3b.Appendix B: Research with Minors
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:
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
Permission: 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.”
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.
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:
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.
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:
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
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:
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: firstname.lastname@example.org or (206) 296-2585.