APPLICATION FOR ETHICS ASSESSMENT – RESEARCH
DATE OF APPLICATION
DETAILS OF PROJECT
Scientific/grant title of
project
Title of project in plain
English
Research method or
fields
Tissue samples
Qualitative methods
Human genetics
Quantitative methods (databanks,
epidemiology)
Human stem cells
Clinical trial
Quality assurance
DETAILS OF CHIEF INVESTIGATOR
Name
Position
Institution
Address
Phone
Email
Mobile
Fax
DETAILS OF CO – INVESTIGATORS
Name:
phone
Position:
fax
Institution:
email
Name:
phone
Position:
fax
Institution:
email
Name:
phone
Position:
fax
Institution:
email
Name:
phone
Position:
fax
Institution:
email
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APPLICATION FOR ETHICS ASSESSMENT – RESEARCH
Provide details of the entire project including documents and information outside the ABMDR’s scope of
review
1. Explain the purpose and background information of the project in ‘plain English’
Ethics committees comprise members of the community who do not have a scientific or medical background. It
is therefore imperative that the proposal is presented succinctly and in a way that will assist them to understand
the exact nature of the research
2. What is the significance and potential benefit of this project?
Explain the hypothesis, aims, research questions and objectives/outcomes
3. What specific material (samples or data) are you requesting from the ABMDR or its donors?
Include exclusion and inclusion criteria
4. What quantity of material is required?
5. How many donors or samples does this involve?
6. Provide a statistical explanation for the number of samples required using power calculation
Include a brief description of the proposed methodology
7. Does your project create any potential risks/adverse outcomes for the AMBDR or for public support for bone
marrow donation or cord blood donation?
8. What is the timeframe for the project?
9. How long will the materials and research data be retained?
The current ABMDR policy is that samples must be disposed of after completion of this project
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APPLICATION FOR ETHICS ASSESSMENT – RESEARCH
10. How will the materials be disposed of after completion of the project?
11. Is an application for funding currently submitted?
a. If yes, will this project proceed if the funding application is unsuccessful?
Yes
No
N/A
Yes
No
N/A
12. Please describe source(s) of financial support for this research
b. In-kind support from an institution
Yes
No
Yes
No
Yes
No
Yes
No
If yes, please provide details
c.
External commercial funding
If yes, please provide details
d. External non-commercial funding (e.g. NHMRC)
If yes, please provide details
e. Other
If yes, please provide details
13. Does this project involve the implantation of cells or tissues which have been previously co-cultured with animal
cells or tissues?
Yes
No
N/A
14. If this project is part of a clinical trial, has this trial been registered on an authorised Clinical Trials Registry?
Yes
No
N/A
15. Is this project part of a multi-centre study?
Yes
No
N/A
Yes
No
N/A
Yes
No
N/A
If yes, please list all participating institutions/ sites
16. Does the project involve a sub-study, i.e. pharmacogenetic, pharmacokinetic, etc?
If yes, please indicate which
17. Has/will the project been/be submitted to another Health Research Ethics Committee?
If no, please indicate why,
If yes, please indicate:
a. Have they made any comments?
Yes
No
If yes, please provide details
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APPLICATION FOR ETHICS ASSESSMENT – RESEARCH
b. How have such comments been addressed?
Yes
No
If yes, please provide details
18. Does your research project require consideration of the provisions of the Health Records and Information
Privacy Act 2002 (NSW) or relevant state legislation?
Yes
No
N/A
Statutory Guidelines on Research available from the Privacy NSW website
www.lawlink.nsw.gov.au/privacynsw
19. Does your project comply with the provisions of the relevant state Human Tissue Act?
Yes
No
N/A
20. If regulated blood or blood products are required, does this require a Clinical Trial Notification approval?
Yes
No
N/A
If yes, please provide details
If no, please outline why
CONSENT AND CONFIDENTIALITY
21. Do you require potentially re-identifiable (de-identified) or anonymised samples or data?
Potentially re-identifiable (de-identified) samples are samples from which all identifying information is
removed but where it is possible to re-identify the sample.
Anonymised samples are samples that cannot be re-identified (i.e. all links to the tissue donor have been
removed).
Additional Comments:
22. Is there any possibility that information of a personal nature could be revealed to persons not directly
connected with this research proposal?
Yes
No
N/A
If yes, please provide details
23. Does this project involve obtaining personal information retrospectively?
Yes
No
N/A
24. Does this project involve obtaining personal information from a Commonwealth agency?
Yes
No
N/A
Yes
No
If Yes, please indicate the number of records involved
25. Explain how the project data and records will be kept confidential and secure?
Please provide details
26. Are there risks to donors as a result of participation in this research project?
If yes, explain what the risks are and how they will be minimised and managed.
For more information about the definition of risk see section 2, points 2.1.6 and 2.1.7 of the National Statement on
Ethical Conduct in Human Research
http://www.nhmrc.gov.au/publications/synopses/e72syn.htm
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APPLICATION FOR ETHICS ASSESSMENT – RESEARCH
27. Do you believe it is necessary to seek consent from all participants?
Yes
No
If No, please provide justification for your belief that consent is not needed, addressing points 2.3.6 (a)-(i) and 2.3.7
(a)-(d) in the National Statement on Ethical Conduct in Human Research.
http://www.nhmrc.gov.au/publications/synopses/e72syn.htm
28. What additional ethical issues are raised by the project?
Please provide details
29. How do you propose to deal with these issues?
Please provide details
CONFLICT OF INTEREST
30. Do the investigators have any affiliation with, or financial involvement in, any organisation or entity with direct or
indirect interests in the subject matter or materials of this project?
Yes
No
N/A
If yes, please provide details
31. Do the investigators expect to obtain any direct or indirect financial or other benefits from conducting this
project?
Yes
No
N/A
If yes, please provide details
INTELLECTUAL PROPERTY
32. Do you feel that this project contains any commercial intellectual property?
Yes
No
N/A
33. Do you give permission for publicly-available information from your project to be published on the ABMDR
website?
Yes
No
N/A
The ABMDR would like to publish on our website the title of the project, the institutions and the names of
researchers involved once the project is approved. Subsequently we would like to publish results of the project
that have been made public via publication or posters.
Please note that you should check with other interested parties before giving permission, or else the value of
intellectual property may be lost
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APPLICATION FOR ETHICS ASSESSMENT – RESEARCH
APPLICATION CHECKLIST
Application for ethical assessments – Research projects which includes a plain
English description of the research
Yes
No
N/A
Participant Information Form and Consent Form (if required) – It is requisite to answer
all the questions. Incomplete forms will be cause the return of the research proposal
Yes
No
N/A
Research Protocol: This should provide a full scientific description of the research
including background, aims, hypotheses, research plan, methods, analysis, potential
significance, outcomes and references.
Yes
No
N/A
Copies of reports of approvals/amendments from any other relevant Scientific Review
Committees
Yes
No
N/A
Evidence of approval/rejection/amendments by other Ethics Committee including
comments and requested alterations to the protocol
Yes
No
N/A
Clinical Trial Notification Form (if required) signed by the Chief Investigator. All
boxes/details must be completed and the form signed by the Chief Investigator prior
to submission
Yes
No
N/A
Quality assurance checklist (quality assurance projects only)
Yes
No
N/A
Name of chief investigator
Institution
Signature
Date (day/month/year)
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