Download questionnaire and checklist for ethics submission - WSLHD

QUESTIONNAIRE AND CHECKLIST FOR ETHICS SUBMISSION
One (only) copy to be completed and submitted with application fee
STUDY TITLE: [insert title here as it appears on the NEAF / Protocol]
STUDY PROTOCOL NUMBER: [if applicable]
CHIEF INVESTIGATOR / DEPT: [WSLHD researcher and department]
CLINICAL TRIAL COORDINATOR (if applicable): [name and contact details, email and phone
Questionnaire To assist with the allocation of your study and prevent delays please
answer the following:
Is this a multicentre study (ie multiple NSW public health organisation sites) for
Classification
Yes
No
M
Lead HREC submission?
Is this a multicentre study (NSW/Qld/Vic/SA sites) under the Mutual
MA
Acceptance initiative for Lead HREC submission?
Is this a sponsored clinical drug trial? If Yes, please name the sponsoring
C
company:
Does this study involve drugs of any kind ie registered drugs / registered drugs
being used off label / supplements / over the counter medication / media?
Has the trial been registered on an authorised Clinical Trials Registry, eg with
ACTR
the Australian Clinical Trials Registry? http://www.actr.org.au
Has funding been awarded for this project through a granting body? If Yes, by
which granting body? ____________________________________ (if
NHMRC, please nominate if it is a program grant or a project grant)
Is an application for funding currently submitted but not yet approved?
If Yes, will this project proceed if funding application is unsuccessful?
Does this project contain any Commercial Intellectual Property?
CIP
If Yes, do you give permission for this project to be forwarded to the WSLHD
Commercialisation Unit? (You should check with other interested parties, eg
universities / industrial partners, before giving permission for assessment by
WSLHD, or else the value of any Intellectual Property may be lost)
Is this a Phase 1 (first time in humans or first time in patients) study?
FTIH / FTIP
Does this project involve transplantation of animal cells or tissue into humans
T
(xenotransplantation)?
Does this project involve the implantation of cells or tissues which have been
PCC
previously co-cultured with animal cells or tissues?
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To assist with the allocation of your study and prevent delays please
answer the following:
Does this project involve the use of any human tissue (incl blood, urine, flesh,
Classification
Yes
No
HT
tumour, saliva, skin, teeth, gum etc)?
Does your proposal comply with the provisions of the Human Tissue Act?
Does this project involve a sub study ie pharmacogenetic, pharmacogenomic,
SS
pharmacokinetic etc? (please indicate which)
Does this project involve genetic / DNA testing?
G
Will tissue collected for this project be banked in a Tissue / DNA Bank? If Yes,
TB / DNA
which Tissue / DNA bank?:
Is this project using tissue previously collected and stored in a Tissue / DNA
PTB
Bank?
Does this project involve radiation of any kind – if so, it should be submitted to
RSC
the Radiation Safety Committee (RSC).
Does this project require submission to the Institutional Biosafety Committee
IBC
(IBC)?
Does this project involve obtaining personal / health information retrospectively
RI
from a NSW government department, eg public hospital?
Does this project involve obtaining personal information from a Commonwealth
CWA
agency? If Yes, please indicate the number of records involved:
Does your proposal require consideration of the provisions of the Health
HRIP
Records and Information Privacy Act 2002 (NSW)’? ‘Statutory Guidelines on
research’ available from the Privacy NSW website
www.lawlink.nsw.gov.au/privacynsw
Does your proposal require access to patients’ medical records?

If Yes, are the medical records to be accessed your patients?

