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class="column"> <div class="inside"> <a id="main-content"></a> <div class="tabs"></div> <div class="region region-content"> <div id="block-system-main" class="block block-system"> <div class="content"> <div id="node-776" class="node node-page slider-secondary clearfix" about="/responding-stipulations-iris" typeof="sioc:Item foaf:Document"> <span property="dc:title" content="Responding to Stipulations in iRIS (Review Response Submission Form)" class="rdf-meta element-hidden"></span><span property="sioc:num_replies" content="0" datatype="xsd:integer" class="rdf-meta element-hidden"></span> <div class="content"> <div class="field field-name-field-body field-type-text-long field-label-hidden"><div class="field-items"><div class="field-item even"><ul> <li><a href="#form">Stipulations, Comments and the Review Response Submission Form</a></li> <li><a href="#components">Revising the Submission Components</a></li> <li><a href="#modifications">Making Unrequested Changes</a></li> </ul> <h2><a id="form" name="form"></a>Stipulations, Comments and the Review Response Submission Form</h2> <p>You may receive a request from IRB to make changes to your submission during the <a href="/irb-review-process">pre-review screening process or after formal IRB review</a>.</p> <p>To receive IRB approval in the shortest possible time, follow the guidelines below in preparing your response to the IRB's request for revisions or more information. For additional help, read the <a href="https://iris-help.ucsf.edu/irb-iris" target="_self">Submission Correct quick guide</a> (also available in the Help section of iRIS).</p> <p>The PI and study contact(s) will receive a Review Response Submission Form in iRIS that lists the IRB's request for revisions or more information. If you do not respond to the request for submission corrections within the specified timeframe, the IRB will withdraw your submission.</p> <h3>Categories of Changes, Clarifications or Comments Requested by the IRB</h3> <h4>Stipulations </h4> <ul> <li>Stipulations are issues that require clarification or changes before the submission can go forward in the review process and approval can be granted. </li> </ul> <h4>Comments that must be addressed</h4> <ul> <li>A submission approved with "comments that must be addressed" is an approved submission. It indicates that the IRB has approved the overall study but requires that a specific issue be addressed before that item is implemented. <ul> <li>Example 1: Release of funding is contingent upon IRB approval, and the study plan is approvable, but the recruitment materials are not yet finalized. The IRB can grant an outcome of “approved with comments that must be addressed,” and the comment would state that you must submit the recruitment materials and have them approved by the IRB before using them.</li> <li>Example 2: In a study where findings from the first arm of the study will inform some portion of the implementation of a second arm, the “comment that must be addressed” would state that the study is approved to begin, but the second arm may not be implemented until its finalized plan is reviewed and approved by the IRB.</li> </ul> </li> </ul> <h4>Comments</h4> <ul> <li>Suggestions, comments, or observations that you may wish to incorporate, but do not necessarily require follow-up or action. <ul> <li>Example 1: The informed consent form contains multiple typographical errors. The typographical errors do not affect understandability, but they do make for a sloppy document that could reflect poorly on UCSF and the PI.</li> </ul> </li> </ul> <h3>Filling Out the Review Response Submission Form</h3> <h4>Accept (or reject) the stipulation and describe how you addressed the stipulation</h4> <ul> <li>You will be asked if you accept each stipulation or comment – e.g. do you agree (or reject) to make the suggested change or provide the requested information? You must respond either Yes, No or N/A to each question. Then describe how you addressed the stipulation in the text box. There is an option to not make a change and describe why a change is not being made. However, the IRB reserves the right to require the change.</li> </ul> <h4>Provide rationale if you disagree with the stipulation</h4> <ul> <li>If you disagree with the IRB’s recommendations and do not wish to make a certain change, provide rationale for not making the change. Without an explanation, the response will not be complete and approval may be delayed.</li> </ul> <h4>Make general comments about the response (optional)</h4> <ul> <li>If you have any general comments to submit with your response, include them in the "Response Comments" section at the bottom of the form.</li> </ul> <h2><a id="components" name="components"></a>Revising the Submission Components</h2> <p>If you need to revise any portion of your study or submit new documents, you must attach the revised or new items. When revising consent forms or other study documents, do NOT highlight or track your changes.</p> <p>See the <a href="https://iris-help.ucsf.edu/irb-iris" target="_self">Submission Correct quick guide</a> (also available in the Help section of iRIS) for more information and screenshots. If you need additional help or have questions about the stipulations, <a href="/contact-us">contact the IRB analyst</a> assigned to the submission.</p> <h3>Reminder: Use standard treatment and compensation for injury consent form statement</h3> <p>If research-related injury is possible in research that is <a href="/levels-review">more than minimal risk</a>, you must include the standard <a href="/treatment-and-compensation-injury">Treatment and Compensation for Injury wording in the consent form</a> verbatim. Your response cannot be approved if different wording is used.</p> <h2> </h2> </div></div></div> </div> </div> </div> </div> <div id="block-views-last-updated-block" class="block block-views"> <div class="content"> <div class="view view-last-updated view-id-last_updated view-display-id-block view-dom-id-14631d1c99239528cd1f0a98ef2d9c15"> <div class="view-content"> <div> <p class="updated-date"> <span>Last updated: </span> August 27, 2024 </p> </div> </div> </div> </div> </div> </div> </div> </div> <div id="sidebar" class="column"> <div class="sidebar"> <div class="section"> <div class="region region-sidebar"> <div id="block-block-16" class="block block-block"> <h3>Quicklinks </h3> <div class="content"> <p><a class="btn--large btn--more--reverse btn--full-width" href="https://ucsf.co1.qualtrics.com/jfe/form/SV_06qk41JwVXpOdMx"><font color="yellow">Questions? </font><font color="lightseagreen">Ask Andy</font> (<font color="lightseagreen">An</font>alyst of the <font 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