Human Research Ethics
Human Research Ethics
At Mater Health Services, ethics approval is a two-tier process, with applications being reviewed by the Scientific Advisory Committee (SAC) before being referred to HREC for final ethical review. Please note that researchers external to Mater Health Services are required to appoint a Mater sponsor.
See HREC Terms of Reference
See HREC Composition
The HREC reviews studies submitted by each closing date. The Committee meets monthly except in January (see Calendar for 2011 and 2012). Studies will only proceed to the HREC for review if they are considered to be scientifically sound by the SAC. HREC review processes are available depending on the level of risk participants may be exposed to as a result of their participation in the research. Regular committee meetings deal with research that is more than low risk.
For low or negligible risk projects, Mater HREC will review the project proposal upon completion of the low and negligible risk application form.
Under exceptional circumstances (e.g. matter of public policy, urgent threat to public health and in national interest), a submission for expedited approval may be made through the Ethics Coordinator to the HREC Chairperson or Deputy Chairperson.
Institutions may also determine that some human research is exempt from ethical review. Research is exempted from review only in accordance with the criteria that it is negligible risk research and involves the use of existing collections of data or records that contain only non-identifiable data about humans. For further clarification see the National Statement 5.1.2.2 and 5.1.2.3.
Human Research Ethics Submissions
For low or negligible risk projects, or to seek exemption from ethical review, the HREC will review the project proposal upon completion of the low and negligible risk application form. For all research that is more than low risk, researchers will need to complete and submit a full NEAF form to a fully constituted HREC for review and approval.
All documents submitted for meetings are required on electronic media (email, CD, DVD, USB). In addition, five hard copy sets are required for new submissions, or three hard copy sets for amendments to existing studies or low and negligible risk applications.
Please see the documents entitled Electronic Submission letter and Minimum requirements for research ethics and governance proposals for details on how to submit your application at Mater.
Progress Reports
It is a condition of ethics approval at Mater Health Services that researchers submit a progress report on an annual basis to inform the HREC and the Research Governance Officer of the status of their project including progress to date, recruitment, data management, funding, safety information and compliance with the approved protocol. Researchers must also inform the HREC of publications, presentations at conferences, education and quality improvement outcomes from this study. If the project was authorised by a certified HREC at another institution, the progress reporting requirements of the authorising HREC must be followed, and a copy of the report must be submitted to Mater Health Services Research Governance Officer.
Progress reports should be submitted on the anniversary date of ethics approval. The ethics approval should be renewed for the next year upon receipt of a satisfactory report. The HREC may choose to conduct an interim audit of the research.
Reporting of Adverse Events Relating to Research
The HREC requires as a condition of approval of each project that researchers report Serious Adverse Events (SAE, as defined by the TGA) and other Adverse Events to the HREC and Research Governance Officer.
Documents to complete for Adverse Event reporting at Mater Health Services are available on the Useful Links section.
For all studies, please refer to the table of requirements for adverse event reporting to HRECs by investigators from the NHMRC Australian Health Ethics Committee (AHEC) Position Statement: Monitoring and reporting of safety for clinical trials involving therapeutic products (May 2009).
Single-site studies
As a condition of ethics approval for research, the Principal Investigator must immediately report to the Mater Health Services HREC anything that might warrant review of the approval of the study, including serious and unexpected adverse events (SAEs, SUSARS, SUDRs). Such events must be reported to the HREC in the specified format, and review outcomes should be forwarded by the Principal Investigator to the Research Governance Officer.
The Principal Investigator must capture and report adverse events in accordance with the protocol, and HREC and institutional requirements. SAEs must be reported to the sponsor within 24 hours of finding out about the SAE, in accordance with the study protocol and GCP guidelines as adopted by the TGA.
Multi-centre studies
For multi-centre studies, the Mater Principal Investigator must send all AE & SAE reports as per the NHMRC AHEC Position Statement: Monitoring and reporting of safety for clinical trials involving therapeutic products (May 2009) to the Coordinating Principal Investigator who will collate and submit these to the approving HREC for review.
In the instance of commercially sponsored clinical trials, the Clinical Research Associate may be involved in this communication. A copy of the report must also be sent to the Research Governance Officer.
Contact
HREC Coordinator
Room 51 Level 3, Quarters Building
Annerley Road
Woolloongabba Qld 4102
Phone: 07 3163 2392
Fax: 07 3163 1571
E-mail: research.ethics@mmri.mater.org.au