The form(s) a researcher needs to complete to undertake research at a Mercy Health facility is dependent on the level of the research.
For Commercial multi-site clinical trial applications where the National Ethics Application Form (NEAF) is already being used at the Principal site, and the Mercy site is an additional site, Mercy Health HREC will accept the NEAF together with the Victorian Site Specific Assessment Form.
From August 31 2017, 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 Online Forms 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
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.
Mercy Health HREC has retained the Common Application Form ( CAF) and the supporting modules. This application has a similar format as the NEAF but is a word document and may be more suitable for some research proposals
Details of these forms can be accessed here.
Mercy Health HREC together with the Department of Health 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 on the link: www.health.vic.gov.au/clinicaltrials/application-instructions.htm#vsm.
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. Tips for developing or updating a PICF to assist with this can be downloaded here
Mercy Health HREC has additional requirements with respect to research undertaken at Mercy Health premises. These details are known as Mercy Unique Requirements
. Please ensure that the relevant details have been included in your application.
Please read through these Participant Information and Consent Forms and choose the form most relevant to your research proposal
All these new research proposals need to be reviewed by the full HREC at the bi-monthly meetings.
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.
The required application forms for this type of research are detailed below :
2014 Expedited review application form
Quality Assurance checklist
Researchers' Declaration form
Low Risk Checklist
If your research
involves accessing Mercy Health HIS data, please also fill in Common
Application Form Section E: Collection/Use/Disclosure of Information – click
For research undertaken at a Mercy Mental Health facility, please contact the Mercy Health HREC Administrative Officer to discuss the best way to approach this.
There are other forms which need to be filled in occasionally once a research proposal has been approved. These are:
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.
Click here to view a copy of the 2017
Progress report form and extension of ethics
Serious Adverse Events
The form for reporting such an event is available here.
Guidelines for the submission of amendments to original protocol
A standard form is available to request an amendment - click here
Researchers are to submit their amendments in the following format:
1. Amendments should be submitted to:
Administrative Officer, Human Research Ethics Committee
c/- Mercy Hospital for Women
163 Studley Road Heidelberg, VIC. 3084
Tel: 03 8458 4808
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.
If your research is
funded by the NHMRC, Mercy Health supports the document written by Professor
Warwick Anderson NHMRC CEO, dated 1 December 2014 – click here.
If you have further queries on research/ethics contact:
Ms Carole Branch, HREC Administrative Officer on firstname.lastname@example.org.