low and negligible risk

Low risk projects being reviewed only for sites in Victoria can be submitted according to the instructions in this section.

IMPORTANT NOTE: Low risk projects that are being submitted for ethical review by the Peter Mac HREC for Australian sites outside of Victoria must be submitted according to the instructions in section Peter Mac Human Research Ethics Committee providing Ethical Review.

This type of review is suited to proposals to conduct prospective data collection research that poses low or negligible risk. Low risk research is defined as research in which the only foreseeable risk is one of discomfort. Negligible risk research is defined as research in which the only foreseeable risk is no more than inconvenience. The types of research that may fall into these categories include, but are not limited to, research that involves surveying staff and/or patients and does not involve a clinical intervention or survey questions or processes that have the potential to cause significant distress, “best practice” research identified through the “evidence based medicine” process and quality assurance activities.

Assessment of the degree of risk to participants in any research activity will be made by the applicant, in the first instance, but must be agreed to by the Low and Negligible Risk Ethical Review Committee (LNR-ERC). For purposes of publication, presentation or obtaining required information from third parties, approval from the LNR-ERC will be considered equivalent to approval by the Ethics Committee.

Submission dates

See Submission and Meeting Dates for upcoming submission dates for ethical review meetings.

Important  – ERM has replaced Online Forms

The Online Forms site has transitioned to a new system called ERM (Ethics Review Manager). From 16 July 2018 to create, submit or manage your ethics and research governance applications use of ERM.

See ERM fact sheet

PREPARING YOUR ETHICS APPLICATION

Note that some of documents and forms or sections of forms may NOT be applicable to your particular project.

I. Ethics Application Forms/Documents

  • LNR VIC (Victoria only) Application Form. Only one signature is required; for single site submission the Principal Investigator, or for multisite submission the Coordinating Principal Investigator.  
  • CVs (if not already submitted within the last two years): Multisite ethical review -Coordinating Principal Investigator and Principal Investigators CVs for sites included in the ethical review. Single site ethical review – Peter Mac Principal Investigator CV

II. Project Documents

  • Protocol (template protocol suitable for a simple Low Risk project is provided if required)
  • Low Risk Participant Information and Consent Form (suggested template suitable for projects with ongoing participation). Multisite ethical review – provide a master PICF. Single site ethical review – provide a PICF on Peter Mac letterhead. For access to Peter Mac letterhead contact ethics.  Find Peter Mac site contact details for use in PICFs here
  • Invitation/Introduction letters (suitable for single questionnaire/survey where consent is indicated by return of the single questionnaire/survey)
  • Questionnaires/surveys and/or other data collection tools

NOTE: Project documents must have a version/date inserted in the footer of all pages e.g. version X dated day month year. This provides for quick and accurate identification of the current approved documents to be used by the project team.

SUBMITTING YOUR ETHICS APPLICATION

  • Please ensure that all required documents are completed and that the electronic files are clearly labelled.
  • Submit all forms and project documents.  

The Coordinating Principal Investigator or Principal Investigator will be advised of the outcome of the review and any further queries or requirements.

Application for governance review at Peter Mac

Governance review is also required for projects to be undertaken at Peter Mac. For detailed information about the requirements for a Peter Mac Governance Review application, please refer to Governance Review.