Guidelines: 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 a participant is unable to provide it. Such cases would include participants with intellectual or physical disabilities which preclude their doing so. Another example is young children. In these cases, it is essential to obtain informed written consent from an authority who may speak legally and responsibly on behalf of the participant. Where the design includes the “research treatment” of participants who are deemed legally incompetent by the Guardianship Act 1987 (NSW), that Act must be complied with.

The HREC acknowledges that there may be experimental procedures which would be altered and defeated if the participants knew in advance what the experiment’s true aim was. This might be the case, for example, in a psychological experiment determining a participant’s emotional responses to particular stimuli. If participants knew what the researchers were testing for, they may alter their true responses. In such situations the HREC adheres to 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 distinct from temporary embarrassment, mild alarm, etc.); and
• At the close of the experiment participants are to be fully informed (debriefed) as to the true nature of the study and the disposition of the results.

For further information, please refer to Chapters 2.2 and 2.3 of the National Statement on Ethical Conduct in Human Research.