{"id":3625,"date":"2018-08-07T13:41:51","date_gmt":"2018-08-07T17:41:51","guid":{"rendered":"https:\/\/www.bumc.bu.edu\/irb\/?page_id=3625"},"modified":"2025-12-10T14:32:19","modified_gmt":"2025-12-10T19:32:19","slug":"irb-templates","status":"publish","type":"page","link":"https:\/\/www.bumc.bu.edu\/irb\/inspir-ii\/irb-templates\/","title":{"rendered":"IRB Templates"},"content":{"rendered":"<p><strong><span style=\"text-decoration: underline;\"><\/span><\/strong><strong>Available IRB Templates:<\/strong><br \/>\n<em>Click on any of the Template group headers below to expand\/collapse the group.<\/em> <\/p>\n<ul>\n<li><em>To learn more about each displayed Template, click on the <span style=\"color: red;\"> <strong>[+\/-]<\/strong><\/span> icon<\/em><\/li>\n<li><em>To download a template, click the link in the Template title<\/em><\/li>\n<\/ul>\n<table cellspacing=\"10\" cellpadding=\"10\" width=\"100%\">\n<tbody>\n<tr align=\"left\" bgcolor=\"#f7f7f7\" width=\"100%\">\n<th width=\"100%\" scope=\"col\"><div class=\"bu_collapsible_container \" aria-live=\"polite\" data-customize-animation=\"false\"><h5 class=\"bu_collapsible\" aria-expanded=\"false\"tabindex=\"0\" role=\"button\">\u25bc\u25b2 &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Information Sheets for Exempt Research<\/h5><div class=\"bu_collapsible_section\" style=\"display: none;\"><\/p>\n<table class=\"table2\" cellspacing=\"10\" cellpadding=\"10\">\n<tbody>\n<tr align=\"left\" bgcolor=\"#cccccc\">\n<th width=\"100%\" scope=\"col\">Template Name<\/th>\n<\/tr>\n<tr bgcolor=\"#FEFFFD\">\n<td>\n<details open=\"\">\n<summary><a href=\"\/irb\/files\/2016\/10\/Exempt-Information-Sheet-Template.docx\"><img loading=\"lazy\" width=\"29\" height=\"24\" class=\"alignnone size-full wp-image-3666\" alt=\"\" src=\"\/irb\/files\/2018\/08\/word-icon-e1534169892123.jpg\" \/> Exempt Information Sheet Template<\/a><span style=\"color: red;\"> \u00a0<strong>[+\/-]<\/strong><\/span><\/summary>\n<p><em>Also called an \u201cabbreviated consent\u201d form. If the exempt research involves obtaining information through intervention or interaction with subjects, \u201cabbreviated consent\u201d must be obtained using this form. Another common use of this template is if you are doing Expedited or Full Board (non-exempt) research and are requesting an alteration of consent to use a shortened consent form.<\/em><\/p>\n<\/details>\n<\/td>\n<\/tr>\n<tr bgcolor=\"#FEFFFD\">\n<td>\n<details open=\"\">\n<summary><a href=\"\/irb\/files\/2025\/09\/Exempt-Information-Sheet-Template-SPN.docx\"><img loading=\"lazy\" width=\"29\" height=\"24\" class=\"alignnone size-full wp-image-3666\" alt=\"\" src=\"\/irb\/files\/2018\/08\/word-icon-e1534169892123.jpg\" \/> Exempt Information Sheet Template (Spanish)<\/a><span style=\"color: red;\"> \u00a0<strong>[+\/-]<\/strong><\/span><\/summary>\n<p><em>Spanish translation of the Exempt Information Sheet. While the template language is translated, you will still need to ensure that the study-specific language is translated by an appropriate translator. NOTE: The IRB does NOT need to review or approve translations done for Exempt studies.<\/em><\/p>\n<\/details>\n<\/td>\n<\/tr>\n<tr bgcolor=\"#FEFFFD\">\n<td>\n<details open=\"\">\n<summary><a href=\"\/irb\/files\/2020\/11\/Parent-Permission-Exempt-Information-Sheet.docx\"><img loading=\"lazy\" width=\"29\" height=\"24\" class=\"alignnone size-full wp-image-3666\" alt=\"\" src=\"\/irb\/files\/2018\/08\/word-icon-e1534169892123.jpg\" \/> Parent Permission Exempt Information Sheet<\/a><span style=\"color: red;\"> \u00a0<strong>[+\/-]<\/strong><\/span><\/summary>\n<p><em>Use this form when you need to obtain abbreviated consent from a parent in order to enroll their child into the research.