Top End Health Service (TEHS) Research Governance Processes
The TEHS Research Governance Office (RGO) has been established as the single portal for seeking organisational approval for:
- Research at all Top End Health Service hospital and Primary Health Care sites;
What sites does this process apply to?
The Research Governance processes apply to the following sites:
- Alan Walker Cancer Care Centre (AWCCC)
- Gove District Hospital
- Katherine Hospital
- Royal Darwin Hospital
- Palmerston Regional Hospital
- Top End Mental Health Service (TEMHS) and Alcohol & Other Drugs Service (AODS)
- Top End Primary Health Care including;
- Hearing Health
- Oral Health
- Darwin Correctional Precinct
- Urban and Remote Primary Health Care Centres
What forms do I need to complete?
For all TEHS sites, researchers are required to submit to the RGO.TEHS@nt.gov.au
- a completed relevant form to permit ethical review (accepted forms include):
In addition, for Primary Health Care sites, researchers are required to submit:
- a completed PHC research proposal form.
What does the process involve?
- Organisational authorisation is a three stage process.
- Unit level endorsement is by unit heads, clinical managers, general and regional managers (including Co-Directors at RDPH);
- Organisational endorsement is by the ED Clinical Innovation & Research (the COO delegate);
- Organisational authorisation by the ED Clinical Innovation & Research (the COO delegate) may be given conditional on Human Research Ethics Committee (HREC) approval or waiver.
HREC review proceeds in parallel to the other stages.
- All stages need to be completed for all research proposals, including extending an existing proposal to another site.
- Authorisation is also conditional upon continued HREC approval, with research governance office notification of any amendments also required.
The TEHS RGO will work with the NT Clinical Trials Coordination Unit for the additional governance requirements for Clinical Trials Research Agreements (CTRA)/Collaborative Research Agreements – Please refer to the Clinical Trials Information.
How do researchers identify endorsers?
- TEHS staff should consult with their unit heads and/or clinical nurse managers to identify the relevant delegates;
- Researchers from external organisations and NT Health staff who are uncertain of the management structure are advised to require assistance from the RGO as the first step. The RGO will assist researchers to identify and contact relevant personnel.
Is Site Specific Approval required for low risk audits conducted for research?
- An SSA is required irrespective of whether the project will undergo full HREC review or an expedited process.
Who oversees the Site Specific Approval process?
- The TEHS Research Governance Office (RGO.firstname.lastname@example.org) oversees the SSA process for the above listed sites.
What does the Research Governance Office do?
The RGO will:
- provide expert advice to investigators seeking to undertake research within the relevant sites in accordance with national, state and local policies;
- provide expert advice to organisational endorsers of each RGO site on all research governance matters;
- recommend endorsement and authorisation of research by the Organisational delegate;
- refer agreements, indemnity and insurance documents to the NT Health Clinical Trials Coordination Unit for review and consultation with Solicitor for the Northern Territory (SFNT) and other NTG services as required;
- refer Clinical Trials and Collaborative Research Agreements to the NT Health Clinical Trials Coordination Unit for execution by NT Health Chief Executive or Chief Operating Officer;
- document all research governance decisions and communicate these with relevant endorsers;
- review and manage amendment documentation related to authorised research projects;
- manage complaints, misconduct or conflicts of interest related to the conduct of authorised research projects; and
- conduct or coordinate audits of research projects, where required.
Who do researcher’s contact first?
When researchers have established relationships with clinical services and/or are NT Health staff, they will ideally seek unit level and Director and/or General Manager endorsement or Primary Health Care clinic level, District Manager and PHC Executive endorsement prior to submission of proposals to the RGO for authorisation.
Researchers from external organisations and NT Health staff who are uncertain of the management structure are advised to request assistance from the RGO as the first step. The RGO will assist researchers to identify and contact relevant personnel.
What constitutes evidence of local unit, clinic endorsement?
- Email endorsement is preferred for its traceability and inherent recording of time. Completion of signature panels on the relevant HREC form also constitutes evidence of endorsement;
- Researchers and endorsers are advised to ensure that email endorsements include the project title.
What constitutes evidence of organisational endorsement?
- For audit/low risk research, the ED Clinical Innovation and Research will sign the low risk form once all governance requirements have been met and return it via email to the researcher;
- For proposals that require a full HREC submission, a letter of endorsement is issued to the researcher by the RGO via email once all governance requirements have been met.
When can research commence?
- Research authorisation is provided when the proposed research receives an unconditional approval or waiver by the relevant HREC and NT Health research governance for appraisal.
- Research cannot commence
- Until evidence of relevant HREC approval has been forwarded to the RGO
- For research involving on-site data collection, clinical access requirements must also be met;
- For clinical trials, an executed legal Agreement must also be in place.
- Researchers requiring clinical access submit a Site Commencement form when these criteria are met and the study is about to commence (this might be at the same time as the above documents)
- The Site Commencement form is also distributed by the RGO to the local TEHs Unit head, clinical manager and Co-Director and/or General Manager who endorsed the proposal.
How can I find out more?
- The RGO can be contacted via the following email:
Last updated: 07 December 2019