Though children cannot be categorically defined as unable to weigh research information objectively so as to make an informed choice, it is accepted that laws, education and development of children limit their abilities to make decisions as an adult would. Further, the normal development of children includes experiences of fear, pain and attachment to caregivers that are not experienced by adults. These aspects of childhood development complicate assessment of risk by the CPHS.

It should also be noted that each research study and its personnel must look at each child, situation, and experiment on an individual basis since no child or circumstance is the same.

	Definitions		Confidentiality
	Respecting the child		Informed Consent by Persons Under the Age of 18
	Inclusion and Exclusion of Children		Informed Assent
	Parental Permission		Compensation
	Assessment of Risk		School-based Research
	Creative Methods for Assent		Other Suggestions for Researchers

Definitions

Children are defined as persons under the age of 18. In some circumstances, children may make decisions regarding their own health care. Because state law is silent on whether children may make decisions regarding research within the context of their healthcare, the CPHS has drawn guidelines for parental permission, assent and consent in these circumstances (see below).

The inclusion of children in research requires an understanding that a child must be respected at his or her own developmental level. Children may be included only after carefully weighing the possible risks and benefits as the child may experience them. In addition, children should be asked whether or not they would like to participate in research, especially when the interventions hold no prospect of benefit to them. When asked to make such a decision, every effort must be made to honor that decision.

Child advocates have emphasized that efforts to protect children from the possible risks of research has led to a dire lack of scholarly research to improve childhood health and welfare. As a result, federal regulations now require that the investigators provide adequate justification if a proposal excludes children.

Federal guidelines require that much of the deliberation about the inclusion of children in research be based upon whether or not there is the prospect of benefit to the potential subject and whether or not the research involves more than minimal risk.

The concept of informed consent depends on the informed and voluntary decision by a subject who is capable of making such a decision. When children are subjects, the law does not recognize them as capable of making decisions. Under such a concept, neither children nor parents can give informed consent but rather informed parental permission and child assent. Thus investigators and the CPHS must turn to child's assent and parental permission as a secondary means to respect the subjects themselves as well as to honor the decisions of those who have protective authority over the child.

Parents are the recognized custodians of a child's welfare and thus, in the absence of informed consent by the child, informed parental permission becomes critical. With regards to permission by persons other than parents, federal guidelines refer only to the parents or legal guardians of the child as those able to give permission for a child-subject's participation in research.
Points to consider:

• Parental permission must be obtained before any discussion occurs with the prospective child subject.
• Does the research involve older adolescents who may consent on their own behalf for selected circumstances (see below)?
• Is child abuse or neglect a concern or an area of study? Consider whether the parent or guardian has the child's best interest in mind.
• Does the research involve transplants/donations among siblings? Consider whether the interests of both children are adequately protected.
• If the study entails greater than minimal risk, or offers no prospect of benefit to the child, the permission of both parents, when applicable or reasonably available, are required.
• What efforts will be made to ensure that parents' permission to involve their children in research studies is free from coercion, exploitation and/or unrealistic promises?
• Will the study require a discussion of risks to an unborn fetus or the necessity to prevent pregnancy? This discussion should take place separately. Consider a separate page in the informed consent document to be presented only to the parents and children for whom there is childbearing potential.

There is no agreed-upon age that all children can be deemed able to assent to research. It can be agreed, however, that typically children age six and under are not likely to appreciate the context of research and thus give a meaningful assent to participate.
Children aged seven and up are asked to give their assent to participate. If a child gives their dissent to participating in a research study, then, in most cases, their dissent overrides even their parent’s permission. However, there may be instances in which investigators and caregivers may be able to override the dissent of a child or simply not request assent.
In the absence of assent or in the case of a child’s dissent, other factors become vital considerations such as:

• the prospect of a meaningful improvement in the well being of the child
• whether the potentially beneficial interventions are only available through the research study
• the level of risk to the child.

