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Office of Research Services (ORS)

Informed consent

For research with minimal risks, you need consent from youth (up to age 19) and their parents/guardians.

Competent children under age 13 years

For minimal risk studies, competent children under age 13 years give their own assent or consent to participate. Parents/guardians also provide consent.

Young children have the right to informed consent if they are capable of comprehending what is expected. A child’s veto overrules consent given by others.

If a child chooses not to participate, this must be respected, no matter who else has consented to the child’s participation. Even if a child is not competent to give consent, they must still be given the opportunity to assent to participation. This assent must be maintained throughout the study period.

If at any time children give any indication that they do not want to participate in the research study, it is not ethical to include them in the research. This is regardless of parental/guardian consent. 

See the Children under age of 13 section in Recruitment for more information.

Competent youth ages 13 to 16 years

See the Youth aged 13 to 16 section in Recruitment for more information.

Competent youth ages 17 to 18

Competent youth ages 17 to 18 can give consent. Parents/guardians do not normally need to be informed. Parents/guardians may be informed of the study if there are other institutional requirements, such as school district requirements.

Exceptions

The HREB may approve a study that does not conform to these specific guidelines. In these cases, it would take into consideration:

  • the nature of the study
  • the potential risks and benefits
  • protecting the youth from harm
  • protecting the privacy and confidentiality of the youth
  • balancing the above issues with parental rights and roles 

Diminished mental capacity

Diminished mental capacity represents a continuum. Each case must be judged individually and carefully.

Many individuals with cognitive impairments are fully capable of providing informed consent. However, if an individual can’t understand what is expected of research participation and the potential consequences of their decision, they cannot give informed consent. In such cases, the individual must still provide ongoing assent to participate. A delegated guardian or authorized representative must provide consent.

See Chapter 3 of the TCPS 2 for more information.

Special vulnerable populations

Special vulnerable populations, such as inmates or hospitalized patients, are afforded special protections.

  • you must take care that no coercion (threats or inducement) is used
  • you must obtain the consent of the appropriate authorities
  • the veto of participants overrules the consent of authorities