Boston University
Charles River Campus IRB
Policies and Procedures
Title: Research Involving Children
Date: March 24, 2015

Purpose

The purpose of this policy is to describe the additional responsibilities and procedures involved when reviewing research that involves children as subjects.

Defined Terms

Assent: A child’s affirmative agreement to participate in research. Note: Failure to object should not, absent affirmative agreement, be construed as assent.

Children: 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 Massachusetts, individuals under the age of 18 are considered to be children unless they meet one of the exceptions as defined by Massachusetts law.

Guardian: An individual who is authorized under applicable State and local law to consent on behalf of a child to general medical care.

Minimal Risk: The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Minor Increase of Minimal Risk: Slightly more than minimal and pose no significant threat to the child’s health or well-being

Parent: A child’s biological or adoptive parent

Permission: The agreement of parent(s) or guardian to the participation of their child or ward in research

Policy

The Charles River Campus (CRCCharles River Campus) Institutional Review Board (IRB) applies additional protections for research involving children in accordance with the Department of Health and Human Services (DHHS) regulations (45 CFR 46, Subpart D) and Food and Drug Administration (FDA) regulations (21CFR 50 Subpart D) which provide additional protections for research that that involves children as research subjects.

Procedures

Permissible Categories of Research:

Children may be involved in research if the research falls into one of the categories below:

1. Category 1 (45 CFR 46.404/21 CFR 50.51):

  • Research is not greater than minimal risk
  • Adequate provisions are made for soliciting the assent of the children and the assent of the parent(s) or guardian

2. Category 2 (45 CFR 46.405/21 CFR 50.52)

  • Research involves greater than minimal risk
  • The research presents the prospect of direct benefit
  • The risk to children is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual subject or by a monitoring procedure that is likely to contribute to the subject’s well-being
  • The risk is justified by the anticipate benefit to the subjects
  • The relation of the anticipated benefit to the risk is at least as favorable to the subjects as presented by available alternative approaches
  • Adequate provisions are made for soliciting the assent of the children
  • Adequate provisions are made for soliciting the permission of the parent(s) or guardian

3. Category 3 (45 CFR 46.406/21 CFR 50.53)

  • The risk represents a minor increase over minimal risk
  • The intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations;
  • The intervention or procedure is likely to yield generalizable knowledge about the subjects’ disorder or condition which is of vital importance for the understanding or amelioration of the subjects’ disorder or condition
  • Adequate provisions are made for soliciting assent of the children
  • Adequate provisions are made for soliciting the permission of the parents or guardians

4. Category 4 (45 CFR 46.407/21 CFR 50.54)

If the IRB believes that the research does not meet the requirements of 45 CFR 46.404, 46.405, or 46.406, but finds that it presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children, it may refer the protocol to HHS or the Commissioner of Food and Drugs (if FDA-regulated) for review. The research may proceed only if the Secretary, HHS, or his or her designee, or the Commissioner of Food and Drugs (if FDA-regulated) after consulting with a panel of experts in pertinent disciplines (e.g., science, medicine, education, ethics, law) and following an opportunity for public review and comment, determines either: (1) that the research in fact satisfies the conditions of 45 CFR 46.404, 46.405, or 46.406, or (2) the following:

  • the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children
  • the research will be conducted in accordance with sound ethical principles; and
  • adequate provisions are made for soliciting the assent of children and the permission of their parents or guardians, as set forth in HHS regulations at 45 CFR 46.408

Assent for Research Involving Children

Adequate provisions for soliciting assent of a child to participate in research are required when the child is capable of providing assent. When determining whether children are capable of assent, the IRB will take is into account the ages, maturity, and psychological state of the children involved. The IRB’s determination of the children’s capacity to consent may apply to some or all of the children in the proposed study. If the assent is not a requirement of some of the children, the IRB will indicate which children are not required to assent. Generally, the IRB does not require assent for children aged 5 years and younger.

Documentation of assent

The IRB has the following recommendations for documenting assent:

  • Parental Permission for minors under 6 years of age
  • Verbal assent for minors 6-11 years of age
  • Written assent from minors ages 12-17 (unless verbal consent is approved for the parents/adult subjects). Children aged 12-17 may sign either a separate assent form or sign the same consent form that is signed by their parent(s) or legal guardian(s).

Waiver of Assent

The IRB may determine that a waiver of children’s assent is appropriate if one of the conditions below applies:

  • If the capability of some or all of the children is so limited that they cannot reasonably be consulted
  • If the intervention or procedure involved in the research holds out the prospect of direct benefit to the health or well-being of the children and is available only in the context of the research
  • If the research meets the same conditions as those for waiver or alteration of informed consent in research involving adults, as specified in the regulations at either 45 CFR 46.116© or 45 CFR 46.116(d)

Parental Permission

Adequate provisions for soliciting the permission of the parent(s) or legal guardian(s).are required for children to participate in research unless the IRB determines that these requirements can be waived.

