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Provides guidance to help study participants understand study purpose, eligibility, procedures, expected time commitment, and key risks and potential benefits. Includes required “Key Information” wording for certain federally funded studies, emphasizes that participation is voluntary and not a substitute for regular medical care, and outlines how questions and withdrawals are handled.",{"@graph":63,"@context":111},[64,80,102],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":36,"@type":70,"position":76},"https://docshare.wps.com/template/forms/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/ochsner-clinic-foundation-research-informed-consent-eirb-v-201905/175519/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/ochsner-clinic-foundation-research-informed-consent-eirb-v-201905/175519.png","ImageObject",442,249,{"name":88,"@type":89},"Ivy","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-10-23","2026-09-02",true,{"@type":98,"interactionType":99,"userInteractionCount":101},"InteractionCounter",{"@type":100},"ViewAction",10,{"@type":103,"mainEntity":104},"FAQPage",[105],{"name":106,"@type":107,"acceptedAnswer":108},"What should participants do if they want to leave the study after enrolling?","Question",{"text":109,"@type":110},"Participants may leave at any time if they change their mind and are encouraged to review the rest of the document and ask the study team any questions before agreeing.","Answer","https://schema.org",{"og:url":78,"og:type":113,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":115,"canonical":78},"index,follow",{"doc_id":117,"site_id":56},175519,1790190715,{"code":4,"msg":5,"data":120},{"doc_id":117,"user_id":121,"nickname":88,"user_avatar":122,"doc_module":9,"category_id":35,"category_name":36,"doc_title":59,"doc_description":61,"doc_content":123,"file_id":124,"file_url":125,"file_type":126,"file_size":127,"view_count":101,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":20,"language":128,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":129,"faqs":130,"seo_title":131,"seo_description":61,"update_tm":132,"read_time":47},549758252649,"https://ap-avatar.wpscdn.com/avatar/8000253669c5317157?_k=1778319167496531819","OCHSNER CLINIC FOUNDATION\nRESEARCH INFORMED CONSENT\nINSERT THE NAME OF YOUR STUDY HERE – as it appears on the protocol\nPrincipal Investigator: PI Name Here\nContact Information: Include mailing address and phone #\nAlternate Study Contact: Name Here and 2nd phone #\nSponsor’s Protocol # as entered in eIRB\nSponsor name: if internally funded, enter Ochsner\nYou have been invited to participate in a research study. The doctors and staff at Ochsner study the nature of disease and attempt to improve methods of diagnosis and treatment.  This is called clinical research.  Understanding this study’s risks and benefits will allow you to make an informed judgment about whether to be part of it.  This process is called informed consent.\nThis consent form may contain words that you do not understand.  Please ask the study doctor or the study staff to explain any words or information that you do not clearly understand.  You may take home an unsigned copy of this consent form to think about or discuss with family or friends before making your decision.\nParticipating in a research study is not the same as getting regular medical care.  The purpose of regular medical care is to improve your health.  The purpose of a research study is to gather information.  Being in this study does not replace your regular medical care.\n[if needed: In this consent form, “you” always refers to the subject.  If you are a legally authorized representative, please remember that “you” refers to the study subject.\nKEY INFORMATION\nThis section is required for federally funded studies. It is optional for non-funded studies or studies regulated by the FDA or the Department of Justice. This section must be brief and in lay-person language. The IRB staff will return for revision if these instructions are not followed.\nThe following is a short summary of this study to help you decide whether you should participate. More detailed information is listed later in this document.\nWhy is this research being done and why am I being invited to take part?\nYou are being invited to take part in a research study because\nFill in study specific details. Fill in the circumstance or condition that makes subjects eligible for the research.\nWhat should I know about being in a research study?\nSomeone will explain this research study to you.\nWhether or not you take part is up to you.\nYou can choose not to take part.\nYou can agree to take part and later change your mind.\nYour decision will not be held against you.\nYou may discuss whether to participate with family, friends and/or your doctor\nYou can ask any questions before making a decision.\nHow long will I take part in this research?\nOutline the expected time commitment to complete the study including the length of time and approximate number of study visits, e.g., “It will take you about 14 months to complete the study. During this time, you will be asked to make 14 study visits\nWhat will I be asked to do in this study?\nProvide a limited number of bullet points with a high-level summary of the procedures that will be done, e.g.,\nYou will be given an investigational drug.\nYou will be asked to come to the study clinic for 3 study visits.\nYou will give a total of 3 blood samples and fill out questionnaires\nMore detailed information about the study procedures can be found under the PROCEDURE section of this form.\nIs there any way this study could be bad for me?\nThere can be risks associated with joining any research study. The type of risk may impact whether you decide to join the study. For this study some of these risks may include\nIndicate reasonably foreseeable risks. This cannot be a list of all potential risks.\nThis is not a complete list of all potential risks. More detailed information about risks can be found under the RISKS section of this form.\nWill being in this study help me in any way?\nSelect one of the options below that describes the potential benefits for participants. Briefly summarize potential benefits\nThis study may offer some","cbCainbOF0ZLRn6N","https://ap.wps.com/l/cbCainbOF0ZLRn6N","docx",48109,"English","# Key Information\n## Voluntary participation and decision-making\n## Duration and number of participants\n# Detailed Information\n## Purpose\n## Length of study and number of participants\n## Procedure\n## Risks and benefits\n## Alternatives and withdrawal","[{\"question\":\"What should participants do if they want to leave the study after enrolling?\",\"answer\":\"Participants may leave at any time if they change their mind and are encouraged to review the rest of the document and ask the study team any questions before agreeing.\"}]","Ochsner Clinic Foundation - Research Informed Consent - eIRB v 2019.05 | DOCX",1788320543]