Health research

To conduct short term clinical audit, case study, case report or simple internal quality assurance activity, using routinely collected data that will be de-identified with no deviation from standard care and no human interaction, please complete the Ethics Clearance Form for Clinical Audits, Quality Assurance, and Case Studies.

Please note that advanced trainees, registrars, medical students, and higher degree candidates should be identified as Co-investigators and not as Principal Investigator.

For students listed as one of the Investigators, please also compete the Student Deed of Undertaking form.

Researchers are advised to include evidence of endorsement by the local Regional Health Service authorising delegates (i.e. Unit Head, Co-Director or General Manager or Regional Executive Director) prior to submission to the NT Health RGO by completing the relevant endorsements sections at the end of this form (section 10) or by submitting email endorsement when lodging this to the NT Health RGO. Please ensure that email endorsements include the full project title. If unsure of
the appropriate authorising delegate(s), please contact NT Health RGO for advice.

NOTE: Organisational authorisation section will be signed by the Director of Clinical Innovation and Research once the NT Health RGO have undertaken their review.

The completed and signed form should be submitted electronically to the NT Health RGO nthealth.rgo@nt.gov.au for review. The NT Health RGO will forward this form to the ethics office (NT HREC) for expedited review.

The NT Health RGO will assess the submitted form and attachments. If further information is required, the Site PI will be notified by the NT Health RGO.

Both NT HREC approval and NT Health RGO organisational authorisation are required before a research project can commence at any NT Health site(s).

All research conducted with NT Health staff, clients/patients, sites and/or data must be approved through the correct governance processes which broadly address the quality, safety, privacy and confidentiality, risk management, financial management and ethical acceptability of research.

Processes and guidelines have been developed to support the changes to the institutional governance procedures for conducting research within NT Health, to bring the NT in line with national best practice in research governance. The role of the NT Health Research Governance Office is to ensure research
is conducted according to established ethical principles, guidelines for the responsible research conduct, relevant legislation, regulations and NT Health policies.

All research projects conducted within NT Health must designate a NT Health-employed individual, qualified by training and experience, to serve as the NT Health Site Principal Investigator (PI) under their NT Health affiliation. The PI must have sufficient authority, relevant scientific knowledge, and the requisite training to personally carry out or supervise all aspects of the project at NT Health. NT Health authorises the Site PI to assume ultimate responsibility for the scientific, technical and administrative aspects of the research project, even when certain tasks have been delegated to other members of the research team.

The governance review undertaken will depend on the type and risk of research. Assessment of applications occurs through site specific assessment (SSA), clearance for clinical audits, quality assurance and case studies, and/or access request for research review; assessing the resources at the NT Health
site and whether they’re sufficient to ensure the satisfactory conduct and completion of the project.

NT Health  is committed to implementing the Australian Commission on Safety and Quality in Health Care (ACSQHC) National Clinical Trials Governance Framework to align with the actions in Clinical Governance Standard and Partnering with Consumers Standard of the NSQHS Standards which are already embedded in routine practices of health service
organisations. The NT Health Research Governance Office (RGO) is responsible for:

• Ensuring awareness of the importance of the NHMRC: National Statement on Ethical Conduct in Human Research and the  Australian Code for the Responsible Conduct of Research across the organisation.
• Monitoring relevant regulatory and policy developments to ensure changes are incorporated into local policies and procedures in a timely manner.
• Leading the development and implementation of systems and implementation of best practice policy, procedures, and standardised systems within the relevant health system to improve the conduct and governance of research projects in collaboration with the governing body, managers, clinicians, patients,
  consumers and sponsors.
• Providing information, education and advice on research governance matters to stakeholders involved in the conduct and management of research projects in accordance with national and local policies, guidelines and other reference material adopted by the Northern Territory.
• Monitoring and evaluating research activity within NT Health throughout the project duration.
• Undertaking risk management assessments regarding research services and procedures to promote responsible research conduct.
• Implementing systems for the management of complaints about research projects including misconduct and/or fraud and manage complaints, misconduct or conflicts of interest related to the conduct of authorised research projects.
• Conducting or co-ordinating audits of research projects, where required.
• Preparing reports to regulatory bodies as required.
• Maintaining records, including databases and filing systems.
• Determining compliance with relevant legislation and policies.

