Version
1.3
Date Updated
Saturday, March 10, 2012
Descripton

Approved by:  Human Protections Administrator, Director of OPRS, and Executive IRB Chair
AAHRPP REF#:  189
AAHRPP Elements:  I.1.G., II.3.G, II.4.A, II.4.B, III.1.C, III.1.F.


POLICY


  1. Children are considered by the federal regulations as being vulnerable to coercion.
    To safeguard their interests and protect them from harm, additional regulatory
    protections exist for research involving children. The UIC IRBs approve research
    involving minors only if the research complies with the safeguards described in this
    policy and procedure.
  2. In its FWA, UIC has elected to not extend OHRP’s authority to all human subjects
    research conducted at UIC; however, the general protections of the Belmont Report
    and the Common Rule [45 CFR 46] will be applied to all research reviewed and
    approved at UIC either in the same way or an a comparable variation. For both
    federally and non-federally funded research involving children as subjects, the IRB
    follows federal regulations at 45 CFR 46 Subpart D and 21 CFR 50 Subpart D, in
    addition to those imposed under UIC HSPP policies, ethical considerations and
    other applicable Federal, state and local laws for review and approval.
  3. It should be noted that the Department of Education and Defense have adopted Subpart D, but the National Science Foundation has not; however, UIC policy affords the same
    protections to children regardless of the funding source and parallels the additional
    protections afforded to children as codified in Subpart D to all research involving
    children.
  4. Definitions.
    1. ASSENT: a child's affirmative agreement to participate in research. The
      child’s failure to object, absent affirmative agreement, should not be
      considered assent.
    2. CHILD/CHILDREN/MINORS: The federal research regulations define children
      as individuals who have not attained the legal age for consent to treatments or
      procedures involved in the research, under the State or local law of the
      jurisdiction in which the research will be conducted (45 CFR 46.402(a)). In
      Illinois, a minor is defined as an individual under the age of 18 years (325
      ILCS 45/2(c)) with the exceptions described below.
    3. FOSTER CHILD: In Illinois, a foster child is a ward of the state since the
      Illinois Department of Children and Family Services, an Illinois state agency,
      holds guardianship of the person for foster children. (Juvenile Court Act of
      1987, 705 ILCS 405; Children and Family Services Act, 20 ILCS 505).
    4. GUARDIAN: DHHS and the FDA define a guardian as an individual who is
      authorized under applicable State or local law to consent on behalf of a child
      to general medical care. In Illinois, the term Guardian “means a court
      appointed guardian of the person who serves as a representative of a minor
      or as a representative of a person under legal disability.” In Illinois, a variety
      of guardianship appointments exist and the investigator should take care to
      document that the guardian’s representation of the ward for the research is
      within the scope of their authority: limited guardianship, plenary guardianship,
      guardian of the person, guardian of the estate, and temporary guardianship.
      (Health Care Surrogate Act, 755 ILCS 40; Juvenile Court Act of 1987, 705
      ILCS 405/1-2).
    5. GUARDIANSHIP OF THE PERSON OF A MINOR: In Illinois, the duty and
      authority to act in the best interests of the minor, subject to residual parental
      rights and responsibilities, to make important decisions in matters having
      permanent effect on the life and development of the minor and to be
      concerned with his or her general welfare. It is includes but is not necessarily
      limited to . . . the authority to consent to major medical, psychiatric, and
      surgical treatment. (Juvenile Court Act of 1987, 705 ILCS 405/1-2). Please
      contact OPRS for guidance in temporary custody situations or for children
      who are placed by court under the guardianship of a probation officer, as
      these are complex situations that may require the advice of University
      Counsel.
    6. WARD: A ward means any child who is placed in the legal custody of the state
      or other agency, institution, or entity, consistent with the applicable federal,
      state, and local laws and regulations. (21 CFR 50.3(g). In Illinois, a ward of
      the state includes but is not limited to a child placed by court under the
      guardianship of the Illinois Department of Children and Family Services. In
      Illinois, children placed in foster care are wards of the state. (Juvenile Court
      Act of 1987, 705 ILCS 405/ 2-7).
  5. Circumstances When Minors Can Consent for Themselves.
  6. Emancipated or Mature Minor. If a minor has been adjudicated as a “mature
    minor” or an “emancipated minor” by an Illinois court with jurisdiction over
    such minor, such minor would also be able to consent to medical treatment
    and research relating to such treatment under Illinois law. Note that if a minor
    has only been partially emancipated under the Emancipation of Minors Act,
    such minor will only have those rights and responsibilities as specified in the
