Appendix D

Procedure for the Participation of Children in Research

1. Applicability: This procedure defines the standards and parameters for the involvement of children in research. Children participating in research constitute a special class of subjects for which special protections apply. Grand Canyon University (GCU) will adhere to those regulations set forth at 45 CFR 46 Subpart D for all research studies that involve children/minors. For purposes of this procedure, 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 Arizona, the age of consent to participate in research is 18.
2. Definitions:
   

   Assent: A child’s affirmative (written or verbal) agreement to participate in research obtained in conjunction with permission from the individual's parents or legally authorized representative/guardian. Simple failure to object should not, absent affirmative agreement, be construed as assent.

   Assent Form: A document written in language that is appropriate to the child subject’s maturity and cognitive level and used as part of the assent process to 1) describe the research study, including the research procedures, risks and benefits, and 2) obtain the child’s written agreement to participate in the study.

   Child/Children: For purposes of this procedure, a child is any individual who at the time of enrollment in a research study has not yet reached the legal age of majority under the law in the jurisdiction in which the research will take place. In the State of Arizona, the age of majority is 18. Investigators working in locations outside Arizona should confirm the local age of majority to determine at what age an individual is considered to be an adult.

   Guardian: An individual who is judicially appointed parental rights for a child including (A) the obligation of care and control; and (B) the authority to make major decisions affecting the child’s education and welfare, including, but not limited to, consent determinations regarding marriage, enlistment in the armed forces and major medical, psychiatric or surgical treatment.

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

   Minimal Risk: The probability and magnitude of harm or discomfort anticipated in the research is not greater in and of itself than that ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

   Parent: A child's biological or adoptive parent.

   Parental Permission Form: A document used to obtain the written permission of a child subject’s parent or guardian allowing that child to participate in research. The parental permission form must be written in a language understandable by the parent/guardian and must contain all elements of informed consent, including a description of the research study, the research procedures, risks and benefits, and right to withdraw at any time.

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

   Ward: For the purpose of this procedure, a ward is a child under the care of a guardian, or other non-parental custody arrangement. For example, children under the protection of a court, child protective services, or under the care of a non-parental relative would be considered to be wards.

3. Procedure 3.10: GCU recognizes that minors engaged in research constitute a special class of subjects for which special protections apply. GCU 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 GCU IRB must describe the additional protections that will be given to the minor subjects.
   1. Risk Categories: The IRB will only approve research involving children as subjects if the research satisfies the federal requirements for the participation of children, the research can be characterized into one of the research categories defined below, and the IRB finds sufficient safeguards in place for protecting the rights and welfare of the child subjects.
   1. Research not involving greater than minimal risk to the children (45 CFR 46.404,). To approve this category of research, the IRB must make the following determinations:
   1. the research presents no greater than minimal risk to the children;and
   2. adequate provisions are made for soliciting the assent of the children and the permission of one or both of parent or guardian.
   2. Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual child subjects involved in the research (45 CFR 46.405,). To approve research in this category, the IRB must make the following determinations:
   1. 1. the risk is justified by the anticipated benefits to the subjects;
   2. 2. the relation of the anticipated benefit to the risk presented by the study is at least as favorable to the subject’s as that provided by available alternative approaches; and
   3. adequate provisions are made for soliciting the assent of the children and the permission of one or both of their parents or guardians.
   3. Research involving greater than minimal risk and no prospect of direct benefit to the individual child subjects involved in the research, but likely to yield generalizable knowledge about the subject's disorder or condition (45 CFR 46.406,). In order to approve research in this category, the IRB must make the following determinations:
   1. the risk of the research represents a minor increase over minimal risk;
   2. the intervention or procedure presents experiences to the child subjects that are reasonably commensurate with those inherent in their actual, or expected medical, dental, psychological, social, or educational situations;
   3. the intervention or procedure is likely to yield generalizable knowledge about the subject's disorder or condition which is of vital importance for the understanding or amelioration of the disorder or condition; and
   4. adequate provisions are made for soliciting the assent of the children and the permission of both parents or guardians, unless one parent is deceased, unknown, incompetent, or not reasonably available or when one parent has legal responsibility for the care and custody of the child subject.
   2. Consent and Assent
   1. 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.
   2. 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.
   3. 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 procedure 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.
   4. 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:
   1. 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).
   2. The subject is legally emancipated.
   3. 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.
   5. 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.
   6. 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.
   7. In all cases in which assent is sought from a minor subject, the assent discussion will include the following:
   1. A simplified description of the purpose of the research, including the risks and benefits
   2. A description of the procedures and interventions to which the minor subject will be exposed
   3. An explanation of any procedures that may hurt and for how long
   4. A statement explaining to the minor child that s/he has the right to decide whether or not to participate in the research study
   5. An explanation of the research alternatives
   6. A question and answer period in which the minor subject will be encouraged to ask questions about her/his participation in the study.
   8. 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:
   1. 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?
   2. What is the possible benefit to you of being in the study? What are the possible risks?
   3. What more would you like to know about the study?
   3. Other Institutional Approvals: Protocols involving children also may require review and approval by other Institutions (schools or clinics) or University committees prior to approval by the IRB. Investigators should consult these offices for information on their submission requirements.
   4. IRB Record Keeping Requirements: When reviewing a protocol including children, the IRB must classify the research into one of four categories (see section 3.1.1). The minutes and/or reviewer checklist must document the category under which the protocol is approved, together with protocol specific findings that justify application of the category under which the protocol is approved as well as determination as to whether one or both parents/guardians must provide permission. The minutes and/or checklist will also document findings related to waiver of consent and/or inclusion of wards.