For people highly dependent on medical care, chapters, 2.2.12, 4.4 & 4.5 in the National Statement on Ethical Conduct in Human Research (2023) acknowledges there may circumstances where participants do not have the capacity to consent, or their capacity may fluctuate. In these instances, consent for them to participate can be complex, as they may have some or no understanding of the research study and the potential burden or benefit.

Sections 4.4.9 states “Consent should be sought from people highly dependent on medical care wherever they are capable of giving consent and it is practicable to approach them. 4.4.10 Where it is not practicable to approach a person highly dependent on medical care, or the person is not capable of making such a decision, consent should be sought from the participant’s guardian, or person or organisation authorised by law, except under the circumstances described in paragraph 4.4.13”.

For people with a cognitive impairment, and intellectual disability or a mental illness, chapter 4.5 in the National Statement on Ethical Conduct in Human Research (2023) acknowledges the capacity to consent and participate is individual and may vary. When able to consent, people with these conditions may be more vulnerable to stress and discomfort, and more care should be taken to minimise these affects. The research design should also consider the participants capacity to receive information and consent, and their ability to participate, as this may change or vary over time.

For vulnerable participants, the consent process should describe how others e.g parent, caregiver, etc, will be involved in the consent process, how their consent will be obtained before collecting consent from the participant, and detailed measures that will be put in place to ensure that the consent decision is not contrary to the person's best interests. A Participant Information Letter and Consent Form for both the participant and the person or appropriate body exercising lawful authority for the potential participant should be provided for the HREC review. 

Please refer to the Research Ethics Manager and the Office of General Council (OGC) for further advice.

Chapter 4.2 in the National Statement on Ethical Conduct in Human Research (2023) outlines the ethical concerns for children and young people in research. In most instances, the parent/guardian and the child should provide consent to participate. The HREC will consider and 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 provide informed consent.

Research with children and young people under 18 years of age raises particular issues around informed consent. Usually, you need to get consent from:

• the child or young person and
• the parent or guardian.

When you are seeking consent from a child or young person, you need to think about:

• their capacity to understand what the research involves and
• the complexity of the research, and its potential risks and benefit.

You should respect the developing capacity of children and young people to be involved in decisions about their participation in research - see Chapter 4.2 in the National Statement on Ethical Conduct in Human Research (2023). In some cases, parental consent may not be necessary. For example, a 17 year-old with good literacy skills may be able to consent to low-risk research.

Justification should be provided to the HREC for the use of young person’s consent and which addresses each of the following points:

• (a) Outline how the researchers would make the determination that the young person is mature enough to understand the relevant information and to give consent, although vulnerable because of relative immaturity in other respects;
• (b) whether the research involves no more than low risk (see Chapter 2.1);
• (c) how the research aims to benefit the category of children or young people to which this participant belongs; AND
• (d) either
  • 1. the young person is estranged or separated from parents or guardian, and provision is made to protect the young person’s safety, security and wellbeing in the conduct of the research (see 4.2.5). (In this case, although the child’s circumstances may mean he or she is at some risk, for example because of being homeless, the research itself must still be no more than low risk); or
  • 2. it would be contrary to the best interests of the young person to seek consent from the parents, and provision is made to protect the young person’s safety, security and wellbeing in the conduct of the research (see 4.2.5)
  • 3. If the child cannot consent, you should still involve them in appropriate discussions about the research. Please refer to our Easy read and Parent and Guardian PICFs for guidance.

Learn more about research with children and young people

Consent from people other than the participant may also be required. This may mean getting consent from authority figures, e.g., to discuss cultural knowledge, or research within a workplace or an organisation, or consent from the data owner.

It is the researcher’s responsibility to ensure engagement with all relevant groups, and to seek the appropriate consent and provide a copy to the HREC.