<\/em><\/p>\n<\/details>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><\/div>\n<\/div>\n<\/th>\n<\/tr>\n<\/tbody>\n<\/table>\n<table cellspacing=\"10\" cellpadding=\"10\" width=\"100%\">\n<tbody>\n<tr align=\"left\" bgcolor=\"#f7f7f7\" width=\"100%\">\n<th width=\"100%\" scope=\"col\"><div class=\"bu_collapsible_container \" aria-live=\"polite\" data-customize-animation=\"false\"><h5 class=\"bu_collapsible\" aria-expanded=\"false\"tabindex=\"0\" role=\"button\">\u25bc\u25b2 &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Consent Forms for Expedited & Full Board (Non-Exempt) Research<\/h5><div class=\"bu_collapsible_section\" style=\"display: none;\"><\/p>\n<table class=\"table2\" cellspacing=\"10\" cellpadding=\"10\">\n<tbody>\n<tr align=\"left\" bgcolor=\"#cccccc\">\n<th width=\"85%\" scope=\"col\">Template Name<\/th>\n<\/tr>\n<tr bgcolor=\"#FEFFFD\">\n<td>\n<details open=\"\">\n<summary><a href=\"\/irb\/files\/2017\/03\/Adult-Consent-Form-Template.docx\"><img loading=\"lazy\" width=\"29\" height=\"24\" class=\"alignnone size-full wp-image-3666\" alt=\"\" src=\"\/irb\/files\/2018\/08\/word-icon-e1534169892123.jpg\" \/> Adult Consent Form Template<\/a><span style=\"color: red;\"> \u00a0<strong>[+\/-]<\/strong><\/span><\/summary>\n<p><em>Use this form with potential adult participants or their Legally Authorized Representative (LAR). This consent form may also be used for minors who can consent for themselves in specific situations (e.g., a pregnant minor who will make decisions for their own pregnancy\/baby).<\/em><\/p>\n<\/details>\n<\/td>\n<\/tr>\n<tr bgcolor=\"#FEFFFD\">\n<td>\n<details open=\"\">\n<summary><a href=\"\/irb\/files\/2025\/09\/Adult-Consent-Form-Template_SPN.docx\"><img loading=\"lazy\" width=\"29\" height=\"24\" class=\"alignnone size-full wp-image-3666\" alt=\"\" src=\"\/irb\/files\/2018\/08\/word-icon-e1534169892123.jpg\" \/> Adult Consent Form Template (Spanish)<\/a><span style=\"color: red;\"> \u00a0<strong>[+\/-]<\/strong><\/span><\/summary>\n<p><em>Spanish translation of the Adult Consent Form Template. While the template language is translated, you will still need to ensure that the study-specific language is translated by an appropriate translator. Submit to the IRB for approval along with an associated <a href=\"\/irb\/files\/2016\/12\/Translator-Qualifications-Form.doc\">Translator Qualifications Form.<\/a><\/em><\/p>\n<\/details>\n<\/td>\n<\/tr>\n<tr bgcolor=\"#FEFFFD\">\n<td>\n<details open=\"\">\n<summary><a href=\"\/irb\/files\/2016\/12\/Translator-Qualifications-Form.doc\"><img loading=\"lazy\" width=\"29\" height=\"24\" class=\"alignnone size-full wp-image-3666\" alt=\"\" src=\"\/irb\/files\/2018\/08\/word-icon-e1534169892123.jpg\" \/> Translator Qualifications Form<\/a><span style=\"color: red;\"> \u00a0<strong>[+\/-]<\/strong><\/span><\/summary>\n<p><em>Use to demonstrate to the IRB that your translations were done by a qualified individual. If the translation is performed by a third-party vendor, the IRB will accept an attestation\/certificate on company letterhead with the name of the document(s) translated and the date.<\/em><\/p>\n<\/details>\n<\/td>\n<\/tr>\n<tr bgcolor=\"#FEFFFD\">\n<td>\n<details open=\"\">\n<summary><a href=\"\/irb\/files\/2017\/03\/Parent-Permission-Form-Template.docx\"><img loading=\"lazy\" width=\"29\" height=\"24\" class=\"alignnone size-full wp-image-3666\" alt=\"\" src=\"\/irb\/files\/2018\/08\/word-icon-e1534169892123.jpg\" \/> Parent Permission Form Template<\/a><span style=\"color: red;\"> \u00a0<strong>[+\/-]<\/strong><\/span><\/summary>\n<p><em>Use this form when you need to obtain parental consent to enroll children into the research. Discuss the process for obtaining child assent in your IRB application, as appropriate.