Federal Regulations for Research with Children: Parental Permission & Child Assent, Lecture notes of Law

Download Federal Regulations for Research with Children: Parental Permission & Child Assent and more Lecture notes Law in PDF only on Docsity! Research with Children - SBE University of Wisconsin - Madison - UW Social & Behavioral Course Switch View Courses Records CEUs Support Admin Content Author Lorna Hicks, MS, CIP Duke University Introduction Based on concerns for the welfare of children as research subjects, protections for children that exceed those for adults were incorporated into the federal regulations for protecting research subjects. At the same time, regulators recognized that some research presents no more than minimal risk to children and allowed for exibility in the parental permission and child assent processes. This module will describe both the required additional protections and the options for exible application of the federal regulations. In addition, it includes a case study about a waiver of parental permission for children to participate in research. Learning Objectives By the end of this module, you should be able to: Know how the federal regulations dene "children." Identify the federal regulations for protecting research subjects that apply to research with children. Describe when research with children may be exempt from the federal regulations and when it may be expedited. Outline the parental permission and child assent processes. Apply the criteria for waivers of parental permission and child assent. Describe the requirements for documenting parental permission and child assent. Defining Children According to the federal regulations, children are persons who have not yet attained f Research with Children - SBE EMILY PUTMAN-BUEHLER ID 5968303 the legal age of consent under the applicable laws in the setting in which the research will take place (Protection of Human Subjects 2018). Generally, though not always, the age of consent is the age at which minors reach the age of majority and are considered adults. In the U.S., state law dictates the age of majority. In most, but not all states, the age of majority is 18. This means that a 17-year-old may be considered a child when applying the federal regulations for protecting research subjects. In Alabama and Nebraska, the age of majority is 19 and in Mississippi it is 21. Some states have a legal process of emancipation that confers adult status on those who are younger than the age of majority. The conditions under which children may be released from parental authority vary by state. In some states, emancipated minors may have the legal authority to provide permission for their own children to become research subjects, but may not be able to consent for themselves unless an Institutional Review Board (IRB) waives the requirement for parental permission. The age of majority may be quite dierent in other countries. It also is possible that a country may have no legal denition of "majority." In such cases, researchers have to rely on community standards and practices to determine whether subjects are considered children or adults. Regulations That Apply to Research with Children There may be many layers of regulations and policies when children are involved as subjects in research, including federal regulations, state and local law, and institutional policies. 1. The basic federal regulations for protecting research subjects, known as the Common Rule (45 CFR 46, Subpart A), have been adopted by numerous federal agencies and departments. 2. The provisions of Subpart D, of the HHS regulations, "Additional Protections for Children Involved as Subjects in Research." The provisions of Subpart D must be applied to all research funded by U.S. Department of Health and Human Services (HHS). However, some federal agencies have agreed to apply the provisions of the Common Rule to research with human subjects, but not the provisions of Subpart D. In that case, institutional policies will they become distressed. At the other end of the continuum are older adolescents who are capable of both making a decision and actively assenting or dissenting to participate in research. No guidelines can replace a researcher's knowledge about the children to be recruited for a study. Researchers should be prepared to support their proposed assent process either with data or experience-based evidence, particularly if the children involved have vulnerabilities other than their youth, or live in a country, community, or society unfamiliar to the IRB. Child Assent Federal regulations specify what kinds of information should be included in an adult consent process. Subpart D notes that the same kinds of information should be provided to parents when asking them to provide permission for their children to be research subjects. However, there are no regulations about the content of the child assent process. A number of factors should be considered when developing child assent processes, including the proposed research activity and the age and maturity of the children involved. When research activities involve adolescents, whose capacity to understand resembles that of adults, the assent procedure should be similar to informed consent procedures designed for adults. If children's age and maturity level limit their ability to fully comprehend the nature of the research activity, but they are still capable of being consulted about participation in research, the assent procedure should reect a reasonable eort to enable the child to understand, to the degree they are capable, what their participation in research would involve. If a study involves children of dierent ages, appropriate assent processes need to be developed for each age group. Cultural Differences Researchers may need to take into account the nationality, ethnicity, and socioeconomic status of their potential subjects in order to design appropriate parental permission and child assent processes. Cultural assumptions about the rights of children vary widely. In some countries or subgroups, it may be inappropriate and perhaps oensive to ask children to make research-related decisions. Longitudinal Studies In order to respect the emerging maturity and autonomy of children and adolescents in longitudinal studies, some researchers advocate revising the child assent process as the child grows older, providing more detail about the study, and rearming assent. Once children reach the age of majority they may sign a consent form for adults. Risk Level, Parental Permission, and Child Assent As the risk level of the research increases, Subpart D has increasing requirements for parental permission and child assent. Categorizing Risk Level Subpart D divides research with children into four categories of risk and related benets. Each category carries specic review requirements, as well as parental permission and child assent requirements. As levels of risk increase and benets to individual children decrease, review criteria become more stringent, and the requirements for permission and assent increase. Most research in the social, behavioral, and educational sciences will fall in two of the four categories: The rst is research with no more than minimal risk (46.404) The second is research with more than minimal risk that has the prospect of directly beneting the children, provided the risk is justied in relation to the anticipated benets (46.405) The requirements for parental permission and child assent are the same for both categories: the permission of one parent and assent of the child, as appropriate. The denition of minimal risk for children is the same as the denition for adults. Minimal Risk: The probability and magnitude of harm or discomfort are not greater in and of themselves than those ordinarily encountered in the daily life or during the performance of routine physical or psychological examinations or tests (Protection of Human Subjects 2018) “Daily life” refers to the daily life of normal children. The remaining two categories (46.406 and 46.407) are relevant for health-related research with greater than minimal risk and no prospect of direct benet to the children and, nally, research that is not otherwise approvable, but may provide an opportunity to understand, prevent, or alleviate a serious problem aecting the health f f or welfare of children. Wards When the research includes children who are wards of the state or any other institution or entity, there are additional considerations required by HHS regulations. Pursuant to 46.409, before wards can be included in research that is greater than minimal risk and approved by an IRB pursuant to 46.406 or 407 (and referred to the Secretary of HHS if under 407), it must meet the following conditions: The research must be either related to the children's status as wards; or conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as subjects are not wards. The IRB must require appointment of an advocate for each child who is a ward, in addition to any other individual acting on behalf of the child as guardian or in loco parentis. State laws and institutional policies may dictate additional protections for wards as well. Documentation of Parental Permission and Child Assent There are documentation requirements when obtaining parental permission and child assent. Child Assent IRBs have the authority to determine the appropriate manner, if any, of documenting child assent. Based on such considerations as the child's age, maturity, and degree of literacy, the IRB should decide what form of documentation, if any, is most appropriate. If adolescents are involved in research where a consent form would have been used if the subjects were adults, it generally would be appropriate to use a similar form to document an adolescent's assent. If young children are involved who are as yet unable to read, documentation should take a form that is appropriate for the purpose of recording that assent took place. Parent or Guardian Permission Documentation of parental or guardian permission for children to become research subjects is required unless waived by an IRB in accordance with the regulations. Waivers of the requirement to document parental or guardian permission may be approved by an IRB in accordance with the same regulations that govern waivers of the requirement to document adult consent. Therefore, such waivers may be permitted under the following three conditions: The documentation of consent (informed consent form) is the only record linking the child to the research, and the principal risk would be potential harm resulting from a breach of condentiality. If subjects wish to have a signed consent form, their wishes will govern. The research presents no more than minimal risk of harm and involves no f