Research Governance authorisation is required for all Queensland Health sites for any research project. Research Governance is the review of research projects and requests involving Mackay Hospital and Health Service (MHHS), within this review the Research Governance Officer (RGO) aims to evaluate project risk for the HHS, legal requirements and accountabilities, policy and procedure implications, logistics, resourcing, feasibility and beneficence to the HHS and the community. In order to fulfill the requirements of the MHHS research governance review please refer to the MHHS Research Governance and Ethics Checklist along with the relevant quick reference guide (QRG) and the below tips for the application process and conducting Research within Queensland Health.
In order to conduct a research project at a Queensland Health site there are a number of approvals required prior to commencing your study:
- Human Research Ethics Committee Approval and/or endorsement depending on your study.
- Public Health Act approval if you are collecting confidential information without consent dependant on the study outline.
- Site Governance Authorisation – this is required for each site or Hospital and Health Service you wish to include in your project.
- If any additional approvals or documentation is required Site Governance will advise.
All Researchers must submit to a certified HREC for approval and/or endorsement, the pathways vary for Research and Non-Research projects, please contact Quality Improvement for all projects deemed Non-Research by a HREC. MHHS Quality Improvement team can be contacted via phone on 07 4885 7506 or emailed MHHS-Quality@health.qld.gov.au
When submitting to an Ethics Committee please refer to the list of NHMRC Certified HREC’s, Townsville Hospital and Health Service HREC have partnered with MIRI to assist Researcher’s from Mackay and surrounds on building capability, research development and support.
Other avenues to consider when thinking about doing Research may include:
- Pathology Queensland for any sample testing or existing data possibly.
- ARPANSA (Australian Radiation Protection and Nuclear Safety Agency
- Public Health Act approvals for the access confidential information without consent, contact PHA@health.qld.gov.au
- Queensland Civil and Administrative Tribunal may need to be considered, to assist in determining their involvement he is a fact sheet outlining their purpose.
Resources to review prior to submitting your Human Research Ethics Application (HREA) include:
- The HREA How To Guide – for a comprehensive look into the HREA and completing the form as required.
- The Australian Code for the Responsible Conduct of Research
- The Queensland Health Code of Conduct for all public service employees.
- Complete Good Clinical Practice (GCP) in order to supply the completion certificate with the SSA Application (see ‘Application Tips’ below for links)
Before logging into the Online Forms site, you need to have completed your Project documentation and plan in full. Ensure you have had peer review or have recruited a Supervisor/Advisor or contact MIRI@health.qld.gov.au for assistance and pathways to networks for additional support internal or external to Mackay Hospital and Health Service. However, to further assist with the documentation to supply in addition to completing the HREA refer to the MHHS Ethics & SSA Checklist.
Once all of the above has be reviewed and made reference to next steps include:
- Create an account or logon to online forms to begin completing your HREA and upload your supporting documents.
- Generate a submission code under the Submission tab (e.g. AU/11/111A111) on the online forms website to finalise your application form.
- Electronically sign though preferred method at the moment is to print the final copy of application form and obtain all necessary signatures including Associate Investigators, Head of Department endorsement, Operation Director authorisation and possibly Business Manager support depending on the requirements of the project.
- Ensure the number of hard copies are completed, printed, signed and submitted to the HREC, an electronic copy emailed to the HREC to advise your applications anticipated arrival is good measure along with ensuring meeting the deadline for submissions to be reviewed at the next Committee Meeting.
Research Project Documentation, planning and Support is key to a successful Research Project’s completion.
Concurrent to the submission of your HREA, a Site Specific Assessment (SSA) Application can be submitted via the Online Forms website. An SSA can be generated and have sections auto-populate from the HREA to save time with double entry.
When completing your SSA please ensure the following have been addressed for this site before submitting:
- All documentation has the Version Number, Documents Title and Date clearly outlined on every document.
- Any site specific versions are also clearly labelled with the version number and date.
- The Budget – ‘in-kind’ support or direct costs are outlined clearly for the site, along with any resourcing necessary to complete the project. Please utilise the MHHS Budget Template as a tool to assist as even ‘in-kind’ costs need to be clearly outlined.
- Once the content of the form has been completed and the documents uploaded, generate a submission code and print the form for signature collection.
When your application looks to be complete as per the MHHS Ethics & RGO Checklist please email or submit a hard copy to MKY-RGO@health.qld.gov.au or Post to:
Mackay Hospital and Health Service
Mackay Institute of Research and Innovation
PO Box 5580
Mackay MC QLD 4740
NOTE: Your application is not considered Valid until all documentation and HREC Approval is received. Once authorisation has been granted The Research Governance Officer will provide you a letter of authorisation.
- Review the NHMRC National Statement to understand the purpose, scope and the values and principles the HREC will apply to your research.
- Review and follow the HREC specifications as outlined on their website and if unsure contact the HREC Coordinator for assistance.
- Complete for GCP Training, MHHS recommend a number of online courses (free and payable) https://gcp.nidatraining.org/ & http://www.transceleratebiopharmainc.com/?s=GCP, however if your project is Sponsored the appropriate course is identified by the sponsor.
- Visit the Library for a full and comprehensive Literature Review, your Librarian an expert when searching for relevant literature for your literature review.
- Follow the checklist provided to the right MHHS Research Governance & Ethics Application Checklist for a guide to documents for inclusion in your applications.
- After completing the Ethics Application form, you can start completing the Site Specific Application form under the SSA tab on the Online Forms website in preparation for the SSA submission. Hint: Tick the Auto Load option to auto fill the SSA form from the Ethics form.
- Follow the guidelines included in the Researcher User Guide (RUG)(PDF, 169KB)
Complaints and suspected Research Misconduct
If you have concerns about possible research misconduct, please contact firstname.lastname@example.org. Your concerns will be treated confidentially.