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Research Compliance - Fairview Health Services

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href="https://web.archive.org/web/20101204081900/http://www.range.fairview.org/">Fairview - University Medical Center - Mesabi</a></li> </ul> </div> </div> <p><br/> <img height="18" alt="Map a hospital near you" width="18" border="0" src="/web/20101204081900im_/http://www.fairview.org/fv/groups/internet/documents/web_assets/fv_map-icon.gif"/> <a href="https://web.archive.org/web/20101204081900/http://www.fairview.org/Hospitals/index.htm">Map a hospital near you</a></p> </div> </div> <div class="menuBottomB png"></div> </div> <!-- END hospitals_subMenu --> <!-- clinics_subMenu --> <div id="clinics_subMenu" class="dropDNmenuB menuTopPosA" style="display:none"> <div class="menuTopB png"></div> <div class="menuContentB"> <div id="Menu2"> <h2>Clinic Quick Search:</h2> <form action="https://web.archive.org/web/20101204081900/http://www.fairview.org/SearchResults/index.htm" method="get"> <div class="quickSearchB_bgnd" style="float: left"><input class="dropDNmenu_search_inputField" 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onfocus="clearDefault(this)" name="ssUserText" value="Search by specialty" type="text"/><input type="hidden" name="qVar1" value="specialty"/></div> <div class="quickSearch_submitBTN" style="float: left"><input id="submit4" type="image" src="/web/20101204081900im_/http://www.fairview.org/fv/groups/internet/documents/web_assets/fv_searchbtn_lrg.gif" name="submit" value="submit"/></div> <div class="clear">&nbsp;</div> </form> <div class="dropDnContentBox" style="float: left; width: 150px; margin-right: 30px"> <h2>Services:</h2> <div class="arrowList"> <ul> <li><a target="" href="https://web.archive.org/web/20101204081900/http://www.fairview.org/Services/Audiology/">Audiology</a></li> <li><a target="" href="https://web.archive.org/web/20101204081900/http://www.fairview.org/Services/CancerCare/">Cancer Care</a></li> <li><a target="" href="https://web.archive.org/web/20101204081900/http://www.fairview.org/Services/HeartCare/index.htm">Heart</a> and <a target="" href="https://web.archive.org/web/20101204081900/http://www.fairview.org/Services/ArteryVeinCare/index.htm">Vascular</a></li> <li><a target="" href="https://web.archive.org/web/20101204081900/http://www.fairview.org/Services/OrthopedicMedSurgery/index.htm">Orthopedics</a></li> <li><a target="" href="https://web.archive.org/web/20101204081900/http://www.fairview.org/Services/SeniorServices/index.htm">Senior Services</a></li> <li><a target="" href="https://web.archive.org/web/20101204081900/http://www.fairview.org/Services/WomensServices/index.htm">Women&rsquo;s Health</a><br/> &nbsp;</li> <li><a target="" href="https://web.archive.org/web/20101204081900/http://www.fairview.org/Services/index.htm"><strong>View All Services</strong></a></li> </ul> </div> </div> <div class="dropDnContentBox" style="float: left; width: 160px"> <h2>Most Popular:</h2> <div class="arrowList"> <ul> <li><a href="https://web.archive.org/web/20101204081900/http://www.fairview.org/UrgentCare/index.htm">Express 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<div class="menuContentA"> <div id="Menu5"> <h2>Health Library Quick Search:</h2> <form action="https://web.archive.org/web/20101204081900/http://www.fairview.org/healthlibrary/Search/index.htm" method="get"> <div class="quickSearchA_bgnd" style="float: left"><input class="dropDNmenu_search_inputField" onfocus="clearDefault(this)" name="search" value="Search by name, specialty or location" type="text"/></div> <div class="quickSearch_submitBTN" style="float: left"><input id="submit5" type="image" src="/web/20101204081900im_/http://www.fairview.org/fv/groups/internet/documents/web_assets/fv_searchbtn_lrg.gif" name="submit" value="submit"/></div> <div class="clear">&nbsp;</div> </form> <div class="dropDnContentBox" style="float: left; width: 150px; margin-right: 30px"> <h2>Health Advisors:</h2> <div class="arrowList"> <ul> <li><a href="https://web.archive.org/web/20101204081900/http://www.fairview.org/healthlibrary/S_014418">Cardiology</a></li> <li><a