Informed consent is an integral component of ethical human research. Chapter 2.2 of the National Statement on Ethical Conduct in Human Research (2018) discusses ethical requirements for consent. Importantly, consent should be voluntary, and participants should have sufficient information to understand the research and any implications of participation.
Participant Information Sheet (PIS)
To comply with Chapter 2.2 of the National Statement (2018), researchers must communicate the purpose, methods, demands, risks and potential benefits of the research. A list of what is required is given in Section 2.2.6 of the National Statement.
A Participant Information Sheet is required for every research project. The ANU Participant Information Sheet (PIS) template is designed to address the requirements in Section 2.2.6 of the National Statement. The Ethics Committees expect researchers to use this template for all ethics applications. Your PIS won't be as long as the template document, which contains extra explanations, suggestions and examples. Not all items on the form apply to every application: you should delete items that are not relevant to your research as appropriate. However, any special provisions relevant to your research should be included (e.g. agreement to the use of audio and/or video).
It is helpful to write your PIS at the start of your ethics application. If there are certain sections of the PIS that you don’t yet have answers to, this may flag ethical issues in your research design that need to be addressed.
Reading the PIS should not be difficult or burdensome for participants. It should be written in plain language and in the second person (e.g. "You are invited to participate in a survey"). The PIS must be available in the language/s in which you are conducting the research (if this is the case, please also provide the translated version for committee consideration).
In some cases, the HREC may approve limited disclosure or deception of participants. Such research must satisfy the conditions outlined in Sections 2.3.1-2.3.4 of the National Statement. Whenever possible and appropriate, participants should afterwards be given a full explanation of the deception and the reasons for it, as well as the opportunity to withdraw their data.
Each participant’s voluntary decision to participate should be clearly established, whether or not they are identifiable in the research. You should keep a record of consent to participate in research so that it can be produced on request if required. If you are collecting personal information, personal information and consent should be stored separately.
The HREC generally prefers that researchers obtain written consent. A Written Consent Form Template is available for this purpose. Tear-off slips at the bottom of an information sheet are not adequate as consent forms. The consent form should be on a separate page.
If the data collected is actually or potentially identifiable, written consent is preferable. The consent form can then be separated from the questionnaire immediately upon its return so that no link can be made between the consent form and the questionnaire responses. Participants should be told in the Information Sheet and Consent Form that this separation will take place.
In the case of low-risk, anonymous surveys and questionnaires, return of the questionnaire can be deemed to constitute consent without a separate signature. Arrangements like this should be made explicit to participants – e.g. "By clicking 'Submit' on this survey you consent to participate in the research".
Written consent doesn't work well in some situations – e.g. with illiterate participants or in particular cultural settings. If you do not propose to seek written consent, you need to explain in your ethics application why oral consent will be sufficient and what your plan is for obtaining and recording informed consent. The HREC may suggest strategies such as audio recording oral consent or having a witness present during the consent process. An Oral Consent Form Template is also available for use.
Special Circumstances for Consent
Consent from Others
In some cases, consent from people other than the participant is also required. This may mean getting consent from authority figures, e.g. to discuss cultural knowledge, or research within a workplace. It is your responsibility as the researcher to ensure you are engaging with all relevant groups, and you should always still seek individual consent to participate.
There also may be cases where the participant may be unable to give informed consent. Researchers should bear in mind that the capacity to consent may fluctuate, and even without that capacity people may have some understanding of the research and the benefits and burdens of their participation (National Statement 2.2.12). Please refer to Section 2.2.12-13, Chapter 4.4 and Chapter 4.5 of the National Statement for more information.
Research with Children and Young People
Consent to a child's or young person's participation in research must come from the child, if they have the capacity to make this decision, as well as their parent, guardian or primary caregiver. A Committee may approve research to which only the young person consents if it is satisfied that the research is low risk, aims to benefit the participant group, and involves only young people who are able to give informed consent. See Chapter 4.2 of the National Statement for more information.
Opt-out Consent and Waivers of Consent
In some cases it may be difficult or infeasible to gain consent from all participants. The HREC may approve an opt-out approach to consent if the research satisfies the conditions in Section 2.3.6 of the National Statement.
Researchers may also request that the Committee waive the requirement for informed consent if their research satisfies the conditions in Section 2.3.10 of the National Statement. This usually applies to use of pre-existing data where it would be difficult to recontact participants. If you believe your research will require a waiver of consent, please contact the Ethics Office for advice.