Research governance

What criteria are considered for granting approval for research?

Applications are assessed against the following criteria and the organisation must be satisfied that:

  1. All external researchers/students involved in the research project have the skills, training and experience necessary to undertake their role;
  2. All NT Health researchers/students involved in the research project have the skills, training and experience necessary to undertake their role;
  3. The research is relevant to the site;
  4. The research is consistent with the strategic objectives of the organisation
  5. There is no conflict of interest for the researcher’s or that the declared conflict of interest is acceptable;
  6. There is evidence of compliance with indemnity requirements;
  7. Requirements for access to organisational data are clear and comply with legislative requirements;
  8. Data management, privacy and confidentiality requirements are described, and comply with legislative requirements;
  9. The research translation strategy is demonstrated and will provide evidence based information for improving patient outcomes, clinical care or service delivery;
  10. There are suitable and adequate facilities and resources for the research project to be conducted at this site;
  11. The resource contribution by the site is clear;
  12. The research project and resource implications have been discussed with relevant staff/delegates;
  13. There is a clear organisational benefit of participation in the research; and
  14. The Organisation benefit of participating in the research is consistent with the resource contribution.
  15. That the research, once completed, is provided back to NT Health via the relevant (authorising) research governance office.

Research governance is NT Health’s process that occurs parallel to the ethical review of research proposals by a recognised Human Research Ethics Committee (‘HREC’) or other ethics review committees.

All research conducted with NT Health staff, clients, sites or data must also be approved through the correct governance processes.

Applications for data release may also occur concurrently and is a separate process.  The governance process (including the site specific assessment (‘SSA’) process) may involve the assessment of the suitability of the resources with respect to site specific research, and the investigator(s) for the proposed research, whether they are sufficient to ensure the satisfactory conduct and completion of the project.

Risk management and the identification of resources that will be required for the conduct and completion of the project are part of this process.  The requirements must be met by either the sponsor or NT Health, and the resources provided ‘in kind’ or ‘actual’ must clearly be sufficient to conduct and complete the study, including processes to add value to NT Health by knowledge or practice improvements.  The governance process is the mechanism for professional, legal and financial accountability and transparency, and ensures that research is consistent with relevant NT legislation and site specific requirements.  It enables NT Health to reduce risk to quantify the contribution of resources and assist with future operational planning and budgets.  It also considers whether appropriate consultation and approval has been granted by local decision makers to permit the project to be undertaken at the site.

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When is governance review / Site Specific Approval Required?

Governance Review/SSA is required when the research conducted involves:

  • enrolling participants into research (including the enrolment of staff);
  • site or unit specific research;
  • carrying out protocol specific research procedures with or on participants including staff; and
  • managing and analysing data, tissue and responses from surveys and questionnaires collected for or by research.

What is the process?

The relevant NT Health Research Governance Office facilitates a researcher initiated ‘bottom up’ process. Researchers are encouraged to discuss proposed research activities with unit heads and site managers/staff as the first step in planning research.

This initiative represents the beginning of a staged process of responding to feedback from clinicians, managers and researchers and the implementation of Research Governance at NT Health sites.  It is also a component of the Australian Government funded NT Health Clinical Trials Coordination Unit (NTCTCU) activities that bring the Northern Territory in line with national best practice in research governance.  In each NT Health organisation there are three main steps:

  1. endorsement at the policy / business unit level, or by the general manager;
  2. organisational endorsement by the responsible governance officer or group;
  3. organisational authorisation to commence the research, once Human Research Ethics; and
  4. Committee (HREC) approval or waiver has been granted.

What site does this process apply to?

The Department of Health, Top End Health Service and Central Australia Health Service have established their Research Governance Offices (RGOs) as the single portals for seeking approval to conduct research in the respective areas.  Refer to the relevant Governance information for:

  • Department of Health research
  • Top End Health Service research
  • Central Australia Health Service Research

Department of Health research governance processes

The DoH Research Governance Office (RGO) has been established as the single portal for seeking organisational approval for research for staff and associated services in the Department.  The contact email for this is research.doh@nt.gov.au

What does the process involve?

  • Organisational authorisation is a three stage process.
    1. Unit level endorsement is by the relevant policy/business unit heads or general managers;
    2. Organisational endorsement is by the NT Health Research Advisory Group; and
    3. Organisational authorisation to commence the research is by the DoH Executive, once Human Research Ethics Committee (HREC) approval or waiver has been granted.  HREC review proceeds in parallel to the other two stages.
  • All stages need to be completed for all research proposals, including extending an existing proposal to another site.  Ethics and governance review proceeds in parallel once local unit level endorsement has been confirmed.
  • Authorisation is conditional upon HREC approval, with research governance office notification of any amendments required.  This encourages communication, and allows parallel processing with minimal delays to research start up times.

A research project involving the Department of Health data collections only, does not require an SSA.  Instead, in addition to ethical review by the relevant HREC, it requires governance review by the Department of Health.  This process for data only research is facilitated by an application as described in the Data Governance Framework and Data Release Guideline.


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;

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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

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.
    1. Unit level endorsement is by unit heads, clinical managers, general and regional managers (including Co-Directors at RDPH);
    2. Organisational endorsement is by the ED Clinical Innovation & Research (the COO delegate);
    3. 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.tehs@nt.gov.au) 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?


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?