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Northern Adelaide Local Health Network  
Other Research Projects 

Submission Guidelines  
 (NOT CLINICAL TRIALS)  



NORTHERN ADELAIDE LOCAL HEALTH NETWORK 

 

Other Research Project Guidelines   2 

CONTENTS 
CONTENTS ..................................................................................................................... 2 

INTRODUCTION ............................................................................................................. 3 

SITE SPECIFIC ASSESSMENTS (SSA) ................................................................................ 4 

Technical Support   GEMS ......................................................................................................... 4 

Helpful Hints ............................................................................................................................ 4 

Dual Submissions ...................................................................................................................... 4 

LOW TO NEGLIGIBLE RISK (LNR) .................................................................................... 5 

INSURANCE ................................................................................................................... 5 

SA Health Employees ................................................................................................................ 6 

Dual Employment ..................................................................................................................... 6 

Non-SA Health Employees ......................................................................................................... 6 

Third Party Sponsor .................................................................................................................. 6 

NALHN Credentialling ............................................................................................................... 6 

ESSENTIAL DOCUMENTS ................................................................................................ 7 

SSA Fee Form ........................................................................................................................... 7 

Human Research Ethics Committee (HREC) ................................................................................. 7 

GOOD CLINICAL PRACTICE CERTIFICATE ...................................................................................... 7 

NEXT STEPS................................................................................................................... 10 

Lodging your application ......................................................................................................... 11 

CONTACT US ............................................................................................................... 12 

  



NORTHERN ADELAIDE LOCAL HEALTH NETWORK 

 

Other Research Project Guidelines   3 

INTRODUCTION 

In accordance with the SA Health Research Governance Directive, all research within the Northern Adelaide Local 

Health Network (NALHN) requires authorisation of the delegated officer (Executive Director of Medi cal Services) 

before commencing.  The Research Governance Office is keen to discuss your project proposals with you at an 

early stage wherever possible and is here to help navigate the necessary paperwork needed to lodge a research 

application. 

While clinical trials have clearly defined governance guidelines, all research projects irrespective of their level of 

complexity must be registered with the Research Governance Office.  Please refer to the clinical trials guidelines 

and investigator initiated guidelines for details.  

Similarly  Quality Assurance and Audits Submission Guidelines projects have specific definitions and rules in their 

separate guideline. 

For all other projects the following guideline will assist researchers in navigating the NALHN research governance 

process. 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

  







NORTHERN ADELAIDE LOCAL HEALTH NETWORK 

 

Other Research Project Guidelines   4 

SITE SPECIFIC ASSESSMENTS (SSA)  
 

Research that involves a risk of harm is considered more than low risk research.  See link to the National Statement on 
Ethical Conduct in Human Research (2007 Updated 2018)  paragraphs 5.1.19 to 5.1.23   
 
Site Specific Assessment Form   Greater than low risk studies are now required to be completed on the Research 
Governance and Ethics Management System (GEMS) website which can be located at, Research GEMS .   Please review 
the user guides for step-by-step instructions on how to navigate the Research GEMS.  

 
GEMS is designed to enable a more consistent and streamlined process for research applicants who wish to conduct 
research within SA Health. 
 
Research GEMS allows researchers to: 

  complete their Human Research Ethics Application and Site-Specific Assessment forms 
  monitor approval progress and 
  submit post approval monitoring to their local Research Office. 

All SA Health sites are now accepting new applications for ethics and site assessments through Research GEMS. All 
Current studies have been migrated into the system and can be accessed through the Research GEMS web-based 
platform. 
 
Feel Free to contact the NALHN Research Secretariat for further guidance or support healthnalhnrgo@sa.gov.au 
 

Technical Support   GEMS 

 

Please review the user guides for step-by-step instructions on how to navigate the Research GEMS system or contact 

the  NALHN Research Secretariat on phone: 818-29346 or email :healthnalhnrgo@sa.gov.au  for further guidance or 

support.  

 

Helpful Hints   

Frequently Asked Questions regarding GEMS  

Completing the site application part C: Department and Services guide   

 

Dual Submissions  

Site assessment and ethical review may occur in parallel.  However, the decision to authorise or not authorise 

the commencement of a research project at the site can only be made once the HREC has approved the project.  

 

  












NORTHERN ADELAIDE LOCAL HEALTH NETWORK 

 

Other Research Project Guidelines   5 

LOW TO NEGLIGIBLE RISK (LNR)  

 

The Low/Negligible Risk form is an abridged site -specific assessment that may be used for studies that meet the 

Low/Negligible Risk criteria:  

The NHMRC National Statement on Ethical Conduct in Human Research (2018) defines low risk research as 

 research where the only foreseeable risk is one of discomfort . Discomfort may include minor side-effects of 

medication, discomfort related to measuring blood pressure or anxiety induced by an interview. Where the risk, 

even if unlikely, is more serious than discomfort, the research is not low risk .  

