HIC POLICY

SUBJECT: Vulnerable Participants: Children as Research Participants: Children as Research Participants and the Consent/Assent Process

BACKGROUND

In addition to the protection provided under the Common Rule (45 CFR 46), federal regulations (45 CFR 46 subpart D) provide additional protection for children involved in research such as obtaining assent from the child and obtaining the permission of the parents/guardians for the child to be enrolled in the research protocol. More specific provisions are based on the degree of risk involved in the proposed research and the nature and degree of anticipated benefit(s).

Most of the Exemptions applicable to research in adults (45 CFR 46.101) also apply to children. However, the exemption at 45 CFR 46.101 (b) (2) for research involving survey or interview procedures or observations of public behavior does not apply when children are involved except for research involving observation of public behavior when the investigator(s) does not participate in the activities being observed.

Definitions

Children (Minor) – persons who are less than 18 years of age. In Michigan the legal age for consent is 18 years of age.

Assent – the child’s affirmative agreement to participate in the research. Mere absence of an objection should not be construed as assent.

Permission – the agreement of parent(s) or guardian to the participation of the child in the research.

Parent – a child’s biological or adoptive parent.

Guardian – an individual who is authorized under state or local law to consent on behalf of a child for general medical care.

Minimal Risk – means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Emancipated Minor – There are no conditions under which a child below the age of 16 can be considered emancipated. Under Michigan law, children 16 years of age or older may be emancipated under the following circumstances:

Without a court order - Only one of the following need apply:

  • When a minor is married; or
  • when a minor is on duty with the US armed forces; or
  • for purposes of consenting to routine non-surgical medical care or emergency medical treatment when the minor is in the custody of a law enforcement agency and the minor’s parents or guardian cannot be located; or
  • for purposes of consenting to his or her own preventative health care or medical care including surgery, dental care, or mental health care, except vasectomies or any procedure related to reproduction, during the period when the minor is a prisoner under the department of corrections or the period when the minor is a probationer residing in a special alternative incarceration facility, but only if the parent or guardian cannot be located by the department of corrections.

By court order - The court will issue an emancipation order if it determines that emancipation is in the best interest of the minor and the minor is able to establish all of the following:

  • the minor’s parent or guardian does not object to the emancipation or if the parent or guardian does object, the parent or guardian is not supporting the minor; and
  • the minor is at least 16 years of age; and
  • the minor is a Michigan resident; and
  • the minor has demonstrated the ability to manage his or her financial affairs, including proof of employment or other means of support; and
  • the minor has the ability to manage his or her personal and social affairs, including but not limited to housing; and
  • the minor understands his or her rights under the act as an emancipated minor.

HIC Policy

Based on the degree of risk and benefit to the child, there are three categories of research involving children that may be approved by the IRBs:

Category 1:

Research not involving greater than minimal risk (45 CFR 46.404)

  1. Adequate provisions are made for parents/guardians to give parental permission (i.e. informed consent) and for the child to give assent, as appropriate, to participate in the research study.

Category 2:

Research involving greater than minimal risk but with a potential for direct benefit to the individual participants (45 CFR 46.405)

  1. the risk is justified by the anticipated benefit to the participants and
  2. the relationship of the benefit(s) to the risk is at least as favorable to the participant as that presented by available alternative approaches
  3. adequate provisions are made for parents/guardians to give parental permission (i.e. informed consent) and for the child to give assent, as appropriate, to participate in the research study.

Category 3:

Research involving greater than minimal risk and with no prospect of direct benefit to the child, but likely to yield generalizable knowledge about the child’s disorder or condition, will be considered on a case by case basis by the IRB (45 CFR 46.406). Children can only be approved for these studies when:

  1. the additional risk represents only a minor increase over minimal risk
  2. the intervention or procedure must present an experience to the child that is reasonably commensurate with those that are inherent in their actual or expected medical or dental condition, social situations, or educational situations.
  3. the intervention or procedure must be expected to yield generalizable knowledge about the subject’s disorder or condition that is of vital importance for the understanding or treatment of the disorder or condition in children.
  4. adequate provisions are made for parents/guardians to give parental permission (i.e. informed consent) and for the child to give assent.

Enrollment of children in a research protocol requires consideration of the following steps for obtaining permission from the parent(s) and the assent from the child.

1. Parental Permission

If children are eligible to be enrolled in a research protocol, parental permission is generally required for each of the three categories listed above before approaching the child for their assent. However, the IRB has the authority to waive the requirement for parental permission under the same conditions that they can waive consent (45 CFR 46.116). If the IRB determines that a research protocol is designed for conditions or participant populations for which parental or guardian permission is not a reasonable requirement to protect the child, it may also waive the consent requirement based on the additional regulations found in 45 CFR 46.408(c). 1 Under such circumstances, the IRB must determine an appropriate substitute mechanism for protecting the child.

For minimal risk research studies regardless of the benefit (category 1) , parental permission from one parent/guardian is sufficient.

