{"id":18,"date":"2016-04-04T18:26:01","date_gmt":"2016-04-04T18:26:01","guid":{"rendered":"https:\/\/web.saumag.edu\/irb\/?page_id=18"},"modified":"2016-04-04T20:06:04","modified_gmt":"2016-04-04T20:06:04","slug":"request-change-protocol-consent-form","status":"publish","type":"page","link":"https:\/\/web.saumag.edu\/irb\/request-change-protocol-consent-form\/","title":{"rendered":"Request for Change in Protocol\/Consent Form"},"content":{"rendered":"<p>Any proposed change to the IRB protocol or consent form(s), including a change in investigator(s) or key personnel, must be reviewed and approved by the IRB prior to implementation, except where an immediate change is necessary to eliminate hazard to the participant.<\/p>\n<script type=\"text\/javascript\">\n\/* <![CDATA[ *\/\nvar gform;gform||(document.addEventListener(\"gform_main_scripts_loaded\",function(){gform.scriptsLoaded=!0}),document.addEventListener(\"gform\/theme\/scripts_loaded\",function(){gform.themeScriptsLoaded=!0}),window.addEventListener(\"DOMContentLoaded\",function(){gform.domLoaded=!0}),gform={domLoaded:!1,scriptsLoaded:!1,themeScriptsLoaded:!1,isFormEditor:()=>\"function\"==typeof InitializeEditor,callIfLoaded:function(o){return!(!gform.domLoaded||!gform.scriptsLoaded||!gform.themeScriptsLoaded&&!gform.isFormEditor()||(gform.isFormEditor()&&console.warn(\"The use of gform.initializeOnLoaded() is deprecated in the form editor context and will be removed in Gravity Forms 3.1.\"),o(),0))},initializeOnLoaded:function(o){gform.callIfLoaded(o)||(document.addEventListener(\"gform_main_scripts_loaded\",()=>{gform.scriptsLoaded=!0,gform.callIfLoaded(o)}),document.addEventListener(\"gform\/theme\/scripts_loaded\",()=>{gform.themeScriptsLoaded=!0,gform.callIfLoaded(o)}),window.addEventListener(\"DOMContentLoaded\",()=>{gform.domLoaded=!0,gform.callIfLoaded(o)}))},hooks:{action:{},filter:{}},addAction:function(o,r,e,t){gform.addHook(\"action\",o,r,e,t)},addFilter:function(o,r,e,t){gform.addHook(\"filter\",o,r,e,t)},doAction:function(o){gform.doHook(\"action\",o,arguments)},applyFilters:function(o){return gform.doHook(\"filter\",o,arguments)},removeAction:function(o,r){gform.removeHook(\"action\",o,r)},removeFilter:function(o,r,e){gform.removeHook(\"filter\",o,r,e)},addHook:function(o,r,e,t,n){null==gform.hooks[o][r]&&(gform.hooks[o][r]=[]);var d=gform.hooks[o][r];null==n&&(n=r+\"_\"+d.length),gform.hooks[o][r].push({tag:n,callable:e,priority:t=null==t?10:t})},doHook:function(r,o,e){var t;if(e=Array.prototype.slice.call(e,1),null!=gform.hooks[r][o]&&((o=gform.hooks[r][o]).sort(function(o,r){return o.priority-r.priority}),o.forEach(function(o){\"function\"!=typeof(t=o.callable)&&(t=window[t]),\"action\"==r?t.apply(null,e):e[0]=t.apply(null,e)})),\"filter\"==r)return e[0]},removeHook:function(o,r,t,n){var e;null!=gform.hooks[o][r]&&(e=(e=gform.hooks[o][r]).filter(function(o,r,e){return!!(null!=n&&n!=o.tag||null!=t&&t!=o.priority)}),gform.hooks[o][r]=e)}});\n\/* ]]> *\/\n<\/script>\n\n                <div class='gf_browser_gecko gform_wrapper gform_legacy_markup_wrapper gform-theme--no-framework' data-form-theme='legacy' data-form-index='0' id='gform_wrapper_3' ><style>#gform_wrapper_3[data-form-index=\"0\"].gform-theme,[data-parent-form=\"3_0\"]{--gf-color-primary: #204ce5;--gf-color-primary-rgb: 32, 76, 229;--gf-color-primary-contrast: #fff;--gf-color-primary-contrast-rgb: 255, 255, 255;--gf-color-primary-darker: #001AB3;--gf-color-primary-lighter: #527EFF;--gf-color-secondary: #fff;--gf-color-secondary-rgb: 255, 255, 255;--gf-color-secondary-contrast: #112337;--gf-color-secondary-contrast-rgb: 17, 35, 55;--gf-color-secondary-darker: #F5F5F5;--gf-color-secondary-lighter: #FFFFFF;--gf-color-out-ctrl-light: rgba(17, 35, 55, 0.1);--gf-color-out-ctrl-light-rgb: 17, 35, 55;--gf-color-out-ctrl-light-darker: rgba(104, 110, 119, 0.35);--gf-color-out-ctrl-light-lighter: #F5F5F5;--gf-color-out-ctrl-dark: #585e6a;--gf-color-out-ctrl-dark-rgb: 88, 94, 106;--gf-color-out-ctrl-dark-darker: #112337;--gf-color-out-ctrl-dark-lighter: rgba(17, 35, 55, 0.65);--gf-color-in-ctrl: #fff;--gf-color-in-ctrl-rgb: 255, 255, 255;--gf-color-in-ctrl-contrast: #112337;--gf-color-in-ctrl-contrast-rgb: 17, 35, 55;--gf-color-in-ctrl-darker: #F5F5F5;--gf-color-in-ctrl-lighter: #FFFFFF;--gf-color-in-ctrl-primary: #204ce5;--gf-color-in-ctrl-primary-rgb: 32, 76, 229;--gf-color-in-ctrl-primary-contrast: #fff;--gf-color-in-ctrl-primary-contrast-rgb: 255, 255, 255;--gf-color-in-ctrl-primary-darker: #001AB3;--gf-color-in-ctrl-primary-lighter: #527EFF;--gf-color-in-ctrl-light: rgba(17, 35, 55, 0.1);--gf-color-in-ctrl-light-rgb: 17, 35, 55;--gf-color-in-ctrl-light-darker: rgba(104, 110, 119, 0.35);--gf-color-in-ctrl-light-lighter: #F5F5F5;--gf-color-in-ctrl-dark: #585e6a;--gf-color-in-ctrl-dark-rgb: 88, 94, 106;--gf-color-in-ctrl-dark-darker: #112337;--gf-color-in-ctrl-dark-lighter: rgba(17, 35, 55, 0.65);--gf-radius: 3px;--gf-font-size-secondary: 14px;--gf-font-size-tertiary: 13px;--gf-icon-ctrl-number: url(\"data:image\/svg+xml,%3Csvg width='8' height='14' viewBox='0 0 8 14' fill='none' xmlns='http:\/\/www.w3.org\/2000\/svg'%3E%3Cpath fill-rule='evenodd' clip-rule='evenodd' d='M4 0C4.26522 5.96046e-08 4.51957 0.105357 4.70711 0.292893L7.70711 3.29289C8.09763 3.68342 8.09763 4.31658 7.70711 4.70711C7.31658 5.09763 6.68342 5.09763 6.29289 4.70711L4 2.41421L1.70711 4.70711C1.31658 5.09763 0.683417 5.09763 0.292893 4.70711C-0.0976311 4.31658 -0.097631 3.68342 0.292893 3.29289L3.29289 0.292893C3.48043 0.105357 3.73478 0 4 0ZM0.292893 9.29289C0.683417 8.90237 1.31658 8.90237 1.70711 9.29289L4 11.5858L6.29289 9.29289C6.68342 8.90237 7.31658 8.90237 7.70711 9.29289C8.09763 9.68342 8.09763 10.3166 7.70711 10.7071L4.70711 13.7071C4.31658 14.0976 3.68342 14.0976 3.29289 13.7071L0.292893 10.7071C-0.0976311 10.3166 -0.0976311 9.68342 0.292893 9.29289Z' fill='rgba(17, 35, 55, 0.65)'\/%3E%3C\/svg%3E\");--gf-icon-ctrl-select: url(\"data:image\/svg+xml,%3Csvg width='10' height='6' viewBox='0 0 10 6' fill='none' xmlns='http:\/\/www.w3.org\/2000\/svg'%3E%3Cpath fill-rule='evenodd' clip-rule='evenodd' d='M0.292893 0.292893C0.683417 -0.097631 1.31658 -0.097631 1.70711 0.292893L5 3.58579L8.29289 0.292893C8.68342 -0.0976311 9.31658 -0.0976311 9.70711 0.292893C10.0976 0.683417 10.0976 1.31658 9.70711 1.70711L5.70711 5.70711C5.31658 6.09763 4.68342 6.09763 4.29289 5.70711L0.292893 1.70711C-0.0976311 1.31658 -0.0976311 0.683418 0.292893 0.292893Z' fill='rgba(17, 35, 55, 0.65)'\/%3E%3C\/svg%3E\");--gf-icon-ctrl-search: url(\"data:image\/svg+xml,%3Csvg width='640' height='640' xmlns='http:\/\/www.w3.org\/2000\/svg'%3E%3Cpath d='M256 128c-70.692 0-128 57.308-128 128 0 70.691 57.308 128 128 128 70.691 0 128-57.309 128-128 0-70.692-57.309-128-128-128zM64 256c0-106.039 85.961-192 192-192s192 85.961 192 192c0 41.466-13.146 79.863-35.498 111.248l154.125 154.125c12.496 12.496 12.496 32.758 0 45.254s-32.758 12.496-45.254 0L367.248 412.502C335.862 434.854 297.467 448 256 448c-106.039 0-192-85.962-192-192z' fill='rgba(17, 35, 55, 0.65)'\/%3E%3C\/svg%3E\");--gf-label-space-y-secondary: var(--gf-label-space-y-md-secondary);--gf-ctrl-border-color: #686e77;--gf-ctrl-size: var(--gf-ctrl-size-md);--gf-ctrl-label-color-primary: #112337;--gf-ctrl-label-color-secondary: #112337;--gf-ctrl-choice-size: var(--gf-ctrl-choice-size-md);--gf-ctrl-checkbox-check-size: var(--gf-ctrl-checkbox-check-size-md);--gf-ctrl-radio-check-size: var(--gf-ctrl-radio-check-size-md);--gf-ctrl-btn-font-size: var(--gf-ctrl-btn-font-size-md);--gf-ctrl-btn-padding-x: var(--gf-ctrl-btn-padding-x-md);--gf-ctrl-btn-size: var(--gf-ctrl-btn-size-md);--gf-ctrl-btn-border-color-secondary: #686e77;--gf-ctrl-file-btn-bg-color-hover: #EBEBEB;--gf-field-img-choice-size: var(--gf-field-img-choice-size-md);--gf-field-img-choice-card-space: var(--gf-field-img-choice-card-space-md);--gf-field-img-choice-check-ind-size: var(--gf-field-img-choice-check-ind-size-md);--gf-field-img-choice-check-ind-icon-size: var(--gf-field-img-choice-check-ind-icon-size-md);--gf-field-pg-steps-number-color: rgba(17, 35, 55, 0.8);}<\/style><form method='post' enctype='multipart\/form-data'  id='gform_3'  action='\/irb\/wp-json\/wp\/v2\/pages\/18' data-formid='3' novalidate>\n                        <div class='gform-body gform_body'><ul id='gform_fields_3' class='gform_fields top_label form_sublabel_below description_below validation_below'><li id=\"field_3_1\" class=\"gfield gfield--type-textarea gfield_contains_required field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible\"  ><label class='gfield_label gform-field-label' for='input_3_1'>Provide a description of the proposed change(s).<span class=\"gfield_required\"><span class=\"gfield_required gfield_required_asterisk\">*<\/span><\/span><\/label><div class='ginput_container ginput_container_textarea'><textarea name='input_1' id='input_3_1' class='textarea medium'     aria-required=\"true\" aria-invalid=\"false\"   rows='10' cols='50'><\/textarea><\/div><\/li><li id=\"field_3_2\" class=\"gfield gfield--type-textarea gfield_contains_required field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible\"  ><label class='gfield_label gform-field-label' for='input_3_2'>Provide justification for the proposed change(s) described above.<span class=\"gfield_required\"><span class=\"gfield_required gfield_required_asterisk\">*<\/span><\/span><\/label><div class='ginput_container ginput_container_textarea'><textarea name='input_2' id='input_3_2' class='textarea medium'     aria-required=\"true\" aria-invalid=\"false\"   rows='10' cols='50'><\/textarea><\/div><\/li><li id=\"field_3_3\" class=\"gfield gfield--type-textarea field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible\"  ><label class='gfield_label gform-field-label' for='input_3_3'>Include any additional comments you wish to make regarding the proposed changes.<\/label><div class='ginput_container ginput_container_textarea'><textarea name='input_3' id='input_3_3' class='textarea medium'      aria-invalid=\"false\"   rows='10' cols='50'><\/textarea><\/div><\/li><\/ul><\/div>\n        <div class='gform-footer gform_footer top_label'> <input type='submit' id='gform_submit_button_3' class='gform_button button' onclick='gform.submission.handleButtonClick(this);' data-submission-type='submit' value='Submit'  \/> \n            <input type='hidden' class='gform_hidden' name='gform_submission_method' data-js='gform_submission_method_3' value='postback' \/>\n            <input type='hidden' class='gform_hidden' name='gform_theme' data-js='gform_theme_3' id='gform_theme_3' value='legacy' \/>\n            <input type='hidden' class='gform_hidden' name='gform_style_settings' data-js='gform_style_settings_3' id='gform_style_settings_3' value='[]' \/>\n            <input type='hidden' class='gform_hidden' name='is_submit_3' value='1' \/>\n            <input type='hidden' class='gform_hidden' name='gform_submit' value='3' \/>\n            \n            <input type='hidden' class='gform_hidden' name='gform_currency' data-currency='USD' value='g3J0JlseQ8ol2c8+zO1VAwJr\/oyrTH5cZlfZ5qcY4IG1Y827+6qfXpc+x+jG1zdZvBpvZz56St7+oL2X\/aWzT2fUT7PEOTuyn5EodLmag\/LWfig=' \/>\n            <input type='hidden' class='gform_hidden' name='gform_unique_id' value='' \/>\n            <input type='hidden' class='gform_hidden' name='state_3' value='WyJbXSIsIjNhOGE4Nzk1MDFkNWU1YzFmZTdjNjdjNGEyOWZlZjJhIl0=' \/>\n            <input type='hidden' autocomplete='off' class='gform_hidden' name='gform_target_page_number_3' id='gform_target_page_number_3' value='0' \/>\n            <input