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Provides investigator guidance on plain-language explanation, voluntary participation, ability to stop at any time, potential risks without minimizing them, confidentiality of study records, and possible benefits to the participant or society. 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Example language is included in this template, but the investigator should write this form in a way that best facilitates understanding for their participant population.\nAssent is not Consent, which means the federal regulations do not require all of the elements of consent be included in the form.\nIt is acceptable to use pictures along with the text in this assent form.\nPlease refer to the Children in Research FAQ page on the HRPP website for additional information and guidance.\nBelow are the answers to some of the questions you may have.  If you have any questions, please ask.  You will be given a copy of this assent form.\nWho are we and what are we doing?\nExample: We are [ex: doctors, researchers] and we want to tell you about a research study we are doing. A research study is a way to learn information about something. We would like to find out more about [insert purpose of study in simple language].  We want you to be in the study because [insert name of medical condition or other reasons for inclusion].\nWhat will we do and how long will it take?\nDescribe the procedures and the duration of participation. Describe what will take place in a language that is both appropriate to the assenting individual’s maturity and age or comprehension.\nExample: If you decide to be in this research study and your [insert “parent or guardian” for children or “legally authorized representative” for adults with impaired decision-making capacity] agrees, this is what will happen [insert simplified explanation of study procedures].\nThese are prompts that you can choose to include, if applicable:\n•\tWe will [insert procedure(s) the study team will do].\n•\tWe will ask you to [insert procedure(s) the study team will ask the participant to do].\n•\tYou will be in the study for [insert amount of time].\nDo you have to be in this research study and can you stop if you want to?\nExplain that the study is voluntary.\nExample: You do not have to be in this study if you don’t want to. Being in this study is up to you. No one will be upset if you don’t want to do it. You can take your time to decide. You can talk to your [insert “parent or guardian” for children or “legally authorized representative” for adults with impaired decision-making capability] before you decide. Even if you say yes now, you can change your mind later and tell us you want to stop.\nWill any part of this study hurt you?\nDescribe any risks to the assenting individual that may result from participation in the research. Risks should be explained in a language understandable to the assenting individual. However, the investigator should not minimize the actual risk by using simple language. For example, a bone marrow aspiration should not be described as a “poke”.\nExample: There is a chance that during this research study you could feel afraid, uncomfortable, or hurt.\nExample (additional text if applicable):\n•\tYou could [insert risk, e.g. get a bruise, get an upset stomach, throw up, feel dizzy, etc.].\n•\tThe questions we ask might make you feel [insert risk, e.g. embarrassed, sad, uncomfortable, etc.].\n•\tThe [insert procedure] may hurt.\nWe will try to help you feel better if any of this happens. You can stop at any time if you want to.\nWill anyone know that you are in this research study?\nExplain how the records will be kept confidential.\nExample: People doing this research will be able to see the information about you from this research study. We will talk about this information with you, your doctors, and your parents.\nOptional Language For instances where ","cbCair7JmGgBtzKP","https://ap.wps.com/l/cbCair7JmGgBtzKP","docx",37934,"English","# Guidance for investigator\n## Who are we and what are we doing?\n## What will we do and how long will it take?\n## Do you have to be in this research study and can you stop if you want to?\n## Will any part of this study hurt you?\n## Will anyone know that you are in this research study?\n## How will this research help you or other people?\n## What if you have questions?\n## Date and signatures","[{\"question\":\"Is assent the same as consent in this template?\",\"answer\":\"No. Assent is not Consent, so federal regulations do not require all consent elements to be included in the form.\"},{\"question\":\"How should the investigator explain procedures and study duration?\",\"answer\":\"The procedures and duration should be described in language appropriate to the assenting individual’s maturity, age, and comprehension, using simplified explanations.\"},{\"question\":\"What should be communicated about risks and confidentiality?\",\"answer\":\"Any risks should be explained in understandable language without minimizing the real risk. The form should also explain how records will be kept confidential and who may access the information.\"}]","7-12% Assent Form Template | DOCX",1788325227]