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Guidelines: Research Involving Minor Age Participants

Age of Consent:

Upon consideration of review guidelines at institutions across Canada and in reviewing relevant Ontario law, it was found that those participants aged 16 or 17 years may not in fact require parental consent to participate in some research activities.

Thus, after careful and lengthy discussion, the committee has established the following guidelines for research involving minor age participants:

  1. For minimal risk research involving participants 16 years of age and older, parental consent is not required;
  2. For more than minimal risk research involving participants 16 – 17 years of age, parental consent may be required;
  3. For participants under the age of 16, parental consent is required.

As there may be contexts in which the guidelines may not be appropriate, it is advised that when utilizing participants under the age of 18, it is best that the Office of Research Ethics be contacted for advice and direction where needed as to the applicable consent processes.

Assent Process:

In keeping with the central tenets of the TCPS, research involving minor age participants requires a greater degree of rigour with regards to the review process and greater consideration as it pertains to the consent process for the participants. Minor age participants are considered vulnerable persons and as such substitute and/or third party consent – from a parent or guardian – is required. Further, in recognition of a participants’ fundamental right to consent to participate in research regardless of age or capacity, informed assent is required.

An assent form is similar to a consent form in that it contains all the necessary elements of the consent process in age appropriate language. It affords the participants the right to have a say in whether they participate or not in the research study. It should be noted, however, for minor age participants, only the third party – parent or guardian – may consent on their behalf to participate. Similarly, it should be noted that should a parent or guardian consent to allow the minor age participant to participate but the participant him/herself does not assent to participate, then consent has not been obtained for that participant.

Assent forms:

A written assent form is generally required for participants under the age of 16. A written assent form, however, should not, in general, be used for participants under the age of 7 as it is doubtful that they would have the cognitive skills necessary to comprehend an assent in any meaningful manner. However, researchers are still cautioned, that they must obtain permission from those participants under the age of 7 at least verbally. Researchers shall append a verbal assent script for such instances.

A standard template for an assent form is difficult to create given that each research project has context specific needs, age-specific language etc. However, regardless of the context or age of the participants, an assent form should address the following:

  1. Explain what the project is about and why it’s being undertaken
  2. Explain that the participants do not have to participate and even if they do agree to participate they can stop at any time
  3. Participants can change their minds at any time, not answer certain questions if they don’t want to
  4. Explain what the risks are and what the benefits are
  5. Explain who the participants can talk to if they don’t like something
  6. Explain that they won’t get in any trouble if they don’t want to continue, and that whatever they say will be kept confidential.

For research involving minor age participants, researchers should:     Include the following documentation in addition to the protocol form and other relevant documentation when submitting a protocol to the HPRC for review:

  1.  An assent form (or script where relevant and necessary). The form and/or script should utilize age appropriate, accessible language;
  2. A parental/guardian consent form, a consent form

EXCEPTION: There are some instances, for example sexual health research involving minor age participants, where obtaining parental consent may be difficult or may in fact have a negative impact on the proposed research study. Researchers are asked to contact the Sr. Manager, Research Ethics for advice and assistance in regards to the preparation of the necessary documentation for such research projects.