The National Statemen on Ethical Conduct in Human Research, provides that institutions may have ethical review 

processes other than full committee review for low/negligible risk studies (see 5.1.18   5.1.23) 

Low &amp; Negligible Risk Application Form (LNR)   this form is used for expedited ethics and governance review of 

research studies that are considered low and negligible risk according to the National Statement (2018).   

Formal determination of whether a study is low/negligible risk and/or is eligible for expedited review is made by 

the Chair of the Ethics Committee upon receipt of an application.  Low and Negligible Ri sk (LNR) Studies require 

both ethical approval from the relevant HREC and governance authorisation to commence at SA Health sites.  

There Are three Types of LNR applications: -  

1. The LNR form is available on our NALHN Research web page. If your application has already achieved 

ethics approval by an National Mutual Accepted HREC please ensure to advise on your application.   

Refer to the Low/Negligible Risk Research Ethics and Governance Application Guidelines  

2. For studies involving other SA Health or public health sites submission is via GEMS system 

3. You already have HREC approval 

To assist with the LNR expedited process please ensure to provide as much detail as possible: - 

 e.g.  Referral site only, recruiting at the site through the distribution of posters, will there be non- SA 

Health staff accessing site, provide details of leaflets, handouts, surveys and questionnaires, advising use 

of data or tissues held at NALHN. 

Contact us at healthnalhnrgo@sa.gov.au or (08) 8182 9346 to discuss any queries  that you may regarding your 

project. 

INSURANCE   

The Principal Investigator (PI) is responsible for confirming the insurance and indemnity arrangement for the 

research project. The PI must provide all required supporting documentation to the RGO. This generally includes 

copies of the relevant insurance certificates PLUS an email from the partnering organisation confirming that this 

study is covered by the insurance.  

Any changes to insurance (including annual renewal) must be lodged with the RGO for ratification.  

Please be aware that some projects will require Legal Governance and Insurance Services (LGIS) to review and 

approve insurance, and this can delay the processing of your SSA. 

 











NORTHERN ADELAIDE LOCAL HEALTH NETWORK 

 

Other Research Project Guidelines   6 

 

SA Health Employees  

SA Health employees conducting a research project in the capacity of their employment with SA Health are 

covered by SA Health insurance where approval from a SA Health HREC or National Mutual Acceptance (NMA) 

HREC has been obtained.  No further supporting documentation is required.  

 

Dual Employment  

If the researcher is an SA Health Employee, but has dual employment with a University or South Australian Health 

and Medical Research Institute (SAHMRI) or another organisation, or is also a university student, and is 

conducting a research trial/project in the capacity of their non SA Health employment, or as part of their private 

studies, indemnity must be provided by the University or SAHMRI and/or third party spon sor. 

 

Non-SA Health Employees  

Conducting research at an SA Health organisation that involve SA Health patients, staff, resources or data to 

support the project, the PI must provide appropriate insurance documentation from the non-SA Health 

organisation. Appropriate insurance documentation includes current insurance certificate/s and written 

insurance approval from the organisation. These requirements include research projects conducted by staff and 

students of academic institutions, such as Universities. 

 

Third Party Sponsor  

For clinical research TRIALS with third party sponsors it is a requirement that the Sponsor indemnifies the trial 

and provides evidence of indemnity, by way of Certificate of Currency (this is in addition to SA Health and/or non- 

SA Health insurance cover).  

For research PROJECTS sponsored by a third party, including commercially sponsored clinical trials, the sponsor 

must supply evidence of its insurance cover. A sponsor s insurance cover must as a minimum identi fy the local 

site, investigator and research staff, and participants involved in the research project. For all commercially 

sponsored clinical trials, the  Medicines Australia Form of Indemnity for Clinical Trials   Standard  must also be 

submitted 

 

NALHN Credentialling  

NALHN must ensure all staff, contractors, visiting private practitioners, volunteers and students are credentialed. 

If any of the investigators listed on the application are working at NALHN in clinical capacity, they must have up -

to-date credentialing within NALHN. If the credentialing details are out of date, we will request evidence of 

renewal and the study will not proceed.  

NALHN Credentialling Officer- Telephone 08 82821699 or email 

Megan Glowik health.nalhncredentialling@sa.gov.au 

 

  




NORTHERN ADELAIDE LOCAL HEALTH NETWORK 

 

Other Research Project Guidelines   7 

ESSENTIAL DOCUMENTS  

SSA Fee Form  

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

Schedule available here. Please see the SA Health Fee Form  SA Health Research Governance Fee Schedule  

Within the SA Health fees schedule there are three categories that are covered:  

1. Clinical Trials with Full Commercial Sponsorship  

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

3. Contract Review  

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 

Human Research Ethics Committee (HREC) 

 

NALHN does not have a Human Research Ethics Committee; however, the Research Governance Office will accept any 
National Mutual Accepted HREC ethics with a Site-Specific Assessment form. NMA Ethics committees can be located 
on the SA Health website. 