Written consent is the HREC’s preferred option where the research involves face-to-face contact, especially if the data will be collected as identifiable or re-identifiable data. The participants should be provided with a copy of the Participant Information Letter and Consent Form (PICF), and provided adequate time to read the information, ask questions or consult with others (e.g., family member or a medical practitioner), before they are asked to provide written consent by signing the consent form. If applicable, an eligibility screening process should be utilised to determine if potential participants meet the inclusion criteria. If conducting an anonymous questionnaire where written consent is obtained, the consent form should be separated from the completed questionnaire to maintain the participants anonymity to the data.

Please see the ACU PICF templates

Email consent can be used in situations where the data collection will not take place in person such as via videoconferencing or prior to a face-to-face contact in advance. Participants are emailed a copy of the participant information statement and consent form. Once provided with a copy of the PICF, the participants should be provided adequate time to read the information, ask questions or consult with others (e.g., family member or a medical practitioner). If applicable, an eligibility screening process should be utilised to determine if potential participants meet the inclusion criteria. Participants who agree to participate should be directed to sign via e-consent or sign and scan and return the consent via email. Researchers should consider whether participants will have the technology to add e-signatures or to scan documents when developing their email consent process. As an alternative, the participants can reply via email stating they confirm that they have received and read the Participant Information Letter and have had the opportunity to ask questions, and they agree to provide their consent to participate in the research. The researchers would then need to keep a copy of the returned email as proof of consent.

For assistance with this process or RedCap and Qualtrics, contact eresearch@acu.edu.au.

e-consent

e-consent is a new technology and a good option for consenting participants in research, such as in REDCap or Qualtrics. However, it is not without challenges, as the researchers will need to ensure that participants have read and understand the Participant Information Letter and are providing informed consent. For online surveys, a copy of the Participant Information Letter and Consent Form (PICF) must be presented to the potential participants prior to the eligibility and consent process, and a downloadable PICF provided.

Participants should also be provided with an opportunity to contact the researchers and ask questions consult with others (e.g., family member or a medical practitioner). If applicable, an eligibility screening process should be utilised to determine if potential participants meet the inclusion criteria. After consenting, the participant should also be able to download their consent form or have it emailed to them.

For assistance with this process or RedCap and Qualtrics, contact eresearch@acu.edu.au.

Please see the ACU PICF templates

Online consent or implied consent

Online consent or implied consent is used in situations where surveys/questionnaires are administered online, in person or in a format that provides anonymity to the participant. The PICF must be provided online prior to the survey and be downloadable, via email, or attached to the front of a hard copy survey prior to the consent process, and the participant provided with an opportunity to contact the researchers and ask questions. Consent can be obtained after reading the Participant Information Letter and consent statement, by clicking a submission button online, checkboxes or by implying consent when returning a completed hard copy survey or questionnaire by mail or in a specific place, for example, a box (such as a voting box).

For anonymous studies, participants should be advised before they submit, that their responses cannot be withdrawn after submission. For identifiable studies, the withdrawal conditions and timeframe to withdraw should be explicit in the consent form. Participants should be provided with a consent form in hard copy or via email for their records or provided with a link to a downloadable version online.

Verbal/Oral Consent involves research conducted face-to-face or via video or telephone consultation and e-consent processes. Verbal consent may be used in situations where the research requires contact with participants who are illiterate, vulnerable, or in particular cultural settings where verbal consent is culturally appropriate. The participant information Letter and consent form (PICF) are to be provided in an accessible format to the participant group.

Please note, the HREC will require a rationale for why you have chosen to only use an Oral Consent script.

For research via the telephone or teleconferencing, the provision of the PICF prior to conducting the research is preferable. At the beginning of the telephone or tele-conference call, the research team should re-iterate the conditions of participation and ensure the participants consent to continue with the interview/questionnaire. If only providing a verbal description of the PICF, then the PICF will need to be read out to the participants prior to collecting any data. The participant should be provided with an opportunity to ask questions or consult with others (e.g., family member or a medical practitioner).

If applicable, an eligibility screening process should be utilised to determine if potential participants meet the inclusion criteria. The Consent process should be recorded or have a witness present.

A Waiver of Consent requires a researcher to seek approval from an ethical review body in order to use a person’s personal information or personal health information without obtaining consent directly from the individual in order to use that information in a research project.

