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Children are considered a vulnerable research population because their intellectual and emotional capacities are limited. They are legally incompetent to give valid informed consent. Investigators interested in enrolling children are required to complete the assocaited questions in the Cayuse IRB submission.
Informed consent is one of the founding principles of research ethics. Its intent is that human participants can enter research freely (voluntarily) with full information about what it means for them to take part, and that they give consent before they enter the research.
Considerations in preparing the informed consent document: Elements of consent present. Complete explanations. Lay language. Protection of confidentiality. No unproven claims of effectiveness. Device studies include a statement that the study includes an evaluation of the safety of the test article.
Include in the consent or parental notification under What you will do/ What your child will do a statement that the teacher/ child will be recorded and for what purpose. You may also need to explain what you will do if a child isnt participating in the study but may be part of the recording.
I have had the opportunity to ask questions about this research and I have received satisfactory answers. I understand the general purposes, risks and methods of this research. I consent to participate in the research project and the following has been explained to me: the research may not be of direct benefit to me.
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Informed consent provides participants with sufficiently detailed information on the study so they can make an informed, voluntary and rational decision to participate. Several specifics are to be divulged to the participants prior to the experiment even starting.
I have had the opportunity to ask questions about this research and I have received satisfactory answers. I understand the general purposes, risks and methods of this research. I consent to participate in the research project and the following has been explained to me: the research may not be of direct benefit to me.
Valid informed consent for research must include three major elements: (1) disclosure of information, (2) competency of the patient (or surrogate) to make a decision, and (3) voluntary nature of the decision. US federal regulations require a full, detailed explanation of the study and its potential risks.

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