Writing a good application is a key component of the ethics review and approval process. A good application will demonstrate consideration of all aspects of the design of your research proposal and consideration for your prospective research participants.

Written in plain English, and clearly communicating all aspects of your human research ethics application, the quality of your application documents will significantly affect the time taken to review and approve your project.

Tips for preparing good application documents

How do I write a good application for human research ethics approval?

A good human research ethics application will increase your chances of gaining ethics approval to commence your research at the earliest opportunity.

A good ethics application provides clear and reasoned explanation of, and justification for, the research proposal.

The application should be written in plain English, avoiding esoteric jargon wherever possible and providing explanation where technical terminology is required. (Remember that ethics reviewers are often drawn from diverse backgrounds and, whilst skilled in examining the ethical suitability of a research proposal, they may not be conversant with some of the technical aspects of your research.)

Please ensure that all documentation is free of errors. This is particularly important in the case of documents like the Participant Information Form (PIF) and Participant Consent Form (PCF) that will need to be provided to your prospective research participants.

Notwithstanding the effort that goes into constructing a strong ethics application, the most valuable research often involves numerous, sometimes subtle, ethics issues. As a result, the ethics approval process regularly involves iterations between researchers and ethics reviewers. This may require you to consult with other researchers and peers.

Where appropriate, you will receive additional feedback from the HREO to assist you in producing a good ethics application; however, it is your responsibility to consider the design and implementation of your research project and to demonstrate that the benefits of your research outweigh any risks, inconvenience or discomfort that it may involve for your research participants.

Information and consent issues for research participants

In most human research projects, obtaining informed consent from prospective research participants is based on the Participant Information Form (PIF) and the Participant Consent Form (PCF).

It is essential that researchers provide appropriate consideration in constructing these documents with the objective of providing a clear and comprehensive explanation of all aspects of the research proposal as the foundation for obtaining informed consent from participants.

A good PIF will address the following items:

• Briefly outline and explain:

Guidelines to assist the University of Western Australia’s research community in developing good PIF and PCF documents are also available.

Implicit (or assumed) consent

In the case of genuinely anonymous surveys, and provided that the researcher has conveyed sufficient explanation of the project to facilitate provision of informed consent by the participants, it is generally for the survey instrument to include a statement that the return of the survey form will be taken as implied consent to participate.

In such cases, signed participant consent would not be required.

Consent of children

Children should be asked to provide their consent to be involved in research whenever they are likely to have sufficient competence to do so. The consent of the child should be sought in addition to the consent of the parent or guardian.

In such cases, it would be typical for the parent or guardian to discuss the research project with the child and for the child to indicate their consent on the consent form.

Despite the existence of a signed consent form, where a child later expresses a desire not to participate, or to withdraw their participation, this should be respected by the researcher.

Working with children and police clearances

To address certain types of risks for researchers and/or participants, an appropriate security clearance may be required.

• Working With Children Check

Working with children

For research with children, registered teachers will need to provide evidence of a Western Australian College of Teaching (WACOT) Criminal Record Check. All other researchers will need a ‘Working With Children’ check.

Copies of these should be provided as part of your ethics application document package.

A ‘Working With Children’ check can be obtained by applying through a Post Office. A ‘Working With Children’ Check

Anonymity and confidentiality

Researchers should distinguish between a research methodology that is based on anonymity for research participants and an approach in which the identifiable (or potentially identifiable) information provided by participants will be treated confidentially.

Remember that ‘anonymity’ is not the same condition as ‘confidentiality’. People’s identifiable (or potentially identifiable) information must always be treated in the strictest confidence (unless they explicitly consent to being identified).

However, in such cases where personal information is managed confidentially, you cannot claim that the methodology is ‘anonymous’.

Anonymity only applies where the information obtained from participants cannot identify them explicitly or implicitly.

Their data must be ‘non-identifiable’ and must not be ‘re-identifiable’, for example, through the application of a code that may have been used to temporarily protect an individual’s identity.

Researchers should also be aware that research information is not legally privileged; it can potentially be obtained by others, for example, through subpoena.

Therefore, researchers cannot provide research participants with an absolute guarantee of confidentiality.

An appropriate statement should be included in all PIFs; for example:

 “…all information provided is treated as confidential and will not be released by the researcher to a third party unless required to do so by law.”

Coercion and pressure in recruiting participants

No person should be subject to coercion or pressure in deciding whether to participate. Even where there is no overt coercion or pressure, consent might reflect deference to the researcher’s perceived position of power, or to someone else’s wishes.

Prospective participants should voluntarily provide their informed consent without feeling any pressure to accede to a request to be involved in a research project.

Limited disclosure, concealment or deception

Sometimes, the objectives and design of a research project require less than full disclosure of information to participants.

In some cases, this methodological requirement extends to active deception.

Where a research project requires such an approach, the researchers must demonstrate that respect for participants is maintained, that the benefits of the research justify an approach involving limited disclosure or deception, that there is no suitable alternative to such an approach, and that any risks to participants will satisfactorily managed.

Reimbursement or rewards for participating in a study

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.

Prizes

Some research contexts involve proposals for prizes as a form of inducement or reward for participants.

Whilst such proposals may be ethically acceptable, they will be reviewed on a case-by-case basis having consideration as to whether the prize(s) could coerce or pressure someone into participating in a study.

Therefore, researchers should recognise that prizes and rewards should be modest in nature and that fair and equitable opportunity should apply.

Advertising for participants

Advertising to attract prospective participants should be clear about the purpose and procedures of the study and provide sufficient information for a person to express an interest in the project and in obtaining further information, where necessary.

Advertising should be an objective, plain-language, non-coercive initial communication to provide for an expression of interest. Please avoid emotive ‘propaganda’.

Support for participants

In instances where it is possible that a participant may have an adverse reaction to the research procedure, for example, an adverse reaction that may be emotional, physical, or psychological, then the researcher should plan ahead for the provision of appropriate support to participants.

This might involve planning for the provision of a counseling service, medical referral, or other professional support in anticipation of a potential adverse event.

A human research ethics application should include recognition and explanation of such a potential circumstance, and proposed contingency plans, where required.

Aboriginal and Torres Strait Islander participants

Research conducted with Aboriginal and/or Torres Strait Islander participants must include a separate statement demonstrating how the issues in the relevant section of the National Statement will be/have been addressed. (Refer to Chapter 4.7 of the National Statement.)

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