Research ethics and governance in Hunter New England

The Committee's membership keeps over the minimum requirements of Section 5.1.30 in the National Statement, and includes:

• A Chairperson.
• A Lawyer.
• A layperson from the local community and not associated with the institution.
• At least 2 people with current experience and knowledge in research regularly considered by the committee.
• At least 1 person with current experience and knowledge in the professional care, counselling and/or treatment of people.

For details of the Committee's composition for a specific meeting email HNELHD-ResearchOffice@health.nsw.gov.au

Committee operations

The Committee follows the National Statement in Ethical Conduct in Human Research and the NSW Health Ethics and Governance policies and guidelines.

Go to the Hunter New England LHD intranet site to learn more about the Committee's terms of reference and standard operating procedures.

Annual and final reporting

The Committee is required by the National Statement in Ethical Conduct in Human Research to check the research protocols it has approved. 

To do this, it needs:

• an annual report of the protocol to be sent to the Research Ethics Governance Information System (REGIS). The coordinating Principal Investigator will receive upcoming and overdue reminders from REGIS.
• a final report at the completion of the protocol; that is, after data analysis is complete and a final report is compiled in REGIS. 

Learn how to submit a progress final report in REGIS (PDF 481KB). 

Safety reporting

The Committe's safety reporting requirements follow the National Health and Medical Research Council's guidelines on safety monitoring in clinical trials involving therapeutic goods.

Note: Annual safety reports in REGIS can be as a general amendment or attached to the annual progress milestone report. 

Commercial and non-commercial sponsored trials

Read NSW Health's policy directive on safety monitoring and reporting for clinical trials conducted in NSW Public Health Organisations. 

Learn more about clinical trial monitoring and safety reporting notifications and pathways.

REGIS safety reporting forms

Learn how to:

• submit clinical trial and/or annual safety reports in REGIS (PDF 402KB)
• complete and submit an ethics amendment in REGIS (PDF 498KB). 

National Health and Medical Research Council (NHMRC)

• Payment of participants in research - advice to help researchers and reviewers of research in decision-making when payment of participants in research is ethically acceptable.
• Relationship between NHMRC peer review and ethical review by institutional ethics committees (PDF 421KB) - NHMRC's official statement of clarification.
• Ethical considerations in quality assurance (QA) and evaluation activities - helps organisations to develop QA policy and proper oversight.

Privacy

• The Health Records and information Privacy Act 2002 (NSW) (HRIP Act)
• Health Records and Information Privacy Regulation 2012 (NSW)
• Health Records and Information Privacy Statutory Guidelines on Research

Research involving Aboriginal Peoples

• Hunter New England LHD criteria document for research involving Aboriginal and Torres Strait Islander Peoples (DOCX 29.15KB)
• The Aboriginal Health and Medical Research Council of NSW (AH&MRC)
• Aboriginal Health Impact Statement - NSW Health Policy Directive
• NHMRC - Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities
• NHMRC - Keeping research on track II

Research involving multicultural communities

• Australian Clinical Trials Alliance (ACTA) CALD project resources
• CALD Communities Health Advisory Group
• NSW Health Multicultural health policy
• Multicultural Health research services
• Clinical trial recruitment resources for CALD communities in NSW

Clinical research information

• Australian clinical trial handbook - guidance on conducting clinical trials in Australia using 'unapproved' therapeutic goods.
• International scientific guideline: ICH guideline for good clinical practice - replaces 'Note for guidance on good clinical practice (CPMP/ICH/135/95)'. 

Other policies and guidelines

• Hunter New England Human Research Committee - Participant Information Statements and Consent forms guideline
• NSW Health and Medical Research - Ethics and Governance policies and guidelines
• Justice Health NSW research
• NSW Health Policy Distribution System (PDS) - all policy documents and guidelines applicable to the NSW Health system.
• Australian Paediatric Research Ethics and Governance Network (APREG) Guide for investigators and sponsors (PDF 273KB)

The Sub-Committee operates by the HNE HREC CTSC Terms of Reference (PDF 148.91KB).