The governance review/SSA is a separate process to the ethical review and should be conducted in parallel to the ethics approval process. It is not necessary to await the ethics outcome before preparing and submitting a governance/SSA application to the NT Health RGO.​ However, ethics approval must
be obtained and provided to the NT Health RGO as part of the final governance review. Both ethics approval and research governance/SSA organisational authorisation are required before a research project can commence at any NT Health site(s).

Please refer to the workflow for overview of NT Health governance and ethics application process. The workflow also includes standard processing times for both governance and ethics authorisation/approval.

A human research project that requires support from a Health Service in the form of access to NT Health patients, staff, tissue or data but does not involve the conduct of research at any facilities, locations or services (site) under the control of that Health Service, is not required to undergo a
governance review using the Site Specific Assessment (SSA). Please complete the access request form for research projects via the online submission.

An Access Request review using this form is required when the research project involves:

• 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 personnel of the Health Service (but not collation and analysis of responses at that Health Service); and
• access to data or tissue held at the Health Service (but not processing or analysis at that Health Service).

The NT Health RGO will assess the submitted form and attachments. If further information is required, the Coordinating Principal Investigator (CPI)/Principal Investigator (PI) will be notified by the NT Health RGO.

Please note that request for completion of an SSA may be requested at the discretion of the reviewing Research Governance Officer.

All research projects conducted with NT Health staff, patients, sites and/or data, require an SSA as a component of research governance. The SSA form is an information gathering tool used to assess the research projects impact on each relevant NT Health site. One SSA may be completed for research being conducted across multiple NT Health regions, so long as all appropriate delegates have provided their endorsement for the research.

For research projects involving Primary Health Care (PHC), an SSA should be submitted to the RGO, whereby the RGO will arrange for the research proposal to have the relevant endorsements and review conducted. The information provided will be reviewed by the appropriate authorising delegate(s) from NT Health to ensure that there are resources available to effectively conduct a research project at the nominated NT Health site(s). The responsible delegate will provide the NT Health RGO with their support or a reason why the project is not supported.

The SSA enables NT Health RGO’s commitment to the research in terms of:

• Alignment and contribution of the research to NT Health strategic goals
• Adequate resources which have been identified as appropriate, accountable and available (financial, human, equipment, consumables and infrastructure) for the research to proceed at NT Health site(s)
• Researchers have the necessary expertise and experience to carry out the work, or have provided evidence they will undergo the relevant training before they carry out their role in the research study
• Compliance with relevant laws, policies, and codes of conduct relating to matters such as indemnity insurance, privacy, confidentiality, consent, bio-safety, professional standards, and radiation safety

For research projects involving an investigational medicinal product (IMP), which is above standard of care then the NT Health Clinical Trials Pharmacy Services Research Request Form must be submitted with the SSA – see Supporting Documents.

Once completed, the SSA form plus electronic copies of all supporting documents must be submitted to the NT Health RGO via the online submission.

The NT Health RGO will assess the submitted form and attachments. If further information is required, the Site PI will be notified by the NT Health RGO.

Both NT HREC approval and NT Health RGO organisational authorisation are required before a research project can commence at any NT Health site(s).

A Conflict of Interest involves circumstances where an individual or organisation’s actions or decisions regarding a research project could be influenced by personal gain. Obligations over the responsibilities of research may be actual or perceived to influence the duties or responsibilities of an individual or organisation.

Any perceived or actual Conflict of Interest must be declared in the SSA, and will be reviewed by the NT Health RGO as per NT Health policy. Advice specific to the Conflict of Interest will be provided to the research team.

Clinical trials that involve 'unapproved' therapeutic goods are subject to requirements of the Clinical Trial Notification (CTN) or Clinical Trial Approval (CTA) schemes. It is the responsibility of the study sponsor to submit the application and pay the submission fee. Information can be found at Australian Government Health and Aged Care website.

The sponsor / collaborative research groups (CRG) is required to complete and validate (but not submit) the online CTN form and provide a copy of this validation form to the NT Health RGO.

Once site authorisation has been granted, the sponsor can submit the CTN form for the site under NT of Australia (legal entity). The NT Health RGO must be provided with a copy of the submitted information and the TGA notification letter as soon as practicable.

Please contact the NT Health RGO in the first instance if you are submitting a CTN form, have any queries about the CTN submission process, or to discuss options for your study.

Research Agreement

Any research that involves a collaboration with an external institution, company or individual must have a fully executed contractual research agreement in place prior to the research commencing. If your study involves an agreement between NT Health and any other party, then this agreement must be submitted to the NT Health RGO for review who will arrange signing by the appropriate NT Health delegate. This includes any confidentiality disclosure agreements, research collaboration agreements, funding agreements, multi-institutional agreements, Clinical Trial/Investigation Research Agreements, data sharing agreements, or other type of research agreements.

