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href="/guidance">Guidance A to Z</a></li> </ul></li> </ul></div> </div> </div> </div> </div> </div> <div id="breadcrumb" class="row-full-width"><div class="inside"><h2 class="element-invisible">You are here</h2><div class="breadcrumb"><a href="/">Home</a> > <a href="/program-description" class="active">About Us</a> > <span class="breadcrumb-page-title">About Us</span></div></div></div> <h1 class="title" id="page-title">Participating in Research</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-156" class="node node-page slider-secondary clearfix" about="/participating-research" typeof="sioc:Item foaf:Document"> <span property="dc:title" content="Participating in Research" 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="#overview">Overview</a></li> <li><a href="#finding">Finding a Research Study</a></li> <li><a href="#before">Before Participating in a Study</a></li> <li class="bodyText"><a href="#survey">Research Participant Survey</a></li> <li class="bodyText"><a href="#studydata">Research Participant Study Data</a></li> <li><a href="#concerns">Concerns or Complaints</a></li> </ul> <h2 class="MsoNormal" style="margin-bottom: 0.0001pt; line-height: normal;"><a id="overview" name="overview"></a>Overview</h2> <p>Volunteering to be in a research study is an important decision. Research is the way doctors and scientists learn about new ways to prevent and treat illness in people, and find answers to the many questions about health, disease or human behavior. It is sometimes called “human research” or a “clinical trial.”</p> <p>There are different ways volunteers participate in research. For example, volunteers may participate by:</p> <ul> <li>Completing a questionnaire about their health or behaviors, or answering questions in an interview with researchers.</li> <li>Donating specimens, such as a tube of blood or a tissue sample.</li> <li>Taking part in a clinical research study to find out if new treatments, or new ways of using known treatments, are safe and effective to use in people.</li> </ul> <p>Research may take place in a variety of locations, including a hospital, doctor's office, nursing home, or even a classroom or via an online survey.</p> <h2><a id="finding" name="finding"></a>Finding a Research Study</h2> <p>These online resources can help you find research studies at UCSF or other institutions.</p> <ul> <li><a href="http://clinicaltrials.ucsf.edu/" target="_blank">UCSF Clinical Trial Finder</a> and <a href="http://www.ucsf.edu/research/clinical-trials-overview">UCSF Clinical Trials Overview</a>—<span class="large"> Includes info on clinical trials and a searchable database of clinical trials at UCSF.</span></li> <li><a href="http://hub.ucsf.edu/who-you-are/participants" target="_blank">UCSF Clinical Research HUB: Resources for Participants</a> <span style="font-size: 12.0pt; font-family: Arial; mso-fareast-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;">–</span> Provides links to clinical trials at UCSF and describes what you should know before joining a study, why clinical trials are important and more.</li> <li><a href="http://clinicaltrials.gov/" target="_blank">ClinicalTrials.gov</a><span class="large"> <span style="font-size: 12.0pt; font-family: Arial; mso-fareast-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;">–</span> </span>A registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.</li> </ul> <h2><a id="before" name="before"></a>Before Participating in a Study</h2> <p>Before deciding to participate in a research study, please review these helpful materials:</p> <ul> <li><a href="http://hrpp.ucsf.edu/sites/hrpp.ucsf.edu/files/volunteering-for-research.pdf" target="_blank">Information for Prospective Volunteers</a> – Provides information you should consider if you are thinking about being in a research study.</li> <li><a href="http://hrpp.ucsf.edu/sites/hrpp.ucsf.edu/files/volunteers-questions.pdf" target="_blank">Questions to Ask the Research Team</a> – Includes common questions you may want to discuss with the researchers.</li> <li><a href="http://hub.ucsf.edu/who-you-are/participants">UCSF Clinical Research HUB</a> – Provides many resources for individuals who are considering participating in a research study.</li> </ul> <h2 class="bodyText"><a id="survey" name="survey"></a>Research Participant Survey</h2> <p>If you have participated in research at our facilities, please complete our <a class="large" href="https://ucsf.co1.qualtrics.com/SE/?SID=SV_3yLN1xEYCixSOZn" target="_blank">Research Participant Survey</a> . Your feedback will help us evaluate how effective we are in providing information to our research participants. The survey is completely anonymous.</p> <h2><a id="studydata" name="studydata"></a>Research Participant Study Data</h2> <p>In general, release of individual study data and return of results to participants is only permitted when:</p> <ul> <li>It is a component of the IRB approved research protocol</li> <li>Identified in the IRB approved consent form</li> </ul> <p>If a participant requests their individual data or return of results, the IRB may determine that a participant’s request may be accommodated based on:</p> <ol> <li>Whether the data collection tools are validated</li> <li>How the data are planned to be used. The IRB may determine that it is not appropriate to release individual participant data if there is a possibility that the data may be misused (e.g. clinical purposes when not appropriate).