<\/em><\/p>\n<\/details>\n<\/td>\n<\/tr>\n<tr bgcolor=\"#FEFFFD\">\n<td>\n<details open=\"\">\n<summary><a href=\"\/irb\/files\/2017\/03\/Parent-Consent-and-Permission-Form-Template.docx\"><img loading=\"lazy\" width=\"29\" height=\"24\" class=\"alignnone size-full wp-image-3666\" alt=\"\" src=\"\/irb\/files\/2018\/08\/word-icon-e1534169892123.jpg\" \/> Parent Consent and Permission Form Template<\/a><span style=\"color: red;\"> \u00a0<strong>[+\/-]<\/strong><\/span><\/summary>\n<p><em>Use this form when you need to enroll both the parent(s) and the child(ren) into the research. Discuss the process for obtaining child assent in your IRB application, as appropriate.<\/em><\/p>\n<\/details>\n<\/td>\n<\/tr>\n<tr bgcolor=\"#FEFFFD\">\n<td>\n<details open=\"\">\n<summary><a href=\"\/irb\/files\/2017\/03\/Consent-to-Collect-Data-after-Withdrawal-Template.docx\"><img loading=\"lazy\" width=\"29\" height=\"24\" class=\"alignnone size-full wp-image-3666\" alt=\"\" src=\"\/irb\/files\/2018\/08\/word-icon-e1534169892123.jpg\" \/> Consent to Collect Data after Withdrawal Template<\/a><span style=\"color: red;\"> \u00a0<strong>[+\/-]<\/strong><\/span><\/summary>\n<p><em>Use this form if you\u2019d like to request to collect future health care data collected for clinical care for participants who otherwise withdraw from active participation on a study.<\/em><\/p>\n<\/details>\n<\/td>\n<tr bgcolor=\"#FEFFFD\">\n<td>\n<details open=\"\">\n<summary><a href=\"\/irb\/files\/2019\/02\/Adult-Authorization-Form-Template.docx\"><img loading=\"lazy\" width=\"29\" height=\"24\" class=\"alignnone size-full wp-image-3666\" alt=\"\" src=\"\/irb\/files\/2018\/08\/word-icon-e1534169892123.jpg\" \/>\u00a0Adult Authorization Form Template<\/a><span style=\"color: red;\"> \u00a0<strong>[+\/-]<\/strong><\/span><\/summary>\n<p><em>Only use if consent form lacks HIPAA authorization language (called \u201cUse and Sharing of Your Health Information\u201d). All templates above contain HIPAA Authorization language, but rarely some sponsors or studies prefer to have this in a separate form from the consent form.<\/em><\/p>\n<\/details>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><\/div>\n<\/div>\n<\/th>\n<\/tr>\n<\/tbody>\n<\/table>\n<table cellspacing=\"10\" cellpadding=\"10\" width=\"100%\">\n<tbody>\n<tr align=\"left\" bgcolor=\"#f7f7f7\" width=\"100%\">\n<th width=\"100%\" scope=\"col\"><div class=\"bu_collapsible_container \" aria-live=\"polite\" data-customize-animation=\"false\"><h5 class=\"bu_collapsible\" aria-expanded=\"false\"tabindex=\"0\" role=\"button\">\u25bc\u25b2 &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Screening Consent Forms <\/h5><div class=\"bu_collapsible_section\" style=\"display: none;\"><\/p>\n<table class=\"table2\" cellspacing=\"10\" cellpadding=\"10\">\n<tbody>\n<tr align=\"left\" bgcolor=\"#cccccc\">\n<th width=\"100%\" scope=\"col\">Template Name<\/th>\n<\/tr>\n<tr bgcolor=\"#FEFFFD\">\n<td>\n<details open=\"\">\n<summary><a href=\"\/irb\/files\/2016\/12\/Brief-Screening-Agreement.docx\"><img loading=\"lazy\" width=\"29\" height=\"24\" class=\"alignnone size-full wp-image-3666\" alt=\"\" src=\"\/irb\/files\/2018\/08\/word-icon-e1534169892123.jpg\" \/> Brief Screening Agreement<\/a><span style=\"color: red;\"> \u00a0<strong>[+\/-]<\/strong><\/span><\/summary>\n<p><em>Use this form if you need to ask eligibility screening questions prior to conducting the full consent process. Do not use this form (use the below \u201cScreening Questions Full Consent Template\u201d) if your screening procedures include clinical procedures (such as a blood draw).<\/em><\/p>\n<\/details>\n<\/td>\n<\/tr>\n<tr bgcolor=\"#FEFFFD\">\n<td>\n<details open=\"\">\n<summary><a href=\"\/irb\/files\/2017\/03\/Screening-Questions-Full-Consent-Template.docx\"><img loading=\"lazy\" width=\"29\" height=\"24\" class=\"alignnone size-full wp-image-3666\" alt=\"\" src=\"\/irb\/files\/2018\/08\/word-icon-e1534169892123.jpg\" \/> Screening Questions Full Consent Template<\/a><span style=\"color: red;\"> \u00a0<strong>[+\/-]<\/strong><\/span><\/summary>\n<p><em>Use this form if your screening procedures involve clinical procedures that occur prior to conducting the full consent process.