What criteria are considered for granting approval for research?
Applications are assessed against the following criteria and the organisation must be satisfied that:
- All external researchers/students involved in the research project have the skills, training and experience necessary to undertake their role;
- All NT Health researchers/students involved in the research project have the skills, training and experience necessary to undertake their role;
- The research is relevant to the site;
- The research is consistent with the strategic objectives of the organisation
- There is no conflict of interest for the researcher’s or that the declared conflict of interest is acceptable;
- There is evidence of compliance with indemnity requirements;
- Requirements for access to organisational data are clear and comply with legislative requirements;
- Data management, privacy and confidentiality requirements are described, and comply with legislative requirements;
- The research translation strategy is demonstrated and will provide evidence based information for improving patient outcomes, clinical care or service delivery;
- There are suitable and adequate facilities and resources for the research project to be conducted at this site;
- The resource contribution by the site is clear;
- The research project and resource implications have been discussed with relevant staff/delegates;
- There is a clear organisational benefit of participation in the research; and
- The Organisation benefit of participating in the research is consistent with the resource contribution.
- 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.
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:
- endorsement at the policy / business unit level, or by the general manager;
- organisational endorsement by the responsible governance officer or group;
- organisational authorisation to commence the research, once Human Research Ethics; and
- 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
Last updated: 24 August 2020
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