
National Statement on the Ethical Conduct of Human Research (hereafter referred to as the 
 National Statement ). 
 
This Policy Directive outlines the operational requirements for Human Research Ethics 
Committees (HRECs) under the jurisdiction of SA Health, and outlines requirements for 
researchers wishing to conduct research within the South Australian public health system. 
 
2. Roles and Responsibilities 
 
Local Health Network Chief Executive Officers are responsible for: 

  Implementing the requirements of this Policy Directive including ensuring staff compliance; 
  Providing appropriate resources and support for Human Research Ethics Committees 

under their jurisdiction; and 
  Supporting a culture of responsible research practice across their Local Health Network. 

 
SA Health HRECs are responsible for the ethical review of research projects being undertaken 
across SA Health, and ongoing monitoring of approved projects, in accordance with their Standard 
Operating Procedures, the requirements of the National Statement of Ethical Conduct in Human 
Research, and other legislative, policy and operational requirements. 
 
Researchers are responsible for undertaking research across SA Health in a safe and ethical 
manner, in compliance with this Policy Directive and all relevant policies, guidelines and 
procedures. 
 
The Department for Health and Wellbeing Office for Research is responsible for monitoring the 
implementation of this this Policy Directive and the ongoing review and update of this Policy 
Directive. 
 
3. Policy Requirements 
 
3.1 STREAMLINED ETHICAL REVIEW 
SA Health promotes efficiency in the ethical and scientific review of research projects being 
undertaken across SA Health by ensuring that reviews are sufficiently rigorous, undertaken in 
accordance with the risk level of the project, and are conducted with reference to the National 
Statement and other relevant guidelines. 
 



 
 

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SA Health supports two approaches for streamlined review based upon the mutual recognition of 
ethical review by properly constituted HRECs. These approaches are complementary, and provide 
two pathways for researchers conducting research within the South Australian public health 
system to efficiently gain ethical approval: 

  The SA Health Single Ethical Review Model   for research taking place within the South 
Australian public health system. 

  National Mutual Acceptance   for multi-centre human research projects taking place across 
participating Australian jurisdictions (public health organisations only). 

 
 
3.2 SA HEALTH SINGLE ETHICAL REVIEW MODEL 
1. Every research project which is to be conducted at a site under the jurisdiction of SA Health 

will be ethically and scientifically reviewed once only by a SA Health HREC or another South 
Australian based NHMRC certified HREC.  The reviewing committee is designated the lead 
HREC.   

2. All sites under the jurisdiction of SA Health that are participating in the proposed research will 
accept the review of the lead HREC without further ethical or scientific consideration, with 
appropriate exceptions established by the LHN board and Chief Executive. 

3. The research ethics applicant (the Coordinating Principal Investigator or CPI) will select a lead 
HREC to undertake single review from a register of HRECs on the SA Health ethics website.  .  
The applicant will assume responsibility for submitting all required documentation in 
accordance with SA Health and local HREC requirements. 

4. Lead HRECs must be appropriately constituted in accordance with the requirements of the 
NHMRC, and fulfil the requirements of the National Statement (section 5.2).  Additionally they 
must have access to the required expertise to undertake a full scientific and ethical review of 
the type of research which is submitted. 

5. Every research application must undergo a separate research governance review at each site 
where the research is to be conducted to permit consideration and approval of the research 
governance requirements at that site (a site specific assessment).  This is distinct from the 
scientific and ethical review by the lead HREC. 

6. The lead HREC will be responsible for the full scientific and ethical review of the research 
application.  Once completed, the lead HREC will be 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.   

7. Under this model, HRECs will have the right to refuse to consider a multi-site application only 
under the following circumstances: 
i. The HREC Chairperson determines there is insufficient expertise on or available to the 

HREC to permit an adequate scientific and ethical review of the proposal; or 
ii. The HREC is not able to review the proposal in a timely manner (e.g. the meeting 

agenda for the next HREC meeting has reached capacity). 
 
8. In these circumstances (7 [i] and [ii]), the HREC should notify the applicant as soon as 

practicable in order that they can then submit to another suitable SA Health HREC. 
 

9.  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).  In addition to a research application having been submitted to and 
reviewed by SA Health HREC, proposals are required to 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 



 
 

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  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 are likely to be of Aboriginal and Torres Strait Islander origin (based on 4.7.6 
of the National Statement, 2007); 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. 
 
