Research Involving Minors (Children)
In Washington State, “minor” (children) refers to persons who have not attained
the legal age for consent to treatments or procedures involved in the research,
under the applicable law of the jurisdiction in which the research will be
conducted. In the state of Washington, minors are
individuals who are less than 18 years old and not emancipated (except with
respect to special circumstances such as research about sexually-transmitted
diseases). Minors are a special group of research participants,
classified as a “vulnerable population” and protected under the Common Rule 45
CFR 46 Subpart D and 21 CFR 50 Subpart D.
These protections include, among other things, IRB review
for certain research protocols involving minor that would be exempt if the
subjects were adults, use of parental permission and child assent instead of
informed consent for participation, and conditions for IRB approval of proposed
research depending on the level of risk.
information on NIH requirements for inclusion of children in research, see NIH Inclusion of Children Policy
Assent: Agreement to participate in research by an individual
(e.g., a child) who cannot provide legally effective informed consent to
participate on his/her own behalf. Note:
Failure to object does not constitute assent.
Minor/Child/Children: Person(s) who have not attained the legal age for consent
to treatments or procedures involved in the research, under the applicable law
of the jurisdiction in which the research will be conducted. For purposes of SU
IRB policy, individuals under 18 years of age are considered children in
Washington unless they meet the definition of emancipated minors.
Emancipated Minors: For purposes of SU IRB policy, the following persons under
the legal age of 18, have the legal rights of adults due to special
circumstances, including the right to consent to treatments or procedures
involved in research:
1) Persons under the age of 18 on active duty in the military
2) Married persons under 18 years of age
Note: Pregnancy or childbirth outside of marriage does not
emancipate a minor in Ohio.
Guardian: An individual who is authorized under applicable state or
local law to consent on behalf of a child to general medical care. In Ohio, a
guardian may be a grandparent, other family member, or other person,
association, or agency other than the biological or adoptive parents who has
been formally appointed as a guardian or legal representative by a court to
care for a child, including to consent on behalf of a child to general medical
care. Note: Grandparents or other family members who are not formally
appointed as guardians or legal representatives by a court generally do not
have the authority to provide consent on behalf of a child without consent by
the child’s parents.
Parent: A child’s biological or adoptive mother or biological or
adoptive father. Human Research Protection Program Policies and Procedures
Approved 02/16/09 – IRB Policy Committee Revised 04/28/09 Page 2 of 6
The agreement of a parent(s) or legal
guardian to the participation of his/her child or ward in research. Note:
Parents/guardians may not give consent on behalf of a child, but
rather “parental permission.”
1) For research protocols involving minors, the IRB must determine that
the proposed research meets the special protections for minors specified by
federal regulations and this policy, as well as the general criteria for human
2) One or both parents (or a guardian) must provide and document
permission for a child to participate in research, unless these requirements
are waived by the IRB. In most cases, children capable of assent must also
express their willingness to participate. For more information on parental
(guardian) permission and assent of minors, see the “Children and Adolescents” section of the SU IRB Informed Consent Policy.
3) Exempt classification of protocols involving survey or interview
procedures or observation of public behavior does not apply to research
with minors, except for research involving observations of public behavior when
the investigator does not participate in the activities being observed. For
more information on exempt research, see the SU IRB general policy.
4) For research involving incarcerated and/or pregnant minors, the protocol
must provide the necessary protections for research involving prisoners and/or
pregnant women, as well as the requirements for research involving minors. For
more information, see the SU IRB policies on Research Involving Prisoners and Research Involving Pregnant Women, Fetuses, or Neonates.
5) If a minor reaches the legal age of consent while enrolled in research
with parental/guardian permission, he/she must provide informed consent (unless
waived) to continue participation.
6) In certain situations, children under 18 years of age may legally
provide informed consent for some or all of the activities involved in research
(e.g., to release information from educational records). For more information
on special circumstances involving assent and parental permission see the SU IRB Informed Consent Policy.
7) In special situations, the IRB may determine that the assent of some
or all minors is not required (e.g., children less than 2 years
old). In such cases, the IRB will indicate which part of the population is not
required to assent.
Permissible Research Categories
The IRB may
approve three categories of research involving minors as described below. For
all categories, the proposed research must satisfy SU IRB requirements for
parental/guardian permission and minor assent.
1) Research involving minimal risk
2) Research involving greater than minimal risk with the prospect of direct benefit if:
the risk is justified by the anticipated benefit
to the child AND
the anticipated benefit to risk ratio is at least
as favorable as available alternative approaches.
