INSTRUCTIONS for USE of THIS TEMPLATE: Use This Template to Create Your Own Consent Cover

INSTRUCTIONS FOR USE OF THIS TEMPLATE: Use this template to create your own Consent Cover Letter.  Delete all instructions in red text and insert your own text where indicated.  Do not adjust the bottom margin or use the footer.  This template is written for use with a questionnaire or survey. Adjust the language as appropriate for the study procedures.  In order to use this document to obtain consent, you MUST request a Waiver of Documentation of Consent in the IRB application.  In order to use this document to obtain Authorization for use of PHI, you MUST request an Alteration of Authorization in the IRB application.

Consent and Authorization Cover Letter <></p><p>The purpose of this research study is <<state purpose of research>>. We are doing this study because <<state the rationale for the study>>. </p><p>Describe procedures (e.g. “I would like to ask you to complete the enclosed questionnaire and return it in the enclosed self-addressed stamped envelope”). If there are any risks or benefits to the participant, please state them here. </p><p>If you have any questions complaints or if you feel you have been harmed by this research please contact <<list contact person, their affiliation (e.g., Department of Psychology, University of Utah) and a phone number>>. </p><p>Contact the Institutional Review Board (IRB) if you have questions regarding your rights as a research participant. Also, contact the IRB if you have questions, complaints or concerns which you do not feel you can discuss with the investigator. The University of Utah IRB may be reached by phone at (801) 581-3655 or by e-mail at irb@hsc.utah.edu. </p><p>It should take <<state amount of time required to complete the study>> to be in this study. Participation in this study is voluntary. You can choose not to take part. You can choose not to finish the questionnaire or omit any question you prefer not to answer without penalty or loss of benefits. By returning this questionnaire, you are giving your consent and authorization to participate and allow us to use information from your medical record, as described below.</p><p>AUTHORIZATION FOR USE OF YOUR PROTECTED HEALTH INFORMATION Include the Authorization and Confidentiality information as outlined:</p><p>Agreeing to this document means you allow us, the researchers in this study, and others working with us to use some information about your health for this research study.</p><p>Ínstitutionª ÍRBª FOOTER FOR IRB USE ONLY Ímage:Stampª Ápprovedª ÁpprovedDateª Version: 102513 Éxpirationª ÉxpirationDateª Ńumberª This is the information we will use and include in our research records: Modify the following list as appropriate – delete or add items as necessary. - Demographic and identifying information like <<name, address telephone number, and email address>> - <<Social Security Number – Tell participants whether they can withhold their social security number and still participate>> - Related medical information about you like <<family medical history, allergies, current and past medications or therapies, and information from physical examinations, such as blood pressure reading, heart rate, temperature, and lab results>> - All tests and procedures that will be done in the study</p><p>How we will protect and share your information:</p><p> We will do everything we can to keep your information private but we cannot guarantee this. Study information will be kept in a secured manner and electronic records will be password protected. Study information may be stored with other information in your medical record. Other doctors, nurses, and third parties (like insurance companies) may be able to see this information as part of the regular treatment, payment, and health care operations of the hospital. We may also need to disclose information if required by law.</p><p> If applicable, please provide a description of the Certificate of Confidentiality and any voluntary disclosure plans by the Investigator(s). For more information regarding Certificates of Confidentiality, please refer to the IRB website.</p><p> In order to conduct this study and make sure it is conducted as described in this form, the research records may be used and reviewed by others who are working with us on this research: o Members of the research team and << insert appropriate institution(s) e.g. University of Utah Health Sciences Center, Primary Children’s Hospital, Shriners Hospital >>; o The University of Utah Institutional Review Board (IRB), who reviews research involving people to make sure the study protects your rights;</p><p>Modify the list below as appropriate - delete or add items as necessary. The examples below are suggestions and may be used as applicable. </p><p> o Other local hospital(s) that we are working with: <<list VA Salt Lake City Health Care System or any other local hospitals where information could be shared>> </p><p>Ínstitutionª ÍRBª FOOTER FOR IRB USE ONLY Ímage:Stampª Ápprovedª ÁpprovedDateª Version: 102513 Éxpirationª ÉxpirationDateª Ńumberª o Other academic research centers we are working with: <<list all other academic centers including those at the University that may not be within UUHSC, and explain their roles in project>> o The study sponsor: <<Name of sponsor>> o A research coordinating office: <<Name of group or company>> o <<Name of federal oversight agencies, i.e. the Food and Drug Administration, Centers for Disease Control, etc.>> o <<Name any other groups that will receive data>></p><p> Include this statement if you will share PHI outside of the University of Utah Health Sciences Center, Primary Children’s Hospital, the VA Salt Lake City Health Care System, and/or Shriners Hospital: If we share your identifying information with groups outside of << insert appropriate institution(s) e.g. University of Utah Health Sciences Center, Primary Children’s Hospital, Shriners Hospital >>, they may not be required to follow the same federal privacy laws that we follow. They may also share your information again with others not described in this form.