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).
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.
3.1. 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.
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.
4.1.1. 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:
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.
4.2.1. 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.
4.3.1. 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:
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.
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).
5.1.1. 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:
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:
5.1.3. Research Designed to Study Conditions in Children
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.
5.2.1. 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
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.
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
