Department of Health Human Research Ethics
Committee
APPLICATION FORM
Research projects involving humans must be reviewed by a Human Research Ethics
Committee (HREC) and must not be undertaken or funded unless and until approval
has been granted.1 The Department of Health Human Research Ethics Committee is
an approved HREC.
Terms of Reference
Functions and Objectives
The role of the Australian Government Department of Health (the ‘Department’)
Human Research Ethics Committee (the ‘Committee’) an approved HREC, is to
provide ethical assessment of non-biomedical research proposals involving humans
that:
 are funded by the Department of Health; or
 require access to or linkage of, Departmental data collections; or
 are initiated or conducted, either wholly or in part, by Departmental staff;
and either


have not been considered by another HREC; or
have been referred to the Committee by a data custodian or by a senior
executive of the Department.
Please refer to the Committee’s website for more information on the Objectives, Role
and Charter at http://www.health.gov.au/internet/main/publishing.nsf/Content/healthethics-index.htm
1
National Statement on Ethical Conduct in Human Research 2007 (Updated May 2015) as issued by the
National Health and Medical Research Council (NHMRC) in accordance with the National Health and
Medical Research Council Act 1992 (Cth).
Department of Health Human Research Ethics Committee Application Form & Checklist
Website: http://www.health.gov.au/internet/main/publishing.nsf/Content/health-ethics-index.htm
Page 1
Acknowledgment
This application form is based on the Department of Human Services, Victoria
proforma.
BEFORE YOU BEGIN
Please refer any questions to the Committee Secretariat, by email at
ethics@health.gov.au or refer to the Committee’s website for further information:
www.health.gov.au/internet/main/publishing.nsf/Content/health-ethics-index.htm
The Department of Health Human Research Ethics Committee is governed by the
National Health and Medical Research Council (NHMRC) guidelines when assessing
research applications involving humans. A copy of the National Statement on Ethical
Conduct in Human Research 2007 (Updated May 2015) and associated guidelines2
can be located on the NHMRC’s website:
http://www.nhmrc.gov.au/guidelines/publications/e72
All fields of the application must be completed, including not applicable fields which
can be marked n/a.
Applicants are to respond as directly and succinctly as possible to the questions asked
in this form. It is not sufficient to submit documentation prepared for other purposes,
with the expectation that the Committee will determine what is and what is not
relevant to the application. If supplementary material is attached, its specific
relevance to the questions asked in the application form must be identified.
Applications that are not easily read and understood by the Members of the
Committee will be returned to the researchers for revision and will be considered at a
subsequent meeting.
CORE APPLICATION
1
Full Project Title
Application Date:
The full technical or scientific title of the Project.
2
Researchers3
The Committee is responsible for ensuring the project is conducted or supervised by
persons or teams with experience, qualifications and competence that are appropriate
for the research (NS* 1.1(e). All researchers directly involved with this project must
be included on the list of researchers (i.e., the principal/senior researcher, associate
researcher/s and relevant research members).
2
A comprehensive listing of the associated guidelines is located at Attachment C.
Researchers are responsible for:
(a) designing the research to minimise the risks of harm or discomfort to participants;
(b) clarifying for participants the potential benefits and risks of the research; and
(c) the welfare of the participants in the research context. (National Statement 1.7).

NS – National Statement on Ethical Conduct in Human Research 2007 (Updated May 2015)
3
Department of Health Human Research Ethics Committee Application Form & Checklist
Website: http://www.health.gov.au/internet/wcms/publishing.nsf/content/health-ethics-index.htm.
Page 2
Principal/Senior Researcher (on occasion, the Principal/Senior Researcher of the
Department/Institution may be called upon to answer questions on behalf of the
project team in a face-to-face meeting/teleconference with the Committee)
Title & Name
Appointment (if applicable):
Name of Department or Institution:
Address:
Role in this project:
(Give qualifications and a brief summary of relevant experience for this project)
Is training required for this project? Yes /No
Direct work phone number:
Mobile number:
Email:
List all researchers involved with this project. Copy and paste the following
information box the number of times required.
Associate Researcher
Title & Name
Appointment (if applicable):
Name of Department or Institution:
Address:
Role in this project:
(Give qualifications and a brief summary of relevant experience for this project)
Is training required for this project? Yes /No
Direct work phone number:
Mobile number:
Email :
Department of Health Human Research Ethics Committee Application Form & Checklist
Website: http://www.health.gov.au/internet/main/publishing.nsf/Content/health-ethics-index.htm
Page 3
The primary contact person for the Department of Health or Institution
Contact Person for Department of Health
Title & Name
Section:
Branch:
Division:
Direct work phone number:
Email:
Contact Person for Institution
Title & Name
Appointment:
Institution:
Address:
Direct work phone number:
Mobile number:
Email :
3
How long will the research project take to complete?
_________ months
4
When do you expect to start the research project?
Please note: Researchers cannot commence the research project outlined in this
application until final/conditional approval has been given by an HREC.
………./…………/…………
5
When do you expect the research project to be completed?
The completion date includes the final data analysis for the project.
………./…………/ …………
Department of Health Human Research Ethics Committee Application Form & Checklist
Website: http://www.health.gov.au/internet/wcms/publishing.nsf/content/health-ethics-index.htm.
Page 4
6
Category of Research
Descriptions of the following categories of research can be found in the National
Statement on Ethical Conduct in Human Research 2007 (Updated May 2015). A copy
is located at: http://www.nhmrc.gov.au/guidelines/publications/e72.
Please tick any research categories relevant to your application:
 Qualitative methods (NS* 3.1)
Qualitative research involves disciplined inquiry that examines people’s
lives, experiences and behaviours, and the stories and meanings
individuals ascribe to them. It can also investigate organisational
functioning, relationships between individuals and groups, and social
environments (e.g., interviews, life story or oral history; focus groups;
observation; archival research; on-line research; action research).
 Databanks (NS* 3.2)
Types of research that commonly make use of databanks include
epidemiology, pathology, genetics and social sciences. Data may be
collected, stored or disclosed as individually identifiable data,
re-identifiable data or non-identifiable data.
The Committee does consider this
type of research.
The Committee does consider this
type of research
This also includes survey-based research (i.e., studies which collect
data by administering questionnaires by mail, in person or over the
Internet to respondents in a given target group).
 Interventions and therapies, including clinical and
non-clinical trials, and innovations (NS* 3.3)
 Human biospecimens in laboratory based research
(NS*3.4)
The Committee does not consider this
type of research
The Committee does not consider this
type of research
 Human genetics (NS* 3.5)
The Committee does not consider this
type of research
 Women who are pregnant and the human fetus
The Committee does not consider this
type of research
(NS* 4.1)
 Children and young people (NS* 4.2)
Research involving children and young people raises particular ethical
concerns about:



