Committee For the Protection of Human Subjects

Research with Children

POLICY

UTHSC-H will follow the Texas law on consent to medical treatment for research consent matters unless clearly inapplicable because there is no applicable Texas law specific to research consent. If the research is being conducted outside of Texas, CPHS will work with the local IRB to determine who is considered a child and who is considered a guardian under the applicable state law. If UTHSC-H is not relying on a local IRB to review the research being conducted outside of Texas, the investigator should submit documentation indicating who is considered a child and guardian in the particular state.

In addition to the criteria for review listed in the policy and procedure Initial Review, in order to approve research in which some or all of the participants are children, CPHS must determine that all research is in compliance with this policy and procedure. The CPHS must classify research involving children into one of four categories and document their discussions of the risk and benefits of the research study.

 

Permissible Categories: The four categories of research involving children that may be approved by the CPHS based on degree of risk and benefit to individual participants, are as follows:

 

Category 404: Research not involving greater than minimal risk to the child (examples: urinalyses, obtaining small blood samples, EEGs, allergy scratch tests, minor changes in diet or daily routine, and/or use of standard psychological or educational tests). CPHS may approve the research only if the CPHS finds that adequate provisions are made for soliciting the assent of the children and permission of their parents, or legal guardians. CPHS may find the permission of one parent sufficient.

 

Category 405: Research involving greater than minimal risk, but presenting the prospect of direct benefit to an individual participant. Research in this category is approvable provided:

a.       The risk represents a minor increase over minimal risk, and is justified    by an anticipated benefit to the participants;

b.      The relationship of risk to benefit is at least as favorable as any available alternative approach; and

c.       Adequate provisions are made for soliciting the assent of the children and permission of their parents, or legal guardians.

d.      CPHS may find the permission of one parent sufficient.

 

Category 406: Research involving greater than minimal risk with no prospect of direct benefit to individual participants, but likely to yield generalizable knowledge about the participant's disorder or condition. Research in this category is approvable provided:

a.       The risk represents a minor increase over minimal risk;

b.      The intervention or procedure presents experiences to participants that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations;

c.       The intervention or procedure is likely to yield generalizable knowledge about the participant’s disorder or condition that is of vital importance for the understanding or improvement of the participant’s disorder or condition; and

d.      Adequate provisions are made for soliciting the assent of the children and permission of their parents, or legal guardians.

e.      The permission of both parents is required unless one parent is deceased, unknown, incompetent or reasonably unavailable, or if one parent has legal responsibility or custody of the child.

 

Category 407: Research that is not otherwise approvable, but which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. Research that is not approvable under 8.1, 8.2 and 8.3 may be conducted or funded by DHHS provided that the CPHS and the Secretary of DHHS, after consultation with a panel of experts, finds:

a.       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;

b.      That the research will be conducted in accordance with sound ethical principles; and

c.       Adequate provisions are made for soliciting the assent of the children and permission of their parents, or legal guardians.

d.      The permission of both parents is required unless one parent is deceased, unknown, incompetent or reasonably unavailable, or if one parent has legal responsibility or custody of the child.

 

Texas law on age of majority – The age of majority in Texas is 18 (with the exception of consumption of alcoholic beverages where the legal age limit is 21) but special rules for minors may also be inapplicable to someone under 18 years of age who has had the disabilities of minority removed.

 

Texas law on consent to medical treatment for research - A child may consent to medical, dental, psychological, and surgical treatment for the child by a licensed physician or dentist under certain limited conditions that include if the child:

a.       is on active duty with the armed services of the United States of America;

b.      is legally married;

c.       is 16 years of age or older and resides separate and apart from the child's parents, managing conservator, or guardian and manages his/her own financial affairs regardless of the source of funds;

d.      consents to diagnosis/treatment of infectious, contagious, or communicable disease that is required by law or a rule to be reported by the licensed physician or dentist to a local health officer or Texas Department of Health;

e.      is unmarried and pregnant and consents to hospital, medical, or surgical treatment, other than abortion, related to the pregnancy;

f.        consents to examination and treatment for drug or chemical addiction, drug or chemical dependency, or any other condition directly related to drug or chemical use;  or

g.       is unmarried, is the parent of a child, and has actual custody of his or her child and consents to medical, dental, psychological, or surgical treatment for the child.

A licensed physician, dentist, or mental health professional may, with or without the consent of a child who is a patient, advise the parents, managing conservator, or guardian of the child of the treatment given to or needed by the child. A physician, dentist, mental health professional, hospital, or medical facility may rely on the written statement of the child containing the grounds on which the child has capacity to consent to the child's medical treatment.

Key Terms

Assent – A child’s affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.

Children – Under Texas state law, children are persons who are less than 18 years of age.

