This course will discuss research with children. We will begin with an overview of the long history of the use of children in research. Almost all of the research prior to the 1950s that used children as subjects occurred without child or parent consent. In many cases, it occurred without their knowledge. The most vulnerable children, those under state care, were frequently targeted as unwilling research subjects. As a reaction to the history of abuse, for a number of years, children were rarely used in research. We will discuss the National Research Act of 1974, which called for the expansion of the use of children in research—as long as that research was necessary and conducted with due caution and with the consent of the parents or guardians of the child. NIH and FDA guidelines for the use of children in research are presented. We will then discuss the conditions under which research with children may be exempt from IRB review or put through an expedited review. Finally, the consent process when children are involved in research is discussed. The module will conclude with a short quiz.
- Identify the historical aspects of children as subjects in research
- Examine the National Research Act of 1974, NIH, FDA, federal regulations, and state regulations as they relate to children and research
- Describe the exempt and expedited classifications of research with children
- Review the requirements for documenting parental consent and child assent
- Understand the Family Educational Rights and Privacy Act (FERPA) and the Protection of Pupil Rights Amendment (PPRA) as they relate to research with children in public elementary and secondary school settings
Research with Children
This Module will discuss research with children. We will begin with an overview of the history of the use of children in research. Almost all of the research prior to the 1950s that used children as subjects occurred without child or parent consent. In many cases, it occurred without their knowledge. The most vulnerable children, those under state care, were frequently targeted as unwitting research subjects. As a reaction to the history of abuse, for a number of years, children were rarely used in research. We will discuss the National Research Act of 1974, which called for the expansion of the use of children in research—as long as that research was necessary and conducted with due caution and with the consent of the parents or guardians of the child. NIH and FDA guidelines for the use of children in research are presented. We will then discuss the conditions under which research with children may be exempt from IRB review or put through an expedited review. We will also cover additional regulations that protect the privacy rights of children in elementary and secondary school settings, specifically the Family Educational Rights and Privacy Act (FERPA) and the Protection of Pupil Rights Amendment (PPRA). The module will conclude with a brief quiz.
History of Children in Research
Historically, children have frequently been used in research—oftentimes neither the children nor their parents gave consent to be a part of the research. Generally, in cases where consent was given, it was often without fully understanding the research. Throughout much of history, children were considered to be property—either of their parents or guardians or of the state. In most cases, children had no choice but to do what they were told to do.
There is no clear indication of when children began to be used as research subjects, but like individuals who were confined to mental institutions, children, especially those without parents or guardians, were convenient for scientists to use in their research. Many scientists even used their own children in their research. In the 1700s children were used in a wide variety of experiments, including research to treat smallpox, measles, pertussis, syphilis, gonorrhea and many other infectious diseases.
In 1885, Louis Pasteur tested his rabies vaccine on children. He did not need to rely on children who were wards of the state to conduct his research; many of the parents of his patients begged him to give the vaccine to their children. In the late nineteenth and early twentieth centuries, research was conducted on children in hospitals, orphanages, and schools. These experiments included attempts to infect healthy children with sexually transmitted diseases to study their natural progression (much like the later Tuskegee Study of Syphilis), inducing scurvy in healthy infants, studying the use of feeding tubes, to name a few. (ref 34) (ref 35)
From the 1950s through the 1970s, Saul Krugman studied the herpes virus by using poor and retarded children from Willowbrook State School in New York. One researcher of the time even commented that the conditions in institutions, like orphanages, were very much like the conditions required for infectious experiments among animals. (ref 34) (ref 35)
The National Research Act of 1974
The National Research Act of 1974 established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. This Commission looked at the requirements for informed consent for children to participate in research. (ref 36)
Expansion of Research Involving Children
Because of the many years of research abuses involving children, researchers became very reluctant to include children in research at all. This led to stringent restrictions on having children in research and it became very difficult for us to learn important things about children through research. In the area of medicine, procedures for children had only been tested on adults and most medications had no recommendations for children—because the research had never been conducted. We lacked an understanding of psychological trauma in children because researchers were reluctant to conduct this research. In an effort to prevent the indiscriminate use of children in research, Belmont’s third principle, Justice, had been forgotten. Children can benefit from research and must be included in research, but that research must be conducted carefully and child research subjects must be protected.
