Frequently Asked Questions

Where a researcher wants to use confidential identifiable or potentially re-identifiable health information without the consent of the participant or substitute decision maker (e.g NOK) for research purposes (i.e the HREC has granted a waiver of consent) or an opt out consent process is being used in the research there are two ways that this may occur:

• Approval under Chapter 6 Part 4 of the Public Health Act 2005 (Qld) (“PHA Approval”) OR
• Permission under Section 150 of the Hospital and Health Boards Act 2011 (“Section 150 Permission”)

1.1 Approval under Chapter 6 Part 4 of the Public Health Act 2005 (Qld) (PHA Approval)

• Researchers can apply for the release of confidential information for the purposes of research under s280 Public Health Act 2005 (Qld)
• In assessing applications consideration given to whether the disclosure is in the public interest: s284(2) and (3) Public Health Act 2005 (Qld)
• PHA application form must be signed by any relevant Data Custodian/s and be submitted with a copy of the HREC approval letter and any other supporting documentation to {"ct":"Yx\/PCZIDr2hgO9V1edOt9CcharhCrEKJvLS6v6K0q5k=","iv":"539ad694353f18306284b19e5f2941ef","s":"933ffa1a939c3bba"} for processing
• Further information regarding the PHA approval process can be obtained at the QH Health Innovation, Investment and research office website

1.2 Permission under Section 150 of the Hospital and Health Boards Act 2011

• Section 150 of the Hospital and Health Boards Act 2011 provides that a 'designated person' may disclose 'confidential information' to another 'designated person' if the disclosure is for the purpose of 'evaluating, managing, monitoring or planning health services'.
• If seeking to access data for research under section 150 HHB Act you must
  • State in your cover letter to THHS RG that you are seeking access to data under s150 HHB Act and how the study meets the requirements of this section.
  • Have the SSA Form signed by the relevant Data Custodian/s as a Supporting Department
• Section 150 Permission is NOT available if researchers are external to QH OR where a QH employee is undertaking the project in another capacity (eg University Capacity), as they are not undertaking the study in their capacity as a 'designated person' (defined in s139 HHB Act)

Queensland Civil and Administrative Tribunal (QCAT) defines clinical research as per The Guardianship and Administration Act 2000:

a) medical research intended to diagnose, maintain or treat a condition affecting the participants in the research, or

b) a trial of drugs or techniques involving the carrying out of health care that may include the giving of placebos to some of the participants in the trial.

Where an adult is unable to give consent, and clinical research as per The Guardianship and Administration Act 2000 is being conducted a written application to QCAT must be undertaken.

A comparative assessment of health care already proven to be beneficial to participants is not medical research as defined by the Act and does not need approval by QCAT.

QCAT does not need to be consulted on matters of research where children are the participants.

• Section 2.1.6 of the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) Code on Exposure of Humans to Ionizing Radiation for Research states that a researcher must obtain an independent assessment or verification by a Medical Physicist if the ionizing radiation is additional to routine clinical care and is being conducted specifically and only for research purposes.
• Where a project requires compliance with the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) Code, a physicist report will be required.
• To obtain a THHS radiation safety report email the THHS Senior Medical Physicist Mark Lee: {"ct":"PY9Jglextq3exb6fGyml65XnXQmGcFms2H\/qYYN04qM=","iv":"b823caf407afb58012ab856df235f5ce","s":"71bb96f2a12d731c"} including the protocol and a list of the tests / services require for the research, which are additional to routine patient care (i.e. only those services which are specific to the research).

• All research projects that involve parties outside of Queensland Health require some form of contractual agreement (QH requirement)
• Research agreements are between institutions / organisations and not between individual parties
• The Townsville HHS CE signs all research agreements on behalf of the HHS
• It is recommended you use either :
  • a Standard Medicines Australia Clinical Trial Research Agreement template OR
  • a Standard Medical Technology Association of Australia research agreement template
• If the above templates are not suitable for your study THHS has other Standard Research Collaboration Agreements / Student Research Collaboration Agreement templates, which are available from TRESA Office

Multi-centre research

If your research is taking place in more than one site then you will be applying to each site's Research Governance Officer for Site Specific Approval and you will need to create 'site specific' versions of any master documents (such as PICFs) for each site

5.1 Master document

A master document is one that has been submitted to and approved by a HREC. The master documents serve as a template for the site specific documents that are submitted to the RGO. It contains all the relevant information for each document however it is generic in the sense that it does not contain any logos, branding, local addresses or names. The master document includes a footer with a version number and a date. This version number and date is listed on the approval letter from the HREC.

For a multi-centre research project, only the application and master supporting documents are required to be submitted to the HREC for review and approval. The HREC does not need to review any site specific documents as these are approved by the relevant site's Research Governance Office.

5.2 Site Specific documents

Once the master documents have been approved by the HREC, a copy of the master documents are then sent to the Research Governance Office of each relevant site with a copy of the HREC approval letter and a 'tracked' and 'clean' site specific version of the document the references the master in the footer. The 'tracked' copy should show the changes made to the site specific version.

The site specific document has a footer that includes the Version number and date of the site specific document as well as making reference to the HREC approved master on which this site specific document is based.

If the HREC has previously approved a version of the document, then a 'tracked' and 'clean' copy of the master document should also be submitted so the RGO can easily identify changes made to the previously approved version.

Single site research

When research is taking place at only one site, the master and site specific documents are one and the same. Therefore the supporting documents submitted to the HREC and RGO should contain site identifying information, logos, names etc.

If you can't find a template, document or resource here are some handy hints:

Use the search function

In the top, right-hand corner of our website you will see a blue 'search' function. 

1. Type keywords into the blue search bar
2. Open the page (if you don't want to lose your place, open it in a new tab). Press 'CTRL + F' on your keyboard to open up the search function
3. Type a specific keyword into your browsers search box. Please note: this function will automatically search for an exact match, so one word is best. If there are expandable headings, open a heading, press enter in the browsers search box and hit enter to search the new information presented from expanding the heading.