Introduction

Well-informed participation

Limits to Informed Consent

Information Sheets

Written Consent

General features

Necessary Information

Necessary Information

1. Record the title of the project in words the subject will understand. (This could differ from a scientific/medical title on a funding proposal. This should be the same as your "Short Title" on the Application Form).

2. Your Division, the names of the researchers (and Supervisor where applicable) and contact telephone numbers should be recorded on the form. Only very rarely should you provide your home address and telephone number on these forms.

3. If the project is essentially a research student's project it should identify the supervisor and indicate on the form that it is a study towards meeting higher degree requirements. For example:

4. Explain the aim/purpose of the research in terms that will meet the subject's need for this information.

5. Explain what will be involved/expected of each participant. Use lay language and if technical words must be used ensure that a simple, easy to understand explanation is provided. This should include:

A description of the procedures/tasks, their frequency and the information to be obtained.

An indication of the expected time commitment.

Other requirements such as physical interventions, wearing special clothing, abstaining from meals etc.

6. An acknowledgment of the use of equipment such as recording audiotapes, videotapes or photographs.

7. Provide an objective statement of risks or discomforts and include advice of the training or expertise of the investigators in relevant techniques. If some participants require follow-up support, researchers should make arrangements in advance for the provision of these services, and the information and consent form should note their availability and how contact can be made. Include information on who would not be able to participate eg. pregnant women, people in AIDS risk groups etc.

8. Details of any payment of money or other remuneration (eg. Course credits) for participation in the study must be provided. It must be made clear at the outset the conditions of this remuneration. For example, must participants complete the entire study to receive the remuneration, if students are participating in research as part of their course requirement, will they still receive this course credit if they withdraw? Where course credit is offered for participation in research it must be made clear to participants that they can obtain equal credit by some other educational activity should they not wish to participate in a research study.

9. Information about how the confidentiality of the data will be maintained. The form should include a statement that any information or personal details gathered in the course of the research are confidential and which procedures will be put in place to ensure this. It is not sufficient to merely state that "confidentiality is guaranteed." The Form should also indicate who else will have access to the data. If other researchers not directly involved in the study may gain access to the data, this should be acknowledged. The original investigator should strictly monitor access and no information that will identify participants should be released without the explicit consent of the participants concerned.

10. The researcher should provide a statement of what the research will be used for and the possibility of publication of the results. There should be an assurance that publications will not include any information identifying individual participants unless specific permission is obtained.

11. Participants should be advised if they will be given the opportunity to preview results or interview transcripts before they are used. For interviews participants should also be advised if they will have the opportunity to withdraw or amend any information anytime during or at the end of the interview.

12. A statement should be included regarding the security of the storage of the data, how long data will be retained and when items such as audio, videotapes or photographs will be destroyed. If you wish to retain the data for comparison purposes for later studies this should be disclosed and consent specifically sought.

13. The form must include a statement guaranteeing participants the right to withdraw from the research at anytime, without having to give a reason and without consequences.

    If the participant is in a dependent relationship to the investigator (eg. a patient, student, or dependent) or to an institution directly or indirectly involved in the research, then it is important to emphasise that any refusal to participate or withdrawal from the research will not prejudice the participant's future care, employment, or academic progress in any way.

    An exception is where research data is collected completely anonymously. Participants cannot be guaranteed the right to withdraw their data "at any time" because the data, once submitted, cannot be identified with specific individuals. The most common case is with anonymous questionnaires.

    The Participant Information Statement should indicate that participants will have the option of having any data already collected destroyed (ie. tapes erased in their presence, questionnaires destroyed etc) should they withdraw from the study.

14. A signed statement of agreement to participate in the research. Please refer to further samples of the Consent Forms under the Section 'Sample Documents'.

15. In certain limited cases the requirement to obtain signed consent statements of agreement to participate is deemed not to apply. These include, for example, mass distribution questionnaires where no information which could identify participants is collected, procedures which may be part of the normal routine (eg. school assessments), research where direct contact with participants does not occur (eg. telephone surveys), and research where potential subjects are unlikely to agree to participate if any identifying information is collected (eg. drug use, HIV/AIDS). In most of these cases, however, it is still necessary to provide potential participants with either written or verbal information about the research and their rights as participants, and to obtain verbal consent, if possible. Morally obtaining verbal consent at the beginning of an audio or videotape recording will satisfy these situations. Exceptional circumstances may require a more creative solution. In the case of anonymous questionnaires, participants should be specifically informed that "return of the questionnaire will be regarded as consent to use the information for research purposes".

16. Include the University of Sydney Human Research Ethics Committee complaints clause in footnote form (but at least size 12 font) that states:

17. Please note that in some instances it will not be appropriate to supply the names and contact details of the researchers and the University Ethics Office. For instance, in research undertaken in prisons with sexual offenders or serial killers etc.