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Page 1 of 7 
NALHN Low/Negligible Risk Ethics and Governance Application Guidelines 
Version 1.1 (October 2019) 

 

Low/Negligible Risk Research Ethics and Governance Application 
Guidelines 

A human research project cannot commence at a site within Northern Adelaide Local Health Network 
without having both ethics and governance approval. 

 

Human ethics review is conducted in accordance with the NHMRC National Statement on Ethical 
Conduct in Human Research (2007). The National Statement provides that institutions may have 
ethical review processes other than full committee review for low/negligible risk studies. i Within 
NALHN this alternative process is review by the relevant Human Research Ethics Committee (HREC) 
Chairperson, followed by endorsement at a committee meeting. 

 

Research governance is a framework through which institutions are accountable for the research they 
allow to be conducted under their auspices. Research must be conducted according to ethical 
principles, guidelines for responsible research conduct, legislation and regulations. Research 
governance is about responsibility and about managing the quality, safety, privacy, risk, finances and 
ethical acceptability of research. 

 

For further information please refer to the SA Health Research Governance Policy and the SA Health 
Research Ethics Operational Policy. 

 

The LNR Ethics and Governance Application Form 

The LNR Ethics and Governance Application (LNR EGA) Form replaces both the previous LNR Ethics 
Application form and the LNR Site Specific Assessment (SSA) application form for low or negligible 
risk research conducted at NALHN sites. The aim of the LNR EGA Form is to provide sufficient detail 
about a low/negligible risk research project to enable ethical review and governance assessment to 
occur concurrently. 

 

When the LNR EGA Form should be used 

The LNR EGA Form should be used for governance and ethical review of research projects that 
involves only low or negligible risk to participants. 

 

The LNR EGA form should only be used for research conducted NALHN only, or NALHN and CALHN 
sites. However if your study is a multi-centre study within South Australia please contact the Research 
Governance Office to discuss the project and we will work with you to ensure governance review is 
efficient. 

 

The NHMRC National Statement on Ethical Conduct in Human Research (2007) 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 Statement describes research as negligible risk where  there is no foreseeable risk of 
harm or discomfort; and any foreseeable risk is not more than inconvenience.  

 
Note: There are several types of human research which require full ethics committee review, even 
though they may have few tangible risks. These research types are listed in Section 3 and Chapter 4 
of the National Statement. 

 
A copy of the National Statement can be found here. 

 

Following receipt of an application, the Chairperson of the relevant HREC may deem that an 
application involves more than low risk, or is not appropriate for the alternative review process, and 
refer it for ethical review by the full committee. Further information or additional documents may then 
be required. 

 







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NALHN Low/Negligible Risk Ethics and Governance Application Guidelines 
Version 1.1 (October 2019) 

 

 

The LNR EGA form may also be used to apply for governance approval of studies at NALHN sites 
that have received human ethics approval from another SA Health HREC, or animal ethics approval. 

 

Audit and quality assurance studies 

 
 

The LNR EGA form should be used for audit or quality assurance studies. Please refer to the Quality 
Assurance and Audits Submission Guideline 

 

Completing the LNR EGA Form 

An electronic copy of the LNR EGA Form Responses must be typed. Hand written responses will not 
be accepted. 

 

To assist the expedient review of applications, researchers are advised to discuss their application 
with the NALHN Research Governance Office prior to submission. 

 
Email: HealthNALHNRgo@sa.gov.au 

 
 

Project full title 
This must be the same as the title on the Study Protocol. 

 

Principal Investigator 
This section must be completed for the lead Investigator. Details of all other Investigators and their 
role in the project must be provided in the Study Protocol. 

 

Reviewing HREC 
Select CALHN HREC if you require the CALHN HREC Chairperson to review your study. If NALHN is 
being added as a site then the reviewing ethics committee may be another HREC within South 
Australia, and a copy of the ethics application and approval letter must be attached with the 
application form. 

 

Other Committee approvals 
Some research projects require approval such as animal ethics, institutional biosafety or radiation 
safety. Where applicable these approval letters / reports must be included as attachments to the 
application. If HREC approval is required for other Committee approvals, this should be advised in the 
 Additional information  section of the LNR EGA Form 

 

Type of application 
 The expression  low risk research  describes research in which the only foreseeable risk is one of 
discomfort. Research in which the risk for participants is more serious than discomfort is not low risk. 
 The expression  negligible risk research  describes research in which there is no foreseeable risk of 
harm or discomfort; and any foreseeable risk is no more than inconvenience.  
The  Access Request  checkbox in the LNR EGA Form may be used in the following cases: 

1. Where there is participant recruitment at the site through distribution of posters, leaflets, 
handouts, and letters of invitation (but not recruitment through direct contact with potential 
participants or enrolment). 

2. Where surveys and questionnaires are distributed through NALHN personnel (but not collation 
and analysis of responses at the NALHN site). 

3. Where there is access being requested for data or tissue held at NALHN (but not processing 
or analysis at the NALHN site). 

