All CHQ research requires completion of a Site-Specific Assessment (SSA) at each participating site to determine the level of support and suitability of a research study to be conducted and completed at a site, whether that study is multi-centre or single-site.

The outcomes of the HREC review and SSA together make up the final documentation that is provided to the Health Service Chief Executive or authorised delegate (CHQHHS Director of Research). These documents collectively allow for consideration of all aspects of the research study governance arrangements and will assist in the decision on granting authorisation to conduct the research at the site. Research cannot be commenced at a site until the Governance Authorisation has been granted.

Research Governance is a framework through which Children’s Health Queensland Hospital and Health Service is accountable for the research it authorises to be conducted within any one of its facilities.

The following information applies to all research projects conducted at or by Children’s Health Queensland, irrespective of whether the Children’s Health Queensland Human Research Ethics Committee (HREC) has provided ethical review for the project.
Complete the following steps.

SSA submission must include

• Cover letter or Checklist
• Completed budget
• Please provide a brief summary of the study and the involvement of CHQ for SSA submission and itemise all documentation submitted.
• Site Specific Assessment Form available on the ERM website. Please ensure all information is completed.
• Please note CHQ Site Principal Investigator must be a CHQ employee.

Other documents

• Research Agreement/Contract as applicable.
• HREC Clearance/Approval from a NHMRC certified paediatric public hospital HREC
• For Non-CHQ HREC approved studies, please supply a copy of the NEAF/Protocol, Master PICF and any other study documents
• Copy of signed Quotes for service providers such as Pharmacy, Pathology and Radiology Services
• One copy of all Site Specific documentation.
  • All Site Specific Participant Information and Consent Forms require the following information in the footer of the document:
  • Master Version X approved XX/XX/XXXX by XXXXX HREC
  • CHQHHS Site Specific version X dated XX/XX/XXXX.

You may need to include the following depending on your project:

• Health Support Queensland (HSQ) pathology or coronial material approval
• Researchers seeking access to HSQ resources (e.g. data, equipment, biological materials, tissue blocks and slides, etc) are required to seek approval from the relevant Senior Branch Director.
• Research Study Radiation Dose and Risk Assessment
• Research that involves radiology requires the review and support from the relevant Director. A copy of the report is to be submitted with the SSA.
• Public Health Act 2005 (PHA) approval
• This is required where confidential patient medical information is to be obtained without consent. Please contact the relevant data custodian and complete the PHA Application Form. Please ensure that when your PHA approval is received it is immediately forwarded to CHQ_RGO@health.qld.gov.au

No hard copy submissions are required. All SSA submissions should be made via the ERM website
Contact details for RGO office:
Research Governance Office
Level 7, Centre for Children’s Health Research
62 Graham Street
South Brisbane QLD 4101
CHQ_RGO@health.qld.gov.au

We strongly encourage parallel submission of your SSA and Ethics documents.
Research Governance Documents Checklist

Any amendments or additions to study documents post authorisation must be submitted for Research Governance Office review.

If the approving HREC is CHQ HREC, you only required to upload a copy of HREC approval letter in the ERM under the SSA Post Authorisation Notification.

If the approving HREC is non CHQ HREC, upload a copy of HREC approval letter and all documents approved by the HREC (both track and clean version)

Agreements: Please note, amendments may have contractual implications. Contact CHQ Research Governance Office to discuss the agreement requirements.

General Amendments: Any amendments to study documentation approved by the HREC must be submitted to CHQ Research Governance Office via ERM with a copy of covering letter explaining the rationale for Governance acknowledgement before use of the documents at CHQ.

Change/Additional Personnel:

• Any changes or updates to Research Personnel (including students, research nurses etc) accessing CHQ data or facilities must be notified to the Research Governance office via ERM with appropriate HREC approval as required. (Please note this requirement may differ across HREC’s)
• Upload the CVs if the study has been approved by non-CHQ HREC
• CHQ Site Principal Investigator must be a CHQ employee

Safety Reports: Any safety Reports relating to CHQ must be notified to CHQ Research Governance Office with appropriate HREC approval as required. (Please note this requirement may differ across HREC’s)

Annual Reports: Submit a copy of Annual Report and relevant HREC approval letter in ERM

Insurance Certificates: Submit a copy of up to date Insurance Certificate in ERM before expiry of current Certificate

Commencement Forms: Email a copy of your study commencement form to CHQ_RGO@health.qld.gov.au.

Making an accurate determination of the type of data you will be working with is vital to planning your research. The following distinctions will impact the level of risk your research carries and as such may impact on your need to complete a LNR or NEAF for ethics approval.

Identifiable data

When the identity of a specific individual can reasonably be ascertained the data is referred to as “identifiable data”. Examples of identifiers may include:

• Name.
• Date of birth.
• Address.
• Postcode (particularly small sets of data or small districts).

Non-identifiable data

“Non-identifiable data” includes the following:

• Data that has never been labelled with individual identifiers.
• Data that has had the identifiers permanently removed in such a way as to ensure no specific individual can be identified.

It should be recognised that the terms “non-identifiable” and “de-identifiable” are used frequently to refer to sets of data from which only names have been removed. Such data may remain “potentially identifiable” and requires further safeguards to become truly non-identifiable.

Re-identifiable data (potentially identifiable data)

Data may have identifiers removed and replaced by a code (including but not limited to UR numbers). In such cases it is possible to use the code to re-identify the person to whom the data relates. In these cases the data are referred to as “potentially identifiable”.