10.  The CPI should provide the AHREC with a copy of the research application and the lead 

HRECs ethical determination on the project for consideration as soon as practicable.  The 
AHREC will then provide their evaluation of the project to the lead HREC for consideration 
prior to providing feedback to the applicant.  The AHREC will expedite their review where 
possible. 

 
11.  Ethics applications involving 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. 

 
12.  Any multi-site project where the primary data being used for the project is held by the 

Department for Health and Wellbeing should be submitted to the Department for Health and 
Wellbeing HREC for review as the lead HREC.  

 
13.  If a research site is added to an existing project that has HREC approval, it is a requirement 

that the project is amended to add the new site and this amendment is approved by the lead 
HREC.  The local investigator should then complete and submit the appropriate research 
governance documents to seek site approval along with a copy of the amendment approval 
letter issued by the HREC. 

 
 
3.3 NATIONAL MUTUAL ACCEPTANCE 
National Mutual Acceptance (NMA) supports the single scientific and ethical review of multi-centre 
human research projects across participating Australian jurisdictions (public health organisations).  
The Standard Principles for Operation for NMA, available on the SA Health website provide the 
overarching framework for NMA and should be referred to by SA Health HRECs, researchers and 
others who may be involved in seeking approval to undertake research using the NMA system. 
 
NMA permits the review of any form of human research, as defined in the National Statement on 
Ethical Conduct in Human Research (2007) or any replacement of that document published by the 
National Health and Medical Research Council (NHMRC), for which an application must be made 
to an HREC for the purpose of research being conducted at a public health organisation. This 
includes low and negligible risk research review by a full HREC using the NHMRC s national ethics 
form.   
 
In accordance with the Standard Principles for Operation, SA Health organisations are required to 
accept the approval of a NHMRC Certified HREC for a project submitted under NMA without 
requiring further ethical and scientific review.  There are two categories of research that are 
exempt from being considered under NMA, being Phase 0 (first time in human) and Phase 1 
Clinical Trials, and Aboriginal and Torres Strait Islander Projects.  For further details on the two 
exemption areas, refer to section 8 of this Policy Directive.   




 
 

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A list of Certified HRECs can be found here. 
 
3.3.1 SA Health HREC Certification 
The following SA Health HRECs have been certified by the NHMRC to undertake review in the 
categories of research outlined. 
 
Women s and Children s Health Network Human Research Ethics Committee (EC00197) 
Certification categories: 

  Clinical trials phase I, II, III, IV. 
  Clinical trials drugs and devices. 
  Clinical trials surgery. 
  Clinical trials other. 
  Clinical interventional research other than clinical trials. 
  Population health and/or public health. 
  Qualitative research. 
  Mental health. 
  Paediatric research. 
  Other health and medical research: 

o Women s health. 
o Genetic studies. 
o Oncology. 
o Tissue banking. 

 
Southern Adelaide Clinical Human Research Ethics Committee (EC00188) 
Certification categories: 

  Clinical trials phase I, II, III, IV. 
  Qualitative research. 
  Mental health. 
  Other health and medical research: 

o Palliative care. 
o Oncology. 
o Intensive care. 

 
Central Adelaide Local Health Network Human Research Ethics Committee (EC00192) 
Certification categories: 

  Clinical trials phase I, II, III, IV. 
  Clinical research other than clinical trials. 
  Population health and/or public health. 
  Qualitative research. 
  Mental health. 

 
SA Department for Health and Wellbeing Human Research Ethics Committee (EC00304) 
Certification categories: 

  Population health and/or public health. 
  Qualitative research. 
  Mental health. 
  Other health and medical research: 

o Data linkage research. 
  




 
 

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3.3.2 Procedures for SA Health HRECs acting as the  lead  HREC for NMA 
1.  South Australian researchers who wish to undertake a new research project eligible for review 

under NMA should identify an appropriate Certified SA Health HREC (the  lead  HREC).   

2. The CPI should submit their ethics protocol to the HREC affiliated with their employing public 
health organisation, where possible.   

3. The CPI must complete the ethics application using the Human Research Ethics Application 
form hosted on Online Forms. 

4. The lead HREC should review the ethics protocol in accordance with their standard operating 
procedures, and usual committee processes. 

