Human Research Ethics Committee (HREC)

Mercy Health promotes research throughout the organisation, supporting innovative projects and trials, across a range of areas; including obstetrics, gynaecology, paediatrics, reproductive medicine, aged care, midwifery and palliative care. The extent and diversity of research undertaken across the group, reflects a high level commitment to research and improvement in the delivery of care.

If you are interested in undertaking research at a Mercy Health facility contact us to confirm the requirements and appropriate forms and documentation for your research project after reviewing the information provided on this page.

Human Research Ethics Committee
Administrative Officer
03 8458 4808
ethics@mercy.com.au

Mercy Health encourages research activity in all clinical areas of the organisation. There has been exceptional achievement across our research program. Several long-term studies within our University of Melbourne Department are yielding results of global significance, and many other areas in our hospitals and facilities are publishing regularly in peer reviewed journals. Research in other areas such as allied health and aged care continues to evolve.

HREC submissions

Dependant on the level of risk of your proposed research, new research proposals may need to be reviewed by the full Mercy Health Research Ethics Committee HREC at the bi-monthly meetings.

The form(s) a researcher needs to complete to undertake research at a Mercy Health facility is dependent on the level of the research.

Details of the submission days and Mercy Health HREC meeting days are as follows:

Human Research Ethics Committee

Bi-monthly meeting & submission dates for 2018

Submission Dates

Monday 2.00pm 

 (2mths (approx.) prior to HREC meeting
unless otherwise specified)​

Meeting Dates

Tuesday 8.00am​

(2nd Tuesday of the month)

4 December 201713 February
5 February10 April
Tuesday 3 April12 June
4 June14  August
6 August9 October
1 October11 December
3 December12 February 2019

Commercial multi-site clinical trials

For Commercial multi-site clinical trial applications The Human Research Ethics Application (HREA) form is a new ethics application form developed by the National Health and Medical Research Council (NHMRC). The HREA replaces the National Ethics Application Form (NEAF).
The HREA will be located on Ethics Review Manager (external site) and used for an application to an ethics committee for more than low risk research at a public health organisation (hospital) and most Mercy Health facilities. If Mercy Health is not the principle site for research then a site specific assessment form (SSA) needs to be completed that is also available on this same  Ethics Review Manager site.

Collaborative research group clinical trials or investigator initiated clinical trials

For collaborative research group clinical trials or investigator initiated clinical trials, these will be reviewed on a case-by-case basis and the principal investigator needs to contact the Mercy Health HREC Administrator prior to submissions day to discuss Mercy Health HREC’s application requirements.

Low-risk / quality assurance research

For low-risk / quality assurance research, it is quite possible that these research proposals can be reviewed by the Expedited Review Working Party. Applications for this type of research can be submitted at any time. Prior to completing an application for expedited review, researchers are asked to contact the Administrative Officer, Human Research Ethics Committee to discuss this possibility.

Participant Information and Consent Forms

Mercy Health HREC together with the Department of Health and Human Services recommend the following Participant Information and Consent Forms. These are to be used with any proposed research which recruits patients and/or staff. They can be accessed at health.vic.gov.au
(please scroll down to Patient Information and Consent Forms section contained on this external website).

Read through these Participant Information and Consent Forms and choose the form most relevant to your research proposal.

Mercy Health recognise that the Patient Information and Consent Form (PICF) can be daunting for potential research participants and urges any researchers to simplify the language as much as possible. To assist review our tips for developing or updating a PICF.

Mercy Health HREC has additional requirements with respect to research undertaken at Mercy Health premises. These details are known as 2018 Mercy Unique Requirements. Please ensure that the relevant details have been included in your application.

After HREC approval: progress reports and amendments

There are other forms which need to be filled in occasionally once a research proposal has been approved including:

Progress Reports

Approved research projects are required to submit annual progress reports, in accordance with the minimum reporting requirements of the National Health and Medical Research Council.
Please download and complete the  2018 Progress report including ethics extension form.

Serious Adverse Events

The form for reporting such an event is available to download from the Department of Health and Human Services website.

Amendments

A standard form is available to request an amendment.  Please download and complete the amendment request form and follow the guidelines for submission of amendments to original protocol.

Researchers are to submit their amendments in the following format:

1. Amendments should be submitted to:

Administrative Officer, Human Research Ethics Committee
Mercy Health
c/- Mercy Hospital for Women
163 Studley Road Heidelberg, VIC. 3084
03 8458 4808
ethics@mercy.com.au

2. Amended documentation (e.g. protocols, investigator brochures, participant information sheets/consent forms, etc.) are to be submitted with tracked and clean changes only.

3. A brief summary of the amendments be provided, divided into 2 sections, as outlined below:

(a) Administrative – referring to company name changes, staff contact details and the like.
(b) Clinical – referring to changes in patient eligibility, participation and treatment changes and so on.

The Committee also determined that in the case of extensive and significant amendments to the research protocol/design, the Principal Researcher will be asked to attend the meeting at which the amendments are considered.

 

For further details on research and ethics requirements please visit  health.vic.gov.au/about/clinical-trials-and-research

Last reviewed December 7, 2017.