Section XV:

Children as Research Participants

WPP #: XV-2

Title 2:

Assent and Parental/Guardian Permission Considerations

Effective Date:

09-24-14

Revision History:

06-07-06; 6-21-06; 08-23-06; 01-15-08; 05-22-14

Policy Statement

The VCU IRB adheres to both state and federal regulatory requirements when reviewing research involving children as participants and the plan for permission by parents or guardians and for assent by children. When submitting to the IRB, the PI must plan for assent and parent/guardian permissions in accordance with the regulations. The IRB will consider the appropriateness of the provided plan as part of its review.

Description and Procedures

NOTE: In Virginia (§1-207), individuals below age 18 years may be termed minors (if they are not legally emancipated), children, juveniles, and/or infants and require permission from their LARs (parent(s) or legal guardian) to participate in research, even if the research comprises activities for which such an individual may ordinarily consent to treatment under statutory exceptions. For purposes of the VCU IRB Written Policies and Procedures, and for research conducted in Virginia, a ‘child’ refers to an individual under the age of 18, unless legally emancipated. Note that in Virginia, an individual below the age of 18 years of age who is legally emancipated (with legal documentation to verify such status) is permitted to make all decisions concerning research participation as would someone 18 and older who is also decisionally capable. In such cases, the ‘legal age for consent,’ as described in both HHS and FDA definitions, has been attained. The individual is no longer considered a ‘child’ under Virginia law or federal definitions. Consequently, the individual’s consent, not assent, is obtained. See Section B Definitions, in WPP XV-1 Permissible Categories for federal definitions of child, parent, guardian, assent and permission. In contrast to federal law, Virginia Code does not specifically define ‘assent’, ‘permission’ or ‘parent’ or ‘guardian.’

Virginia law broadly views all individuals described in the prioritized legally authorized representative (LAR) list, at Virginia Code 32.1-162.16, to be Legally Authorized Representatives (see WPP XI-3 Legally Authorized Representatives). As such, an individual designated as an LAR provides consent on behalf of the research subject who is not otherwise able to do so on his or her own behalf. For purposes of research with unemancipated minors, individuals who may serve as ‘LARs” for children/ unemancipated minors are: 1) “the parent or parents having custody of a prospective subject who is a minor, 2) ‘the legal guardian of a prospective subject,’ or 3) ‘any person or judicial or other body authorized by law or regulation to consent on behalf of a prospective subject to such subject’s participation in the particular human research.’ Note that in Virginia, an individual below the age of 18 years of age who is legally emancipated (with legal documentation to verify such status) is permitted to make all decisions concerning research participation as would someone 18 and older who is also decisionally capable.

Children (as defined above) who are in court-appointed or state custody or any other agency, institution, or entity can be included in research only with the signature of an individual named as the Legally Authorized Representative (LAR). For information and IRB review criteria regarding child wards and emancipated minors, please see VCU IRB WPP#XV-3: Children in Court-Appointed or State Custody and Emancipated Minors.

For research conducted outside of Virginia, relevant law for the jurisdiction in which the research is being conducted will determine whether an individual is considered a child to whom DHHS or FDA regulations apply for the conduct of research.

Investigators and research staff should assess whether some or all children at least seven (7) years of age and older are able to offer assent or withhold assent to participate in research. Children ought to be apprised of the intended research activity even if the requirement for assent is waived by the IRB of record.

This policy is based upon the principles found within the Belmont Report, which are established in federal regulations and the Report of the National Commission for the Protection of Human Subjects, which addresses research involving children.

In summary: Respect for Persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards of informed consent are satisfied. Special provisions may need to be made, when comprehension is severely limited, for example, by conditions of immaturity (Belmont Report, III, C, 1).

In so doing and in accordance with U.S. federal regulations the VCU IRB will determine that adequate provisions are made for soliciting the assent of children, when (in the judgment of the IRB) the children are capable of providing or withholding assent. In determining whether children are capable of assenting, the VCU IRB will take into account the ages, maturity, and psychological state of the children involved.

  1. VCU IRB Requirements:
    In order to enact this policy, the VCU IRB will consider the following (as documented by the Sponsor's Protocol [if applicable] and/or VCU IRB approved protocol):
    1. The process of assent/dissent and documentation of assent/dissent;
    2. The process for obtaining parental permissions; and,
    3. The process of documenting parental permission.

    Please note that the process of assent/dissent and parental permission is similar to the informed consent process. That is, assent and/or parental permission are not concluded upon signing of a document. The PI and research team must make every effort to ensure that the child and parents/guardians who have agreed to research participation continue to understand the research and agree to on-going participation over the course of the research.