Study Protocol 

The Study Protocol is an essential document for both the HREC and the RGO.  

Participant Information Sheets and Consent Forms (PISCF)   

NALHN endorses use of the NHMRC standardised PICFs which are designed for three categories of participants 

identified by the National Statement:  

When completing the Master PISCF and Site Specific PISCF please refer to the Participant Information Sheets and 

Consent Forms fact sheet. 

Investigator CVs 

Investigators should provide a current copy of their Professional/Academic CV. Please ensure that the CV details 

relevant research experience, academic qualifications and publications. 

GOOD CLINICAL PRACTICE CERTIFICATE 

As part of the implementation of the National Clinical Trials Governance Framework and the Therapeutic Goods 

Administration (TGA) GCP Inspection Audits, investigators will be required to undertake GCP training and 

subsequent refresher training to meet compliance as mandated by SA Health. 

The various Health Networks are working with SA Health towards ensuring that all staff involved in  any clinical 

research (not only those involved in the design and conduct of clinical trials) undertake GCP train ing and hold a 

current certificate in GCP. This includes principal investigators, associate investigators, trial 

managers/coordinators and research nurses etc. 

To ensure NALHN is compliant with the minimum training requirements, all staff (NALHN, SAHMRI, University 

etc) involved with undertaking any clinical research at NALHN must undertake GCP training. Evidence of GCP 

training will be part of the research ethics and research governance approval processes.  










NORTHERN ADELAIDE LOCAL HEALTH NETWORK 

 

Other Research Project Guidelines   8 

Certificates are kept on file in the Research Governance Office, so if you have provided a certificate within the 

past two years, you do not need to provide it with every new SSA application.  

Further information can be found on the Therapeutic Goods Administration website.  

  Global Health Network Training Centre 

  Syneos Health (formerly INC Research) 

Please note: This is interim advice and further information will be provided when available from SA Health  

Police Clearances  

Non-SA Health staff coming on site as part of a research study must provide a NALHN confidentiality deed and 

National Police Certificate (NPC) if they are working with adults at NALHN.  If the study involves participants 

under the age of 18, child-related employment screening through the Department of Human Services (DHS) must 

be provided in place of an NPC. This is to be in compliant with the South Australian Health Criminal and Relevant 

History Screening Policy Directive available Criminal and Relevant History Screening. There are numerous options 

for a police check online via accredited agencies. As a way to ensure compliance, screening and confidentiality 

are standard conditions on our governance authorisation:  

   It is the responsibility of the Principal Investigator to ensure any non-SA Health personnel who conducts or 

monitors research meets SA Health screening requirements as per the SA Health Criminal &amp; Relevant History 

Screening Policy Directive before they access any SA Health site. The cost of any such screening is the 

responsibility of the individual accessing the site or their employer. Working with children check  

Confidentiality Agreement for non- SA Health Staff  

A NALHN confidentiality deed will need to be signed by all non-SA Health staff that will require access to SA 

Health data. 

Radiation Safety Report / Standard of Care Declaration by PI  

Standard of Care Radiation Letter Template 

Research involving gene technology and related therapies, drugs and/or ionising radiation may require specific 

notification, registration or licence requirements. Please refer to the SA Health Research Ethics Operational Policy  

Directive. 

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). 

Evidence of these requirements (including the HREC approval) should be attached to the SSA to permit the RGO 

to assess whether the appropriate processes and documents have been completed by the applicant.  

Advertising   

All advertisements including the SA Health Logo, and all radio/television/press/social media advertising must be 

first approved by the NALHN Communications Department: 

HEALTH.NorthernCommunication@sa.gov.au 

Evidence of approval from Media and Communications must be included with your SSA/LNR.  











