CHILD ASSENTCHILD ASSENT

IRB Member Continuing IRB Member Continuing EducationEducation

AAHRRP Element 1I.4. B.AAHRRP Element 1I.4. B.

The IRB or EC has and follows The IRB or EC has and follows written policies and procedures written policies and procedures requiring appropriate requiring appropriate protections for prospective protections for prospective participants who cannot give participants who cannot give consent or whose decision-consent or whose decision-making capacity is in question.making capacity is in question.

HRPP 8.6HRPP 8.6 Research Involving Children Research Involving Children

The IRB will make protocol-specific The IRB will make protocol-specific determinations regarding whether determinations regarding whether adequate provisions should be made for adequate provisions should be made for soliciting the assent of the children soliciting the assent of the children younger than 12-years old, when in the younger than 12-years old, when in the judgment of the IRB members, the judgment of the IRB members, the children are capable of providing assent. children are capable of providing assent. This determination will be documented This determination will be documented in the IRB minutesin the IRB minutes. .

ASSENTASSENT

A child’s affirmative agreement to A child’s affirmative agreement to participate in research. Mere failure participate in research. Mere failure to object should not, absent to object should not, absent affirmative agreement, be construed affirmative agreement, be construed as assent. as assent. This means the child must actively show This means the child must actively show

his or her willingness to participate in the his or her willingness to participate in the research, rather than just complying with research, rather than just complying with directions to participate and not resisting in directions to participate and not resisting in any way.any way.

45 CFR 46.408(a)45 CFR 46.408(a)Requirements for permission by parents or guardians and for Requirements for permission by parents or guardians and for

assent by childrenassent by children

The IRB shall determine that adequate The IRB shall determine that adequate provisions are made for soliciting the provisions are made for soliciting the assent of the children, when in the assent of the children, when in the judgment of the IRB the children are judgment of the IRB the children are capable of providing assent.capable of providing assent.

This judgment may be made for all This judgment may be made for all children to be involved in research under children to be involved in research under a particular protocol, or for each child, as a particular protocol, or for each child, as the IRB deems appropriate.the IRB deems appropriate.

CHILD ASSENTCHILD ASSENT

When judging whether children When judging whether children are capable of assent, the are capable of assent, the Institutional Review Board (IRB) Institutional Review Board (IRB) is charged with taking into is charged with taking into account the ages, maturity, and account the ages, maturity, and psychological state of the psychological state of the children involved.children involved.

Waiver of AssentWaiver of Assent The regulations at 45 CFR 46.408(a) identify three The regulations at 45 CFR 46.408(a) identify three

types of circumstances where the IRB may determine types of circumstances where the IRB may determine that waiver of children’s assent is appropriate:that waiver of children’s assent is appropriate: if the capability of some or all of the children is so limited if the capability of some or all of the children is so limited

that they cannot reasonably be consulted; that they cannot reasonably be consulted; if the intervention or procedure involved in the research if the intervention or procedure involved in the research

holds out the prospect of direct benefit to the health or well-holds out the prospect of direct benefit to the health or well-being of the children and is available only in the context of being of the children and is available only in the context of the research. the research.

if the research meets the same conditions as those for if the research meets the same conditions as those for waiver or alteration of informed consent in research waiver or alteration of informed consent in research involving adults, as specified in the regulations at either involving adults, as specified in the regulations at either 45 CFR 46.116(c) or 45 CFR 46.116(d) . .

Documentation of AssentDocumentation of Assent The HHS regulations do not require The HHS regulations do not require

documentation of assent. documentation of assent. Institutional Review Board (IRB) has the Institutional Review Board (IRB) has the

discretion to determine the appropriate discretion to determine the appropriate manner, if any, of documenting child assent. manner, if any, of documenting child assent.

If young children are involved who are as If young children are involved who are as yet unable to read, documentation should yet unable to read, documentation should take a form that is appropriate for the take a form that is appropriate for the purpose of recording that assent took place. purpose of recording that assent took place. The IRB may also decide that The IRB may also decide that documentation of assent is not warranted.documentation of assent is not warranted.