"If the study involves children or persons with impaired decision-making capacity, how will the assent of each
person be obtained?"
Gene transfer studies may enroll children or cognitively impaired persons if the investigator can provide justification
for their participation in the study. In such instances, investigators must obtain permission from the legally authorized
representative of the child or cognitively impaired person. Investigators must also obtain the assent of the potential
participant when appropriate.
Permission from Legally Authorized Representatives: For potential participants who cannot give
consent, investigators must obtain permission from a legally authorized representative of the potential participant.
For children, this is usually the parent. For adults, it may be someone designated as health care proxy. The
permission process should include instruction to the parents and/or legally authorized representatives regarding the
difference between permission for treatment and permission for research participation. Legal counsel should be consulted
to determine who is permitted to act as a legally authorized representative for research enrollment in the state(s) in
which participants will be enrolled. It should be noted that authority for treatment decision-making does not always
extend to decision-making about research participation.
Cognitively Impaired: If a potential participant is cognitively impaired and judged to be incapable
of giving consent, the potential participant must still be asked and agree to participate in the study even though he
or she may not fully understand its purpose, benefits, and risks - unless the impairment completely precludes any
meaningful communication. The investigator should follow institutional guidelines for obtaining assent and addressing
dissent from cognitively impaired individuals.
Minors: Investigators should follow Federal regulations, namely,
45 CFR 46 Subpart D
and FDA guidance
on assent of children for enrolling minors (generally children under age 18) in research. Investigators should obtain
parental permission, and the assent of the minor when appropriate. In addition, investigators should plan how dissent
from minors should be addressed - a determination that is specific both to the age of the child and the design and
purpose of the study. Information should be appropriate for the developmental age of the child. It is generally a
good idea to approach individuals who assented to participate in research as a minor once they reach the age of
majority for either continued participation in the study or continuation of long-term follow-up.