href="https://web.archive.org/web/20101204081900/http://www.fairview.org/healthlibrary/S_014423">Emergency and Trauma</a></li> <li><a href="https://web.archive.org/web/20101204081900/http://www.fairview.org/healthlibrary/S_014439">Eye Health</a></li> <li><a href="https://web.archive.org/web/20101204081900/http://www.fairview.org/healthlibrary/S_014430">Medications</a></li> <li><a href="https://web.archive.org/web/20101204081900/http://www.fairview.org/healthlibrary/S_014431">Mental Health</a></li> <li><a href="https://web.archive.org/web/20101204081900/http://www.fairview.org/healthlibrary/S_014440">Orthopedics</a></li> <li><a href="https://web.archive.org/web/20101204081900/http://www.fairview.org/healthlibrary/S_014443">Pediatrics</a></li> <li><a href="https://web.archive.org/web/20101204081900/http://www.fairview.org/healthlibrary/S_014451">Senior Health</a></li> <li><a href="https://web.archive.org/web/20101204081900/http://www.fairview.org/healthlibrary/S_014436">Women&rsquo;s Health</a></li> </ul> </div> </div> <div class="dropDnContentBox" style="float: left; width: 160px"> <h2>Health Tools:</h2> <div class="arrowList"> <ul> <li><a href="https://web.archive.org/web/20101204081900/https://sslforms.fairview.org/staywell/quizzes.aspx">Health Quizzes</a></li> <li><a href="https://web.archive.org/web/20101204081900/https://sslforms.fairview.org/staywell/calculators.aspx">Health Calculators</a></li> <li><a href="https://web.archive.org/web/20101204081900/https://sslforms.fairview.org/staywell/assessments.aspx">Risk Assessments</a></li> </ul> </div> </div> <div class="clear">&nbsp;</div> </div> </div> <div class="menuBottomA png"></div> </div> <!-- END healthLib_subMenu --> <!-- about_subMenu --> <div id="about_subMenu" class="dropDNmenuB menuTopPosA" style="display:none"> <div class="menuTopB png"></div> <div class="menuContentB"> <div id="Menu6"> <h2>Employee Quick Search:</h2> <form 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href="https://web.archive.org/web/20101204081900/http://www.fairview.org/careers/index.htm">Careers at Fairview</a></li> <li><a target="" href="https://web.archive.org/web/20101204081900/http://www.fairview.org/About/Communitycommitment/">Community commitment</a></li> <li><a target="" href="https://web.archive.org/web/20101204081900/http://www.fairview.org/About/Contact/">Contact Fairview</a></li> <li><a target="" href="https://web.archive.org/web/20101204081900/http://www.fairview.org/About/MediaCenter/">Fairview news</a></li> <li><a target="" href="https://web.archive.org/web/20101204081900/http://www.fairview.org/giving/index.htm">Giving to Fairview and Ebenezer</a></li> <li><a target="" href="https://web.archive.org/web/20101204081900/http://www.fairview.org/About/S_014291">Innovation</a></li> <li><a target="" href="https://web.archive.org/web/20101204081900/http://www.fairview.org/Research/">Research</a></li> <li><a target="" href="https://web.archive.org/web/20101204081900/http://www.fairview.org/About/S_002704">Welcome to Fairview</a></li> <li><a target="" href="https://web.archive.org/web/20101204081900/http://www.fairview.org/about/">Visit our About home page</a>&nbsp;&nbsp;</li> </ul> </div> </div> </div> </div> <div class="menuBottomB png"></div> </div> <!-- END about_subMenu --> <!-- patient_subMenu --> <div id="patient_subMenu" class="dropDNmenuB menuTopPosA" style="display:none"> <div class="menuTopB png"></div> <div class="menuContentB"> <div id="Menu7"> </div> </div> <div class="menuBottomB png"></div> </div> <!-- END patient_subMenu --> <!-- END subNav layers --> <!-- logoNav --> <div id="fairviewLogo"><a href="/web/20101204081900/http://www.fairview.org/index.htm"><img src="/web/20101204081900im_/http://www.fairview.org/fv/groups/internet/documents/web_assets/fv_logo1.gif" alt="Fairview" width="182" height="32" border="0"/></a></div> <div class="assistTools"> <div class="liveSupportBTN" 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src="/web/20101204081900im_/http://www.fairview.org/fv/groups/internet/documents/web_assets/fv_print.jpg" width="46" border="0"></a></span> </div> <!