The Committee does consider this
type of research
their capacity to understand what the research entails, and
therefore whether their consent to participate is sufficient for their
participation;
their possible coercion by parents, peers, researchers or others to
participate in research; and
conflicting values and interests of parents and children.
Department of Health Human Research Ethics Committee Application Form & Checklist
Website: http://www.health.gov.au/internet/main/publishing.nsf/Content/health-ethics-index.htm
Page 5
 People in dependent or unequal relationships
(NS* 4.3)
The Committee does consider this
type of research
These relationships may compromise the voluntary character of
participants’ decisions, as they typically involve unequal status (e.g.,
carers and people with chronic conditions or disabilities; health care
professionals and their patients and clients; government or private
sector service providers and especially vulnerable communities to
whom the service is provided).
 People highly dependent on medical care who may be
unable to give consent (NS* 4.4)
The Committee does consider this
type of research
People can become highly dependent on interventions and treatments
and may be incapable of comprehending their situation or of
communicating about it. At the same time, research on those
interventions and treatments is necessary to assess and improve their
efficacy.
 People with a cognitive impairment, an intellectual
disability, or a mental illness (NS* 4.5)
The Committee does consider this
type of research
People with these conditions may be more-than-usually vulnerable to
various forms of discomfort and stress.
 People who may be involved in illegal activities
(NS* 4.6)
The Committee does consider this
type of research
Research that is intended to study or expose illegal activity or that is
likely to discover it must be reviewed and approved by a HREC, except
where that research uses collections of non-identifiable data and
involves negligible risk, and therefore be exempted from ethical review.
 Aboriginal and Torres Strait Islander Peoples (NS* 4.7)
HRECs are required to apply the Values and Ethics: Guidelines for
Ethical Conduct in Aboriginal and Torres Strait Islander Health
Research (2003) as well as the National Statement on Ethical Conduct
in Human Research 2007 (Updated May 2015) in the consideration of
this type of research.
 People in other countries (NS* 4.8)
Research conducted overseas by researchers from Australian
institutions must comply with the National Statement on Ethical Conduct
in Human Research 2007 (Updated May 2015).
 Quality Assurance Activities
Quality assurance includes ‘peer review’, ’quality assurance’, ‘quality
improvement’, ‘quality activities’, ‘quality studies’ and ‘audit’ (including
The Committee does consider this
type of research
The Committee does consider this
type of research
The Committee does consider this
type of research
Department of Health Human Research Ethics Committee Application Form & Checklist
Website: http://www.health.gov.au/internet/wcms/publishing.nsf/content/health-ethics-index.htm.
Page 6
all types of audit such as medical, clinical, surgical and record audit).
These terms are often used interchangeably.
 Research involving Section 95 and 95A of the
Privacy Act 1988
The Committee does consider this
type of research
The s95 Guidelines apply to medical research that involves access to
personal information held by Commonwealth agencies where identified
information needs to be used without consent from the individual(s)
involved.
The s95A Guidelines apply to the collection, use or disclosure of health
information held by organisations in the private sector for the purposes
of research, or the compilation or analysis of statistics, relevant to public
health or public safety, and to the collection of health information held
by organisations for the purpose of health service management.
 Research that is a repeat of a previously approved research
protocol
The Committee does consider this
type of research
 Other (please specify) …………………………
Department of Health Human Research Ethics Committee Application Form & Checklist
Website: http://www.health.gov.au/internet/main/publishing.nsf/Content/health-ethics-index.htm
Page 7
7
Summary of Protocol in Plain English
Unless the proposed research has merit, and the researchers who are to carry out the
research have integrity, the involvement of human participants in the research cannot
be ethically viable. In filling out this section of the form please refer to Section 1 of
the National Statement, “Values and principles of ethical conduct”.
The Summary of Protocol will be the basis of your application. The Summary should
be no longer than 10 pages in length with the total length of the application no longer
than 50 pages.
The Plain English protocol must include:

The broad aims of the research project.

If applicable, a brief summary of any previous research on which this research
project is based.

Brief summary of project including the hypotheses and research design.

Survey questions (if applicable).