3) Research involving greater than minimal risk without the prospect of direct benefit, but likely to yield
generalizable knowledge about the child’s disorder or condition if:
the risk presents no more than a minor increase
over minimal risk,
the research involves experiences that are
reasonably equivalent to those in the minor’s actual (or expected) medical,
dental, psychological, social, or educational situations, AND
the research is likely to yield generalizable
knowledge about the minor’s disorder or condition that is of critical
importance for the understanding or improvement of the disorder/condition.
Subject to DHHS Regulations Requiring Additional Review (“407 Review”)
does not fall into one of the three
categories outlined above, but presents a reasonable opportunity to further the
understanding, prevention, or alleviation of a serious problem affecting the
health or welfare of minors requires additional review, and may be conducted
only if ALL of the following
conditions are met:
1) The IRB can documents that the research presents a reasonable
opportunity to further the understanding, prevention, or alleviation of a
serious problem affecting the health or welfare of minors, AND
2) The research is reviewed by OHRP (on behalf of DHHS), in consultation
with a panel of experts in pertinent disciplines (e.g., science, medicine,
education, ethics, law, etc.) and relevant child advocates, AND
3) An opportunity is provided for public review and comment (including a
public meeting announced in the Federal Register), AND
4) The Assistant Secretary for Health (on behalf of the Secretary)
the research satisfies the regulatory conditions
for approval, OR
the research presents a reasonable opportunity to
further the understanding, prevention, or alleviation of a serious problem
affecting the health or welfare of minors; will be conducted in accordance with
sound ethical principles; and adequate provisions will be made for soliciting
the assent of children and the permission of parents/guardians.
regulations also apply to the research, OHRP delegates its authority to FDA to
convene a panel of experts (i.e., FDA Pediatric Advisory Committee, Pediatrics
Ethics Subcommittee) to review the research, solicit public comment, and advise
the Secretary (DHHS).
For more information on the 407 review process,
see OHRP Guidance on the HHS 45 CFR 46.407
(“407”) Review Process.
Research Not Subject to DHHS Regulations
Requiring Additional Review
involving children that does not fall into one of the three categories of
approvable research described above and that is not subject to DHHS
regulations may be conducted under the following conditions:
1) The IRB finds that the research presents a reasonable opportunity to
further the understanding, prevention, or alleviation of a serious problem
affecting the health or welfare of minors, AND
2) Consultation is obtained, as necessary, from expert(s) in pertinent
disciplines (e.g., science, medicine, education, ethics, law, etc.) and
relevant child advocates, AND
3) An opportunity is provided for review and comment by the local
community where the research is to be conducted, AND
4) The SU Research Compliance Officer, in consultation with the above
groups, determines that the research is consistent with sound ethical
principles and the requirements of SU IRB policy regarding assent and parental
The principal investigator and any consultants
assisting with the review will be invited to attend the IRB meeting at which
the research is discussed.
protections are required for minors who are also wards of the state or any
other agency, institution, or entity.
1) Children who are wards may be included in research involving greater
than minimal risk without the prospect of direct benefit but likely to yield
generalizable knowledge about the child’s disorder or condition if the research
Related to their status as wards
Conducted in schools, camps, hospitals,
institutions, or similar settings in which the majority of children involved as
participants are not wards.
2) When wards are included in the research described above, an advocate
must be appointed for each child who is a ward to protect the child, to the
extent possible, from exploitation, coercion, or undue influence. The following
requirements apply to individuals serving as advocates:
The advocate will serve in addition to any other
individual acting on behalf of the child as a guardian or in loco parentis
An individual may serve as an advocate for more
than one child
The advocate must be an individual who has the
background/experience and agrees to act in the best interests of the child
throughout the child’s participation in the research
This includes helping to ensure that the child
understands what will be required of him/her during the research, and if
capable, that the child provides assent to participate
Acting in the best interests of the child could
also include evaluating the ongoing effect(s) of the research on the child
The advocate must not be associated in any way
(except in the role as an advocate or IRB member) with the research,
investigator(s), or guardian organization.
3) Individuals who might serve as advocates include: IRB members, patient
advocates, caseworkers, social workers, or counselors knowledgeable about
minors’ rights and welfare. An advocate appointment should be made by a group
or individual with no interest in or
affiliation with the research being conducted. The IRB should review and
approve the process for appointing advocates.
Please direct all questions to: email@example.com or (206) 296-2585