Assent and Consent Requirements for Children

Version date: February 21, 2007

Introduction

The ethical mandate of IRBs such as the UW Health Sciences Institutional Review Board is to protect the rights and welfare of human research subjects. The IRB is obligated to ensure that research studies do not endanger the safety or well-being of human subjects or undermine public confidence in the conduct of research. The special vulnerability of children makes consideration of involving them as research subjects particularly important. To safeguard their interests and to protect them from harm, special ethical and regulatory considerations are in place for reviewing research involving children. Title 45 CFR Part 46, Subpart D provides "Additional Protections for Children Involved as Subjects of Research." Research that is contrary to the rights and welfare of child-subjects is prohibited.

Purpose

The purpose of this policy is to provide researchers and IRB members with a guide for determining how a child's assent for research participation should be obtained and documented. For the purposes of this policy, children are persons who have not attained the legal age for consent to treatments or procedures involved in research, under applicable law of the jurisdiction in which the research will be conducted.

Regulatory Basis for Policy

The importance of obtaining both parental permission and child assent for participation in research is expressed in the regulations governing research with children as subjects, 45 CFR 46, Subpart D, 46.408. This regulation outlines the requirements for permission by parents and guardians and for assent by children. In part, the regulation states that:

"...the IRB shall determine that adequate provisions are made for soliciting the assent of children, when in the judgement of the IRB the children are capable of providing assent. In determining whether children are capable of assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved. This judgement may be made for all children to be involved in research under a particular protocol, or for each child, as the IRB deems appropriate. If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research 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, the assent of children is not a necessary condition for proceeding with the research. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement under circumstances in which consent may be waived...

...In addition to the determinations required under other applicable sections of this subpart, the IRB shall determine, in accordance with and to the extent that consent is required by §46.116 of Subpart A, that adequate provisions are made for soliciting the permission of each child's parents or guardian".

Definitions:

Therapeutic trials - these studies hold the prospect for direct personal benefit for the child. 
Non-therapeutic trials - these studies hold no prospect for direct personal benefit for the child. They are conducted to yield generalizable knowledge about the subject's disorder or condition. 
Informed Assent - A child's expressed willingness to participate in the research, given with the understanding of what is involved.
Informed Consent - The legal agreement of a parent(s) or legal guardian for the child to participate in the research, given with the understanding of what is involved. 
Dissent - A child's expressed desire, verbally or non-verbally, not to participate in the research. Mere failure to object should not, absent affirmative agreement, be construed as assent as this may be the child's way of communicating dissent.
Parent - a child's biological or adoptive parent. 
Guardian - an individual, who is authorized under applicable State or local law, to consent on behalf of a child to general medical care.

Resources:

45 CFR 46, Subpart D

Assent/Consent Requirements for Children Participating in Research

Therapeutic Trials

7-Year Old to 14-Year Old

All therapeutic trials enrolling children ages 7 to 14 should have a separate document explaining the study in terms that a 7 year-old can understand. In addition, children with the potential capacity of understanding the informed consent document (i.e., 12 to 14 year olds) may also read this document if desired but must sign the assent document indicating their actual willingness to participate. This document should be used as part of the process of informing the child, with the intent of obtaining assent for participation. These studies should also have a consent form, signed by the child's parent(s) or guardian, containing the required elements of consent.

The IRB recognizes that it is the responsibility of the physician and the family to determine whether research participation is a therapeutic trial is within the best interests of the child. Although attempts to obtain the assent of the child should be made, it should be noted that a child's dissent may be overruled by his/her parents in therapeutic trials. However, the IRB may determine that assent is an absolute requirement of participation for certain trials that may be deemed to be especially burdensome and that pose a very limited possibility of personal benefit to the child.

Older Children

Studies enrolling children 15 to 17 years of age should use the consent form for the purpose of informing the child and obtaining assent for participation, provided the children being enrolled are capable of understanding the document. In studies in which these children will be enrolled, the consent form should be modified to add a separate authorization section where a child and Investigator or person obtaining assent can sign, providing documentation of assent to participate. If, in the clinician’s best judgement, the children being enrolled are not capable of understanding the consent document, the IRB approved assent document should be used instead.

Younger Children

The IRB emphasizes the need for a process of informing children younger than 7 about study participation. It is the Investigator’s responsibility to ensure that an attempt has been made to help a young child understand the study in terms that he/she can understand. In general, if a procedure or intervention is causing extreme and persistent distress of the child, dissent should be respected. If study participation is critical to the health of the child, dissent can, in general, be overruled. If the study is unlikely to benefit the child, the IRB generally agrees that dissent cannot be overruled.

Assent documents for therapeutic trials should include the following elements:

Purpose - the reason(s) why the research is being done.