type='hidden' autocomplete='off' class='gform_hidden' name='gform_source_page_number_3' id='gform_source_page_number_3' value='1' \/>\n            <input type='hidden' name='gform_field_values' value='' \/>\n            \n        <\/div>\n                        <p style=\"display: none !important;\" class=\"akismet-fields-container\" data-prefix=\"ak_\"><label>&#916;<textarea name=\"ak_hp_textarea\" cols=\"45\" rows=\"8\" maxlength=\"100\"><\/textarea><\/label><input type=\"hidden\" id=\"ak_js_1\" name=\"ak_js\" value=\"199\"\/><script>document.getElementById( \"ak_js_1\" ).setAttribute( \"value\", ( new Date() ).getTime() );<\/script><\/p><\/form>\n                        <\/div><script type=\"text\/javascript\">\n\/* <![CDATA[ *\/\n gform.initializeOnLoaded( function() {gformInitSpinner( 3, 'https:\/\/web.saumag.edu\/irb\/wp-content\/plugins\/gravityforms\/images\/spinner.svg', true );jQuery('#gform_ajax_frame_3').on('load',function(){var contents = jQuery(this).contents().find('*').html();var is_postback = contents.indexOf('GF_AJAX_POSTBACK') >= 0;if(!is_postback){return;}var form_content = jQuery(this).contents().find('#gform_wrapper_3');var is_confirmation = jQuery(this).contents().find('#gform_confirmation_wrapper_3').length > 0;var is_redirect = contents.indexOf('gformRedirect(){') >= 0;var is_form = form_content.length > 0 && ! is_redirect && ! is_confirmation;var mt = parseInt(jQuery('html').css('margin-top'), 10) + parseInt(jQuery('body').css('margin-top'), 10) + 100;if(is_form){jQuery('#gform_wrapper_3').html(form_content.html());if(form_content.hasClass('gform_validation_error')){jQuery('#gform_wrapper_3').addClass('gform_validation_error');} else {jQuery('#gform_wrapper_3').removeClass('gform_validation_error');}setTimeout( function() { \/* delay the scroll by 50 milliseconds to fix a bug in chrome *\/  }, 50 );if(window['gformInitDatepicker']) {gformInitDatepicker();}if(window['gformInitPriceFields']) {gformInitPriceFields();}var current_page = jQuery('#gform_source_page_number_3').val();gformInitSpinner( 3, 'https:\/\/web.saumag.edu\/irb\/wp-content\/plugins\/gravityforms\/images\/spinner.svg', true );jQuery(document).trigger('gform_page_loaded', [3, current_page]);window['gf_submitting_3'] = false;}else if(!is_redirect){var confirmation_content = jQuery(this).contents().find('.GF_AJAX_POSTBACK').html();if(!confirmation_content){confirmation_content = contents;}jQuery('#gform_wrapper_3').replaceWith(confirmation_content);jQuery(document).trigger('gform_confirmation_loaded', [3]);window['gf_submitting_3'] = false;wp.a11y.speak(jQuery('#gform_confirmation_message_3').text());}else{jQuery('#gform_3').append(contents);if(window['gformRedirect']) {gformRedirect();}}jQuery(document).trigger(\"gform_pre_post_render\", [{ formId: \"3\", currentPage: \"current_page\", abort: function() { this.preventDefault(); } }]);        if (event && event.defaultPrevented) {                return;        }        const gformWrapperDiv = document.getElementById( \"gform_wrapper_3\" );        if ( gformWrapperDiv ) {            const visibilitySpan = document.createElement( \"span\" );            visibilitySpan.id = \"gform_visibility_test_3\";            gformWrapperDiv.insertAdjacentElement( \"afterend\", visibilitySpan );        }        const visibilityTestDiv = document.getElementById( \"gform_visibility_test_3\" );        let postRenderFired = false;        function triggerPostRender() {            if ( postRenderFired ) {                return;            }            postRenderFired = true;            gform.core.triggerPostRenderEvents( 3, current_page );            if ( visibilityTestDiv ) {                visibilityTestDiv.parentNode.removeChild( visibilityTestDiv );            }        }        function debounce( func, wait, immediate ) {            var timeout;            return function() {                var context = this, args = arguments;                