The Sub-Committee's members include:

• A clinical pharmacologist
• A clinical research nurse
• A pharmacist with relevant experience.
• A statistician with experience designing clinical trials.
• Persons with research experience and/or relevant skills in research areas reviewed by the Sub-Committee. 

The National Clinical Trials Governance Framework (Governance Framework) is an initiative by the Australian Commission on Safety and Quality in Health Care (ACSQH). 

The framework helps to accredit health service organisations in the conduct of clinical trials.

To learn more about the Governance Framework and how it is implemented, go to the ACSQH website or watch this short video.

You can also watch our video on implementing the framework in Hunter New England LHD.

This is the ethics review pathway for greater than low risk research. Research projects that will require a full review by the the Committee include:

• exposure to illegal activities.
• research involving vulnerable groups of participants.
• active concealment of planned deception of participants.
• research specifically involving or focusing on Aboriginal and/or Torres Strait Islander peoples.
• interventions and therapies, including clinical and non-clinical trials and innovations or new treatment modalities.

An expedited review process for research projects is undertaken when the research project is of low and/or negligible risk to participants. 

Research that can be considered as low and with negligible risk is where the:

• threat to participants' privacy and confidentiality is unlikely.
• level of intrusiveness and disruption to participants is minimal.
• project does not (or does not have the potential to) involve sensitive information about participants.

Human Research Ethical Application (HREA) reference guides

• Guidance to completing the HREA in REGIS (PDF 1.41MB)
• Quick reference guide to completing an ethics application - REGIS
• NHMRC Human Research Ethics Application form resources

Quality improvement, service evaluation and audit activities (non-research activities)

• Checklist for ethical considerations in non-research activities (PDF 182.37KB)

Clinical case reports

• Clinical case report application form (PDF 161.48KB)
• Clinical case report consent form (PDF 211.99KB)

Participant Information Sheets and Consent forms

• Master parent or guardian consent form
• Hunter New England Human Research Committee - Participant Information Statements and Consent forms guideline

For other enquiries or for support with your ethics application email HNELHD-ResearchOffice@health.nsw.gov.au

All SSAs must be sent via REGIS for each Hunter New England LHD (District) site approved by the Hunter New England Human Research Ethics Committee (the Committee). 

Follow these steps to send an SSA for projects in the District:

1. Complete the SSA within REGIS (PDF 697KB).
2. If the lead Human Research Ethics Committee (Committee) is not within REGIS (outside NSW) create and complete a project registration (PDF 620KB) and upload all Committee approved documents, approvals and site documents.
3. If the lead Committee is within REGIS (in NSW) a site application (PDF 343KB) will automatically be generated. You will only need to upload documents specific to the site location.
4. Complete the SSA using District-specified documents. Use this guide (DOCX 107.68KB) and research governance checklist (DOCX 107.61KB) to complete the SSA to the Hunter New England Research Office via REGIS.
5. Complete and upload a cover letter (DOCX 27.15KB).

Please note: Any patient-facing documents that have been approved by the lead Committee will also require site-specific versions (such as participant information sheets and consent forms) and must meet the District's requirements. 

Further resources

• REGIS - Researcher training webinars
• REGIS Factsheet - Submitting a new version of an application after an ineligible notification (PDF 429KB)
• Video - Creating a new site application in REGIS (when ethics is under review, approved or external to REGIS)

All patient-facing documents used at Hunter New England LHD (District) sites must use the correct logo(s).

Note: Researchers who are not current District employees must have the District's approval before using the logo in their patient-facing documents. 

All patient facing documents intended for use at Hunter New England LHD (District) sites must be made into a site-specific document. 

A site-specific document is a copy of the Human Research Ethics Committee (Committee) approved master document and includes information that is specific to the site where the research is to be conducted.

