Research Governance ensures that research meets the standards of quality, safety, privacy, risk management, financial management and ethical acceptability. It provides a framework for health districts, facilities, managers and researchers to share accountability for research conduct.
Site Specific Assessment is required for sites under the control of a NSW public health organisation, even if the project has low or negligible risk to participants, if the project involves one or more of the following activities:
- enrolling participants into research (e.g. obtaining informed consent, screening)
- carrying out protocol-specific research procedures with or on participants
- managing and analysing data, tissue, and responses from surveys and questionnaires collected for or from research.
To obtain authorisation, researchers need to submit a Site-Specific Assessment (SSA) via REGIS, that meets the requirements of the SSA Checklist.
Queries can be directed to ISLHD-ResearchGovernance@health.nsw.gov.au.
Site Specific Authorisation
Site Specific Assessment (SSA) applications will be reviewed by the Research Governance Office in accordance with NSW Health PD 2010_056 Research - Authorisation to Commence Human Research in NSW Public Health Organisations. All applications must be made on the standard Site Specific Assessment Form in REGIS (Research Ethics and Governance Information System).
For instructions on how to complete the SSA in REGIS, please see the Quick Reference Guide: SSA Part 1: Completing the Application & Requesting Head of Department Support.and Quick Reference Guide: SSA Part 2: Submitting SSA to Research Office.
Before submitting your SSA, please ensure that you have personally contacted the Head/s of Department/s (HoD) to discuss your resource request and have their in-principal support for the project. Please also note that any requests made for furthe information form the Research Office must be responded to within 30 days, or the project will be withdrawn.
Requirements for SSA Applications
| Site team | All non ISLHD staff team members will require Contingent Worker Status for the study to gain Site Specific Authorisation and for the study to commence. | ||||||||
| Project budgets | Research project budgets must be itemised using either the ISLHD Research Project Budget Template or the OHMR Clinical Trial Budget Costing Tool. The budget must be attached to your SSA and approved by the Head of Department (HoD) prior to being submitted to the Research Office. | ||||||||
| Departments and services |
The resource requirements for conducting research must be approved by the Head of Department (HoD) in which the study is taking place, as well as HODs that will support the study. Examples of supporting departments include:
In the event that the HoD is on the study team, the resource requirements will need to be approved by their line manager. |
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| Ethics approval | Correspondence from a Lead HREC certified by the National Mutual Acceptance Scheme approving conduct of the study at the site is required, plus subsequent amendment approvals including master versions of study documents (protocol, PICF, surveys, data tools). | ||||||||
| Site specific documents |
When a project is approved by a Lead HREC as a multi-centre project, study master documentation will need to be customised for each site. Documents for use at ISLHD sites will need to:
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| Radiation safety report | Research that exposes humans to ionising radiation must be submitted to the site Radiation Safety Officer. The Radiation Safety Report must be attached to the SSA. | ||||||||
| Contracts and indemnities |
Contracts and indemnities are to be submitted via REGIS as part of the SSA and must be signed by the Sponsor and PI prior to submission. The Research Office accepts scanned and electronic signatures and will return executed versions back to research teams via REGIS. Details to be used on contracts are:
The standard agreements available on Medicines Australia, without alteration, are accepted. The process for requesting changes to these agreements is managed outside of ISLHD. Further information is available on the OHMR website. |
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| Insurance |
Commercially sponsored and collaborative group trials require a current insurance certificate held in the name of the local sponsor with AUS $20M cover. Students and external researchers must provide evidence of insurance cover from their university or employer, as stated under the Site Team section. |
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| Clinical trial notifications and exemptions |
Clinical trial sponsors are required to notify or seek exemption from the TGA when they intend to use unapproved therapeutic goods. Evidence of CTN or CTX submission will need to be attached to the SSA. Where ISLHD is the sponsor, the Research Office will submit the CTN or CTX in conjunction with the Principal Investigator. In this instance, please contact the office prior to submitting your SSA. |
Site Access Requests
Research projects that require access to ISLHD patients, staff, tissue or data but do not involve the conduct of research at ISLHD sites require the submission and approval of a formal Access Request as opposed to Site Specific Authorisation.
Research activities that require an Access Request include:
- Participant recruitment through leaflets or posters that does not involve any direct contact with potential participants;
- Distribution of surveys or questionnaires through ISLHD staff where collation and analysis are not occurring at an ISLHD site;
- Access to data or tissue held within ISLHD where processing and analysis is not occurring at a ISLHD site.
Access requests should be made by the Coordinating Principal Investigator to the Research Governance Officer via email. The Coordinating Principal Investigator is responsible for obtaining written agreement from relevant heads of the facilities, locations and services that will provide the access required. Site access requests for access to data, physical visits to sites, direct contacts with patients and staff will generally be advised to submit a site-specific application and nominate a SESLHD staff member as the principal investigator (PI).
To submit a site access request please via email to ISLHD-ResearchGovernance@health.nsw.gov.au:
- A completed site access form from https://www.medicalresearch.nsw.gov.au/Site-authorisation/
- Written support from the relevant head/s of department/s (email accepted)
- A cover letter outlining:
- Project title
- Relevant project identifiers
- Coordinating Principal Investigator name and contact information
- Name of the study sponsor, if applicable
- Human Research Ethics Committee approval letter with ISLHD site/s listed
- The resources/services/access being requested
- Attached letters or emails confirming the head of Department support
- If distributing a survey or conducting an interview, please include a data dictionary or list of questions that will be posed.
