Introduction

Well-informed participation

Limits to Informed Consent

Information Sheet

Written Consent

General features

Necessary Information

Written Consent

In many cases, written consent of participants is required. Details on the Consent Form should parallel with the Participant Information Statement given in writing to the participant - with the consent being obtained at a reasonable time after the participant has had the opportunity to read the written information provided.

Exceptions to written consent

Exceptions to written consent might be mass-distribution questionnaires. For some questionnaires, the return of the questionnaire is reasonably taken as an indication of voluntary consent to participate, and this fact should be clearly stated on the questionnaire itself. This might be achieved with a statement along the lines of:

Italics 'This questionnaire seeks information about your attitudes to drug dependency. We would be grateful if you would agree to take part in our study by answering all questions and returning the questionnaire to .....'

In cases where it is not appropriate to provide a written Participant Information Statement (eg. young children, Aboriginal communities or other oral cultures, where it would be more appropriate to provide them with a verbal explanation), a Dialogue Statement, of the verbal information that will be communicated, should be presented to the Committee. Where participants are under the age of 18, written consent should be sought from the participant as well as their parent/guardian for involvement in the project, if participants are of an age and/or intellectual ability where they can understand the proposed procedures.

There has been a great deal of confusion about what a researcher should include in "informed consent forms" and "information sheets" when they are approaching someone to ask them to participate in their research. The suggested forms that have previously been distributed with guidelines for applying for ethics clearance are particularly cumbersome and somewhat threatening to potential research participants (or their parents, in the case of children). Consent forms should be in plain English and be written in a user-friendly (lay terms) manner rather than a formal manner. When writing Consent Forms and Participant Information Statements the researcher should use language that is appropriate for the particular research sample. Rather than require that you follow exact wording, the Human Research Ethics Committee require only that forms are in accordance with the following guidelines (as relevant to the research proposal):