The Northern Territory of Australia through its agency the Department of Health is the legal entity that can enter into research agreements. The NT prefers to use the relevant Medicines Australia Clinical Trials Research Agreements template or for medical device research, the use of Medical Technology Association of Australia (MTAA) Clinical Investigation Research Agreements template. The Northern Territory of Australia through its agency the Department of Health, is required to comply with the Northern Territory Treasurer's Direction (TD) in respect of insurance arrangements. The NT Health RGO will insert a signature block for the institution and ensure specific amendments in Schedule 4 ‘Special Conditions’ are included, as appropriate, to provide clarity and ensure full compliance with this TD. Please speak with the NT Health RGO to ensure a timely approval process.

Please be aware that review of an agreement by NT Health Legal is required for any non-standard research agreements, any changes made to the body of a standard template agreement, or other agreements where conditions are outlined in the NT Health delegation schedule. Legal review can lengthen approval times by a minimum of 2 months. The NT Health RGO will arrange legal review on your behalf as required.

Where fees are chargeable, the appropriate fee will be charged as outlined in the NT Health fees schedule

Insurance and indemnity

The Northern Territory of Australia through its agency the Department of Health self-insures.

Indemnity - NT Health employees

NT Health employees conducting a research project in the capacity of their employment with NT Health are automatically covered by NT Health self-insurance arrangements where approval from the reviewing HREC and NT Health RGO has been obtained.

Indemnity - commercial sponsor

For commercially sponsored clinical trials or contract research organisations (acting on behalf of the sponsor), the sponsor must supply evidence of its insurance cover. A sponsor’s insurance cover must indemnify the local site, investigator and research staff. For all commercially sponsored clinical trials, use of the Medicines Australia standard indemnity form is the preferred form executed on behalf of the sponsor prior to the site specific assessment (SSA) submission. If a sponsor has not signed the indemnity form prior to SSA submission, the NT Health RGO must be provided with an executed copy prior to final SSA authorisation.

The NT Health RGO will review ‘indemnified party’ details and insert the signature block for the ‘institution’ prior to approval for sign off, please contact the NT Health RGO.

The NT Health RGO will arrange for the indemnity to be executed on behalf of the institution, please note the executed version will be sent out with the authorisation email.

Indemnity - collaborative research group

For CRGs the indemnity arrangements are outlined in the clinical trials research agreement, in general, the NT of Australia will cover NT Health employees conducting research activities under a CRG, however if the research activities are performed by a non-NT Health employee on NT Health facilities or with NT Health confidential data the non-NT Health employee’s organisation must provide indemnity for their employee.

Certificate of currency - requirements for all clinical trials

For clinical trials, the entity that has accepted the role of the sponsor will be required to submit a certificate of currency (CoC) to the NT Health RGO. This insurance will indemnify the participants involved in the research project and requires submission to the NT Health RGO.

The participant information sheets and consent form (PISCF) require the insertion of the NT Health name block/logo where NT Health is the site and a paragraph informing participants how to contact the NT Health RGO. Please use the below paragraph as a guide for insertion into the participant
information statement (PIS). This is in addition to the reviewing ethics and site PI contact details.

The conduct of this study at name of site has been authorised by Northern Territory Health. Any person with concerns or feedback (complaints or compliments) about the conduct of this study may contact the NT Health Research Governance Officer on 08 8922 7764 or email nthealth.rgo@nt.gov.au and quote reference number insert SSA reference number.

The NT Health RGO facilitates a researcher initiated ‘bottom up’ process. Researchers are encouraged to discuss proposed research projects with the unit heads and site managers as the first step in planning research.

Any division or department that is involved in the research must endorse the research being conducted in their department. This includes departments that are actively involved in the research, for example wards, pharmacy, radiology, medical imaging. It may also include departments that are not actively involved, but will experience some impact from the conduct of research, for example, participants will be recruited from the department. All relevant divisional or department heads must confirm support either by signing the SSA form or providing an email of support.

Depending on the type and risk of research, the SSA may also need to be endorsed by the relevant institutional head.

It is a conflict of interest for any person who is an Investigator, whether as the Principal Investigator or Associate Investigator, to also provide endorsement as the head of department. If the head of department is an Investigator, the endorsement must be provided by the next highest level of authority. For example, where a department head is also the Principal Investigator, the divisional head must provide the endorsement.

