FAQ - Children in Research
When is a child capable of assent?
There is no absolute regulatory or ethical standard for assent. 45 CFR 46.408(a) requires that "adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent." In short, it’s the
IRB’s call. But some guidance is offered: "In determining whether children are capable of assenting,
the IRB shall take into account the ages, maturity, and psychological state of the
children involved."
As a "rule of thumb," many IRBs use the age of seven years as the approximate time when it becomes appropriate to seek assent. Seven is of course a mystical number, and moral theologians have used this age for several centuries as the "age of reason," at which one becomes capable of sin. They may not have been far off, as more recent scholarship would indicate that complex decision making, especially that including altruistic motivation and personal autonomy, is taking shape in many children by age seven.
It is more important to look at the child than it is to look at the birth certificate. A bright child who’s asking questions should be involved in the process, even if s/he’s only 5-1/2. A child who’s more sluggish and passive may be hard to involve until later. And of course, a child with mental retardation may not be capable of assent until much later.
This IRB has generally subscribed to the age-seven "rule of thumb" as a reasonable approximation for children who are intellectually normal, and our IRB will expect seven-year-olds to be involved unless there’s a documented good reason otherwise.
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What about documenting assent?
There is no absolute regulatory or ethical standard for documentation of assent. 45 CFR 46.408(e) states: "When the IRB determines that assent
is required, it shall also determine whether and how assent must be documented."
That being said, there’s a strong implication that documentation would be the
usual requirement. That is, the regulations go to the extent of giving the IRB the authority
to waive the requirement for assent in certain circumstances. That level of
regulatory oversight suggests that failure to solicit assent is considered to be a
serious violation; that in turn suggests that there should be a mechanism for
knowing whether such a violation has occurred.
The IRB has expected investigators to describe what they are doing about assent of minors in research, and how they’re documenting it. We often encourage (or even require) the use of a written assent form for a couple of reasons:
- First of all, it is symbolic – saying that the child’s right to involvement in this process is real.
- Second, the form, if well done, is a useful tool in explaining the study to a child, and serves as a reference source for that child.
- Third, making the investigator think through a study well enough to be able to write a clear and simple assent form may make the researcher actually understand the study better and do a better job on the adults’ consent form, too.
- Fourth, the use of a form satisfies the documentation issue.
An oral assent process with less detailed documentation may certainly also be acceptable, especially in studies of very low risk. Researchers may wish to propose this option.
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Is assent always required?
There is an assent requirement for each of the four categories(45 CFR 46.404 - 407) of allowable research. However, the IRB has the same authority to waive the requirement that it has to waive consent in other contexts (as set forth in 45 CFR 46.116). The first requirement for the waiver of consent is that the research not
involve greater than minimal risk—so this is really only applicable to the first of the
four categories.
There’s also a special consideration. A parent or guardian may choose to have a
child receive medical treatment over that child’s objections. When a study provides access to a therapy not
otherwise available, and that therapy seems likely to be superior to anything
available outside of a study context, the parents’ right to make medical decisions for
a child may come into conflict with the child’s right to grant or withhold assent. In
that case, an IRB may waive the requirement for assent. Again, the researcher should consider these facts and propose a waiver if deemed appropriate.
This IRB has viewed this as having no real impact on the level of information it is
appropriate to provide to the child. If the child is old enough to be involved in the
process, s/he should be involved in the process. The ethical principle of respect for
persons doesn’t go away, simply because the decisional authority resides elsewhere.
But now the exchange becomes an information-only process rather than an information-and-assent process, and it’s best to avoid terms like "assent" or "assent form" and use "information" or "info sheet".
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What should be covered in an assent process?
The regulations provide little guidance. The essential elements of the consent information should be provided, at a level and to the extent that the child is able to understand it. A lot of the formulaic elements (like compensation) can be
omitted, but one should include:
- What the subject is being asked to do,
- What the risks are likely to be,
- What benefits there might be,
- That participation is entirely voluntary,
- A statement of what the research is about.
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Is parental permission always required?
There is a parental permission requirement for each of the four categories of allowable research(45 CFR 46.404 - 407). However, the IRB has the same authority to waive the
requirement that it has to waive consent in other contexts (as set forth in 45 CFR 46.116). The first requirement for the waiver of consent
is that the research not involve greater than minimal risk—so, like the waiver of
assent, this is really only applicable to the first of the four categories(45 CFR 46.404).
There are circumstances in which getting parental
permission may be against the best interests of the child. The specific example cited
in 45 CFR 46.408(c) is a study of abused or neglected children. In that case, the
IRB may waive the requirement for parental permission, provided that adequate
other protections are in place to protect the rights and welfare of the children.
Appropriate protections would be very study-specific; for the example cited, there
may be a person-appointed by a court or a child protection agency who would be an
appropriate person to approve (or not) the inclusion of the child in the study.