5. A timeframe of 60 days (the 60 day clock) will apply to the ethical and scientific review of 
proposals. 

6. Once the review of the protocol is complete, the lead HREC will notify the CPI of the outcome 
of the ethical and scientific review.   

7. The CPI will be responsible for communicating the outcomes of the ethical and scientific 
review to all participating research sites through their Principal Investigators.   

8. Where a protocol is not approved, the CPI may resubmit the protocol to the lead HREC, 
providing the grounds for non-approval are remedied. 

9. The lead HREC will be responsible for reviewing any amendments to the protocol that are 
submitted during the life of the research project.  In all cases, the CPI is responsible for 
notifying other participating sites of the outcomes of the review rather than the HREC. 

10. The lead HREC will be responsible for reviewing all adverse events that may occur during the 
life of the research project. 

 
 
3.4 ETHICS FORM REQUIREMENTS 
The Human Research Ethics Application (HREA) form has been developed by the NHMRC as a 
standardised human research ethics application form that may be accepted by Australian research 
ethics committees.  A licensed version of the HREA is available on Online Forms.  
 
SA Health supports the use of the HREA and the following guidelines should be observed. 
 
3.4.1 SA Health only research 
For multi-centre research proposals being conducted across SA Health, SA Health HRECs are 
encouraged to accept the HREA.  Ethics applicants may discuss alternative application forms with 
the reviewing HREC.  For single-site research only, the HREC may choose to accept proposals 
using a locally developed ethics application form or the HREA. 
 
3.4.2 National Mutual Acceptance 
Use of the HREA is a requirement for all research ethics proposals submitted under NMA. 
 
 
3.5 ETHICS APPLICATION SUBMISSION 
SA Health HRECs are responsible for ensuring human research ethics submission requirements 
are published appropriately and readily available to applicants. 
 
While the electronic submission of HREC applications is preferable, each SA Health HREC is 
responsible for developing submission guidelines that meet their individual needs.  
 





 
 

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The ethics applicant is responsible for submitting all required documents to the HREC in 
accordance with the submission requirements.   
 
3.5.1 Low and Negligible Risk Research 
The National Statement enables HRECs to adopt processes for expediting the review of low risk 
projects.  Low risk projects are those where the  only foreseeable risk is one of discomfort , while 
negligible risk projects include those which may only involve  inconvenience  to research 
participants.  Projects that are of negligible risk only may be exempt from ethical review. 
 
SA Health HRECs should have clear and documented processes for expediting the review of low 
risk project applications included in their SOPs.  These processes should be consistent with the 
requirements of NMA in relation to low and negligible risk research (refer to section 3.3 of this 
Policy Directive). 
 
To facilitate the efficient review of research applications deemed to be low/negligible risk within 
South Australia, SA Health has developed a Low and Negligible Risk (LNR) Ethics Application 
Form. 
 
The determination as to whether a project qualifies as low or negligible risk must be made by the 
reviewing HREC in consultation with the National Statement.  Interventional studies including 
clinical trials generally should not be considered for expedited review as they are not typically  low 
risk , and nor should projects involving research on sensitive personal or cultural issues or 
involving  at risk  individuals or groups. 
 
Researchers should contact their local HREC office to discuss the proposed research and identify 
whether the project may be considered for expedited review. 
 
 
3.6  BENCHMARKS FOR REVIEW: THE 60 DAY CLOCK 
SA Health adopts a benchmark of 60 calendar days (60 day clock) for full scientific and ethical 
review of research proposals.  This clock commences upon receipt of a valid (complete) research 
ethics application.   
 
Should the ethics application be incomplete, the CPI will be requested to resubmit the application 
and supply any additional information required by the HREC.  The clock is effectively stopped if the 
HREC requests further information in order to make a decision about the application. 
 
It should be noted that the 60 day clock is a measure of performance only.  Should the review 
period exceed 60 days, the CPI is not entitled to any remedies, such as the return of any ethics 
review fees that may be charged by the HREC. 
 
 
3.7 STANDARD OPERATING PROCEDURES 
SA public health system HRECs are required to develop and publish their own standard operating 
procedures (SOPs) that describe how their HREC operates.  The SOPs must be made available to 
all HREC members and research ethics applicants, and should be maintained and updated 
appropriately.   
 