<\/em><\/p>\n<\/details>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><\/div>\n<\/div>\n<\/th>\n<\/tr>\n<\/tbody>\n<\/table>\n<table cellspacing=\"10\" cellpadding=\"10\" width=\"100%\">\n<tbody>\n<tr align=\"left\" bgcolor=\"#f7f7f7\" width=\"100%\">\n<th width=\"100%\" scope=\"col\"><div class=\"bu_collapsible_container \" aria-live=\"polite\" data-customize-animation=\"false\"><h5 class=\"bu_collapsible\" aria-expanded=\"false\"tabindex=\"0\" role=\"button\">\u25bc\u25b2 &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Non-English Short Form Consent Documents<\/h5><div class=\"bu_collapsible_section\" style=\"display: none;\"><\/p>\n<p><em><b>Why Short Forms exist:<\/b> Federal regulations require that consent be presented in a language understandable to all participants. The short form consent process meets this requirement for participants with limited English proficiency when full translation isn&#8217;t available.<\/p>\n<p><b>When to use:<\/b> Your study may potentially enroll participants whose preferred language is listed below, but you don&#8217;t expect many. Full translation remains the requirement for languages you anticipate enrolling regularly, or after repeated use of an approved Short Form for the same language.<\/p>\n<p><b>You must submit this form with the PI name and number fields filled out as part of a request using the Change Request and Amendments form in INSPIR to the IRB. <span style=\"color: red;\">It must be stamped with IRB approval and the amendment must be approved before you use it with participants. Use of any individual Short Form document below without IRB approval for the specific language constitutes a major deviation and noncompliance<\/span><\/b><\/em><br \/>\nTo view an English version of the Short Form, click <a href=\"\/irb\/files\/2025\/11\/short-form-english.pdf\" target=\"blank\" rel=\"noopener\">here<\/a>.<\/p>\n<p><input type=\"text\" id=\"searchInput\" placeholder=\"Search for language...\" onkeyup=\"searchTable()\" \/><\/p>\n<table id=\"myTable\" class=\"table2\" cellspacing=\"10\" cellpadding=\"10\">\n<tbody>\n<tr align=\"left\" bgcolor=\"#cccccc\">\n<th width=\"50%\" scope=\"col\"><\/th>\n<th width=\"50%\" scope=\"col\"><\/th>\n<\/tr>\n<tr bgcolor=\"#FEFFFD\">\n<td><a href=\"\/irb\/files\/2025\/11\/short-form-albanian.pdf\" target=\"blank\" rel=\"noopener\"><img loading=\"lazy\" width=\"24\" height=\"22\" class=\"align none size-full wp-image-3230\" alt=\"\" src=\"\/irb\/files\/2017\/04\/pdfIcon.jpg\" \/> Short Form \u2013 Albanian<\/a><\/td>\n<td><a href=\"\/irb\/files\/2025\/11\/short-form-haitian-creole.pdf\" target=\"blank\" rel=\"noopener\"><img loading=\"lazy\" width=\"24\" height=\"22\" class=\"align none size-full wp-image-3230\" alt=\"\" src=\"\/irb\/files\/2017\/04\/pdfIcon.jpg\" \/> Short Form \u2013 Haitian Creole<\/a><\/td>\n<\/tr>\n<tr bgcolor=\"#FEFFFD\">\n<td><a href=\"\/irb\/files\/2025\/12\/short-form-Amharic.pdf\" target=\"blank\" rel=\"noopener\"><img loading=\"lazy\" width=\"24\" height=\"22\" class=\"align none size-full wp-image-3230\" alt=\"\" src=\"\/irb\/files\/2017\/04\/pdfIcon.jpg\" \/> Short Form \u2013 Amharic<\/a><\/td>\n<td><a href=\"\/irb\/files\/2025\/12\/Short-Form-Hindi.pdf\" target=\"blank\" rel=\"noopener\"><img loading=\"lazy\" width=\"24\" height=\"22\" class=\"align none size-full wp-image-3230\" alt=\"\" src=\"\/irb\/files\/2017\/04\/pdfIcon.jpg\" \/> Short Form \u2013 Hindi<\/a><\/td>\n<\/tr>\n<tr bgcolor=\"#FEFFFD\">\n<td><a href=\"\/irb\/files\/2025\/12\/short-form-arabic.pdf\" target=\"blank\" rel=\"noopener\"><img loading=\"lazy\" width=\"24\" height=\"22\" class=\"align none size-full wp-image-3230\" alt=\"\" src=\"\/irb\/files\/2017\/04\/pdfIcon.jpg\" \/> Short Form \u2013 Arabic<\/a><\/td>\n<td><a href=\"\/irb\/files\/2025\/12\/short-form-Igbo.pdf\" target=\"blank\" rel=\"noopener\"><img