Subject: Special Categories of Research: Children

Policy:

It is the policy of Mayo Clinic's Office for Human Research Protection – Institutional Review Board (IRB) – to review research involving children and approve only research which satisfies the requirements of 45 CFR 46 Subpart D ^[1] and other applicable Federal, State, and local laws. ^[2], ^[3]

1. Categories of Research Involving Children
   1. Research not involving greater than minimal risk.

   2. The IRB may approve research in which the IRB finds that no greater than minimal risk to children is presented, only if the IRB finds that adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians, as set forth in IRB Policy IV.D. ^[4], ^[5]

   3. Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects.

   4. The IRB may approve research in which the IRB finds that greater than minimal risk to children is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is likely to contribute to the subject's well-being, only if the IRB finds that:

      1. The risk is justified by the anticipated benefit to the subjects;
      2. The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches; and
      3. Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians, as set forth in IRB Policy IV.D. ⁵, ^[6]
   5. Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition. The IRB may approve research in which the IRB finds that greater than minimal risk to children is presented by an intervention or procedure that does not hold out the prospect of direct benefit for the individual subject, or by a monitoring procedure which is not likely to contribute to the well-being of the subject, only if the IRB finds that:
   6. 1. The risk represents a minor increase over minimal risk;
      2. 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;
      3. The intervention or procedure is likely to yield generalizable knowledge about the subjects' disorder or condition which is of vital importance for the understanding or amelioration of the subjects' disorder or condition; and
      4. Adequate provisions are made for soliciting assent of the children and permission of their parents or guardians, as set forth in IRB Policy IV.D. ⁵, ^[7]
   7. The IRB generally may not approve research that does not meet the requirements of sections I.A., I.B., or I.C of this policy. However, if the research presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children, the IRB may approve the research if the following has occurred:
   8. 1. The IRB 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; and
      2. The Secretary of DHHS, after consultation with a panel of experts in pertinent disciplines (for example: science, medicine, education, ethics, law) and following opportunity for public review and comment, has determined either:
      3. 1. That the research in fact satisfies the conditions of Sections I.A., I.B., or I.C of this policy (45 CFR 46.404; ⁴ 45 CFR 46.405; ⁶ 45 CFR 46.406 ) ⁷ as applicable, or
         2. the following:
         3. 1. The research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children;
            2. The research will be conducted in accordance with sound ethical principles;
            3. Adequate provisions are made for soliciting the assent of children and the permission of their parents or guardians, as set forth in IRB Policy IV.D. ⁵, ^[8]
2. Wards of the State or Other Agency.
   1. Children who are wards of the state or any other agency, institution, or entity can be included in research approved under I.C and I.D. of this policy only if the IRB finds and documents that such research is:
   2. 1. Related to their status as wards; or
      2. Conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as participants are not wards.
   3. If the research is approved under section II.A of this policy, the IRB will require appointment of an advocate for each child who is a ward, in addition to any other individual acting on behalf of the child as guardian or in loco parentis. One individual may serve as advocate for more than one child. The advocate shall be an individual who has the background and experience to act in, and agrees to act in, the best interests of the child for the duration of the child's participation in the research and who is not associated in any way (except in the role as advocate or member of the IRB) with the research, the Investigators, or the guardian organization. ^[9]
3. Exemptions.
   1. The exemptions specified in Sections I.C.1,3,4,5 and 6 of IRB Policy III.C., ^[10] all apply to research involving children. Only the IRB may determine which activities qualify for an exempt review. Investigators do not have the authority to make an independent determination that research involving human subjects is exempt and must contact the IRB concerning the status of proposed research or changes in ongoing research.
   2. The exemption specified in Section I.C.2 of IRB Policy III.C., ^[11] only applies for research involving observation of public behavior when the Investigator does not participate in the activities being observed. The exemption does not apply where the research involves survey or interview procedures or any direct interaction with the participants being observed. ^[12]

^[1] 45 CFR 46 Subpart D

^[2] 45 CFR 46.403

^[3] 21 CFR 56.111 (b)

^[4] 45 CFR 46.404

^[5] IRB Policy IV.D

^[6] 45 CFR 46.405

^[7] 45 CFR 46.406

^[8] 45 CFR 46.407

^[9] 45 CFR 46.409

^[10] IRB Policy III.C Section 1,3,4,5 and 6

^[11] IRB Policy III.C 2

^[12] 45 CFR 46.401 (b)