![]() ![]() ( 45 CFR 46.405 and 21 CFR 50.52) Research involving greater than minimal risk, but presenting the prospect of direct benefit to an individual participant, or a monitoring procedure that is likely to contribute to the participant’s well-being may be approved if the IRB finds that: ![]() ( 45 CFR 46.404 and 21 CFR 50.51) Research that does not involve greater than minimal risk may be approved if the IRB finds that adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians. The research categories are described as follows: The IRB assesses the potential risks and benefits for each research proposal, and the provisions for permission and assent, to determine if the activity satisfies the conditions for a category of research permitted for children, as specified in DHHS 45 CFR 46.404, 46.405, 46.406, 46.407 and 46.409 and FDA 21 CFR 50.51, 50.52, 50.53, 50.54 and 50.56. The IRB reviews all research involving children as participants and approves only research that satisfies all of the conditions of applicable federal regulatory subpart sections. Parent - A child’s biological or adoptive parent. Mere failure to object should not be construed as assent without an affirmative agreement. Permission - The agreement of parent(s) or guardian to the participation of the child in research.Īssent - An affirmative agreement by the child to participate in research. In addition, a child who is in the custody of Children and Youth Services is considered a ward of the state, and the procedures set forth below for enrolling wards must be followed. Only the birth or adoptive parent(s) can provide the legally authorized consent to participation in research. Therefore, such persons do not meet the federal definition of “guardian” and cannot provide consent for the participation of a foster child in a research study.
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