loading=\"lazy\" width=\"24\" height=\"22\" class=\"align none size-full wp-image-3230\" alt=\"\" src=\"\/irb\/files\/2017\/04\/pdfIcon.jpg\" \/> Short Form \u2013 Igbo<\/a><\/td>\n<\/tr>\n<tr bgcolor=\"#FEFFFD\">\n<td><a href=\"\/irb\/files\/2025\/12\/short-form-Bulgarian.pdf\" target=\"blank\" rel=\"noopener\"><img loading=\"lazy\" width=\"24\" height=\"22\" class=\"align none size-full wp-image-3230\" alt=\"\" src=\"\/irb\/files\/2017\/04\/pdfIcon.jpg\" \/> Short Form \u2013 Bulgarian<\/a><\/td>\n<td><a href=\"\/irb\/files\/2025\/12\/short-form-Pashto.pdf\" target=\"blank\" rel=\"noopener\"><img loading=\"lazy\" width=\"24\" height=\"22\" class=\"align none size-full wp-image-3230\" alt=\"\" src=\"\/irb\/files\/2017\/04\/pdfIcon.jpg\" \/> Short Form \u2013 Pashto<\/a><\/td>\n<\/tr>\n<tr bgcolor=\"#FEFFFD\">\n<td><a href=\"\/irb\/files\/2025\/12\/short-form-Burmese.pdf\" target=\"blank\" rel=\"noopener\"><img loading=\"lazy\" width=\"24\" height=\"22\" class=\"align none size-full wp-image-3230\" alt=\"\" src=\"\/irb\/files\/2017\/04\/pdfIcon.jpg\" \/> Short Form \u2013 Burmese<\/a><\/td>\n<td><a href=\"\/irb\/files\/2025\/12\/short-form-Polish.pdf\" target=\"blank\" rel=\"noopener\"><img loading=\"lazy\" width=\"24\" height=\"22\" class=\"align none size-full wp-image-3230\" alt=\"\" src=\"\/irb\/files\/2017\/04\/pdfIcon.jpg\" \/> Short Form \u2013 Polish<\/a><\/td>\n<\/tr>\n<tr bgcolor=\"#FEFFFD\">\n<td><a href=\"\/irb\/files\/2025\/12\/short-form-Cambodian.pdf\" target=\"blank\" rel=\"noopener\"><img loading=\"lazy\" width=\"24\" height=\"22\" class=\"align none size-full wp-image-3230\" alt=\"\" src=\"\/irb\/files\/2017\/04\/pdfIcon.jpg\" \/> Short Form \u2013 Cambodian<\/a><\/td>\n<td><a href=\"\/irb\/files\/2025\/12\/short-form-portuguese.pdf\" target=\"blank\" rel=\"noopener\"><img loading=\"lazy\" width=\"24\" height=\"22\" class=\"align none size-full wp-image-3230\" alt=\"\" src=\"\/irb\/files\/2017\/04\/pdfIcon.jpg\" \/> Short Form \u2013 Portuguese<\/a><\/td>\n<\/tr>\n<tr bgcolor=\"#FEFFFD\">\n<td><a href=\"\/irb\/files\/2025\/12\/short-form-Cape-Verdean.pdf\" target=\"blank\" rel=\"noopener\"><img loading=\"lazy\" width=\"24\" height=\"22\" class=\"align none size-full wp-image-3230\" alt=\"\" src=\"\/irb\/files\/2017\/04\/pdfIcon.jpg\" \/> Short Form \u2013 Cape Verdean<\/a><\/td>\n<td><a href=\"\/irb\/files\/2025\/12\/short-form-Romanian.pdf\" target=\"blank\" rel=\"noopener\"><img loading=\"lazy\" width=\"24\" height=\"22\" class=\"align none size-full wp-image-3230\" alt=\"\" src=\"\/irb\/files\/2017\/04\/pdfIcon.jpg\" \/> Short Form \u2013 Romanian<\/a><\/td>\n<\/tr>\n<tr bgcolor=\"#FEFFFD\">\n<td><a href=\"\/irb\/files\/2025\/12\/short-form-chinese-simplified.pdf\" target=\"blank\" rel=\"noopener\"><img loading=\"lazy\" width=\"24\" height=\"22\" class=\"align none size-full wp-image-3230\" alt=\"\" src=\"\/irb\/files\/2017\/04\/pdfIcon.jpg\" \/> Short Form \u2013 Chinese Simplified<\/a><\/td>\n<td><a href=\"\/irb\/files\/2025\/12\/short-form-Russian.pdf\" target=\"blank\" rel=\"noopener\"><img loading=\"lazy\" width=\"24\" height=\"22\" class=\"align none size-full wp-image-3230\" alt=\"\" src=\"\/irb\/files\/2017\/04\/pdfIcon.jpg\" \/> Short Form \u2013 Russian<\/a><\/td>\n<\/tr>\n<tr bgcolor=\"#FEFFFD\">\n<td><a href=\"\/irb\/files\/2025\/12\/short-form-chinese-traditional.pdf\" target=\"blank\" rel=\"noopener\"><img loading=\"lazy\" width=\"24\" height=\"22\" class=\"align none size-full wp-image-3230\" alt=\"\" src=\"\/irb\/files\/2017\/04\/pdfIcon.jpg\" \/> Short Form \u2013 Chinese Traditional<\/a><\/td>\n<td><a href=\"\/irb\/files\/2025\/12\/short-form-Somali.pdf\" target=\"blank\" rel=\"noopener\"><img loading=\"lazy\" width=\"24\" height=\"22\" class=\"align none size-full wp-image-3230\" alt=\"\" src=\"\/irb\/files\/2017\/04\/pdfIcon.jpg\" \/> Short Form \u2013 