 

 

 

 

 

SA Health sites involved in the study 

All SA Health sites at which the study will be conducted must be listed. For a list of NALHN sites, 







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NALHN Low/Negligible Risk Ethics and Governance Application Guidelines 
Version 1.1 (October 2019) 

 

please see http://www.basilhetzelinstitute.com.au/research/information-for-researchers/nalhn/ . 
 

Only one LNR application is required for all NALHN sites. 
 

If the study is being conducted at a University or SAHMRI, the section can be completed as  Nil . 
 

Non SA Health sites involved in the study 
All non SA Health organisations and locations that will be involved in the study, e.g. University, 
SAHMRI, an interstate public or private organisation etc. must be listed. 

 
If the study is being conducted by just NALHN employees at NALHN sites, this section can be 
completed as  Nil . 

 

Conflict of interest 
Declarations of conflicts of interest are required by the NHMRC. In the event of a conflict, details must 
be provided in the Study Protocol. 

 

Data 

For both existing and new data collection, the application must indicate whether participant consent 
will be obtained prior to access or collection. 

 

Further details about data access and collection, including participant consent processes, must be 
provided in the Study Protocol. 

 

Tissue/samples 
If access to existing tissue/samples is required for the study, whether participant consent has been 
obtained must be reported on the LNR EGA Form. 

 
Where existing samples are held outside of the Principal Investigators  department, approval from the 
person or department responsible for authorising access must be attached to the application. If HREC 
approval is required prior to seeking this approval, this must be indicated in the  Additional 
information  section of the LNR EGA Form. 

 
Further details about the tissue/sample source and access must be provided in the Study Protocol. 

 

New sample collection 

Where new tissue/samples will be collected as part of the study, whether participant consent will be 
sought must be reported on the LNR EGA Form. 

 
Further details about tissue/sample collection, including whether collection is within the Principal 
Investigator s standard of care/employment must be provided in the Study Protocol. 

 

Peer review 

Peer review is defined as an  impartial and independent assessment of research by others working in 
the same or a related field . Some studies have undergone a peer review process prior to the ethics 
and governance application, for example as part of a grant application. If applicable, details of the 
reviewing organisation must be reported on the LNR EGA Form, and review comments attached to 
the application. 

 

Funding 

Details of funding for the study must be reported on the LNR EGA Form. 
 

In-kind support: report details of the number of personnel and hours of support, including all 
investigators and research assistants. Approval from the appropriate unit Business Manager must 
also be provided. 

 
Internal department funding: report details of the source, the amount of funding, and CALHN cost 
centre. 

 
External source funding (either to or from a NALHN site): provide details of the external organisation, 
the amount of funding and, where appropriate, NALHN cost centre. 




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NALHN Low/Negligible Risk Ethics and Governance Application Guidelines 
Version 1.1 (October 2019) 

 

 

Budget 
If funds are to be paid to or from NALHN, an approved budget must be submitted for review. The 
budget must report the actual costs incurred to undertake the research at each site within NALHN, 
including salaries for research personnel (investigators and research assistants), consumables and 
equipment. The actual funds that will be paid to or by each NALHN site must be specified in the 
budget. 

 

Note: funding and budget details are not required if the study will be conducted outside of NALHN, 
and no NALHN staff or resources will be involved. 

 
NALHN Finance/Business Consultants must sight and consider the project budget and any 
associated costs to the site(s) before giving authorisation. A copy of the project budget and 
evidence of authorisation must be provided with the LNR EGA Form. 

 

Agreement 

If funds are to be paid to or from a NALHN site, an agreement must be in place. 
 
Possible agreements include collaborations with a third party, corporate sponsorship, service 
agreements, material transfers, or grants. A copy of the agreement must be attached to the 
application. 

 

Non SA Health investigators 

All researchers working on an SA Health site that are not SA Health employees must have a signed 
Confidentiality Deed and current police check. If these have not been previously submitted to the 
Research Office, they must be submitted with the LNR application. 

 
Where these documents have been completed as part of an induction process, an email from the 
appropriate HR/Admin/Laboratory Manager in the NALHN Department confirming that the 
Investigators have completed these requirements may instead be submitted with the application. 

 

Insurance/indemnity 

All research projects hosted by SA Health institutions involving SA Health or external staff must have 
appropriate insurance and indemnity prior to the project commencing. 

 
Indemnity for projects undertaken by SA Health researchers within the capacity of their employment is 
automatically provided through SA Health s corporate insurance arrangements. No further 
documentation is required. 

 
If an SA Health employee has dual employment with a University or SAHMRI or another organisation, 
or is also a university student, and is conducting a research project outside of their SA Health 
employment capacity, indemnity must be provided by the University or other institution. For wholly 
private or commercially sponsored studies, indemnity must be provided by the researcher s institution 
or sponsor. In both these circumstances a copy of a certificate of currency for the indemnity must be 
provided with the LNR EGA form. Further information is available from Legal Governance and 
Insurance Services. 