Points to consider:

• The age of the child and the nature of the protocol (sensitive versus non-sensitive) should be considered when contemplating whether or not to have the parent present in the room when obtaining assent.
• Some children may feel added pressure to assent when in the presence of their parent(s). The setting in which to obtain the child’s assent will be the decision of the PI. So much depends on the nature of the study and the ability of the researchers to know the quality of the parent-child relationship. It is important to keep in mind that children may feel their dissent may get them into varying degrees of difficulties with their parents when they go home.
• When approaching a child to participate in a research protocol, all efforts should be made to provide a setting that is private and comfortable for the child.
• It should, however, be reaffirmed with the child that he/she does indeed want to participate and understands exactly what they will be expected to do or under go if they take part in the study.
• If the child says no for any reason, then all discussions will end. Either way, the child should be reassured that the doctor will not be angry at them for not participating.
• A child’s comprehension truly depends on the individual child and not solely on the age of the child. Younger ones may not understand such concepts as benefit to self versus benefit to the population as a whole. The PI must ultimately be responsible for ensuring that the child understands what the study is about, what will be expected of them, and what the child will experience during the study.
• The research protocol and application should describe the experience of working with children among those involved in the study.
• Although it is at the PI’s discretion as to who will obtain the assent/parental permission, it remains the ultimate responsibility of the PI to ensure that assent/parental permission is properly obtained.
• Assent should not be obtained in the day-surgery setting since it may be considered coercive to approach a child on the day of surgery.
• While it is acknowledged that some patients are not seen by the PI prior to the day of surgery, it is suggested that, in these cases, the PI work with a referral source such as a general surgeon so that potential subjects may be identified earlier than the day of surgery.

Because childhood experience varies widely, assessment of risk varies accordingly depending upon the age and experience of the child. In all cases, consider whether the interventions required by the study are commensurate with those experienced in the child's typical educational, medical, psychological or social experiences.

Points to consider:

• Venipuncture poses varying risks depending on the age of the child. Contrast the physiological needs of neonates, or the "needle fear" of toddlers, to the routine blood draw for a teenager.
• Numbing cream or EMLA should be considered when venipuncture or injection is required.
• Physical exams may be more stressful to a preteen than to a two-year old.
• Confidentiality - Discussion of sexual activity, family relationships, injuries, drug and alcohol use may introduce stresses for children who are under the authority of parents or institutional officials such as school administrators.
• Children may not appreciate the ramifications of their responses to sensitive questions.
• Small changes from the daily experiences of small children can have emotional and psychological effects.
• When the risks of the study are greater than minimal, there must be benefits of the study to the child or there must be knowledge generated about the child's condition or disorder.

Please use the Pediatric Risk Assement Form for new protocols involving subjects less than 18 years of age. This form is avaible in the iRIS system.

Preparations for assent of children should include the exploration of various ways to communicate the key elements of information to the child at his or her level. Creative ways of providing information, such as the use of drawings or "pretend" procedures can enhance assent as well as satisfaction and compliance with the procedures.

There have been changes in recent months (and more will be forthcoming) surrounding the regulations protecting patient privacy and confidentiality. Researchers must ensure that ample provisions are in place to protect the dignity and privacy of young persons who take part as research subjects just as they are for adult research volunteers.

Points to consider:

• Are appropriate mechanisms in place to protect a child’s privacy and the confidentiality of information regarding them?
• Evidence of child abuse must be reported and this information must be included in the consent document.
• There may be special problems with regard to confidentiality when issues of teenage sexual practices or other practices, e.g. drug abuse or eating disorders, emerge during the course of screening or the ongoing clinical trial.

The concept of independent informed consent can only be applied in situations for which the law recognizes the decision-making rights attributed in adulthood. Emancipation into adulthood before age 18 is only afforded by a court of law and occurs when the adolescent is a resident of Texas and the following are in place:

• Age of 17, and fully self-supporting financially; OR
• Age of 16, living away from parent’s home and fully self-supporting financially
  Independent informed consent by persons under age 18 for purposes of healthcare is recognized by state law for teenagers who are:
• pregnant where consent to treatment is related to the pregnancy but not abortion,
• parents consenting to treatment for their child but not for themselves, or
• seeking healthcare for sexually transmitted disease, mental health or substance abuse.

