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Resources

Forms and Templates

Application Forms

MQ  Ethics Application Form  (Faculty of Science applications will only be accepted via the online form).
We recommend researchers to open the form using Microsoft Office 2007 version due to formatting reasons.

Research Protocol
If you are submitting an application for a clinical trial, randomised controlled trial, interventional research or clinical research, please complete and submit this form in addition to your ethics application.

Clinical Trials Checklist

National Ethics Application Form (NEAF).

Prior Review Form (for onsite projects).

Externally Approved Application Form (EAAF) (for offsite projects).


Appendixes

(Appendix A) Research Involving Aboriginal and Torres Strait Islander People.

(Appendix B) Research to be Undertaken Outside Australia.

(Appendix D) Privacy and Access to Personal Information.

(Appendix F) Exposure to Ionizing Radiation.

(Appendix G) The Administration of Illegal Drugs, Legal Drugs and/or Medication not Part of a Clinical Trial.


Information and Consent

Information and Consent Form - Guidelines.

Information and Consent Form - Example and Checklist.

PICF templates covering Genetic, Interventional and Non-interventional research, please consult the Human Research Ethics Portal:
The Human Ethics team will provide MQ PICF templates for these types of research on the Forms page once these are complete.


Post Approval Forms

Amendment Request Form

Macquarie University Adverse Events Form

Progress Report - Please complete this form if you are still collecting, or intend to collect, data from participants.

Final Report - Please complete this form if you have finished collecting data from participants


Please do not download these forms and save them onto your computer for later use, as they are updated on an ongoing basis. Always download a fresh form from this web page.

Please contact the Ethics Secretariat on +61 2 9850 4459 or by email at ethics.secretariat@mq.edu.au for assistance with your application or for further information.

Fee Schedule for Commercially Sponsored and External Research Projects

A fee will not be charged for applications or amendments submitted for assessment by the HREC (Human Sciences and Humanities) or HREC (Medical Sciences) from researchers who are full-time, part-time, or visiting appointees to the University, unless engaged in sponsored research.

A fee will be charged for applications or amendments submitted for assessment by the HREC (Human Sciences and Humanities) or HREC (Medical Sciences) from researchers who have no formal affiliation with the university or researchers who are appointees of Macquarie University Hospital. These researchers will be invoiced according to the Macquarie University fee structure outlined below.

Fees for amendments to an approved research project apply to each version change to Investigator's Brochures (or equivalent) and protocol documents (or equivalent). The amendments fees do not apply to minor administrative changes. 

Services RenderedProject TypeGST - Inclusive
Submission to the Full HRECsCommercially-sponsored research project including co-operative/collaborative research project with commercial sponsorship. $3,300
External research project (e.g universities and external entities).$2,500
Low/negligible Risk ProjectsCommercially-sponsored Prior Review Projects requesting to include MQ/MUH as a site.$1,650
Co-operative/collaborative research project with commercial sponsorship.$300
External research project (e.g universities and external entities).$100
Amendments to Approved Research ProjectCommercially-sponsored research project including co-operative/collaborative research project with commercial sponsorship.$550
Substantial amendments for commercially-sponsored research project.$1,650
External research project (e.g universities and external entities).$150

How to Pay: Please email Ethics Secretariat the relevant contact information (sponsor/organization name, email, phone, address and ABN) to which the invoice should be forwarded.

Training and Information Sessions

To learn more about the National Statement on Ethical Conduct in Human Research and the Macquarie University application process for human ethics, all MQ staff and students are welcome to attend our information sessions.

These sessions will be presented by Dr Karolyn White - Director, Research Ethics and Integrity at Macquarie University– and include an opportunity to ask Dr White questions. No RSVP is required.

The Human Ethics Information Sessions will be held throughout 2015:

Date: March 12 (Thursday)
Time:
1:00pm - 2:00pm
Venue: 
W5C 335 Tute Rm

Dates: May 7, June 4, August 6 and October 1 (Thursday)
Time: 1:00pm - 2:00pm
Venue: C8A 310 Senate Room

Any questions about these sessions should be directed to Ms Kay Bowes-Tseng (kay.bowes-tseng@mq.edu.au) or the human ethics secretariat (ethics.secretariat@mq.edu.au).

Policies

It is the responsibility of every researcher to ensure that their research and teaching projects comply with all legislation and relevant external and internal guidelines and policies. Prior to preparing your ethics application, please refer to the following policies, legislation and guidelines.

Macquarie University Human Ethics policy 

The MQ Human Ethics policy outlines how Macquarie University fulfils its responsibilities for ensuring compliance with the National Health and Medical Research Council's Australian Code for the Responsible Conduct of Research (the Code) and the National Statement on Ethical Conduct in Human Research (the National Statement).

Review of medical sciences ethics applications policy establishes guidelines for the submission of ethics applications to conduct research including sponsored trials, clinical trials and clinical research.

MQ HREC Participant Reimbursement Policy

MQ HREC Passive Consent in Child Research Policy


Market Research Companies/Use of Organisation Databases Policy

Macquarie University Travel Policy

If your research involves domestic or overseas travel you need to be familiar with the Macquarie University Travel  If you plan to travel to restricted areas see sections 3 and 21 of the document.  Attach all correspondence about travel to restricted areas from the Vice-Chancellor's representative to your ethics application.

All research conducted at Macquarie University must adhere to the Macquarie University Code for the Responsible Conduct of Research.

Legislation

Human Tissue Act 1983 (NSW)

Anatomy Act 1977 (NSW)

Privacy Act 1988 (Cth)

Guidelines under Section 95 of the Privacy Act 1988 developed by the Australian Health Ethics Committee, accepted by the NHMRC and tabled in Parliament.

Guidelines Approved under Section 95A of the Privacy Act 1988 endorsed by NHMRC and approved by the federal Privacy Commissioner on 19 December 2001.

Privacy and Personal Information Protection Act 1998 No. 133 (NSW)

Health Records and Information Privacy Act 2002 (NSW)

Commission for Children and Young People Act 1998 (NSW) - This legislation established the NSW Commission for Children and Young People The Commission is an independent statutory organisation within Government that advocates for the children and young people of NSW. 

See: http://www.kids.nsw.gov.au/kids/about.cfm#ixzz2PXd2yxO1 for further information regarding working with children. 

State Records Act 1998 (NSW) - applies to retention and disposal of research data. (Note that other considerations affecting retention of research data may need to be taken into account). Generally, the HRECs require that researchers securely store research data for a minimum of five (5) years from the date of the most recent publication of the research. If the research is not published, research data should be securely stored for a minimum of five (5) years from completion of the research.

Guidelines

National Statement on Ethical Conduct in Human Research (2007)

Australian Code for the Conduct of Responsible Research (2007)

Challenging Ethical Issues in Contemporary Research on Human Beings

Australian Electoral Commission Supply of Elector Information for use in Medical Research

Statement on Consumer and Community Participation in Health and Medical Research

World Medical Association Declaration of Helsinki (8th revision)

Values and Ethics - Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research

AIATSIS Guidelines for Ethical Research in Indigenous Studies

Understanding Consent in Research Involving Children: The ethical issues (Spriggs 2010)

Department of Education and Training - Guidelines for approving applications from external agencies to conduct research in NSW Government Schools

Oral History Association of Australia 'Guidelines of Ethical Practice'2007