  2. Assent and Documentation of Assent:
    1. Language: The process of assent of children shall include an explanation in language suitable to the age and competence of the children, describing the purpose of the research and an explanation of risks and benefits associated with the child’s participation in the research.
    2. Assent Process: The assent procedure can include variations presented by the investigator, such as:
      1. An oral and/or written explanation of the research, presented to the child. Unlike the consent or parental permission process, federal regulations do not specify the elements of assent. The content of the assent process should be developmentally appropriate as to length and content.
      2. How, and whether, assent is applicable to all, some, or no children. If assent is only applicable to some children, indicate which children are asked to provide their assent to participate.
      3. The child is asked to assent orally and may be asked to sign the assent or parental permission form, indicating willingness to participate in the proposed research study.
      4. Although written documentation of the child's assent is not required, the investigator and the IRB will consider providing an assent signature line for children to sign, as appropriate.
    3. Documentation of Assent: If a child assents to participate in research, but is frightened, unable, or reluctant to sign the assent or parental permission document, the person eliciting assent should sign a note on the assent or permission form that the child assented to participate in the research, but was frightened, unable or unwilling to sign the assent/permission document.
    4. Conditions for Waiver of Assent: Assent may be waived in accordance with waiver of consent regulations at 45 CFR 46.116 (Subpart A), for research not regulated by the FDA, or at 21 CFR 50.55(d) for research regulated by the FDA.

      Unless age-specific waiver of assent is requested and approved, children of age 7 and higher are expected to be part of the discussion about the research. To request a waiver of assent for some or all participants, due to age or anticipated condition, the PI must provide a sufficient justification. Child participants not meeting the age or condition specified (in the waiver) must give assent in order to participate in the research. An IRB approved waiver of assent for children below age 7 is not required. The justification for waiver of assent may include (but is not limited to) the following examples:

      • The PI has determined that some or all of the subjects over age 7 will not be capable of providing assent based on their developmental status or impact of illness (Note: The PI will need to support this determination, but the VCU IRB relies upon the professional opinion of the investigator for determining an individual's capacity for assent;
      • The research offers a prospect of direct benefit not available outside of the research; and/or,
      • The same conditions under which parental permission can be waived apply [45 CFR 46.116(c-d)].
    5. Documentation of an Individual Assent Waiver: In cases where the VCU IRB has approved a waiver of assent for individual subjects, the PI must provide a clear process for authorizing a determination that soliciting assent from the child is not appropriate. When this authority is utilized, the PI should provide a notation on the assent/parental permission form (indicating the justification for waiver of assent specific to that individual).
    6. Waiver of Assent vs. Objections: If a child’s parent or parents give the required permission for the child to participate in research, and if there are grounds for waiving assent, then the assent should be waived. Nevertheless, the child must be informed about the proposed research intervention. Therefore, it is possible that a child may voice an objection (dissent) to participate (even when assent has been formally waived by the IRB). In this case of "waiver of assent" versus "individual objection," the PI (together with the parents) should assess the child’s dissent and respect this choice when and if possible. If the PI and the parents determine that the objection cannot be respected, the PI is to consider consultation with the IRB; off-protocol access to identical research therapies; and/or consultation with the VCU ethics committee. The results of any consultation and plans for proceeding should be reported to the VCU IRB.
  3. Parental/Guardian Permissions:

    For research protocols that do not involve an FDA-regulated product, all of the requirements of 45CFR46.116 concerning informed consent apply to parental permission, including the general and required elements. Additionally, there will be an appropriate mechanism for protecting the children who will participate as participants in the research.

    1. *Parental/Guardian Signatures: Consent forms should be drafted to allow for BOTH parents to provide permission for a child to participate in research. The inclusion of two consent signature lines will help to ensure that both parents are encouraged to provide and document their permission in all cases, however:
      1. For research involving categories 404 and 405, the permission of one parent or guardian may be allowed by the IRB (if the IRB deems this to be appropriate and the solicitation of only one signature is clearly requested by the PI in the application).
      2. For research involving categories 406 or 407, the permission of BOTH parents is required (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).

      *45 CFR 46.408(b) and 21 CFR 50.55(e)

      Only for categories 404 and 405, may the IRB decide that the permission of one parent or guardian is sufficient. IRB considerations for the inclusion of one or both parents are based on a solid determination of whether the research comes under Category 404 or 405. For Category 405 in particular, considerations for 1 or 2 parents’ permission are best served by obtaining the opinion of a pediatric practitioner on the IRB Panel, or through consultation.

    2. Waiver of Parental Permission: For research NOT subject to FDA REGULATION, parental/guardian permission may be waived only if the IRB determines that a research protocol is designed in such a way where parental/guardian permission is not a reasonable requirement in order to ensure the protection of the research participants (for example, neglected or abused children). If the research is subject to FDA regulation, parental/guardian permission cannot be waived.
    3. Guardian Permission: Note that any persons acting in place of or instead of a child's parent or parents must be a legally authorized guardian for the child.
    4. Children who are in court-appointed or state custody: For information regarding wards of the state, see VCU IRB WPP#: XV-3: Children in Court-Appointed or State Custody and Emancipated Minors.
  4. Documentation of Parental Permission:

    As stated in 45CFR46.408(d): Permission by parents or guardians shall be documented in accordance with and to the extent required by 45 CFR 46.117 of Subpart A. Parental/guardian permission will be documented by the use of a written permission form approved by the IRB and signed by 1 or 2 parents (see Section C1 above) or legal guardian.. A copy shall be given to the person signing the form).

References

45 CFR 46, Subpart D
21 CFR 50
Belmont Report
VCU IRB WPP XV-3: Children in Court-Appointed or State Custody and Emancipated Minors.