greater western human research ethics committee
TRANSCRIPT
Greater Western Human Research Ethics Committee
incorporating the Western NSW & Far West Local Health Districts
RESEARCH GOVERNANCE GUIDELINES
WHAT IS RESEARCH GOVERNANCE?
Each research project is reviewed by a Human Research Ethics Committee who considers
whether it is scientifically and ethically sound. The Committee doesn’t look at the capacity of
the proposed study sites to carry out the research. This is why research governance is
necessary.
Once ethical approval has been granted each participating site must submit a Site Specific
Assessment (SSA) to the Research Governance Officer (RGO) responsible of that site for
review. This is in line with NSW Health Policy (PD 2010_056 Authorisation To Commence
Research in NSW Public Health Organisations)
The issues considered in the SSA include:
Has scientific and ethical approval for the site been granted by an HREC?
Do the site investigators have the necessary skills and credentialing to undertake the
research?
Are there adequate facilities and resources at the site?
Is the project adequately funded?
Have legislative requirements been met?
Are there adequate indemnity and insurance arrangements in place for clinical trials?
WHO SHOULD COMPLETE THE SITE SPECIFIC ASSESSMENT APPLICATION?
The SSA for each site is initiated by the Coordinating Principal Investigator (CPI) or Principal
Investigator (PI) who initiated the original NEAF or LNR. This will then be forwarded to the
Principal Investigator at the site for completion.
WHAT IS THE SSA SUBMISSION PROCEDURE?
1) If the project has been approved by the Greater Western Human Research Ethics
Committee and involves only a site or sites within Western NSW and/or Far West
NSW LHDs
The CPI or PI who completed the NEAF or LNR should:
Log into the Australian Online Forms website at www.ethicsform.org.au
Open the project
Select the SSA tab (Some of the information from the NEAF or LNR will
automatically populate the SSA form
Choose the number of SSAs required
If a single site, the form can then be completed
If there are a number of sites, the SSAs can be transferred to the Principal
Investigators at the participating sites for completion
Where a project involves only data collection or the completion of questionnaires
at a number of sites it may be appropriate to complete only one SSA for Western
NSW and Far West NSW LHDs as long as the Head of Department (HOD) at
each site completes the declaration on the SSA.
Once the SSA(s) have been completed and signed (electronic signatures are
acceptable), click on the “Submission tab. (This will get rid of the “draft”
watermark and a submission code will appear in the bottom right hand corner of
the form. The form can then be printed and forwarded to the RGO.
2) If the project was approved by the Greater Western Human Research Ethics
Committee and involves sites external to the Western NSW and Far West LHDs
Log into the Australian Online Forms website at www.ethicsform.org.au
Open the project
Select the SSA tab (Some of the information from the NEAF or LNR will
automatically populate the SSA form
Choose the number of SSAs required. (More sites can be added at a later date)
SSAs can now be transferred to the PIs at each site for completion and
submission to the relevant RGO
3) If the project was approved by an Ethics Committee other than the GW HREC
The SSA should be transferred to the site by the Coordinating Principal
Investigator via the Ethics Form website
Once the SSA has been completed and signatures obtained click on the
“Submission tab”, print out the form and submit to the RGO along with the other
required documentation (see below)
WHAT OTHER DOCUMENTS NEED TO BE SUBMITTED?
All SSAs/LNRSSAs will need to be accompanied by:
Site specific Participant Information Sheet(s) and Consent Form(s) based on the
Master Version(s) approved by the Lead HREC. (If applicable)
If the GW HREC was not the approving ethics committee then the following documents also
need to be submitted:
Copy of the HREC approval letter naming the sites
Copy of the original NEAF or LNR
Copy of the approved Master Participant Information Sheet(s) and Consent
Form(s)
Copies of any other study-related documentation e.g. protocol, questionnaires
etc.
CVs for site investigators
For sponsored clinical trials, the following are also required:
Investigator’s brochure
Clinical Trial Protocol
Standard Medicines Australia Form of Indemnity – three originals
Standard Medicines Australia Clinical Trials Research Agreement (CTRA) for
Commercially Sponsored Trials – at least two originals
OR
Standard Medicines Australia Clinical Trials Research Agreement (CTRA) for
Contract Research Organisations acting as the local sponsor – at least two
originals
Certificate of Insurance which names the commercial sponsor, covers the conduct of
the relevant clinical trial in Australia, is current for at least the period of the clinical
trial, contains insurance cover for at least AUD20 million per occurrence and in the
annual aggregate and does not contain an excess greater than AUD25,000 for each
claim.
All legal documents should name: Western NSW Local Health District, 22 Hawthorn
Street, DUBBO NSW 2830 ABN: 50 629 556 404
WHAT SHOULD THE LOCAL PARTICIPANT INFORMATION SHEET AND CONSENT
FORM CONTAIN?
The local PIS should read exactly the same as the approved Master Version except that it
should contain:
The name and contact details of the local investigator
The name and contact details of the Lead HREC
The following: “The conduct of this study at (name of site) has been authorised by the
Greater Western Human Research Ethics Committee. Any person with concerns or
complaints about the conduct of this study may contact the Research Governance
Officer on 02 6330 5948 and quote reference: xxxxx”
A footer: (Name of site) version x dated aa/xxx/20xx based on Master Version x
dated xx/xxx/20xx
WHAT ABOUT CLINICAL TRIAL NOTIFICATION?
A trial of any medicine or device (or its software) not entered onto the Australian Register of
Therapeutic Goods (ARTG) including any new formulation of an existing product or any new
route of administration must be conducted under the CTN Scheme.
All CTNs must be submitted using the online system. Guidance is available at
https://www.tga.gov.au/form/ctn-scheme-forms
It is the responsibility of the clinical trial sponsor to complete and lodge the CTN via the TGA
Business Services (TBS) website.
Sponsors should not submit the online CTN until written HREC approval has been received.
They should only add each site to the online CTN’s “trial site details” after receiving written
site authorisation.
A copy of the TGA acknowledgement of a receipt of the CTN should be sent to the RGO as
soon as it is available for inclusion in the study file.
WHEN SHOULD I SUBMIT THE SSA?
The SSA can be submitted at any time during the review process but it can only be
authorised following ethical approval.
ARE THERE ANY FEES FOR SUBMITTING AN SSA?
If the research project has full industry sponsorship there is a fee of $3,740 (including GST).
There is no fee involved for other projects.
WHO SHOULD I SUBMIT THE SSA TO?
The Research Governance Officer, Population Health Unit, PO Box 143, Level 1, 230
Howick Street, BATHURST NSW 2795 (02 6330 5948)
WHAT IS AN ACCESS REQUEST FORM
If a project has been ethically approved and the researchers wish to use another NSW public
health site for the following, completion of an SSA may not be necessary:
Recruitment of participants using leaflets, posters, handouts or letters of invitation
but not active enrolment;
Distribution of surveys and questionnaires but not collation or analysis of the
responses;
Access to data or tissue held at the site but not analysis of the data or tissues at the
site.
Instead, it may be possible to lodge an Access Request Form available at
https://www.ethicsform.org.au . The application should be accompanied by a written
confirmation from the relevant site that they are happy to provide the required access.