Comment on the relevance of your proposed research project to current medical
or health problems and its potential to contribute to existing knowledge,
treatment, disease prevention or health promotion and whether this research will
affect broader issues of health care delivery (e.g., by decreasing demand for
hospitals).
Department of Health Human Research Ethics Committee Application Form & Checklist
Website: http://www.health.gov.au/internet/wcms/publishing.nsf/content/health-ethics-index.htm.
Page 8
8
Acronyms list
An Acronyms list must be included with the application form.
9
Summary of relevant literature findings
Research that has merit is based on a thorough study of the current literature, as well
as previous studies (NS* 1.1(c)). The literature findings should address the research
described in this application and the target group. This may also include a review of
the literature concerning the validity of particular research methods and approaches
proposed.
Attach a summary of findings and include where appropriate years searched, search
headings, relevant references etc. Also attach and refer to any unpublished articles
or reports or documents-in-progress that have been reviewed that assisted you in
developing the research project.
10 Participants
Researchers are responsible for: designing the research to minimise the risks of harm
or discomfort to participants; clarifying the potential benefits and risks of the
research for participants; and the welfare of the participants in the research context.
Whether or not participants will be identified, research should be designed so that
each participant’s voluntary decision to participate will be clearly established.
Information about research should be presented to participants in ways that help
them to make good choices about their participation and support them in that
participation. For further information please refer to Attachment A.
Total number of participants in each project group:
Total number of project groups:
Total number of participants:
Age range of participants:
Competence level of participants for consent purposes (please refer to Attachment A):
If applicable, justify the involvement of minors, dementia patients etc:
Attention should also be paid to inclusion/exclusion criteria (i.e., ensuring that speakers
of languages other than English are not inadvertently excluded).
Department of Health Human Research Ethics Committee Application Form & Checklist
Website: http://www.health.gov.au/internet/main/publishing.nsf/Content/health-ethics-index.htm
Page 9
11 Recruitment of Participants
Summarise the recruitment procedure or the sampling procedure (if applicable),
including the criteria for inclusion and exclusion. Provide samples of forms to be
used, printed advertisements, transcripts, telephone calls, images, posters, letters of
invitation etc.
Provide details of the expected participation rate and any follow up procedures to be
used for people who respond and who do not respond to your request for
participation. Give details on the types of participants you are aiming to recruit into
the project.
12. Consequences of Participation
Participants must be informed of the consequences of participating in your research
project in the Plain Language Statement and Consent Form.
What, if any, are the benefits to participants in participating in the research?
Will there be any risks to participants compared to those who do not participate (e.g.,
psychological and physical risks, or potential invasion of privacy etc)?
Will it be necessary to conduct any specific counselling or debriefing of participants?
Yes/No.
If yes, name the person/s who will conduct the debriefing, a copy of their qualifications
and the methods to be used in the debriefing/counselling. This person must be
independent of the research project.
Department of Health Human Research Ethics Committee Application Form & Checklist
Website: http://www.health.gov.au/internet/wcms/publishing.nsf/content/health-ethics-index.htm.
Page 10
13 Payments
It is generally appropriate to reimburse the costs to participants of taking part in
research, including costs such as travel, accommodation and parking. Sometimes
participants may also be paid for time involved. However, payment that is
disproportionate to the time involved, or any other inducement that is likely to
encourage participants to take risks, is ethically unacceptable (NS* 2.2.10).
Will you pay or offer compensation to participants? If so, why, how much and/or
what type of compensation?
14 Final Report to Participants
Research outcomes should be made accessible to research participants in a way that
is timely and clear (NS* 1.5). Participants need to be informed at the start of the
project if a final report will be made available, when the results may be made
available to participants, how it will be made available (e.g., hardcopy, email etc)
and the types of results that it will contain.
1. Will a final report be made available to those participating in your research
project? Yes/No
2. If Yes, give details of the report/s. If No, explain why.
15 Public Report
Will a report of the project outcomes (e.g., group data) be publicly accessible at the
end of the project? Yes/No
If No, explain why not.
Department of Health Human Research Ethics Committee Application Form & Checklist
Website: http://www.health.gov.au/internet/main/publishing.nsf/Content/health-ethics-index.htm
Page 11
16 Other Ethical Issues concerning Participants
Provide details of any other ethical issues not described above and how these issues
will be addressed by your project. Refer to the National Statement on Ethical
Conduct in Human Research 2007 (Updated May 2015) for further information.
17 Adverse Events and Unexpected Outcomes
Researchers are responsible for notifying the Committee that mechanisms for
monitoring the research (monitoring of research refers to the process of verifying that
the conduct of research conforms to the approved proposal) are in place, and for
satisfying the review body that the mechanisms are appropriate to the research
(NS* 5.5.4). Serious adverse events/reactions are to be reported immediately to the
Chair of the Committee.
Explain the monitoring, reporting and other procedures set up to manage adverse
events/reactions and unexpected adverse events/reactions with your project.
Department of Health Human Research Ethics Committee Application Form & Checklist
Website: http://www.health.gov.au/internet/wcms/publishing.nsf/content/health-ethics-index.htm.
Page 12
18 Data Sources4
It is the duty of the custodian to ensure that the data are used responsibly and
respectfully, and that the privacy of participants is safeguarded (NS* 3.2.5).
(a) Department of Health datasets
1. List the Department of Health datasets to be used for this research project.
Complete the following questions by placing a tick in the box/es that apply to your
project:
1. Will the Department of Health datasets be linked to other datasets for use in this
research? 
2. Will the project involve de-identified and/or potentially identifiable data
(NS* 3.2)?
3. Will the data be subject to the Privacy Act 1988 or any other relevant legislation? 
If any of the above questions apply to your project, provide comprehensive details.
Ethical approval of your research involving humans does not guarantee access to the Department of
Health and other institutional information and resources. The negotiations for information and
resources for a given research project are outside the parameters of the role of the Committee and the
approval process.
4
Department of Health Human Research Ethics Committee Application Form & Checklist
Website: http://www.health.gov.au/internet/main/publishing.nsf/Content/health-ethics-index.htm
Page 13
(b) Information from Other Sources
1. List the names of the datasets from other sources (e.g., State and Territory registers
etc) including the names of the data custodians that will be used to complete your
project.
2. Does the project involve collection or disclosure of personal information from
sources other than the individuals themselves and without their consent, (e.g., medical
records, state government department or agency, or state-based registers)? Yes/No
If Yes, name the source(s) and specify the type of data to be collected:
(c.1) Statistical Analyses of the Results
Summarise the validity of the research, and the extent to which the generalisations of
the results to the wider population will be possible.
Summarise the proposed statistical analyses of the data to be used with the research
project.
Department of Health Human Research Ethics Committee Application Form & Checklist
Website: http://www.health.gov.au/internet/wcms/publishing.nsf/content/health-ethics-index.htm.
Page 14
(c.2) Qualitative Analyses
Explain the methods of data analysis, explaining the process for coding and the
approach that will be used for data presentation, especially noting the ways that data
will be non-identifiable.
19 Protection of Privacy
Does your project comply with Commonwealth, State and Territory privacy
legislation? Provide details of the procedures to be used to protect the privacy of the
participant and to make any personal information anonymous.
Identify if there are circumstances in which confidentiality may be broken (e.g.,
mandatory reporting of child abuse observed during a home interview). This
information must also be disclosed in the Plain Language Statement and Consent
Form.
20 Storage and Security of Information
When planning a databank, researchers should clearly describe how their research
data will be collected, stored, used and disclosed, and outline how that process
conforms to the National Statement (NS* 3.2.1)
1. Provide details for the storage of data used in your project. This includes records
and personal information.
2. Provide details of the length of time the data will be stored and the method by
which it will be securely destroyed after that time in line with relevant
Commonwealth, state and territory legislation requirements – noting that in
general, the minimum recommended period for retention of research data is 5
years from the date of publication. However, policies for data retention should be
Department of Health Human Research Ethics Committee Application Form & Checklist
Website: http://www.health.gov.au/internet/main/publishing.nsf/Content/health-ethics-index.htm
Page 15
appropriate for the specific type of research (Joint NHMRC/AVCC Statement and
Guidelines on Research Practice, Section 2).
3. Provide details on how electronic data used in the project will be kept secure.
4. Provide details on who will have access to the data.
1.
2.
3.
4.
21
Research Protocol
 Description of how the proposed research will complement, enhance or
contribute to existing knowledge. Include a summary of previous
literature and studies:

 Justification as to why this research is necessary:

 Primary hypotheses:

 Project design (include questionnaires and surveys). Provide sufficient
detail so that the Committee can determine the strength of the research
methodology :

 Procedures and/or research questions:

 Parameters and outcomes:

 Statistical analyses:

22 Informed Consent and Competence
Consent to participate in research must be voluntary, and based on sufficient
information and adequate understanding of both the proposed research and the
implications of participation in it. The requirement for consent may sometimes be
justifiably waived – this will require approval from an HREC.
In some research, consent may need to be renegotiated or confirmed from time to
time, especially where projects are complex or long-running, or participants are
vulnerable. Research participants should be told if there are changes to the terms to
which they originally agreed, and given the opportunity to continue their
participation or withdraw (see NS* 5.2.16 and 5.2.17).
Participants are entitled to withdraw from the research at any stage. Before
consenting to involvement in the research, participants should be informed about any
consequences of such withdrawal (NS* 2.2.20).
Department of Health Human Research Ethics Committee Application Form & Checklist
Website: http://www.health.gov.au/internet/wcms/publishing.nsf/content/health-ethics-index.htm.
Page 16
Refer to Attachment A for further information that will assist you in completing the
application.
Will you be obtaining written or oral consent of the applicant? Yes/No
If not, why not?
If Yes, attach all consent forms and information packs to your application form.
Does your application comply with the requirements of Informed Consent and
Competence outlined in Attachment A?
23
Plain Language Statement and Consent Form for Participants
As a general guide, the Plain Language Statement and Consent Form should be
pitched at the reading level of a person with below average adult reading ability that
avoids technical terms or jargon. A sample Plain Language Statement and Consent
form is at Attachment B.
Attach a copy of the Plain Language Statement and Consent Form that you intend to
use to explain the project to the participant and, if required, their parent or guardian.
Make sure it is printed on the Institution letterhead, has a version number and date.
Attach third party consent forms if applicable.
-
Does the Plain Language Statement and Consent form include sufficient
information about the purpose, procedures, demands, benefits, risks,
inconveniences and discomforts of the research and clearly spell out the risks and
benefits of participation to the participants? Yes/No
If not, why not?
-
Does the Plain Language Statement contain contact details for participants who
have questions or wish to withdraw?
-
Does the Plain Language Statement and Consent form contain the contact details
of the person nominated by the Committee to receive complaints (NS* 5.6.1)?
The following sentence is an example of the wording that may be used in advising
participants of a complaints mechanism:
"If you have any concerns or complaints on the ethical conduct of this research,
please contact the Committee Secretariat, Department of Health Human Research
Ethics Committee, Department of Health, by email at ethics@health.gov.au .The
issue will then be referred to the Chair of the Committee."
Department of Health Human Research Ethics Committee Application Form & Checklist
Website: http://www.health.gov.au/internet/main/publishing.nsf/Content/health-ethics-index.htm
Page 17
If the Plain Language Statement and Consent Form are in language(s) other than
English, attach a certified, translated version(s).
Department of Health Human Research Ethics Committee Application Form & Checklist
Website: http://www.health.gov.au/internet/wcms/publishing.nsf/content/health-ethics-index.htm.
Page 18
DECLARATION OF FINANCIAL DETAILS5 AND POTENTIAL
CONFLICT OF INTEREST
Full Project Title:
1
Project Budget
Responsibility for the ethical design, review and conduct of human research is exercised
at different levels, from the detail of research conduct to the more general oversight of
review and funding (NS* Chapter 5.7).
The Committee needs to be satisfied that the funding proposed is adequate to conduct
and complete the project.
Have you included in your calculations:
 Salaries with on-costs
 Administration costs
 Research consumables
 Participant reimbursement
 Departmental charges (e.g., pharmacy, pathology etc).
 All estimated indirect costs over and above the project’s direct costs (e.g., travel,
conference costs, recruitment incentives, equipment etc).
2
Source of Funding
How will this project be funded? For example, grant, commercial sponsorship,
departmental funds.
Institution/Department/other
organisation/s who supplied the
funding for this project
$ value of
funding
Funding status
Available
Applied for
Yes/ No
Yes/ No
Yes/ No
Yes/ No
5
A researcher should disclose to the Committee the amount and sources or potential sources of funding
for the research and disclose any actual or potential conflicts of interest, including any financial or other
interest or affiliation that bears on the research (National Statement 5.2).
Department of Health Human Research Ethics Committee Application Form & Checklist
Website: http://www.health.gov.au/internet/main/publishing.nsf/Content/health-ethics-index.htm
Page 19
3
Funds Coverage
Do the funds presently available or applied for cover all requirements to conduct the
project? Yes /No
If No, please explain how the shortfall will be made up.
4
Indirect Costs
Will there be payments over and above the direct costs of this project (for example, travel
and conference, recruitment incentives, equipment)? Yes /No
