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The FDA's Assent Requirements are slightly different than the Common Rule's and can be found in
21 CFR 50.55 (b) Assent means a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent. (c) Permission means the agreement of parent(s) or guardian to the participation of their child or ward in research. (d)
Parent means a child's biological or adoptive parent. (e) Guardian means an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care. (A guardian is the equivalent of a legally authorized individual acting on behalf of an incapacitated adult.) The regulations at
45 CFR 46.408 includes the requirements for obtaining or waiving parental permission and assent of child participants. 408(a) defines when assent of children will be required and when it can be waived. The IRB can waive the requirement of assent if either some or all of the children will not be capable; under some circumstances when the study holds out the
prospect for direct benefit; or For more details, see related web page on Waiver of Assent. 408(b) requires just a single parent to provide permission for research approved under either 45 CFR 46.404 or 405 but ups the requirement to both parents for research approved under either 45 CFR 46.406 or 407. 408(c)
allows the IRB to waive parental permission when it is not a reasonable requirement for the research, provided that there is an alternative mechanism in place to protect the participants. This is most frequently invoked for research involving adolescents but might also apply to research involving younger children such as those who are abused or neglected. Assent is usually sufficient as an alternative mechanism for protection for teenagers but some other substitute (e.g. an advocate) for a
parent will generally be required for younger children. 408(d) the documentation requirements for parental permission are the same as for informed consent. 408(e) this part of the regulation is vague with regard to the details of documentation of assent. At CHOP, it is usually just documented on the Consent Form. However, investigators may propose alternatives, including a separate assent form, documentation in the study records or medical chart or no documentation. How should assent be documented?It is up to the IRB to determine when assent is required and when it is, the way it should be documented. To document assent, some IRB's require the use of an assent form while some do not. The CHOP IRB's prefers that investigator document each child's assent on the consent form signed by their parent(s); the IRB prefers that investigators not use a separate form. The abilities and needs of children vary widely and investigators should provide the information in a format tailored to the child in front of them. In many cases, assent forms are simplified consent forms that include elements that are irrelevant to assent (e.g. risk assessment, confidentiality) and are rarely written with sufficient simplicity of style and readability to achieve their intended objective. Does the child need to sign anything to indicate their assent?The CHOP IRB does not require children to sign their name. On our template consent form signature pages, the signature of the child is left optional. Our preference is for investigators to focus on the assent process rather than on obtaining a signature for a form. Summary:
Title 45 CFR Part 46, Subpart D provides for “Additional Protections for Children Involved as Subjects of Research.” See also: “Research with Children FAQs – U.S. Department of Health & Human Services. Kean University Policy Governing Research Involving Children The legal age of adulthood in New Jersey is 18. Federal regulations and Kean University policy require these protections for children and adolescents involved as subjects of research. Note that the IRB may require additional protections on a case-by-case basis. Research studies involving children or individuals from vulnerable populations should be submitted for full review so the IRB has sufficient information to determine risk/benefit. The IRB will only approve research involving not greater than minimal risk to children that also satisfies all the conditions of additional protections for children. Parents or guardians must give their permission (consent) for their children to participate in research. Protocols for research involving children that use a passive parental consent procedure will not be approved. Parental consent forms must not be unduly long, must be written in terms understandable to the general population, and must include all appropriate details about the research that are most relevant to the parent’s decision to allow a child to participate in the study. Children must give their agreement (assent) to participate in research. When reviewing whether adequate provisions have been made for soliciting assent, the IRB will review the procedures and assent form taking into account the age, maturity and psychological state of the children involved (see guidelines below). Guidelines for Obtaining Consent/Assent1 Consent for involvement of a child in a research study is a two-stage process. The first stage is obtaining parental consent (throughout these guidelines “parent” also denotes “guardian”). Researchers must obtain and retain for each child involved in a study a signed parental consent form. This parental consent must be obtained before a researcher may approach a child to solicit the child’s assent (stage two). Parental Consent A “passive” parental consent procedure, also called an “opt-out” procedure, typically involves distributing a letter to the child’s parents describing the study and instructing them to return the form only if they do not want their child to participate. The Kean University IRB will not approve protocols for research involving children that use a passive parental consent procedure. The parental consent form must contain the same elements as a typical consent form (sample here) and be addressed to the parent(s). The wording of the parental consent document should be appropriate to the typical educational background of the research population. Parents must be informed that participation in a research study is separate from instruction, and that refusal to allow their child to participate, or withdrawing their child from participation, will not in any way affect their child’s grade, class standing, or participation in standard educational activities. Assent “Assent is a child’s affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent” [45 CFR 46.402(b)] Researchers should solicit assent directly from children and in an environment/setting