If not your patients, details should be submitted of whose patients they
are, how it is planned to access those medical records and by whom
Have equipment / devices to be used in this proposed project received TGA
approval/registration? If so, evidence of TGA approval/registration must be
submitted. If unapproved/unregistered, please supply full details/specifications
for assessment by a Biomedical Engineer.
Have equipment / devices to be used in this proposed project already been
submitted to Biomedical Engineering for approval?
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CHECKLIST FOR HREC SUBMISSION
Required documents and completion guidelines (where applicable)
No required
No required
√ or
(proposals
(proposals not
N/a
involving drugs)
involving drugs
/ devices)
National Ethics Application Form (NEAF) signed by the
Original + 24
Original + 20
Coordinating Principal Investigator
Total 25
Total 21
Victoria Specific Module (for studies submitted under Mutual
1
1
1
1
25
21
25
21
5
N/a
1
N/a
Multi-centre submission - Medicines Australia Form of
3 x Originals
N/a
Indemnity (HREC review only) from trial sponsor addressed to
signed by
Western Sydney Local Health District ABN 48 702 394 764
sponsor
Acceptance initiative for single ethical review ie NSW/Qld/Vic/SA)
NSW Privacy Form in addition to NEAF (required for all studies)
to be included in original documentation
Participant Information and Consent Form (Master for
Multicentre, Local for Single Site) – must have version
number, date and page numbering in footer. (Templates
available from Research Office)
Separate Scientific Protocol / Study Plan including aims,
hypotheses, research plan, methods, analysis, potential
significance, reference list etc – must have version number,
date and page numbering in footer. (Template available from
Research Office)
Investigator Brochure (if applicable) or Product Information (if
study drug is registered)
CTN Form (if required) signed by the Coordinating Principal
Investigator. All boxes / details must be completed prior to
submission. Please do not double side.
Westmead Hospital Campus, Institute Road, Westmead NSW
2145 ‘the Authority’ indemnifying the HREC and including the
name of each investigator and site in paragraph 1. This must be
signed by the sponsoring pharmaceutical company prior to
submission. Not required for single site.
Medicines Australia Form of Indemnity (Standard) from trial
2 x Originals
sponsor to WSLHD (addressed as above). This must be signed
signed by
as above prior to submission with Site Specific Assessment
sponsor
N/a
(SSA) application
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Required documents and completion guidelines
(where applicable)
Number required
Number
√
(proposals
required
or
involving drugs /
(proposals not
N/a
devices)
involving drugs
/ devices)
Certificate of Currency (Clinical Trials / Public Liability
Insurance) for a minimum of AUD $20,000,000
25
N/a
25
21
25
21
bodies (if applicable)
25
N/a
WSLHD Radiation Safety Committee Report (if applicable)
25
21
One completed copy of this Submission Questionnaire /
1
1
Form (one only). Application will not be accepted without fee.
1
1
One completed copy of the HREC Submission Cover Sheet
1
1
Copy of study questionnaire/s, survey questions, interview topics
to be covered, recruitment advertisement / flyer, patient diary etc
ie any document which will be given to study participants. These
should be on WSLHD letterhead with the study title on each
page, together with version number / date and page
numbering ie ‘Page 1 of …’ etc in footer.
NB Recruitment advertisement/flyer must contain the study title, a
version number and date, and a statement ‘This study has been
approved by the WSLHD Human Research Ethics Committee’
Evidence of approval / rejection by other HRECs outside NSW
including comments and requested alterations to the protocol
Objections / comments by the TGA or overseas regulatory
Checklist
Application fee – Cheque, Receipt or Submission Fee Transfer
(attached) completed with details of all documents being
submitted for HREC approval
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HREC SUBMISSION COVER SHEET
Listing all documents included in the application - to be submitted with all HREC applications, drug and nondrug. Please submit one copy only
Study Title:
Chief Investigator / Dept:
No
submitted
Document
Reference No
NEAF - Submission code
AU/
Scientific Protocol / Study Plan
Version No
Investigator’s Brochure / Product
Information
Edition No
Participant Information & Consent Form
Master
Site Specific
Version No
PI&CF (Tissue banking / storage)
Master
Site Specific
Version No
PI&CF (Tissue collection / genetic testing)
Master
Site Specific
Version No
Patient Diary
Version No
Questionnaire / Survey
Version No
Date
N/a
Medicines Australia Standard Form of
Indemnity x
(number of copies)
Medicines Australia HREC Review Only
Form of Indemnity x
(number of copies)
Certificate of Currency / Clinical Trial
Insurance ($20,000,000 minimum) with
______________________ Insurance Co
Policy No
Recruitment Poster
Version No
Recruitment Flyer
Version No
Current to
Radiation Safety Committee Report (if
applicable)
Other (please specify)
Other (please specify)
1
Submission fee (Cheque, Receipt or
Internal Departmental Cost Code form)
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