NORTHERN ADELAIDE LOCAL HEALTH NETWORK 

 

Other Research Project Guidelines   9 

Corporate Identity Policy  

https://www.sahealth.sa.gov.au/wps/wcm/connect/ddbe6580462bc31e8967896dc301fde5/Directive_Corporat

e%2BIdentity_Nov2014.pdf?MOD=AJPERES&amp;CACHE=NONE&amp;CONTENTCACHE=NONE 

 Social Media Policy 

https://www.sahealth.sa.gov.au/wps/wcm/connect/public+content/sa+health+internet/contact+us/social+med

ia+policy+terms+and+conditions+of+use 

SA Health Logos 

 

 

 

 

 

 

 

 

Other Contracts and Amendments  

It is essential that any third-party agreements be negotiated and presented for signing at the same time as the 

researcher lodges the SSA.  These commonly include: 

 

  Collaboration agreements with Universities/Medical Research Institutes/Hospitals 

  Funding agreements 

  Material Transfer Agreements (MTAs) 

  Multi-Institution Agreements (MIAs) 

  Intellectual Property Deeds 

  Moral Rights declarations 

  Service agreements 

  Import/Export permits 

  Student scholarship agreements 

  Sanctioned Country clearances 

 

Researchers should be aware that contract negotiations may take months, so these should be discussed with the 

Research Secretariat at the earliest opportunity. 

 

 

 

 







NORTHERN ADELAIDE LOCAL HEALTH NETWORK 

 

Other Research Project Guidelines   10 

NEXT STEPS  

Signing  

There are two types of sign off  

Low to Negligible Risk Studies (LNR) and Greater than Low Risk Studies (GEMS-SSA) 

1. Before lodging your LNR application, you must obtain the necessary approvals from all of the various 

departments, units, divisions pertinent to your study. For further information about delegated 

signatories please contact the NALHN Research Secretariat email : healthnalhnrgo@sa.gov.au   

Please be aware of the below three step parallel process for LNR submissions: - 

1. Send all documents through to the RGO for validity check  
2. The RGO will confirm validity, you will be required to send through to the HREC for Ethics 

approval 
3. Once the HREC approval has been undertaken it must be provided to the RGO for execution to 

executive, you will then receive a letter of approval from the RGO to commence your study.  
 

2. If your application is Greater than Low Risk and will be submitted via Research GEMS, please ensure 

to include the all of the various departments, units, divisions pertinent to your study- Head of Unit, 

Divisional Director, Business Consultant, etc.  If your study is cross divisional, we will also require 

both divions to note their support. See helpful hint  - Completing the site application part C: 

Department and Services guide  

Feel free to contact the Research Secretariat- PH: 08 81829346 or email  healthnalhnrgo@sa.gov.au should 

you have any other queries.  

  








NORTHERN ADELAIDE LOCAL HEALTH NETWORK 

 

Other Research Project Guidelines   11 

Lodging your application 

How to submit your applications: -  

? Follow the above Low to Negligible pathway or  the Greater than Low Risk - GEMS ( SSA) submission 
pathway 

? Complete the required steps / forms (for you process to be managed with promptness it helps to ensure 
your application is provide in complete form) 

? Low to Negligible Risk (LNRs)- Email the cover sheet, LNR, and ALL supporting documents to 
healthnalhnrgo@sa.gov.au for validation check ( this step is required prior to submitting to the HREC)     

? Greater than Low Risk (SSA)   Follow the GEMS system process as listed above.  

Hard copies are not required (except for CTRA and Medicines Australia Indemnity forms)  

Note that if your submission is being managed via GEMs you will need to ensure that the CTRA and Medicines 

Australia Indemnity forms are provided to the Research secretariat via email healthnalhnrgo@sa.gov.au  

NOTE CONTRACTS are not managed via GEMS.  You need to email these to us. healthnalhnrgo@sa.gov.au  

Once submitted, your application is reviewed by the RGO for final authorisation by the CEO/delegate.  The 

project must not commence until you receive a letter of authorisation from the RGO. 

NALHN supports dual submission of ethics and governance.  While SSAs/LNRs can be submitted at any time 

before the project commences, dual submission allows the governance and ethical review to occur in parallel.  

Your HREC approval is not sufficient to start the study. A final endorsement letter will be provided for the SSA/ 

LNRs only where HREC approval is obtained and the letter provided to the RGO. 

Partially completed (unsigned/invalid) applications will be returned to the applicant.  If you have not 

submitted an application within 3 months of receiving ethical approval, the RGO will contact the Principal 

Investigator for clarification.  Please contact the RGO if you anticipate a lengthy delay in submitting an SSA.  

 

  






NORTHERN ADELAIDE LOCAL HEALTH NETWORK 

 

Other Research Project Guidelines   12 

 

CONTACT US  

The team at the Research Secretariat are happy to assist you in navigating the necessary documents and 

processes outlined in this guide, and to give advice on project-specific information.   

Contact us on +61 8 8182 9346 or healthNALHNrgo@sa.gov.au  

 

 

For more information 
NALHN Research Secretariat 

Lyell McEwin Hospital  

Level 2 Clinical Trials Unit  

Haydown Road 

ELIZABETH VALE SA  5112 

(08) 8182 9346 

email:  healthNALHNRGO@sa.gov.au 

sahealth.sa.gov.au/nalhn 




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