Institutional Review Board for Health Sciences Research (IRB-HSR)

Special Issues

Vulnerable Subjects - Children / Minors

The legal mandate of the IRB is to protect the rights and welfare of human subjects. This task becomes more difficult when considering children as research subjects. OHRP provides an FAQ on this topic. The Federal regulations provide for “Additional Protections for Children Involved as Subjects of Research.” Subpart D of 45 CFR 46. "Children" are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted (45CFR46.402(a). In the state of Virginia the legal age is 18 however some exceptions may apply.

Definition of Children

The definition of “children” also takes into account the particular treatments or procedures involved in the proposed research; for example, minors may legally consent to certain medical treatments under Virginia law (see below), and so if the involvement of human subjects in a proposed research activity consists of these treatments, then they may be considered as adults for that purpose. If a proposed activity includes something for which the subject has not yet reached the legal age of consent, however, that person must be considered a child.

Under Virginia law, minors are deemed to be adults for purposes of consenting to the following:

  1. venereal disease or other reportable infectious or contagious disease
  2. birth control, pregnancy or family planning except for the purposes of sexual sterilization;
  3. outpatient care, treatment or rehabilitation for substance abuse;
  4. outpatient care, treatment or rehabilitation for mental illness or emotional disturbance;
  5. for pregnant minors, consent for both herself and her child to surgical and medical treatment relating to the delivery of her child, during the hospital admission for delivery; thereafter, consent for any treatment for the child, but not for herself unless it falls into categories 1-4 above.
  6. any treatment for a minor who is or has been married, except sexual sterilization.
An FAQ from OHRP states


If by law a child is able to consent to treatment without parental permission, can they also consent to participate in research related to that treatment?


HHS regulations at 45 CFR 46.402(a) define “children” as “persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.” If research on a specific treatment involves solely treatments or procedures for which minors can give consent outside the research context (under applicable state** and local laws, for example, research on sexually transmitted diseases or pregnancy), such individuals would not meet the definition of children as defined at 45 CFR 46.402(a). Thus, subpart D would not apply to the research and parental permission (or waiver thereof) is not a consideration for these minors. Under these circumstances, minors may provide their own informed consent.

**Virginia Code § 54.1-2969. Authority to consent to surgical and medical treatment of certain minors.
For additional information see section Emancipated Minors

Issues to consider when proposing to involve children in research

Permitted Categories for Research with Children

Federal regulations classify permissible research involving children into four categories based on degree of risk and type of individual subjects. These categories are described in relation to " minimal risk ":

Parental Permission

Because children cannot legally provide consent for research on their own behalf, permission by at least one parent or legal guardian is required prior to enrollment of a minor in a research study.

NOTE: If there are two parents available to give permission but they disagree about allowing their child to participate in the study, the child should not be enrolled unless that disagreement can be resolved. This policy applies to all permissible categories of research involving children.

*Unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child. If these circumstances are present, the researcher should document this in the subject's research record.
Process of Obtaining Parental Permission

Unless the IRB has granted a “Waiver of Documentation of Consent” the answer is NO.  It is true that verbal permission from the parent/guardian is allowed in the clinical setting, however this is not allowed in research.
FDA Guidance contains the following information:
May informed consent be obtained by telephone from a legally authorized representative?

A verbal approval does not satisfy the 21 CFR 56.109(c) requirement for a signed consent document, as outlined in 21 CFR 50.27(a). However, it is acceptable to send the informed consent document to the legally authorized representative (LAR) by facsimile and conduct the consent interview by telephone when the LAR can read the consent as it is discussed. If the LAR agrees, he/she can sign the consent and return the signed document to the clinical investigator by facsimile.

OHRP Guidance contains the following information:

How should parental permission for research involving children be documented?

Permission by parents or guardians shall be documented in accordance with and to the extent required by 46.117 of subpart A of 45 CFR part 46. Essentially, parental permission should be documented in a manner similar to that used to document informed consent. An Institutional Review Board (IRB) may find that waiver of documentation of informed consent is appropriate under the HHS regulations at 46.117.
45CFR46.117 Documentation of informed consent.

(a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form.

Wards of State

This information is from the OHRP website.
Children who are wards of the state or any other agency can be involved in research that is:

NOTE: The foster parent is usually not the legal guardian of a child in foster care. The social services department usually has legal authority for the child.

Emanicipated Minors

Note: The Department of Motor Vehicles indicates legally emancipated status on a driver’s license if the court order for emancipation was provided to the DMV by the individual.

The IRB-HSR acknowledges Virginia Commonwealth University for the information above regarding Emancipated Minors.Child Assent
In addition to parental permission, federal regulations require that research studies involving children include adequate provisions for soliciting the assent of a child to participate in research when the child is capable of providing assent.  Assent is defined as “a child’s affirmative agreement to participate in research.” However, the mere absence of an objection by the child should not be construed as assent.

The IRB must find that adequate provisions are made for soliciting the assent of children when, in the judgment of the IRB, the children are capable of providing assent. In determining whether children are capable of assenting, the IRB will take into account the ages, maturity, and psychological state of the children involved. When a child’s assent is required, the child should be given an explanation of the proposed research procedures in a language that is appropriate to the child’s age, experience, maturity and condition.
The requirement for documenting informed consent by use of a written consent/assent form approved by the IRB and signed by the participant or the participant’s legally authorized representative applies when children are the subjects of research, unless this requirement is waived by the IRB (see below). A parent (one or both) or, in some cases, a guardian must document permission for his/her child to participate in research.
If verbal consent/assent will be obtained, the IRB must review a written description of the information (i.e. consent/assent) that will be provided to the children during the assent process. As with written consent/assent, a parent (one or both) or, in some cases, a guardian must document permission for his/her child to participate in research.

The regulations do not specify an age at which assent is required. The UVA IRB-HSR requires either verbal or written documentation of assent for participation of subject's ages 7 – 17 (when determined to be appropriate) unless waived as explained below.

If an investigator chooses not to use the stand alone assent form for children ages 7-14 or the written documentation on the main consent from the minor ages 15-17, the investigators should seek verbal assent from children as appropriate to their age, maturity and psychological state. The protocol should detail the process of obtaining assent. In this case, the main consent will document the person obtaining verbal assent from the minor.

The IRB may waive assent under the following circumstances:

Difficult Issues/Sensitive Matters involving Children

Discovery and Disclosure of Sensitive Information
In the course of research with children, especially adolescents, researchers may discover sensitive information about subjects that is not related to the study itself. For example, such information as sexual activity, STDs, use of illegal substances, and child abuse.

Enrolling Children in Long-Term Studies

Long-term research studies may involve subjects who are children at the time of enrollment but reach the age of consenting for themselves (in Virginia, usually 18 years old) while study procedures or follow-up are still ongoing. The IRB will consider on a protocol-by-protocol basis whether obtaining new consent from such subjects is required.
If there is continued interaction with subjects who were first enrolled as children, "re-consenting" when a subject's legal status changes will usually be required. If the only continuing study procedures are follow-up activities such as review of records or examination of biological specimens, the original consent may suffice. OHRP Guidance