Introduction

Well-informed participation

Limits to Informed Consent

Information Sheets

Written Consent

General features

Necessary Information

Limits to Informed Consent

Wherever possible, written informed consent of the participant is required. In some special cases it will not be possible to obtain informed consent because those participating are not competent to offer such consent. (eg. because they are comatose, have an intellectual disability or are young children). In these cases it is essential to ensure that there are authorities that may speak responsibly on their behalf and to ensure that the informed consent of those authorities is obtained. Where the design includes participants' "research treatment" of legally incompetent persons as defined in the Guardianship Act 1987 (NSW), that Act must be complied with.

It is acknowledged that there may be experimental procedures, which would be defeated if the participants knew in advance what was happening. This might be the case, for example, in a psychological experiment determining a person's emotional responses to particular stimuli. For such situations the Committee works with the following guidelines.

• Participants should not be subject to any procedure which is reasonably likely to prove either physically harmful to them or of enduring psychological harm (which is to be distinguished from temporary embarrassment, mild alarm, etc.), and
• Participants are to be fully informed (debriefed) at the close of the experiment as to its nature and the disposition of results.

For further information see "National Statement on Ethical....." p.12, pt 1.7 and subsequent paragraphs