Assent means a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.
Assent means a child’s affirmative agreement to participate in research. Mere failure to object should not, ab- sent affirmative agreement, be con- strued as assent.
Assent means 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).
Examples of Assent in a sentence
This Act comes into operation on the day on which it receives the Royal Assent 1.
This Act comes into operation on the day on which it receives the Royal Assent.
This Act commences on the day on which this Act receives the Royal Assent.
This Act shall come into operation on the day on which it receives the Royal Assent 1.
Assent uses numerous factors to determine the level of risk that each smelter poses to the supply chain by identifying red flags.
More Definitions of Assent
Assent means a signed statement of affected producers or handlers consenting to the terms of a marketing agreement.
Assent means a child’s affirmative agreement to participate in a clinical investigation. Mere failure to object should not, absent affirmative agree- ment, be construed as assent.
Assent when used in this Chapter means a process by which a provider of medical services helps the patient achieve a developmentally appropriate awareness of the nature of his or her condition; informs the patient of what can be expected with tests and treatment; makes a clinical assessment of the patient’s understanding of the situation and the factors influencing how he or she is responding; and solicits an expression of the patient’s willingness to accept the proposed care.
Assent means the expression of approval or agreement.
Assent means a minor’s affirmative agreement to participate in research. Mere failure to object should not be interpreted as assent.
Assent means a child’s affirmative agreement to take part in a clinical investigation, not just the failure to object. (21 CFR 50.3(n).) Child assent, when appropriate, and parental (or guardian) permission taken together meet the ethical requirement to obtain informed consent. Absent a waiver of the assent requirement (21 CFR 50.55(d)), the IRB must determine that there are adequate provisions for soliciting the assent of children when, in the IRB’s judgment, the children are capable of providing assent. (21 CFR 50.55(a).) In deciding whether children are capable of providing assent, the IRB must consider the ages, maturity, and psychological state of the children to be involved in the clinical investigation.62 (21 CFR 50.55(b).) A child does not need to fully understand the clinical investigation in order to provide assent provided the child is capable of understanding the interventions and the related procedures. For a complex clinical trial, a child may be able to understand and provide assent if he/she appreciates and agrees to the interventions and/or procedures in the trial (e.g., drawing a blood sample for a test), even though he/she may not be capable of understanding a randomized clinical trial.
Assent means a child’s affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent. In other words, the child must actively show his or her willingness to participate in the research, rather than just complying with directions to participate and not resisting in any way. The IRB has the discretion to judge children’s capacity to assent for all of the children to be involved in a proposed research activity, or on an individual basis.