In 1983, the Department of Health and Human Services published its first guidelines that specifically addressed research involving children—this is CFR 45, subsection 46, Subpart D, which is widely cited within this Module. In the 1990s NIH and the FDA began to push to expand the use of children in research to address the specific medical, psychological, pharmacological, physical, and social needs of infants, children and adolescents. It has been noted that even in the early 1990s, eighty percent of the medications listed in the Physician’s Desk Reference had no prescribing information for children. And, while procedures and treatments for children must be researched on child subjects, there is a deep concern that all research involving children should be well-executed and that no category or subgroup of children be either excluded from research or overburdened as research participants. They stress that there must be a robust system in place to protect child participants and that there must be appropriate expertise in child health at all stages in the design, review, and conduct of child research. (ref 34)
NIH Policy and Guidelines
The National Institute of Health published policy and guidelines concerning research with children in 1998. The goal of this policy was to increase the ethical participation of children in research. The impetus for the creation of this policy was the fact that medical treatments applied to children at that time had only been tested on adults. Also in 1996, the Federal House Appropriations Committee were concerned about this and wanted to devote more monies and attention to research involving children. (ref 37)
Conducting human subjects research requires protection of privacy and confidentiality of all participants similar to when working with children or other vulnerable populations. This video, intended for youth workers, does an excellent job describing the privacy and confidentiality protections afforded all research participants, regardless of age or vulnerability status. In addition, the information on mandated reporting describes the limited circumstances under which privacy and confidentiality requirements are waived. (Video ref 45)
The National Institutes of Health (NIH) policy defines children as individuals under the age of 21 and states that children must be included in NIH research unless there are specific reasons not to include them. In fact, NIH requires all proposals for research involving human subjects to contain a section entitled “Participation of Children” which should include either plans to include children in the research, a rationale for excluding certain ages of children, or the reason why children will not be included. When children are included in a study, an explanation of the expertise of the individuals working on the study for working with children must also be included. (ref 37)
NIH policy states that children may be excluded under the following circumstances: when the topic is irrelevant to children, there are laws or regulations that prohibit the inclusion of children, the knowledge being sought is redundant, a separate age-specific study is warranted and preferable, the risks to children cannot be determined, study designed aimed at collecting additional data on pre-enrolled adult study participants (e.g. longitudinal studies that did not originally include children). (ref 37)
FDA Regulations for Research With Children
The Code of Federal Regulations Title 21, Chapter I, Part 50, Subpart D outlines additional safeguards for children in clinical investigations. If the study is only minimal risk, assent must be obtained from the children and the permission of their parents or guardians must be obtained. Studies that are more than minimal risk are permitted if the intervention or procedure might directly benefit the child-subject. However, the risk must be balanced by the benefit. (ref 38)
Studies that are more than minimal risk that involve no direct benefit to the child-subject may involve children as subjects if the IRB finds that the increased risk is only a minor increase over minimal risk, the intervention or procedure is what the subject would experience in their actual or expected medical, dental, psychological, social or educational settings, the intervention; the intervention is likely to yield generalizable knowledge about the subjects’ disorder; adequate provisions have been made to obtain child assent and parental permission. Research may also be approved if it holds out the possibility of furthering the understanding, prevention, or alleviation of a serious problem that impacts children. (ref 38)
While we saw above that the NIH definition of a child as an individual under the age of 21, that is not a standard definition. CFR 45, subsection 46.402(a) defines children as “persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.” (ref 27) It should be noted that this definition only provides guidance as to where to look to determine who is a child and who is not. The researcher must look to the individual state in which the research is being conducted to determine the legal status of the child-subject. Each state defines “child” in its’ own way and the rights that children have are different. Some states allow children to consent to some types of medical procedures but not necessarily research. In the United States the age of majority is typically 18 but ranges by state from 16-21. A few states have set the age of majority at 19 and Mississippi has set it at 21. Main point here is that researchers are responsible for knowing the age of majority for the state(s) from which they will be recruiting participants. (ref 66)