All site documents must:

1. have the right site logo
2. have the local Hunter New England Research Office complaint details
3. have the local Principal Investigator contact details
4. be named as per the Committee approval.
5. include site version and master version in the footer. You can do this in 2 ways:
   • Option 1: Site-specific PICF version - Date (DD/MM/YY)
   • Option 2: Master document name - Version number and date (DD/MM/YY) - Site name - Document name - Version number and date (DD/MM/YY)

Please remember:

• If recruitment involves different participant groups, clearly label and prepare an information sheet for each group.
• The document name, information in the footer and filename should all match.
• If documents listed on the Committee approval letter are NOT intended for use within our District, please advise the Hunter New England Research Office with a cover letter along with your SSA submission in REGIS.
• If you are not sure if you need site-specific documentation, email HNELHD-ResearchOffice@health.nsw.gov.au

The CAPA plan for site authorisation breach process (SOP100) explains how to complete a CAPA plan if there is a site authorisation breach (breach) for research conducted within Hunter New England LHD.

SOP100: CAPA plan process

Responsibility

• The site Principal Investigator (PI) must stop all project activity at the Hunter New England site until the correct site authorisation has been received.
• The project Coordinating Principal Investigator (CPI) can help the site PI to complete the CAPA. This task can be assigned to a trained individual; however, the site PI and project CPI must manage the whole CAPA process. 
• The site PI and project CPI set up and change processes after investigating the root causes of the breach. They also must make sure the right site authorisation is received before restarting research at the Hunter New England site.
• The Hunter New England Research Governance team oversee the CAPA and ensuring the approving Human Research Ethics Committee (Committee) receive notice of the breach. 
• The approving Committee reviews the CAPA at its next meeting and decides on the use of existing data or samples collected before the breach.

Guide to completing the CAPA

1. Report the breach as accurately and completely as possible, including:
   • who was involved
   • what happened
   • where the event happened
   • how it happened and why.
2. Recount the project's progress when the breach was found, including:
   • a detailed description of the research at the site.
   • data or samples collected.
3. Describe the immediate action taken after finding the breach. This will help reassure the Research Governance team and approving committee that research was stopped the moment the breach was found.
4. Use the Root Cause Analysis (RCA) method to find system failures that were not clear during the first review. You can find incident management resources, including an RCA toolkit on the Clinical Excellence Commission website.
5. Present actions that address the root cause and provide long-term solutions, including:
   • staff training
   • work process modifications 
   • review of workplace procedures
   • reviewing resource allocations or requirements
   • retraining the specific investigator site to receive the right authorisation before research starts on site.

The site PI or Delegate will track the completion of required actions and assess if the implemented actions have addressed the issues.

Submission

• The site PI, site Head of Department and project CPI must sign the completed CAPA and then email it to HNELHD-ResearchOffice@health.nsw.gov.au 
• The site PI must save or store the completed CAPA documentation in the specified Investigator Site file.
• If the CAPA is not accepted, the site PI must respond within the given timelines.
• After acknowledging the CAPA, Hunter New England Research Governance and the Committee will return it to the site PI or project CPI. 
• The HNE site must receive the right site authorisation before restarting the project.

Access request review should be used if the project involves one or more of the following activities at the PHO:

• participant recruitment using posters, leaflets, handouts and letters of invitation (but no direct recruitment or enrolment with potential participants). 
• distribution of surveys and questionnaires through staff of the PHO (but no collation and analysis of responses at that PHO)
• access to data or tissue held at the PHO (but no processing or analysis at that PHO).

Researchers only need to fill one access request form for projects in Hunter New England LHD (District). 

The Hunter New England Research Governance Officer can decide that an application should be sent for a Site-Specific Assessment if they think the project involves conducting research at a Public Health Office (PHO) site. 

A completed access request application must include: 

1. a copy of the Human Research Ethics Committee letter of approval.
2. a copy of the Human Research Ethics Application form.
3. all documents to be distributed at the facilities, locations or services within the PHO.
4. written confirmation of support from each District facility, location or service that you seek access to participants, tissue and data.

