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SOP 015: Assent and Parental Permission

1. Purpose

This SOP describes the requirements for assent and parental (or guardian) permission for research involving children (and in some cases, adults with impaired consenting or decision-making capacity).

2. Overview

Assent and parental (or guardian) permission must be obtained as required by federal regulations and IRB determinations for research involving children. Assent is generally required for children based on their ages, maturity, condition, and the nature of the research, unless assent can appropriately be waived for some or all the children that are not capable of providing assent.

3. General Information

3.1. The requirements for obtaining the informed consent of research participants or their legally authorized representatives apply when children are the subjects of research, unless these requirements are waived by the IRB. A parent (one or both) or, in some cases, a guardian, must provide permission for their child to participate in research based on sufficient information and adequate opportunity to consider the child’s voluntary participation. For more information about the requirements for informed consent processes, see SOP 012: Informed Consent Requirements.

3.2. The requirement for documenting informed consent by use of a written consent form (electronic or hard copy), approved by the IRB, and signed by the subject or the subject’s legally authorized representative, applies when children are the subjects of research, unless this requirement is waived by the IRB. A parent (one or both) or, in some cases, a guardian, must document permission for their child to participate in research as described below and in SOP 016: Documentation of the Informed Consent Process.

3.3. Although according to federal regulations children cannot provide valid informed consent to participate in research, they may be able to assent to participation. In general, investigators should obtain the assent of children to participate in research whenever children are capable of assenting. The IRB is responsible for determining when assent of some or all children is required in proposed research and the appropriate method for documenting a child’s assent (if any), as described below.

3.4. Assent may also be appropriate for adults with impaired decision-making capacity and other adults unable to consent for themselves, for whom a legally authorized representative will provide informed consent. For more information about assent in adults, see SOP 013: Vulnerable Populations.

4. Assent of Children

For research involving children, the requirements for obtaining and documenting a child’s assent, or the waiver of these requirements are described below. Additional requirements for research involving children are described in SOP 013: Vulnerable Populations.

4.1. Assent Process

4.1.1. In addition to the requirements for parental or guardian permission, adequate provisions for soliciting the assent of a child to participate in research are required when the child is capable of providing assent. In determining whether proposed participants are capable of assenting, investigators and IRBs will consider the ages, maturity, condition, and psychological/emotional states of the children involved. The IRB’s determination of the children’s capacity to assent may apply to some or all the children to be involved in a proposed research activity.

4.1.2. Assent processes are to include the key elements of informed consent as described in SOP 012: Informed Consent Requirements and are to be provided in language appropriate for children, based on the nature of the study and the expected capacity of the potential participant(s) to understand the purpose and procedures involved in the research.

4.1.3. For research activities involving older children or adolescents whose capacity to understand is similar to that of adults, the assent process will include information similar to what would be provided for informed consent by adults or for parental/guardian permission. For children whose age and/or maturity level limits their ability to fully understand the research but who are still capable of being consulted about participating, it may be appropriate to focus only on providing an accurate description of the experience itself (e.g., what will happen, how long it will take, whether it might involve any pain or discomfort, etc.)

4.1.4. The assent of children to participate in research is to be obtained except in the following circumstances:

    • The children are not capable of providing assent based on age, maturity, or psychological state;
    • The capability of some or all the children is so limited that they cannot reasonably be consulted;
    • The intervention or procedure involved in the research holds out a prospect of direct benefit to the health or well-being of the children and is available only in the context of research; or
    • Assent can be waived using the criteria for waiver (or alteration) of informed consent or parental/guardian permission, as described below (see “Waiver or Alteration of Parental Permission”).

4.1.5. The IRB may determine that the assent of some or all children is not required. If assent is not a requirement of some children, the IRB should indicate which children (e.g., children less than 2 years old) are not required to assent.

4.2 Documentation of Assent

4.2.1. When a child’s assent is required, investigators and the IRB must determine the appropriate method, if any, of documenting assent. This decision should be based on considerations such as the length and complexity of the research and the child’s age, maturity, and degree of literacy.

4.2.2. If older children or adolescents will be involved in research for which a consent form would have been used if the participants were adults, a similar form to document the child’s assent is generally appropriate. For younger children who are still unable to read or other children unlikely to be familiar with signing documents (e.g., through prior experience with testing or other procedures normally encountered in their everyday lives), documentation of assent may be limited to verifying that assent took place using a witness or other method. Alternatively, the IRB may decide that documentation of assent for children of any age is not warranted.

4.2.3. Assent form templates containing the basic elements of informed consent are available on the WVU OHRP website. When documentation of assent is required, use of the applicable assent template language is generally required. Alternatively, based on the age and literacy level of the children and nature of the research, for some studies investigators may add an assent signature line to the consent document that parents will sign. The IRBs can also approve assent forms on a case-by-case basis in other formats that may more appropriately satisfy requirements for obtaining and documenting assent.

4.2.4. If verbal assent will be obtained, the IRB must review a written description of the information (i.e., a script) that will be provided to children during the assent process.

4.3 Parental Permission

4.3.1. For research involving children, the permission of a parent(s) or guardian must be obtained and documented for their child to participate in research, unless these requirements are waived by the IRB. The requirements for informed consent processes apply when children are the subjects of research, including disclosure (to parents or guardians) of the basic and additional elements of consent. For more information about the requirements of informed consent, see SOP 012: Informed Consent Requirements and SOP 016: Documentation of the Informed Consent Process.

