For example, a school-based study of minimal risk (e.g., investigating children’s responses to music), could be posed to children in the school setting. Most current version of protocol and grant application submitted to and reviewed by the IRB and modified by the principal investigator if required by the IRB. The research may proceed only if the Secretary, HHS, or his or her designee, after consulting with a panel of experts in pertinent disciplines (e.g., science, medicine, education, ethics, law) and following an opportunity for public review and comment, determines either: (1) that the research in fact satisfies the conditions of 45 CFR 46.404, 46.405, or 46.406, or (2) the following: For more information on the HHS 45 CFR 46.407 review process see OHRP Guidance, Children Involved as Subjects in Research: Guidance on the HHS 45 CFR 46.407 ("407") Review Process. When a proposed research study involves children and is supported or conducted by HHS, the research institution's Institutional Review Board (IRB) must take into consideration the special regulatory requirements that provide additional protection for the children who would be involved in the research. Assent: Affirmative agreement by the child to participate in the research. The HHS regulations further require that the advocate not be associated in any way (except in the role as advocate or member of the IRB) with the research, the investigator(s), or the guardian organization. Studies involving children that are determined to be minimal risk may be eligible for expedited review. The HHS regulations at 45 CFR part 46, subpart D permit IRBs to approve three categories of research involving children as subjects: 45 CFR 46.404- Research not involving greater than minimal risk to the children. For research that is FDA regulated, investigators must comply with the regulations at 21 CFR 50, Subpart D. Studies conducted or supported by NIH and/or which involve the use of the Clinical and Translational Research Center (CTRC) must be compliant with the NIH guidelines that require including children when conducting clinical research, unless there is a strong scientific and/or ethical reason for their exclusion. Procedures that are deemed minimal risk in a healthy population may not be deemed minimal risk when considered in a population suffering from a disease or condition. 45 CFR 46.407- Research that the IRB believes does not meet the conditions of 45 CFR 46.404, 46.405, or 46.406, but finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children. For research activities involving adolescents whose capacity to understand resembles that of adults, the assent procedure should likewise include information similar to what would be provided for informed consent by adults or for parental permission. The research does not present a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health and welfare of children and does not fit any of the other categories and therefore cannot be approved.
If the child participant will provide verbal assent, the study team should document the child’s verbal assent in the research record to include the date and time verbal assent was obtained, any questions or concerns the child expressed during the process, the resolution of those questions and concerns and who obtained the verbal assent from the child. Subpart D requires the reviewing IRB to identify the level of risk, the potential for direct benefits to the subjects, and other specified features of the research during the approval process. Similarly, if the research does not involve any ongoing interactions or interventions with the subjects, but continues to meet the regulatory definition of “human subjects research” (for example, it involves the continued analysis of specimens or data for which the subject’s identity is readily identifiable to the investigator(s)), then it would be necessary for the investigator(s) to seek and obtain the legally effective informed consent of the now-adult subjects. The advocate should represent the individual child subject’s interests throughout the child’s participation in the research. If the research involves pregnant minors, then the requirements of subpart B must be met and if the research involves incarcerated minors then the requirements of subpart C must be met.
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