Somali<\/a><\/td>\n<\/tr>\n<tr bgcolor=\"#FEFFFD\">\n<td><a href=\"\/irb\/files\/2025\/11\/short-form-english.pdf\" target=\"blank\" rel=\"noopener\"><img loading=\"lazy\" width=\"24\" height=\"22\" class=\"align none size-full wp-image-3230\" alt=\"\" src=\"\/irb\/files\/2017\/04\/pdfIcon.jpg\" \/> Short Form \u2013 English<\/a><\/td>\n<td><a href=\"\/irb\/files\/2025\/12\/short-form-Spanish.pdf\" target=\"blank\" rel=\"noopener\"><img loading=\"lazy\" width=\"24\" height=\"22\" class=\"align none size-full wp-image-3230\" alt=\"\" src=\"\/irb\/files\/2017\/04\/pdfIcon.jpg\" \/> Short Form \u2013 Spanish<\/a><\/td>\n<\/tr>\n<tr bgcolor=\"#FEFFFD\">\n<td><a href=\"\/irb\/files\/2025\/12\/short-form-Farsi.pdf\" target=\"blank\" rel=\"noopener\"><img loading=\"lazy\" width=\"24\" height=\"22\" class=\"align none size-full wp-image-3230\" alt=\"\" src=\"\/irb\/files\/2017\/04\/pdfIcon.jpg\" \/> Short Form \u2013 Farsi<\/a><\/td>\n<td><a href=\"\/irb\/files\/2025\/12\/short-form-Swahili.pdf\" target=\"blank\" rel=\"noopener\"><img loading=\"lazy\" width=\"24\" height=\"22\" class=\"align none size-full wp-image-3230\" alt=\"\" src=\"\/irb\/files\/2017\/04\/pdfIcon.jpg\" \/> Short Form \u2013 Swahili<\/a><\/td>\n<\/tr>\n<tr bgcolor=\"#FEFFFD\">\n<td><a href=\"\/irb\/files\/2025\/12\/short-form-french.pdf\" target=\"blank\" rel=\"noopener\"><img loading=\"lazy\" width=\"24\" height=\"22\" class=\"align none size-full wp-image-3230\" alt=\"\" src=\"\/irb\/files\/2017\/04\/pdfIcon.jpg\" \/> Short Form \u2013 French<\/a><\/td>\n<td><a href=\"\/irb\/files\/2025\/12\/short-form-Tigrinya.pdf\" target=\"blank\" rel=\"noopener\"><img loading=\"lazy\" width=\"24\" height=\"22\" class=\"align none size-full wp-image-3230\" alt=\"\" src=\"\/irb\/files\/2017\/04\/pdfIcon.jpg\" \/> Short Form \u2013 Tigrinya<\/a><\/td>\n<\/tr>\n<tr bgcolor=\"#FEFFFD\">\n<td><a href=\"\/irb\/files\/2025\/12\/Short-Form-Greek.pdf\" target=\"blank\" rel=\"noopener\"><img loading=\"lazy\" width=\"24\" height=\"22\" class=\"align none size-full wp-image-3230\" alt=\"\" src=\"\/irb\/files\/2017\/04\/pdfIcon.jpg\" \/> Short Form \u2013 Greek<\/a><\/td>\n<td><a href=\"\/irb\/files\/2025\/12\/short-form-vietnamese.pdf\" target=\"blank\" rel=\"noopener\"><img loading=\"lazy\" width=\"24\" height=\"22\" class=\"align none size-full wp-image-3230\" alt=\"\" src=\"\/irb\/files\/2017\/04\/pdfIcon.jpg\" \/> Short Form \u2013 Vietnamese<\/a><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><script>\r\n  function searchTable() {\r\n    const input = document.getElementById(\"searchInput\").value.toLowerCase();\r\n    const table = document.getElementById(\"myTable\");\r\n    const rows = table.getElementsByTagName(\"tr\");\r\n\r\n    for (let i = 1; i < rows.length; i++) {\r\n      const cells = rows[i].getElementsByTagName(\"td\");\r\n      let match = false;\r\n\r\n      for (let j = 0; j < cells.length; j++) {\r\n        if (cells[j].innerText.toLowerCase().includes(input)) {\r\n          match = true;\r\n          break;\r\n        }\r\n      }\r\n\r\n      rows[i].style.display = match ? \"\" : \"none\";\r\n    }\r\n  }\r\n<\/script><br \/>\n<\/div>\n<\/div>\n<\/th>\n<\/tr>\n<\/tbody>\n<\/table>\n<table cellspacing=\"10\" cellpadding=\"10\" width=\"100%\">\n<tbody>\n<tr align=\"left\" bgcolor=\"#f7f7f7\" width=\"100%\">\n<th width=\"100%\" scope=\"col\"><div class=\"bu_collapsible_container \" aria-live=\"polite\" data-customize-animation=\"false\"><h5 class=\"bu_collapsible\" aria-expanded=\"false\"tabindex=\"0\" role=\"button\">\u25bc\u25b2 &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Recruitment Scripts & Opt-Out Letters<\/h5><div class=\"bu_collapsible_section\" style=\"display: none;\"><\/p>\n<table class=\"table2\" cellspacing=\"10\" cellpadding=\"10\">\n<tbody>\n<tr align=\"left\" bgcolor=\"#cccccc\">\n<th width=\"85%\" scope=\"col\">Template Name<\/th>\n<\/tr>\n<tr