What is informed consent and when, why, and how must it be obtained?

“Informed consent” is the voluntary agreement of an individual, or his or her authorized representative, who has the legal capacity to give consent, and who exercises free power of choice without any form of constraint or coercion to participate in research.

Consenting is a process where the research team clearly communicates the risks and benefits of the study, the voluntary nature of their participation in the study, and their expectations while participating in the study.

A person 18 years and older is considered an adult and therefore can provide consent to participate in a study without parental permission. For participants 17 years old and younger are considered to young to give informed consent so their parents or guardians must sign the parental permission form while the child provides their assent. Assent are described in more detail below.

 Federal regulations 45 CFR 46.116 (b)(c) provide the framework for the type of information that must be included as part of the consent process.  

The basic required elements of informed consent can be found in the HHS regulations at 45 CFR 46.116(a).

The regulations require that the following information must be conveyed to each subject:

• a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
• a description of any reasonably foreseeable risks or discomforts to the subject;
• a description of any benefits to the subject or to others which may reasonably be expected from the research;
• a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
• a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
• for research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
• an explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject; and
• a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

Additional elements are described at 45 CFR 46.116(b).

TAMUK Adult Consent form template

Obtaining Child Assent and Parent Consent in Research

Overview

Federal regulations require additional safeguards when it comes to the rights and welfare of children in research. By definition, children are not able to provide informed consent to participate in research, but they are able to provide their assent. Institutional Review Boards (IRBs) are tasked with ensuring the child’s age, maturity and psychological state allow them to assent to participate in research. If the child is able to assent then certain guidelines need to be put in place to ensure they provide their assent before they participate in any research project. The parents/guardians of children in research must be notified and provided the information needed regarding the research so they can make an informed decision on whether their child may participate.

 

What is child assent?

The federal regulations define children as persons who have not attained the legal age for consent to treatment or procedures involved in research, under the applicable law of the jurisdiction in which the research will take place (45 CFR 46.402(a)). This means children are unable to provide informed consent to participate in research, but they might be able to give their assent. The federal regulations define Assent as a child’s affirming agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent (45 CFR 46.402(b)).

Children or minors are considered a vulnerable research population because their intellectual and emotional capacities are limited, and they are legally incompetent to give valid consent. Special procedures and considerations are required by the Federal regulations for the review of research involving children or minors. When assenting a child, they must show their willingness to participate in the research rather than simply complying with directions to participate. The IRB is tasked with taking into account the child’s age, maturity, and psychological state of the child involved in the research.

How should child assent for research participation be documented?

The IRB has the discretion to determine the appropriate manner, if any, of documenting child assent. This will be based on the child’s age, maturity level, and degree of literacy. The IRB will decide what type of consent form will be appropriate. Whether that be an assent script or an assent form. Below there will be an explanation on the difference between an assent script and an assent form.

If a child is able to assent and the IRB warrants an assent is required then the assent of the child must be completed before they can participate in the research project. If a child disagrees with participating in the project, but their parent/guardian have approved, the child’s decision triumphs the parent/guardian’s permission. However, the federal regulations state that the IRB may waive the assent requirements if the intervention or procedure involved in the research holds out the prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of research.

Children up to 6 years old

In most cases, children this young will not be able to participate in the assent process, and only a permission form for the parents or legal guardians will be needed (Parent Permission).

• If the PI deems a child in this age range capable of being involved in the assent process. The child should be given a simple verbal explanation of what will happen to them during the study via an (Assent Script). The child’s assent should be recorded on the parental permission form, if applicable.

An assent script is typically used with young children or with individuals who are developmentally delayed or affected in a way that they are unable to read or comprehend the standard written consent. Full consent will be signed by the parent or the LAR.

Children 7 to 12 years old

In most cases, children this age will be able to participate in the assent process, using a simplified assent form (Assent form 7-12 years old). A separate, more detailed permission form will be needed for the parents or guardians (Parent Permission).

This age and maturity level may limit their ability to fully comprehend the nature of the research project. If their cognitive abilities allow, they should be consulted about whether they want to participate in the research.

• The assent form should be brief and study specific, with subheadings or numerical paragraphs, and contain language that is both appropriate to the child’s development and age. The assent form should have a simple format that is easy to read.

Adolescents 13 to 17 years old

In most cases, adolescents should be fully informed about a study and give assent to their own participation in the research. A simplified assent form is written for adolescents (Assent form 13-17 years old). A separate, more detailed permission form is written for the parents or guardians (Parent Permission).

• This assent/consent form should use clear, straightforward language (eighth grade reading level).

When can a child assent be waived?

The IRB shall determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent. However, if the child is not capable of providing assent the IRB can waive their assent based on the following:

The regulation  45 CFR 46.408(a) identify types of circumstances where the IRB may determine that waiver of children’s assent is appropriate:

1. if the capability of some or all of the children is so limited that they cannot reasonably be consulted;
2. 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.
3. if the research meets the same conditions as those for waiver or alteration of informed consent in research involving adults in accordance with 45 CFR 46.116 (a).

What is parental permission in the context of research involving children?

Permission by parents or guardians must be documented by the use of a written informed consent form approved by the IRB and signed (including in an electronic format) by the parent(s) or legal guardian.

What does permission mean:

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

What does parent or guardian mean:

• Parent means a child’s biological or adoptive parent.
• Guardian means an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care.
  • In accordance with Texas state law, a guardian means a person who is appointed by the court to protect the person of one who does not have the capacity to protect his or her own interests.

Do both parents need to provide permission for their child to participate in the research?

In most cases permission should be obtained from both parents before their child can enroll in a research project. However, in certain types of research the IRB may find only one parent needs to provide permission for their child to participate in a research project. These types of studies fall under regulations 45 CFR 46.404 or 45 CFR 46.405.

• 45 CFR 46.404 is research that does not involve greater than minimal risk.
• 45 CRF 46.405 is research involving greater than minimal risk but presents the prospect of direct benefits to the individual subjects.
• Minimal risk means that 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,” 45 CFR 46.102(j).
• The prospect of direct benefits means the intervention or procedure holds out the possibility of direct benefit to the individual subject, or the study involves a monitoring and diagnostic procedures that may contribute to the subject’s care or well-being.” 45 CFR 46.405, 21 CFR 50.52.

When research is to be conducted under 45 CFR 46.406 and 45 CFR 46.407 permission must be obtained from both parents, 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.

• 45 CRF 46.406 is research involving greater than minimal risk¹ and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject’s disorder or condition.
• 45 CFR 46.407 is research not otherwise Approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.

Can parental or guardian permission for research involving children be waived?

Yes, under certain circumstances. The IRB may waive the requirement for obtaining parental or guardian permission if it makes and documents the findings under either 45 CFR 46.116(c) or (d)

In addition to the provisions for waiver contained in the federal regulations, if the IRB determines that a research protocol is designed to study conditions in children or 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 parental permission requirements provided that an appropriate mechanism is in place to protect the children, and provided that the waiver is not inconsistent with federal, state, or local law (45 CFR 46.408(c)). The choice of an appropriate substitute mechanism (for example, appointing a child advocate or an assent monitor) for protecting children participating in research would depend on the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and the child’s age, maturity, status, and condition.

Parent Permission Form

Assent script up to 6 years old

Assent form 7-12 years old

Assent form 13-17 years old