Access to health information for the purposes of research should obtain consent from the participants involved in the study. However, when consent will not be obtained, or is not viable (i.e. retrospective) then two legislative requirements can occur:

• Approval under Chapter 6 Part 4 of the Public Health Act 2005 or,
• Permissions under Section 150 of the Hospital and Health Boards Act 2011.

Only the Human Research Ethics Committee can grant waiver of consent, and the research must be no more than low risk. Full guidelines for waiving consent are available in Section 2.3 Qualifying or Waiving Conditions for Consent of the National Statement on Ethical Conduct in Human Research (2007).

Information regarding release of confidential health information for the purposes of research under Section 280 of the Public Health Act 2005 (PHA approval) and the application form is online. Research using identifiable or potentially re-identifiable health information for which the researchers are unable to obtain participant consent to use their personal or identifying information for a clearly specified research The application for PHA approval can only occur after researchers have obtained HREC approval.

The Hospital and Health Boards Act 2011 relates to giving information to another person. If information is used without being given to another person, it does not apply. For example, a health practitioner may collect personal information for the purpose of health service delivery and then decide at a later date to contact the person themselves and invite them to be part of a discussion group for the condition.

Release of data under Section 150 of the HHB Act can only occur if the person releasing the data is a ‘designated person’ and the disclosure is to another ‘designated person’ for evaluating, managing, monitoring or planning health service. Please refer to Section 139A of the HHB Act for a definition of a ‘designated person’ but generally this means both persons must be Qld Health employees.

Legal agreements

A study agreement is required when your research involves but not limited to:

• CHQ premises, staff, resources or patients and at least one other external institution
• When CHQ is sharing identifiable or non-identifiable data or materials
• When the research involves students including those undertaken as part of a higher degree

Children’s Health Queensland uses Medicines Australia’s Clinical Trial Research Agreements (CTRA) as mandatory for all industry sponsored and contract research organisation sponsored clinical studies conducted within its facilities.

Please submit all contracts, agreements and indemnities electronically to CHQ_RGO@health.qld.gov.au for review and approval prior to obtaining signatures.

When obtaining signatures for the contract/agreement/indemnity, only the Children’s Health Queensland Chief Executive or delegated (CHQHHS Director of Research) authority can authorise an agreement upon receiving recommendation from the Research Governance Office.

It is important that the correct legal entity is included exactly as outlined below on both the cover page of the contract/agreement, signature page and any other legal agreements such as indemnification forms.

Institution

Children’s Health Queensland Hospital and Health Service
ABN:
62 254 746 464
Address:
Queensland Children’s Hospital, 501 Stanley Street, South Brisbane QLD 4101
Switchboard:
3068 1111

Contact for Notifications

Research Governance Office
t: (07) 3069 7008
f: (07) 3069 7419

• Clinical Trial Research Agreement (CTRA) Standard Form – used when clinical trials are industry sponsored, the parties are the Children’s Health Hospital and Health Service and a company.
• Clinical Trial Agreement Collaborative or Cooperative Research Group Studies – used for other research activity such as collaborative research projects with non-profit organisations including nongovernment organisations, universities or CSIRO.
• Clinical Trial Research Agreement – Phase VI Clinical Trial (Medicine) – used for Clinical Trials when the research activity is at post marketing phase, i.e. clinical investigation is conducted after satisfying the pre-market regulatory requirements, with the focus being to collect additional clinical data to assess a variety of endpoints, such as long-term performance and safety, health economics, etc.
• MTAA Standard Clinical Investigation Research Agreement – used for commercially sponsored studies of medical technology, when the parties are Children’s Health Queensland Hospital and Health Service and a commercial sponsor.

Research undertaken by a university employee or student requires an agreement between Children’s Health Queensland Hospital and Health Service via (the name of the relevant institution/facility) and the relevant university.
If you are a university employee or student, please contact your institution’s legal representative to request a contractual arrangement:

• University of Queensland
  Faculty of Medicine
  e: med.rpms@uq.edu.au
  Faculty of Health and Behavioural Sciences
  e: habs.researchcontract@uq.edu.au
• Queensland University of Technology
  e: ors.contracts@qut.edu.au
  t: (07) 3138 1533
• Griffith University
  e: research-contracts@griffith.edu.au
  t: (07) 3735 4105
• Mater
  e: research-agreements@mater.uq.edu.au

Where a sponsor or collaborative group requires the Children’s Health Queensland Hospital and Health Service to enter into a Confidentiality Disclosure Agreement, these documents should first be forwarded to the Principal Investigator for review and confirmation of the terms of the agreement.

Confidentiality Disclosure Agreements are made between the external organisation and Children’s Health Queensland Hospital Health Service.

The Children’s Health Queensland Chief Executive or delegated (CHQHHS Director of Research) must sign the CDA before any information is disclosed to sponsor.

An indemnity is a contractual promise by one party to the other party from and against certain specific actions, claims or losses.
Commercial sponsors proposing to engage in clinical trials or other research must provide indemnification by using the Medicines Australia Standard Form of Indemnity for Clinical Trials.

Research that is not commercially sponsored and involves collaboration with an external organisation must also provide assurances of indemnity. Where appropriate, this may be included within the Research Agreement.

A current public/products liability certificate of insurance from the commercial sponsor must be provided before final approval for the research proposal can be given. It must name the insured corporate entity acting as the commercial sponsor.