Please note that if a waiver of assent is requested and approved by the IRB, the IRB may request that an informational sheet explaining what will happen during the study in language appropriate for the subject population be provided to each child.
New study submissions/A Blanket Waiver of Assent:
A waiver of assent can be requested in Section III of the Request form for the Inclusion of Children in Research Form. It is important to provide as much detail as possible when explaining why obtaining assent from that subject population is not reasonable. Please note that “because the information may scare the subject” is not justification for requesting a waiver of assent.
If you are working on a study and it is thought that a potential subject is not capable of providing assent, a justification for why that particular subject is not capable of assent can be made. The request should be submitted as an amendment to the Board. Detail regarding the specific circumstances and why it is thought that the subject cannot provide assent should be provided. Additionally, the Board may request the PI provide an informational sheet detailing what will happen during the study in language appropriate for the subject population.
If you encounter an situation where one a potential subject is not capable of providing assent, please contact our office for further guidance.
Guidelines for a Waiver of Assent [Also see the Obtaining and Documenting Informed Consent SOP]:
The IRB may approve a waiver of assent in the following circumstances:
• The intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research.
- It should be noted that, in such circumstances, a child’s dissent which should normally be respected, may be overruled by the child’s parents at the IRB’s discretion. When research involves the provision of experimental therapies for life-threatening diseases such as cancer, however, the IRB should be sensitive to the fact that parents may wish to try anything, even when the likelihood of success is marginal and the probability of extreme discomfort is high. Should the child not wish to undertake such experimental therapy, difficult decisions may have to be made. In general, if the child is a mature adolescent and death is imminent, the child’s wishes should be respected.
• The research meets the required criteria for a waiver of consent stated in 45 CFR 46.116(d)(1-4) and 21 CFR 50.55(d).
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