Children

There are four classifications of research involving children based on the degree of risk and the benefit to individual participants. For any protocols involving children, PIs should submit the Pediatric Risk Assessment Form in iRIS to indicate the level of risk in their studies. These categories are briefly described below.

Minimal Risk: 

• This protocol does not involve risk (physical or emotional) greater than that ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. 
• Only one parent need give consent.

Greater than minimal risk and direct benefit: 

• This protocol does involve greater than minimal risk but also presents the prospect of direct benefit to the individual subject.
• Only one parent need give consent.

Greater than minimal risk and no reasonable prospect of direct benefit: 

• This protocol does involve greater than minimal risk and no reasonable prospect of direct benefit to the individual subject but is likely to yield generalizable knowledge about the subject’s disorder or condition.
• Both parents or legally appointed guardians must give consent unless one parent or guardian is deceased, unknown, incompetent, not reasonably available, or does not have legal responsibility for the custody of the minor.

Research not otherwise approvable: 

• This research is not otherwise approvable but presents an opportunity to understand, prevent, or alleviate serious problems affecting the health or welfare of children. 
• Requires approval by the Secretary of Health and Human Services
• Requires consent of both parents or guardians.

Parental Permission

The investigator will always be required to obtain parental permission documents and may not approach the child for assent until written permission has been given. Permission of one parent is sufficient if the research involves minimal risk; permission of both parents is necessary if the research involves more than minimal risk. However, if one parent is deceased, unknown, incompetent or reasonably unavailable, or if one parent has legal responsibility or custody of the child, one parent permission is acceptable.

1. The CPHS must determine for each protocol whether the permission of both parents is necessary, and the conditions under which one parent may be considered “not reasonably available”.
2. Parental permission may sometimes be insufficient to protect the child’s interests particularly when the interests of one child conflict with those of a sibling or other relation. In such cases, CPHS may seek legal guidance to clarify authority.

Children Who are Wards of the State
Children who are wards of the state, an agency, institution, or entity can be included in approved research only if it is either related to their status as wards or the research is conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as participants are not wards. In this way, if the research is not related to the experience and environment of a ward, their status is made equal with the other non-ward participants.

However, if the research is approved under 45 CFR §46.409(a) the CPHS must require appointment of an advocate for each child who is a ward.
The advocate will serve in addition to any other individual acting on behalf of the child as guardian or in the place of a parent.

• One individual may serve as advocate for more than one child.
  
• The advocate must be an individual who has the background and experience to act in, and agrees to act in, the best interest of the child during the child’s participation in the research.
  
• Aside from their duties as an advocate or member of the CPHS, the advocate must not be associated in any way with the research, the investigator, or the guardian organization.
  

Obtaining Assent from a Child

The difference between assent and consent is a child assents without the complete understanding of the purposes of the research and consent happens when there is a complete understanding of risks, benefits, purposes of the research, and their rights as human research subjects.

The investigator must make their best effort to ask the child for permission in order to determine if he/she assents. In determining this, the investigator takes into account the child’s age, maturity, and psychological state. This judgment may be made for all children involved in research under a particular research protocol, or for each child. The child should be given an explanation of the research procedures in a language that is appropriate to the child’s age, experience, maturity, and condition. This includes a discussion of any discomforts or inconveniences, or if the child will be required to spend time in an unfamiliar place.

For some research activities, the CPHS may require that either a CPHS member, research intermediary or an advocate for the child be present during the assent and permission procedures to verify the child’s understanding and to support the child’s preference. The CPHS may also require that the parents or a close family member be present during the research, especially if a young child will be exposed to significant discomfort or inconvenience, or if the child will be required to spend time in an unfamiliar place.

Waiver of Assent
Generally, the child’s veto of participation is sufficient to make the child ineligible for inclusion in the study. However, the parent or guardian, with CPHS and physician approval, may override the veto if the intervention will benefit the child. The CPHS may determine that the assent of the child is not necessary:

• When the research offers the child the possibility of a direct benefit that is important to the health or well-being of the child and is available only in the context of the research; or
  
• When research involves the provision of experimental therapies for life-threatening diseases such as cancer.

CPHS should be sensitive to the fact that parents may wish to try anything, even when the likelihood of success is marginal and the probability of extreme discomfort is high. Should the child not wish to undertake such experimental therapy, difficult decisions may have to be made. In general, if the child is a mature adolescent and death is imminent, the child’s wishes should be respected.

Compensation
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.

School-Based Research
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.

Other Suggestions for Researchers:
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.

Texas Law on Consent to Treatment of Children
A child may consent to medical, dental, psychological, and surgical treatment for the child by a licensed physician or dentist under certain limited conditions that include if the child:

• Is on active duty with the armed services of the United States of America;
  
• Is legally married;
  
• Is 16 years of age or older and resides separate and apart from the child’s parents, managing conservator, or guardian and manages his/her own financial affairs regardless of the source of funds;
  
• Consents to diagnosis/treatment of infectious, contagious, or communicable disease that is required by law or a rule to be reported by the licensed physician or dentist to a local health officer or Texas Department of Health;
  
• Is unmarried and pregnant and consents to hospital, medical, or surgical treatment, other than abortion, related to the pregnancy;
  
• Consents to examination and treatment for drug or chemical use; or
  
• Is unmarried, is the parent of a child, and has actual custody of his or her child and consents to medical, dental, psychological, or surgical treatment for the child.

Informed Consent by Persons Under the Age of 18

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:

Pregnancy and Teen Parents
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.

Sexually-Transmitted Disease
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.