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AUTHORISATION & DOCUMENT REQUIREMENTS FOR NEW SINGLE-SITE APPLICATIONS Authorisation & Document Requirements for New Single-Site Applications Version 7 – January 2017 GREATER THAN LOW RISK NEGLIGIBLE RISK Application Forms Application for Exemption of Ethics Committee Review Form: Signatures to be obtained from PI and HoD (and supporting HoDs where applicable) (executive sign off required at discretion of HoD) Note: All projects including Quality Assurance (QA), quality improvement, or audit activities, where there is no foreseeable risk of harm or discomfort, may be eligible for exemption of ethics committee review. Application Forms LNR Application Form via Online Forms: Signatures to be obtained from PI and research team LNR SSA Application Form via Online Forms (click here to confirm requirements) Signatures to be obtained from PI, research team and HoD Note: If an LNR SSA is not required, HoD sign off must be obtained using the Declaration by HoD form Application Forms NEAF Application Form via Online Forms: Signatures to be obtained from PI and research team SSA Application Form via Online Forms: Signatures to be obtained from PI, research team and HoD Eligible Applications: Reviewed out of session Supporting Documents Protocol, waiver of consent (please see Waiver of Consent Checklist), questionnaires, surveys, CVs of all members of the research team, etc. Supporting Documents Protocol, waiver of consent (please see Waiver of Consent Checklist), PICF (if applicable), MHDAS Module (if applicable), agreement (if project is multi-site), questionnaires, surveys, CVs of all members of the research team, etc. Supporting Documents Protocol, waiver of consent (please see Waiver of Consent Checklist), PICF (if applicable), MHDAS Module (if applicable), agreement (if project is multi-site), questionnaires, surveys, CVs of all members of the research team, etc. PRIOR APPROVAL Barwon Health Single-Site Applications: Reviewed by Barwon Health HREC Barwon Health Single-Site Applications: Reviewed by Barwon Health HREC Application Forms Acknowledgement of Prior HREC Approval Form: Signatures to be obtained from PI and HoD (and supporting HoDs where applicable) (executive sign off required at discretion of HoD) Note: Prior HREC approvals are only accepted from universities and non-NMA HRECs (in NT, WA & TAS). Approvals from NMA HRECs (in VIC, NSW, QLD & SA) are not eligible for ‘prior approval’ and must be submitted via SERP. Supporting Documents HREC approval letter, all HREC approved documents listed on the HREC approval letter Eligible Applications: Reviewed out of session LOW RISK

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AUTHORISATION & DOCUMENT REQUIREMENTS FOR NEW SINGLE-SITE APPLICATIONS

Authorisation & Document Requirements for New Single-Site Applications Version 7 – January 2017

GREATER THAN LOW RISK NEGLIGIBLE RISK

Application Forms

Application for Exemption of Ethics

Committee Review Form: Signatures to be

obtained from PI and HoD (and supporting

HoDs where applicable) (executive sign off

required at discretion of HoD)

Note: All projects including Quality Assurance

(QA), quality improvement, or audit activities,

where there is no foreseeable risk of harm or

discomfort, may be eligible for exemption of

ethics committee review.

Application Forms

LNR Application Form via Online Forms:

Signatures to be obtained from PI and

research team

LNR SSA Application Form via Online Forms

(click here to confirm requirements)

Signatures to be obtained from PI, research

team and HoD

Note: If an LNR SSA is not required, HoD sign

off must be obtained using the Declaration by

HoD form

Application Forms

NEAF Application Form via Online Forms:

Signatures to be obtained from PI and

research team

SSA Application Form via Online Forms:

Signatures to be obtained from PI, research

team and HoD

Eligible Applications:

Reviewed out of session

Supporting Documents

Protocol, waiver of consent (please see

Waiver of Consent Checklist), questionnaires,

surveys, CVs of all members of the research

team, etc.

Supporting Documents

Protocol, waiver of consent (please see

Waiver of Consent Checklist), PICF (if

applicable), MHDAS Module (if applicable),

agreement (if project is multi-site),

questionnaires, surveys, CVs of all members

of the research team, etc.

Supporting Documents

Protocol, waiver of consent (please see

Waiver of Consent Checklist), PICF (if

applicable), MHDAS Module (if applicable),

agreement (if project is multi-site),

questionnaires, surveys, CVs of all members

of the research team, etc.

PRIOR APPROVAL

Barwon Health Single-Site Applications:

Reviewed by Barwon Health HREC

Barwon Health Single-Site Applications:

Reviewed by Barwon Health HREC

Application Forms

Acknowledgement of Prior HREC Approval

Form: Signatures to be obtained from PI and

HoD (and supporting HoDs where applicable)

(executive sign off required at discretion of

HoD)

Note: Prior HREC approvals are only accepted

from universities and non-NMA HRECs (in NT,

WA & TAS). Approvals from NMA HRECs (in

VIC, NSW, QLD & SA) are not eligible for ‘prior

approval’ and must be submitted via SERP.

Supporting Documents

HREC approval letter, all HREC approved

documents listed on the HREC approval letter

Eligible Applications:

Reviewed out of session

LOW RISK