Updated IRB Policies for Research Involving Minors

After reviewing current regulatory guidances and industry best practices, Advarra has updated its IRB policies for research involving minors. This includes policies on obtaining a child’s assent as well as parental consent requirements. These revised policies are effective immediately.

Assent

Assent is defined as a child’s affirmative agreement to participate in research. In general, Advarra recommends assent by obtained from participants ages 7 and older. Assent from participants younger than 7 is not permitted, and assent from participants 10 and older is required. The IRB is flexible regarding assent from participants ages 7-10 and will review client proposals that vary from these general guidelines on a case-by-case basis.

The IRB will review assent/consent documents to ensure the language and scope of information is age-appropriate for the proposed age range. Note that assent forms do not need to include all elements of consent. The following table outlines the IRB’s general assent requirements:

Parental Consent Requirements

The regulations define whether 1 or 2 parents must sign the ICF for research involving minors. The following table describes the criteria the IRB uses when determining how many parents must consent:

*If any component of the study meets the 2 parent criteria, then the IRB will require 2 parent signatures for the entire study. (Review our blog on component analysis for more information.) For research involving placebo, note that placebo presents no direct benefit, so the IRB may  require 2 parent signatures for these studies.

The regulations include possible exceptions to the 2 parent consent requirement, including situations where:

• 1 parent is deceased, unknown, incompetent, or not reasonably available
• Only 1 parent has legal responsibility for the care and custody of the child, if consistent with state law

Investigators should follow site policies for determining and documenting when a parent is not reasonably available. For more information on when 1 parent’s signature is sufficient, see 45 CFR 46.404/21 CFR 50.51 and 45 CFR 46.405/21 CFR 50.52. For more information on when 2 parents’ signatures are required, see 45 CFR 46.406/21 CFR 50.53 and 45 CFR 46.407/21 CFR 50.54.

For more information on how this policy might apply to a specific study, contact Business Development.

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