 
3.8 HREC COMPLAINTS AND APPEALS PROCESS 
Section 5.1(4) of the National Statement requires institutions to establish processes to handle 
complaints concerning research.  Where a SA public health system HREC rejects a research 
proposal outright on ethical grounds, makes an unfavourable decision about a component of the 
research proposal, or fails to reach a decision about the ethics of a research proposal, the 
investigator has the following rights: 



 
 

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a) Where a proposal has been rejected, the investigator may submit a new application to the 
HREC, taking due account of the HREC s concerns.  The revised application will be 
processed and reviewed in accordance with the HREC s usual processes; or 

b) Where (a) does not apply, the investigator may lodge a written appeal with the HREC 
Chairperson specifying the grounds of the appeal. The Chairperson will investigate the 
appeal, and recommend to the HREC the appropriate course of action within 4 weeks from 
the date of the appeal being lodged. The HREC will notify the appellant of the course of 
action and determination in a timely manner. 

 
3.8.1 Appeals Mechanism 
Following an appeal being lodged to the HREC Chairperson, if the appellant considers that the 
HREC has not followed due process or remains unsatisfied with the outcome, they may choose to 
lodge an appeal with the Chief Executive Officer / delegate responsible for the HREC. 
 
The following process will be followed: 

a) The Chairperson will provide the Chief Executive Officer / delegate with all relevant 
material, including: 

a. Details of the appeal; 
b. Material reviewed by the HREC; and 
c. The outcome/decision of the ethical review process. 

 
b) The Chief Executive Officer / delegate will determine if further investigation of the appeal is 

necessary. If so, a panel will be established to consider the appeal. The panel will include 
the following members: 

a. The Chief Executive Officer / delegate; 
b. Two nominees of the Chief Executive Officer / delegate (not members of the 

HREC);  
c. At least one nominee with relevant expertise in human research ethics; and 
d. Expert(s) in a discipline of research related to the project under consideration. 

 
c) The panel will allow the HREC and the appellant the opportunity to make submissions. 

 
d) The Chief Executive Officer / delegate will notify the HREC and the appellant of the 

outcome of the investigation. The possible outcomes include: 
a. The appeal is dismissed; or 
b. The appeal is upheld and the panel makes recommendation to resolve the issues 

based on the findings of the panel.  The panel does not have the authority to 
approve an ethics application, but may choose to refer an ethics application to an 
independent ethics committee for re-review. 

 
If the panel or Chief Executive Officer / delegate requests that a second ethical review is required 
as a recommendation of the investigation, an alternative SA public health system HREC (where 
possible) with suitable expertise and no prior involvement in the matter will be invited to undertake 
this review.   
 
The panel or Chief Executive Officer / delegate cannot reverse the final determination of any 
HREC. 
 
 
3.9  USE OF APPROVED AND UNAPPROVED MEDICINES AND MEDICAL DEVICES 
Research that involves the use of approved or unapproved medicines, medical devices, blood, 
tissues and chemicals must be compliant with the legislation, regulations and guidelines of the 
Therapeutic Goods Administration (TGA). 
 



 
 

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Use of medicines or medical devices within the context of an approved research project does not 
guarantee their use beyond the scope of the research project.   
 
 
3.10  CLINICAL RESEARCH TRIALS CONDUCTED UNDER THE CTN OR CTX SCHEMES 
The TGA permits the use of unregistered or unapproved medicines or medical devices to assess 
their safety and efficacy within the context of a monitored clinical research trial under Sections 18 
and 19 of the Therapeutic Goods Act (1989).  This is done through either the Clinical Trial 
Notification (CTN) or Clinical Trial Exemption (CTX) schemes. 
 
For the CTN scheme, the reviewing HREC has sole responsibility for reviewing all the data relating 
to the trial, such as safety data pertaining to the investigative medicine or device.  It also has 
responsibility for making a determination about the scientific and ethical merit of the trial. 
 
For the CTX scheme, the TGA has responsibility for reviewing relevant data including preclinical 
data pertaining to the investigative medicine or device.  The TGA s review of this data is taken into 
account by the reviewing HREC, who will then make a determination about the scientific and 
ethical merit of the trial as a whole. 
 
Under both schemes, the reviewing HREC has the authority to approve (or reject) the trial based 
on the scientific and ethical merit of the trial. 
 
