Procedure for Additional Safeguards for Children Involved in Research Including Assent - IRB PRO108

Abstract:
This procedure lists the responsibilities delegated to the Investigators, OIRB and IRB for ensuring the protection of children involved in research.
Effective Date:
10/1/2007
Responsible Party:
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:

HRPP Document: PRO108

Effective Date: 3/30/07

Revision Dates: 10/1/07

Subject: Procedure for Additional Safeguards for Children Involved in Research Including Assent

PROCEDURE

Investigator Responsibilities

The Investigator:

  • Identifies children (unemancipated minors less than 19 years of age) as a target population for research activities on FOR200 the Human Subjects Protocol (HSP);
  • Submits the FOR222 Special Populations Review Form–Children at the time of initial review and a memorandum confirming the Children’s Risk Level (CRL) at the time of continuing review for protocol submissions in which children will be involved;
  • Includes in the HSP a description of how assent of the child and permission of the parent or guardian will be obtained and documented for IRB review and approval:
    • Explains intention to obtain permission from one or both parents. (Note: For all research, both parents must give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child, unless the IRB finds that the permission of one parent is sufficient even if the other parent is alive, known, competent, reasonably available, and shares legal care and custody of the child.);
  • Describes methods to obtain and document assent based on the age, maturity, and psychological state of the children involved. The UAB IRB recommends the following:
    • Parental permission using an informed consent document;
    • Ages less than 7 years: An oral script in very simple language appropriate for children less than 7 years of age;
    • Ages 7 to 12 years: An assent form written simply and at a comprehension level appropriate for a child 7 years of age; and
    • Ages 13 through 18 years: An assent form that may be in the same language as the adult consent document.
  • Justifies any proposed waiver of assent based on the age, maturity, and psychological state of the children involved and/or the direct benefit of the research;
    • In situations where the potential benefits of the study are such that the physicians and parents will enroll the child regardless of the child’s wishes, the child should simply be told what is planned and should not be deceived. In such cases, the investigator should request a waiver for assent from the IRB;
  • Justifies proposed waiver of permission (consent) by parents or guardian;
  • Obtains and documents assent and parental permission unless waiver of assent and/or parental permission has been granted;
  • May not approach the child to assent to the research study until the parents or guardians have signed the consent (permission).

IRB Responsibilities

For convened IRB review each Primary Review Team Member:

  • Reviews the protocol at the time of initial or continuing review;
  • Using the GUI318 checklist for children as a discussion guide, presents the protocol including the additional protections for children.

The IRB, or Experienced IRB Member for expedited review:

  • Reviews the proposed research taking into consideration all applicable policies, specifically including the degree of risk involved in the research, prospects of direct benefits to individual subjects, and likelihood of the research to yield generalizable knowledge before making one of the following determinations:
    • Proposed research meets criteria under 45 CFR 46.404 and 21 CFR 50.51, if applicable, and 34 CFR 97.404, if applicable, i.e. Children’s Risk Level (CRL) 1;
      • If greater than minimal risk (i.e., not CRL 1) in expedited procedure, reviewer sends to convened IRB for review.
    • Proposed research meets criteria under 45 CFR 46.405 and 21 CFR 50.52, if applicable, and 34 CFR 97.405, if applicable (CRL 2);
    • Proposed research meets criteria under 45 CFR 46.406 and 21 CFR 50.53, if applicable, and 34 CFR 97.406, if applicable (CRL 3).  
  • If IRB believes research is not approvable under one of the CRLs above, makes finding whether proposed research meets criteria under 45 CFR 46.407 and 21 CFR 50.54, if applicable, and 34 CFR 97.407, if applicable (CRL 4);
    • For research satisfying CRL 4, refers research to OHRP, FDA, and Department of Education, as applicable, for determination if research can proceed ethically.
  • Documents the appropriate Children’s Risk Level (See "Definitions" in POL008 UAB Policy on Additional Safeguards for Children Involved in Research.):
    • 45 CFR 46.404, 21 CFR 50.51, 34 CFR 97.404 = CRL 1
    • 45 CFR 46.405, 21 CFR 50.52, 34 CFR 97.405 = CRL 2
    • 45 CFR 46.406, 21 CFR 50.53, 34 CFR 97.406 = CRL 3
    • 45 CFR 46.407, 21 CFR 50.54, 34 CFR 97.407 = CRL 4
  • Approves research designated CRL 4 and not under federal jurisdiction only after determining the research may proceed ethically in accordance with the Belmont Principles;
  • Determines that adequate provisions are present for obtaining consent (permission) and assent, or waiver of consent (permission) and/or assent, from the children and parents or guardians in accordance with 45 CFR 46. 408 and 21 CFR 50.55, 34 CFR 97.408, if applicable:
    • Takes into account the age, maturity, and psychological state of the children determining whether children are capable of assent. This determination may apply to all children involved in the study or on a case-by-case basis, as deemed necessary by the IRB.
    • Determines if assent is not a necessary condition for proceeding with research because:
      • Some or all children are so limited they cannot reasonably be consulted; or
      • Intervention or procedure involved holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the research context.
    • Waives the assent requirement only after finding and documenting:
      • The research involves no more than minimal risk to the subjects;
      • The waiver will not adversely affect the rights and welfare of the subjects;
      • The research could not practicably be carried out without the waiver; and
      • Whether it is appropriate for the subjects to be provided with additional pertinent information after participation.
  •  Determines that permission (consent) of each child’s parents or guardian will be obtained in accordance with the informed consent provisions in 45 CFR 46.116, 46.408 and, if applicable, 21 CFR 50.27, 50.55 and 34 CFR 97.116, 97.408:
    • For research involving parental permission (consent):
      • Decides and documents if permission (consent) of one parent is sufficient for research designated CRL 1 or CRL 2:
      • Requires permission (consent) of both parents for research designated CRL 3 or CRL 4 unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has responsibility for the care and custody of the child, if consistent with state law.
    • For non- FDA-regulated research, waives parental or guardian permission (consent) after determining:
      • The waiver provisions of 45 CFR 46.116 and 34 CFR 97.116, if applicable, are satisfied (see POL036 policy on, PRO153 procedure for waiver of informed consent process);
      • Protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (e.g., child abuse/neglect);
      • Appropriate mechanisms to protect children-participants are substituted based on the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and on their age, maturity, status, and condition;
      • The waiver is consistent with federal, state, and local law.
    • Determines whether to waive documentation of permission (consent) in accordance with 45 CFR 46.117 and, if applicable, 21 CFR 50.27, 56.109(c), and 34 CFR 97.117 (see POL036, PRO153).
    • Determines and documents how documentation of consent (permission) will be noted and documented.
  • Defers research under federal jurisdiction, as applicable, that has been designated a CRL 4 (45 CFR 46.407, 21 CFR 50.54, 34 CFR 97.407) until a determination is finalized by OHRP, FDA, or Department of Education that research may proceed ethically;
  • Notifies, through OIRB senior staff, the OIRB Director within 5 working days when an IRB determines a study is designated CRL 4;
  • Grants final approval of CRL 4-designated protocol under federal jurisdiction after federal agency approval;
  • Reviews through the amendment process any changes proposed by federal agencies;
  • Requires the following when children as wards of the state are involved in research determined to be CRL 3 or CRL 4:
    • Appointment of an advocate for each child in addition to any other individual acting on behalf of the child as guardian or in loco parentis (An advocate may serve for more than one child.);
    • The advocate to be an individual who has the background and experience to act in, and agrees to act in the best interests of the child for the duration of the child’s participation in the research; and
    • The advocate to have no association in any way (except in the role as advocate or member of the IRB) with the research, the investigator(s), or the guardian organization.

OIRB Responsibilities

The Senior Staff:

  • Verifies that FOR222 Special Populations Review Form–Children is completed as part of the initial study application for review;
  • Verifies that the investigator, at the time of continuing review, has provided a memorandum confirming the previously assigned CRL;
  • Reviews the HSP to confirm CRL appears appropriate;
  • Takes into consideration the age, maturity, and psychological state of the children targeted in the proposed research when pre-reviewing the assent/permission (consent) documents;
  • Reviews HSP for requests to waive assent and/or permission (consent) or waiver of documentation of assent and/or permission (consent);
  • Ensures that the minutes reflect the deliberations of the IRB and the CRL is entered in IRB database;
  • Notifies the OIRB Director within 5 working days of when an IRB determines a study meets CRL 4;
  • Prepares and submits information required for review by OHRP, FDA, or Department of Education, as appropriate, for research under federal jurisdiction that the IRB had determined to be a CRL 4. Documentation sent to the agencies includes:
    • IRB minutes from the convened meeting documenting the IRB findings;
    • The complete IRB application and informed consent documents;
    • The relevant protocol and/or grant application; and
    • Any supporting material, including the Investigator’s Brochure if applicable.

The Administrative Staff:

  • Enters CRL in database;
  • Prepares minutes reflecting deliberation and CRL determination, in addition to other information discussed by the IRB.


Approved on October 1, 2007, by:

Ferdinand Urthaler, MD
IRB Chair

Sheila Deters Moore, CIP
OIRB Director