authorisation & document requirements for new … · hod) note: prior hrec approvals are only...
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AUTHORISATION & DOCUMENT REQUIREMENTS FOR NEW SINGLE-SITE APPLICATIONS
Authorisation & Document Requirements for New Single-Site Applications Version 9 – July 2018
GREATER THAN LOW RISK *See Application Guide
NEGLIGIBLE RISK *See Application Guide
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
HREA via ERM: Signatures to be obtained
from PI and research team
LNR SSA Application Form via ERM (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
HREA via ERM: Signatures to be obtained
from PI and research team
SSA Application Form via ERM: 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 *See Application Guide