Campbell (2004) points out that the first issue that concerns the investigator is the age of majority in the particular state is because those individuals who are above the age of majority are not afforded special protections because they are not considered to be children. This establishes a “bright-line” which is clear-cut and below which all individuals are considered to be children and above which they are adults. Please note that the age of majority does not address maturity-level, cognitive-level, or decision-making capacity—these are separate issues. There are a variety of state laws that will make individuals even below this “bright-line” adults or give them decision-making capacity. Three of these are the “mature minor rule,” the “consent to treatment provisions,” and “emancipation.” A “mature minor” is a minor who is seen as mature enough to make certain decisions. It is a form of emancipation, but not total emancipation. From “mature minor,” the ability of minors to consent to certain medical treatments has evolved. Consent to treatment provisions allow minors to consent to certain medical treatments. The age at which they may consent varies from state to state. “Emancipation” frees a minor from parental control and may occur in a variety of ways, including marriage, military service, financial independence, and court order. Keep in mind, not all states have emancipation statutes, consent to treatment statutes or recognize the concept of a mature minor. The key point is that researchers need to be aware of what the laws and statutes governing the definition of child and who may give consent are in their own jurisdiction, because there is no over-arching standard to rely upon. (ref 39)
Exempt and Expedited Research with Children
There are certain circumstances in which research with children may be exempt from IRB review or meet expedited review criteria. A more narrow range of research is exempt from review when it involves children. These include research involving educational tests or observations of public behavior where the investigator does not participate. Also, to fall into the exempt category, data must be recorded without individual identifiers or not place the subjects at risk if disclosed. (ref 65)(ref 28)
The Code of Federal Regulations permits research to be conducted with child subjects under three circumstances. The first involves research which presents no more than minimal risk to the child. The second involves research which presents more than minimal risk but offers direct benefit to the individual child-subject. The third involves research which presents no direct benefit to the individual child-subject but consists only of a minor increase over minimal risk. Research with children that falls outside of these three circumstances cannot be permitted. (ref 28)
Previously approved (by a convened IRB) research with children may be subject to an expedited review if the IRB is only reviewing minor changes to an existing study and those changes occur within one year of original study approval and those changes do not increase the risk level of the study. These modifications should be reviewed by the IRB chair or another experienced reviewer. (ref 67)
Informed Consent When Conducting Research with Children
Children are considered vulnerable to coercion and undue influence and legally are not considered able to engage in contracts. Obtaining informed consent when conducting research with children is different from the consent process utilized with adult non-vulnerable subjects. Research with children, except under very special circumstances must involve obtaining the permission of the child’s parent(s) or guardian(s). The Code of Federal Regulations discusses and differentiates “child assent” and “parental permission.”
CFR46.402(b) defines “child assent” as “a child’s affirmative agreement to participate in research.” This must be an active assent and not simply a failure to object to participation in the research. The IRB that is overseeing the research must determine whether or not the child is capable of providing assent. Some children, because of age or cognitive deficits cannot assent. The IRB must also assure that permission from the child subject’s parent(s)/guardian(s) is obtained. CFR46.402(c) defines parental permission as “the agreement of the parent(s) or guardian to the participation of their child or ward in research.” (ref 27)
Research with Children in School Settings
Conducting research with children in school settings involves some unique ethical considerations. Frequently, teachers and others use school settings to conduct research. It is important to be aware that teachers have significant influence over students, and students often do not feel they can say no to something when requested by their own teacher. Parents, too, can feel coerced into participating in something when asked by the school to do so. When conducting research with children in school settings, extra care should be taken to ensure that parents and students have the right to decline to participate, and activities for children who are not participating in research should be made available.
Often classroom activities are in a gray area and it can be difficult to determine whether they are research involving children, requiring IRB review, or simply normal educational practices, which would meet exempt review criteria. Only an IRB can make this determination, so best practice is to submit a proposal to an IRB for review.