For further information, relevant forms or templates, contact the Hunter New England LHD Research Office at (02) 4921 4140 or email HNELHD-ResearchOffice@health.nsw.gov.au 

Please note:

• you do not need to complete a form each individual facility, location or service within the District.
• your access request application must include written confirmations of support from each District facility, location or service you'll access participants' tissue or data. 
• Written confirmation of support can be received from a:
  • head of department or manager who has agreed to distribute questions or surveys to staff by email.
  • head of department or data custodian providing access to medical records, tissue or data from their collections or databases. It must meet the ethical conditions required by the approving Human Research Ethics Committee.
• we will not accept
  • letters of support from the District's site staff members. 
  • applications without the correct letter(s) of support from the District. 

As per the NSW Health's policy directive on research authorisation to commence human research in NSW Public Health Organisations (PHOs) all human research that takes place in PHOs must meet governance standards. 

This includes support for research to be received from the nominated Head of Department (HoD) or manager for the Hunter New England LHD (the District) facility or department where the research will be conducted before it is recommended to the District's Chief Executive Delegate for site authorisation. 

The Manager of Hunter New England Research Governance is the District's Delegated Research Authority for research authorisation, related contracts and agreements. 

HoD responsibilities

The HoDs review and approve District research site applications as part of the research governance process. 

They make the sure the department/service can support the conduct of research and consider if:

• the budget and resources are adequate. 
• the research is consistent with the institutional strategic plans.
• staffing is available from a/the department/facility's perspective.
• the research can be conducted without disruption to clinical services and other routine department activities.

The HoDs must have access to the Research Ethics and Governance Information System (REGIS) to review and record decision outcomes for District site applications relevant to their department or service.

Our Guide to Research Governance for HoDs and Managers (PDF 193.67KB) has more information on the process.

Please note:

• When managers are asked to provide HoD support in REGIS, it is one of many reviews a research project will undergo before it can start in the District. 
• While all projects may not undergo every review process, all projects must have approval from a Human Research Ethics Committee and the Research Governance review process.

NSW Health metrics for research approvals

Research governance authorisations receive Key Performance Indicators (KPIs) based on NSW Health service performance measures, developed as part of the NSW Health Performance framework.

The aim is for HoDs and managers to:

• assess the efficiency and drive the improvement of site authorisation processes.
• meet site authorisation timelines, which is now timed in days. 

Site authorisation timelines begin from the submission date and include the time the application is with:

• the HoDs for approval.
• the researchers, the Research Office and the Chief Executive Delegate. 

To manage this, the Hunter New England Research Office sends reminders to HoDs where applications are outstanding for 14 and 28 days. 

Escalation can occur from the next Hunter New England delegation of the service or facility if the project has not received any outcome or response from the HoD after 30 days.

Recording HoD decisions in REGIS

The HoD and/or manager will be asked to confirm support in REGIS, declaring that:

• there are suitable and adequate facilities and resources for the project to be conducted and/or the services of the proposed department/facility is available for the duration of the project.
• the project has been costed appropriately and there's sufficient funds to cover the project within the proposed department/facility. 
• if the HoD is the Principal Investigator (PI) or a member of the research team, a declaration has been obtained from the HoD's manager or a suitable alternative. 

The PI must discuss the proposed research project and its resource implications with the HoD (or divisional director or other authority) responsible for the department or service.

Quick steps to provide a declaration of support in REGIS

1. Create an account in REGIS.
2. Select the Decisions icon or link.
3. Select and download the application you wish to review.
4. Review the application, select your decision, and provide comments.

Read the full instructions on how to provide declarations of support in REGIS.

Changes to HoD list 

Email HNELHD-ResearchOffice@health.nsw.gov.au with your request to change the District's REGIS HoD list and the reason for the change to the site or department's outgoing or incoming HoD.

The Hunter New England Reseach Office will seek approval from the right executive leadership team member prior to making any changes. 

Contacts

Questions about the research project?

Contact the site's Principal Investigator listed in the site application.

Questions about the approvals, the process or REGIS?

Email the Hunter New England Research Office at HNELHD-ResearchOffice@health.nsw.gov.au 

If you believe you are not the correct approver for the project, contact the Hunter New England Research Office as soon as possible to re-allocate the project.

