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INFORMED CONSENT

The general requirements for obtaining informed consent and the elements of legally effective consent documents appear in the “INFORMED CONSENT PROTOCOL” program which can be selected at the beginning of this program under PROGRAM OPTIONS.  Also included are the provisions for obtaining waivers from the requirement to obtain written informed consent. All of these provisions apply to research involving children as subjects, with the understanding that CRP will expect investigators to demonstrate great sensitivity to protecting the child from the risks of research.

Although some categories of research are exempt from review by the CRP the investigator must still obtain the informed cornet of the subject. With children, this means obtaining parental permission or consent and also obtaining the assent of the child. The process of obtaining consent from those under 18 years old requires special attention to the child’s age, his/her ability to understand what is asked of him/her, and his/her relationship to parent or guardians. The proposed consent procedures, whether they involve written or oral processes, should be developmentally appropriate to the age and circumstances of the subject. The circumstances should account for both the maturity and the psychological state of the children involved. In evaluating proposed consent Procedures for a project, CRP may treat the child subjects as a group or individually, as the nature of the research and of the subject pool dictate. Generally, CRP uses the following rules of thumb as a guide.

1. Parental consent or permission: For research involving unemancipated minors—generally, children under 18 years old—investigators must obtain written permission or consent from parents or guardians for the participation of the child in the project. Ordinarily, the signature of one parent or guardian satisfies this requirement. However, if the research involves greater than minimal risk without direct benefit to the child subject, both parents or guardians must consent, unless the child is in the custody of only one parent or guardian due to the death of a spouse, divorce, court directive, or similar reason. For minimal risk research, especially when attached to normal school program testing and similar situations, CRP will consider reasonable requests for waivers under the condition that there are appropriate mechanisms for protecting the children and that the river does not violate federal, state, or local law.

2. Child’s written consent: From about junior high or middle school onward, children can read and comprehend a well-constructed consent form. Therefore, written consent from the child (in addition to written permission of parents) becomes appropriate. the investigator should carefully word the consent explanation to match the ability of the children to understand, and he/she should supplement the written material with verbal explanations whenever necessary.

3.Child’s oral assent: For elementary school age children, the investigator should obtain (in addition to parental permission) the child’s oral assent to participate. Oral assent should be informed; that is, the explanation to the child should contain all the requisite elements of informed consent, but expressed in a form the child can understand. A conversational question-and-answer setting is often necessary to achieve this goal. When describing the means of obtaining informed consent on Form B, include a copy of the explanation to be given to the child and other information regarding responses by anticipated questions. In addition, the child’s assent should be positive and not merely lacking dissent. 

4. Very young children: To children blow school age—including infants, toddlers, and preschoolers—investigator should give explanations that match the level of understanding. In many instances, the child’s nonresistant behavior may b interpreted as assent.  However, the investigator must use special care to discontinue the participation of children who appear to experience undue stress from the research procedures.

These rules of thumb generally apply to normal, healthy children and to research that presents the children with minimal risk. Therefore, the rules have many exceptions. If you wish to use alternative procedures, justify them fully in appropriate section of Form B.  CRP will review on a case-by-case basis any project proposing to use special categories of children, e.g., those under psychological care or those classified as retarded. In all such cases, CRP relies upon the researcher to provide a sound rationale for using such children in research and for the proposed methods of obtaining informed consent .

The use of children in research often presents complex problems of research design simultaneously to obtain needed data and to protect the safety and rights of the subjects. Early consultation with CRP through the Office of Research Administration can sometimes eliminate the need for later project redesign.

CRP will use exceptional care in reviewing projects proposing to use children as research subjects to ensure the protection of their safety and rights. For this reason, otherwise expedite able projects may be referred to the full Committee. the most sensitive projects involve placing a child under 18 years old at greater than minimal risk with little or no direct benefit to the child. Although there is much that we need to learn about children, our research must place the protection of the child subject before any other goal.