Section 2
From Whom Do I Obtain Informed Consent?
Every potential subject who is a physically and mentally able adult must provide consent to participate in research prior to the conduct of any activities that constitute the research encouner. Regulations define an adult as anyone at least 18 years old. The coconcepts of mental and physical normalcy are based upon the potential subject's ability to provide truly informed and voluntary consent. Variations from this norm may a function of age or the circumstances of the project.
Children
Obtaining permission to conduct research involving children - that is, persons under 18 years old - requires special attention to the child's age, his/her ability to understand what is asked of him/her, and their relationship to parents or guardians. In all cases, the investigator must demonstrate respect for the righs of the subject within the proposed consent procedures, which should be developmentally appropriate to the age and circumstances of the subject. Sample child assent forms can be viewed here.
- 1. Parental Consent: Parental permission or consent in writing is generally quired for all minors, under the age of 18, who participate in research. Sample forms can be found here.
- 2. Adolescent's Written Assent: From about junior high or middle school onward, a child's written assent is needed (in addition to parental consent), because children in this age group can usually read and comprehend a well-constructed assent form. However, the investigator should use supplementary verbal explanations wherever needed.
- 3. Child's Assent: For elementary school age children, the investigator should obtain (in addition to parental consent) the child's assent to participate. The explanation to the child should contain elements of consent expressed in a form the child can understand. A conversational question-and-answer setting is often necessary to achieve this goal. In addition, the child's assent should be positive, not merely a lack of dissent. If the child is able to render a signature, investigators are required to obtain a signed assent form.
- 4. Very Young Children: For children below school age the investigator should give explanations that match the level of understanding of the child. In many instances, the child's nonresistant behavior may be interpreted as assent, but the the investigator must use special care to discontinue the participation of children who appear to experience undue stress from the research procedures.
- Children who are wards of the state may participate in research only under very limited circumstancves with the appointment of an advocate for the child for the duration of the research.
