The following applies to all research involving children, regardless of funding source. The requirements in this section are consistent with Subpart D of 45 CFR 46, which applies to DHHS-funded research and Title 21, Part 50, Subpart D, which applies to FDA research.
Per the Kansas State Annotated 38-2223, mandated reporters are required to report suspected child maltreatment immediately when they have “reasonable cause to believe” that a child known to them in their professional or official capacity may be an abused or neglected child. KSA 38-2223 identifies school administrators and other employees of an educational institution as mandated reporters.
- Child – In Kansas a child is defined as an individual who has not attained 18 years of age. Note: For research conducted in jurisdictions other than Kansas, the research must comply with the laws regarding the legal age of consent in all relevant jurisdictions.
- Guardian – In Kansas a “Guardian” of a minor means the duty and authority to act in the best interests of the minor, subject to residual parental rights and responsibilities, to make important decisions in matters having a permanent effect on the life and development of the minor, and to be concerned with his or her general welfare. Note: For research conducted in jurisdictions other than Kansas, the research must comply with the laws regarding guardianship in all relevant jurisdictions.
- Assent – A child’s affirmative agreement to participate in research. Mere failure to object, absent affirmative agreement, should not be construed as assent.
- Permission – The agreement of parent(s) or legal guardian(s) to the participation of their child or ward in research.
- Parent – A child’s biological, foster, or adoptive parent.
Research on children must be reviewed and categorized by the IRB into one of the following groups:
- Research not involving physical or emotional risk greater than that ordinarily encountered in daily live or during the performance of routine physical or psychological examinations or tests (i.e., minimal risk). (45 CFR 46.404)(21 CFR 50.51) Note: The IRB may find that the permission of one parent is sufficient.
- Research involving greater than minimal risk, but presenting the prospect of direct benefit to the individual subject. (45 CFR 46.406)(21 CFR 50.52). (a) The risk is justified by the anticipated benefit to the subjects; (b) the IRB may find that the permission of one parent is sufficient, (c) requires assent of the child.
- Research involving greater than minimal risk and no reasonable prospect of direct benefit to the individual subject, but likely to yield generalizable knowledge about the subject’s disorder or condition (45 CFR 46.406)(21 CFR 50.53). (a) The risk represents a minor increase over minimal risk; (b) 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; (c) the intervention or procedure is likely to yield generalizable knowledge about the participants’ disorder or condition which is of vital importance for the understanding or amelioration of the participants’ disorder or condition; (d) permission of either both parents, or legal guardian, is required unless one parent is deceased, unknown, incompetent, or not reasonably available; or only one parent has legal responsibility for the care and custody of the child; (e) requires assent of the child.
- Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate serious problems affecting the health or welfare of children. (45 CFR 46.407)(21 CFR 50.54)
- DHHS-funded research in this category must be approved by the Secretary of Health and Human Services, and requires consent of either both parents, or legal guardian. If the IRB determines that the research falls in this category, the research will be sent to the IRB Chair for DHHS review.
- For non-federally-funded research, IRB will consult with a panel of experts in pertinent disciplines (for example: science, medicine, ethics, law). Based on the recommendation of the panel, the IRB may approve the research based on either: (a) that the research in fact satisfies the conditions of the previous categories, as applicable; or the following (b) the research presents a reasonable opportunity to further understanding, prevention, or alleviation of a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates; (c) The research will be conducted in accord with sound ethical principles; and (d) informed consent will be obtained in accord with the provisions for informed consent and other applicable sections of this manual.