Exceptions to written consent
Consent may be expressed orally, in writing or by some other means (for example, return of a survey, or conduct implying consent), depending on:
(a) the nature, complexity and level of risk of the research; and (b) the participant’s personal and cultural circumstances (NS 2.2.5).
Return of a Survey/Questionnaire
A separate Participant Consent Form is not required where consent is built into the process for returning an anonymous survey or questionnaire. The appropriate wording should be included in the Participant Information Statement.
In some cultures it is not appropriate to use a Participant Consent Form (PCF). Alternatives include using a spoken script to obtain oral consent. Researchers should include a statement indicating how they would begin such a dialogue and provide a copy of the script to be used. In these cases, consent may be obtained orally and recorded either by being audio-recorded or by appropriately referenced field notes by the researcher. It is of course imperative that participants understand exactly what is expected of them and to what they are consenting.
A signed consent form or identifiable record of consent may not be appropriate for some sensitive topics (e.g. drug use) where anonymity is important to protect privacy and prevent identification of participants. In this case consent may also be obtained as above.
If a written PCF is not to be used the ethics application must make a clear case for alternative approaches and specify how the standards of the National Statement will be met.
Participants who are unable to give 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. 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 study includes participants who are deemed legally incompetent by the Guardianship Act 1987 (NSW), that Act must be complied with.
Waiver of Consent
The requirement for consent may sometimes be justifiably waived. In this case research participants will characteristically not know that they, or perhaps their tissue or data, are involved in the research.
‘Limited disclosure’ to participants regarding the aims and/or methods of research may sometimes be justifiable. This is because in some human research (for example, in the study of behaviour), the aims of the research cannot be achieved if those aims and/or the research method are fully disclosed to participants (NS 2.3). In this case, participants should be debriefed regarding the aims and methods of the research following completion of their participation.
Any request for waiver of consent or limited disclosure to participants must be justified by researchers in the ethics application. Please consult Chapter 2.3 of the National Statement on Ethical Conduct in Human Research