SUPPLEMENTARY FORM A
APPLICATION FOR ETHICAL REVIEW OF RESEARCH INVOLVING HUMANS
Therapeutic Intervention and Clinical Trial Research –
Supplementary Information
(To be submitted together with the standard Human Research Ethics Application form)
Applicants are requested to refer to the NHMRC National Statement Chapter 3.3 and to the Therapeutic Goods
Administration’s publication titled The Australian Clinical Trials Handbook when completing this form.
1. Research project
Project Title:
Chief Investigator:
Co-investigators:
(including students)
2. Investigator experience
Provide details of investigators’ qualifications and/or expertise related to the therapeutic intervention (substance, device or
technique) to be used.
Chief Investigator:
Co-investigators:
3. Student investigators
a) Will students be involved in any aspect of the delivery of the therapeutic intervention to participants?
Yes
No
If YES, describe what the student(s) will do in the context of this project?
b) What training or experience does the student(s) have relevant to the therapeutic substance, device or
technique(s) to be used in the intervention?
Provide details of student
training/experience:
If none, indicate what training
will be provided and when:
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4. Investigator roles
Describe the role(s) of each investigator (including any student researchers) in the project.
Chief Investigator:
Co-investigator 1:
Name:
Co-investigator 2:
Name:
Student Investigator 1:
Name:
Student Investigator 2:
Name:
5. Sponsorship
a) Is the research or intervention to be sponsored?
Yes
No
If YES, provide details of the sponsorship and any contractual or financial agreements entered into by the researchers.
b) Will the sponsorship be disclosed to participants?
Yes
No
6. Use of substance(s)
a) Does the research involve the use of a drug, supplement or other type of substance?
Yes
No
If YES, provide details of the substance, dosage(s) and mode of administration.
b) Where will the substance(s) be sourced from?
7. Use of therapeutic device
a) Does the research involve the use of a therapeutic device?
Yes
No
If YES, provide details about the device(s):
b) Where will the device(s) be sourced from?
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8. Use of physical intervention (non-device)
Does the research involve the use of a physical intervention such as physical manipulation or physical activity?
Yes
No
If YES, provide details about the intervention(s):
9. Use of psychological, social or behavioural (non-physical) intervention
Does the research involve the use of a psychological, social or behavioural intervention?
Yes
No
If YES, provide details about the intervention(s):
10. Modification to participants’ treatment and daily activities
a) Will participants in the study be requested to modify any other treatments or interventions they may be receiving?
Yes
No
If YES, provide details:
b) Will participants in the study be requested to modify their regular daily activities (e.g., dietary intake, sleep, exercise)?
Yes
No
If YES, provide details:
11. New procedures or interventions
a) Will the research involve the use of a new intervention or treatment that has not been used before and/or that does not have
standards approval (e.g. from TGA, Food Standards ANZ)?
Yes
No
If YES, provide details:
b) How will the efficacy and safety of the intervention be monitored during the course of the research?
c) Will participants be informed that the intervention is new?
Yes
No
If NO, provide reasons:
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12. Non-standard procedures or interventions
a) Will the intervention be administered or undertaken in a way that is different to standard practice or to that for which it has
been approved?
Yes
No
If YES, provide details:
b) How will the efficacy and safety of the intervention be monitored during the course of the research?
c) Will participants be informed that the intervention or procedures are non-standard or not approved?
Yes
No
If NO, provide reasons:
13. Use of placebo group(s)
Does the research involve the use of a PLACEBO/CONTROL ONLY group (i.e., group that does not undertake the intervention/
treatment at any stage of the research)?
Yes
No
If YES, will participants in the placebo/control group be given the opportunity to undertake the intervention if it is found to be
effective (e.g. separate to the study)?
Yes
No
Provide details:
14. Side-effects and contraindications of intervention
a) Are there any likely or expected negative side-effects of the intervention?
Yes
No
If YES, provide details:
b) Are there any contraindications of the intervention that would exclude certain population groups (e.g. with medical
conditions, undertaking certain forms of treatment)?
Yes
No
If YES, provide details:
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15. Participant monitoring
a) How will the investigators monitor the health and well-being of participants throughout the duration of the project?
b) Will the investigators monitor the health and well-being of participants for any period after completion of the study?
Yes
No
If YES, provide details:
16. Reporting of findings
Are there any limitations or restrictions on the reporting or publication of results by researchers (e.g. of negative results or
adverse events)?
Yes
No
If YES, provide details:
17. Reporting of adverse event
Provide details of how a serious adverse event relating to the intervention, if it occurs, will be disseminated to the relevant
scientific, medical and/or clinical communities.
18. Registration of research involving a clinical trial
a) Is this research a clinical trial?
Yes
No
b) If YES, has the research been registered in Australia as a clinical trial?
Yes
No
If YES, indicate where it is registered:
Australia and NZ Clinical Trial Registry
Registration Number:
Other: provide details:
Registration Number:
If NO, indicate where and when it will be registered? (NOTE: all clinical trials must be registered):
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19. CTN notification - substances and devices
Notification under the CTN scheme (or application under the Clinical Trial Exemption (CTX) scheme) is required for
clinical investigational use of:
• any medicine or device not entered in the Australian Register of Therapeutic Goods, including any new formulation of an
existing product or any new route of administration; or
• a marketed medicine, substance or device beyond the conditions of its marketing approval, including new indications extending
the use of the product to a new patient group and/or the extension of doses or duration of treatments outside the approved
range.
Does the research require TGA notification under the CTN scheme?
Yes
No
If YES, has the TGA been notified?
Yes
No
If YES, attach evidence.
If NO, provide details:
20. Other relevant information
21. Signature of Chief Investigator
Name
Date:
Signature
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