-- SS_END_SNIPPET(fragment4,Drop Point)--> <!--Sub Left--> <div id="sub-left"> <div id="nav-container"><!-- SS_BEGIN_SNIPPET(fragment2,2)--> <div class="smaller" style="text-transform: uppercase; font-weight: lighter">&lt; <a href="/web/20101204081900/http://www.fairview.org/index.htm">Home</a></div> <h2><a href="/web/20101204081900/http://www.fairview.org/Research/index.htm">Research</a></h2> <div class="sidebarNav sidebarNavLinks"> <ul> <li> <a href="/web/20101204081900/http://www.fairview.org/Research/Administration/index.htm">Research administration&nbsp;</a> </li> <li> <a class="focus" href="/web/20101204081900/http://www.fairview.org/Research/Forresearchers/index.htm">For researchers&nbsp;</a> <ul> <li> <a href="/web/20101204081900/http://www.fairview.org/Research/Forresearchers/Researchaccountsandbilling/index.htm">Research accounts and billing&nbsp;</a> </li> <li> <a href="/web/20101204081900/http://www.fairview.org/Research/Forresearchers/Researchagreementsandcontracts/index.htm">Research agreements and contracts&nbsp;</a> </li> <li> <a href="/web/20101204081900/http://www.fairview.org/Research/Forresearchers/Researchpersonnelrequirements/index.htm">Research personnel requirements&nbsp;</a> </li> <li> <a class="focus" href="/web/20101204081900/http://www.fairview.org/Research/Forresearchers/Researchcompliance/index.htm">Research compliance&nbsp;</a> <ul> </ul> <li> <a href="/web/20101204081900/http://www.fairview.org/Research/Forresearchers/Humansubjectsprotections/index.htm">Human subjects protections&nbsp;</a> </li> <li> <a href="/web/20101204081900/http://www.fairview.org/Research/Forresearchers/Quickreference/index.htm">Quick reference&nbsp;</a> </li> </ul> <li> <a href="/web/20101204081900/http://www.fairview.org/Research/Forstudysponsors/index.htm">For study sponsors&nbsp;</a> </li> <li> <a href="/web/20101204081900/http://www.fairview.org/Research/Forstudyvolunteers/index.htm">For study volunteers&nbsp;</a> </li> <li> <a href="/web/20101204081900/http://www.fairview.org/Research/trials/index.htm">Clinical trials search&nbsp;</a> </li> </ul> </ul> </div> <!-- SS_END_SNIPPET(fragment2,2)--></div><!-- SS_BEGIN_SNIPPET(fragment3,Display)--><div class="left-action-btns"> <div class="appt-btn"><a href="https://web.archive.org/web/20101204081900/http://sslforms.fairview.org/ClinicAppointment/AppointmentRequest.asp"><img height="25" alt="Request Appointment" src="/web/20101204081900im_/http://www.fairview.org/fv/groups/internet/documents/web_assets/fv_make-appt.gif" width="131" border="0"></a></div> <div class="help-btn"><a href="https://web.archive.org/web/20101204081900/https://www.fairview.org:8089/ci/index.jsp?loc=defaultfv"><img height="25" alt="Live Help" src="/web/20101204081900im_/http://www.fairview.org/fv/groups/internet/documents/web_assets/fv_live-help.gif" width="64" border="0"></a></div></div> <div class="clear"></div> <!-- SS_END_SNIPPET(fragment3,Display)--> <div class="clear"></div><!-- SS_BEGIN_OPENREGIONMARKER(region3)--> <!-- SS_END_OPENREGIONMARKER(region3)--> <div class="txtBox" id="leftAddress"><!--SS_BEGIN_ELEMENT(region3_element1)--><div><strong>Fairview Research Administration</strong></div><div>2200 Riverside Ave.</div><div>Minneapolis, MN&nbsp; 55454</div><div><em>Phone:</em> 612-672-7690</div><div><em>Fax:</em> 612-672-7691</div><div>&nbsp;</div><div><span class="emphasis">Research Helpline: </span>612-672-7692</div><div><em>or toll free </em>1-866-508-6961</div><p>&nbsp;</p><!--SS_END_ELEMENT(region3_element1)--></div><!-- SS_BEGIN_CLOSEREGIONMARKER(region3)--><!-- SS_END_CLOSEREGIONMARKER(region3)--> </div><!--Sub Right--> <div id="sub-right"><!-- SS_BEGIN_OPENREGIONMARKER(region1)--> <!-- SS_END_OPENREGIONMARKER(region1)-->&nbsp;&nbsp; <div id="content" style="MIN-HEIGHT: 500px; WIDTH: 618px"> <h3><!--SS_BEGIN_ELEMENT(region1_element1)-->Research Compliance<!--SS_END_ELEMENT(region1_element1)--></h3> <p><!