Site authorisation

Site authorisation

Access requests

An access request is available to projects that only involve:

  • Recruiting participants through posters, leaflets, handouts, and letter of invitation but not recruitment through direct contact with potential participants or enrolment at SCHN.
  • Distributing surveys and questionnaires through staff of the SCHN but not collating and/or analysing responses at SCHN.

Final determination if the project is an access request will be decided by SCHN Research Governance.

Please contact the Research Governance Office if you believe your project is eligible to be reviewed under the access request pathway.

Site Specific Assessment (SSA) applications are required for any research project to commence at an SCHN site. Ethics approval is required before site authorisation can be granted.

All site authorisation applications to the SCHN Research Governance Office must be submitted via REGIS. REGIS offers users a variety of Quick Reference Guides (QRGs) and instructional videos to support in making submissions.

Please use the information below to ensure the success of your application at SCHN.

How to submit a Governance application

Please note if you are undertaking a clinical trial in which SCHN is the nominated sponsor, please review our sponsorship page before submitting a Governance application.

Creation of a Governance application in REGIS

When a Governance application is created on REGIS, an STE reference number is generated specific for your project. An STE reference number should look like 20XX/STEXXXXX.

Please note, that due to cybersecurity and privacy requirements, SCHN only accepts institution email addresses (e.g. @health.nsw.gov.au, @university.edu.au, @institute.org.au) rather than personal email addresses (e.g. @gmail.com) for the registration of REGIS accounts.

Ethics approval was through REGIS

For research projects that were granted Ethics approval through REGIS (e.g. a HREC in NSW), the SSA is generated automatically.

Ethics approval was not through REGIS

If a research project was granted Ethics approval from a HREC not through REGIS, a project registration must be completed before the SSA is generated. It is important to check if the Ethics approval was provided by a HREC accredited under the National Mutual Acceptance (NMA) Scheme. Ethics approval from a NMA accredited HREC can be accepted by Research Governance Offices across Australia. The list of NMA accredited HRECs can be found on the NHMRC website, under 'National Mutual Acceptance Scheme'.

Organise the mandatory pre-submission meeting

The pre-submission meeting is an informal, high-level overview of your project. It aims to identify any potential issues that may cause delays in the review process of an application. The SSA that has not had a pre-submission meeting will be deemed ineligible for review.

Please email the Research Governance Office to book an appointment for a pre-submission meeting before submitting your SSA in REGIS. Ensure you include the following information in the email:

  • REGIS STE reference number
  • 3 preferred meeting dates/times

Available days are Mondays, Wednesdays, and Thursdays.

It is recommended that the Principal Investigator (PI) attends this meeting.

Before completing the application

Contractual agreements

It is important to discuss any contractual agreements (excluding Clinical Trial Research Agreement) with the Research Governance Office before submitting the SSA. This is because contract negotiations can delay the authorisation of a research project.

See more on our contracts and agreements page.

Use of X-rays, Dexa or CT scans

If the research project involves the use of X-rays, Dexa or CT scans, please review radiation safety assessments before submitting the SSA.

Unapproved therapeutic good/device

If the research project involves an unapproved therapeutic good/device, please review the following information:

For externally sponsored clinical trials (commercial or collaborative group):

  • It is the responsibility of the sponsor to draft and submit the Clinical trial Notification/Clinical Trial approval (CTN/CTA).
  • To assist sponsors with completing their CTN/CTA form, please see our SCHN TGA CTN/CTA factsheet containing SCHN site details.
  • Once the SSA receives site authorisation, the sponsor will then submit the CTN/CTA electronically to the Therapeutic Goods Administration (TGA).

For internally sponsored clinical trials where the sponsor will be SCHN (investigator initiated or collaborative group), please see our sponsorship page.

Genetically Modified Organisms (GMOs)

If the research project involves the use of GMOs, approval by an accredited Institutional Biosafety Committee (IBC) is required.

Please visit the Office of the Gene Technology Regulator (OGTR) website for more information and please contact the Research Governance Office via email.

Completing the application

The following information is designed specifically for the SSA submitted to SCHN and will also assist with an efficient SCHN Research Governance review process.

