Guide To Projects Involving
Minors As Subjects

The special nature of research involving children as subjects is reflected in the fact that federal regulations include special provisions for research involving minors. A subpart to the human subjects regulations is entitled, “Additional Protections for Children Involved as Subjects in Research.”

• Compliance With The Buckley Amendment
  • The Family Educational Rights and Privacy Act of 1979 (the Buckley Amendment) is a federal law which states that “An educational agency or institution shall obtain the written consent of the parent of a student, or the eligible students before disclosing personally identifiable information from educational records of a student, other than directory information. . .” Thus, for any research which involves obtaining identifiable information from student records, the investigator must obtain written permission from the parents. Blanket permission giving access to any information in the records is not acceptable.

• All investigations involving human subjects and particularly those involving minors must adhere to certain ethical standards in order to protect the rights of subjects. These principles are described completely in Truman State University’s “Policy Statement Regarding Humans as Subjects in Research.” In brief, the project design and execution must satisfy the following conditions:
  • 1. Research procedures should minimize the risk of physical, psychological, social and emotional hardship to the subjects.
    
  • 2. Any remaining risk must be reasonable in relation to anticipated benefits.
  • 3. Research must respect the privacy of subjects.
  • 4. The researcher must make available to subjects, or those legally responsible for the subject, information requested about any aspect of the research likely to be significant to the subject.
  • 5. The researcher shall not induce subjects to participate by means that might affect the subject’s ability to decide freely about his or her participation.
  • 6. Researchers who promise confidentiality are responsible for maintaining it and for informing subjects of limits on their capacity to meet the responsibility.
  • 7. Researchers shall explain to subjects, prior to their participation, the purposes of the research. Any project involving deception must be reviewed and approved by the IRB.
  • 8. Selection of subjects must be done equitably.
  • 9. Informed consent must be obtained. This consent must be in writing unless approved by the IRB. The investigator shall not use an individual as a subject unless satisfied that the subject, or those legally responsible for the subject, consent to participate in the study knowingly and willingly.
  • 10. Data must be maintained so as to ensure confidentiality and privacy.
• Review Procedures
  • All research involving minors as subjects must be reviewed by the Truman State University Institutional Review Board. The review of projects involving minors at Truman is intended to result in mutually acceptable research procedures that accomplish the investigator’s objectives while protecting the rights and welfare of the subjects. The IRB tries to be as flexible as possible and reviews each project as a separate case rather than imposing rigid requirements. A primary role of the IRB is educational and, consultation with the IRB at all stages of the research and review process is encouraged.
• Projects That Do Not Involve Greater Than Minimal Risk
  • A. Research that does not involve direct intervention with children does not usually require parental consent or child assent. However, permission of the school (superintendent or principal) and compliance with the provisions of the Buckley Amendment are required.
    Examples of research that does not involve direct intervention with children include:
    • 1. anonymous, non-interactive, non-participating observation of public behavior
      
    • 2. secondary analysis of existing data
      
    • 3. education research that does not modify or disrupt regular classroom activity; e.g., testing of curricula or teaching methods, or observation of classroom activity
      
    • 4. research involving the use of educational tests if information taken from these sources is recorded in such a manner that subjects cannot be identified
  • B. Projects that involve direct intervention with children require permission from the school district and parental consent. In addition, assent from the child is required when appropriate. Compliance with the Buckley Amendment is also required.
    Examples of research that involves direct intervention with children include:
    • 1. research on individual or group behavior of children
    • 2. interviews and surveys
    • 3. education research that modifies or disrupts regular classroom activity; e.g., introduces unusual activities or tests, or takes children individually or in groups out of the classroom
    • 4. the use of identifiable test information
• Research Involving Greater Than Minimal Risk
  • Research involving greater than minimal risk to children should only be conducted when absolutely essential to the investigation. Such research raises important ethical questions which must be given serious consideration by both researchers and the IRB. Federal regulations distinguish between two types of research involving greater than minimal risk to children:
    • 1. Research presenting the prospect of direct benefit to the individual subjects. Federal regulations state that an IRB can approve such research only if it finds that:
      • a. the risk is justified by the anticipated benefit to the subjects,
      • b. the relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches, and
      • c. adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians.
    • 2. Research presenting no prospect of direct benefit to individual subjects but likely to yield generalizable knowledge about the subject’s disorder or condition. Federal regulations state that an IRB can approve such research only if it finds that:
      • a. the risk presents a minor increase over minimal risk,
      • b. the intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations,
      • c. 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 of the subject’s disorder or condition, and
      • d. adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians.
    • Of course, for research involving school children, permission from the school district is also required as is compliance with the provisions of the “Buckley Amendment.”
    • Given the serious issues raised by this type of research, the IRB will take the following additional steps when reviewing this research:
    • In order to ensure that the interests of the children are being adequately protected, the IRB, when reviewing research in this category, shall have, as a member, an individual who shall serve as a “child advocate.” This individual should be one whose professional responsibility is primarily concerned with the welfare of children. When appropriate, the IRB may require that the “child advocate” monitor the consent process.
    • Since approval of research in this category involves evaluating the potential benefits of the research, the IRB shall solicit recommendations from individuals with sufficient professional expertise to evaluate these benefits. These individuals shall not be associated with the research project.
    • In order to ensure that all aspects of the research project are given serious consideration, including the interests of the researcher, the IRB shall invite the researcher or a representative of his/her choosing to the meeting where the project is being considered.