Applications

Low risk review | Full review | Participant information sheet | Consent form | Contacts and independent complaints sheet

The HREC will assess the project in accordance with the NHMRC National Statement on Ethical Conduct in Research Involving Humans (2007) and in accordance with its own guidelines. The following implications are central and common to all projects:

• the informed consent of participants must be gained
• the rights of participants who are children, dependants, or employees must be seen to be respected and preserved
• the sensibilities, mores, inhibitions (etc) of recognised special groups must be respected.

All applications must be accompanied by the documents with which it is intended to gain informed and written consent of participants, namely the Consent Form and the Participant Information Sheet.

Ethics approval is granted for a period of three years subject to annual progress reporting. Ethics approvals may be extended subject to submission of a satisfactory ethics renewal report prior to the project approval expiry date.

Low risk review

Applications for ethical approval of 'low risk research' must include the following documents:

• 2013 Application for Review of Low Risk Research including all requested documents
• Participant Information Sheet (refer to guidelines in Participant Information Sheet section below)
• Consent Form (refer to the template links in the Consent form section below)
• Contacts and Independent Complaints Procedure Sheet.

To prevent processing delays, applicants are advised to ensure the application is submitted using the latest version of the form and templates available for download from this site. 

Full review

Applications for full review must include the following documents:

• Cover sheet for application. Consists of two pages which summarise the protocol and includes the investgators' signatures. In the case of a student project, the supervisor is to be the applicant with the student named as also involved.
• List of headings for application This list of headings applies to all applications and sets out the points which need to be addressed in the application.
• Participant Information Sheet (refer to the guidelines in the Participant information sheet section below)
• Consent Form (refer to the Consent form section below for the template links)
• Contacts and Independent Complaints Procedure Sheet.

OR

If your research is multi-institutional the University of Adelaide Human Research Ethics Committee accepts ethics applications on the National Ethics Application Form (NEAF). The NEAF is a web-based form that has been developed by the National Health and Medical Research Council to enable researchers from all disciplines to complete and submit an ethics application. The NEAF is available for completion at www.neaf.gov.au.

Participant information sheet

The HREC requires an information sheet to be given to all potential research participants to assist them with their decision to take part.

The information sheet is one aspect of providing information so that people may come to informed decisions about their involvement in research. It must not replace personal communication between the investigator and the potential participant.

The investigator should ensure that the potential participant is given sufficient time to consider the verbal and written information provided, and to discuss it with other people, before being asked to give consent to involvement.

The sheet must be translated if non-English speaking participants are to be recruited.

The following items will usually be included:

• the University of Adelaide logo or departmental letterhead
• the title of the project 
• a clear plain language statement explaining the purpose of the study
• a clear plain language statement explaining what will be asked of the participant, what will be involved and the time it will take
• the possible benefits from the study, to the participant and/or the community, indicating that these benefits are by no means assured
• all procedures that involve the participant, including the use of drugs or radioisotopes
• foreseeable risks, side effects, discomforts, inconveniences and restrictions, both immediate and later that will be involved, e.g. travel, absence from work
• an explanation that randomisation and/or placebos may be used
• a statement about how information collected will be used and results reported and publicised
• a statement about how the information and project records will be confidentially stored, who will have access to them and how long they will be kept
• a statement that the participant may withdraw from the study at any time
• assurances of confidentiality, if applicable to the project
• measures that will be taken in the event of an adverse event
• the name, title and telephone numbers of all members of the research group
• a statement referring participants to the University's contacts and independent complaints procedure sheet which is attached to the information sheet.

The information sheet, consent form and independent contacts and complaints procedure sheet are to be given to the participant. The information sheet is to remain the property of the participant and a copy of the signed consent form should also be provided on request.  

Consent form

Generally, written consent of participants to be part of a research project is required. Approval for obtaining the oral consent of participants is given only in special circumstances.

Consent forms should contain the following minimum requirements:

• the University of Adelaide logo or departmental letterhead
• the title of the research project.
• reference to the Information sheet.
• a statement that the participant has been informed that information provided will be kept confidential.
• a statement that makes it clear that the participant is free to withdraw consent at any time.
• provision for a witness to sign.
• a statement, signed by the person explaining the research, that the participant has been informed of and understands the proposed research. The person explaining the research must be of an appropriate status, and that status must be described on the consent form.

At all times, the participant should be given a copy of the signed consent form and a copy of the information sheet.

There are four standard consent form templates depending on the nature of the research and/or the participants involved:

• Consent Form - for participants in a Non Health/Medical research project
• Consent Form - for participants in a Health/Medical research project
• Consent Form - for Professionals 
• Consent Form - for University Students

Where the research involves a person under 18 years, the mentally ill or those in dependent relationships or comparable situations, it is also necessary to obtain the informed consent of the parent, legal guardian or authorised third party. There are two third party consent form templates:

• Consent Form - Third Party to Participation in Non Health/Medical Research

• Consent Form - Third Party to Participation in Health/Medical Research.

Contacts and independent complaints procedure sheet

The contacts and independent complaints procedure sheet is to be given to research participants together with the information sheet. This sheet provides participants with the appropriate contact details for seeking additional information on the project, when raising a concern and when making a complaint.