If Yes, please provide details of payments and justification for them.
5
Potential Conflict of Interest
A conflict of interest in the context of research exists where a person’s individual interests
or responsibilities have the potential to influence the carrying out of his or her institutional
role or professional obligations in research; or an institution’s interests or responsibilities
have the potential to influence the carrying out of its research obligations (NS* 5.4).
Any researcher involved with this project must disclose the amount and sources or
potential sources of funding for the proposed research and must declare any affiliation or
financial interest.
Is there a potential conflict of interest with any of the researchers involved with this
project? Yes/No
If Yes, please provide details.
Department of Health Human Research Ethics Committee Application Form & Checklist
Website: http://www.health.gov.au/internet/wcms/publishing.nsf/content/health-ethics-index.htm.
Page 20
DECLARATION BY RESEARCHER(S)
All members of the research team are required to sign and date this form.
Full Project Title:
I/We, the researchers agree to abide by the conditions as set out in the National
Statement on Ethical Conduct in Human Research 2007 (Updated May 2015) as issued
by the National Health and Medical Research Council. I/We note that the research
outlined in this application cannot commence until approval has been granted by the
Department of Health Human Ethics Research Committee ( the ‘Committee’).
I/We, the researcher(s) will:
 conduct the research outlined in this application only when adequate funding is
available to enable the project to be carried out according to good research practice;
 provide additional information as requested by Committee;
 disclose any actual or potential conflicts of interest, including any financial or other
interest or affiliation, that bears on the research;
 annually, and at the completion of the project, provide reports including information
on:
(a) progress to date, or outcome in the case of completed research;
(b) maintenance and security of records;
(c) compliance with the approved proposal; and
 provide a copy of any published material resulting from the research at the end of the
research project;
 store information securely as required by law and to maintain the confidentiality of all
data collected from or about project participants, taking every precaution to prevent
the data becoming available for uses to which participants did not consent;
 notify the Committee in writing immediately if any change to the project is proposed or
an adverse event occurs; and
 agree to an audit if requested.
Name of Principal/Senior Researcher: ………………………………………………………….
Signature…………………………………………… Date…………..
Name of Associate Researcher …………………………………………………………….
Signature…………………………………………… Date…………..
Department of Health Human Research Ethics Committee Application Form & Checklist
Website: http://www.health.gov.au/internet/main/publishing.nsf/Content/health-ethics-index.htm
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CERTIFICATION BY PRINCIPAL/SENIOR RESEARCHER AND
HEAD OF DEPARTMENT OF HEALTH OR INSTITUTION
Head of Department is Assistant Secretary or above for Departmental
Staff. Institutions/research organisations/etc will require certification at a senior
management level that has the authority to approve an application of the type you are
proposing.
Please note:
Full Project Title:
Certification by Principal/Senior Researcher
I accept responsibility for the conduct of this research project according to the principles
as set out in the National Statement on Ethical Conduct in Human Research 2007
(Updated May 2015) as issued by the National Health and Medical Research Council.
I certify that all researchers and other personnel involved in this project are appropriately
qualified and experienced or will undergo appropriate training to fulfil their role in this
project.
Name of Principal/Senior Researcher:……………………………………….
Signature…………………………………………… Date…………..
Acceptance by Head of Department of Health or Institution
I certify that I have read and endorse the research project application submitted by the
Principal/Senior Researcher.
Name of Head of Department of Health or Institution: ……………………………….
Signature…………………………………………… Date…………..
Department of Health Human Research Ethics Committee Application Form & Checklist
Website: http://www.health.gov.au/internet/wcms/publishing.nsf/content/health-ethics-index.htm.
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CORE APPLICATION CHECKLIST
All fields must be completed before the Department of Health Human Research Ethics
Committee (the ‘Committee’) will consider your application.
Full Project Title
Have you answered every question or indicated ‘not applicable’ where
appropriate?

Have you defined all technical terms, abbreviations used and included an
acronyms list with your application?

Have you included all questionnaires or surveys to be used in the research
project?

Have you completed the Financial Details and Potential Conflict of Interest
Declaration Form?

Have you attached a detailed project budget?

If your research requires a Plain Language Statement and Consent Form
are they printed on Institution letterhead?

Are all pages numbered in sequence and dated in the footer?

Have you completed the form “Declaration by Researcher(s)”?

Have you completed the form “Certification by Principal/Senior Researcher
and Head of Department”?

Have you included any other documentation specifically required by the
Institutions at which you wish to conduct your research?

Have you obtained all the signatures specified in this application form?

Are all sections of your application marked?

Have you emailed a copy of your application to the Committee, including
scanned copies of the signature pages?

