Tasmanian Health and Medical Human Research Ethics Committee
Low Risk AUDIT + WAIVER OF CONSENT Application Form
This application form is only to be used for clinical audit/evaluations/quality assurance activities where
there is a research output, ie publication AND where the proposed research has no greater risk than
negligible/low risk and a waiver of consent is being sought. For all other research activity please consult
www.utas.edu.au/research for more information and appropriate application forms.
Please submit an electronic version of this form to human.ethics@utas.edu.au
including a privacy and finance and administration forms.
For queries contact 03 6226 2764
Project Title:
Period for which approval is sought.
Date data collection is to commence:
Date data collection is expected to be completed:
Date project is expected to be completed:
Name
Position
Contact Details
Chief Investigator:
Phone:
Email:
Postal Address:
Co-Investigator(1):
Phone:
Email:
Postal Address:
Co-Investigator(2):
Phone:
Email:
Postal Address:
UTAS Student
Investigator Details (if
applicable)
Name:
Honours, PhD etc:
School/Departm
ent/Organisation
Student ID #:
Date of Birth:
Phone #:
Email:
What training/induction has the student been given regarding research ethics issues, such as confidentiality and
privacy?
1. FUNDING
Under the National Statement (2.2.6) a researcher must disclose:

the amount and sources or potential sources of funding for the research; and

financial or other relevant declarations of interest of researchers, sponsors or institutions
Do the investigators have any financial interest in this project? No
Funding Body:
Yes
Amount:
If no external funding has been obtained, please indicate how any costs of research will be met:
INSERT PROJECT TITLE VERSION NUMBER AND DATE
Research Integrity and Ethics Unit reference: Version 1 February 2015
Page 1 of 4
2. REVIEW OF ETHICAL CONSIDERATIONS
Research is only considered to be Low Risk if you answer in the negative to all the following questions. If you answer in
the positive, you may need to complete a full application using the NEAF (National Ethics Application Form)
Does your research specifically target any of the following groups of people; (specifically target
means they are the central group of participants, as opposed to potentially being incidentally
recruited as part of the general population)









Women who are pregnant and the human foetus
Children and young people
Those highly dependent on medical care who are unable to give consent
People with a cognitive impairment, intellectual disability or mental illness
People who may be involved in illegal activities or residents of custodial institutions
Aboriginal and Torres Strait Islander Peoples
People in other countries
People who are unable to give informed consent because of difficulties in understanding an
information sheet (i.e. non English speakers etc)
People in dependant or unequal relationships
Collection, use or disclosure of personal information
Does the proposed research involve the collection, use or disclosure of personal information
(including medical records) held by a Commonwealth or State agency, or an organisation in the
private sector?
No
Yes
Yes
If yes, please
complete &
submit the
Privacy Form
along with your
application.
No
3. RESEARCH DESIGN
1.
A brief description of the clinical area to be audited and a justification for undertaking this audit.
(Please provide a brief literature review).
2.
What are the aim(s) of the audit? Please give a concise description of the main objectives and/or hypothesis
of the study ensuring that the data analysis strategy will support these aims.
3.
How will the audit will be conducted? (Retrospectively or prospectively, using what kinds of information:
provide the specific items of information to be collected; include inclusion and exclusion criteria and the year(s) for
which the records are eligible (e.g 2008 – 2013)
4.
Who will collect the data?
How will the data be collected?
How many records are anticipated to be accessed, and on what basis is this number considered sufficient to
address study aims? Sample size justification may be statistical or pragmatic depending on the nature and scope of
the study
INSERT PROJECT TITLE VERSION NUMBER AND DATE
Research Integrity and Ethics Unit reference: Version 1 February 2015
Page 2 of 4
How will data be de-identified following data collection?
Is the data: (Please refer to Chapter 3.2 of the National Statement on Ethical Conduct in Human Research)



Identifiable;
Re-identifiable; or
Non-identifiable.
Additional comments:
5.
How will confidentiality be maintained?
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).
7.
How will the data be analysed? Provide details of the data analysis strategy specifying which statistical tests
will be used, relating this to the study aims.
8.
How will the information be fed back to the clinical team?
4. WAIVER OF CONSENT
Why do the benefits of the research justify any risks of harm associated with not seeking consent? (National Statement
2.3.10(b))
Why is it impracticable to obtain consent? (National Statement 2.3.10(c))
Is there any reason for thinking that participants would not consent if they were asked? (National Statement 2.3.10(d))
Will the results of the research have significance for the participants’ welfare?
Yes
If yes, how will the information arising from the research be made available to the participants?
(National Statement 2.3.10(g))
No
How will the participant’s privacy be protected? (National Statement 2.3.10(e))
Explain how confidentiality of participants and their data will be protected in the dissemination of research results?
(National Statement 2.3.10(f))
INSERT PROJECT TITLE VERSION NUMBER AND DATE
Research Integrity and Ethics Unit reference: Version 1 February 2015
Page 3 of 4
5. APPROVALS FROM OTHER DEPARTMENTS/INSTITUTIONS
Does this project need the approval of any institution other than the University of Tasmania and/or the
Department of Health and Human Services?
If ‘YES’, Please indicate below what Institutions are involved and what the status of the Approval.
No
Yes
(please detail):
Name of Other Institution(s):
Status:
Does this project need the approval of any other HREC?
If ‘YES’, Please indicate below which HREC and the status of the
application.
No
Yes
(please detail):
Other HREC(s):
Status:
6. DECLARATIONS
The Head of School or the Head of Department is required to certify that:

He or she is familiar with this project and endorses its undertaking;

The resources required to undertake this project are available;

The researchers have the skill and expertise to undertake this project appropriately or will undergo
appropriate training as specified in this application.
If the Head of School/Department is one of the investigators, this statement must be signed by an appropriate person.
This will normally be the Head of School/Department in a related area or by the Dean. Please note: this declaration
is only required on the final approved application, not at the initial application submission stage.
Name
Position
Signature
Date
Conformity with NHMRC Guidelines
The Chief Investigator is required to sign the following statement:
I have read and understood the National Statement on Ethical Conduct in Human Research 2007 and the Australian
Code of Conduct for Responsible Research 2007. I accept that I, as Chief Investigator, am responsible for ensuring
that the investigation proposed in this form is conducted fully within the conditions laid down in the National Statement
and any other conditions specified by the HREC.
Supervision of students:
Where it is proposed that the student(s) has access to patient medical records, I am satisfied that they understand
and respect patient confidentiality and the issues surrounding research privacy.
Name of chief investigator
Signature
Date
Support of Data Custodian (if different from Head of Department)
Name of Organisation
Authorising Person (name)
Signature:
Position:
Date
Signatures of Other Investigators The other investigators should sign to acknowledge their involvement in the
project and to accept the role of the Chief Investigator.
(Name)
(Signature)
(Date)
(Name)
(Signature)
(Date)
INSERT PROJECT TITLE VERSION NUMBER AND DATE
Research Integrity and Ethics Unit reference: Version 1 February 2015
Page 4 of 4