  • For research approved under Categories 1 and 2 (listed above), permission of one parent is sufficient
  • For research approved under Categories 3 and 4 (listed above), both parents must give their permission unless one parent is deceased, unknown, incompetent, or not reasonably 4 available, or when only one parent has legal responsibility for the care and custody of the child.

When permission for a child to participate in research is to be obtained from a legal guardian(s) rather than from the child’s biological or adoptive parent(s), the guardian must provide documentation of the legal ability to consent to the child’s general medical care. The IRB and Investigators will consult with General Counsel as necessary.

Documentation of Parental Permission

Parental permission should be documented in accordance with 45 CFR 46.117 unless the IRB waives the requirement for documentation of consent under one of the options listed below:

Option 1

  • The research is not FDA regulated
  • The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality

Option 2

  • The research presents no more than minimal risk of harm to subjects
  • The research involves no procedures for which written consent is normally required outside of the research context.

Waiver of Parental Permission

The IRB may waive the requirement for parental permission using the following options:

Option 1

  • The research is not FDA regulated
  • The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine:
    • public benefit or service programs;
    • procedures for obtaining benefits or services under those programs;
    • possible changes in or alternatives to those programs or procedures; or
    • possible changes in methods or levels of payment for benefits or services under those programs
  • The research could not practicably be carried out without the waiver or alteration

Option 2

  • The research is not FDA regulated
  • The research involves no more than minimal risk to the subjects
  • The waiver or alteration will not adversely affect the rights and welfare of the subjects
  • The research could not practicably be carried out without the waiver or alteration
  • Whenever appropriate, subjects will be provided with additional pertinent information after participation. If the investigator is not providing this information, he/she must provide the rationale for why it is not necessary to provide additional information after participation.

Option 3

A research 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 (for example, neglected or abused children), it may waive the requirement for parental permission, provided an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and provided further that the waiver is not inconsistent with federal, state, or local law.

In determining an appropriate mechanism for protecting children, the IRB will consider the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and their age, maturity, status, and condition.

Wards

There are additional requirements for children who are wards of the state who are participating in research approved under Categories 3 or 4. Children who are wards of the state or any other agency, institution, or entity can be included in research approved under Categories 3 and 4 only if the research is:

  • Related to their status as wards OR
  • Conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as subjects are not wards

If the research is approved under Category 3 or 4, the IRB will require appointment of an advocate for each child who is a ward, in addition to any other individual acting on behalf of the child as guardian or in loco parentis. One individual may serve as advocate for more than one child. The advocate will 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 who is not associated in any way (except in the role as advocate or member of the IRB) with the research, the investigator(s), or the guardian organization

The IRB will consult with General Counsel as needed in regards to research involving wards.

Children who Reach the Legal Age of Consent While Enrolled in a Study

When a child who was enrolled in research with parental or guardian permission subsequently reaches the legal age of consent, the subject’s participation in the research is no longer regulated by the requirements regarding parental or guardian permission and subject assent. Legally effective informed consent must be obtained (unless waived by the IRB) from the now-adult subject for any continued participation (including analysis of individually identifiable data or specimens) in the study.

Reimbursements to Children and/or Parents

The IRB will review reimbursements to children and parents to ensure that the reimbursements are age-appropriate and not coercive. Generally, the IRB recommends that children be reimbursed in the form of a gift card or other token instead of cash. The reimbursement amount and schedule should be designed so that it is not a factor in the child’s decision whether to participate or the parent’s decision to give permission for a child’s participation.

Special Considerations

Under Massachusetts Law the following individuals under the age of 18 are subject to exceptions that take them out of the definition of children (as defined on page 1 of this policy).

1. Individuals under the age of 18 who fall into one of the categories below:

  • Married/widowed/divorced
  • A parent
  • A member of the armed forces
  • Is living separate and apart from a parent or guardian and is managing his or her own financial affairs
  • In the case of a female, pregnant or believes herself to be pregnant, unless the procedures involved in the research include abortion as described below:
    • If the research procedures involve abortion, a female under the age of 18 who is not and has never been married meets the definition of “children” as defined on page 1 of this policy
  • Seeking care for a disease defined under Massachusetts law to be dangerous to the public health (the right to consent is limited to the diagnosis and treatment of the disease)

The IRB will consult with General Counsel as needed when determining if an individual meets the definition of “children”.

For research outside of Massachusetts, a determination of who meets the definition of “children” will be made with consultation from General Counsel.

Title: Research Involving Children

Author: Cynthia Monahan

Effective Date: March 24, 2015

Last Review/Update Date:

Revision #:

Approved: Cynthia Monahan, IRB Director Kathryn Mellouk, Associate Vice President-Research Compliance

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