POLICY
MQ HREC Use of Passive ‘opt-out’
Consent in Research Involving
Children
Purpose
To outline the conditions under which the Human Research Ethics
Committee will consider the use of passive consent 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”.
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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
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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
Date Approved
Approval Authority
Date of Commencement
Amendment Dates
Date for Next Review
Related Documents
Director, Research Ethics
22 February 2013
Deputy Vice Chancellor (Research)
22 February 2013
No amendments made
22 February 2016
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
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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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