--SS_BEGIN_ELEMENT(region1_element2)--><div style="line-height: 12pt">Fairview Research Administration can provide assistance with any research-related compliance concerns or questions, including the following:</div><div style="line-height: 12pt">&nbsp;</div><ul><li><a target="" href="#ResearchDocInMRAnchor">Required Research Documentation in Medical Records</a></li><li><a target="" href="#HIPAAandResearchAnchor">HIPAA and Research</a></li><li><a target="" href="#RSRCAnchor">Fairview Research Scientific Review Committee</a></li><li><a target="" href="/web/20101204081900/http://www.fairview.org/Research/Forresearchers/Researchcompliance/Researchpolicies/S_014248">Fairview Research&nbsp;Policies</a></li></ul><div>&nbsp;</div><div><strong>Contact Information for Questions or Concerns</strong></div><div>Research Regulatory Affairs Officer, Fairview Research Administration</div><div>Phone: 612-672-7680</div><div>&nbsp;</div><div>&nbsp;</div><h4><strong><a name="ResearchDocInMRAnchor"></a>Required Research Documentation in Medical Records</strong></h4><div style="line-height: 12pt">Fairview requires some amount of research documentation in their patients&rsquo; medical record (MR) to further patient safety, continuity of care and billing compliance. <a target="" href="/web/20101204081900/http://www.fairview.org/Research/Forresearchers/Researchcompliance/S_033237">Fairview's research documentation policy</a><span class="red"> </span>says researchers enrolling Fairview patients or seeing study participants at Fairview facilities are required to provide study-specific documentation in their participants&rsquo; Fairview MRs.</div><div>&nbsp;</div><div style="line-height: 12pt"><b>Required Research Elements </b></div><div style="line-height: 12pt">At a minimum, researchers are required to document four basic research (study-specific) elements</div><ul><li>University of Minnesota Institutional Review Board (IRB) number</li><li>Principal Investigator&rsquo;s phone and pager number</li><li>Study Coordinator&rsquo;s phone and if applicable, pager number</li><li>Date of patient enrollment into the study and expected length of participation</li></ul><div style="line-height: 12pt">&nbsp;</div><div style="line-height: 12pt">Researchers can enter these elements directly in the patient&rsquo;s electronic medical record (EMR) by using the designated research-structured note section -- refer to&nbsp;the <a target="" href="/web/20101204081900/http://www.fairview.org/fv/idcplg?IdcService=GET_FILE&amp;dDocName=S_032124&amp;RevisionSelectionMethod=Latest">EMR note instructions</a>. For paper records, the researchers can complete&nbsp;the <a target="" href="/web/20101204081900/http://www.fairview.org/fv/idcplg?IdcService=GET_FILE&amp;dDocName=S_032125&amp;RevisionSelectionMethod=Latest">paper form</a> to send to Fairview&rsquo;s Health Information Management Services.</div><div style="line-height: 12pt">&nbsp;</div><div style="line-height: 12pt">&nbsp;</div><h4><strong><a name="HIPAAandResearchAnchor"></a>HIPAA and Research</strong></h4><div style="line-height: 12pt"><div style="line-height: normal">Parts of the Health Insurance Portability and Accountability Act (HIPAA)&nbsp;regulations are designed to ensure our patients' privacy and the security of the information we use and retain within Fairview. Researchers accessing, using or retaining protected health information (PHI) of Fairview patients must abide by Fairview&rsquo;s HIPAA-related policies.</div><div style="line-height: normal">&nbsp;</div><div style="line-height: normal"><strong>Related Policies</strong></div><ul><li><a target="" href="/web/20101204081900/http://www.fairview.org/Research/Forresearchers/Researchcompliance/S_033238">Access to PHI for Research Activities</a></li><li><a target="" href="/web/20101204081900/http://www.fairview.org/Research/Forresearchers/Researchcompliance/S_033249">Confidential Information Access</a></li></ul><div>&nbsp;</div><div><strong>Related Forms</strong></div><ul><li><a target="" href="/web/20101204081900/http://www.fairview.org/fv/idcplg?IdcService=GET_FILE&amp;dDocName=S_032126&amp;RevisionSelectionMethod=Latest">Request for External Reviewer Access to Information Systems</a><span class="red"><br/></span></li><li><a target="" href="https://web.archive.org/web/20101204081900/http://www.irb.umn.edu/guidance/hippa.html">Institutional Review