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Provides placeholders to describe the study purpose, how participants are identified, who conducts and funds the research, expected participant numbers, and procedures including frequency, duration, study groups, and any usual-care elements. Includes guidance for communicating investigational drugs/devices, explaining research-only test purpose, and addressing whether and how clinically relevant results will be shared with participants or health care providers.","Indiana University Informed Consent Statement [and Authorization] for Research\n[Insert Protocol Title]\n[Insert IRB Protocol Number]\n[Insert Sponsor Name and Sponsor Protocol Number, if applicable]\nYou are being asked to participate in a research study. This consent [and Authorization] form will give you information about this study to help you decide whether you want to participate. It is your choice whether or not you want to be in this research study. Please read this form, and ask any questions you have, before agreeing to be in this study.\nImportant Things to Know:\n[Write a concise and focused summary of the key information most likely to assist a subject in understanding why they may or may not want to participate in the study. If consent is concise as written (no more than a few pages), this section is not required and you can instead start with the Why Is This Study Being Done section.\nBe creative with format and language. Consider including bulleted lists, pictures, icons, or flowcharts to describe your study.\nAvoid large paragraphs of text. Additional guidance about the concise presentation is available at \u0013 HYPERLINK \"https://research.iu.edu/compliance/human-subjects/guidance/informed-consent.html\" \u0014https://research.iu.edu/compliance/human-subjects/guidance/informed-consent.html\u0015.]\nPlease review the rest of this document for more details about this study and the things you should know before deciding whether to participate.\nWhy is This Study Being Done?\n[Insert explanation for why the research is being done. Use language understandable to the subject (i.e., eighth grade level).]\n[If the study involves the use of an investigational drug or device, explain that “investigational” means it is not approved by the Food and Drug Administration (FDA).]\nWe are asking you if you want to be in this study because [Insert explanation regarding how and/or why the subject was identified].\nThe study is being conducted by [Insert investigator(s) name(s) and University/Departmental affiliation]. It is funded by [Insert Sponsor name, if any, and include if the Sponsor is also the manufacturer of the drug/device being studied, if applicable].\nHow Many People Will Be in the Study?\n[This section is only required for greater than minimal risk research. Otherwise, this section can be deleted.]\nYou will be one of [Insert number] participants taking part in this study. [For multi-center studies, include both the local and multi-site number of subjects.]\nWhat Will Happen During the Study?\n[Insert explanation of all procedures/tests that are included in the study using language understandable to the subject (i.e., eighth grade level). This should include, when applicable, randomization, assignment to study groups, study visits, administration of study medications, x-rays or imaging, blood draws, collection of information from medical records, surveys and questionnaires, audio or video recordings, and all other study procedures.\nFor each procedure, explain:\nWhere the procedures are performed\nHow frequently they are performed\nThe expected amount of time each procedure and/or visit will last\nIf applicable, whether the procedure is part of usual care for patients\nFor measurements, such as blood draws, translate the amount to common measurement terms (e.g., teaspoons or cups; note that 5 ml = 1 teaspoon, 15 ml = 1 tablespoon)\nInclude the total duration of subject participation, e.g., You will be in this study for about two years.]\n[If clinically relevant results will be generated by the research but will NOT be given to subjects]: We will not share the results of these tests or procedures with you because they are being done only for research purposes.\n[If you will return research results to participants, carefully customize the following language to align with your plan for returning results. See the IU HRPP Guidance on \u0013 HYPERLINK \"https://research.iu.edu/compliance/human-subjects/guidance/returning-research-results.html\" \u0014Returning Research Resul","cbCaiibYEnzqvT1Z","https://ap.wps.com/l/cbCaiibYEnzqvT1Z","docx",62148,13,"English","en",105,"# Important Things to Know\n# Why Is This Study Being Done?\n# How Many People Will Be in the Study?\n# What Will Happen During the Study?","[{\"question\":\"What is the purpose of the informed consent [and Authorization] form?\",\"answer\":\"It provides information about the research study so you can decide whether to participate, and it explains your choices regarding participation. It is your decision whether or not to be in the study.\"},{\"question\":\"Why does the form ask you to review information about investigational drugs or devices?\",\"answer\":\"If the study uses an investigational drug or device, the form explains that “investigational” means it is not approved by the Food and Drug Administration (FDA).\"},{\"question\":\"Will you receive results from tests or procedures done for research?\",\"answer\":\"It depends on the study plan. The template includes language for cases where results are not shared because tests are for research only, and it also provides customizable options for sharing clinically relevant information with participants and/or health care providers.\"}]","Indiana University Informed Consent Statement - and Authorization - for Research | DOCX",1788186454,5,{"code":4,"msg":31,"data":32},"ok",{"site_id":24,"language":23,"slug":33,"title":14,"keywords":34,"description":15,"schema_data":35,"social_meta":87,"head_meta":89,"extra_data":91,"updated_unix":28},"indiana-university-informed-consent-statement-and-authorization-for-research","",{"@graph":36,"@context":86},[37,54,69],{"@type":38,"itemListElement":39},"BreadcrumbList",[40,44,48,51],{"item":41,"name":42,"@type":43,"position":11},"https://docshare.wps.com","Home","ListItem",{"item":45,"name":46,"@type":43,"position":47},"https://docshare.wps.com/template/","Template",2,{"item":49,"name":13,"@type":43,"position":50},"https://docshare.wps.com/template/forms/",3,{"item":52,"name":14,"@type":43,"position":53},"https://docshare.wps.com/template/indiana-university-informed-consent-statement-and-authorization-for-research/166204/",4,{"url":52,"name":14,"@type":55,"author":56,"headline":14,"publisher":58,"fileFormat":61,"inLanguage":23,"description":15,"dateModified":62,"datePublished":63,"encodingFormat":61,"isAccessibleForFree":64,"interactionStatistic":65},"DigitalDocument",{"name":9,"@type":57},"Person",{"url":41,"name":59,"@type":60},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-09-01","2026-08-31",true,{"@type":66,"interactionType":67,"userInteractionCount":11},"InteractionCounter",{"@type":68},"ViewAction",{"@type":70,"mainEntity":71},"FAQPage",[72,78,82],{"name":73,"@type":74,"acceptedAnswer":75},"What is the purpose of the informed consent [and Authorization] form?","Question",{"text":76,"@type":77},"It provides information about the research study so you can decide whether to participate, and it explains your choices regarding participation. It is your decision whether or not to be in the study.","Answer",{"name":79,"@type":74,"acceptedAnswer":80},"Why does the form ask you to review information about investigational drugs or devices?",{"text":81,"@type":77},"If the study uses an investigational drug or device, the form explains that “investigational” means it is not approved by the Food and Drug Administration (FDA).",{"name":83,"@type":74,"acceptedAnswer":84},"Will you receive results from tests or procedures done for research?",{"text":85,"@type":77},"It depends on the study plan. 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