Examples:
 “This study is being done ..."
"...to find out what amount of ____ medicine works best for children with ____"
"...to find out which medicine works better for children with ____"

Procedures
- what will happen to the child during study participation, with a focus on any interventions.
These should be explained as simply as possible, e.g.: 
“You will have your arm pricked by a needle so that we can draw blood.” 
“We will do a test of how your heart is working called an ECG. This test won’t hurt at all, but we will have to stick some wires to your chest during the test.” 
“A special cream called Emla may be put on your skin where you will have the needle prick to help make it hurt less” 
“The doctor or nurse will give you a check up. They will ask you to take off your clothes and wear a gown while the study doctor listens to your heart with a stethoscope…”

Risks - the discomforts, both physical and emotional, that the child will experience.
"It may hurt when we prick your arm with a needle."
"You may feel embarrassed when we ask you questions about your feelings"
"You may feel scared when we ask you to lie still in the MRI machine."

Benefits - the benefits that the child will gain directly.
"You may or may not get better if you decide to be in this study.  If you do decide to be in this study, it may help doctors learn more about how to take care of other children with ___"

Questions - contact information for the PI or study personnel

Authorization
to be signed by study personnel, as authorization that the document has been reviewed with the child, and that the child’s questions have been answered. This section should include a paragraph stating, “I have discussed this clinical research study with the child using language that is understandable and appropriate. I believe I have fully informed the participant of the nature of the study and its possible risks and benefits. I believe the participant understood this explanation.”

Non-therapeutic trials

7-Year olds to 14-Year olds

All non-therapeutic trials enrolling children ages 7 to 14 must have a separate assent document, which is used for the dual purpose of guiding the process of informing the child and documenting the child’s agreement to participate. The document should be written in terms that a 7 year old can understand. These studies should also have a consent form, to be signed by the parent(s) or legal guardian, that contains the required elements of consent. For some studies, the IRB may determine that the consent of both parents is required. For non-therapeutic trials, assent must be obtained. A child’s dissent may not be overruled by the child’s parents.

Older Children

For children ages 15 to 17, the consent form may be used to obtain assent of the child, provided the clinician determines that those children can comprehend the consent form.. For studies enrolling this age group, the consent form should be modified by adding a separate authorization section for the child and the person obtaining assent.

Younger Children

The IRB emphasizes the need for a process of informing children younger than 7 about study participation. It is the Investigator’s responsibility to ensure that an attempt has been made to help a young child understand the study in terms that he/she can understand. In general, if a procedure or intervention is causing extreme and persistent distress of the child, dissent should be respected.

Assent document for non-therapeutic trials should include the following elements:

Purpose - the reason(s) why the research is being done

Examples:
 "This study is being done to find out how children with ___ get along with their families and in school.” 
“…to find out which of these medications works best for children with ____” 
Voluntary statement – that the child may choose whether or not to participate. 
“You can decide whether or not you want to be in this study, and you can stop being in it if you want to.”

Duration - how long the study and its procedures will last. 
“You will be in this study for 1 year. You will come to the clinic to answer questions 3 times, and each time will last about an hour.”

Procedures - what will happen to the child during study participation, with a focus on any interventions. These should be explained as simply as possible. 
“You will have your arm pricked by a needle so that we can draw blood.” 
“We will do a test of how your heart is working called an ECG. This test won’t hurt at all, but we will have to stick some wires to your chest during the test.” 
“A special cream called Emla may be put on your skin where you will have the needle prick to help make it hurt less” 
“The doctor or nurse will give you a check up. They will ask you to take off your clothes and wear a gown while the study doctor listens to your heart with a stethoscope…”

Compensation - the money or goods that the child and his/her family will receive. 
“If you decide to be in this study, you and your parent(s) will be paid for the time you spend doing the study visits.”

Risk - the discomforts, both physical and emotional, that the child will experience. 
“It may hurt when we prick your arm with a needle.” 
“You may feel embarrassed when we ask you questions about your feelings” 
“You may feel scared when we ask you to lie still in the MRI machine.”

Benefits - the benefit to society, particularly generalizable knowledge about disorder being studied. 
“This study is not expected to provide any benefit to you. If you decide to be in this study, it may help doctors to learn more about how to take care of other children with ____”

Alternatives - the other options that exist. 
“You don’t have to be in this study for doctors to take care of your ___. You can decide not to be in this study, and no one will be mad at you.”

Questions - contact information for the PI or study personnel

Authorization - to be signed by the child and by the study personnel, as authorization that the document has been reviewed with the child, and that the child agrees to participate in the study. This section should include a paragraph stating, “I have discussed this clinical research study with the child using language that is understandable and appropriate. I believe I have fully informed the participant of the nature of the study and its possible risks and benefits. I believe the participant understood this explanation and assented to participate in this study.”

See Also:




Keywords:assent, child, kid, minor, adolescent, consentDoc ID:27037
Owner:Monica E.Group:Health Sciences IRBs
Created:2012-10-25 12:03 CSTUpdated:2017-07-11 13:02 CST
Sites:Health Sciences IRBs
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