Human Research Ethics Committee (HREC)

Undertaking human research at Mercy Health requires approval from the Human Research Ethics Committee (HREC). The committee facilitates and manages human research in accordance with the requirements of the National Health & Medical Research Council (NHMRC). Research can be submitted as either low risk or more than low risk. Low risk research can be submitted at any time. Research that is more than low risk must be reviewed by the full HREC committee.

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

The type of application and required documents are dependent on the level of risk of the proposed research.

  • Low risk research may be reviewed by the Expedited Working Party, a subcommittee of the Mercy Health HREC.
  • More than low risk research must undergo review by the Mercy Health HREC.

Low risk/quality assurance research

The National Statement on Ethical Conduct in Human Research 2007 (the National Statement) describes research as ‘low risk’ where the only foreseeable risk is one of discomfort.

Low-risk or quality assurance research proposals can be reviewed by the Expedited Review Working Party, a subcommittee of the Mercy Health HREC. Applications for this type of research can be submitted at any time and are reviewed on a rolling basis.

Examples of low risk research:

  • Questionnaire studies:  that do not involve personally intrusive questions, major time commitment, plans to publish information that could identify patients
  • Most student projects: involving data collection via questionnaires or from records
  • Some quality assurance projects: with only minor privacy concerns

Required low risk application forms

Supporting documents (required where applicable to the project):

  • Protocol
  • Participant Information and Consent Forms (PICFs), Participant Explanatory Statements
  • Section 2 of the Victorian Specific Module (when accessing medical records)
  • Advertisements, media content
  • Flyers, posters, leaflets
  • Letters to participants, phone scripts
  • Questionnaires, interview guides
  • Data collection sheets
  • CVs for additional researchers
  • Approvals from any other HRECs
  • Grant or funding information
  • Budget

Please note:

  • Researchers must liase with the heads of the department they wish to conduct research in and collect Heads of Departments/Divisional Director sign offs before research can be submitted to the HREC office
  • The CEO signature will be collected by the HREC office for your convenience
  • We aim to review your research within a one month period, however actual time frames for approval may differ depending on the project. We ask that you please consider this possibility in your planning.

More than low risk research

Research which involves a risk of harm is considered more than low risk research. Most clinical intervention research which involves the use of drugs or devices is considered more than low risk.

Examples of more than low risk research:

  • Clinical trials involving new therapies and drug trials
  • major surveys or epidemiological studies that requires extensive data collection from patients
  • major studies involving the extraction of personally sensitive information from records
  • studies that involve vulnerable groups
  • research involving invasive procedures.

All more than low risk research will receive a facilitator to review the project and to aid in the application process prior to the HREC meeting.

Required more than low risk application forms

Document:

Description:

Access here:

Human Research Ethics Application (HREA)The Human Research Ethics Application (HREA) form is an ethics application form developed by the National Health and Medical Research Council (NHMRC).

The HREA replaces the National Ethics Application Form (NEAF) and is created on the Ethics Review Manager* website.

Ethics Review Manager
Victorian Specific Module (VSM)The Victorian Specific Module has been designed so that the HREC can address Victorian specific legislative requirements.Health.vic website
Site Specific Application (SSA)Research governance application, required for site approval.

The SSA is created from the HREA on the Ethics Review Manager website.

Ethics Review Manager
ProtocolRequired by Mercy Health HRECN/A

*Please note that the Online Forms website has been replaced by the Ethics Review Manager (ERM) in Victoria.

Supporting documents (required where applicable to your project):

  • Participant Information and Consent Forms (PICF)
  • Participant Explanatory Statements
  • Advertisements, media content
  • Flyers, posters, leaflets
  • Letters to participants, phone scripts
  • Questionnaires, interview guides
  • Data collection sheets
  • CVs for researchers working on site at Mercy
  • Approvals from any other HRECs
  • Grant or funding information
  • Clinical Trial / Collaborative Research Agreements
  • Indemnity agreement
  • Insurance

Additional Documents for Clinical Trials:

  • Investigator Brochure/Product Information
  • Instructions for participants

Please note: Original signatures are required on CTRA and Indemnity documents.

 

Mercy Health HREC Bimonthly Meeting & Submission Dates

Submission Dates

Monday 2:00pm

Meeting Dates

Tuesday 8:00am

3rd December 201812th February 2019
4th February 20199th April 2019
1st April 201911th June 2019
3rd June 201913th August 2019
5th August 20198th October 2019
7th October 201910th December 2019
2nd December 201911th February 2020

Collaborative research group clinical trials or investigator initiated clinical trials

Collaborative research group clinical trials or investigator initiated clinical trials will be reviewed on a case-by-case basis. The principal investigator (PI) needs to contact the Mercy Health HREC Administrator prior to submissions day to discuss Mercy Health HREC’s application requirements.

After HREC Approval

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

Progress Reports

  • Annual progress reports are due on the anniversary of the HREC approval date.
  • 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 progress report form.
  • Please submit to ethics@mercy.com.au

Serious Adverse Events

Amendments

  • A standard form is available to request an amendment.
  • Please download and complete the amendment request form.
  • Amended documentation (e.g. protocols, investigator brochures, participant information sheets/consent forms, etc.) must be submitted with tracked and clean changes.
  • Please submit via email to ethics@mercy.com.au

Contact Mercy Health HREC

If you have any additional questions or queries regarding Mercy Health HREC please contact:

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

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

Last reviewed December 7, 2017.