Amendments cannot be reviewed by the RGO without evidence of relevant Human Research Ethics Committee (Committee) approval, except for contract and local team personnel changes as follows:

Site general amendment

Submit a site general amendment in REGIS for:

• changes to the study protocol, including the conduct and/or design of the study.
• changes to any other study documentation (e.g. study tools, consent and recruitment material).
• site-specific versions of approved master documents must be uploaded for all amended patient-facing documents.

If the approving Committee is outside NSW, the approval and all approved documents must be uploaded to REGIS along with all site-specific documents.  

Changes to personnel

Submit site changes to personnel amendment for:

• changing site investigators
• changing administration contact
• changing Committee (outside NSW) to CPI/PI, upload the approval and CV. 

Please note:  

• To change HREC (in NSW) to CPI/PI: the NSW Committee will automatically update REGIS. Other site amendment is not needed. 
• Make sure to provide a current Good Clinical Practice Certificate (GCP) if you are adding internal or external team members for clinical trial study(s).
• Make sure to nominate all external researchers that will attend on site or will access identifiable patient data within the study team. Refer to the Hunter New England Intranet site and eMR access for external researchers. 

Contract changes

Submit all contract amendments through site amendment contract changes in REGIS (PDF 483KB).

Note:

• Make sure the Clinical Reference Group and Hunter New England Principal Investigator have signed the contract amendments before submission. 
• For more information refer to electronic signatures.

Request for an extension of Human Research Ethics Committee (Committee)

Submit a site amendment request for an extension of the Committee only if the approved Committee is outside NSW. 

The expiry date is automatically updated once the request has been approved by the District's Committee.

Please note: For an extension of the Committee that is in NSW, the NSW HREC automatically updates the expiry date in REGIS. No other site amendment is needed.

Research Governance Officers (RGOs) oversee authorised research projects by reviewing milestones provided by the Principal Investigator (PI). 

This includes any recommendations made by the Human Research Ethics Committee (Committee) following the review of progress and final reports.

Progress / final reports

Only use the progress/ final report milestones in REGIS (PDF 481KB) for projects with approving Committees outside NSW and provide:

• a copy of the progress or final report.
• the Committee approval or acknowledgement letter.

If the milestone does not appear in REGIS, email HNELHD-ResearchOffice@health.nsw.gov.au to request a milestone report be created and allowed for submission.

Please note:

For projects with approving Committees in NSW, the reviewed and approved progress, final reports and approvals are automatically shared in REGIS. No other milestone submission is needed. 

The Hunter New England Research Office will only contact you if they have any queries or concerns.

Updated Certificate of Currency (CoC)

Upload updated evidence of insurance milestone in REGIS (PDF 397KB) for RGO acknowledgement. 

If your milestone does not appear in REGIS, email HNELHD-ResearchOffice@health.nsw.gov.au to request a milestone report be created and allowed for submission.

Committee approval is NOT needed for this milestone submission.

The Hunter New England LHD institution details should be used in (but not limited to) the following documents:

1. Research agreements (including Clinical trial research agreements)
2. Forms of indemnity (standard) 

Research agreements (incl. Clinical trial research agreements)

 Authorised Research Delegate for research contracts

Medicines Australia - Form of Indemnity (standard)

Address to: 

Hunter New England Local Health District
Lookout Road
New Lambton Heights
NSW 2305
Australia 

ABN: 63 598 010 203 (the Indemnified Party)

Process for research contract and indemnity signatures

After the sponsor and Hunter New England Principal Investigator has signed the contract, send the documents (Site-Specific Application or Site Amendment) via REGIS for the Hunter New England's Authorised Research Delegate's signature.

In line with Medicine Australia's joint position statement (PDF 236KB) the Hunter New England Research Office (Research Office) accepts electronic signature platforms by executing research agreements and other research-related regulatory documents. 

We also still accept Adobe certified and wet signatures. 

All documents sent to the Research Office from electronic signing platforms must follow the standard operating procedure for electronic signatures via DocuSign (SOP 001). The instructions are provided in this section.