Part B: Site team members

If there are site team members who are not SCHN staff, they will require SCHN Contingent Worker Approval.

Part C: Departments and services

Any departments who are supporting study activities must be included as a Supporting Department. See more information under Head of Department approval and support.

If the research requires access to medical records, approval from the Head of Department of the SCHN Health Information Unit is needed. See more information under medical record access.

Part D: Recruitment, records, tissue and data

Retrospective only studies can answer 'no' to both questions in this section.

If the study involves recruitment/enrolment at SCHN of participants that are 16, will turn 16 during the study or over 16, an Age of Admission Exemption may be required.

If the study is a clinical trial and involves recruitment/enrolment at SCHN of participants that are 16, will turn 16 during the study or over 16, do not have the capacity to provide informed consent, SCHN Research Governance requires NSW Civil and Administrative Tribunal (NCAT) approval.

Part F: Attachments

The SSA will be deemed ineligible if it does not have all necessary documentation attached. Please ensure the following are attached to the application:

Contact Heads of Department

When submitting a new SSA in REGIS an automated email is sent to each Head of Department (that was nominated in Part C) for approval. The Research Governance Office will receive the SSA application only after all Heads of Department have provided approval.

Hence, it is recommended that Heads of Department are made aware of the research project before submitting the SSA so that they are ready to action the automated REGIS email when it is received.

Often this process is what causes delays in the review of applications.

Please use the REGIS Quick Reference Guide Applicants – Site Application – Completing, Requesting Support and Submitting to check which Head of Department approval is outstanding (at the bottom of page 3).

Eligibility assessment

After an SSA has received approval from all nominated Heads of Department it will be received by the Research Governance Office to determine if it is eligible or ineligible for review.

When an application is ineligible

Before you resubmit the SSA, please follow the instructions outlined on the ineligibility email. Resubmitting the SSA does not require re-approval from nominated Head of Departments and the SSA will be re-submitted directly to the Research Governance Office for another eligibility assessment.

When an application is eligible

The eligible SSA will be assigned to a SCHN Research Governance Officer who will conduct a review of the study. If any further information is required, a Request for Further Information (RFI) email will be sent.

Application review and authorisation

Request for Further Information

A Request for Further Information (RFI) is an email from the SCHN Research Governance Officer reviewing your site application. This email will state the necessary information or actions required before site authorisation can be granted. At this stage of the review, the SSA is returned to the research team where they will have 30 days to compile a response to the RFI.

To ensure the response to an RFI is reviewed as quickly as possible:

  • Please follow the ‘General Reminders’ at the bottom of the RFI letter (attached to the email sent via REGIS).
  • Include a clean and tracked version of any updated documents.
  • Send any queries about the RFI to the reviewing Research Governance Officer.
  • Please do not resubmit your application until all queries in the RFI have been resolved.

Please note that if the RFI response is not submitted within 30 days of receiving the RFI email, your SSA will be withdrawn on REGIS and a new SSA submission will be required. Please contact the Research Governance Office via email if you require a new SSA submission.

Site authorisation

Site authorisation is granted when a Research Governance Authorisation Letter has been issued. Authorisation may be granted with conditions, so please follow any conditions listed on the letter.

Contingent Worker Approval - approval for non-SCHN research personnel

Any non-SCHN personnel (including students), who will:

  • Conduct study activity on a SCHN site or;
  • Access SCHN patients’ identifiable information or;
  • Have face-to-face contact with SCHN patients, families and staff,

Will require Contingent Worker Clearance Approval from SCHN Workforce.

To obtain this approval please contact SCHN Workforce Services via email or via phone 7825 3547.

The Research Governance Office will require evidence of this approval before the researcher/s can be authorised to be a part of the SCHN aspect of the study.

Head of Department approval and support

Please use the following information as a guide on which Heads of Department need to be added in Part C of the SSA form:

  • The Principal Investigator’s (PI) head of department.
  • All listed Sub-Investigators/Associate Investigators departments (if this is different to the PIs’ department).
    • Please note an alternative approval is required if the listed investigator is also listed as a head of department. This alternative approval will be the individual the investigator reports to. If you cannot locate the alternative approval representative on REGIS, please contact the Research Governance Office via email for further assistance.
  • All departments that will assist in procedures that are additional to standard of care (e.g. Echocardiogram tests will require approval from the Cardiology Department and Magnetic Resonance Imaging (MRI) scans will require approval from the Medical Imaging Department).
  • The Pharmacy Department if study involves dispensing of drug/s.
  • The Pathology Department if study requires sample collection, processing and/or testing.