that minimizes influence, or the perception of influence, from parents or persons of authority. Researchers may provide less detailed explanations to younger children and more detailed explanations to older children. Assent forms should be written at a level of education and maturity appropriate to the youngest potential subjects in the age range, and the information delivered using suitable methods. In most cases, 7 years of age is a reasonable minimum for a child with normal cognitive development to be capable of participating in a meaningful written assent process. A researcher may need to be flexible in the approaches for obtaining assent; a single method of obtaining assent may not be appropriate for all potential subjects. The means of obtaining assent from children must not only be age-appropriate but also must be developmentally-appropriate for the proposed population. “Because the subject’s ability to understand is a function of intelligence, rationality, maturity and language, it is necessary to adapt the presentation of the information to the subject’s capacities. Investigators are responsible for ascertaining that the subject has comprehended the information. While there is always an obligation to ascertain that the information about risk to subjects is complete and adequately comprehended, when the risks are more serious, that obligation increases. Special provision may need to be made when comprehension is severely limited — for example, by conditions of immaturity or mental disability. Each class of subjects that one might consider as incompetent (e.g., infants and young children, mentally disabled patients, the terminally ill and the comatose) should be considered on its own terms. Even for these persons, however, respect requires giving them the opportunity to choose to the extent they are able, whether or not to participate in research.”2 The age ranges below apply to typically-developing children. Age of Child ParticipantWritten Assent FormParental Consent Form Toddler – 6 years oldNo – submit verbal script Yes School age 7 – 13Yes – age appropriate Yes Adolescent 14 -17Yes – similar to adult ICF Yes 18 and olderYes No Examples of Assent: Very young children: Researchers should give explanations that match the level of understanding for children below school age (toddlers, preschoolers). A simple oral request for assent is sufficient, and assent may be oral. The protocol must include the procedure for documenting a “yes” or “no” response. The verbal script is considered the assent form and must be submitted as part of the protocol. For example, the researcher might ask the child if he or she would join the researcher in the next room to look at pictures. If the child were to say “yes”, that would imply assent for this age group. If the child were to say “no”, the researcher should respect the child’s wishes. It should be possible, however, to ask the child once again several minutes later. Sometimes children may not communicate verbally their refusal to participate. For example, a child may begin working on another task unrelated to the research activity. The researcher should be aware of such a cue and end the activity. The researcher must use special care to discontinue the participation of any child who appears to experience undue stress from the research procedure. Sample Child Assent Script (ages 6 and younger) developed by Smith College IRB Sample Assent Script with documentation of yes/no response (ages 6 and younger) adapted from Northwestern University IRB Children ages 7-13: The request for assent should include: (1) a general description of the purpose of the child’s participation; (2) a brief description of the experimental tasks/participation; (3) an assurance that the child’s participation is voluntary and that he or she may withdraw from the study at any point; and (4) an offer to answer questions. A researcher studying reading comprehension might say the following: “I am studying how fourth grade students read. I am going to ask you to read a few stories for me and answer questions about the stories when you are finished. You don’t have to read if you do not want to do so. If at any point you want to stop, that is fine; you may stop and go back to class.” Written assent should be obtained. Assent Form Template developed by Seattle Children’s Hospital for children 7-13 years of age who can read Sample Child Assent Form developed by Cornell University IRB Sample Child Assent Form (ages 7-13) developed by Smith College IRB Adolescents ages 14 -17: The request for assent should include the elements of informed consent presented to adults, but presented in language appropriate to the child’s level of comprehension. Written assent should be obtained. ________________________ 1 Some of this material was developed by the Research Integrity Services staff, University of New Hampshire, and is used with permission. 2 The Belmont Report (1979). The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research. www.hhs.gov/ohrp/humansubjects/guidance/belmont.html What is the name of the process used to obtain a child's agreement for participation in a study?"Assent" means a child's affirmative agreement to participate in research; that is, to say "OK." Assent may be gained by talking with the child and supporting that talk with a written assent document (form NIH-2514-2) appropriate to the child's age and comprehension level.
What is the name of the process used to obtain a child's agreement for participation in a study quizlet?What is the name of the process used to obtain a child's agreement for participation in a study? Assent. A friend of yours has agreed to participate in a research study. However, she is upset that she has to contact the researcher to obtain a copy of the study results.
When children are participants in a research study?Thus, in most research studies, if children under the age of 18 are to be enrolled, the parent or guardian of the child must provide informed consent on behalf of the child. Following this “local law” satisfies 45 CFR 46 Subpart D -- Additional Protections for Children Involved as Subjects in Research (“Subpart D”).
What is consent form in research?The consent form provides potential research subjects sufficient written information to decide whether to participate in a research study or not based on an explanation of the proposed research and the nature of the participation that is requested of them.
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What is the name of the process used to obtain a childs agreement for participation in a study?
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