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Provides step-by-step formatting and readability requirements, including lay-language, second-person wording at an appropriate grade level, font and margin standards, page numbering format, and guidance on revising or removing instruction text and bracketed placeholders. Specifies required and suggested statement structures for the overview section, covering voluntariness, study purpose, duration, procedures, risks, benefits, and alternatives, and includes compliance notes for IRB submission.","Instructions for Completing the Consent Form Template\nJanuary 2019\nIMPORTANT - Please review the following as you prepare the consent form:\nDELETE this instruction page and all information in [brackets] from the template in the final document.  This information is meant only as a guide for researchers in preparation of the document.  Unless otherwise noted, through the use of required and suggested statements, the text within each section may be revised to be appropriate for your study.  The required and suggested statements are given in quotation marks to make it easier for you to locate where the statements begin and end.  Please DELETE all quotation marks when incorporating these statements.\nYou should select a font that is easy to read such as Times Roman , Arial, or Garamond and use a font size no smaller than 12 point. Make the font one color in the final document.  Separate large blocks of text into paragraphs. Text should line up along the margin.\nAvoid widows and orphans. A widow is generally a single line of a paragraph appearing at the top of a page and an orphan is generally a single line of a paragraph appearing at the bottom of a page.\nThe consent document must be written using lay language, at an 8th grade reading level (similar to the level used in popular magazines and newspapers) that is appropriate for the participant population.  A 5th grade reading level should be used as a benchmark for incarcerated participants.  It must also be written in the second person (e.g., you are invited to participate, you will be asked, etc.).  The IRB has tips on writing for lay audiences (https://www.kpwashingtonresearch.org/about-us/capabilities/research-communications/prism/) and Microsoft Word has a tool to assess readability.  DO NOT use language copied from the protocol or a grant proposal . Avoid technical jargon. The form should be written as if the investigator and participant are engaged in conversation.\nThe use of bulleted lists and/or tables may be helpful to explain study procedures, timelines, inclusion/exclusion criteria, etc.\nAll pages must leave 1 inch margins on all sides to allow for sufficient white space and space for the IRB electronic validation.\nConsent form pages must be numbered and should follow the following format “page X of X.”  When amending the consent form include the revision date in the footer.\nStudents may not be listed as Principal Investigator.\nWhen appropriate, write the full name of the study sponsor (e.g. National Institutes of Health, National Institute of Mental Health).\nUnless otherwise noted all sections of the consent form (formatted as shown with proper headings) are required.  The format of the template is appropriate for most research studies.  If you feel that the format of the consent template would not be appropriate for your study, please explain why this is the case in the IRB-1 protocol application at the time of submission and submit an alternative version.\nIf you have questions concerning use of the template or need assistance preparing the consent form, please contact RCS at 6-8802.\n\u000fConsent Form for Participation in a Research Study\nPrincipal Investigator:\nStudent Researcher: [Remove if n/a]\nStudy Title:\nSponsor: [Remove if n/a]\nOverview of the Research\n[Investigators are responsible for developing/providing this overview section which must include a concise and focused presentation of the key information that is most likely to assist a prospective participant or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the consent must be organized and presented in a way that facilitates comprehension. In general this section should include concise statements that touch on the following: 1) that consent is being sought for research and participation is voluntary 2) the purpose of research, expected duration of participation and procedures to be followed 3) reasonable foreseeable risks o","cbCaiez49fPKuNHn","https://ap.wps.com/l/cbCaiez49fPKuNHn","docx",60447,10,"English","en",105,"# Instructions for Completing the Consent Form Template\n## Formatting and readability requirements\n## Writing language and wording guidance\n## Required structure for the consent overview\n## Consent form page and compliance notes\n## Consent Form for Participation in a Research Study\n## Overview of the Research","[{\"question\":\"What should be removed from the consent form template before final submission?\",\"answer\":\"Delete the instruction page and all information in brackets from the template in the final document. When incorporating required statements, remove the quotation marks.\"},{\"question\":\"What language and reading-level requirements apply to the consent form?\",\"answer\":\"Write using lay language appropriate to the participant population at an 8th grade reading level, with a 5th grade benchmark for incarcerated participants. Use second-person wording and avoid technical jargon copied from the protocol or grant proposal.\"},{\"question\":\"What elements must the “Overview of the Research” section include?\",\"answer\":\"It must cover voluntariness of participation, the purpose of the research, expected duration, and procedures, along with foreseeable risks and potential benefits. It should also describe appropriate alternatives or courses of treatment, if any.\"}]","Consent Form Template - Informed Consent | DOCX",1788173815,4,{"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":86,"head_meta":88,"extra_data":90,"updated_unix":28},"consent-form-template-informed-consent","",{"@graph":36,"@context":85},[37,53,68],{"@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":29},"https://docshare.wps.com/template/consent-form-template-informed-consent/165584/",{"url":52,"name":14,"@type":54,"author":55,"headline":14,"publisher":57,"fileFormat":60,"inLanguage":23,"description":15,"dateModified":61,"datePublished":62,"encodingFormat":60,"isAccessibleForFree":63,"interactionStatistic":64},"DigitalDocument",{"name":9,"@type":56},"Person",{"url":41,"name":58,"@type":59},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-09-02","2026-08-31",true,{"@type":65,"interactionType":66,"userInteractionCount":50},"InteractionCounter",{"@type":67},"ViewAction",{"@type":69,"mainEntity":70},"FAQPage",[71,77,81],{"name":72,"@type":73,"acceptedAnswer":74},"What should be removed from the consent form template before final submission?","Question",{"text":75,"@type":76},"Delete the instruction page and all information in brackets from the template in the final document. When incorporating required statements, remove the quotation marks.","Answer",{"name":78,"@type":73,"acceptedAnswer":79},"What language and reading-level requirements apply to the consent form?",{"text":80,"@type":76},"Write using lay language appropriate to the participant population at an 8th grade reading level, with a 5th grade benchmark for incarcerated participants. Use second-person wording and avoid technical jargon copied from the protocol or grant proposal.",{"name":82,"@type":73,"acceptedAnswer":83},"What elements must the “Overview of the Research” section include?",{"text":84,"@type":76},"It must cover voluntariness of participation, the purpose of the research, expected duration, and procedures, along with foreseeable risks and potential benefits. 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