Human Research Protection Program

There are three categories of research involving children that the federal regulations state can be approved by an IRB. A proposal involving children that does not fall into one of these three categories cannot be approved by the IRB:

1. Research not involving greater than minimal risk to the children. 

To be approved, the research must satisfy both of the following conditions:

• It presents no greater than minimal risk to the children.

• Adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians.

2. Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual child subjects involved in the research. 

To be approved, the research must satisfy all of the following conditions:

• The risk is justified by the anticipated benefits to the subjects.

• The relation of the anticipated benefit to the risk presented by the study is at least as favorable to the subjects as that provided by available alternative approaches

• Adequate provisions are made for soliciting the assent of the children and the permission 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.

To be approved, the research must satisfy all of the following conditions:

• The risk of the research represents a minor increase over minimal risk.

• 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.

• 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.

• Adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians.

A fourth category exists, however it must be reviewed and approved by the HHS secretary after consultation with a panel of experts and public comment:

4. Research presenting a reasonable opportunity to further the understanding, prevention or alleviation of a serious problem affecting the health or welfare of children.

To be approved, the research must satisfy all of the following conditions:

• The research presents a reasonable opportunity to further the understanding, prevention or alleviation of a serious problem affecting the health or welfare of children.

• The research will be conducted in accordance with sound ethical principles.

• Adequate provisions are made for soliciting the assent of children and the permission of their parents or guardians.

Children are considered by the Federal Code of Regulations to be a "vulnerable population" due to their (assumed) inability to fully understand how to weigh the risks and potential benefits of research (or what they are), as well as their susceptibility to undue influence.

Legally, children are not able to provide informed consent on their own behalf; therefore, obtaining informed consent for the involvement of children as research subjects is a two-step process: the investigator must obtain permission from the child's parent(s)/guardian(s), or legally authorized representative (LAR), as well as assent from the child, assuming s/he is capable.

Obtaining permission from a child's LAR involves the same process as does obtaining informed consent from an adult on their own behalf. The pertinent information regarding the research is reviewed with the LAR, and the LAR is encouraged to ask questions to ensure an informed decision is made. When appropriate, the LAR should discuss the research with the child.

After documented permission has been obtained from the LAR, the investigator must, assuming the child is capable, obtain informed assent from the child. In determining whether children are capable of assenting, the investigator should take into account the ages, maturity, and psychological state of the children involved. This judgment may be made for all children to be involved in research under a particular protocol or for each child individually. When a child is capable of providing assent, they should be given an explanation of the proposed research procedures in a language that is appropriate to the child's age, experience, maturity and condition. 

Informed assent may be written or it may be verbal, depending on the age of the child and the appropriateness of requiring the child to give written assent: the assent process should be tailored to the age and capabilities of the child.

Note that for children who turn 18 during the course of the research, they must be re-consented, or give informed consent as an adult, and be given the opportunity to withdraw their participation in the research.

Waiver of Assent

An Institutional Review Board may waive the requirements for obtaining subject assent in circumstances in which the subject population does not have the capacity to comprehend the research or associated procedures. This judgment may be made for all subjects involved in the research or for each child individually. If the IRB determines either of the following to be true, then the assent of the child is not a necessary condition for proceeding with the research:

• The capability of some or all of the subjects is so limited that they cannot reasonably be consulted.

• When the research offers the subject the possibility of a direct benefit that is important to the health or well being of the subject and is available only in the context of the research.

The IRB will take into account the age, maturity and psychological state of the subjects involved in determining whether a waiver of assent is appropriate.

Waiver of LAR Permission

An IRB may waive the requirements for obtaining LAR permission if the conditions for a general waiver of informed consent are met. Note that the research may involve no more than minimal risk to the children, however. 

In addition, the IRB may, for the protection of the subjects, waive the requirements for obtaining LAR permission if the IRB determines that a research protocol is designed for conditions or for a subject population for which LAR permission is not a reasonable requirement (for example, neglected or abused children). In such cases, there must be another mechanism in place for the protection of the subjects.

Investigators must obtain letters of support from the educational agencies (elementary schools, secondary schools or school districts) in which the research is to be performed. This letter should be attached to the Institutional Review Board application.

Educational records are defined as records containing information (in any medium: paper, electronic, microfilm, etc.) that directly relate to a student and are maintained by an educational institution or by a party acting for the institution.

Research involving students' educational records may be subject to the Family Educational Rights and Privacy Act. FERPA applies to all educational agencies and institutions that receive federal funding. FERPA has two purposes:

1. To provide parents and students with the rights to inspect a student's records and request the correction of incorrect information.

2. To ensure the privacy of such records. As a result, investigators must take into consideration this right to confidentiality when conducting research on students and their educational records. 

When planning to do research involving students' educational records, the investigator has three options:

1. The investigator may obtain consent for each student to have access to that student's records. [Consent forms must specify the records to be disclosed, state the purpose of the disclosure, identify the party to whom the disclosure is to be made and be signed and dated by the parent or student (if over age 18 or attending an institution of postsecondary education).]

2. A school official (other than the investigator) who has legitimate access to the records may strip the records of all personally identifying information and provide the investigator with the de-identified data. Note that when research involves the use of de-identified student records data, a letter from the school district's superintendent (for K-12) or the university registrar  (for postsecondary schools) approving the de-identification of the student's records must accompany the IRB application. 

3. Limit the data to "directory information" such as the student's name, address, telephone number, date and place of birth, honors and awards, and dates of attendance. Note that each educational institution designates what information is considered to be directory information and FERPA requires that students be given the opportunity to file a request to prevent disclosure of directory information (known as "opting out"), disallowing the institution from releasing any educational records, including directory information. 

For additional information on FERPA, see:

• Code of Federal Regulations 34 CFR 99: Family Educational Rights and Privacy

• Department of Education

• Family Policy Compliance Office

• Oregon State University — FERPA Applicability Decision Tree

The Protection of Pupil Rights Amendment applies to local educational agencies (elementary schools, secondary schools, school districts or local boards of education) that receive funds from the U.S. Department of Education, and requires parental consent for research involving surveys, analysis or evaluation in which the primary purpose is to reveal information concerning one or more of the following:

• Political affiliations or beliefs of the student or the student's parent.

• Mental and psychological problems potentially embarrassing to the student or his or her family.

• Sex behavior or attitudes.

• Illegal, antisocial, self-incriminating and demeaning behavior.

• Critical appraisals of other individuals with whom the student has close family relationships.

• Legally recognized privileged and analogous relationships, such as those of lawyers, physicians and ministers.

• Religious practices, affiliations or beliefs of the student or student's parent.

• Income, other than that required by law to determine eligibility for participation in a program or for receiving financial assistance under a program.

Prior to conducting research involving any of the protected information listed above, written parental consent is required. The IRB cannot approve waivers of parental permission for surveys, analyses or evaluations involving such protected information. In addition, parents have the right to inspect all materials involved before they are administered or distributed and to opt the student out of the surveys if they wish.

Investigators whose research is subject to PPRA should review the policies of the local educational agency.

For additional information on PPRA, see:

• Department of Education — What is the PPRA?

• Family Policy Compliance Office