Human Research Ethics Committee
of the Northern Territory Department of Health
and Menzies School of Health Research (EC 00153)
OFFICE USE ONLY
Project ID Number:
___________________________
AUDIT / CASE STUDY – ETHICS CLEARANCE FORM
1. PROJECT CLASSIFICATION
Is the investigation a quality assurance activity/audit whereby de-identified/unidentified
data collected during routine clinical care is compared to a standard clinical practice and
expected clinical outcomes?
Yes
No*
Is the investigation a retrospective case study consisting of analysis of de-identified/
unidentified clinical data concerning patient(s) that were treated according to national
guidelines and agreements and not subject to experimental or new protocols or primary
research?
Yes
No*
* If NO to both of the above, please do not proceed with this form. All researchers undertaking other
potentially low risk research including those conducting other audits should complete the Low Risk
Human Research Risk Assessment Checklist and submit the checklist with a completed HREC Application
Form for possible expedited review.
2. PROJECT TITLE
(A title that indicates the area of clinical activity to be audited. The title should be informative.)
3. INVESTIGATORS
Name of Chief
Investigator:
(Student’s supervisor if
applicable)
Position
Dep’t and Organisation
Contact Details
Ph (W):
Ph (Mob):
Email:
Postal Address:
Name of CoInvestigator 1:
(Student if applicable)
Ph (W):
Ph (Mob):
Email:
Postal Address:
Name of CoInvestigator 2:
Ph (W):
Ph (Mob):
Email:
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Postal Address:
4. AUDIT SITES (Please Mark as Applicable)
Royal Darwin Hospital
Alice Springs Hospital
Gove District Hospital
Other (please specify)
______________________________
Katherine Hospital
5. PERIOD FOR WHICH APPROVAL IS SOUGHT
Project start date:
Expected completion date:
Time period covered by collected data:
6. RESEARCH CATEGORIES
(Please tick applicable boxes)
Targeted
Incidental
Aboriginal and Torres Strait Islander people
Women who are pregnant and/or the human foetus
Children and young people
People with a cognitive impairment, an intellectual disability, or a mental illness
People who may be involved in illegal activities
People in dependent or unequal relationships
People highly dependent on medical care who may be unable to give consent
People in other countries
7. AUDIT / CASE STUDY DETAILS
7.1. A brief description of the clinical area to be audited or presented as a case study.
(Please provide a brief literature review).
7.2. A statement of the standards the team is intending to relate their practice to.
(The statement does not have to contain the standards themselves, only sufficient information to indicate that such standards
exist and how to locate them, if required).
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7.3. How the audit will be conducted? (Retrospectively or prospectively, using what kinds of information?)
7.4 Does the proposal involve randomisation or the use of a control group or a Yes
placebo?
(Proposals involving comparison with published or prior treatment results with other groups are
acceptable.)
No
7.5 Does the proposal involve any alteration to routine clinical care provided to Yes
patients or seek to gather information beyond that collected during routine clinical
care?
No
(If YES, then please submit the HREC application form and not this form.)
7.6 Is there a foreseeable effect on patients as a result of the research that is Yes
different from any effect resulting from normal clinical management?
No
(e.g. physical, psychological, spiritual, or social, which could cause distress, stigmatisation or
discrimination.)
(If YES, then please submit the HREC application form and not this form.)
7.7 Does the research pose greater than negligible risk to participants?
Yes
i.e. There is no foreseeable risk of harm or discomfort to participants as a result of
the research and any foreseeable risk is no more than of inconvenience.
No
(These exclude the risks that participants may have been exposed to as part of their routine
diagnosis and treatment irrespective of any research.)
8. DATA COLLECTION
8.1 Who will collect the data?
8.2 How will the data be collected?
8.3 How many records/cases are expected to be analysed?
8.4 Is the original data: (Please refer to Chapter 3.2 of the National Statement on Ethical Conduct in Human Research)
Identifiable
Re-identifiable
Non-identifiable
8.5 Will the data be de-identified?
Yes
No
9.1 Will consent be obtained from patients? If not, justification will need to be provided Yes
No
If YES, how will data be de-identified following data collection?
If NO, please explain why?
9. CONFIDENTIALITY
as per the NHMRC ‘Guidelines approved under Section 95A of the Privacy Act 1988’
If NO, why not?
9.2 Is the proposed audit/ case study to be conducted by a person who does not Yes
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normally have access to the patient’s records for clinical care? If yes, who and please
explain the circumstances and how privacy will be protected.
9.3 Access to case notes: Is it intended that confidential information concerning any Yes
patient or staff will be made available to any person who would not, in the course of
normal clinical management, have such access?
No
(Review of medical records unavoidably risks the privacy of individuals. However, authorised
audit of records is an extremely valuable quality assurance activity. Provided the individual
reviewing the records is bound by legislation or a professional code of ethics, this question can
be answered in the negative.)
9.4 Does the project risk breaching the confidentiality of any individual’s personal Yes
information, beyond that experienced in the provision of routine care?
No
(A letter, fax or email to a patient indicating health information could breach confidentiality if
the correspondence is accidentally opened by a friend, relative or another person .)
9.5 How will confidentiality be maintained?
(It is important to remember that information should not be held or published in such a form that a patient could be identified
by an unforeseen breach of confidentiality. Please refer to the Northern Territory Freedom of Information Act ).
9.6 Storage of data and security
(Please indicate where data i.e. hardcopies and electronic files; will be stored, who will have access, and how and when it will
be destroyed. (Please refer to section 2.1 of the Australian Code for the Responsible Conduct of Research).
10. DATA ANALYSIS and IMPACT
10.1 How will the data be analysed?
10.2 How will the results of the investigation be disseminated and to whom?
10.3 How will the impact of the audit be monitored?
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Signature of Applicant:
_______________________________
Signature of Supervisor: _____________________________
Printed Name of Applicant: ____________________________
Printed Name of Supervisor:__________________________
Date: ________________________________________________
Date: _____________________________________________
Name of Organisation where research is to be conducted:
_________________________________________________
Signature of Head of Organisation**: ______________________________________________________________________
Printed Name of Head of Organisation: ____________________________________________________________________
Date: ___________________________________________________________________________________________________
**Please note: All research studies conducted at Royal Darwin Hospital require a letter of support and signing off from the Director
of Medical Services and Education Royal Darwin Hospital, Dr. Sara Watson. The Executive Assistant to Dr Sara Watson, Ms.
Radhika Krishnan, assists Dr. Watson in this process. You will need to make an appointment to see Ms. Krishnan three (3)
weeks before the deadline to clarify all submission requirements with her on behalf of Dr. Watson. Applications submitted on the
day of the deadline for signing off will not be accepted. Ms Krishnan’s contact phone number is (08) 8922 6170 and email is
Radhika.Krishnan@nt.gov.au
The completed audit application should be submitted electronically. Please scan and email the form with the
signature page to the Ethics Administration Officer.
Email: ethics@menzies.edu.au
Menzies School of Health Research,
Phone: (08) 8946 8600
John Matthews Building (Building 58),
Fax: (08) 8946 8464
Royal Darwin Hospital Campus,
Tiwi NT 0810.
PO Box 41096
Casuarina NT 0811.
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