Informed Consent

Informed consent is a critical requirement for conducting research ethically. There are two aspects to informed consent:

1. Is the participant given adequate information to make an informed decision about participating in the research?
2. Can the participant consent to participate in this research? Has the participant voluntarily consented to participating in this research?

Adequate information

Participants must understand what the research involves and what will be done with their data before they consent to take part (see National Statement, Chapter 2.2). This information is communicated to the participant using an Information Sheet. This information sheet is kept by the participant. Please use the Information Sheet Template to ensure that all necessary information is included is communicated to the participant. An example of how this template is to be used is also available.

There may be cases where the disclosure of information is limited (e.g., covert observation, deception). For guidance about conducting such research, see: Introduction – Chapter 2.3 and Limited Disclosure, Guidelines – Chapter 2.3 of the National Statement.

Consent

Consent must be based on adequate information about the research, and given voluntarily (free from coercion or pressure; National Statement, Chapter 2.2. See also Recruitment and Remuneration for Participants sections below). The usual way to obtain informed consent is in writing, by use of a written consent form that is signed by the participant, although there may be cases where consent is expressed orally (oral consent form template). The consent form is kept by the researcher as a record of the agreement.

There may be cases where a person other than the participant is involved in the consent process. Please refer to National Statement 2.2.12-13; National Statement Chapter 4.2: Children and young people, Chapter 4.4: People highly dependent on medical care who may be unable to give consent, and Chapter 4.5: People with a cognitive impairment, an intellectual disability, or a mental illness.

Further information regarding informed consent and the templates for these documents are available on the Information Sheets and Consent Forms page of our website.

Declining to consent and withdrawing consent

Participants are free to choose not to participate in a research project. They do not need a reason for their decision, and they should not suffer disadvantage as a result of their decision (National Statement 2.2.19). Participants who chose to participate in a research project may withdraw from the research at any time (National Statement 2.2.20).