Table 2 Best practices for drafting paediatric research consent forms in Canada

Scope of parental consent

Broad consent

· The possibility of future, unspecified research uses should be mentioned prior to obtaining consent and the consent form should be worded accordingly.

Ability to assent/provide future consent

· When the child is considered to be legally able to provide consent, consent should be renewed, if feasible.

· Where feasible, data and/or samples should be coded (not anonymised) in order to allow researchers to maintain contact with the child.

Ability to dissent

· The possibility of a child’s right to dissent, provided there is an ability to understand the significance of research or his/her role in it, should be disclosed.

Risks and benefits

Financial, social, and psychological issues

· Consideration of potential harms must include physical as well as psychological, social or financial harms.

Cumulative harms considered in assessing individual harms

· Cumulative harms should be considered.

How ‘benefit’ is characterised

· Risks and benefits should be considered from the child’s perspective.

Withdrawal

Ability for withdrawal

· The child’s ability to withdraw should be explicitly disclosed, as well as any circumstances that might limit the ability (e.g. if immediate withdrawal could harm the child).

Extent of withdrawal

· The extent of the ability to withdraw should be explicitly disclosed (e.g. if data and/or samples are anonymised, the consent form should state that withdrawal is not feasible).

Informational entanglement

· The potential for a child and parents to disagree about whether to withdraw, and its potential impact on the research project, should be described.

Return of research results and incidental findings

The potential and process for returning research results and incidental findings

· The potential for disclosing research results and incidental findings, as well as its process (including who discloses and the possibility for entitlement to non-disclosure), should be described.

Returning actionable individual results and incidental findings

· Individual research results and incidental findings that have clinical significance should be communicated to the child and/or parents when either prevention or treatment is available during childhood, and with adequate counselling provided. The interconnected nature of the potential risks and benefits of such communication should be disclosed.

Duty to receive information

· Parents should be made aware that they will receive clinically significant information about conditions that are preventable or treatable during childhood.

Privacy and confidentiality

Parents’ right to access information concerning their child

· In research projects that collect and use particularly sensitive information, such as pregnancy status, drug use, or sexual history, consent forms should disclose what information will and will not be communicated to parents, and which information disclosure requires the child’s consent.

Nomenclature for data/sample identifiability

· Standardised sample identifiability terminology should be used: coded (including single-coded and double-coded), anonymised, and anonymous.

· Biobanking or genetic research consent forms should declare that anonymised or coded data and samples cannot absolutely guarantee privacy.

Retention of and access to data/samples

Retention period(s) of data/samples

· Consent forms should clearly distinguish between what is a legally required data/sample retention period and a retention period decided upon by the researcher.

Access to data/samples

· The policies and procedures for access to data and/or samples should be disclosed.

· These policies and procedures should consider the privacy impact (both to the parents and child) of access to coded or anonymised information, including: organisational safeguards, technological measures, physical measures, and ethics oversight.

· If feasible, researchers should disclose a method for listing all approved projects that are accessing the data and/or samples.