    court order. When research involves subjects who claim that they are
    “emancipated” or “mature” minors, the investigator must review and document
    in the research record the court order that provides such designation before
    allowing such subject to consent as an adult for the research. An individual
    aged 17 who is enrolled in the military is also not considered a minor under
    some circumstances in Illinois.
  7. Illinois law also grants minors the legal capacity to consent to medical
    treatment in certain situations. The Illinois Consent by Minors to Medical
    Procedures Act (410 ILCS 210/1) permits:
    1. A married minor, a minor parent, or a pregnant minor to provide his or
      her own informed consent to the performance of a medical or surgical
      procedure performed by: (i) a physician licensed to practice medicine
      and surgery, (ii) an advanced practice nurse who has a written
      collaborative agreement with a collaborating physician that authorizes
      provision of services for minors, or (iii) a physician assistant who has
      been delegated authority to provide services for minors.
  8. A minor parent to provide the informed consent for performance on his
    or her child of a medical or surgical procedure by a physician licensed
    to practice medicine and surgery, an advanced practice nurse who has
    a written collaborative agreement with a collaborating physician that
    authorizes provision of services for minors, or a physician assistant
    who has been delegated authority to provide services for minors, or a
    dental procedure by a licensed dentist.
    1. Other instances where the Minors Medical Procedures Act deems a
      minor to have the same legal capacity to consent as an adult include:
      1. Emergency treatment or first aid or emergency dental treatment.
        (410 ILCS 210/3(a)).
      2. Medical care or counseling related to the diagnosis or treatment
        of any disease or injury arising from predatory criminal sexual
        assault of a child, aggravated criminal sexual assault, criminal
        sexual assault, aggravated criminal sexual abuse or criminal
        abuse of a child. (410 ILCS 210/3(b)).
      3. Medical care or counseling related to the diagnosis or treatment
        of a minor 12 years of age or older who may have come into
        contact with any sexually transmitted disease (STD), or may be
        determined to be an addict, an alcoholic or an intoxicated
        person, or who may have a family member who abuses drugs or
        alcohol. (410 ILCS 210/4).
    2. The UIC IRB extends the provisions of the Minors Medical Treatment
      Act to research. Specifically, under the circumstances or for the
      conditions stipulated in the Act, the UIC IRB views the minor to have
      the same legal capacity to act and has the same powers and
      obligations as has a person of legal age to consent for research
      involving such medical or surgical procedures. The minor is not
      deemed to be able to provide consent for research involving conditions
      not stipulated by the Act or involving medical or surgical procedures not
      covered by the Act. Thus, a 13 year old male seeking medical
      treatment for alcohol addiction can consent to participate in research
      involving addiction treatment. The research may not however involve
      additional activities unrelated to clinical management of the addiction,
      such as genetic research.
    3. A minor who is able to give consent (as described in IV A.-B. above)
      under Illinois State Law is not considered a child under federal
      regulations.
  9. When assent is required by the IRB, the decision of the child assenting is binding,
    provided parental or guardian permission, when necessary, has been obtained.
  10. When the duration of the children’s participation in a research project may
    continue beyond the age of majority, the investigator must include provisions for
    obtaining the legally effective consent from the now-adult participants for proceeding
    with their research participation.
  11. A UIC investigator applying to conduct a research activity involving children in
    another jurisdiction (i.e., state) must become familiar and provide evidence of
    compliance to the IRB with all applicable legal, professional, and ethical
    requirements for the conduct of research involving children for each jurisdiction
    where the research will be conducted.
  12. Studies that involve children or other vulnerable populations, are greater than
    minimal risk and are not conducted in Illinois must be reviewed and approved by an
    IRB in the appropriate jurisdiction (i.e., state) as well as the UIC IRB.
  13. IRB approval obtained in accordance with 45 CFR 46, Subpart D and 21 CFR
    50; and
  14. VA R&D approval obtained; and
  15. Waiver from VA Chief Research & Development Officer (CRADO).
  16. VA Research: Research involving children cannot be conducted by VA  investigators while on official VA duty, using VA resources, completely or partially in a VA facility or at a VA-approved off-site facility unless a waiver has been granted by the CRADO and research is not greater than minimal risk.  Research involving biological specimens or data obtained from children is considered by the VA to be research involving children.