For research involving greater than minimal risk but with the potential of benefit to the child (category 2), parental permission of one parent/guardian is sufficient.

For research involving greater than minimal risk and no prospect of direct benefit to the child but likely to yield generalizable knowledge about the child’s disorder or condition (category 3), both parents must give parental permission. Only one signature is required when one parent is deceased, unknown, incompetent, not reasonably available, or if only one parent has the legal responsibility for the care and custody of the child. This should be documented in the research records. When there is disagreement between the two parents, the child may not be enrolled in the research study.

In certain types of research with children, the term “passive consent” may have been used. For example, a notice may have been sent to the parents that their child would be asked to participate in a research project conducted in the school setting unless the parent called a certain number or returned a post card. The investigator then assumed that because he/she did not hear from the parent, the parent had given "passive consent" (i.e., waived consent) for their child to participate in the research activity. From an IRB perspective, that term actually referred to a "waiver" of parental permission with the assent obtained from the child. Investigators who wish to utilize this concept should 1) request a "waiver" of parental permission with an information sheet sent home (via 1 st class mail) to parents; and 2) obtain assent from the child.

2. Child Assent Procedures

Children cannot consent to participate in research themselves. Therefore, the parental permission of parents/guardians and assent of the child must be obtained as stated below. While there are no regulatory standards 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 determining whether children are capable of assenting, the IRB shall take into account the age, maturity, and psychological state of the children involved.”

As an ethical standard, the HIC recommends that oral assent be obtained for children between the ages of 7 and 12 and written assent be obtained for children ages 13 and older. However, the IRB may deviate from this recommendation based upon a request and adequate justification from the investigator.

Under 45, CFR 46.408 (a) the IRB may approve the waiver of assent when:

  1. the capability of the children included in the study is so limited that they cannot reasonably be consulted,
  2. the intervention or the procedure in the study holds out a prospect of a direct benefit that is important to the health or well–being of the children and is only available in the context of the research study, or
  3. circumstances where consent [parental permission] could be waived in accord[ance] with 45 CFR 46.
For minimal risk research studies when there is no benefit to the child (category 1), assent from the child should be obtained as appropriate depending upon the age and mental status of the child.

For minimal risk research studies when there is benefit to the child (category 1), assent may be obtained as appropriate depending upon the age and mental status of the child. However, assent may be waived by the IRB when there is benefit to the child that may only be available from the research study. An information sheet can be used to provide information about the study to the child, when appropriate.

For research involving greater than minimal risk but with a potential of benefit to the child , (category 2), assent from the child should be obtained as appropriate depending upon the age and mental status of the child. However, assent may be waived by the IRB when there is benefit to the child that may only be available from the research study. An information sheet can be used to provide information about the study to the child, when appropriate.

For research involving greater than minimal risk with no prospect of benefit to the childbut with the prospect ofyielding generalizable knowledge about the child’s disorder or condition (category 3), assent should be obtained as appropriate depending upon the age and mental status of the child.

In general, a child’s dissent should be respected. Ordinarily, a disagreement between parent(s) and the child may be because the child is depressed, the parents have unrealistic hopes, the child may have different goals and outcomes from the parents, or the real prospects may have been misunderstood. Every effort should be made to reach consensus between parent(s) and child. However, when the research offers the child the possibility of direct benefit important to his/her own health and may be available only through research (Category 2), the parent’s wishes generally prevail over the dissent from the child. A rule of thumb: a “no” from a child (unless category 2 research), overrides a “yes” from the parent; but a “yes” from a child does not override a “no” from a parent unless the IRB has waived the requirements for parental permission.

IRB Submission

When enrolling children into research it is necessary to address the risk level (category 1-3) of the protocol and the consent and assent requirements. This is addressed in the Medical/Behavioral Protocol Summary Form.

For children ages 7-12, parental permission forms should have a line for oral assent and should be signed by the person obtaining the assent. A copy of the oral assent script should be submitted with the submission of the protocol.

For children ages 13-17, written assent must be obtained by a document that is written at an appropriate reading level. If the parental permission form is written at a grade level that is understandable for children ages 13-17, it is acceptable to add a line for child assent and use the forms for both the children and parents. However, separate assent and consent forms may be required because the language in the consent form is so complex that the child may not be able to understand the consent/assent form.

All parental permission forms, child assent forms, information sheets, and description of oral assent should be submitted to the IRB for review and approval. Submission without any of these elements will result in “tabling” because the IRB would be unable to assess the risk/benefit ratio of the protocol.

1 45 CFR 46.408 (c) In addition to the provisions for waiver contained in § 46.116 of Subpart A, if the IRB determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), it may waive the consent requirements in Subpart A of this part and paragraph (b) of this section, provided an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and that the waiver is not inconsistent with Federal State or local law.

Approved by Steering Committee 03/16/05

Approved by All IRB Committees 04/28/05

Administrative Approval 05/02/05