According to the National Statement on Ethical Conduct in Human Research (2007), the guiding principle for researchers is that a person’s decision to participate in research is to be voluntary, and based on adequate information and adequate understanding of both the proposed research and the implications of participation in it.
For participation to be voluntary the decision to participate must be based on an adequate understanding of the purpose, methods, demands, risks and potential benefits of the research.
HRECs usually insist that potential participants are given a written information sheet containing this information, and that if, after consideration of this information, individuals decide to participate, they sign a written consent form which states exactly what they have agreed to.
In some circumstances, it may be more appropriate to explain information orally, and there may be some circumstances in which it is most appropriate to obtain consent another way. Respect for human beings must always be shown in any alternative arrangements for deciding whether potential participants are to enter research.
It is also important to recognise that there are circumstances in which a person’s consent is not enough to justify his or her participation.
According to Section 2.2.6 of the National Statement, for consent to be deemed voluntary the following information must be given to potential participants:
- The purpose, methods, demands, risks and potential benefits of the research.
- Any alternatives to participation.
- How the research will be monitored.
- Provision of services to participants adversely affected by research.
- Contact details of a person to receive complains.
- Contact details of the researchers.
- How privacy and confidentiality will be protected.
- The participants right to withdraw from further participation at any stage, along with the implications of withdrawal and whether it will be possible to withdraw data.
- The amounts and sources of funding for the research.
- Financial or other relevant declarations of interests of researchers, sponsors or institutions.
- Any payments to participants.
- The likelihood and form of dissemination of the research results including publication.
- Any expected benefits to the wider community.
- Any other relevant information, including research specific information which is required by other ethical guidelines in the National Statement.
Templates of information sheets and consent forms
The HREC (Tasmania) Network has developed some templates of information sheets and consent forms for various types of research, which researchers are free to use if they are appropriate for any particular project.
- Information sheet for health and medical research for a clinical trial (46.5KB).
- Information sheet for health and medical research involving tissue banking or storage of tissue samples (28.5KB).
- Information sheet for health and medical research involving genetic testing and collection of human tissue (42.5KB).
- Consent form (32.0KB) for health and medical research.
- Information sheet for social sciences research (33.0KB).
- Consent form (33.5KB) for social sciences research.