Helpful Hints for Completing the National Ethics Application Form (NEAF)

The National Ethics Application Form (NEAF) (opens in a new window) is “a web-based tool that has been developed to enable researchers of all disciplines to complete research ethics proposals for submission to Human Research Ethics Committees (HRECs), and to assist HRECs to consistently and efficiently assess these proposals. It has been designed to meet the requirements of relevant guidelines with the aim of increasing the efficiency and quality of the ethical review process for all parties involved” (National Ethics Application Form (NEAF) (opens in a new window)).

As with any universally developed tool, however, there is always the potential for misinterpretation. The following table contains a list of the most commonly misinterpreted questions and suggestions on how to accurately answer to avoid potential delays during the review of your application.

NEAF Reference
 Question
 Hint
4.1.0

In how many Australian sites, or site types, will the research be conducted?

In how many overseas sites, or site types, will the research be conducted?

 One common error that the HREC often see is researchers listing Online Surveys as overseas sites because of the potential for overseas participants.

Online Surveys are not considered overseas sites and should be nominated only as being an Australian site.
6.1.1
 Tick as many of the following “types of research participants ‘ who will be included because of the project design, or their inclusion is possible, given the diversity of Australia’s population. If none apply, please indicate this below
 HINT – You don’t have to tick anything!

Only nominate what is absolutely necessary.
For example, if you are researching children, then tick “Primary Intent of Research”, however, if you are only researching adults, then leave this field blank.

When you tick “Primary Intent”, “Possible Coincidental Recruitment” or “Specifically Excludes” for any of the nominated participant groups, further questions will be opened that requests information on how you will manage risks to these groups (where they are the primary intent of the research) or how you intend to screen for them (where the design specifically excludes).

By only answering what is necessary in this question, you are eliminating the need to justify how a social science researcher, for example, is able to screen for persons with a mental illness without accessing confidential medical documents.
6.5.2
 Is it proposed to ‘screen’ or assess the suitability of the potential participants for the study?
 This question in part relates to those groups nominated at 6.1.1.

If you nominate that your research design “specifically excludes” the participant group “People with a cognitive impairment, an intellectual disability or a mental illness” then you are required to nominate how you intend to screen for such participants. Unless you are a medical researcher, who will have access to their confidential medical records, then you will obviously not be able to screen for such groups.

Any nomination of screening potential participants must be justified through the researcher’s  relevant expertise in being able to identify such groups.
6.5.3

Describe how initial contact will be made with potential participants.

Do you intend to include both males and females in this study?

What is the expected ratio of males to females that will be recruited into this study and does the ratio accurately reflect the distribution of the disease, issue or condition within the general community?

Please explain why only one sex is involved in the study. In doing this you will need to demonstrate why this approach is valid.

 These questions relate to both the Research Merit and Integrity of the proposal as well as ethics.

In describing how initial contact will be made, the Committee prefers researchers to use a written mode,  for initial contact, except where this is inappropriate for the potential participant group. For example, potential participant groups that have a high rate of illiteracy would benefit from  verbal approach.

For professional groups, school groups, or those awaiting treatment in hospital, for example, a flyer or written letter of invitation would be the more appropriate form of approach.

In terms of the gender ratio of participants,  answer these questions in as much detail as possible. Where there is a higher ratio of men to women, or vice versa, there should be reasonable justification provided. The justification should support the merit of the research.
6.6.1
 Will consent be sought from all the participants?
...and related questions
 The issue of consent is one of the main focuses of the HREC when considering and approving ethics protocols.  When completing the NEAF, it is best to provide a considerable amount of information as developed as part of the consent component of your research design in this section.

Waiver of Consent
If you are requesting the waiver of consent, then reasonable justification must be provided. Chapter 2.3 of the National Statement should be referred to, and your justification referenced against that Chapter.