 
3.11  REGULATION OF GENE TECHNOLOGIES AND RELATED THERAPIES 
Health and medical researchers in South Australia are legally required to comply with the Gene 
Technology Act (2001) and the Gene Technology Regulations (2002) for research involving 
Genetically Modified Organisms. 
 
SA Health facilities in which researchers are using gene technology must be accredited and 
maintain, or have an established link with, a properly constituted Institutional Biosafety Committee 
(IBC) within a collaborating organisation. 
 
Any formal review provided by an IBC should be given to the lead HREC by the applicant upon 
submission of a new application for review. 
 
All research protocols involving gene therapy and related gene technologies including 
xenotransplantation must be submitted to a HREC for review. 
 
Research involving embryos must comply with the Prohibition of Human Cloning for Reproduction 
and the Regulation of Human Embryos Research Amendment Act (2006), and the Ethical 
Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research 
(NHMRC, 2007). 
 
 
3.12  IONISING RADIATION 
All research involving any form of radiation must comply with relevant National and State 
legislation, organisational policies and procedures, and codes and standards of practice provided 
by the NHMRC and the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA). 
 
SA Health HRECs assessing research proposals involving exposure of participants to ionising 
radiation must be provided with a written report from an accredited medical physicist. 
 
In South Australia, the Environment Protection Authority (EPA) has responsibility for administering 
the Environmental Protection Act (1993) and Radiation Protection and Control Act (1982).  The 



 
 

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Radiation Protection Branch of the EPA must be notified of all research involving exposure of 
research participants to ionising radiation.  This form should be used for notification purposes.  
 
 
3.13  RESEARCH INVOLVING SA HEALTH DATA 
For research ethics applications that require access to data or confidential information held by SA 
Health, it is a requirement that access be granted on the basis of ethical approval from an 
appropriate Certified HREC and project authorisation by the appropriate Institution/s, following 
submission of a complete and satisfactory SSA. 
For projects being undertaken in South Australia only, the CPI should contact the HREC affiliated 
with their Institution to determine whether it is able to review the ethics application.   
 
Any SA based project where the primary data being used for the project is held by the Department 
for Health and Wellbeing (e.g. ISAAC or Cancer Registry Data) may be submitted to the 
Department for Health and Wellbeing HREC for ethical review.  
 
The data custodian has ultimate responsibility to approve or refuse the release of data for a 
specific research project, independent of the ethical determination made by the reviewing HREC. 
 
 
3.14  COMPLAINTS PROCESS 
Each SA Health HREC is responsible for maintaining an appropriate complaints process for health 
and medical research projects that undergo ethics review and/or ethics approval that should 
consider: 

  Complaints made by research participants and/or research (or other) staff concerning the 
conduct of approved research being undertaken at an Institution; 

  Complaints made by ethics applicants regarding the ethical review process and/or 
outcome. 

 
The process for dealing with such complaints should be documented in the HREC SOPs, and be 
published on the local HREC website. 
 
SA Health organisations must also have policies and/or procedures for managing complaints 
related to health and medical research projects in the event the complaint cannot be resolved by 
the HREC, or falls outside the scope of the HREC responsibilities.  
 
 
3.15 SUSPENSION OR WITHDRAWAL OF RESEARCH ETHICS APPROVAL 
SA Health HRECs reserve the right to suspend activity on an approved research project should the 
CPI fail to observe the HRECs conditions of approval or any other reasonable requirement of the 
HREC.  Grounds for suspending the activity on a project may include: 

  Failure to provide regular (at least annual) reports of progress; 
  The reporting of a serious adverse event that poses a risk to other participants involved in 

the research at the local Institution; 
  A complaint issued by a research participant and/or staff member that has ethical or 

scientific implications for the ongoing conduct of the project. 
 
It is recommended that each SA Health HREC has documented processes that outline how 
breaches of ethical approval will be managed.  These processes should be included in the HREC 
SOPs, and provide a consistent and transparent approach to these issues.   
 
All matters concerning possible breaches of research ethics approval should be dealt with in a 
timely manner, and any decision to either suspend or withdraw ethics approval should be 
communicated clearly to all key parties involved with the conduct of the project.   



