Research Governance

Central Australia Health Service (CAHS) Research Governance Processes

What site does this process apply to?

The CAHS Research Governance Office (RGO) has been established as the single portal for seeking organisational approval for research at all Central Australia Health Service hospital sites and associated services including:

  • Alice Springs Hospital;
  • Tennant Creek Hospital;
  • Central Australia Mental Health Service (CAMHS); and
  • Central Australia Alcohol & Other Drugs Services (AODS).

For enquiries about CAHS research governance processes please contact: RGO.CAHS@nt.gov.au

Please note, TEHS Research Governance Office (not Central Australia) provides organisational approval for the following Central Australian research:

  • Central Australia Primary Health Care Centres;
  • Central Australia Hearing Health;
  • Central Australia Oral Health;
  • Alice Springs Correctional Centre;

Process

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What forms do I need to complete?

For all CAHS Primary Health Care sites, researchers are required to submit to the RGO.CAHS@nt.gov.au

AND

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 involving:
    1. endorsement by CAHS unit heads, clinical managers, general and regional managers;
    2. organisational endorsement by the CAHS Executive Director of Medical and Clinical Services (EDMCS); and
    3. Organisational authorisation following Human Research Ethics Committee (HREC) approval by the CAHS EDMCS.
  • 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 required.

How do researchers identify endorsers?

CAHS and staff should consult with their unit heads and/or clinical nurse managers to identify the relevant delegates.

  • Researchers from external organisations and CAHS or 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 (rgo.cahs@nt.gov.au)

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 approval or the low risk/audit HREC review process.

Who oversees the Site Specific Approval process?

  • The Research Governance Office (RGO.CAHS@nt.gov.au) at Central Australia Health Service oversees the SSA process for the above listed sites.

What does the RGO 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 and the CAHS Chief Operating Officer (COO) (via the Executive Director of Medical and Clinical Services) on all research governance matters;
  • Recommend endorsement and authorisation of research by the Executive Director of Medical and Clinical Services (EDMCS) who is the CAHS data custodian;
  • 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 of the relevant COO and NT Health Chief Executive.
  • 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 CAHS staff at the above sites, they will ideally seek unit level and Co-Director and/or General Manager endorsement prior to submission of proposals to the CAHS RGO for authorisation.

Researchers from external organisations and CAHS or 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 endorsement?

  • Email endorsement is preferred for its traceability and inherent recording of time.  For audit/low risk research, the CAHS Executive Director, Medical and Clinical Services (EDMCS) will sign the low risk form once all governance requirements have been met and returned 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.

What constitutes evidence of organisational endorsement?

  • Email endorsement is preferred for its traceability and inherent recording of time.  For audit/low risk research, the CAHS Executive Director, Medical and Clinical Services (EDMCS) will sign the low risk form once all governance requirements have been met and returned 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 unconditional approval or waiver by the relevant HREC
  • Research cannot commence:
    • Research cannot progress until evidence of relevant HREC approval has been forwarded to the RGO;
    • For research involving on-site data collection, clinical access requirementsmust also be met;and
    • 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 CAHS Unit head, clinical manager and Co-Director and/or General Manager who endorsed the proposal.

How can I find out more?

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Last updated: 07 December 2019

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