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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 participant and/or the participant'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 participant and/or parent/guardian makes an informed decision about enrolment into the study. In United States, if the participant 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 participant is obtained directly based on their maturity, level of understanding and psychological state. Please review and follow your state or provincial regulations.

Continuing Consent (Re-consenting)
Participants are enrolled in CHSS studies for life. As such, your REB/IRB may require continuing consent (re-consent) as the participant gets older. 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 and how continuing consent should be obtained. Once continuing consent is obtained, Tthe participant, not the parent(s)/legal guardian, will directly be followed in the future. Participants over the age of 18 will not be contacted by the Data Center until applicable continuing consents are obtained, or an institutionís IRB has waived the requirement for continuing consent. Please speak with your IRB about a possible waiver or alteration of the consent requirement if obtaining continuing consent for all enrolled adult participants is not feasible.

Assents
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, may be 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 childís level of understanding and the IRB/REB assent process requirements for the study. Please adhere to the assent policy at your institution.

Assents may be required when:

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

OR

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

Please inform the Data Center if assent is required in order to contact a participant for follow-up. Due to the minimal-risk nature of the CHSS studies, we encourage PIs/coordinators to request a waiver of assent from their REB/IRB.