 
 

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3.16  DATA STORAGE, RETENTION AND DISPOSAL REQUIREMENTS 
 
3.16.1 SA Health records management requirements 
SA Health organisations are required to comply with the specific organisational requirements that 
apply to the retention, storage and disposal of HREC related materials, and research material and 
data specifically outlined in the General Disposal Schedule No. 28: Clinical and Client-Related 
Records of Public Health Units in South Australia (Section 6: Research and Ethics).   
 
3.16.2 General requirements for researchers 
Researchers are responsible for ensuring appropriate arrangements with respect to the collection, 
storage and disposal of research materials including data, in compliance with all applicable 
requirements.  Access to data and information collected during the conduct of research should be 
limited to those who are directly involved in the conduct of the project, and mechanisms such as 
use of locked filing cabinets or password protected computers may be warranted.  Arrangements 
should be established for the ongoing handling of research materials in the event the investigator 
leaves the organisation. 
 
The Australian Code (section 2) outlines general requirements for the retention of research data, 
which should be observed by researchers undertaking approved research across SA Health:  

  In general, the minimum recommended period for retention of research data is 5 years from 
the date of publication. However, in any particular case, the period for which data should be 
retained should be determined by the specific type of research. For example: 

o For short term research projects, that are for assessment purposes only (e.g. 
research projects completed by students), retention of research data for 12 months 
after completion of the project may be sufficient.  

o For clinical trials, data should be retained for a minimum of 15 years for adult 
studies or 25 years for paediatric studies after formal notification is received that all 
study procedures are completed and the study is closed.  

o For areas such as gene therapy, research data must be retained permanently (e.g. 
patient records).  

o If the work has community or heritage value, research data should be kept 
permanently, preferably within a national collection.  

 
 
3.17  RESEARCH MONITORING AND REPORTING 
Each SA Health HREC is required to include the agreed monitoring and safety reporting 
requirements for ethically approved studies in their SOP s.  Upon ethical approval of a research 
project, the lead SA Health HREC shall require the investigator to notify the HREC of anything 
which might warrant review of the ethical and scientific approval of the project.  As a general 
principle, the level of monitoring performed by the HREC should correspond to the risk profile of 
each project approved by the HREC. 
 
The following approaches may be utilised by HRECs to support effective monitoring of approved 
studies:  

  Requiring submission of annual reports; 
  Review of reports from independent agencies (e.g. data and safety monitoring boards); 
  Review of adverse event reports; 
  Auditing of research records, e.g. consent documentation; 
  Consideration of feedback including complaints provided by research participants. 

 
 
 
 
  



 
 

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3.17.1 Clinical Trials 
 
For clinical trials, SA Health requires safety reporting to be consistent with the requirements of the 
NHMRC s (2016) Safety monitoring and reporting in clinical trials involving therapeutic goods.   
 
 
3.18 MANAGEMENT OF RESEARCH ETHICS APPLICATIONS 
SA Health requires HRECs to use the approved research management system for all research 
ethics submissions.  HRECs are required to maintain complete records of human research ethics 
applications, including correspondence and decisions relating to the review of HREC submissions, 
in accordance with the requirements of Section 5 of the National Statement.  SA Health HRECs 
are also required to record review times for HREC submissions using the approved research 
management system to enable appropriate monitoring and reporting as required.   
 
  




 
 

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4. Implementation &amp; Monitoring 
 
Each Local Health Network through the Chief Executive Officer is responsible for implementing the 
requirements of this Policy Directive.  
 
The Department for Health and Wellbeing Office for Research is responsible for monitoring the 
implementation of this Policy Directive in conjunction with the Local Health Networks.   
 
The Local Health Networks will report on key research outputs and performance measures linked 
to this Policy Directive through their annual research report provided to the Chief Executive, SA 
Health, as a component of the Service Level Agreements.   
 
 
5. National Safety and Quality Health Service Standards 
 

 
 
6. Definitions 
 
In the context of this document: 
 
AHREC means Aboriginal Health Research Ethics Committee. 
 
Certified HREC means a Human Research Ethics Committee that has received certification by the 
NHMRC to undertake the single scientific and ethical review of a multi-centre research project. 
 
Clinical trial means a research study designed to test the safety and/or efficacy of a medical 
treatment or intervention, often involving a treatment and control arm.   
 
CTN means the Clinical Trial Notification scheme developed by the Therapeutic Goods 
Administration (TGA) to permit unregistered medicines and medical devices to be used in the 
context of a clinical research trial.  For CTN trials, the local HREC is solely responsible for 
reviewing and determining the safety and appropriateness of the medicine/device in the context of 
the trial. 
 