var later = function() {                    timeout = null;                    if ( !immediate ) func.apply( context, args );                };                var callNow = immediate && !timeout;                clearTimeout( timeout );                timeout = setTimeout( later, wait );                if ( callNow ) func.apply( context, args );            };        }        const debouncedTriggerPostRender = debounce( function() {            triggerPostRender();        }, 200 );        if ( visibilityTestDiv && visibilityTestDiv.offsetParent === null ) {            const observer = new MutationObserver( ( mutations ) => {                mutations.forEach( ( mutation ) => {                    if ( mutation.type === 'attributes' && visibilityTestDiv.offsetParent !== null ) {                        debouncedTriggerPostRender();                        observer.disconnect();                    }                });            });            observer.observe( document.body, {                attributes: true,                childList: false,                subtree: true,                attributeFilter: [ 'style', 'class' ],            });        } else {            triggerPostRender();        }    } );} ); \n\/* ]]> *\/\n<\/script>\n\n    <script>\n        jQuery( document ).ready(function() {\n        setTimeout(() => {  }, 1000);\n        })\n    <\/script>\n    \n<p>If the changes are significant, a completely revised protocol form may be requested, with proposed changes highlighted. Changes will be reviewed initially by the IRB Office, and the investigator will be notified whether the changes require review by the expedited method or by the convened board at the next scheduled meeting. Minor changes may be administratively approved by the Chair. Appropriate steps will be taken in the IRB Office to ensure a timely review and approval of the changes.<\/p>\n<div class=\"alert alert-warning\">A protocol may be changed without prior IRB approval where necessary to eliminate apparent immediate hazards to the participants or others. However, the IRB must be notified IN WRITING within 72 hours of any change, and IRB review is still eventually required.<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Any proposed change to the IRB protocol or consent form(s), including a change in investigator(s) or key personnel, must be reviewed and approved by the IRB prior to implementation, except where an immediate change is necessary to eliminate hazard to the participant. If the changes are significant, a completely revised protocol form may be requested,&#8230; <a class=\"more-link\" href=\"https:\/\/web.saumag.edu\/irb\/request-change-protocol-consent-form\/\"> Read More<\/a><\/p>\n","protected":false},"author":564,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_genesis_hide_title":false,"_genesis_hide_breadcrumbs":false,"_genesis_hide_singular_image":false,"_genesis_hide_footer_widgets":false,"_genesis_custom_body_class":"","_genesis_custom_post_class":"","_genesis_layout":"","footnotes":"","_links_to":"","_links_to_target":""},"class_list":{"0":"post-18","1":"page","2":"type-page","3":"status-publish","5":"entry"},"_links":{"self":[{"href":"https:\/\/web.saumag.edu\/irb\/wp-json\/wp\/v2\/pages\/18","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/web.saumag.edu\/irb\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/web.saumag.edu\/irb\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/web.saumag.edu\/irb\/wp-json\/wp\/v2\/users\/564"}],"replies":[{"embeddable":true,"href":"https:\/\/web.saumag.edu\/irb\/wp-json\/wp\/v2\/comments?post=18"}],"version-history":[{"count":0,"href":"https:\/\/web.saumag.edu\/irb\/wp-json\/wp\/v2\/pages\/18\/revisions"}],"wp:attachment":[{"href":"https:\/\/web.saumag.edu\/irb\/wp-json\/wp\/v2\/media?parent=18"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}