Name of Principal/Senior Researcher :……………………………………….
Signature…………………………………………… Date…………..
Department of Health Human Research Ethics Committee Application Form & Checklist
Website: http://www.health.gov.au/internet/main/publishing.nsf/Content/health-ethics-index.htm
Page 23
ATTACHMENT A
VALID AND INFORMED CONSENT
All documents and other material used in recruiting potential research participants, including
advertisements, letters of invitation, information sheets and consent forms will need approval
from the Department of Health Human Research Ethics Committee (the ‘Committee’) prior to
commencement of the research (NS* 5.2.23).
What is consent and capacity to consent?
The guiding principle for researchers is that a person’s decision to participate in research is to
be voluntary, and based on sufficient information and adequate understanding of both the
proposed research and the implications of participation in it. Consent may be expressed
orally, in writing or by some other means (e.g., return of a survey, or conduct implying
consent), depending on:
1. the nature, complexity and level of risk of the research; and
2. the participant’s personal and cultural circumstances.
This information must be presented in ways suitable to each participant (NS* Chapter 2)
Where a potential participant lacks the capacity to consent, a person or appropriate statutory
body exercising lawful authority for the potential participant should be provided with relevant
information and decide whether he or she will participate. That decision must not be contrary
to the person’s best interests. The National Statement outlines the responsibilities of
researchers when obtaining consent from vulnerable populations such as children and young
people; people highly dependent on medical care who may be unable to give consent; and
people with a cognitive impairment, an intellectual disability, or a mental illness.
Within some communities, decisions about participation in research may involve not only
individuals but also properly interested parties such as formally constituted bodies, institution,
families or community elders. Researchers need to engage with all properly interested parties
in planning the research.
ETHICAL CONSIDERATION SPECIFIC TO PARTICIPANTS (NS* SECTION 4)
Children and young people and consent (NS Chapter 4.2)
The child or young person’s particular level of maturity has implications for whether his
or her consent is necessary and/or sufficient to authorise participation (NS* Chapter 4.2).
A child or young person’s refusal to participate in research should be respected wherever
he or she has the capacity to give consent to that same research. Where a child or young
person lacks this capacity, his or her refusal may be overridden by the parents’
judgement as to what is in the child’s best interest.

National Statement on Ethical Conduct in Human Research 2007 (Updated May 2015)
Department of Health Human Research Ethics Committee Application Form & Checklist
Website: http://www.health.gov.au/internet/wcms/publishing.nsf/content/health-ethics-index.htm.
Page 24
Except in the circumstances described in paragraphs 4.2.10 and 4.2.11 of the National
Statement, specific consent to a child’s or young person’s participation in each research
project should be obtained from:
1. the child or young person whenever he or she has the capacity to make this
decision; and
2. either
a. one parent, except when, in the opinion of the review body, the risks
involved in a child’s participation require the consent of both parents; or
where applicable
b. the guardian or other primary care giver, or any organisation or person
required by law.
People in dependent or unequal relationships (NS* Chapter 4.3)
Being in a dependent or unequal relationship may influence a person’s decision to
participate in research. In the consent process, researchers should wherever possible
invite potential participants to discuss their participation with someone who is able to
support them in making their decision. Researchers should identify and take steps to
minimise potentially detrimental effects.
People highly dependent on medical care who may be unable to give consent
(NS* Chapter 4.4)
Consent should be sought from people highly dependent on medical care wherever they
are capable of giving consent and it is practicable to approach them. Where it is not
practicable to approach a person highly dependent on medical care, or the person is not
capable of making such a decision, consent should be sought from the participant’s
guardian, or person or organisation authorised by law, except under the circumstances
described in paragraph 4.4.13 of the National Statement.
As soon as reasonably possible, the participant and/or the participant’s relatives and
authorised representative should be informed of the participant’s inclusion in the
research and of the option to withdraw from it without any reduction in quality of care.
People with a cognitive impairment, an intellectual disability, or a mental illness
(NS* Chapter 4.5)
While research involving these people need not be limited to their particular impairment,
disability or illness, their distinctive vulnerabilities as research participants should be
taken into account.
People who may be involved in illegal activities (NS* Chapter 4.6)
Aboriginal and Torres Strait Islander Peoples (NS* Chapter 4.7)
Please refer to the Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and
Torres Strait Islander Health Research (2003), as issued by the National Health and
Medical Research Council.
People in other countries (NS* Chapter 4.8)
Research conducted overseas by researchers from Australian institutions must comply
with the National Statement.
Department of Health Human Research Ethics Committee Application Form & Checklist
Website: http://www.health.gov.au/internet/main/publishing.nsf/Content/health-ethics-index.htm
Page 25
Communicating the research objectives to participants
Information about research should be presented to participants in ways that help them to make
good choices about their participation. These ways must take into account:
1. whether the information is best communicated through speech, writing, some other
way, or a combination of these;
2. the need for accurate and reliable translation (written and/or oral) into a participant’s
first language or dialect;
3. culture and its effects on how language (English or other) is understood;
4. educational background and level;
5. age; and