</p><p> Include this statement if you will not share PHI outside of the University of Utah Health Sciences Center, Primary Children’s Hospital, the VA Salt Lake City Health Care System, and/or Shriners Hospital: If we share your information with groups outside of << insert appropriate institution(s) e.g. University of Utah Health Sciences Center, Primary Children’s Hospital, Shriners Hospital >>, we will not share your name or identifying information. We will label your information with a code number, so they will not know your identity.</p><p> If testing is performed as a result of study participation for any communicable or infectious diseases reportable by Utah State law, the following must be addressed in this section (refer to http://health.utah.gov/epi/report.html for a current list of Utah’s reportable diseases): o Tell the participant about the state reporting. o Describe how results will be given to the participant to comply with state reporting requirements. o Describe the methods or opportunities participants will be given for appropriate counseling and medical care.</p><p> If you do not want us to use information about your health, you should not be part of this research. If you choose not to participate, you can still receive health care services at << insert appropriate institution(s) e.g. University of Utah Health Sciences Center, Primary Children’s Hospital, Shriners Hospital >>. </p><p>What if I decide to Not Participate after I agree to the Consent and Authorization Form? You can tell us anytime that you do not want to be in this study and do not want us to use your health information. You can also tell us in writing. If you change your mind, we will not be able </p><p>Ínstitutionª ÍRBª FOOTER FOR IRB USE ONLY Ímage:Stampª Ápprovedª ÁpprovedDateª Version: 102513 Éxpirationª ÉxpirationDateª Ńumberª to collect new information about you, and you will be withdrawn from the research study. However, we can continue to use information we have already started to use in our research, as needed to maintain the integrity of the research. </p><p>This authorization does not have an expiration date. </p><p>Include the following paragraph if participants will not have access to their information during the study: You have a right to information used to make decisions about your health care. However, your information from this study will not be available during the study; it will be available after the study is finished.</p><p>Conclude with a statement which expresses appreciation for participation.</p><p>Ínstitutionª ÍRBª FOOTER FOR IRB USE ONLY Ímage:Stampª Ápprovedª ÁpprovedDateª Version: 102513 Éxpirationª ÉxpirationDateª Ńumberª</p> </div> <div class="ft-cover"> <a href="#" id="scrollLink"><i class="iconfont icon-top-1-copy i-bottom"></i> Load more</a> </div> </div> </div> </div> </div> </div> <div class="about-item" data-tab-item="article"> <div class="article-container" id="loader"></div> <div class="load-content flex-column-center"> <p class="load-p" id="onLoadMore"><span id="surplus"></span></p> <p class="load-p" id="load-text"></p> </div> <div id="downTop"> <div class="reader-tools-bar"> <div class="tools flex-justify"> <a href="javascript:void(0);" title="previous page" class="tools-prev flex-justify"> <i class="iconfont icon-top-1-copy left"></i> </a> <input type="text" class="page-cur" value="1" /><span class="page-num"> 4</span> <a href="javascript:void(0);" title="next page" class="tools-next flex-justify"><i class="iconfont icon-top-1-copy right"></i></a> </div> <div class="bar-download"> <a href="javascript:;" id="copyLink"><i class="iconfont icon-lianjie i-size"></i> Copy Link</a> </div> </div> </div> </div> </div> </div> </article> <section class="recommend"> <div class="panel-box"> <div class="panel-success"> <div class="panel-heading"> <div class="panel-flex"> <div class="panel-left"> Recommended publications </div> </div> </div> <div class="panel-body"> <ul class="panel-body-ul"> </ul> </div> </div> </div> </section> </div> <div class="rw-right row-pd" id="side-right"> <aside class="side" id="side-list"> <div class="side-download"> <a href="" class="side-load-a flex-justify" title="Download"> <i class="icon-load"></i> <span>Download</span> </a> </div> <div class="side-tag"> <ul class="side-tag-ul"> <li><a href="javascript:;" data-tab-target="featured" class="active">Featured</a></li> <li><a href="javascript:;" data-tab-target="last" class="">Last Commenis</a> </li> <li><a href="javascript:;" data-tab-target="popular" class="">Popular</a></li> </ul> <div class="tab-items"> <div class="tab-item active" data-tab-item="featured"> <ul> <li><a href="/doc/13966629/minnesota-chemical-dependency-program">Minnesota Chemical Dependency Program</a></li> <li><a href="/doc/13966628/lab-predicting-chemical-reactions">Lab: Predicting Chemical Reactions</a></li> <li><a href="/doc/13966627/table-i-9-line-of-sight-annual-attenuation-statistics-at-optical-wavelengths">TABLE I-9 Line-Of-Sight Annual Attenuation Statistics at Optical Wavelengths</a></li> <li><a href="/doc/13966626/has-adopted-the-local-authority-s">Has Adopted the Local Authority S</a></li> <li><a href="/doc/13966625/2-15-jsa-forms-and-workplace-checklist">2.15 JSA Forms and Workplace Checklist</a></li> <li><a href="/doc/13966624/Hiv-Aids-Prevention-Education">Hiv/Aids Prevention Education</a></li> </ul> </div> <div class="tab-item" data-tab-item="last"> <ul> <li><a href="/doc/13966623/the-following-abstract-appeared-recently-in-an-epidemiology-journal">The Following Abstract Appeared Recently in an Epidemiology Journal</a></li> <li><a href="/doc/13966622/employ-appl-attch-c-warr-trac">Employ. 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