 
Legal Governance and Insurance Services email: Health.LGISResearchTrials@sa.gov.au 

 

CV 
A copy of a current brief CV (approximately 1-2 pages) for all researchers and students involved in 
the study must be registered with the Research Office. It should contain information about the 
researcher s relevant qualifications, training and experience. If a CV has not been submitted within 
the previous 12 months it must be provided with the LNR application. For studies involving animal 
ethics approval, the appropriate training completion reference number for each researcher is 
sufficient. 

 

Study Protocol 

The Study Protocol is the most important part of the application. It provides comprehensive detail 
about the research project. 

 




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NALHN Low/Negligible Risk Ethics and Governance Application Guidelines 
Version 1.1 (October 2019) 

 

The protocol should provide information about the investigators conducting the research; the purpose 
and aims of the study; participant recruitment; methodology/procedures; data collection, analysis and 
storage; and any ethical considerations pertinent to the study. 

 
The LNR application must include all recruitment flyers, information brochures, participant information 
sheets and consent forms and any other documentation relevant to the study. Each document should 
be clearly labelled and given a version number. The version number, revision date, page number and 
total number of pages of each document must be included in the document footer. 

 
Guides to drafting to the following are available from the Research Office: 

? LNR Study Protocol 

? Participant Information and Consent forms. 

 

Advertisements and flyers 

All advertising material (flyers, posters, brochures etc) must be reviewed and approved by NALHN 
Media and Communications once ethics approval has been obtained. 

 
Email: Health.NorthernCommunication@sa.gov.au 

 

Declarations by investigators, head/s of department and divisional directors 

Declarations must be completed by all research personnel involved in the study and all 
Divisional Directors involved in hosting the project.  Supporting e-mails from Medical Records, 
Business Consultant and Heads of Departments must be attached to the LNR 

 
For multi-site studies, declarations must be completed for the lead site (the site conducting ethical 
review) and for each participating site. Before submitting an application for review of a multi-site 
study, please contact the NALHN Research Governance Office. 

 
Email: HealthNALHNRGO@sa.gov.au 





Page 6 of 7 
NALHN Low/Negligible Risk Ethics and Governance Application Guidelines 
Version 1.1 (October 2019) 

 

Submission documents checklist 
 

? LNR EGA Form   completed and all signatures obtained 
? Where applicable 

o Other Committee approvals 
o Data access approval 
o Tissue/sample access approval 
o Peer review comments 
o Budget 
o Agreement 

? Non SA Health researchers (if not previously submitted) 

o Confirmation from Admin/HR/Laboratory Manager of approval to be on site 
o Insurance/indemnity confirmation 

? 1-2 page CVs for each Investigator (if not previously submitted) 

? Study Protocol 

o Attach all Participant Information and Consent Forms, recruitment flyers, 
questionnaires etc. as separate documents. 

 

Submitting the LNR Application 

Following completion, the LNR EGA declarations must be signed by all investigators and heads of 
department. 

 

For review by the CALHN HREC: 

The signed completed LNR EGA Form and all attachments must then be sent by email to the CALHN 
Research Office. 

 

Email: Health.CALHNResearchLNR@sa.gov.au 
 

For governance review: 

The signed completed LNR EGA Form and all attachments must be sent by email to the NALHN 
Research Governance Office. 

 
Email: HealthNALHNRGO@sa.gov.au 

 

What happens next? 

Ethics review 

The CALHN Research Office will assess whether the application is valid (complete) and ready for 
review. If the application is valid it will be sent to the HREC Chairperson who will conduct ethical and 
scientific review, who may request further information or documentation if required. 

 

Governance review 

The NALHN Research Governance Officer will review the governance component of the submission 
and will request further information or documentation if required. 

 

When the ethical and governance reviews are complete, the NALHN Research Governance Officer 

will make a recommendation as to whether the project should be authorised, not authorised, or 
requires Chief Executive/delegate consideration. 

 

Following consideration, the NALHN Research Governance Officer will notify the Principal 
Investigator in writing whether or not the project is authorised for commencement at the site. 





Page 7 of 7 
NALHN Low/Negligible Risk Ethics and Governance Application Guidelines 
Version 1.1 (October 2019) 

 

LNR ethics approval from other SA Health Human Research Ethics 
Committees 

NALHN has mutual acceptance arrangements for LNR ethics approval with other SA public health 
system HRECs. However governance authorisation is still required for research conducted on CALHN 
sites. A LNR EGA Form and all attachments must still be submitted via email and a copy of the 
relevant public health HREC approval must be included. 

 

 

Contacts 

NALHN Research Governance Office 
Northern Adelaide Local Health Network Inc. | SA Health 

 

Postal address: 

 
Lyell McEwin Hospital 
Level 2 Clinical Trials Unit 
Haydown Road 
ELIZABETH VALE  SA 5112 

 
 

Email: HealthNALHNRgo@sa.gov.au 
 

Phone: +61 8 8182 9346 
 
 
 
 

i Paragraphs 5.1.18 to 5.1.23, NHMRC National Statement on Ethical Conduct in Human Research (2007). 
ii Section 1, NHMRC Ethical Considerations in Quality Assurance and Evaluation Activities (2014). 



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