Human Research Ethics Application

Prior to commencing a Research Project, researchers require ethics and governance approval. A Human Research Ethics Committee (HREC) provides ethics approval, whilst an institution provides Site Specific Authorisation for a study to be conducted at a particular site.

Research Support Services Festive Closure – Research Support Services will be closed from 5:00pm on Thursday 22 December 2022 and will re-open at 8:30am on Tuesday 03 January 2023. In order for researchers to receive a response to items such as; post-approval amendments, project notifications, new governance applications/site authorisation applications, HREC conditions of approval or Quality Assurance applications, the item must be submitted no later 5:00pm on Thursday 15 December 2022. This enables time for the team to seek advice from HREC members (if required) and manage the high workload.

New applications for Low Risk Human Research Ethics Review or Full Human Research Ethics review for 2022 close at 5:00pm on Wednesday 23 November 2022. New Applications for 2023 are open from 03 January 2023 for consideration at the 02 February 2023 HREC meeting.

For urgent issues i.e. an issue involving patient safety, please contact the team by phone in the first instance Research Support Services Contact List.

The Monash Health HREC are able to provide HREC Review for other institutions, however, Site Specific Authorisation to conduct the study at a site must still be obtained from each institution prior to the study commencing.

If a researcher already has obtained HREC Review from an Institution which is NHMRC Certified for multi-centre review for that category of research, Monash Health will not duplicate HREC Review and will require an application for Site-Specific Authorisation Only.

Electronic Submission

Step 1
Researchers are asked to lodge new submissions via ERM https://au.forms.ethicalreviewmanager.com/Account/Login

Step 2
Please ensure that the Victorian Specific Module (VSM), Protocol, CVs Consent Forms and any other participant facing materials are included in your HREA submission (Please note, we cannot access the HREA for other institutions on ERM).

Step 3
Following lodging the submission please send an email to research@monashhealth.org informing the team of the new submission.

The email must include the following:

  • The Project Title
  • The ERM Project ID
  • The Monash Health New Project Fee Form (if applicable)
  • The only documents required in hard copy, will be legal documents such as the HREC Review Only Form of Indemnity/Standard Form of Indemnity and Research Agreements if commercial sponsors prefer a wet ink signature. All agreements must be emailed to research@monashhealth.org to enable legal review prior to initiation of signing.

Need further information
Email us at research@monashhealth.org. Please note, that whilst our staff are able to meet with researchers prior to a submission, we strongly suggest making an appointment first and sharing a list of your queries.

HREC Meeting Dates and Submission Deadlines

Meetings are held on Thursdays at 3pm.

2022

Submission dateMeeting date
19 January03 February
23 February03 March
23 March07 April
27 April12 May
25 May09 June
22 June07 July
20 July04 August
24 August08 September
28 September13 October
26 October10 November
23 November08 December

2023

Submission dateMeeting date
18 January02 February
15 February02 March
22 March13 April
26 April11 May
24 May01 June
21 June06 July
19 July03 August
23 August07 September
20 September05 October
18 October02 November
22 November07 December

Committee Membership

Committee membership is constituted in accordance with the National Statement on Ethical Conduct in Human Research (NHMRC, 2007 – updated 2018) and consists of lay members, a Lawyer, a Minister of Religion and members representing the relevant disciplines, who have scientific/research backgrounds.

The representative of the relevant department/discipline may be approached by the researcher prior to the committee meeting to ensure that the representative (or his/her alternate) will be in attendance at the meeting. They will be able to provide further information on the committee, the interview and procedures to be followed.

Each committee comprises:

  • a chairperson
  • at least two members who are lay people, one man and one woman, who have no affiliation with the institution and do not currently engage in medical, scientific, legal or academic work
  • at least two members with current research experience that is relevant to research proposals to be considered at the meetings they attend
  • at least one member with knowledge of, and current experience in, the professional care, counselling or treatment of people; for example, a nurse or allied health professional
  • at least one member who performs a pastoral care role in a community, for example, an Aboriginal elder, a minister of religion
  • at least one member who is a lawyer.

Requests from Pharmaceutical Companies for lists of HREC members’ names and positions are quite common. Researchers are advised that it is a policy of the Board of Monash Health that this information cannot in any circumstances be released. However, a standard letter is provided at the time of final approval, stating that the committee is legally constituted in accordance with the National Statement on Ethical Conduct in Human Research (NHMRC, 2007). This is acceptable to pharmaceutical companies.