Please note that this section does not apply to multi-site clinical trials reviewed under the streamlined ethical review process. Click here for further information on the streamlined ethical review process for multi-site clinical trials, or visit the Consultative Council for Human Research Ethics website.
Applications that do not require full Committee review are reviewed out-of-session by the HREC Convenor and the Executive Sponsor of Research. However, if the project is deemed to pose more than negligible risk to participants, the project will undergo full Committee review.
Applications that do require full Committee review are reviewed by two allocated Committee members (one Peninsula Health representative and one community representative) to assess in detail the ethical considerations in accordance with the National Statement prior to the meeting at which the project will be discussed. Refer to the ethical review template for further information.
If the project is investigator-initiated, non-sponsored and single-centre (ie Peninsula Health only) the project will also undergo a methods assessment by a member of the Methods Review Panel. The reviewer will assess the application using the methods review template.
Researchers should refer to the 2011 meeting and submission dates and fee schedule for more information.
Interviews
The Principal Investigator will be required to attend for interview at the meeting in which their research proposal is being considered, if the proposal is investigator-initiated, non-sponsored and single-centre. The HREC may also request the presence of a researcher for any research proposal submitted for consideration.
Interviews are held in the Frankston Hospital Boardroom and usually take 15 – 30 minutes depending on the complexity of the project to be discussed. Researchers will be required to provide a brief overview of their project, discussing the research in terms of the four principles and values outlined in the National Statement, and will be required to address the concerns raised by the HREC. Where possible, the Research Program will forward questions from the allocated HREC reviewers prior to the meeting.
Researchers required to attend for interview will be contacted by the Research Program approximately one week prior to the meeting to arrange a suitable time.
Notification of Outcome
Researchers will be notified of the outcome of their research proposal within one week of the HREC meeting. Initial notifications will be via email and will outline any conditions of approval where applicable.
All revised documents and responses to the conditions outline by the Committee are to be sent to the Research Program. Revisions should be sent electronically via the Research Program generic email ResearchEthics@phcn.vic.gov.au and must clearly list the project number. Hard copies are to be sent where documents are more than 10 pages in length and an electronic notification outlining the documents that have been sent is recommended for tracking purposes. Please do not email documents in excess of 3mb without contacting the Research Program beforehand. Researchers should also list which conditions they are responding to either by cover letter or via a checked list to ensure prompt follow-up.
NB: All revised documents must include the project number and must contain a new version number and date.
Depending on the nature of the conditions to be addressed, the revised submission may be checked by the Research Program, Reviewers, Executive Sponsor of Research and/or full Committee. The time taken for revisions to be approved is dependent on which parties are to review the revised submission.
NB: The December / January period is a peak period for annual leave and may result in significant delays in review of revised documents. Researchers are encouraged to respond to Committee concerns promptly in order to expedite the approval of projects reviewed at the November and December meetings.
Approval to Commence
An Approval to Commence letter, signed by the Executive Sponsor of Research on behalf of the HREC, will be issued once there are no further issues with the application.
Please contact the Research Program if there are special requirements regarding the documents to be listed on the Approval to Commence letter.
Approval is ongoing but will lapse if a Progress Report is not received by the anniversary of the approval date, or is not deemed satisfactory by the HREC.
