Research governance

Research governance is a process whereby an institution determines whether their organisation or sites within that organisation have the resources or capacity to undertake a given project.  This involves reviewing the appropriate research governance application, HREC approved documentation, site specific documents, study budget, Clinical Trial Research Agreements (CTRA) (if applicable) and most importantly the insurance and indemnity arrangements. It also involves ensuring there is an appropriate monitoring framework in place for the conduct of research and ensuring there are the appropriate policies and procedures to support this.

 

The research governance review is a risk assessment to ascertain whether research can be undertaken at a given site.

CCLHD and research governance

CCLHD Research Office has a process for undertaking the research governance review of research projects prior to their commencement at a CCLHD site or associated community health centre/ service including Gosford Hospital, Wyong Hospital, Woy Woy Hospital and Long Jetty Healthcare Centre.

The research governance process follows the ethical review process, with three different application options, which are dependent on the type of associated Human Research Ethics Committee (HREC) application:

  1. Site Specific Assessment (SSA) for low/negligible risk research
  2. Site Specific Assessment (SSA) for National Ethics Application form
  3. Access request

Each of the forms, like the Human Research Ethics Committee (HREC) application must be completed on the NSW Health Online Forms website.

External page link Online Forms for Research

Site specific assessment for low/negligible risk research 

Once approval has been received from a Lead NSW Health Human Research Ethics Committee (HREC) (multi-centre projects) or CCLHD (single-site CCLHD projects) via the low/negligible risk research (LNR) application form an LNR Site Specific Assessment (SSA) is required. A separate application must be made for each site at which the research project is to be conducted. For example, even if the project is to be conducted at two sites under the control of a single Public Health Organisation (PHO), a separate application must be made for each site*.

This form, like the LNR application form, must be completed on the NSW Health Online Forms website. The two forms will be linked to one another in this system and once finalised will each have a unique submission code.

The reason application is required via this portal is that it links to the IT system utilised by NSW, SA, QLD and VIC Research Governance Officers to manage and report on SSA applications to each states Health department.  

The Online Forms website provides guidance on completing the form and supporting documents required for making an application, however as each LHD  is independently operated each site may have its own individual application requirements. Principal Investigators are therefore advised to contact the relevant Research Governance Officer and any individuals that need to provide a declaration and start to prepare an application at the earliest possible opportunity.

Any queries related to using the Online Forms website should be directed to the help desk on:

Tel: +61 2 903 78 404 (available from 10am to 4pm AEST Monday to Friday) or helpdesk@infonetica.net 

The completed form and supporting documents must be printed** and submitted to the Research Governance Officer responsible for the site (for CCLHD please forward to the Research Manager), Contact details for Research Governance Officers and information on the facilities, locations and services covered by them are maintained by NSW Health research and ethics.

SSA authorisation must be granted at each individual Public Health Organisation (PHO) in which the research is to be undertaken and cannot commence at a given site until this process has been completed.

Please see the CCLHD - SSA - LNR flowchart to review the CCLHD process for the submission, review and authorisation of LNR SSA applications.

PDF Document CCLHD - SSA - LNR - flowchart (357 KB)

The CCLHD - SSA - LNR - checklist has been drafted to assist with the submission of an LNR SSA application form for a CCLHD site.

PDF Document CCLHD - SSA - LNR - checklist(352 KB)

Use the checklist and ensure all required documentation is supplied on submission. Completed applications for CCLHD sites should be submitted to:

CCLHD Research Office

Level 1, Health Services Building (inside the Library)

Hospital Road, Gosford Hospital

Gosford NSW 2250

*As processes vary between sites it is recommended you contact the relevant Research Governance Officer for individual submission requirements.

**It is important to note that submission on the online system will not trigger notification in the relevant Research Governance Officer's system. It is therefore recommended applicants contact the relevant Research Governance Officer for specific details on the individual application requirements prior to submission.

Site specific assessment for the national ethics application form

Once approval has been received from a Lead NSW Health Human Research Ethics Committee (HREC) or one of the participating Mutual Acceptance states accredited HRECs (if conducting a multi-centre clinical trial) via the National Ethics Application Form (NEAF), a NEAF Site Specific Assessment (SSA) is required. A separate application must be made for each site at which the research project is to be conducted. For example, even if the project is to be conducted at two sites under the control of a single Public Health Organisation (PHO), a separate application must be made for each site*.

This form, like the NEAF, must be completed on the NSW Health Online Forms website. The two forms will be linked to one another in this system and once finalised will each have a unique submission code.

The reason application is required via this portal is that it links to the IT system utilised by NSW, SA, QLD and VIC Research Governance Officers to manage and report on SSA applications to each states Health department. 

The Online Forms website provides guidance on completing the form and supporting documents required for making an application, however as each LHD  is independently operated each site may have its own individual application requirements. Principal Investigators are therefore advised to contact the relevant Research Governance Officer and any individuals that need to provide a declaration and start to prepare an application at the earliest possible opportunity.

