Sample Policy for the Participation of Children and Minors in Research

I. To What Does This Policy Apply:

This policy defines the standards and parameters for the involvement of children in research. This organization will adhere to those regulations set forth at 45 CFR 46.408, et seq. for all research studies that involve children/minors. For purposes of this policy, a minor is any individual who has not yet reached the legal age for consent to treatment or the research procedures under the law in jurisdiction in which the research will take place at the time of enrollment into the research study. In the State of Connecticut the age of consent to participate in research is 18.

II. Definitions:

Assent: An individual's affirmative agreement to participate in research obtained in conjunction with permission from the individual's parents or legally authorized representative. Mere failure to object should not, absent affirmative agreement, be construed as assent.

Children/Minors: According to Federal regulations, children are "persons who have not attained the legal age for consent to activities or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted." In Connecticut, the legal age for consent is 18 years of age.

Legal Guardian: An individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care.

Legally Authorized Representative: An individual, judicial, or other body authorized under applicable law to grant permission on behalf of a prospective participant for participation in research activities.

Parent: A child's biological or adoptive parent.

Permission: The agreement of parents or legal guardians to the participation of their child or ward in research.

III. Policy Statement:

This organization recognizes that minors engaged in research constitute a special class of subjects for which special protections apply. This organization will ensure that all minors enrolled in research conducted at or by this organization will be treated in a manner commensurate with their special status and that their participation in research will be ethical and in compliance with the federal regulations for the participation of minors in research (45 CFR 46, Subpart D). All such research studies submitted to a Yale IRB must describe the additional protections that will be given to the minor subjects.

A. Risks

Children can participate as research subjects only if the research meets certain standards, defined in the federal regulations (Subpart D of 45 CFR 46). This organization will only conduct research with children when the research risks can be characterized as follows:

• Not greater than minimal risk and adequate provisions are provided for assent of children and permission of parents or guardians.
• Greater than minimal risk, but the research presents the prospect of a direct benefit to the individual minor subject:
  In those studies where the minor subjects are exposed to "greater than minimal risk" (as defined by federal regulations at 45 CFR 46, Subpart D) and the research presents the prospect of a direct benefit to the individual minor subject, such research will be allowable only if a) the risk is justified by the anticipated benefit to the minor subject and b) the relation of risk to benefit is at least as favorable to the subjects as established alternatives.
• Greater than minimal risk and the research presents no prospective direct benefit to the individual minor subject, however the research may provide valuable information about the subjects' condition:
  In those studies where the minor subjects are exposed to "greater than minimal risk" (as defined by federal regulations at 45 CFR 46, Subpart D) and the research presents NO prospect of a direct benefit to the individual minor subjects, such research will be allowable only if a) the risk is only a minor increase over minimal risk, b) the research interventions are comparable to those that subjects would experience in actual or expected medical, dental, psychological, social or education situations and c) the research must be likely to provide valuable information about the subjects' condition which could lead to greater benefits to society.

B. Consent and Assent

• Written parental permission will be obtained for studies involving children and, depending on the nature of the research and the availability of both parents, one or both parents must provide written consent.
• The permission of one parent/guardian will be acceptable only if a) the research is a minimal risk study or b) the research exposes the minor to greater than minimal risk, but the research presents the prospect of a direct benefit to the minor subject. In both such cases, the consent procedures must be approved by the appropriate IRB.
• Both parents/guardians must give their permission for a minor's participation in research if the research exposes the minor subject to greater than minimal risk and there is no prospect of a direct benefit to the individuals. The only exception to this policy is if one parent is deceased, unknown, incompetent or not reasonably available or if only one parent has legal responsibility for the care and custody of the child.
• Under certain limited conditions it may be possible for the minor subject to consent on her/his own behalf, without the need for parental permission. In such cases the IRB must grant a waiver of parental permission in advance of subject enrollment. The following are the only conditions under which a waiver of parental permission will be acceptable:
  • The research involves a treatment for which a minor's consent is permissible under law (i.e., outpatient mental health care, pregnancy, treatment for venereal disease or treatment for alcohol or drug dependence).
  • The subject is legally emancipated.
  • Parental permission is not a reasonable requirement because it poses additional risk or may be at odds with the interests of the minor subject (i.e., research concerning neglected or abused children, reproductive health issues, etc). In such cases the research protocol will propose an alternative to parental permission appropriate to the nature and purpose of the research, the risk and anticipated benefit to the minor subjects, as well as one's age, maturity, status and condition.
• Once parental permission has been obtained, the agreement or assent of the child will be obtained. While the parents/guardians must provide legal consent for the child to participate in research, the child must always assent to his/her own participation; assent being an active affirmation of a desire to participate. Children who are able to read and write will participate in the consent process by using an assent form written in language especially for the child. As with parental consent, the assent procedures must be approved by the appropriate IRB.
• In determining whether participants are capable of assenting, the IRB shall take into account the age, maturity, and psychological state of the participant involved. This judgment may be made for all participants to be involved in research under a particular protocol, or for each participant, as the IRB deems appropriate. If the IRB determines that the capability of some or all of the participants is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the participant and is available only in the context of the research, the assent of the participant is not a necessary condition for proceeding with the research. Even where the IRB determines that the participants are capable of assenting, the IRB may still waive the assent requirement under circumstances in which consent may be waived.
  • In all cases in which assent is sought from a minor subject, the assent discussion will include the following:
  • A simplified description of the purpose of the research, including the risks and benefits
  • A description of the procedures and interventions to which the minor subject will be exposed
  • An explanation of any procedures that may hurt and for how long
  • A statement explaining to the minor child that s/he has the right to decide whether or not to participate in the research study
  • An explanation of the research alternatives
  • A question and answer period in which the minor subject will be encouraged to ask questions about her/his participation in the study.
• So as to encourage the minor subject to ask questions, and to ensure that s/he understands the nature and purpose of the research, the principal investigator or person obtaining assent will ask the minors subjects open-ended questions as appropriate to their age and comprehension level. Such questions may include the following:
  • Just so that I'm sure that you understand what is expected of you, would you please tell me in your own words what you will be doing in this study?
  • Would you please tell me the purpose of the study in your own words?
  • What is the possible benefit to you of being in the study? What are the possible risks?
  • What more would you like to know about the study?

DEPARTMENT: Yale University
POLICY NUMBER:
SECTION: IRB Policies for Research Affiliate Institutions
REVIEW RESPONSIBILITY: IRB Leadership and Research Collaborators
ORIGINAL CREATION DATE: April 14, 2005
REVISION DATES: August 13, 2005

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