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Congenital Heart Surgeons' Society Data Center
Consents and Assents

Each institution is responsible for ensuring that initial consent, continuing consent and assent are obtained in accordance with state or provincial regulations. Please see a general explanation for these different types of consent and assent, below. If you have any questions, please consult with your Institutional Review Board (IRB).

Initial Consent
Initial Consent is when the subject and/or the subject’s parent(s)/legal guardian is first approached to be a part of a study cohort. The site coordinator explains the purpose of the study and the subject and/or parent/guardian makes an informed decision about enrolment into the study. In United States, if the subject is 18 years and older (or as per your State/Province’s law), they can consent for themselves, otherwise the parent(s)/legal guardian consents to do the study. In Canada, Ontario has no age of consent, but a consent from the subject is obtained directly based on their maturity, level of understanding and psychological state. Please review and follow your state or provincial regulations.

Continuing Consent
During longitudinal studies, a subjects must be approached to provide continuing consent to participate in the study. The age at which continuing consent should be obtained is dependent on your state or provincial laws. In the United States, continuing consent is typically obtained when the subject becomes a legal adult (usually at 18 years of age). Please check with your local regulations to determine when continuing consent should be obtained. At this age, site coordinators should contact subjects directly to confirm their interest in continuing in the study. If they consent to continue being a part of the study, they would need to sign a ‘Continuing Consent’. The subject, not the parent(s)/legal guardian, will directly be followed in the future. Subjects cannot be followed until applicable continuing consents are received by the CHSS Data Centre.

Unlike consent, assents do not require a patient to be of a ‘legal’ age. Assents from children (subjects), along with parent(s)/legal guardian consents, are typically required by your respective IRB/REB if and when subjects are mature enough to understand what the study is about and what they are expected to do. For example, some children as young as 7 years old may be able to provide assent for a study, but this varies depending on factors such as the child’s level of understanding and the IRB/REB assent process requirements for the study. Please adhere to the assent policy at your institution.

Please note that assents are required when:

- the subject is of an assenting age/capacity during initial contact


- when the child turns into an assenting age/capacity during the longitudinal study.