The ACU HREC will only consider a Waiver of Consent where there are extenuating circumstances and researchers must provide justification for why it is not possible or impractical to seek consent from the original participants. A waiver of consent refers to cases where researchers are collecting data or tissue about people without their knowledge or consent. Chapter 2.3 of the National Statement on Ethical Conduct in Human Research (2023) provides guidance on qualifying or waiving conditions for consent. Where it is impractical to obtain explicit consent for the use of their information and the purpose of the research can be serviced by using non-identifiable information, researchers must comply with Guidelines approved under Section 95 or 95A of the Privacy Acting 1988. The ACU HREC requires that researchers respond to the following requirements when requesting a Waiver of Consent. Section 2.3.10 of the National Statement on Ethical Conduct in Human Research (2023).

Requests to waive the requirement for consent must be sought by including a justification at section 3.6 (a) of the UNSW Ethics Application Form or section 3.2 (b) of the Negligible Risk Ethics Application Form. The justification must address points (a) to (i) of section 2.3.10 of the National Statement on Ethical Conduct in Human Research (2023):

• (a) involvement in the research carries no more than low risk (discomfort) to participants;
• (b) the benefits from the research justify any risks of harm associated with not seeking consent;
• (c) it is impracticable to obtain consent (e.g., due to the quantity, age or accessibility of records);
• (d) there is no known or likely reason for thinking that participants would not have consented if they had been asked;
• (e) there is sufficient protection of their privacy;
• (f) there is an adequate plan to protect the confidentiality of data;
• (g) in case the results have significance for the participants’ welfare there is, where practicable, a plan for making information arising from the research available to them (for example, via a disease‐specific website or regional news media);
• (h) the possibility of commercial exploitation of derivatives of the data or tissue will not deprive the participants of any financial benefits to which they would be entitled;
• (i) the waiver is not prohibited by State, federal, or international law.

1. Personal information (i.e. identifiable information) is information or an opinion that identifies a person or could identify them, and includes information about their health. Examples: individual’s name, signature, address, telephone number, date of birth, medical records, bank account details and commentary or opinion about a person (Privacy Act 1988).

2. Health information (i.e. collected for clinical rather than research purposes) is any information about a person’s health or disability, as well as any other personal information collected while they are receiving a health service. It is regarded as one of the most sensitive types of personal information.

3. Human biospecimens refers to any biological material obtained from a person including tissue, blood, urine and sputum and any derivative of these, such as cell lines. It does not include non‐human biological material such as microorganisms that live on/in a person.

The National Statement on Ethical Conduct in Human Research (2023) at section 2.3.5 says that researchers should respect people’s capacity to make their own decision. This normally means that people should give express consent to take part in a project.

Sometimes it may be justifiable to use an alternative approach. You may be able to use an opt-out approach. This might be appropriate if you are running a large scale, low risk project and it is not feasible to get express consent from each person. The opt-out approach is unlikely to constitute consent if you are applying Commonwealth privacy legislation to the handling of sensitive information, including health information.

Using an opt-out approach means that participants are included in the research unless they give their express decision to be excluded. Their decision must be informed. Therefore, you still need to provide a Participant Information Letter about your project and provide a method or contact details to opt-out. Once you have done this, you can assume that they are willing to take part in your project unless they say they do not want to. However, Participants must be informed and provided with written information about the project, that they are able to read and understand, so they can decline to participate. See 2.3.6 in the National Statement on Ethical Conduct in Human Research (2023) for further information and conditions.

The ACU HREC is of the view that “silence” or “no response” does not necessarily constitute consent and opt-out is a significant deviation from our usual expectations. Researchers are expected to make significant efforts to ensure participants are made aware of the project and its requirements.

Researchers are expected to provide a strong argument to the HREC to support any requests for an Opt-out Approach.

Researchers may find that the use of deception, or limited disclosure, is a necessary tool for their study. However, the use of such techniques raises special issues that the HREC/Ethics Panels will review closely.

Learn more about limited disclosure