A Participant Information Sheet is required for every research project. A Consent Form or Oral Consent Form is also required, with the exception being if you are conducting an online survey, and then the click of the "submit" button online or return in the mail is deemed consent. The purpose of this Information Sheet is to explain the research, what will be asked of participants, and the safeguards in place for them. The Information Sheet should be brief, written in plain language, and provide sufficient detail to allow an informed decision by the participant on whether to take part in the research project or not.
The Information Sheet template linked here is designed to accompany applications for ethics approval at ANU and contains all of the elements typically required for this purpose. It is expected that this template will be used for all ethics applications, and those Information Sheets submitted using another format will be returned for revision to the required format before approval. Not all items on the form will be needed for all applications, so items that are not relevant for a particular application should be deleted as appropriate. Ideally, Information Sheets should be one to two pages in length, so please keep this in mind as you prepare your Information Sheet using the above template.
Within the National Statement on Ethical Conduct in Research Involving Humans (2007) - Updated May 2015, chapter 2.2 outlines information that should be communicated to participants of research.
The following should be communicated to participants:
- participation is voluntary
- any alternatives to participation
- how the research will be monitored
- provision of services to participants adversely affected by the research
- contact details of a person to receive complaints
- contact details of the researchers/supervisor/HREC details and if overseas research, a local contact
- how privacy and confidentiality will be protected
- the participant's right to withdraw from further participation at any stage, along with any implications of withdrawal, and whether it will be possible to withdraw data
- the amounts and sources of funding for the researcher
- financial or other relevant declarations of interests of researchers, sponsors or institutions
- any payments to participants
- the liklihood and form of dissemination of the researchers results, including publication
- any expected benefits to the wider community
- any other relevant information including research-specific information required under other chapters of this National Statement.
The information sheet should include contact details for the Human Research Ethics Committee in case of any ethical concerns (See the National Statement). Any special provisions should also be included, e.g. agreement to the use of audio and/or videotapes, with details about how these will be stored and handled. Tear-off slips at the bottom of an information sheet are not adequate as consent forms. The consent form should provide the same details as the information sheet. They should be on separate pages.
Generally speaking the HREC prefers that written consent be obtained. However in some cases, e.g. with illiterate participants or in particular cultural settings, it may not be possible to seek written consent. If researchers do not propose to seek written consent, they need to explain to the HREC in their submission why oral consent will be sufficient and how they propose to obtain it. This should include a list of the points that will be made in order to obtain informed consent. If possible in such situations the HREC asks whether it might be possible to have a witness present during the oral consent process. Even where consent is obtained from people in positions of authority, e.g. village elders, community groups etc., individual consent from each participant should still be sought in principle.
It may be possible to dispense with the need for a consent form in the case of questionnaires, where return of the questionnaire can be deemed to constitute consent. This can be done with low-risk anonymous questionnaires. However if the questionnaire is actually or potentially identifiable the HREC prefers a written consent form, which can be separated from the questionnaire immediately upon its return so that no link is possible between the consent form and the questionnaire in most cases. Participants should be told in the information sheet and consent form that this separation will take place.
Consent to a child's or young persons participation in research must be obtained from: (a) the child or young person whenever he or she has sufficient competence to make this decision; and either (b) the parents/guardian in all but exceptional circumstances; or (c) any organisation or person required by law.
Copies of the consent form and information sheet should be attached to the application. The application should provide full details on how consent will be obtained.