</li> <li>Evaluating the process for sharing the data. One of the considerations in evaluating whether the process for sharing is appropriate is based on whether the study team involves appropriate research personnel or clinical staff to provide counseling for the participant. The IRB may require that key personnel be added to the study to facilitate the appropriate sharing method.</li> </ol> <p>Under no circumstances will the IRB permit disclosing individual participant data associated with investigational, unvalidated assays as they can be harmful when used to guide clinical decisions.</p> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p>Participant Rights under HIPAA, CIPA and The Common Rule?</p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p>UCSF is a hybrid entity comprised of a covered health care component (UCSF Health) and a non-covered component (Campus). The research function is excluded from HIPAA coverage at UC, which means that any research data that is not associated with a health care service is considered research health information (RHI), and not PHI; accordingly, RHI is not subject to the HIPAA Privacy and Security Rules, although other privacy laws and human subjects regulations may apply.</p> <p>With few exceptions, federal and state privacy laws give patients the right to inspect and obtain a copy of their health information that is maintained by a covered entity or its business associate in a “designated record set.” A designated record set is a group of records which a covered entity uses to make decisions about individuals, and includes a health care provider’s medical records and billing records, and a health plan’s enrollment, payment, claims adjudication, and case or medical management record systems. While it’s unlikely that a researcher would be maintaining a designated record set, any research records or results that are maintained by the covered entity as part of a designated record set would be accessible to research participants unless one of the Privacy Rule’s permitted exceptions applies.</p> <p>One of the permitted exceptions applies to protected health information (PHI) created or obtained by a covered health care provider/researcher for a clinical trial. The Privacy Rule permits the individual’s access rights in these cases to be suspended while the clinical trial is in progress, provided the research participant agreed to this denial of access when consenting to participate in the clinical trial. In addition, the health care provider/researcher must inform the research participant that the right to access protected health information will be reinstated at the conclusion of the clinical trial. </p> <p>California’s Information Practices Act (CIPA) and Patient Access to Health Records Act (PAHRA) also give patients access rights. Under CIPA, the study is not required to disclose personal information if it pertains to the physical/psychological condition of the person, if the study determines that disclosure would be detrimental to the person. However, the information shall, upon the individual’s written authorization, be disclosed to a licensed medical practitioner or psychologist designated by the person. <a href="https://leginfo.legislature.ca.gov/faces/codes_displayText.xhtml?lawCode=CIV&division=3.&title=1.8.&part=4.&chapter=1.&article=8">Cal. Civ. Code Sec. 1798.40(f)</a>.</p> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p>Common Rule Provisions</p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p>The Common Rule requires that research subjects be informed whether clinically relevant research results, including individual research results, will be disclosed to subjects, and under what conditions. 45 C.F.R. § 46.116(c)(8), (d)(6). <strong>However, the law is silent as to the circumstances in which research results should be returned to subjects. </strong></p> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p>Sharing Individual, clinically relevant data</p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p>It is appropriate to share clinically relevant data to individual research participants when the plan to share is IRB approved via Initial IRB approval or when it is approved via a study modification.</p> <p>Factors to consider:</p> <ul> <li>Ensure that the Informed Consent document adequately informs participants that they can expect to receive their research results.</li> <li>Available resources for participants for follow up care if necessary</li> <li>Appropriate study staff with for the clinically relevant expertise</li> </ul> </div> </div> <h2><a id="concerns" name="concerns"></a>Concerns or Complaints</h2> <p>If you have concerns or complaints, please follow the steps outlined in the <a href="http://hrpp.ucsf.edu/reporting-research-concerns-and-complaints">Reporting Research Concerns and Complaints</a> page<span class="large">. </span><strong>The HRPP takes all research concerns and complaints very seriously. </strong></p> </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-d438e6058b7fe24a2223070aeccbfed8"> <div class="view-content"> <div> <p class="updated-date"> <span>Last updated: </span> October 6, 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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