Research with Children

Introduction
Although children are recognized as a vulnerable population, federal
regulations do permit institutions, typically through their Institutional
Review Board (IRB) offices, to exempt some types of research with
children. The regulations also specifically prohibit exempting certain
research activities with children. This module reviews the application of
exemption criteria to research with children.

Learning Objectives

By the end of this module, you should be able to:

 Describe what is meant by the term "children."

 Identify the types of research involving children that may be
exempt.

Defining "Children"
According to the federal regulations, children are persons who have not
yet attained the legal age of consent under the applicable laws in the
jurisdiction in which the research will be conducted (Protection of Human
Subjects 2017). In the U.S., state law dictates the age of majority. In most
states, the age of majority is 18, but there are exceptions (such as,
Nebraska where the age is 19). Researchers should also be aware that the
age of majority might be quite different in other countries.

Exempt Research with Children as Subjects

Research with children may be specifically exempt under two categories
when it involves certain activities:
Research with children may not be exempt under category 2 when it
involves:

 Interviews with children

 Surveys of children
 Observation in which the researcher participates in the activities
observed
Research with children may also be exempt under other categories if the
conditions of the exemption are met, including:

 Category 4 - Secondary research for which consent is not

required.
 Category 5 - Research and demonstration projects that are
conducted or supported by a federal department or agency, or
otherwise subject to the approval of department or agency
heads (or the approval of the heads of bureaus or other
subordinate agencies that have been delegated authority to
conduct the research and demonstration projects), and that are
designed to study, evaluate, improve, or otherwise examine
public benefit or service programs.
 Category 6 - Taste and food quality evaluation and consumer
acceptance studies.
  Category 7 - Storage or maintenance for secondary research for
which broad consent is required.
 Category 8 - Secondary research for which broad consent is
required.

Examples of Exempt and Non Exempt Research for Category 2

It is important to note that some of the activities in the exempt box above
may not meet the regulatory definitions of human subjects and research,
and therefore, may be considered “not human subjects research.” It is
important to check with institutional policy as well for review
requirements beyond the federal regulations.

Summary
Federal regulations permit research with children to be exempt from the
regulations, but only if the research falls within certain categories and with
certain restrictions.