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Illiterate, or Cannot Talk or Write</h1> <div class="content-top"> </div> <div id="main-wrapper"> <div id="main" class="clearfix"> <div id="content" 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-752" class="node node-page slider-secondary clearfix" about="/enrolling-subjects-who-are-legally-blind-illiterate-or-cannot-talk-or-write" typeof="sioc:Item foaf:Document"> <span property="dc:title" content="Enrolling Subjects Who Are Legally Blind, Illiterate, or Cannot Talk or Write" 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="#blind">Legally Blind Subjects</a></li> <li><a href="#illiterate">Illiterate Subjects</a></li> <li><a href="#talk">English-Speaking Subjects Who Cannot Talk or Write</a></li> </ul> <p><strong>Important note</strong>: It is always the investigator鈥檚 responsibility to judge the subject鈥檚 comprehension of the consent information including the understanding that participation is voluntary and that the subject has the right to withdraw at any time during the study. If you doubt聽the subject鈥檚 consent comprehension, do not enroll the subject in the study.</p> <p>If you are obtaining informed consent from a community that doesn鈥檛 have a written language (e.g., Mam): Oral presentation of the informed consent form and Bill of Rights in their native language via interpreter, and follow the instructions for <a href="#illiterate">Illiterate Subjects</a>.</p> <h3><a id="blind" name="blind"></a>Legally Blind Subjects</h3> <p>If you are enrolling subjects who cannot read the consent materials due to blindness, or if the subject鈥檚 legally authorized representative is legally blind:</p> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p><a class="vtab">Oral presentation of consent materials</a></p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p>Orally present the IRB-approved consent materials. Allow sufficient time for questions to be asked and answered, both by the subject and by the person obtaining consent to ensure the subject comprehends the consent information.</p> <p>Note: The聽<a href="/experimental-subjects-bill-rights">California Experimental Participants Bill of Rights</a>聽(required for biomedical studies)聽is available in Braille. Call the IRB office at 415-476-1814 for a copy.</p> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p><a class="vtab">Impartial witness</a></p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p>It is recommended that an impartial witness observe the consent process.</p> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p><a class="vtab">Video/audio recording</a></p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p>Consider using a video/audio recording of the consent discussion as part of the documentation of informed consent.</p> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p><a class="vtab">Documentation/signatures</a></p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p>These recommendations are consistent with guidance endorsed by the FDA and set forth by the <a href="http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf" target="_blank">ICH E-6 4.8.9</a>. If the subject (or subject鈥檚 legally authorized representative) verbally agrees to participate in the study:</p> <ul> <li>Subject (if capable of doing so):聽Signs and personally dates the consent form.</li> <li>Witness: Signs and personally dates the consent form. By doing so, the witness attests that the consent information was accurately explained and that the subject apparently understood the information, and informed consent was given freely.</li> <li>Person obtaining consent: Signs and dates the consent form.</li> <li>Give a signed copy to the subject.</li> </ul> </div> </div> <h2><a id="illiterate" name="illiterate"></a>Illiterate Subjects</h2> <div class="vtab-content"> <ul> </ul> </div> <p>If you are enrolling subjects who cannot read the consent materials due to illiteracy:</p> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p><a class="vtab">Oral presentation of consent materials</a></p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p>Orally present the consent materials, including the <a href="/experimental-subjects-bill-rights">California Experimental Participants Bill of Rights</a> if enrolling in a biomedical study.聽Allow sufficient time for questions to be asked and answered, both by the subject and by the person obtaining consent to ensure the subject comprehends the consent information.</p> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p><font color="#0071ad">Impartial witness</font></p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p>It is recommended that an impartial witness observe the consent process</p> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p><a class="vtab">Video/audio recording</a></p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p>Consider using a video/audio recording of the consent discussion as part of the documentation of informed consent.</p> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p><a class="vtab">Documentation/signatures</a></p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p>These recommendations are consistent with guidance endorsed by the FDA and set forth by the聽<a href="http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf" target="_blank">ICH E-6 4.8.9</a>. If the subject verbally agrees to participate in the study:</p> <ul> <li>Subject (if capable of doing so):聽Signs or marks an X to signify consent.</li> <li>Witness: Signs and personally dates the consent form. By doing so, the witness attests that the consent information was accurately explained and that the subject apparently understood the information, and informed consent was given freely.</li> <li>Person obtaining consent: Signs and dates the consent form.</li> <li>Give a signed copy to the subject.</li> </ul> </div> </div> <h2><a id="talk" name="talk"></a>English-Speaking Subjects Who Cannot Talk or Write</h2> <div class="vtab-content"> <ul> </ul> </div> <p>Consistent with the FDA guidance, a person who can understand and comprehend spoken English, but is physically unable to talk or write, can be entered into a study if they are competent and able to indicate approval or disapproval by other means.</p> <p>If the person (1)聽retains the ability to understand the concepts of the study and evaluate the risk and benefit of being in the study when it is explained verbally (still competent) and (2) is able to indicate approval or disapproval to study entry, he/she may be entered into the study.聽Obtain and document informed consent聽as follows:</p> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p><a class="vtab">Oral presentation of consent materials</a></p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p>Orally present the consent materials, including the <a href="/experimental-subjects-bill-rights">California Experimental Participants Bill of Rights</a> if enrolling in a biomedical study.聽Allow sufficient time for questions to be asked and answered, both by the subject and by the person obtaining consent to ensure the subject comprehends the consent information.</p> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p><font color="#0071ad">Impartial witness</font></p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p>An impartial witness should be present during the entire consent discussion.聽</p> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p><a class="vtab">Video/audio recording</a></p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p>Consider using a video/audio recording of the consent discussion as part of the documentation of informed consent.</p> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p><a class="vtab">Documentation/signatures</a></p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p>If the subject indicates agreement to participate in the study:</p> <ul> <li>Annotate聽the consent form by hand to describe the method used for communication with the subject and the specific means by which the聽subject communicated agreement to participate in the study.</li> <li>Witness: Signs and personally dates the consent form. By doing so, the witness attests that the consent information was accurately explained and that the subject apparently understood and informed consent was given freely.</li> <li>Person obtaining consent: Signs and dates the consent form.</li> <li>Give a signed copy to the subject.</li> </ul> </div> </div> <p>聽</p> <div class="vtab-content"> <ul> </ul> </div> </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-08511f1e95c7f72562f8d6e1f0ad4f23"> <div class="view-content"> <div> <p class="updated-date"> <span>Last updated: </span> September 27, 2023 </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? 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