bgcolor=\"#FEFFFD\">\n<td>\n<details open=\"\">\n<summary><a href=\"\/irb\/files\/2023\/06\/Opt-Out-Template.docx\"><img loading=\"lazy\" width=\"29\" height=\"24\" class=\"alignnone size-full wp-image-3666\" alt=\"\" src=\"\/irb\/files\/2018\/08\/word-icon-e1534169892123.jpg\" \/> Opt-Out Recruitment Template<\/a><span style=\"color: red;\"> \u00a0<strong>[+\/-]<\/strong><\/span><\/summary>\n<p><em>Use this form to create a recruitment opt-out letter or electronic message to send to potential subjects. This recruitment method helps avoid \u201ccold calling\u201d when you need to introduce the study to potential participants with whom you have no prior relationship (i.e., clinical or previous study) and when there is no warm hand-off available from a treating clinician. NOTE: Cold calls are generally not allowed per institutional policy.<\/em><\/p>\n<\/details>\n<\/td>\n<\/tr>\n<tr bgcolor=\"#FEFFFD\">\n<td>\n<details open=\"\">\n<summary><a href=\"\/irb\/files\/2016\/10\/Recruitment-Script-Template.docx\"><img loading=\"lazy\" width=\"29\" height=\"24\" class=\"alignnone size-full wp-image-3666\" alt=\"\" src=\"\/irb\/files\/2018\/08\/word-icon-e1534169892123.jpg\" \/> Recruitment Script Template<\/a><span style=\"color: red;\"> \u00a0<strong>[+\/-]<\/strong><\/span><\/summary>\n<p><em>Use this form to demonstrate to the IRB what the study team will say to a participant if meeting them in person or following up a letter with a phone call. While this is a guide, it must not contain inaccurate information and must be consistent with other study materials.<\/em><\/p>\n<\/details>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><\/div>\n<\/div>\n<\/th>\n<\/tr>\n<\/tbody>\n<\/table>\n<table cellspacing=\"10\" cellpadding=\"10\" width=\"100%\">\n<tbody>\n<tr align=\"left\" bgcolor=\"#f7f7f7\" width=\"100%\">\n<th width=\"100%\" scope=\"col\"><div class=\"bu_collapsible_container \" aria-live=\"polite\" data-customize-animation=\"false\"><h5 class=\"bu_collapsible\" aria-expanded=\"false\"tabindex=\"0\" role=\"button\">\u25bc\u25b2 &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Study Protocols & CAPA Plans<\/h5><div class=\"bu_collapsible_section\" style=\"display: none;\"><\/p>\n<table class=\"table2\" cellspacing=\"10\" cellpadding=\"10\">\n<tbody>\n<tr align=\"left\" bgcolor=\"#cccccc\">\n<th width=\"85%\" scope=\"col\">Template Name<\/th>\n<\/tr>\n<tr bgcolor=\"#FEFFFD\">\n<td>\n<details open=\"\">\n<summary><a href=\"\/irb\/files\/2016\/10\/Protocol-Template.docx\"><img loading=\"lazy\" width=\"29\" height=\"24\" class=\"alignnone size-full wp-image-3666\" alt=\"\" src=\"\/irb\/files\/2018\/08\/word-icon-e1534169892123.jpg\" \/> Protocol Template<\/a><span style=\"color: red;\"> \u00a0<strong>[+\/-]<\/strong><\/span><\/summary>\n<p><em>Use this for studies that require an external protocol IN ADDITION to the INSPIR application. A separate protocol is REQUIRED for all initial submissions of medical or surgical clinical trials, multi-site clinical trials of any type, NIH-funded clinical trials of any type, and for any study that is required to post results on ClinicalTrials.gov.<\/em><\/p>\n<\/details>\n<\/td>\n<\/tr>\n<tr bgcolor=\"#FEFFFD\">\n<td>\n<details open=\"\">\n<summary><a href=\"\/irb\/files\/2017\/01\/CAPA-Template.doc\"><img loading=\"lazy\" width=\"29\" height=\"24\" class=\"alignnone size-full wp-image-3666\" alt=\"\" src=\"\/irb\/files\/2018\/08\/word-icon-e1534169892123.jpg\" \/> CAPA Plan Template<\/a><span style=\"color: red;\"> \u00a0<strong>[+\/-]<\/strong><\/span><\/summary>\n<p><em>Use this when you need to create a corrective and preventative action plan for a major deviation or unanticipated problem. Attach this within the Reportable Event and New Information form submission in INSPIR.