If you have different requirements for your electronic signature platform email HNELHD-ResearchOffice@health.nsw.gov.au for help.

SOP 001: DocuSign instructions

If the sponsor of the research project requests signature on contract via DocuSign, the requester (sponsor or research team) must request the Hunter New England LHD (District) Authorised Research Delegate to e-sign the document.

Note: If you are using a non-standard contract, please make sure the Research Office has reviewed the agreement before continuing with the following steps.

1. Make sure you have added the correct name and position/title to the signatory section on the agreement.
   • Signed on behalf of the institution:
     • Name: Kristy Morris
     • Position/Title: Manager, Research Governance
2. Upload the document for signature to REGIS for:
   • new Site-Specific Applications (SSAs)
   • site amendments (contract changes)
   • Important: You must complete Step 2. The Research Governance team will let you know when the DocuSign request can be sent to the Authorised Research Delegate. 
   • The DocuSign request will be rejected if you don't complete step 2 with instruction from the Research Governance team. 
3. The recipients must be set and signed in the following order: 
   • FIRST signature: Sponsor; name and email
   • SECOND signature: District Site Principal Investigator; name and email
   • LAST signature: District Authorised Research Delegate; Kristy Morris, Kristy.Morris@health.nsw.gov.au
4. The DocuSign subject line must include the agreement information and the REGIS STE agreement reference number.
   • Example: CTRA Variation 1 for project; 2023/STE098866

Maintaining confidentiality of information is important and a serious matter. Commercial and non-commercial research sponsors often require a non-disclosure agreement (NDA) or confidentiality agreements before they share information, e.g. a study protocol. 

These agreements are generally legally binding; and if broken, can result in court action.

HNELHD CDA requirements

Hunter New England LHD (the District) require all CDAs:

• must be project-specific and reference the specific protocols. We will not support CDAs that are not protocol specific. 
• must have space for 3 signatures. All District CDAs are to be signed by the District's Research Delegate and staff member receiving the information.

If you are asked to sign a CDA or NDA

• Use the standard District-approved CDA template (DOCX 64.34KB).
• Make sure the correct Institution details are included.

CDA submission instructions

• For the District-approved CDA template: complete the form, including signatures from the sponsor and proposed District Principal Investigator. Email it to HNELHD-ResearchOffice@health.nsw.gov.au for review and to request the Authorised Research Delegate's signature. 
• For all other CDAs (non-standard): Email the CDA draft for review in the first instance. The review of non-standard CDAs will take a minimum of 14 days.

• Make sure to use the correct Institution details.
• If your agreement includes special conditions with National Clinical Trial Agreement (NaCTA) approval: please upload the NaCTA approval with your site application.
• If your agreement includes special conditions without NaCTA approval: email your agreement for review before sending your site application.
• Make sure agreements are signed by the sponsor and Principal Investigator before sending it with your Site-Specific Application (SSA) or Site Amendments (contract changes) via REGIS.
• Fully executed agreements will be signed and returned with project authorisation or site amendment via REGIS.
• If Hunter New England LHD is the Clinical Research Group (CRG): all agreements must be signed by Hunter New England LHD first. Email your draft agreement for review.

CTRA approved templates

The following CTRA templates from Medicines Australia are approved for us in NSW Public Health Organisations (PHOs):

• Medicines Australia Standard Form
• Contract Research Organisation (CRO) acting as the local sponsor
• Collaborative or Cooperative Research Group (CRG) studies
• Phase 4 Clinical Trial (Medicines)
• Phase 4 Clinical Trial (Medicines) CRO acting as the local sponsor

Teletrials subcontract 

The CTRA Teletrials subcontract for studies conducted under a Teletrial Model is designed to complement the CTRA Medicines Australia Standard Form as the head agreement. 

Note: Changes cannot be made to the standard clauses (page 2 - 17). Any clauses included at Schedule 4 or 7 must be approved by the National Clinical Trial Agreement (NaCTA) Panel (previously known as SEBS). The application must include evidence of NaCTA approval.

