Introduction

Well-informed participation

Limits to Informed Consent

Information Sheets

Written Consent

General features

Necessary Information

Participant Information Statements

In almost all cases it is essential that participants be provided with a written summary of the research procedure, its benefits, harms and risks, and that they be able to take this information away with them. What is given to participants should be brief and clearly written, and written from the participants' point of view.

Participant Information Sheets should identify the host institution for the research (for example, the University of Sydney), the researchers who are ultimately responsible for the project, those who will actually make direct contact with the participants, a means by which participants are able to be in touch with the researchers to ask further questions etc. (eg. a telephone number). The document should include a schedule for the destruction of personal identifying information.

The Participant Information Statement should be written in a personal style, and in "Plain Language", that is, in simple non-technical terms. Participants should be clearly informed of what they are being asked to do, and what the potential consequences are for them, should they participate.

The information should make clear the risks of any physical or psycho-social harm, and what has been done to minimise these risks. It is important to consider whether a change in procedure (even where it might cause more inconvenience to the researcher) might reduce or eliminate the harm, while still achieving the aims of the research.

It should be made clear to participants in writing that there are no disadvantages/penalties/adverse consequences for not participating, or for withdrawing prematurely from the research. This is particularly important when the would-be participant is dependent on the researcher or close colleagues for continued treatment/interaction.

However, it may not be appropriate for the Participant Information Statement to give every detail of the procedure. It should be an incisive summary, in simple language, of the essential points that any reasonable person would wish to know before agreeing to participate.