Because children could avoid or delay healthcare for these conditions if parental permission was required, the state has offered means for obtaining care in the face of individual and community health risk. In the absence of specific law relating to health care research, the CPHS recognizes decision-making authority for research in these conditions and follows the state's health care criteria in its guidelines for research:

Texas state law recognizes the independent decision-making authority for informed consent by children who are pregnant or who are parents themselves. In these cases, an adolescent may make decisions about her own prenatal healthcare and the care of her child. Because the law is silent on independent informed consent to research, the CPHS limits the approach of those under the age of 18 for inclusion into research to:

• Pregnant adolescents making decisions about research within the context of their own prenatal care; or
• Adolescent parents making decisions about research participation for their child(ren);
  AND
• the clinical trial is considered a part of community standard for prenatal care. (AIDS or cancer trials, for example, which may include experimental medication as part of the plan of care); or
• the research aims to answer psychosocial questions related to adolescent prenatal health; or
• are decisions by an adolescent as the parent giving permission for a child to participate in any research for which the child is qualified.

Texas state law recognizes the independent decision-making authority for informed consent by children who seek routine examinations for sexual health and/or treatment for a sexually transmitted disease.
Again, because the law is silent on independent informed consent to research, the CPHS limits the approach of adolescents to participate in research to:

• Adolescents seeking examination and/or treatment for sexually transmitted disease; and
• Psychosocial research, which is related to sexual health; or
• The clinical trial is considered a part of community standard of care.

Mental health and substance abuse services may also be sought independently by adolescents. The law is silent on whether adolescents may give informed consent to research similar to informed consent for treatment. The CPHS thus limits independent informed consent to:

• adolescents seeking examination and/or treatment related to mental health or substance abuse; and
• psychosocial research which is directly related to mental health or substance abuse; OR if
• the clinical trial is considered a part of community standard of care.

Points to consider:

• Be certain to forewarn parents that research findings concerning their teenage adolescents will be shared with them only with permission from the adolescent in question.
• Is there sufficient privacy provided for discussion between the researchers and adolescents?

The presence of parents or guardians as authorities over children complicates considerations of reimbursement and compensation. Should children be compensated for time commitment when they would not be compensated for their time in daily life? Can compensation to parents for time commitment cloud their judgment in giving permission to participate? (See Reimbursement and Compensation)

Some investigators wish for compensation to be useful to the children who participate. Gift certificates or small tokens of appreciation may be offered to children at the close of the study, while reimbursement to the parent who must provide transportation, meals, lost time from work etc, also may be so given. These reimbursements may be mentioned during the consent process with the parents.

Points to consider:

• Efforts to make up for the discomforts of children participating in research by the offer of a reward may be coercive. Such efforts may pose an opportunity to reconsider the risks and benefits of the study as well as to consider whether the decision to participate is clouded by the prospect of a reward.
• Above all, there should be a balance in the favor of the subject as to benefit or compensation. The child should receive a “thank you gift” while the parent should, if possible, be reimbursed for travel and parking expenses as well as for time off from work.
• See Reimbursement and Compensation for guidelines.

Research conducted with school students holds special concerns as it relates to coordination with school districts and schools as well as obtaining informed permission from parents.
Early in the planning for the research project, investigators must establish contact and potential collaboration within the school district from which potential subjects will be drawn.
Procedural requirements vary between school districts as to parental permission and children's assent.

In general, obtaining active informed permission of parents will be expected of investigators. However, certain circumstances may lead a school district to prefer alternative means of permission and assent (for example, the provision of a document containing a description that the child will participate in the study unless the parent expresses a choice for the child not to participate is preferred by some districts). It follows that such a procedure can only be possible for certain kinds of research such as:

• Surveys
• Research in which no identifiers are recorded; and
• Research that does not involve questions of sensitive nature.

Prospectively obtained informed parental permission and assent are required for research involving:

• Interventions with children;
• Review of academic, behavioral or school-clinic medical records;
• Surveys with questions of a sensitive nature (i.e. sexual behavior, illicit substance use, criminal behavior or family relationships).

Points to consider:

• Assent in a school setting should be done in a way so that children not willing to participate in a study will not be identified or embarrassed by their decision.
• Research personnel, not the schoolteacher, should explain the study and invite study participation.

• Present the families with a list of questions that should have been covered during the consent/assent process. The family should read over the list before they sign onto the study to make sure that they understand the study and what is being asked of them (include outline of standard care versus experimental care).
• The principal investigator may petition the CPHS if some aspect as outlined above cannot be met.