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UM Policies & Procedures - HSRO/IRB
1. Preface
2. Background Topics
3. Authorities and Responsibilities
4. Conflict of Interest
5. Institutional Review Boards
6. IRB Meetings
7. General Principles for IRB Reviews
8. Definition of IRB Review Types
9. IRB Review of Initial Studies
10. IRB Review of Continuing Studies
11. Amendments
12. Closing Studies and Final Reports
13. Suspension, Termination and Administrative Closure of IRB Approved Research
14. Unanticipated Problems and Adverse Events
15. Study Violations
16. Compliance Audits
17. Data Safety Monitoring Boards
18. Ancillary Committees
19. External IRB's
20. Policies Specific to Certain Types of Research
21. Informed Consent
22. Participant Recruitment Methods, Advertising Materials and Recruitment-Relevant Payment Arrangements
23. Vulnerable Populations
24. Privacy, Security, Confidentiality and HIPAA
25. Subcontracts/Agreements for UM-Initiated Studies that Engage or Involve non-UM Institutions or Investigators
26. International Research
27. Emergency Use
28. Record Retention
Other Policies
UChart Forms & Guidance
HSRO Forms & Documents
University Fees
Ancillary Committee Information
eProst User Guide
Ethics, Federal Regulations & Guidance
Western IRB (WIRB)
About the HSRO

Basic Folder Information

23.5 Children

Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Current Approval Date:

October 16, 2006

23.5(a) General Principles, Consent and Assent

23.5(a) General Principles, Consent and Assent

Federal regulations [45 CFR 46, Subpart D and 21 CFR 50, Subpart D] and University ethical standards require that Principal Investigators and the IRB shall be sensitive to the vulnerability of subjects who are children and apply special conceptual and regulatory protections to research involving children. Principal Investigators and the IRB shall also be responsive to the need to include children in human subject research unless there are scientific or ethical reasons not to include them.

OHRP/FDA defines "children" as persons who have not attained the legal age for consent to treatments or procedures involved in the research/clinical investigations, under the applicable law of the jurisdiction in which the research/clinical investigation will be conducted. The age of majority in the State of Florida is eighteen (18) [§743.07].

Consent: For subjects under 18 years of age, consent must be obtained from the child's biological or adoptive parents or court-appointed legal guardian. A court-appointed legal guardian must obtain court approval to provide consent for a child to participate in research studies. Where parental permission is to be obtained, the IRB may find that the permission of one parent is sufficient if: a) the research does not involve greater than minimal risk; or b) the research involves more than minimal risk but presents the prospect of direct benefit to the individual child. If the research does not fit within one of the two categories and consent is to be obtained from parents, both parents must give consent unless one parent is deceased, unknown, incompetent, or not reasonably available or unless only one parent has legal responsibility for the care and custody of the child [45 CFR 46.408].

The IRB may approve a waiver of the consent requirements for studies involving children if the conditions for waivers of other studies are met [see policy on Informed Consent and 45 CFR 46.116] and if the IRB determines that the study is designed for conditions or for a subject population for which parental or guardian consent is not a reasonable requirement to protect the subjects (for example, neglected or abused children). The granting of a waiver of consent may be made if the IRB approves the substitution of an appropriate mechanism for protecting the children who will participate as subjects in the research and provided further that the waiver is not inconsistent with Federal, state or local law. The choice of an appropriate mechanism shall depend upon 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.

Assent: In addition to the consent of parents or the legal guardian, the IRB shall require, from children 7 through 17 years of age and who, in the judgment of the IRB, are capable of providing assent, the child's affirmative agreement (assent) to participate in research. In the absence of affirmative agreement, the child's failure to object to research participation should not be considered as assent.

In determining whether children are capable of assent, the IRB shall take into account the ages, maturity, and psychological state of the children involved (45 CFR 46.408, 21 CFR 50). This judgment may be made for all children to be involved in research within a particular study, or for each child, as the IRB deems appropriate.

The assent of child-subjects is not a necessary condition for proceeding with a study if the IRB determines either of the following:

  1. The capability of some or all of the children is so limited that they cannot reasonably be consulted; OR
  2. The intervention or procedure in the study 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 context of the research

Even if the IRB determines that the participants are capable of assenting, the IRB may waive the assent requirement if it finds and documents that:

  1. The research involves no more than minimal risk to the participants; AND
  2. The waiver will not adversely affect the rights and welfare of the participants; AND
  3. The research could not practicably be carried out without the waiver; AND
  4. Whenever appropriate, the participants will be provided with additional pertinent information after participation

The IRB shall determine whether and how assent must be documented. The process for obtaining assent from children shall include a brief description of the study. This description should be appropriate to the level of reading and understanding of the child and should be followed by the statement such as:

I agree _______I do not agree ________to participate in this study which I have read or which has been explained to me by ____________________

Signature and date lines for the child, parent, and the person obtaining assent are needed.

23.5(b) IRB Review of Research Involving Children

23.5(b) IRB Review of Research Involving Children

In addition to the general review conditions defined within regulations and the policies contained in this document that pertain to all studies, the IRB may approve a study involving children only if there are adequate provisions for soliciting the assent of the children and the permission of their parents or guardians (see above) and only if such research fits within one of the categories permitted by federal regulations (45 CFR 46.404-407 and/or 21 CFR 50.51-54). These categories are:

  1. the research involves no greater than minimal risk
  2. The research involves greater than minimal risk, but presents the prospect of direct benefit to an individual subject. Research in this category is may be approved if the IRB determines the following:
    1. The risk is justified by the anticipated benefit to the subjects ; AND
    2. The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches
  3. The research involves greater than minimal risk and no prospect of direct benefit to individual subjects, but the research is likely to yield generalizable knowledge about the subject's disorder or condition. Research in this category may be approved if the IRB determines the following:
    1. The risk represents a minor increase over minimal risk; AND
    2. 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; AND
    3. The intervention or procedure is likely to yield generalizable knowledge about the subjects' disorder or condition that is of vital importance for the understanding or amelioration of the subjects' disorder or condition
  4. The study is not otherwise approvable but the research presents an opportunity to understand, prevent or alleviate a serious problem affecting the health or welfare of children. A study determined by the IRB to be in this category may be approved by the IRB if the IRB determines that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children. However, the HSRO shall not issue IRB approval for the study, and the study may not be initiated, until a determination is issued by the Secretary of the U.S. Department of Health and Human Services concurring with the determination of the IRB.