For research approved under 45 CFR 46.406 or 407, the regulatory requirement is for permission from both parents. Obviously, that’s not always possible. There may be only one parent or guardian; one parent may have sole custody after a divorce; there may be only a single guardian; one parent may be unavailable for reasons honorable or no. The regulations allow for single-parent or single-guardian permission in such circumstances. A simplified way to read this requirement is that, if there are two parents in the picture and they disagree about allowing the child to participate in the research, the child may not be enrolled in the research unless that disagreement can be resolved. Note that the circumstance where the research has real potential benefit, 45 CFR 46.405, the two-parent rule does not apply.
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What should be covered in a parental permission process?
The requirements are exactly the same as those for a consent process when the prospective subject is a competent adult. 45 CFR 46.408(b) says
simply "the IRB shall determine, in accordance with and to the extent that consent
is required by 46.116 of Subpart A, that adequate provisions are made for
soliciting the permission of each child's parents or guardian." (italics added)
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What about documentation of parental permission?
The requirements are exactly the same as those for a consent process when the prospective subject is a competent adult. 45 CFR 46.408(d) says simply "Permission by parents or guardians shall be documented in accordance with and to
the extent required by 46.117 of Subpart A." (italics added)
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What about emancipated minors?
Emancipated minors are not specifically covered by federal research regulations, and emancipated minor laws do not address research participation.
In many jurisdictions, a person may become "emancipated" before the age of
majority by marrying or be demonstrating full independence. For example, if the
parents of a 16- or 17-year-old are killed, and that "child" is already employed or
headed to college on a scholarship or otherwise capable of living independently, no
guardian may be appointed and the child may have most of the legal rights of an
adult—including the full right to consent to medical care.
Although no emancipated minor statute addresses consent for research participation,
the authority to grant such consent seems a reasonable inference from the other
legal entitlements of the emancipated state.
Even less clear is the situation of "selective emancipation." Many states have laws
allowing minors to seek medical attention for certain problems such as drug abuse,
pregnancy, contraception, sexual assault, sexually transmitted diseases or the
sequelae of parental abuse or neglect. Sometimes the provision is a part of the
emancipated minor statute ("…shall be considered as emancipated for the purposes
of…"); sometimes it’s separate ("…shall be entitled without parental consent or
permission to seek medical attention for…"). Semantically, one can make an
argument that the former sort of wording should entitle the minor to give consent
for research specifically in the area for which s/he is "selectively emancipated."
However, the statute does not actually make such an
entitlement explicit, and there is no case law offering guidance.
This IRB has traditionally been very cautious on this point. If the
research would qualify for waiver of parental permission, that finding is more
clearly allowable than is a finding that the child can be his or her own consent
authority. If the research would not qualify for such a waiver, this IRB has been
very reluctant to approve it. Extreme scenarios can be imagined, but they are
certainly not common.
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What about minors who want to refuse therapy?
The parents’ authority to make medical decisions for a child "trump" the child’s decision not to grant assent. Although these
are matters typically discussed with an attorney, it is appropriate for investigators and
IRBs to be aware that the parents’ authority may not be absolute in this context.
Courts have on many occasions ruled that a "mature adolescent" may decide against
further medical care and that such a decision should be honored.
The scenario is
easy to imagine: The desperate parents are grasping at any straw to save their child;
the child has had enough, and the therapy being offered is a "long shot" with a lot of
toxicity. If that therapy is available only in a study context, such a case may fall into
the IRB’s lap.
Sometimes it’s not a practical question, because the child’s co-operation is key to
the therapy’s administration—if the child dissents, it simply isn’t going to happen.
Other times, the child’s active resistance might be required to prevent the therapy,
and s/he may be too sick to resist.
Ordinarily, this sort of discrepancy between the parents’ decision and the child’s
decision is symptomatic of a problem that is not a matter of regulatory mandate or
legal entitlement. The child may be depressed; the parents may have unrealistic
hopes; the child may value different goals and outcomes differently from the
parents; the real prospects may have been misunderstood; there may have been
mixed messaged from different information sources. The first intervention should
probably be to try to understand the reasons for the different decisions, and see if a
resolution can be found that respects everyone’s concerns. Social work and clinical
psychology consultation may be helpful (remembering that their role is not to talk
the child into accepting the therapy).
If no resolution is forthcoming, the arbiter
probably should be a court of law rather than the IRB. The decision is likely to
hinge on whether the child in question is a "mature adolescent," and
the IRB ought not get into the business of making that sort of decision about an
individual potential subject.
The IRB’s role in such a circumstance should be to insist on respect for the autonomy of the subject. The child’s decision should not be lightly overridden by the parents’ preferences if the child is mature enough to make the decision. There should be a process, rather than a fiat.
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Are there any other resources on
research with children?
OHRP provides a set
of Frequently Asked Questions (FAQs) to help clarify issues
related to research involving children.
You also may access these FAQs from the OHRP website's Policy
and Guidance page under the header "children."
The FAQs may also be accessed from the HHS
homepage, by selecting "Questions" at the top right
of the page and then on the "Questions and Answers" page
under the "Category" drop-down menu, selecting "Human
Research," and sub-menu, selecting "Human Research."
OHRP plans to continue expanding the number of FAQs on human subject
protection issues.
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