POLICY
/ MQ HREC Use of Passive ‘opt-out’ Consent in Research Involving Children
Purpose / Tooutline the conditions under which the Human Research Ethics Committee will consider the use of passiveconsent in research involving children.
Overview / Macquarie University is committed to conducting its research an ethical and accountable way.
DEFINITION
National Statement: refers to the National Statement on Ethical Conduct in Human Research(2007). The National Statement clarifies the responsibilities of institutions, researchers and review bodies for the ethical design, review, conduct and dissemination of results of human research.
MQ HREC Expedited Ethical Review Checklist: refers to the form used by the Ethics Secretariat to assess the risk level of all ethics applications.
Consent:The National Statement outlines the general requirements for consent as follows: “The guiding principle… is that a person’s decision to participate in research must be voluntary, and based on sufficient information and adequate understanding of both the proposed research and its implications”.
Passive consent: a form of ‘opt-out’ consent whereby parents are provided with information about a research project and are asked to sign and return a consent form if they do not wish their child to take part in the research. Children whose parents do not return the consent form are assumed to have consented to their child’s participation.
Negligible risk research: As defined in the National Statement, this is research where there is “no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience”.
Low risk research: As defined in the National Statement, this is research where the “only foreseeable risk is one of discomfort”.
Greater than low risk research: As defined in the National Statement, this is research where “the risk for participants is more serious than discomfort”.
Scope / The policy applies to all staff, students, visiting academics, volunteers and other personnel involved in the conduct of human research involving children under the affiliation of, or in collaboration with, Macquarie University.
Policy / 1.The Human Research Ethics Committee (HREC) recognizes that the use of passive consent carries inherent risks to the participants, the researchers and the university. These risks include significant concerns about whether consent has been properly given or obtained.
To minimize this risk, the HREC will only consider applications requesting the use of passive consent for negligible or low risk research, as defined in the National Statement and in reference to the MQ HREC Expedited Ethical Review Checklist.
2. Applications requesting the use of passive consent will be reviewed by the main HREC and cannot be considered by the Faculty ethics sub-committees. Requests for the use of passive consent in research involving children will be considered on a case by case basis. The following criteria will be taken into account:
  • The age of the children
  • The type of research activity undertaken
  • The nature of the research
3.Passive consent may be acceptable in studies that involve the following activities:
  • Overt observation of children engaged in certain activities
  • Seeking children’s opinions on impersonal topics
  • Research that is closely aligned to, or cannot be separated from, the school curriculum or usual classroom activities.
4. In considering a request to use passive consent, the HREC must be reasonably satisfied that the researchers have:
  • Used appropriate strategies to deliver the information about the research to parents
  • Provided parents with a reasonable period of time to consider their child’s participation and to return the consent form if they do not wish their child to participate.
  • Provided parents with opportunities to review the research materials and/ or to discuss their child’s involvement in the research with the researchers (or the school/pre-school/child care Director/Principal, if appropriate).
  • Provided parents with low literacy or English proficiency levels with information about the research, e.g. via information and consent forms in lay language or translated into languages other than English, etc.
5. The HREC will not consider the use of passive consent in research that is considered greater than low risk. This includes research that:
  • Asks children to recount their involvement in illegal activity, e.g. underage drinking, narcotics and sexual experience
  • Seeks children’s opinion of parental or family behaviour or parental decision making
  • Conducts covert observation of children engaged in certain activities
  • Involves filming, photographing and or interviewing young children and toddlers
  • Involves sensitive topics, e.g. all forms of bullying (psychological, physical, cyber, etc)
  • Uses methodologies that raise ethical issues, e.g. administration of peer review measures
Active ‘opt-in’ consent must be obtained from parents in all of the above cases.
COMPLIANCE AND BREACHES
The University may commence applicable disciplinary procedures if a person to whom this policy applies breaches this policy (or any of its related procedures).
Contact Officer / Director, Research Ethics
Date Approved / 22 February 2013
Approval Authority / Deputy Vice Chancellor (Research)
Date of Commencement / 22 February 2013
Amendment Dates / No amendments made
Date for Next Review / 22 February 2016
Related Documents / Human Research Ethics Policy
Responsible Conduct of Research Policy
Australian Code for the Responsible Conduct of Research (2007)
National Statement on Ethical Conduct in Human Research (2007)
Macquarie University HREC Low Risk Assessment Form
Policies/Rules Superseded by this Policy
Keywords / Passive consent, parental consent, children, National Statement, negligible risk, low risk, greater than low risk

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