Research Governance
Research governance is the process to ensure that research conducted is properly accounted for and governed.
- Ethical approval from Far North Queensland Human Research Ethics Committee (HREC) or a recognised NHMRC certified HREC
- Internal review of suitability to conduct research on site
- Financial management, risk management
- Site Specific Assessment application
- Legal issues, contracts, indemnity and insurance
- Compliance with relevant legislation, regulations, guidelines and codes
- Institutional policies and procedures for responsible conduct of research and managing research misconduct
- Management of collaborative research
- Reporting and monitoring requirements
Research Strategy (PDF 770 kB) addresses research priorities, collaboration activity, research capacity building, governance arrangements and the corporate support for research, which will be undertaken in the Torres and Cape Hospital and Health Service (TCHHS).
Research application and approval procedure (PDF 553 kB) provides employees and visitors with consistent processes and accountabilities for the approval of research activities within TCHHS.
Research Ethics and Governance is responsible for consultation, development and review of state-wide research ethics and research governance policies.
Note: Having a HREC clearance letter does not allow you to commence a study on site. You will need an authorisation letter signed by the Health Service Chief Executive before you can commence research.
Requests for clinical health records
Refer to Access to clinical health records for research and clinical audit procedure (PDF 282 kB) should clinical health records (electronic, paper based or hybrid) be sought by staff or researchers.
Ethics Review Management Queensland (ERM Qld) application
What is required for SSA Submission:
Signatures
It is the researchers responsibility to obtain the signatures via email from the Heads of Department in HHS in which the research is being undertaken
|
Follow this diagram
- Valid HREC Approval Letter (from HREC)
- Completed and signed ORIGINAL SSA FORM (drafts not accepted). One complete submission is required for each proposed research site.
- One HARD COPY set of all relevant HREC approved documents for each site(s) ie 2 primary health centres as research facilities requires 2 sets of documentation. This includes a copy of all documents as noted in the HREC approval letter.
- Curriculum Vitaes of investigators who have not submitted one in the last 6 months.
- For researchers who are not solely QH employees a research contract is required.
- Public Health Act (PHA) Approval letter – if applicable: If your research is accessing data/samples WITHOUT patient consent, a PHA approval letter from the Health and Medical Research (HMR) office is required before research authorisation. Complete your PHA application form and obtain the required signatures from the relevant data custodians, prior to submitting your request to Health and Medical Research. To determine the relevant data custodian, refer to the Queensland Department of Health and HHS Data Custodian (PDF 241 kB)
- Ensure that all budget and finance sections of the SSA are completed. If in-kind support is being sought by the Researcher, the estimated value of the in-kind support must be listed and not left as blank. The HHS Chief Financial Officer is required to approve this budget section prior to signing the SSA form.
- Electronic SSA Submission Please remember to submit your SSA online as electronic documents and send the signed hard copies completed SSA's with the submission codes visable on the left hand bottom footer. If the printed SSA has the word DRAFT as a watermark printed across in the background this means you have not yet successfully submitted your SSA online. This DRAFT SSA cannot be accepted. This implies you have not yet successfully locked your SSA on the "online form ". A locked and electronically loaded SSA will have a right footer with an alphanumeric submission code. Eg. AU/14/2B6578
Note: As mentioned above, researchers are required to obtain the relevant signatures and submit hard copy(ies) of completed and signed SSAs. Submitting an application online does not mean it has been sent to the HHS Research Governance Officer. - Parallel Review SSA submission in parallel with HREC submission is acceptable. Online SSA review can be submitted in parallel with a HREC submission. Please remember to submit the HREC approval letter once available with all of the revised approved supporting documentation (one hard copy for each proposed research site to be sent as a hard copy and the other uploaded as electronic documents).
- Schedule of Fees
Additional documents for clinical trials
- Medicines Australia agreements
- Indemnity
- Clinical Trial Notification / Exemption (CTN or CTX) form if applicable.
- Valid insurance certificate - minimum $10 million for liabilities in Queensland
Note: If a non-standard Clinical Trial Agreement is used, it will require external legal review.
Go to Medicines Australia for more information regarding the types of Medicine Australia Clinical Trial Agreement please
All research involving academic institutions or other third parties requires a Research Agreement/Contract.
Contact and submission details
Submit both a hard copy and soft copy of your completed SSA forms and relevant documentation.
| Contact | Email | Post | Phone |
Mrs Rosemary Schmidt Level 9, CITI Link Building | Torres-Cape-Research-Governance@health.qld.gov.au PO Box 5607 | Tel: +61 7 4226 5966 |
Ethics Administrator | Cairns.Ethics@health.qld.gov.au, | Tel: +61 7 4226 5513 |
| Visit the HREC contacts site for other Human Research Ethic Committees | ||
