Research involving children and adolescents

Question 1

As adolescents near the age of majority, their agreement to
participate in research may be ethically (though not
legally) equivalent to consent. In this situation, parental
consent is ethically best considered as “co-consent” but
legally, the adolescent’s agreement remains assent. If child
or adolescent participants reach the legal age of
majority according to applicable law and become capable
of independent informed consent during the research, their
written informed consent to continued participation
must be sought and their decision respected

Answer 1

Assent & ReConsent

Question 2

“Deliberate objection,” which differs between an
older child and an infant, “…must be respected
even if the parents have given permission, unless
the child or adolescent needs treatment that is
not available outside the context of research, the
research intervention has a clear prospect of
clinical benefit, and the treating physician and
the legally authorized representative consider the
research intervention to be the best available
medical option for the given child or adolescent

Answer 2

Superseding Dissent of Child

Question 3

▪ RECs “may waive parental permission…but
special protections must be devised to
ensure…best interests…children or adolescents are
being served; …such as permission of a parent is
not feasible or is undesirable…; studies…(on)
investigation of adolescents’ beliefs and behavior
regarding sexuality or use of recreational drugs; …
domestic violence, sexually transmitted diseases,
pregnancy, abortion, or child abuse.”
▪ Premise: Parental knowledge of the topic of the
research may place the children or adolescents at
risk of questioning, intimidation, or even physical
harm by their parents.

Answer 3

Waiver of Parental Permission

Question 4

A parent or legally appointed guardian who
gives permission for a child or adolescent to
participate in research must generally be given
the opportunity, to a reasonable extent and
without violating the privacy of other study
participants, to observe the child’s
participation as the study proceeds

Answer 4

LAR Entitlement

Question 5

▪ Use of tablets or computers as the
medium for information and seeking
consent
▪ Same regulations apply to electronic
consent forms & paper-based
consent
▪ Signature must be trustworthy,
reliable, and equivalent to
handwritten signature and capture
the date

▪ Can supplement or replace paper-
based

▪ REC is the ultimate approving body

Answer 5

▪ Use of tablets or computers as the
medium for information and seeking
consent
▪ Same regulations apply to electronic
consent forms & paper-based
consent
▪ Signature must be trustworthy,
reliable, and equivalent to
handwritten signature and capture
the date

▪ Can supplement or replace paper-
based

▪ REC is the ultimate approving body