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S in writing informed consent documents. Use of the templates will generally ensure that all informed consent document requirements are met. However, these templates will not work for all situations. Contact the IRB Coordinator if you wish to significantly alter or modify the informed consent documents. Formatting using the templates provided on the WSU IRB website: Delete all red font italicized instructions before finishing your form. Also delete any sections or information that is not re.
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NYU FAQ
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Consent to Participate I have been encouraged to ask questions and all of my questions have been answered to my satisfaction. I have also been informed that I can withdraw from the study at any time. By signing this form, I voluntarily agree to participate in this study.
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Generally, a consent form should outline all the terms of the agreement and should excuse you from any liability in the instance of harm, injury, or damages. It should outline the risks the child might be exposed to during the activity and allow the parent or guardian to provide their permission via signature.
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The consent form must include: A statement that the study involves research. ... Purpose of the research. ... Procedures. ... Risks or discomforts to the subject. ... Benefits of the research to the subject. ... Treatment Alternatives. ... Costs of Participation. ... Confidentiality.
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The consent form should describe if/when identifiable data will be destroyed and how such data will be protected and how it will be used or shared. Language - Consent forms should be written in the 2nd person (i.e., "you are") and in a language that is clear, concise, and understandable to the subject population.
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What is the difference between consent and assent? Consent may only be given by individuals who have reached the legal age of consent (in the U.S. this is typically 18 years old). Assent is the agreement of someone not able to give legal consent to participate in the activity.
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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.
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A parental consent form should include the name and age of the child, the name and contact information of the parent or legal guardian, the name and contact information of an emergency contact, and a clear description of the activity or event.
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The consent form must include: A statement that the study involves research. ... Purpose of the research. ... Procedures. ... Risks or discomforts to the subject. ... Benefits of the research to the subject. ... Treatment Alternatives. ... Costs of Participation. ... Confidentiality.
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