Applications

An ethics application should comprise the following documents:

1. Cover sheet for application
2. List of headings for application
3. Consent form
4. Information sheet
5. Contacts and independent complaints

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.

Applications must be signed by all investigators named in the protocol and eleven copies submitted to the

Secretary, Human Research Ethics Committee
Research Ethics and Compliance Unit
Research Branch
Level 7, 115 Grenfell Street
University of Adelaide  SA  5005

An application must be accompanied by the documents with which it is intended to gain informed and written consent, namely the Consent Form and the Information 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.

Approval of projects is for twelve months only.

Ethical approval is renewed subject to receipt of a satisfactory brief report on the researchers' progress and their adherence to proper ethical standards.

Cover sheet for application

Consists of two pages which summarise the protocol and includes the investgators' signatures.

Cover sheet

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.

List of headings for application

Consent form

Generally, written consent of participants to be part of a research project is required.

Approval for the obtaining of oral consent is given only in special circumstances.

Consent forms should contain the following minimum requirements:

• 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 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.

If research is to be undertaken on a child, the mentally ill or those in dependent relationships or comparable situations, it is necessary to obtain the informed consent of the parent/guardian.

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

There are two types of consent form. Please tailor the wording of these to suit the particular project. 

Standard consent for people who are participants in a research project

Guardian consent for people who are participants in a research project and require consent to be obtained from a parent or guardian

Information sheet

The HREC requires an information sheet to be given to potential research participants to assist them in their decision about involvement. An information sheet must accompany each consent form. Whenever possible, the information sheet should be on the reverse side of the consent form or securely attached to it.

In order to assist researchers in preparing information sheets the following guidelines on content and use have been prepared. 

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 information sheet is to remain the property of the participant and a copy of the signed consent form should also be provided on request. 

Include the University of Adelaide logo or letterhead and use simple language with minimal technical terminology or jargon. 

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

The following items will usually be included: 

• purpose of the study
• 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 
• a comparison of the likelihood and probability of adverse effects from other procedures (or drugs) used for the same purpose
• an explanation that randomisation and/or placebos may be used
• a statement that the participant may withdraw from the study at any time without prejudice to his/her future treatment (may be on consent form)
• assurances of confidentiality (may be on consent form) 
• measures that will be taken in the event of an adverse event
• the name, title and telephone numbers (work and after hours numbers) of all members of the research group who can be contacted if any problems arise

Contacts and independent complaints

The Independent complaints procedure form should be given to research participants together with the information sheet. The form provides participants with details on how to obtain additional information on the project as well as the procedures to follow for raising concerns.