Assent Guidelines by xiagong0815


									                                 Assent of Minor
                            NYU SoM/NYULMC IRB
What does the IRB require for Assent of Minor?

 In addition to parental permission, federal regulations require that research studies
involving children include adequate provisions for soliciting the assent of a child to
participate in research when the child is capable of providing assent. Assent is defined as
“a child’s affirmative agreement to participate in research.” However, the mere absence
of an objection by the child should not be construed as assent.

The regulations do not specify an age at which assent is required. The NYU SoM IRB
requires written documentation of assent for participation of subjects ages 12 – 17 unless
waived as explained below. However, the IRB encourages researchers to use the assent
form for children ages 7-11. If an investigator chooses not to use the assent form for
children ages 7-11 the investigators should seek verbal assent from children as
appropriate to their age, maturity and psychological state. The protocol should detail the
process of obtaining assent and the IRB submission should include a script detailing the
discussion between the researcher and the child.

Why is Assent important?

The assent process fosters an element of understanding, cooperation and feeling of
inclusion on the part of the child while demonstrating the investigator’s respect for the
rights and dignity of the child in the context of research.

Assent means a child's affirmative agreement to participate in research, including a
clinical investigation. The mere failure of a child to object may not be construed as assent
unless there is an affirmative agreement by the child to participate.

When possible and appropriate, adequate provisions should be made for soliciting assent
from children (individuals who are under 18 years of age) to participate in a research
study. In some cases, particularly for research that is not intended to be therapeutic, the
IRB may request that an age-appropriate assent form or an assent script be developed.

Waiving Assent of Minor and Not requiring Assent of Minor

In addition to making a determination of risk and benefit as required by Subpart D
(“Children Findings”), the IRB will determine whether assent is appropriate for the study.
The decision of the IRB regarding assent depends on the specifics of the study. For
example, approval of a waiver of assent may likely be indicated for a trial of primary
induction therapy for a new malignancy where there is a real prospect of direct benefit to
subjects. However, in some Phase I studies for recurrent malignancies, where direct
benefit is not probable, the IRB will consider whether it is appropriate to allow the child
to refuse participation. If a waiver is not considered justifiable by the IRB, assent would
be required.

In certain circumstances, the IRB may either waive the assent or not require assent.
                                  Assent of Minor
                             NYU SoM/NYULMC IRB
The IRB may grant a waiver of assent in any study involving children when:

   1.   The study is minimal risk
   2.   the waiver will not adversely affect the rights and welfare of the child
   3.   It is not practicable to obtain assent
   4.   Any information resulting from the study will be shared with the child

Investigators may request a waiver of assent in their IRB application. When requesting a
waiver of assent, justification and measures to protect the child should be described.

Regulations allow the IRB to determine that Assent of Minor is not required when:

   • The capacity of some or all of the children to be studied is so limited that they cannot
   reasonably be consulted; or
   • The research offers the prospect of a direct benefit that is important to the health or
   well-being of the child and is available only in the context of the research.
   Here, the parents’ right to make medical decisions for their child may come into
   conflict with the child’s right to give or withhold assent. In this situation, the IRB can
   waive the requirement for assent, but the child should be appropriately informed about
   the study.

The Investigator may request the IRB make these finding in the initial proposal to the
IRB or in an amendment after IRB approval has been granted.

What if Assent cannot be obtained?

Occasionally, in studies for which the IRB has required assent by minor subjects, an
Investigator may find that an individual child is incapable of providing assent due to
illness or cognitive status. In this case, the investigator should obtain permission from the
child’s parent(s)/guardian and should record on the informed consent document the
reason the child was unable to assent. In keeping with the ethical principals of justice and
respect for persons, reasonable efforts should be made to conduct research using children
capable of assent before enrolling those unable to assent. Remember just like with
Consent of Adults you should way the importance of the child’s assent in relation to the
importance of participation in the research. For example, a research database,

Investigators who plan to enroll children in their protocols should describe in their
protocol applications the assent process that will be followed, taking into account the age
ranges of the children, as well as the maturity and physical and psychological state of the

 Even if a child is too young to provide assent, investigators should consider and describe
in their applications to the IRB how the investigator will identify and respond to
situations where the child does not want to participate. Respect for a child’s
unwillingness to participate is especially critical in research that does not have a
therapeutic intent and that exposes the child to some risk.
                                    Assent of Minor
                              NYU SoM/NYULMC IRB
 For more information regarding the assent requirements for research participants who are
children, see 45 CFR 46, Subpart D and 21 CFR 50, Subpart D.

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