Post Approval
Study changes that are made after ethics approval and site authorisation must be reviewed and approved by the Lead HREC. Approved changes must then be notified to the ISLHD Research Office via REGIS.
Types of amendments
- Protocol amendments – Changes to approved protocols that are administrative, scientific or logistical must be notified.
- Investigator Brochure (IB) updates – Changes to the Investigator Brochure for a drug or device are not required ISLHD Research Governance unless the update results in changes to other documents (i.e. PISCF).
- Amendments to site specific Participant Information Sheet and Consent Forms (PISCF)
- Changes to Study Personnel – If the HREC is within REGIS, changes to CPI and PI will automatically be shared with the relevant RGOs. Other personnel changes are not required by RGO unless approved study documents are being updated.
- Research Agreement changes – The Research Office will facilitate re-execution of agreements where necessary.
- Annual Safety Report - Not required to be submitted to ISLHD RGO - should be submitted to reviewing HREC.
- Development Safety Update Report (DSUR) - Not required to be submitted to ISLHD RGO. The executive summary can serve as the Annual Safety Report to be submitted to the reviewing HREC.
Submission of amendments
All amendments must be submitted via REGIS. Please use the Quick Reference Guides and videos available for guidance.
When ethics is in REGIS, the following ethics approved amendments will be automatically shared with the NSW Research Governance Offices and do not require separate submission to RGO:
- Change to CPI/PI
- Request for an Extension of ethics approval
Amendment requests must include:
- The HREC approval (if HREC is external to REGIS)
- Revised study documents as listed on the HREC approval letter
- For contract revisions, a copy of the updated contract signed by the PI and Sponsor.
Certificates of currency
Commercially sponsored clinical trials require evidence of insurance to be submitted annually. New certificates of currency should be submitted via the relevant milestone in REGIS for one site only. One site can submit this document on behalf of all REGIS sites. If the milestone does not appear in your STE, you do not need to submit this document.
First participant recruitment
The NSW OHMR requires NSW Health sites to collect metrics relating to participant recruitment to commercially sponsored clinical trials.
REGIS will automatically generate a first patient in milestone. Please complete this and detail:
- The date the first participant was recruited, if not within 40 calendar days please provide a brief reason
- If the study has not yet recruited, please provide a brief reason for not reaching the enrolment target.
Safety reporting and serious breaches
Significant Safety Issues and SUSAR/USADE/URSAE safety reports must be submitted in accordance with Safety Reporting Guidelines via REGIS.
The NSW OHMR endorses the NHMRC Safety Reporting Guidance and has published 'Safety Monitoring and Reporting for Clinical Trials Conducted in NSW Public Health Organisations'.
For further details please refer to the OHMR website.
ISLHD RGO require reporting of:
- All Significant Safety Issues (SSI) (See REGIS guide on reporting).
- All SUSARs/USADEs occurring at an ISLHD site (See REGIS guide on reporting).
- Any clinical incidents in accordance with NSW Health Policy Directive PD2020_047
- Serious GCP and/or protocol breaches (see Guideline: NHMRC Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods).
In trials where ISLHD is the sponsor, reporting responsibility is delegated by the ISLHD CE to the Coordinating Principal Investigator or Principal Investigator. It is the responsibility of the CPI/PI to ensure compliance with NHMRC and OHMR policy and guidance. Where the sponsor is another entity, you should seek guidance from that institution. It is likely that the delegation will be to the Principal Investigator.
Please also see the following policies/guidelines for further information:
- Safety Monitoring and Reporting for Clinical Trials Conducted in NSW Public Health Organisations
- Safety Monitoring and Reporting for Clinical Trials
- Risk-based Management and Monitoring of Clinical Trials Involving Therapeutic Goods
- Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods
Research Governance Review Fees
In line with the NSW Health Policy Directive PD2023_015 Fee Schedule for Research Ethics and Governance Review of Clinical Trial Research, ISLHD is required to charge the below fees for Research Governance Review.
| Institution-sponsored Clinical Trials | Non-commercial External sponsor | Commercial External Sponsor | |
| SSA Review | $0 | $1,000 | $4,500 |
| Non-standard contract review | see section 4.6 of the PD | $500 | $2,000 |
| Major Amendment | $0 | $250 | $750 |
| Minor Amendment | $0 | $100 | $325 |
Governance Resources
The Checklist for Site Specific Assessment submissions to the ISLHD Research Governance Officer has been developed to assist investigators in preparing their SSA submission.
Research Protocol – the Research Protocol Template outlines the plan for how a study is run, a well-written and complete protocol is essential for a high quality study, ensures clarity as to what has been ethically approved and will make publishing the results easier.
A Research Budget Template must be completed for research conducted within the ISLHD which involves ISLHD staff, funding, or resources. The Business Rule: Process for Approval of Budgets for Research Projects has been developed to ensure that research projects involving funding or resource implications have the necessary ISLHD approvals in place.
Research policies and guidelines can be found here: www.medicalresearch.nsw.gov.au/policies-guidelines/.