If unsure of the appropriate authorising delegate(s), please contact the NT Health RGO for advice.

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 PDF (946.7 KB) of the organisation
5. There is no conflict of interest for the researchers 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;
14. The organisation benefit of participating in the research is consistent with the resource contribution; and
15. That the research, once completed, is provided back to NT Health via the relevant (authorising) research governance office and disseminated/implemented to the relevant staff and/or participants.

This will be the final review for the SSA form post support by all other relevant delegates. The NT Health RGO will facilitate the final authorisation for the research which is provided by the Executive Director of Research. The Site PI will be notified by the NT Health RGO of the outcome via email.

Once NT Health RGO organisational authorisation is granted, the terms and conditions of research governance authorisation are included in the authorisation email from the NT Health RGO, and are in addition to the terms and conditions of Human Research Ethics Committee (HREC) approval.

Researchers are required to comply with reporting requirements and other conditions. Failure to comply will have significant implications for the ongoing site authorisation of the research project. In the event there are other conditions of research governance authorisation, these will be detailed in
the research governance authorisation email.

The link to access the NT Health RGO post authorisation reporting forms is provided on approval of your project. For any projects approved prior to the introduction of our online submission form, or if you have misplaced your return link, please email nthealth.rgo@nt.gov.au and quote your SSA reference number.

Site commencement

Once the authorised research project is ready to commence at an NT Health site(s), it is the responsibility of the site PI to notify the NT Health RGO of project commencement date via the online NT Health RGO Site Commencement Form, for which the link will be provided on authorisation of the research.

Project amendment

It is the responsibility of the site PI to complete an amendment application when any of the following occurs:

• changeover of site PI
• addition or removal of research personnel at NT Health site(s) – both NT Health or non-NT Health staff
• addition or removal of NT Health site(s)
• changes to project documentation, including protocol, PICF, etc.
• other changes to the research project that might have an implication to NT Health.

Please complete the online NT Health RGO Amendment Form and provide any supporting documents, the relevant HREC correspondence and approval (usually provided by Sponsor/CPI) to the NT Health RGO. The link to access the online Project Amendment form is provided to the site PI on authorisation of the
research. For any research approved prior to the introduction of the online submission or if you have misplaced the link, please contact nthealth.rgo@nt.gov.au and quote your reference number.

The NT Health RGO will send an email to the site PI and site contact person to approve the project amendment(s). Any further actions that may be required will be detailed in this email.

Progress report

It is the responsibility of the site PI to complete a progress report to the NT Health RGO for each research project regardless of the progress of the research or whether it has commenced. A condition of the research governance authorisation continued approval is the provision of a copy of the reviewing HREC annual report and response.

Progress reports can be submitted to the NT Health Research Governance Office at any time. Compliance with annual reporting is reviewed annually with outstanding reports due on the 30^th April, up until project completion.

Failure to submit a report to NT Health RGO will result in the Head of Department/Division being notified and may lead to suspension of the project

Please complete the online NT Health RGO Progress Report and provide the relevant supporting documents, the relevant HREC correspondence and approval (usually provided by Sponsor/CPI) to the NT Health RGO. The link to access the online Progress Report form is provided to the site PI or can be requested from the NT Health RGO by the research team.

The NT Health RGO will send an email to the site PI and site contact person to acknowledge receipt of the progress. Any further actions that may be required will be detailed in this email.

Final report - site closure

It is the responsibility of the site PI to complete a final report at the completion of their research project to the NT Health RGO via the online NT Health RGO Final Report Form, Study Close Out Checklist and Declaration of Archiving Research Documents along with providing all supporting
documents, the relevant HREC correspondence and acknowledgement (usually provided by Sponsor/CPI).

The NT Health RGO will send an email to the site PI and site contact person to acknowledge receipt of the final report. Any further actions that may be required will be detailed in this email.

It is the responsibility of the site PI to report any significant safety issues or any serious unexpected serious adverse reactions or breach that occurred to NT Health participants or within NT Health, to the NT Health RGO within 72 hours.  The report will include confirmation that the incident has been reported in the NT Health risk management system (RiskMan), a summary of any immediate actions that were undertaken, the risk rating, a copy of the documents submitted to the lead HREC and the HREC acknowledgement.

For safety and breach reporting please email nthealth.rgo@nt.gov.au.