4.3.2. Parental permission form templates (or consent documents) containing the basic elements of informed consent are available on the WVU OHRP website. To streamline IRB review and assure that regulatory requirements are met, use of the applicable template language is generally required. The IRBs can also approve parental permission/consent documents on a case-by-case basis in other formats that may more appropriately satisfy requirements for obtaining and documenting permission.

4.3.3. Based on the regulatory requirements, when children are involved in research, investigators and IRBs must determine whether the permission of both parents is required or if the permission of one parent is sufficient as described below.

4.3.4. For research that involves only minimal risk (OMR) or more than minimal risk (MMR) with the prospect of direct benefit to the individual child, the IRB may determine either of the following:

    • 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; o
    • Permission of one parent is sufficient.

4.3.6. For research that involves MMR without the prospect of direct benefit to the individual child, 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.

4.3.7. For children who are wards of the state (or any other agency, institution, or entity), a guardian must provide permission for the ward to participate in research, in lieu of a child’s biological or adoptive parents. When research involves MMR without the prospect of direct benefit to the individual child, an advocate who agrees to act in the best interests of the child throughout the duration of the child’s participation, including ensuring that to the extent possible the child understands what will be required of them during the research, must also be appointed.

4.3.8. Additional requirements for research involving children, including children who are wards of the state, are described in SOP 013: Vulnerable Populations.

5. Waiver or Alteration of Parental Permission

In the limited circumstances described below, the IRB can waive or alter the requirements for obtaining parental or guardian permission.

Note: “Passive consent” is sometimes used in research with children to describe a situation where the investigator assumes that the parent permits a child to participate (e.g., information about a study is mailed to the parent and if the parent does not want their child to participate, they must return a form “opting out”). This procedure is not consistent with the regulatory requirement to obtain parental permission. In these instances, the investigator can request the IRB to consider if the conditions for a waiver of parental permission can be met under 45 CFR 46.408(c) or 45 CFR 46.116(f)(3).

5.1 Research on Public Benefit or Service Programs

5.1.1. The IRB can waive or alter the requirements for parental permission for non-exempt research examining state or local public benefit or service programs or certain features of those programs if all of the following criteria are met:

    • The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine public benefit or service programs, procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs;
    • The research could not be practicably carried out without the waiver or alteration; and
    • The research is not FDA-regulated.

5.1.2. Minimal Risk Research
The IRB can waive or alter the requirements for parental permission for non-exempt research that meets all of the following criteria:

    • The research involves no more than minimal risk to participants;
    • The waiver or alteration will not adversely affect the rights and welfare of participants;
    • The research could not practicably be carried out without the waiver or alteration;
    • If the research involves using identifiable private information or identifiable bio-specimens, the research could not practicably be carried out without using such information or bio-specimens in an identifiable format; and
    • Whenever appropriate, subjects or their parent/guardian will be provided with additional pertinent information after participation

5.1.3. Research Designed to Study Conditions in Children

    1. The IRB can waive or alter the requirements for parental permission for non-exempt research designed to study conditions in children or a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (e.g., neglected or abused children) when the following additional criteria are also met:
      1. An appropriate mechanism is in place to protect the children: and
      2. The waiver is not inconsistent with federal, state, or local laws.
  • Note: IRBs may waive the requirement for obtaining parental or guardian permission as described above even if the research involves more than minimal risk to the participants.

When determining an appropriate mechanism for protecting child participants (e.g., appointment of an advocate or assent monitor), investigators and IRBs will consider the nature of the research (including any potential risks and anticipated benefits) and the children’s ages, maturity, condition, and psychological/emotional states.

5.1.4. Planned Emergency Research
The IRB can approve a waiver of the requirements for informed consent for non-exempt research in life-threatening situations in which it is not possible to obtain informed consent from subjects or their legally authorized representatives (i.e., parent or legal guardian), including studies in which children are the subjects of the research. For more information, see SOP 054: Planned Emergency Research.

5.2. Special Circumstances

5.2.1. A mother under 18 years of age (i.e., a parent that is legally still a child) can provide permission for her child to participate in research. However, for her own research participation, the permission of one or both of the mother’s parents is required, unless the requirement for parental permission is waived by the IRB.

5.2.2. Under the Family Educational and Rights Privacy Act (FERPA), a child under 18 years of age who attends a school beyond the high school level (e.g., a college or university) can consent to release information from their educational records for use in research. However, to participate in research the child must also have the permission of one or both parents, unless the requirement for parental permission is waived by the IRB

6. Children Who Reach the Legal Age of Consent While Enrolled in a Study

Informed consent is an ongoing process throughout the duration of a research study. When a child who was enrolled in research with parental (or guardian) permission reaches the legal age of consent, the subject’s participation is no longer regulated by the requirements regarding parental permission. Legally effective informed consent must be obtained (unless waived by the IRB) from the now-adult participant for any continued interactions,interventions, or other activities that meet the definition of “research involving human subjects,” including analysis of individually identifiable data or specimens.

7. References

WVU Policies:
SOP 012: Informed Consent Requirements
SOP 013: Vulnerable Populations
SOP 016: Documentation of Informed Consent Process
SOP 054: Planned Emergency Research

Federal Regulations:
21 CFR 50.3
21 CFR 50.20
21 CFR 50.25
21 CFR 50.51-55
21 CFR 56.109
21 CFR 51.111
45 CFR 46.111
45 CFR 46.116
45 CFR 46.402-408

AAHRPP:
Standard II.4