Institutional Review Board Manual
Special Population Requirements
Children: Special Provisions and Requirements
Definition: defined by South Carolina law as “persons under the age of 16.” Adolescents, age 16 or older, may give informed consent independent of parental informed consent or that of legal guardians, as may emancipated minors.
Research involving the use of educational tests (cognitive, diagnostic, aptitude, and achievement) with children as subjects is exempt from Institutional Review Board (IRB) review provided that:
- Information obtained is recorded in such a manner that human subjects can not be identified, directly or through identifiers linked to the subjects; and
- Any disclosure of the human subjects' responses outside the research could not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
Note: Research with children involving survey or interview procedures or observation of public behavior may not be exempted from IRB review.
All categories of research eligible for Expedited Review approval are applicable to research involving children although there are special limitations on blood samples as specified in http://www.hhs.gov/ohrp/humansubjects/guidance/expedited98.htm
Risk Determination in Research Involving Children:
In weighing the risk/benefit equation for research proposals involving children, there are four categories into which allowable research may fall and which govern the IRB decision-making process. These are:
- Research presenting no greater than minimal risk to children. Research in this category must include adequate provisions for soliciting the assent of the children and the permission of parents or guardians. Where parental permission is to be obtained, the IRB may find that the permission of one parent is sufficient for research to be conducted.
- Research involving greater than minimal risk but presenting the prospect of direct benefit to individual child subjects. Within this category the IRB must determine that:
- The research risk is justified by the anticipated benefit to the subjects;
- 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
- Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians. Where parental permission is to be obtained, the IRB may find that the permission of one parent is sufficient for research to be conducted.
- Research involving greater than minimal risk to children and an intervention or procedure that does not hold out the prospect of direct benefit for the individual subject, or by a monitoring procedure which is not likely to contribute to the well‑being of the subject. Research in this category may be approved only if the IRB finds that:
- The risk represents a minor increase over minimal risk;
- 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;
- The intervention or procedure is likely to yield common knowledge about the subjects' disorder or condition which is of vital importance for the understanding or amelioration of the subjects' disorder or condition; and
- Adequate provisions are made for soliciting assent of the children and permission of their parents or guardians. Where permission is to be obtained from parents, both parents must give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.
Assent means a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent. For a discussion on Assent/Consent considerations, refer to http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.408
- Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare children.
An IRB must find that the research in this category presents a reasonable opportunity to further understanding, prevention or alleviation of a serious problem affecting the health or welfare of children. Where permission is to be obtained from parents, both parents must give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.