<\/em><\/p>\n<\/details>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><\/div>\n<\/div>\n<\/th>\n<\/tr>\n<\/tbody>\n<\/table>\n<table cellspacing=\"10\" cellpadding=\"10\" width=\"100%\">\n<tbody>\n<tr align=\"left\" bgcolor=\"#f7f7f7\" width=\"100%\">\n<th width=\"100%\" scope=\"col\"><div class=\"bu_collapsible_container \" aria-live=\"polite\" data-customize-animation=\"false\"><h5 class=\"bu_collapsible\" aria-expanded=\"false\"tabindex=\"0\" role=\"button\">\u25bc\u25b2 &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Single Patient Use Templates and FDA Drug\/Device Guidance<\/h5><div class=\"bu_collapsible_section\" style=\"display: none;\"><\/p>\n<table class=\"table2\" cellspacing=\"10\" cellpadding=\"10\">\n<tbody>\n<tr align=\"left\" bgcolor=\"#cccccc\">\n<th width=\"85%\" scope=\"col\">Template Name<\/th>\n<\/tr>\n<tr bgcolor=\"#FEFFFD\">\n<td>\n<details open=\"\">\n<summary><a href=\"\/irb\/files\/2023\/07\/Single-Patient-Expanded-Access-Consent-Template.docx\"><img loading=\"lazy\" width=\"29\" height=\"24\" class=\"alignnone size-full wp-image-3666\" alt=\"\" src=\"\/irb\/files\/2018\/08\/word-icon-e1534169892123.jpg\" \/>\u00a0Single Patient Expanded Access Consent Template<\/a><span style=\"color: red;\"> \u00a0<strong>[+\/-]<\/strong><\/span><\/summary>\n<p><em>Use this form for individual patient treatment using an investigational device or drug as part of FDA-approved Expanded Access.<\/em><\/p>\n<\/details>\n<\/td>\n<\/tr>\n<tr bgcolor=\"#FEFFFD\">\n<td>\n<details open=\"\">\n<summary><a href=\"\/irb\/files\/2016\/10\/IDE-requirements.pdf\"><img loading=\"lazy\" width=\"24\" height=\"22\" class=\"alignnone size-full wp-image-3230\" alt=\"\" src=\"\/irb\/files\/2017\/04\/pdfIcon.jpg\" \/> Guidance for abbreviated IDE requirements<\/a><span style=\"color: red;\"> \u00a0<strong>[+\/-]<\/strong><\/span><\/summary>\n<p><em>This guidance document provides instructions for requesting a \u201cnonsignificant risk\u201d determination from the BMC\/BUMC IRB in relation to the use of an investigational device.<\/em><\/p>\n<\/details>\n<\/td>\n<\/tr>\n<tr bgcolor=\"#FEFFFD\">\n<td>\n<details open=\"\">\n<summary><a href=\"\/irb\/files\/2023\/08\/Guidance-for-Individual-Patient-IND-and-Emergency-Use.docx\"><img loading=\"lazy\" width=\"29\" height=\"24\" class=\"alignnone size-full wp-image-3666\" alt=\"\" src=\"\/irb\/files\/2018\/08\/word-icon-e1534169892123.jpg\" \/> Guidance for Individual Patient IND and Emergency Use<\/a><span style=\"color: red;\"> \u00a0<strong>[+\/-]<\/strong><\/span><\/summary>\n<p><em>This guidance document provides detailed step by step instructions on obtaining FDA and BMC\/BUMC IRB approval for use of investigational drug(s) with an individual patient.<\/em><\/p>\n<\/details>\n<\/td>\n<\/tbody>\n<\/table>\n<p><\/div>\n<\/div>\n<\/th>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p>Available IRB Templates: Click on any of the Template group headers below to expand\/collapse the group. To learn more about each displayed Template, click on the [+\/-] icon To download a template, click the link in the Template title<\/p>\n","protected":false},"author":874,"featured_media":0,"parent":768,"menu_order":4,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"_links":{"self":[{"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/pages\/3625"}],"collection":[{"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/users\/874"}],"replies":[{"embeddable":true,"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/comments?post=3625"}],"version-history":[{"count":50,"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/pages\/3625\/revisions"}],"predecessor-version":[{"id":5169,"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/pages\/3625\/revisions\/5169"}],"up":[{"embeddable":true,"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/pages\/768"}],"wp:attachment":[{"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/media?parent=3625"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}