Submissions

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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.

These electronic forms can be found at www.neaf.gov.au and www.health.vic.gov.au/clinicaltrials/application-instructions.htm#vsm.

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.
 
Details of the submission days and Mercy Health HREC meeting days for 2016 are enclosed below:
2017 HREC meeting and submission dates ​         

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 
NHMRC 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 here.

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.


Other Forms
There are other forms which need to be filled in occasionally once a research proposal has been approved. These are:

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.

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.

Amendments
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:

Carole Branch
Administrative Officer, Human Research Ethics Committee
Mercy Health
c/- Mercy Hospital for Women
163 Studley Road Heidelberg, VIC. 3084
Tel: 03 8458 4808
e-mail: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.

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 ethics@mercy.com.au.
 

 

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