Board (IRB) template forms </a></li></ul><div>&nbsp;</div><div><strong>Reporting Privacy Breaches</strong></div><div style="line-height: normal">If a patient&rsquo;s privacy (such as PHI) is breached to an unauthorized individual or entity, then federal law requires that the breach be evaluated to determine if the patient should be notified. In order to comply with this law, Fairview Health Services requires that all breaches involving Fairview patients or research participants immediately be reported as follows:</div><ul><li>Report privacy breaches relating to participation in a research study to the Fairview Research Regulatory Affairs Officer at 612-672-7680.</li><li>Breaches relating to patient care, separate from research participation, must be reported to Fairview&rsquo;s Privacy Office at 612-672-5647.</li></ul><div>&nbsp;</div>Whether it is a misdirected fax or mailing or a more serious breach, such as the loss of a external-data drive containing patient information, be sure to report possible breaches as soon as possible. <p>&nbsp;</p><h4><strong><a name="RSRCAnchor"></a>Fairview Research Scientific Review Committee (RSRC)</strong></h4><div><div style="line-height: normal">The University of Minnesota Institutional Review Board (IRB), which is also the IRB for Fairview, requires some studies to undergo <a target="" href="https://web.archive.org/web/20101204081900/http://www.irb.umn.edu/guidance/scientific-review.html">scientific review</a> prior to IRB submission and review. Fairview&rsquo;s Research Scientific Review Committee (RSRC) reviews study protocols, which have not already undergone appropriate scientific review by another peer-review committee (e.g. Fairview Nursing Research Council), for submission to the IRB by Fairview or community researchers.</div><div>&nbsp;</div><div><strong>RSRC Submission Process</strong></div><div>If a study requires RSRC review, the researcher should submit to Fairview Research Administration an electronic copy of the protocol and drafted IRB application (no signatures necessary), along with the Investigator&rsquo;s Brochure or Device User Manual, if available. After the RSRC has reviewed and approved the study, Fairview Research Administration will notify the researcher of any concerns.</div><div>&nbsp;</div><ul><li><a target="" href="/web/20101204081900/http://www.fairview.org/Research/S_033287">RSRC policy and overview</a></li><li>RSRC review fee</li></ul><div>&nbsp;</div><div><strong>Contact Information for Questions or Concerns</strong></div><div>Research Regulatory Affairs Officer, Fairview Research Administration</div><div>Phone: 612-672-7680</div></div></div><div>&nbsp;</div><div>&nbsp;</div><h4>&nbsp;</h4><p>&nbsp;</p><!--SS_END_ELEMENT(region1_element2)--></p> <p>&nbsp;</p></div><!-- SS_BEGIN_CLOSEREGIONMARKER(region1)--><!-- SS_END_CLOSEREGIONMARKER(region1)--></div> <div class="clear"></div></div></div><!-- footer --> <!--stopindex--> <div id="footerContainer" class="footerSwoosh_above png"> <div class="footerNavBox"> <div id="footerNav"> <!--c="so it behaves differently on production"--> <ul> <li class="start"><strong>Inside Fairview</strong>:</li> <li><a href="https://web.archive.org/web/20101204081900/http://www.fairview.org/Hospitals/index.htm">Hospitals</a></li> <li><a href="https://web.archive.org/web/20101204081900/http://www.fairview.org/Clinics/index.htm">Clinics</a></li> <li><a href="https://web.archive.org/web/20101204081900/http://www.fairview.org/Providers/index.htm">Doctors &amp; Providers</a></li> <li><a href="https://web.archive.org/web/20101204081900/http://www.fairview.org/Services/index.htm">Services</a></li> <li><a href="https://web.archive.org/web/20101204081900/http://www.fairview.org/HealthLibrary/index.htm">Health Library</a></li> <li class="end"><a href="https://web.archive.org/web/20101204081900/http://www.fairview.org/About/index.htm">About Fairview</a></li> </ul> <div class="clear">&nbsp;</div> </div> <div id="footerSubNav"> <!--c="so it behaves differently on production"--> <ul><li class="start">&copy; 2010 Fairview Health Services. 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