CTX means the Clinical Trial Exemption scheme developed by the Therapeutic Goods 
Administration (TGA) to permit unregistered medicines and medical devices to be used in the 
context of a clinical research trial.  For CTX trials, the TGA is also involved in assessing the safety 
and appropriateness of the medicine/device in the context of the trial. 
 
Coordinating Principal Investigator (CPI) means the lead investigator on a research study 
taking overall responsibility for the conduct of the study at all of the study sites. 
HREA means the Human Research Ethics Application form developed by the NHMRC. 
 

 
 

National 
Standard 1 

 
Governance 

for Safety 
and Quality 

in Health 
Care 

 

 
 

National 
Standard 2 

 
Partnering 

with 
Consumers 
 
 
 

 
 

National 
Standard 3 

 
Preventing 

&amp; 
Controlling 
Healthcare 
associated 
infections 

 
 

National 
Standard 4 

 
Medication 

Safety 
 
 
 
 

 
 

National 
Standard 5 

 
Patient 

Identification 
&amp; Procedure 

Matching 
 
 

 
 

National 
Standard 6  

 
Clinical 

Handover 
 
 
 

 

 
 

National 
Standard 7 

 
Blood and 

Blood 
Products 

 
 

 

 
 

National 
Standard 8 

 
Preventing 

 &amp; 
Managing 
Pressure 
Injuries 

 

 
 

National 
Standard 9 

 
Recognising &amp; 
Responding to 

Clinical 
Deterioration 

 
 

 
 

National 
Standard 10 

 
Preventing 

Falls &amp; 
Harm from 

Falls 
 
 

? ? ? ? ? ? ? ? ? ? 







































































 
 

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HREC means Human Research Ethics Committee. 
 
IBC means Institutional Biosafety Committee. 
 
ISAAC means the Integrated South Australian Activity Collection (ISAAC), an admitted patient 
morbidity data collection maintained by SA Health. 
 
Lead HREC means the human research ethics committee responsible for the single ethical and 
scientific review of a research ethics application. 
 
National Mutual Acceptance (NMA) means the single scientific and ethical review of human 
research projects across participating jurisdictions. 
 
National Statement means The NHMRC s National Statement on Ethical Conduct in Human 
Research (2007). 
 
NHMRC means National Health and Medical Research Council. 
 
NHMRC Certified HREC means an institution/HREC that has been certified by the NHMRC to 
undertake the single scientific and ethical review of human research projects. 
 
OACIS means an electronic clinical patient information system owned by SA Health. 
 
Principal Investigator means the lead investigator responsible for the conduct and management 
of a research project at a local Institution or Site. 
 
RGO means Research Governance Officer. 
 
SA Health means the health portfolio of services and agencies responsible to the Minister for 
Health, Minister for Mental Health and Substance Abuse and the Minister for Ageing.   
 
SAE means: Serious Adverse Event. 
 
SOP means: Standard Operating Procedure. 
 
SSA means: Site Specific Assessment. 
 
TGA means: Therapeutic Goods Administration. 
 
  



 
 

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7. Associated Policy Directives / Policy Guidelines and Resources 
 
SA Health Research Governance Policy Directive (2020) 
 
SA Health Privacy Policy Directive (2017) 
 
General Disposal Schedule No. 28: Clinical and Client-Related Records of Public Health Units in 
South Australia (2014) 
 
 
8. Document Ownership &amp; History 

Approval 
Date Version Who approved New/Revised Version Reason for Change 

16/07/20 3.2 DCE, SPSD Changes to scope of ethical mutual acceptance 

13/11/17 3.1 Portfolio Executive General updates 

04/01/16 3 Portfolio Executive NMA and general updates, removal of obsolete material 

01/07/13  2 Portfolio Executive Inclusion of NMA requirements 

01/04/12  1 Portfolio Executive Original approved version 
 

Document developed by:  Office for Research, Department for Health and Wellbeing 
File / Objective No.: 2018-13236 
Next review due:   01/07/2023  
Policy history: Is this a new policy: N 
 Does this policy amend or update and existing policy?   Y 
 If so, which version? V3.1 
 Does this policy replace another policy with a different title?  N 
ISBN                                      978-1-76083-304-6 
 

 






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