Can we survey minors or vulnerable participants in our program?

Do we need a parent's permission to survey students?

For minors, you usually do need a parent's or guardian's permission to survey students. The federal rule's protections for children are in 45 CFR 46, subpart D, which covers research the U.S. Department of Health and Human Services (HHS) conducts or supports. Under them, the IRB must make sure there are adequate provisions for asking each child's parent or guardian for permission, to the extent consent is required. It can waive that requirement only in limited circumstances. Who counts as a child depends on where the evaluation takes place. The rule defines children as people who haven't reached the legal age of consent for the procedures involved, under the law of that jurisdiction.

In programs funded by the U.S. Department of Education, a survey that asks students about certain sensitive topics, such as mental health or family income, can require a parent's written consent first. That rule (34 CFR 98.4) covers activities not directly related to academic instruction whose primary purpose is to reveal certain kinds of information. The topics it lists are political affiliations; mental and psychological problems potentially embarrassing to the student or family; sex behavior and attitudes; illegal, anti-social, self-incriminating, and demeaning behavior; critical appraisals of close family members; legally recognized privileged relationships; and income beyond what's needed to determine eligibility. For a student who is an unemancipated minor, it requires a parent's or guardian's prior written consent.

What does it mean for a young person to agree to take part?

For a young person, agreeing to take part means giving their own assent: alongside a parent's permission, the IRB usually expects the young person's own agreement, asked for in words they understand. The federal rule defines assent as a child's affirmative agreement to participate, and it says that simply not objecting shouldn't be read as assent.

The IRB decides whether the children involved are capable of assenting, taking into account their ages, maturity, and psychological state, and it decides whether and how assent must be documented. In practice, that means planning how the survey will be introduced to young people: what they'll be told about it, in what words, and how they'll be asked whether they agree.

Who counts as a vulnerable participant?

Vulnerable participants, under the federal rule, include children, prisoners, and pregnant women, for whom it adds specific protections. It also suggests using caution with other groups such as individuals with impaired decision-making capacity. The HHS regulations for the protection of human subjects in research (45 CFR 46) set out the first three in their own subparts, for research the department conducts or supports. They also ask IRBs to look for added safeguards whenever participants are likely to be vulnerable to coercion or undue influence. The groups they name there are children, prisoners, individuals with impaired decision-making capacity, and economically or educationally disadvantaged persons.

Your IRB may treat others as vulnerable, depending on the setting. In an education or workforce program, the setting can include who is asking: a student surveyed by their own instructor, or a participant surveyed by the staff who provide their services. How do we evaluate students or participants ethically? covers that power dynamic and how an external evaluator removes it.