Research Involving Minors (Children)

Overview

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.

For more information on NIH requirements for inclusion of children in research, see NIH Inclusion of Children Policy Implementation.

Definitions

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

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.”

Procedures

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 subjects research.

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.

Research Subject to DHHS Regulations Requiring Additional Review (“407 Review”)

Research that 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) determines that:

·         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.

When FDA 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

Research 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 permission.

The principal investigator and any consultants assisting with the review will be invited to attend the IRB meeting at which the research is discussed.

Wards

Specific 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 is either:

·         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:  irb@seattleu.edu  or (206) 296-2585