Review of Projects

How the process works

1. The Human Research Ethics Committee (HREC) meets on a Wednesday each month usually the 3^rd Wednesday). There is no meeting in January. Proposals for new projects must be lodged with the Office of the Research Directorate no later than 4.00pm on the Wednesday – 14 calendar days before the meeting. Researchers are encouraged to submit proposals as early as possible. This will enable the detection of any problems that may delay approval.
   
   
2. Submission of a new research project by the 4:00 pm deadline is not a guarantee that a project will be accepted for review by the HREC at its next meeting.
   Following the submission deadline each month, all projects received will be carefully checked using the HREC New Project Checklist to ensure that projects meet the criteria required to allow a thorough review of the project.  Any project not meeting these criteria in full will not be accepted for review at the next HREC meeting and will be returned to the principal researcher for attention.  A copy of the HREC New Project Submission Checklist will be provided with returned submissions.
   
   
3. Applications (including the form itself) must be typed. The forms and guidelines can be downloaded from the HREC Application Forms and Guidelines page of this website. 
   
   
4. For projects initiated outside Melbourne or Western Health, a senior staff member of the relevant Health Service should be included as a co-researcher. If this is not possible, a member of the senior medical staff must be appointed as 'sponsor' of the project and must sign a Statement of Approval Form in this regard.
   
   
5. HREC approval of a project is generally valid for three years from project commencement.  After three years, a new application should be submitted. It is the principal researcher's responsibility to advise the HREC of project commencement and completion dates.  Requests for HREC approval of more than 3 years’ duration must be specifically justified, in writing, by the principal researcher to the HREC.
   
   
6. All projects approved by HREC are subject to an 'Annual Audit of Research Projects'. Letters requesting a progress report are sent out annually.
   
   
7. As each new project is received, it is allocated two Spokespersons from amongst suitably qualified members of the HREC. It is the spokespersons' responsibility to thoroughly review a project before a meeting and present the project to the rest of the HREC at the meeting. The “Scientific” spokesperson is a clinician or scientist, with relevant research expertise, who is responsible for assessing the scientific merit, safety and statistical aspects (where relevant) of a project. The”Ethics“ Spokesperson is a member of the HREC with no clinical or scientific background. It is their responsibility to review the ethical aspects of the project - consent process, plain language statement, questionnaires, etc.  Many projects are also referred to external consultants for expert statistical review.
    
   The spokespersons may contact the principal researcher prior to the meeting to clarify aspects of a project.  Additionally, the HREC may seek independent expert scientific and/or ethical advice in relation to any given project, if this is deemed necessary.
   
   
8. Following initial review of a project at a meeting of the full HREC, any replies to queries, requests for approval of protocol amendments, serious adverse event reports or other project-related correspondence received by the Office of the Research Directorate, is sent directly to one or both of the spokespersons (depending upon the nature of the correspondence). The spokespersons review the correspondence and send back a written comment indicating approval or requesting further information.
   
   If the correspondence is approved by the spokespersons, the matter is simply registered on the agenda of the next full meeting of the HREC for confirmation of approval. This entire process takes place daily, between HREC meetings, to ensure that new projects, amendments and serious adverse event reports are approved and/or dealt with as quickly as possible. 
   
   
9. Clinical Trials: All Phase 1 and Phase 2 CTN drug trials, all non-commercially sponsored CTN drug trials (all phases), and all CTN device trials must be sent to the Victorian Managed Insurance Authority, VMIA (insurer of all public hospitals in Victoria), and their lawyers, DLA Phillips Fox, for advice and approval. This process is prescribed by the VMIA Guidelines for Clinical Trials for Victorian Public Hospitals and is required under the insurance policies of Melbourne and Western Health. New projects are forwarded to the VMIA by the Office of the Research Directorate, after they have been reviewed by the HREC together with a copy of the HREC approval/comments letter. VMIA and their lawyers have undertaken to reply within 14 days of receipt of a new research project application.