Research in school settings falls into two basic types of research, broadly characterized as applied research and basic, or empirical research. Very little research involving children is exempt from IRB review, unless it doesn’t meet the federal definition of research with human subjects. According to the Department of Health and Human Services, “the only research activities involving children that may fall under this (45 CFR 46.101(b)(2)) exemption are those involving educational tests or observation of public behavior where the investigators do not participate in the activity being observed. To be exempt, these activities must also meet the condition that the data are recorded without individual identifiers, or the condition that disclosure of the recorded responses would not place the subjects at risk of criminal or civil liability or be damaging to their financial standing, employability, or reputation. Otherwise, all the requirements of the human subjects regulations apply.” (ref 65)
As with all human subjects research, the Common Rule applies to research with children in elementary and secondary school settings. There are additional regulations that also apply, and at times it can be difficult for educational researchers to understand the interaction of multiple regulations governing research with children in school settings. Included in these additional regulations are the Family Education Rights and Privacy Act (FERPA), and the Protection of Pupil Rights Amendment (PPRA).
Family Education Rights and Privacy Act (FERPA)
FERPA, or the Family Education Rights and Privacy Act, protects the privacy of student records, regardless of the age of that student. When a student reaches age 18 or transfers from a secondary school to a post-secondary institution, the rights afforded to parents in elementary and secondary schools transfer to the student him or herself.
(Video ref 92)
Under FERPA, parents or eligible students are afforded the following rights:
- Review student educational records for that school
- Request corrections to records they believe are inaccurate
- Request a formal hearing, in the event that records are not corrected or amended as requested
- Provide written permission for the release of any information from an education record
Schools are allowed to disclose records without parent or eligible student consent to the following parties or under the following circumstances (34 CFR § 99.31):
- School officials with legitimate educational interest;
- Other schools to which a student is transferring;
- Specified officials for audit or evaluation purposes;
- Appropriate parties in connection with financial aid to a student;
- Organizations conducting certain studies for or on behalf of the school;
- Accrediting organizations;
- To comply with a judicial order or lawfully issued subpoena;
- Appropriate officials in cases of health and safety emergencies; and
- State and local authorities, within a juvenile justice system, pursuant to specific State law.
Under FERPA, schools have the right to disclose directory information without parent or eligible student consent. Directory information is determined by the schools, and the school must tell parents and eligible students exactly what is included in that school’s directory information, allowing them time to review and make a decision about whether they will allow their directory information to be disclosed. Directory information may include information such as student name, address, phone number, date or year of birth, telephone number, dates of attendance, and honors or awards. Disclosing directory information for a student where it has been prohibited is a violation of FERPA. Schools are also required to provide annual notification about student rights under FERPA, and to annually allow parents and eligible students to withdraw their permission to have directory information shared. (ref 93)
Research that involves the use of school records must adhere to FERPA regulations, and must take care to ensure that all appropriate and explicit consents to use, review, or report information from student records beyond directory information has been obtained.
Protection of Pupil Rights Amendment (PPRA)
Additional protection for students in public elementary and secondary schools where research is conducted is afforded by the Protection of Pupil Rights Amendment (PPRA). This policy protects the rights of parents and students in programs that receive funding from the US Department of Education. Specifically, this amendment (34 CFR Part 98) ensures that parents have the opportunity to review instructional materials that will be used in a Department of Ed funded survey, analysis or evaluation that involves their students. It also ensures that schools obtain parental consent before children are involved in any investigation that asks about or involves the following information:
- Political affiliations;
- Mental and psychological problems potentially embarrassing to the student and his/her family;
- Sex behavior and attitudes;
- Illegal, anti-social, self-incriminating and demeaning behavior;
- Critical appraisals of other individuals with whom respondents have close family relationships;
- Legally recognized privileged or analogous relationships, such as those of lawyers, physicians, and ministers; or
- Income (other than that required by law to determine eligibility for participation in a program or for receiving financial assistance under such program). (ref 94)
This Module discussed research with children. An overview of the long history of the use of children in research was presented. Almost all of the research prior to the 1950s that used children as subjects occurred without child or parent consent. In many cases, it occurred without their knowledge. The National Research Act of 1974 was presented and called for the expansion of the use of children in research—as long as that research was necessary and conducted with due caution and with the consent of the parents or guardians of the child. NIH and FDA guidelines for the use of children in research were presented. We then discussed the conditions under which research with children may be exempt from IRB review or put through an expedited review, and the consent process when children are involved in research was discussed. Finally, we took a look at research with children in school settings and discussed FERPA and PPRA regulations as they apply to research with children.