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Ethics Procedures

Applications for ethical approval of projects involving humans are made to the Human Research Ethics Committee. The most up-to-date information and forms are available to download directly from the Research and Development website .

Other information available on this page:

Notes for Researchers
Consent Form and Information Sheet
Use of Sensitive Test
Reference Publications and Web Sites
Additional Online Information

Form A (New Projects)

Complete Form A, using the examples provided on the School's website as an indication of the level of detail required. Additional useful information is included on pages 3-5 of this document. Make sure you read the questions carefully before answering as some sections may not be relevant.
Attach to Form A, a copy of your research proposal (<10 pages) as well as the following (where applicable).
1. Participant Information Form (see examples on School of Physiotherapy website)
2. Consent Form (see examples on School of Physiotherapy website)
3. Advertisements and letters of invitation
4. Survey instruments including list of intended questions for interviews (or, if not yet developed, the proposed content of the instrument)
5. Details of ethical approval from other Institutional Ethics Committees as applicable
Submit one original and two (2) complete copies, including relevant signatures, to the Secretary for Postgraduate Studies/ Higher Degrees/ Research in the School of Physiotherapy.
If your study involves any of the following situations, it will be forwarded to the University Human Research Ethics Committee for approval.
1. Participants will be exposed to physically invasive techniques or radiation.
2. Participants will be given drugs.
3. The project involves giving an exercise program to at-risk groups.
4. The researchers are staff who will be conducting research on their own students (ie. students in dependent relationships).
5. The study will involve induction of sustained physical pain.
6. The study will involve an intervention that might reasonably be expected to cause discomfort, embarrassment, or psychological or spiritual harm to the participants.
7. The study will involve disclosure of the response outside the research which could place the participants at risk of criminal prosecution, or civil liability or be damaging to their financial standing, employability, professional or personal relationships.
If none of these situations are involved, your application may be fast-tracked by internal reviewers in the School of Physiotherapy. You must complete your application as described above and attach a completed fast-track cover sheet. This cover sheet which can be downloaded from this website.
Applications will ordinarily take an average of three weeks to review by the Central Committee. Fast tracked applications can be reviewed in 7-10 days.
If an application is deemed to require further information or amendment, the researcher will be contacted in writing and advised accordingly.
Applications will be approved only when the Committee is satisfied that all ethical considerations and associated documentation have been fulfilled.
Approval is granted for one year and is subject to renewal.

The best way of ensuring your application is processed quickly is to complete it correctly. Taking time now to read the appropriate advice may slow you down by an hour or so but having to amend incomplete forms may add an extra week to your timeframe.

Queries

Any proposal with which the applicant or reviewer has any uncertainty or doubts in regard to ethical issues should be first referred to the Academic Secretary or the Director of Research for the School of Physiotherapy. If they are unable to advise you, they will refer the query to the Secretary of the Human Research Ethics Committee.

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Form B (ethics previously approved)

Investigators who have current ethics approval for a project are required to complete and submit for approval a Progress Report Form/Application for Renewal (Form B) at certain times. Primarily, the Form B is used to apply for renewed approval, but is also used to report on progress, provide details of any ethical issues that may have arisen, or advise where the project has been completed or abandoned. The Form B must be completed in the following circumstances:

Expiry date is reached - All investigators are required to return this form when ethics approval for the project has expired.
Changes to the protocol - If at any time during the study there is a modification to the study design, or if any ethical considerations arise, the researcher must complete and submit for approval a Form B. Modifications may include changes to the methods, information sheet, consent forms, or questionnaires. The application should provide full details of the changes and include copies of any amended documents.

Prior to the expiry date of the project, a Form B will be sent to the researcher. In the case of students this form will be distributed through the project supervisor. This form should be submitted prior to the expiry date of the project wherever possible. It is imperative that the Form B is completed and returned as it is a Commonwealth obligation of human research ethics committees to monitor research projects until completion and to ensure that each project continues to conform with approved ethical standards.

Please forward the completed copy of Form B to:
The Secretary, Human Research Ethics Committee, Office of Research and Development
Level 1, Building 100, Curtin University of Technology, GPO Box U1987, Perth 6845.

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Notes for Researchers

Confidentiality: The applicant must indicate in detail how confidentiality and privacy will be maintained, for example, what procedures and safeguards will be employed. A simple statement of intent to maintain confidentiality is not sufficient.
Anonymity and Identifiable Participants: researchers have a responsibility to take all reasonable steps to protect participant's privacy and to fully inform participants, prior to participation, of any possible risks regarding identification in published material. Researchers should give participants the opportunity to review draft material before it is published, including interview transcripts, to further ensure that the rights and privacy of participants is protected.
Access to Curtin Staff and Students: researchers who would like permission to have access to the personal details of staff or students of Curtin for the purposes of directly inviting them to participate in a research study (e.g. contact details) will require both the approval of (i) the Human Research Ethics Committee and (ii) the General Manager, Student and Staff Services, in that order.
Informed Consent: The application must provide details of how consent will be obtained and must include copies of the Consent Form and Information Sheet. See Q 3 of Form A and section below.
Risks/Benefits: The proposed benefits of the study must outweigh any potential risk, and any such risks to participants must be minimised and fully communicated to participants before consent is obtained. See Q 1 of Form A.
Adequacy of Method: Applicants should ensure that proposals provide sufficient detail in order to demonstrate to the Committee that the project is justified, relevant and that all methods are clearly outlined.
Invasive Techniques: Any proposals involving invasive techniques should automatically be referred to the Human Research Ethics Committee in order to be vetted by a suitably qualified expert.
External Institutional Approval: Proposals that require external institutional approval, ie approval from institutions outside Curtin University of Technology should be referred by formal submission to the Human Research Ethics Committee.

