Externally Approved Application Form - Research Office

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MACQUARIE UNIVERSITY

HUMAN RESEARCH ETHICS COMMITTEES

EXTERNALLY APPROVED APPLICATION FORM (EAAF)

Guidelines for completion and submission of the EAAF:

1. Complete this form if your research, i.e. data collection, will not be undertaken at

Macquarie University (MQ) and/or Macquarie University Hospital (MUH) as a site, and you have received approval from one of the following:

 NSW Health HRECs (or state-equivalent) or Lead HRECs http://www.health.nsw.gov.au/ethics/research/contactshrec.asp

 Cancer Institute NSW Clinical Research Ethics Committee http://www.cancerinstitute.org.au/cancer_inst/research/ethics.html

 An Australian University registered with the NHMRC https://www.nhmrc.gov.au/health-ethics/human-research-ethics-committeeshrecs

2. Complete this PREF electronically—hand-written forms will not be accepted.

3. EAAFs must be signed by the Principal Investigator (MQ staff member, or supervisor in the case of student research) in one of the following ways - unsigned applications will

not be accepted:

 Scanned into the document

 Handwritten and then the document can be scanned

 Submission of the EAAF from the Principal Investigator’s email address: the email will be accepted as the Principal Investigator’s signature.

4. EAAFs must be submitted to the Ethics Secretariat via email as a PDF document, in addition to:

 One (1) copy of the National Ethics Application Form (NEAF) or other ethics application—as submitted to the HREC from which you have already received approval—plus all approval correspondence

 One (1) copy of each different Participant Information and Consent Form (PICF) relevant to each site(s)

 One (1) copy of each different recruitment advertisement relevant to each site(s)

Please submit your application electronically to ethics.secretariat@mq.edu.au

.

MQ HRECS EAAF Version 2- July 2015 1

FOR OFFICE USE ONLY

SURNAME:

ETHICS REFERENCE NUMBER:

MACQUARIE UNIVERSITY

HUMAN RESEARCH ETHICS COMMITTEES

EXTERNALLY APPROVED APPLICATION FORM (EAAF)

ALL RESEARCHERS MUST COMPLETE SECTIONS 1–5

To use checkboxes correctly in Microsoft Word:

 Select the relevant response

 Double-click the checkbox beside your response

 When the menu appears, go to the “Default value” heading and select “Checked”

 Click “OK”

For further information on how to complete this form see:

The National Statement on Ethical Conduct in Human Research http://www.nhmrc.gov.au/_files_nhmrc/file/publications/synopses/e72-jul09.pdf

The Australian Code for the Responsible Conduct of Research (The Code) http://www.nhmrc.gov.au/_files_nhmrc/file/publications/synopses/r39.pdf

The Macquarie University Code for the Responsible Conduct of Research http://www.mq.edu.au/policy/category.html#research

SECTION 1: TITLE

1 Full project title:

MQ HRECS EAAF Version 2- July 2015 2

SECTION 2: INVESTIGATORS AND RESEARCH PERSONNEL

List the details of the Principal Investigator, and any Co-Investigators, Associate

Investigators, Supervisors, Research Assistants or Research Co-ordinators who are

affiliated with Macquarie University and will be conducting research at the

external sites.

2.1 Principal Investigator/Supervisor

The Principal Investigator is:

A Macquarie University staff member

The first point of contact for the MQ HREC regarding this protocol

Note: If the project is to be undertaken by an MQ Honours/Masters/PhD student, the supervisor will be considered the Principal Investigator. The student may be named as a co-investigator.

Title

First name:

Surname:

MQ Staff no.

Full mailing address:

Faculty

Department/Unit:

Position:

Tel No. (W):

Tel No: (H):

Mobile No:

Fax number:

E-mail address:

Relevant qualifications and expertise:

Prof Dr

Medicine and

Health Sciences

Arts

Mr Mrs

Human

Sciences

Business and Economics

Ms Other:

Science and Engineering

MQ Offices and Units

MQ HRECS EAAF Version 2- July 2015 3

2.2. How many known other MQ investigators/personnel will play a specified role in the conduct of the research project?

0  Proceed to Section 3. 1 or more  Complete 2.3

2.3 Other MQ Investigator(s)/Personnel

Role Co-Investigator

Research Assistant

Prof Dr Mr Title

First name:

Surname:

Investigator type

Staff/Student no.

Full mailing address:

Faculty

Staff

Medicine and

Health Sciences

Arts

Mrs

Human

Sciences

Business and

Economics

Department/Unit:

Position:

(students to specify degree/course)

Tel No. (W):

Associate Investigator

Research Coordinator

Ms Other:

Student

Science and Engineering

MQ Offices and Units

Tel No: (H):

Mobile No:

Fax number:

E-mail address:

Relevant qualifications and expertise:

Note: To list additional “Other Investigators/Personnel”, please copy and paste the above table into the space below and complete the details for all personnel at this site.

MQ HRECS EAAF Version 2- July 2015 4

SECTION 3: EXTERNAL HRECS

3.1. State the name and code of each external HREC that has approved the research as it appears in the list of HRECs on the NHMRC website: https://www.nhmrc.gov.au/health-ethics/human-research-ethicscommittees-hrecs

Name of External HREC NHMRC Code

Note: To list additional external HRECs, insert another row to the table above.

3.2 Name the HREC that will be providing ethical oversight for the research.

3.3 Indicate the proposed start date of the project.

Date: / /

3.4

Indicate the proposed finish date of the project.

Date: / /

SECTION 4: ATTACHMENTS

4.1 List all the documents attached to this application

Document Description Version Number Date

Note: To list additional documents, insert another row to the table above. Please delete any unused rows.

MQ HRECS EAAF Version 2- July 2015 5

SECTION 5: SIGNATURE OF PRINCIPAL INVESTIGATOR

Signature of Principal Investigator:

Name of Principal Investigator:

(BLOCK LETTERS)

Date:

MQ HRECS EAAF Version 2- July 2015 6

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