Emancipated Minor – A legal status conferred upon persons who have not yet attained the age of legal competency as defined by Texas state law, but who are entitled to treatment as if they had by virtue of assuming adult responsibilities, such as self –support, marriage or procreation.  Those who have had the disabilities of minority removed for limited or general purposes by the State of Texas.

Guardian – An individual who is authorized under applicable state or local law to give permission on behalf of a child to general medical care.

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

Parent - a child’s biological or adoptive parent.

Ward - 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. 

 

PROCEDURE

When research involves children, in addition to the materials listed in the policy on initial review, investigators must submit a child assent form and parental permission form.

CPHS shall review the parental permission documents and the plan provided by the investigator to ensure that these documents are signed by parents, or the legally appointed guardian, of children under age 18. The CPHS must determine for each protocol whether the permission of both parents is necessary, and the conditions under which one parent may be considered “not reasonably available”.

CPHS may seek a legal guidance to clarify authority when parental permission may be insufficient to protect the child's interests particularly when the interests of one child conflict with those of a sibling or other relation. 

 

Assent:  The CPHS must determine for each protocol – depending on such factors as the nature of the research and the age, status and condition of the proposed participants – whether all or some of the children are capable of assenting to participation taking into account the ages, maturity, and psychological state of the children involved. In general, verbal assent should be obtained from children under the age of 7 whenever possible and assent documents should be signed by participants 7 to 18 years of age provided the child is mature enough to understand the planned intervention.

CPHS shall determine that adequate provisions have been made for soliciting the assent of children and the permission of their parents or guardian. CPHS shall determine that if assent is sought, the information/explanation of the proposed research procedures are in a language that is appropriate to the child’s age, experience, maturity, and condition.

Generally, the child's veto of participation is sufficient to make the child ineligible for inclusion in the study. However, the parent or guardian, with CPHS and physician approval, may override the veto if the intervention will benefit the child.

 

Alteration or Waiver of Parental Permission/Assent: CPHS may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent, or waive the requirements to obtain informed consent provided that CPHS finds and documents that:

a.       The research involves no more that minimal risk to the participants;

b.      The waiver or alteration will not adversely affect the rights and welfare of the participants;

c.       The research could not practicably be carried out without the waiver or alteration;

d.      Whenever appropriate, the participants will be provided with additional pertinent information after participation;

e.      The research is not subject to FDA regulation.

When the research offers the child the possibility of a direct benefit that is important to the health or well being of the child and is available only in the context of the research, the CPHS may determine that the assent of the child is not necessary.  Assent may also be considered not necessary if the capability of some or all of the children is so limited that they cannot reasonably be consulted.

Minor participants should be re-approached after they attain their majority to confirm that they are still willing to participate in the research study, as demonstrated by the signing of an adult consent form.

 

Special Circumstances: For some research activities, the CPHS may require that a CPHS member, research intermediary or an advocate for the child be present during the assent and permission procedures to verify the child's understanding and to support the child's preferences. The CPHS may also require that the parent(s) or a close family member be present during the research, especially if the child will be exposed to significant discomfort or inconvenience, or if the child will be required to spend time in an unfamiliar place.

CPHS may waive or alter the consent process if it finds that the research is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the children who are subjects and that the investigator provides appropriate alternate mechanism for protecting children who are subjects.

 

Wards of State: Children who are wards of the State or any other agency, institution, or entity can be included in approved research only if it is either related to their status as wards; or conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as participants are not wards.

CPHS shall require appointment of an advocate for each child who is a ward.

a.       The advocate will serve in addition to any other individual acting on behalf of the child as guardian or in loco parentis.

b.      One individual may serve as advocate for more than one child.

c.       The advocate must be an individual who has the background and experience to act in, and agrees to act in, the best interest of the child for the duration of the child’s participation in the research.

d.      The advocate must not be associated in any way (except in the role as advocate or member of the CPHS) with the research, the investigator(s), or the guardian organization.

 

APPLICABLE REGULATIONS

1.       45 CFR 46.111(b)

2.       21 CFR 56.111(b)

3.       21 CFR 56.111(c)

4.       45 CFR 46 Subpart D – Additional DHHS Protections for Children Involved as Subjects in Research

5.       21 CFR 50 Subpart D – Additional Safeguards for Children in Investigations

6.       OHRP Guidance on Children Involved as Subjects in Research

REFERENCE TO OTHER POLICIES

1.       Initial Review.

ATTACHMENTS

1.       Application Form Panel - Research Involving Children

If you find errors in this document, contact clinicaltrials@uth.tmc.edu

 

Document Number:

101-C08

Document Name:

Research Involving Children

Approved by:

ORSC Director

Effective:

1 Aug 2008

Revision History:

1 Jan 2009

1 Aug 2011


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iRIS HELPLINE    713-500-7960
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Committee for the Protection of Human Subjects
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