It is highly recommended that you discuss your research project with all relevant supporting Head of Department/s before you submit you application in REGIS.

Medical records access

Any research that needs/has access to the Medical Record must receive approval from the Head of Department of the SCHN Health Information Unit (HIU – SCHN data custodian).

To obtain approval from the HIU, please complete the following steps:

  1. Add HIU to Part C of your SSA form on REGIS.
  2. Contact the HIU Head of Department via email. Your email must answer the following questions (even if the information is in the protocol and HREA):
    • What is your REGIS SSA reference number? (e.g. 20XX/STEXXXXX)
    • Is your research for The Children’s Hospital at Westmead or the Sydney Children’s Hospital, Randwick, data or for both (The Sydney Children’s Hospitals Network)?
    • What kind of data are you collecting?
    • How much data will you collect?
    • How will your data be stored?
    • Is the data identifiable or de-identifiable?
    • Who can access the data?

Please note that SCHN branded USBs should only be used for information sharing if required. To obtain a SCHN branded USB contact the HIU Head of Department. Data as part of your project cannot be reused without approval from an appropriate HREC.

Radiation safety assessment

Research that involves the use of ionising radiation for any purpose (standard of care or additional to standard of care) requires a completed radiation safety assessment form. Please ensure the below forms are completed and approved by the relevant Radiation Safety Officer before you submit your Research Governance application. Please ensure the radiation statement/s in your site specific documents are also represented appropriately.

Note for The Children’s Hospital at Westmead (CHW) applications

There is a fee of $250.00 per report associated with the generation of these reports as an external consultant is required. Please allow up to 1 month for the review and generation of a radiation dosimetry report from the date of your submission. If the report needs an independent review due to exceeding dose constraints, please allow for additional time. The following documents listed below must be submitted with this request form. The request will not be processed until all relevant documents are received:

  • Study protocol
  • Imaging manual (if available)
  • Medical physicist radiation report from the lead site (if CHW is not the lead site)
  • Participant and Information Consent Forms (PICFs)

Age of Admission Exception - recruitment of participants over 16

An Age of Admission Exemption may be required if participants are equal or greater than (≥) 16 years of age during the conduct of the research project. This includes when participants turn ≥ 16 years of age in the duration of the research project.

Please note that the Age of Admission Exemption only applies to participant enrolment at SCHN sites. See more information on SCHN Age of Admission/Treatment Policy or contact the Research Governance Office.

The purpose of this exemption is to ensure that participants in your research project have the proper arrangements in place for study visits, clinical care and a transition plan to adult care.

NSW Civil and Administrative Tribunal - inability to consent

NSW Civil and Administrative Tribunal (NCAT) approval is required only for clinical trials involving participants who are equal or greater than (≥) 16 years of age and do not have the capacity to provide informed consent during the conduct of the clinical trial.

Please visit the NCAT website for further information.

The Research Governance Office will require evidence of NCAT approval for site authorisation.

Site specific documentation

A site specific document is a separate document where the general study document approved by the HREC (usually referred to as the 'master' version) has been amended to include details specific to the particular site.

Please note that if a master document has sections in it that require site specific information (e.g. [Insert site name]/[site contact details]) a separate document (the site specific version) will be required.

All SCHN site specific documents may include the following:

  • Appropriate SCHN site logo (e.g. SCHN logo)
  • SCHN Research Governance Office contact details
  • The site Principal Investigator contact details (email and phone number)
  • The footer must include the site version and master version (e.g. CHW flyer version 1.0 dated 30 August 2023 based on Master flyer version 2.0 dated 21 July 2023)
  • The filename should reflect the site specific version and date (e.g. CHW flyer_v1_300823)
  • A tracked change version and a clean version of the site specific document/s should be uploaded as part of your application
Last updated Wednesday 15th May 2024