module 10

Child Assent

IRBs have the authority to determine the appropriate way of documenting child assent. Based on the child's age, maturity, and degree of literacy, For adolescents 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.

The General Process

1. parents (or legal guardians) provide permission for their children (or wards) to participate 2.the researcher contacts the children. 3.Children then provide their assent(affirmative agreement to participate) to become subjects. dissent does not equal assent. 3. parental permission can only override a child's dissent when the health of the child is at stake. 4. No guidelines can replace a researcher's knowledge about the children to be recruited for a study. 5.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.

Wards must meet the following conditions:

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 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.(in the place of a parent) State laws and institutional policies may dictate additional protections for wards as well.

Parent or Guardian Permission Waiver.

Documentation of parental or guardian permission for children to become research subjects is required unless waived 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 confidentiality. 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 procedures for which consent is normally required outside the research environment. If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects, and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained. When waived, the IRB may require the researcher to present each subject (or parent or guardian) with a written statement regarding the research.

Parental Permission and Child Assent

Parental permission is generally required when children participate in research as subjects.

Limitations for Category 2 research subject to Subpart D include:

Research activities are limited to educational tests and observation of public behavior If the research involves observation of public behavior, the researcher does not participate in the activities being observed Research approved with a limited IRB review under part (iii) of Category 2 (which involves recording information in such a manner that the identity of the subjects can be readily ascertained) is not permitted

Limitations for Category 3

Research involving benign behavioral interventions , in conjunction with the collection of information, cannot be exempt for children as it is applicable only for adult subjects.

Regulations That Apply to Research with Children

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. The provisions of Subpart D, of the HHS regulations, "Additional Protections for Children Involved as Subjects in Research." State and local law, and institutional policy, as applicable. For example, provisions for waiving parental permission for neglected or abused children cannot violate federal, state, or local law.

An IRB may waive the requirement to secure child assent if either:

The capability of some or all of the children is so limited that they cannot reasonably be consulted. 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. The IRB may also waive the assent requirement if the research meets the same criteria as for waivers of informed consent 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 "Daily life" refers to the daily life of normal children.

Expedited Review When Children Are Subjects

an option when the research activities pose no more than minimal risk to subjects and fall within one or more of the explicitly defined categories of activity. exception of limits on the amount and frequency of blood that may be drawn from children, there are no regulatory restrictions on using the expedited review process when children (minors) are subjects.

factors should be considered when developing child assent processes

include the proposed research activity and the age and maturity of the children involved. research activities involving 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 reflect a reasonable effort 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 different ages, appropriate assent processes need to be developed for each age group.

ends of the continuum

infants and toddlers, are not capable of making a decision about whether to participate, although they may communicate their dissent if they become distressed. are older adolescents who are capable of both making a decision and actively assenting or dissenting to participate in research.

Cultural Differences

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 offensive to ask children to make research-related decisions.

Exempt Category 2 parts (i) (ii)and (iii)

only apply for research involving educational tests or observation of public behavior when the investigator does not participate in the activities being observed. Exempt Category 2 part (iii) may not be applied to research subject to Subpart D, nor may Exempt Category 3 (research involving benign behavioral interventions with adults).

two categories (46.406 and 46.407)

relevant for health-related research with greater than minimal risk and no prospect of direct benefit to the children research that is not otherwise approvable, but may provide an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.

Longitudinal Studies

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 reaffirming assent. Once children reach the age of majority they may sign a consent form for adults.

True or false The provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research apply to: all research funded by HHS

true

True or false Federal regulations do not require the documentation of minors' assent.

true

Which categories does most research in the social, behavioral, and educational sciences will fall in

two of the four categories: The first 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 benefiting the children, provided the risk is justified in relation to the anticipated benefits (46.405)