Method and timeline for review of HREC submissions

Submissions requiring full HREC review

What happens after I submit my application?

Your application will be reviewed in the lead up to the HREC meeting and discussed at the meeting.  Minutes are prepared in the days following and a review of your application will be emailed to the CPI and cc’d to the Contact Person by the Friday following the meeting.  If changes are required an explanation of how to respond will be included in the email.  If no changes are required an approval letter will be sent.  If the application cannot be approved a letter of rejection will be sent.

Benchmark timeframe

The benchmark for receipt of an ethical decision is 60 days from receipt of a valid ethics application.  The length of time from submission of a research application to the researcher receiving a decision depends on a number of factors including:

  • Completeness of the submission;
  • Quality of the submission (including the quality of the research protocol, quality of the HREA and other documentation, correct adherence to policies regarding accessing, maintaining and storing data and/or tissue etc.);
  • Time taken by researchers to respond to HREC concerns and requests.

Low or negligible risk submissions

Low or negligible risk applications are able to be reviewed between HREC meetings.  The MML HREC process for low risk review includes review by two members of the MML HREC or its advisory committee as well as by the Chairperson with the aim for a decision to be made within 10-14 days from receipt of a valid application.

Waiver of consent

If you are not seeking consent from participants to use their data for a secondary purpose (research), justification for a waiver of consent should be provided as part of your application.  This should refer to the value of the research, the risk and burden to participants in seeking their consent and should be based the information outlined in Chapter 2.3 of the National Statement (page 21) and Section 95A of the Privacy Act (page 23-24, D.5).

A request for waiver of consent must be considered by the full HREC. Applications that require a waiver of consent will be added to the agenda for the next scheduled HREC meeting.