Subject: Requirements for Permission by Parents or Guardians and for Assent by Children

Policy:

It is the policy of Mayo Clinic’s Office for Human Research Protection – Institutional Review Board (IRB) – that adequate provisions are made for soliciting permission of each child’s parents or guardian and the assent of each child for the participation in research, when in the judgment of the IRB the children are capable of providing assent, unless the IRB has granted a waiver of the permission and / or assent requirements as defined by Federal regulations.

1. In addition to the determinations required under IRB Policy VIII.C ^[1] the IRB will determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent. In determining whether children are capable of assenting, the IRB will take into account the ages, maturity, and psychological state of the children involved. This judgment may be made for all children to be involved in research under a particular protocol, or for each child, as the IRB deems appropriate. If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the research. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement under circumstances in which consent may be waived in accord with IRB Policy IV.C. ^[2]
2. In addition to the determinations required under IRB Policy VIII.C ¹ the IRB will determine, in accordance with and to the extent that consent is required by IRB Policy IV.A ^[3] or IV.C ² that adequate provisions are made for soliciting the permission of each child's parents or guardians. Where parental permission is to be obtained, the IRB may find that the permission of one parent is sufficient for research to be conducted under in accordance with Sections A or B of IRB Policy VIII.C. ^[4] Where research is covered by Section C or D of IRB Policy VIII.C ^[5] and permission is to be obtained from parents, both parents must give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.
3. In addition to the provisions for waiver contained in IRB Policy IV.C, ² if the IRB determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), it may waive the consent requirements in IRB Policy IV.A ³ and Section B of this policy, provided an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and provided further that the waiver is not inconsistent with Federal, State, or Local law. The choice of an appropriate mechanism would depend upon the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and their age, maturity, status, and condition.
4. Permission by parents or guardians shall be documented in accordance with and to the extent required by IRB Policy IV.B. ^[6]
5. When the IRB determines that assent is required, it will also determine whether and how assent must be documented. ^[7]

^[1] IRB Policy VIII.C

^[2] IRB Policy IV.C

^[3] IRB Policy IV.A

^[4] Sections A or B IRB Policy VIII.C

^[5] Section C or D of IRB Policy VIII.C

^[6] IRB Policy IV.B

^[7] 45 CFR 46.408