Any queries related to using the Online Forms website should be directed to the helpdesk on:

Tel: +61 2 903 78 404 (available from 10am to 4pm AEST Mon to Fri) or helpdesk@infonetica.net 

The completed form and supporting documents must be printed** and submitted to the Research Governance Officer responsible for the site (for CCLHD please forward to the Research Manager), Contact details for Research Governance Officers and information on the facilities, locations and services covered by them are maintained by NSW Health.

SSA authorisation must be granted at each individual Public Health Organisation (PHO) in which the research is to be undertaken and cannot commence at a given site until this process has been completed.

Please see the CCLHD- SSA - NEAF flowchart to review the CCLHD process for the submission, review and authorisation of a NEAF SSA.

PDF Document CCLHD - SSA - LNR - flowchart (357 KB)

The CCLHD - SSA - NEAF- checklist has been drafted to assist with the submission of a NEAF SSA for a CCLHD site.

PDF Document CCLHD - SSA - LNR - checklist (352 KB)

Use the checklist and ensure all required documentation is supplied on submission. Completed applications for CCLHD sites should be submitted to:

CCLHD Research Office

Level 1, Health Services Building (inside the Library)

Hospital Road, Gosford Hospital

Gosford NSW 2250

*As processes vary between sites it is recommended you contact the relevant Research Governance Officer for individual submission requirements.

**It is important to note that submission on the online system will not trigger notification in the relevant Research Governance Officer's system. It is therefore recommended applicants contact the relevant Research Governance Officer for specific details on the individual application requirements prior to submission.

Access Request

An Access Request should be completed for those human research ethics applications which require support from a NSW Public Health Organisation (PHO) in the form of access to participants, tissue or data but do not involve the conduct of research at that Public Health Organisation (instead of a low/negligible risk (LNR) research or National Ethics Application Form (NEAF), Site Specific Assessment (SSA)).

For example, an Access Request should be used if the project involves one or more of the following activities at the PHO:

  • Participant recruitment through posters, leaflets, handouts and letter of invitation but not recruitment through direct contact with potential participants or enrolment.
  • Distribution of surveys and questionnaires through staff of the Public Health Organisation but not collation and analysis of responses at that Public Health Organisation.
  • Access to data or tissue held at the Public Health Organisation but not processing or analysis at that Public Health Organisation.

Prior to submitting an Access Request a researcher must first complete the appropriate Human Research Ethics Application. This must be on the LNR Research Application or the NEAF.

Once the appropriate ethical approval has been granted it is recommended contacting the relevant Research Governance Officer to ascertain whether an Access Request would be appropriate for submission to the given Local Health District/Health Service or whether the appropriate Site Specific Assessment will be required instead*. The Research Governance Officer has the discretion to request that the application is submitted on the relevant Site Specific Assessment if they consider that the project involves the conduct of research at a site.

Access Request authorisation must be granted at each individual PHO where research support is required.

The completed form and supporting documents must be printed** and submitted to the Research Governance Officer responsible for the site (for CCLHD please forward to the Research Manager. Contact details for Research Governance Officers and information on the facilities, locations and services covered by them are maintained by NSW Health research and ethics.

This form, like the LNR and NEAF, must be completed on the NSW Health Online Forms website. The two forms will be linked to one another in this system and once finalised will each have a unique Submission Code.

The reason application is required via this portal is that it links to the IT system utilised by NSW Research Governance Officers to manage and report on SSA applications to NSW Health.

The Online Forms website provides guidance on completing the form and supporting documents required for making an application, however as each LHD  is independently operated each site may have its own individual application requirements. Principal Investigators are therefore advised to contact the relevant Research Governance Officer and any individuals that need to provide a declaration and start to prepare an application at the earliest possible opportunity.

Any queries related to using the Online Forms website should be directed to the helpdesk on:

Tel: +61 2 903 78 404 (available from 10am to 4pm AEST Mon to Fri or  helpdesk@infonetica.net 

The completed form and supporting documents must be printed** and submitted to the Research Governance Officer responsible for the site (for CCLHD please forward to the Research Manager, Contact details for Research Governance Officers and information on the facilities, locations and services covered by them are maintained by NSW Health research and ethics.

*As processes vary between sites it is recommended you contact the relevant Research Governance Officer for individual submission requirements.

**It is important to note that submission on the online system will not trigger notification in the relevant Research Governance Officer's system. It is therefore recommended applicants contact the relevant Research Governance Officer for specific details on the individual application requirements prior to submission.

NSW Health requirements

All human research that takes place in NSW Public Health Organisations must be reviewed, approved and conducted in accordance with the National Statement on Ethical Conduct in Human Research (National Health and Medical Research Council (NHMRC), Australian Research Council (ARC) and Australian Vice-Chancellors Committee (AVCC) 2007).

This requirement must be met in order for Public Health Organisations to grant authorisation for the commencement of human research projects, in accordance with NSW Health policy directive PD2010_056 Authorisation to Commence Human Research in NSW Public Health Organisations.

External page link Authorisation to Commence Human Research in NSW Public Health Organisations