To obtain approval by the DHHS Secretary, the HSRO shall provide all required documentation (through OHRP).

If the IRB approves a study involving prisoners, and if the study is supported by the U.S. Department of Health and Human Services, the study must be submitted to the Secretary of Health and Human Services for approval [c.f. 45 CFR 46.306]. The HSRO shall not issue IRB approval for the study, and the study may not be initiated, until approval is given by the DHHS Secretary.

The HSRO shall be responsible to provide required documentation to the DHHS Secretary (through OHRP) necessary to decide whether the IRB has appropriately reviewed and approved the research pursuant to regulations and UM policies. The DHHS Secretary, after consultation with a panel of experts in pertinent disciplines (for example: science, medicine, education, ethics, law) and following opportunity for public review and comment, shall issue a determination which, if positive, will permit the HSRO to issue a letter to the Principal Investigator approving the study.

In assessing benefits and the probability and magnitude of risk to children especially in health care situations, Principal Investigators and the IRB should consider the current and anticipated health status and emotional maturity of the child, the risks and discomforts inherent in the proposed research and the burden regardless of whether the child is accustomed to the proposed procedures. In assessing risks in non-health care related (social science) research involving children, Principal Investigators and the IRB should consider that risks may be emotional/psychological or to social standing. An IRB member or consultant with appropriate background and experience in Pediatrics or a related topic should participate in the IRB's calculation of the risks and benefits with consideration of the circumstances of the subjects under study.

23.5(c) Wards of the State or Other Agency, Institution or Entity

23.5(c) Wards of the State or Other Agency, Institution or Entity

Review Responsibility:

IRB Policy and Procedure Committee

Current Approval Date:

June 28, 2006

In general, a 'ward' is a child (or adult) whose welfare is the responsibility of the State or any other agency, institution or entity. For example, the FDA [21 CFR 50.3(q)] defines a ward as a "child who is placed in the legal custody of the State or other agency, institution, or entity, consistent with applicable Federal, State or local law" while Florida Statute 755.102(2) defines a ward as "a person for whom a guardian has been appointed." This policy applies to wards of the State or other agency, institution or entity who are children or adults. Such individuals can be included in research studies approved pursuant to these policies [c.f. 45 CFR 46.409, 21 CFR 50.56] only if such research is either:

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

A principal investigator seeking to enroll a ward of the state in a research study must contact the agency/individual that has jurisdiction/guardianship of the ward to determine the status of the parental rights and whether or not a guardian has been appointed in order to seek permission and to obtain any relevant court orders. Depending on the status of parental rights, the investigator must also seek authorization from the Court before the ward may participate in the study. In order to accomplish the latter, the investigator must justify the requirements of Florida Statues (see below).

If parental rights have not been terminated, investigators must involve the parent(s) in the decision-making process unless appropriate court documents are presented that define any custody issues that eliminate the requirement that the non-custodial parent be present. Even where parental rights are still partially intact, however, investigators may still be required to provide the IRB with appropriate court documents that demonstrate that authorization to allow the ward to participate in the research study was granted by the Court.

If the IRB approves a study involving wards of the State, the IRB shall require appointment of an advocate for each child who is a ward. The advocate shall serve 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 shall be an individual who has the background and experience to act in, and who agrees to act in, the best interest of the child for the duration of the child's participation in the research. The advocate may not be associated in any way (except in the role as advocate or member of the IRB) with the study, the investigator(s) or the guardian organization.

Additional regulatory requirements are defined under title XLIII, Chapter 744 of the Florida Statutes. These are as follows:

744.3215 – Rights of Persons Determined Incapacitated:

    1. Without first obtaining specific authority from the court as described in 744.3725 (procedure for extraordinary authority) a guardian may not:
    2. Consent on behalf of the ward to the performance on the ward or to the participation by the ward in any biomedical or behavioral experiment or procedure

Under Florida Statute 744.32215(4)(b), the court may permit such performance or participation by the ward only if:

  1. It is of direct benefit to, and is intended to preserve the life of or prevent serious impairment to the mental or physical health of the ward; OR
  2. It is intended to assist the ward to develop or regain his or her abilities

744.3725 -- Procedure for Extraordinary Authority

Before the Florida court may grant authority to a guardian to exercise any of the rights specified in 744.3215(4), the court must:

  1. Appoint an independent attorney to act on the incapacitated person's behalf, and the attorney must have the opportunity to meet with the person and to present evidence and cross-examine witnesses at any hearing on the petition for authority to act
  2. Receive as evidence independent medical, psychological, and social evaluations with respect to the incapacitated person by competent professionals or appoint is own experts to assist in the evaluations
  3. Personally meet with the incapacitated person to obtain its own impression of the person's capacity, so as to afford the incapacitated person the full opportunity to express his or her personal views or desires with respect to the judicial proceeding and issue before the court
  4. Find by clear and convincing evidence that the person lacks the capacity to make a decision about the issue before the court and that the incapacitated person's capacity is not likely to change in the foreseeable future
  5. Be persuaded by clear and convincing evidence that the authority being requested is in the best interests of the incapacitated person

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