Hunter New England LHD CTRA submission instructions

Refer to and follow the submission instructions.

A device trial is known as a 'clinical investigation' rather than a 'clinical trial'. 

The Medical Technology Association of Australia (MTAA) has developed regulatory documents for use in commercially sponsored studies of medical technology.

Hunter New England LHD CIRA submission instructions

Refer to and follow the submission instructions.

The Collaborative Research Agreement template is used for projects not involving clinical trials. It helps simplify multi-jurisdictional, multi-party non-clinical trials research. 

This template agreement is not mandatory. It follows the model of the Medicines Australia and Medical Technology Association of Australia clinical trial research agreement templates. 

Please note: any change to any of the clauses shall be made between the contracting parties and their respective legal counsel in Schedule 1. Changes to clauses in this agreement will not be reviewed by the National Clinical Trial Agreement (NaCTA) Panel (previously known as SEBS).

How to meet Hunter New England LHD requirements

You must include the Principal Investigator's acknowledgement with signature on page 20 of the agreement template before sending it via REGIS for the Authorised Research Delegate's signature.

Use the Research Collaborative Agreement template (DOCX 114.99KB) for research that requires an agreement but does not meet the approved Medicines Australia and Medical Technology Association of Australia clinical trial research agreement templates. 

Hunter New England LHD RCA submission instructions

• Refer to and follow the submission instructions.
• Refer to electronic signatures for instructions. 

Use the MTA and Standard Agreement if your research involves transfer of data, materials or samples from Hunter New England LHD to an external site. 

Examples of data, materials or samples include:

• cell lines
• blood
• tissue
• CT and/or MRI scans
• other clinical data.

An MTA must be used when the research does not require a Clinical Trial Research Agreement (CTRA) or other collaborative agreements.

Please note: If you are unsure or require an MTA review before sending your Site-Specific Assessment application, email HNELHD-ResearchOffice@health.nsw.gov.au for help.

The Hunter New England Research Office strongly recommends using the standard agreements mentioned and referenced in the regulatory documents section.

The use of non-standard agreements will require further reviews and could result in authorisation delays. 

If you use a non-standard agreement:

• Email the draft agreement (including any supporting documents) to HNELHD-ResearchOffice@health.nsw.gov.au
• The email subject line should read as: Attn: RGO Non-standard contract for review [include the Principal Investigator's surname].
• The first review of all non-standard agreements will take a minimum of 14 days.

A standard indemnity form must be included with the Site-Specific Assessment application if Hunter New England LHD is providing:

• the premises only 
• the premises for the conduct of the study.

Indemnity forms for commercially sponsored clinical investigations are available from:

• Medicines Australia - Indemnity and compensation guidelines
• Medical Technology Association of Australia - Agreements, forms of indemnity and compensation guidelines

Hunter New England LHD submission instructions

• Make sure the correct HNELHD Institution details are included.

An insurance certificate must be included with the Site-Specific Assessment application for all commercially sponsored clinical trials.

Forcommercially sponsored clinical trials, the insurance certificate must:

• cover a minimum of A$20 million
• have an Australian-named sponsor
• an excess/deductible or self-insured retention amount not greater than A$25,000 for every claim. 

For externally sponsored non-commercial research, sponsors must provide indemnity or insurance arrangements that cover all their sponsor-related liabilities.

For more information, refer to NSW Health's Policy Directive for Clinical Trials Insurance and Indemnity (PD_2011_006).  

Please note: 

• The Hunter New England Research Office (Research Office) collects and stores certificate insurances from non-commercial sponsors, so researchers don't have to repeatedly source/provide this. 
• If/when a certificate expires or the Research Office cannot find the insurance, researchers may be asked to source/provide evidence of insurance.

If your study/research requires NCAT approval, you must provide this approval before sending your application. 

Clinical trials that seek to involve a person/persons aged 16 years or older with decision-making disability must be approved by the Guardianship Division of the NCAT, under Part 5 of the NSW Guardianship Act 1987.