6. visual, hearing or communication impairment.
Letter of invitation
In some cases it may be appropriate to use a letter of invitation rather than a Plain Language
Statement and Consent Form (e.g., mail-out questionnaire). In these cases, the letter of
invitation must be attached and contain the information normally included in a Plain
Language Statement and Consent Form. A returned and completed questionnaire implies that
the consent has been given.
Written or Oral Consent?
The Committee requires researchers to provide information as to how they will obtain
evidence that a participant has given valid consent before approval for the commencement of
the research project will be given.
The Committee generally requires that written consent will be obtained from all participants
and the Consent Form is evidence that valid consent has been obtained. If relevant,
participants must be given the choice of whether they wish to remain anonymous.
Consent may be expressed orally, in writing or by some other means (e.g., return of a survey,
or conduct implying consent), depending on the nature, complexity and level of risk of the
research; and the participant’s personal and cultural circumstances (NS* 2.2.5). If oral
consent is relevant to this proposed research, please give details of how consent will be
obtained and how this will be recorded. Examples may include a video or audio-tape record
or researcher’s notes of a conversation in their journal notes, or oral consent given over the
telephone before a telephone interview.
Signatures on the Consent Form
The Consent Form must be signed by the project participant and by the member of the
research team who explained the project to the participant.
It is generally expected that a witness will also sign the Consent Form. The witness may be
anybody who can certify that a person they believe to be the named project participant has
actually signed the Consent Form.
The signature of the researcher explaining the project implies they certify that the research
protocol for explaining the project has been followed and informed consent from a
prospective project participant has been obtained. Although any member of the research team
may give the information as part of the consent process, the legal responsibility for the
adequacy of the explanation lies with the principal researcher and the Institution approving
the project. The principal researcher must ensure the adequacy of this explanation of the
project either personally or through the appropriate delegate.
Department of Health Human Research Ethics Committee Application Form & Checklist
Website: http://www.health.gov.au/internet/wcms/publishing.nsf/content/health-ethics-index.htm.
Page 26
Legally effective consent implies that the participant understands the proposed research and is
willing to participate, as well as giving a signature on paper. The Committee recommends
that the researcher who gives the explanation also records this information by making detailed
written notes and placing a copy in the participant’s file. The information to be recorded
needs to include a description of the explanation given, details of benefits and risks explained,
and a list of questions raised and answers given. Also record that the consent and signature
were obtained and the place, date and time together with a list of all people present.
All parties signing the Consent Form must also put the date next to their signature.
Department of Health Human Research Ethics Committee Application Form & Checklist
Website: http://www.health.gov.au/internet/main/publishing.nsf/Content/health-ethics-index.htm
Page 27
ATTACHMENT B
SAMPLE PLAIN LANGUAGE STATEMENT
and consent form
Filling out this Form
Recommended text is in plain type
Instructions for preparation are in italic text
On Institution’s Letterhead
Plain Language Statement
Version # Dated #
Site ##
Full Project Title:
Principal/Senior Researcher:
Associate Researcher(s):
This Plain Language Statement and Consent Form are # pages long. Please make sure
you have all the pages.
1.
Your Consent
You are invited to take part in this research project entitled Name of Project.
(If the research is for the purpose of obtaining a degree or other educational qualification,
please state this here.)
This Plain Language Statement contains detailed information about the research project.
Its purpose is to explain to you as openly and clearly as possible all the procedures
involved in this project before you decide whether or not to take part in it. You do not
have to take part in this research project and there will be no repercussions if you choose
not to. Please read this Plain Language Statement carefully. Feel free to ask questions
about any information in the Statement.
Once you understand what the project is about and if you agree to take part in it, you will
be asked to sign the Consent Form. By signing the Consent Form you are
acknowledging that you understand the information outlined in this Plain Language
Statement and that you give your consent to participate in this research project.
You will be given a copy of both the Consent Form and this Plain Language Statement
for your records.
Department of Health Human Research Ethics Committee Application Form & Checklist
Website: http://www.health.gov.au/internet/wcms/publishing.nsf/content/health-ethics-index.htm.
Page 28
2.
Description of the Project
The purpose of this project is (state the aims of the project).
The total number of people participating in this project is…………..
Previous experience has shown that (provide a one sentence summary of the literature
review and the justification for the project).
You are invited to participate in this research project because (state why the participant’s
involvement is sought/desirable and how they were selected).
Participation in this project will involve (state the nature, number, timing and time
commitment of all procedures. Explain and describe randomisation procedures if
applicable. Include the use of placebos and their purpose, quantify the participant’s
commitment where possible, e.g., an interview of half an hour, use of videos or
audiotapes).
3.
Possible Benefits
Possible benefits include (describe any likely benefits to participants or other people in
the future. If applicable, include words to the effect that “We cannot guarantee or promise
that you will receive any benefits from this project”).
4.
Possible Risks
The possible risks and discomforts from participating in this research include:

List and quantify all risks, for (e.g., one in a million). Where possible, risks should
also be put in the context of everyday events, for (e.g., compared to the risk of death
in a car accident).

Include a general statement advising that participants can suspend or even end their
participation in the project if distress occurs. If applicable, include a warning or
exclusion statement about conception, pregnancy and breast feeding.

There should be explicit consideration of psychological risks.

If adverse reactions during interviewing are possible, ensure counselling is available.
Make clear how the person can gain access to this counselling.
5.
Confidentiality and Disclosure of Information
Any information obtained in connection with this project and that can identify you will
remain confidential. It will only be disclosed with your permission, except as required by
law. If you give us your permission by signing the Consent Form, we plan to (discuss or
publish the results, with X or Y to Z. If relevant, provide information regarding the review
of health records by researchers and by representatives of regulatory authorities and the
sponsor for the purpose of verifying the procedures and the data. Also state if there will
be commercial development of the research results).
If any information is published as a result of this research, your information will be
provided in such a way that you cannot be identified and it will be published in
accordance with the Privacy Act 1988. (Describe how confidentiality will be maintained.
Research involving focus groups presents special problems – you need to describe in
detail the process of maximising confidentiality and protection of privacy in these
situations.)
List the relevant legislation that applies to the research you are proposing.
Department of Health Human Research Ethics Committee Application Form & Checklist
Website: http://www.health.gov.au/internet/main/publishing.nsf/Content/health-ethics-index.htm
Page 29
6.
New Information Arising During the Project
The researcher may become aware of new information about the risks and benefits of the
project during the period within which the research is conducted. If this occurs, you will
be notified in writing of this new information. This new information may mean that you
can no longer continue participating in this research. If this occurs, the person(s)
supervising the research will stop your participation.
7.
Results of Project
State whether and how participants will be informed of the results when the research
project is finished.
8.
Further Information or Any Problems
If you require further information or have any problems concerning this project, you can
contact the principal researcher. (List other appropriate persons involved in the project.)
The researchers responsible for this project are: (list names and contact phone
numbers).
If you have any concerns or complaints on the ethical conduct of this research, please
contact the Committee Secretariat at ethics@health.gov.au.
9.
Other Issues
If you have any complaints about any aspect of the project such as the way it is being
conducted or any questions about your rights as a research participant, then you may
contact
Name:
Position:
Telephone:
You will need to tell (name) the name of (one of) the researchers given in section 9
above.
10.
Participation is Voluntary
Participation in any research project is voluntary. If you do not wish to take part in this
research project you are not obliged to do so. If you decide to take part and later change
your mind, you are free to withdraw from the project at any stage. You will not be
penalised in any way if you make a decision to withdraw from the project. Any
consequences of withdrawing from the research are outlined in this document.
Your decision on whether to take part or not, or to take part and then withdraw, will not
affect your relationship with (the Institution).
Before you make your decision, a member of the research team will be available so that
you can ask any questions you have about the research project. You can ask for any
information you want. Only sign the Consent Form once you have had a chance to ask
your questions and have received satisfactory answers.
Before deciding whether or not to take part, you may wish to discuss the project with a
relative or friend or your local health worker.
If you decide to withdraw from this project, please notify a member of the research team
before withdrawing. This notice will allow that person or the research supervisor to
inform you if there are any consequences linked to withdrawing (e.g., health information
revealed during the course of the research that you may wish to follow up with your
general practitioner).
Department of Health Human Research Ethics Committee Application Form & Checklist
Website: http://www.health.gov.au/internet/wcms/publishing.nsf/content/health-ethics-index.htm.
Page 30
11.
Ethical Guidelines
This project will be carried out according to the National Statement on Ethical Conduct in
Human Research 2007 (Updated May 2015) as issued by the National Health and
Medical Research Council. The National Statement provides the guidelines by which the
Department of Health Human Research Ethics Committee and other Human Research
Ethics Committees operate.
The ethical aspects of this research project have been approved by the Department of
Health Human Research Ethics Committee.
Notes for Researchers
Each page of the Plain Language Statement and Consent Form must be numbered using
the format page x of y and include a site name, date and version number.
For participants aged less than 18 years, please provide a Plain Language Statement in
words that will be understood by that age group.
Department of Health Human Research Ethics Committee Application Form & Checklist
Website: http://www.health.gov.au/internet/main/publishing.nsf/Content/health-ethics-index.htm
Page 31
SAMPLE CONSENT FORM
(attach to plain language statement)
On Institution’s Letterhead
Consent Form
Version # Dated #
Site ##
Full Project Title
I understand the Plain Language Statement dated………….which I have read/had
translated to me in my first language – version number…………..
My participation in the research is voluntary and is based on sufficient information and
adequate understanding of both the proposed research and the implications of
participation in it. I am aware that I can choose to withdraw from the research at any
stage and will be advised if there are any consequences if I choose to withdraw.
I have been given a copy of the Plain Language Statement and Consent Form for my
records.
The researcher has given the undertaking that my identity and personal details will not be
revealed if information about this project is published or presented publicly.
You may withdraw from the research/study at any time and your decision to withdraw will
have no effect on your services or care. The researchers will ensure that you are given
any information that comes to light during the research that you may need to know about,
should you wish to withdraw from the research.
Participant’s Name (printed) ……………………………………………………
Signature………………………………………………….Date………………..
Witness Name (printed) ……………………………………………………
Signature…………………………………………………..Date………………….
Researcher’s Name (printed) ……………………………………………………
Signature……………………………………………………Date………………….
Witness Name (printed)………………………………………………………….
Signature…………………………………………………….Date…………………..
Note: All parties signing the Consent Form must date their own signature.
Department of Health Human Research Ethics Committee Application Form & Checklist
Website: http://www.health.gov.au/internet/wcms/publishing.nsf/content/health-ethics-index.htm.
Page 32
SAMPLE THIRD PARTY CONSENT FORM
(attach to plain language statement)
Please note, where a potential participant lacks the capacity to consent, a person or
appropriate statutory authority for the potential participant should be provided with
relevant information and decide whether he or she will participate. That decision
must not be contrary to the person’s best interests.
On Institution’s Letterhead
Consent Form
Version # Dated #
Site ##
Full Project Title
I understand the Plain Language Statement dated ………… which I have read/had
translated to me in my first language - version number…………
I give my permission for (Participant’s name) to participate in this project according to the
conditions outlined in the Plain Language Statement.
I understand that participation in the research is voluntary and that (participant’s name)
can withdraw from the research at any stage and I will be informed if there are any
consequences if this was to occur.
I have given a copy of the Plain Language Statement and the Consent Form to the
participant for their records and kept a copy for my records.
The legal rights of (Participant’s name) have not been infringed upon by my signature
appearing on this Consent Form.
The researcher has given an undertaking that (Participant’s name) identity and personal
details will not be revealed. This includes information that is published or publicly
presented.
Participant’s Name (printed) ……………………………………………………
Name of Person giving Consent (printed) ……………………………………………………
Category (strike out that which is not applicable):
Next of Kin
Medical treatment agent
Guardian
Signature………………………………………………………..Date…………………………..
Researcher’s Name (printed) …………………………
Signature…………………………………………………………Date…………………………..
Witnessed by (printed)……………………………
Signature…………………………………………………………Date……………..
Note: All parties signing the Consent Form must date their own signature.
Department of Health Human Research Ethics Committee Application Form & Checklist
Website: http://www.health.gov.au/internet/main/publishing.nsf/Content/health-ethics-index.htm
Page 33
ATTACHMENT C
Guidelines issued by the National Health and Medical Research Council for Human
Research Ethics Committees (HRECs):
National Statement on Ethical Conduct in Human Research 2007 (Updated May
2015)
Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait
Islander Health Research (2003)
Guidelines approved under Section 95A of the Privacy Act 1988
Guidelines under Section 95 of the Privacy Act 1988
Copies of these guidelines can be located on the National Health and Medical
Research Council (NHMRC) website: http://www.nhmrc.gov.au
Department of Health Human Research Ethics Committee Application Form & Checklist
Website: http://www.health.gov.au/internet/wcms/publishing.nsf/content/health-ethics-index.htm.
Page 34