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Consent Form and Information Sheet

A Consent Form and Information Sheet must be provided to participants in all but exceptional circumstances. In preparing these documents reference should be made to the NHMRC National Statement on Ethical Conduct in Research Involving Humans (see paragraph on Consent 1.7 1.12). Paragraph 1.7 of the National Statement says:

"Before research is undertaken, whether involving individuals or collectivities, the consent of the participants must be obtained, except in specific circumstances defined elsewhere in this Statement [see paragraphs 1.11, 6.9, 14.4, 15.8, 16.13]."

So as to conform with ethical and legal requirements, obtaining consent should involve:

provision to participants, at their level of comprehension, of information about the purpose, methods, demands, risks, inconveniences, discomforts, and possible outcomes of the research (including the likelihood and form of publication of research results); and

the exercise of a voluntary choice to participate.

Other main points to note from the National Statement are:

A participant may refuse to participate without giving a reason or justification (paragraph 1.8).
A participant's consent must be clearly established, and the consent of all properly interested parties obtained (paragraph 1.9). When appropriate, consent may need to be sought at both an individual and an organisation level.
Consent must not be the subject of coercion, or to any inducement or influence which could impair its voluntary character (paragraph 1.10).
Circumstances in which consent from participants may not be necessary include: the use of de-identified data in epidemiological research, observational research in public places, or the use of anonymous surveys (paragraph 1.11).
A participant must be free at any time to withdraw consent to further involvement in the research.

Consent Form

A consent form would normally include the details listed below:

title of project
statements of confirmation, such as:
"I have been informed of and understand the purposes of the study."
"I have been given an opportunity to ask questions."
"I understand I can withdraw at any time without prejudice."
"Any information which might potentially identify me will not be used in published material."
"I agree to participate in the study as outlined to me."
name of participant, signature and date.

Information Sheet

The main purpose of the Information Sheet is to provide participants with a plain language statement that clearly describes the aims of the project and the nature of involvement of participants. Participants should be clearly informed of their rights and any risks associated with participation. At all times the researcher must observe the welfare of the participants and respect the dignity and personal privacy of the individual.

An Information Sheet must include the following:

The aims of the project;
A description of what will be required of the participants (include details of amount of time required of participants);
A statement which addresses confidentiality and security of information. Details of who will have access to personal information and the purpose(s) for which participant information will be used, including whether participants would be potentially identifiable in any published material;
A statement that advises participation is completely voluntary; participants are at liberty to withdraw at any time without prejudice or negative consequences; non-participation will not affect an individuals rights/access to other services/care (eg in the case of patients);
Any risks / benefits to participants;
The contact details of the investigators (and supervisor where the principal investigator is a student) should the participant require further information;
The contact details of the Human Research Ethics Committee (Secretary) should participants wish to make a complaint on ethical grounds;
Confirmation that the project has been approved by the Curtin University Human Research Ethics Committee.

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Use of Sensitive Tests

Researchers have a duty of care if their research uncovers information about individual subjects that has a bearing on their wellbeing. If the data are valid at the individual level, the researcher has a duty of care to those discovered to be at risk.
Diagnostic tests and procedures should only be used if they are specific to the research questions asked. Diagnostic tests should only be analysed by persons with the appropriate qualifications and competence to interpret the results.
If the instrument used in collecting information from the participant is a diagnostic test, and has been collected by someone professionally able to interpret it diagnostically, then the duty of care may require feedback to the individual concerned or to someone responsible for the individual (such as their physician or in the case of school children, the school principal) if the individual is identified as being at risk.
If the instrument is not diagnostic, but is still indicative or raises concerns about the individual's well-being (eg traits, states, conditions or tendencies), then feedback may still be necessary if a participant's score is extreme.
If the instrument is non-diagnostic or non-indicative, it is recommended that data should be collected in ways that would not allow an individual's score to be identified, ie, collected anonymously.
The Information Sheet to participants should clearly state whether the information is to be collected anonymously. If collected anonymously, it should state clearly that individual scores will not be identifiable or made available for any purpose. If not collected anonymously, the researcher should "inform potential subjects of the possibility of diagnosis and the way the results will be handled. In particular, the researcher must outline to whom and how results, which indicate that the subject of the research is 'at risk', will be communicated."
Where feedback to an individual or carer of the individual is warranted, extreme care is necessary to avoid possible negative consequences such as "false alarms".
The researcher's duty of care to participants pertains only to the information that is central to the purpose of the research.

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Reference Publications and Web Sites

Applicants should refer to the following publications where applicable to assist with their application:

The following document may have particular relevance to research conducted in the social sciences:

* Also available in the Closed Reserve section of the Library

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Additional Online Information

Survey Guidelines - Access to the University's Students and Staff

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Human Research Ethics Committee Forms

To download the most up-to-date HREC forms, please visit the Research and Development website .

To assist in the preparation of documents for Form A, examples of Form A completed for experimental research and for qualitative research as well as subject information sheets and consent forms are available below.

Application for Ethical Approval of Research Involving Humans (Form A)

Form A - Experimental Example (MS Word)
Form A - Experimental Example (Adobe PDF)
Form A - Qualitative Example (MS Word)
Form A - Qualitative Example (Adobe PDF)

Subject Information Form and Subject Consent Form (SIS&SCF)

SIS & SCF - Experimental Example (MS Word)
SIS & SCF - Experimental Example (Adobe PDF)
SIS & SCF - Qualitative Example (MS Word)
SIS & SCF - Qualitative Example (Adobe PDF)

Fast-Track Cover Sheet

Fast-Track Cover Sheet (MS Word)
Fast-Track Cover Sheet (Adobe PDF)

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