Human Research Ethics

Streamlined Ethical Review of Multisite Clinical Drug or Device Trials

Southern Health has been accredited and will be a reviewing HREC as part of the introduction of the state wide initiative in Streamlining Ethical Review (SER) of Multi-site Clinical Trials in Victoria from Monday 16 November 2009. The initiative streamlines the ethical review process for multi-site trials, meaning researchers need only apply for one approval rather than separate approvals for each site so that the approval process is expedited.
 
If you are unsure whether your project falls within SER, please call the Research Directorate on (03) 9594 4605 to discuss.
 
If your project does not fall into this category, please apply for ethics review using the normal process as indicated below.
 
If your project does fall into the new SER scheme, there are several steps to follow: click here 
 
There is a new fee structure with projects falling in this category: see the new fees

 

Other projects not covered by the Streamlined Ethical Review Process

Please follow normal processes as indicated below.

The following two committees are constituted in accordance with the National Statement on Ethical Conduct in Human Research:

Southern Health Human Research Ethics Committee A

This Committee will review projects that relate to the following programs and program areas:

  • General Medical
  • Respiratory and Sleep Medicine
  • Gastroenterology
  • Emergency Medicine
  • Medical Oncology
  • Palliative Care
  • Critical Care (ICU, Anaesthetic, Theatre)
  • Mental Health
  • Rehabilitation and Aged Services Program
  • Other Special Medicine

Meeting and submission cut-off dates for HREC A 2010

Southern Health Human Research Ethics Committee B

This Committee shall review projects that relate to the following program areas:

  • Allied Health
  • Nursing
  • Primary Care
  • Speciality Program (Cardiology, Cardio-thoracic, Neurology, Neurosurgery, Nephrology)
  • Surgery Program (General Surgery, Gastrointestinal, Orthopaedic, Plastic Surgery, Vascular, Urology, Ophthalmology, ENT, Other Surgical)
  • Women's and Children's Program
  • Other (ie Projects from PHI and Jean Hailes)

Meeting and submission cut-off dates for HREC B 2010

 Application Forms

Site Specific Requirements

Instructions for research applicants

Low Risk Projects Review Process

In accordance with the National Statement on Ethical Conduct in Human Research (NHMRC 2007), all minimal or low risk research will be reviewed by a Low Risk Review Panel. Low risk applications are referred to two (2) HREC members for detailed review. Any questions raised by the reviewers will be referred back to the investigator and the responses will be checked reviewed by the designated HREC members. Approval will be ratified at the HREC meeting. Low risk applications can include:

  • Questionnaire studies that do not involve:
    • personally intrusive questions
    • a major time commitment from staff and/or patients
    • plans to publish information that could potentially identify specific individuals.
  • Most student projects involving data collection (by questionnaires or from records) from small numbers of patients
  • Some quality assurance projects - particularly those involving minor privacy concerns
  • Clinical research projects involving patient record review

 Quality Assurance Proposals

Please see the following documents:
 

 

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