Ability of Children to Provide their own Consent
The NSW Supplement to the National Statement has issued the following statement on the ability of children to provide their own consent:
  • Under 14 years old: for research participants under the age of 14 years, the consent of the parent of guardian is necessary;
  • 14 or 15 years old: for research participants who are 14 or 15 years old, it is necessary to make a judgement about the consent to be obtained, whether the participants’ consent is sufficient, or whether it should be supplemented by the consent of the parent or guardian; and
  • 16 years old and over:  for research participants 16 years old and over, their own consent is sufficient.
When conducting research with children, HREC will expect  a clear research based justification as to why it is essential for children to participate and that the research objectives cannot be achieved through other means.

Participants who do not have the capacity to provide their own consent
When conducting research where there is the potential for persons to not have the capacity to consent for themselves, for example, those with mental illnesses, the researcher must consider how consent will be sought. The researcher, in this situation, must also justify how they will make the determination that the person is not freely able to provide their own consent.
6.6.3
 Do you propose to obtain consent from individual participants for your use of their stored data/samples for this research project?
 This question refers to the use of existing databases or stored samples “for” your research, and not the collection of data samples “from” your research. Typically this answer will be ‘No’.
8.1.1
 The information collected by the research team about participants will be in the following form(s). Tick more than one box if applicable:
-    Individually Identifiable
-    Non-Identifiable
-    Re-Identifiable
 Please note that this question refers to information collected, and not the analysis or dissemination of data.

Please consider the following when answering this question:
  • If the information is being collected directly from a participant than the information is “individually identifiable”
  • If the information is being accessed from re-coded data then it is “re-identifiable”
  • If the information is being collected from anonymous online surveys, for example, than the data is “non-identifiable”
8.3.7
 What arrangements are in place with regard to the storage of the information collected for, used in, or generated by this project in the event that the principal researcher/investigator ceases to be engaged at the current organisation?
 Specific details need to be provided.

The University’s Research Code of Practice states that “(96) In the event that the Chief Investigator leaves the University, the academic unit or division should ensure that the outgoing Investigator transfers storage protocols to another member of the University staff. It is imperative that the University continues to maintain the data and observe storage requirements”
Information Sheet /
Consent Forms		 •    Where there is engagement with Human Participants, there is a requirement for a Participant Information Sheet to be included with the Ethics Application. The webpage currently has several templates (Pro-forma (General) / Pro-forma (Medical) / Pro-forma (Parent or Care-Giver) which the HREC prefers that researchers use.

•    Where there is engagement with Human Participants, there is a requirement for consent to be obtained.

Consent, however, can be achieved in different ways dependent on the context of the survey instruments. If a survey is being conducted, either in paper format, or online, then a statement at the beginning of the survey noting that completion and return of the survey is indication of consent will suffice. For all other information collection processes, a Consent Form is required. A pro-forma template of this document is available on the Ethics webpage.

Common Errors

•    Incorrect Contact Details on Information Sheet

Please ensure that the correct templates are used which are available on the webpage. The contact phone number for the Human Ethics Office should be listed as 02 4736 0229 and the disclaimer statement as below must be included:

“If you have any complaints or reservations about the ethical conduct of this research, you may contact the Ethics Committee through the Office of Research Services on Tel +61 2 4736 0229, Fax +61 2 4736 0013 or email humanethics@uws.edu.au”

•    “Will anyone else know the results? How will the results be disseminated?”

This is a two part question which often gets missed. The first question has a standard response in the pro-forma “All aspects of the study, including results, will be confidential and only the researchers will have access to information on participants”.

For the second part of the question, the researcher should consider Section 8.6.7 of the NEAF. The answers provided at this section should be consistent with that being provided in the Information Sheet.

•    “What is the study about?” and “What does the study involve?”

These two questions are often misinterpreted.
“What is the study about?” refers to what the study is trying to achieve so you should give a brief description about the research problem and how this piece of research may contribute to our understanding of that problem.

“What does the study involve?” on the other hand, refers to what the participant is required to do – ie from the participants perspective it is What does the study involve for me?”.
For example, in a project that assesses the extra curricula interests of students for program development, “What is the study about?” could be “This study is aimed at improving the extra curricula activities of the school by directing efforts at what is the preferred activities of our students”.

“What does the study involve?” could then be, “Participants are asked to complete a questionnaire of 40 questions which surveys their current interests and what other activities they would like to have available to them. The survey is expected to take approximately 10 minutes”.

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