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<div class='syndicate'><h1>Guidance Regarding Social Media Tools</h1><div><p><strong><em>These guidelines were developed by the NIH Office of Intramural Research and provide best practices when using social media tools and new technologies to recruit to clinical trials.</em></strong></p>
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<p><strong><em>This additional guidance does not change the HHS regulations at 21 CFR Part 56 and 45 CFR Part 46 and implementing guidance at <a href="http://www.fda.gov/RegulatoryInformation/Guidances/ucm126428.htm">http://www.fda.gov/RegulatoryInformation/Guidances/ucm126428.htm</a> and <a href="http://www.hhs.gov/ohrp/policy/clinicaltrials.html">http://www.hhs.gov/ohrp/policy/clinicaltrials.html</a></em></strong></p>
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<h3>Background</h3>
|
||
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<p>NIH Institutes and Centers with intramural programs increasingly rely on the use of new technologies such as social media networks (also known as Web 2.0) for informing potential participants about or recruiting them to clinical trials. Therefore, guidance is needed to define appropriate use of these tools by NIH employees, contractors, or partners who are engaged in OIR recruitment of patients to clinical trials.</p>
|
||
|
||
<h3>Scope</h3>
|
||
|
||
<p>This guidance is focused on social media tools and technologies that allow people to exchange information in real (or delayed time) on platforms that are public — including but not limited to — social networks (such as Facebook), micro blogs (such as Twitter), automated feeds (such as RSS), image/video sharing sites (such as YouTube), social bookmarking services, blogs, forums and other emerging technologies with the purpose of social interaction.</p>
|
||
|
||
<p>These media are inherently different from the print environments that have controlled messages in text where potential subjects come to the announcements of clinical research opportunities by reading papers, magazines, posters, or hearing/seeing radio and television ads that are pre-produced. (When a trial recruiter purchases an ad space or ad time for a recruitment, the information is contained and is placed where one expects it to appear and in the pre-determined form. Outlets are selected to reach appropriate populations.)</p>
|
||
|
||
<p>In the social media environment the movement and placement, context and content of information, may all be manipulated. Also, audiences may be highly-targeted without individuals in those audiences self-selecting to be reached (as in the purchase of a magazine, responding to a poster, or seeing an ad and calling an 800 number.)</p>
|
||
|
||
<h3>Our Responsibility to Protect Potential (or Actual) Study Volunteers</h3>
|
||
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||
<p>To fulfill our responsibilities in using new and social media for recruiting research participants, the Investigators should consider the following questions.</p>
|
||
|
||
<ol class="spaced">
|
||
<li>
|
||
<p>Have I considered the full implications of privacy in this new and less-controlled environment?</p>
|
||
|
||
<p>The Principal Investigator (PI) and Institutional Review Boards (IRB) should assure the procedures followed adequately protect the rights and welfare of the prospective subjects as well as the accuracy of information for decision making. The PI should assure the IRB that the information provided by individuals will be appropriately handled. [As with current policy: A simple statement such as “confidentiality will be maintained” is not sufficient to inform the IRB about the procedures that will be used]. When using social media, PIs need to be familiar with and should describe to the IRB the privacy/confidential/information practices of any platform being used to collect and store information that is not owned or operated by the U.S. Government. For example, some Web services maintain copies of all information submitted through their sites, including answers to investigator-posted surveys or screening instruments. In this scenario, an individual is no longer providing information solely to the government, but also to a third-party who is not necessarily bound by the same laws and regulations and who can analyze and search the data for its own purposes, monitor it at will, lawfully or unlawfully, or sell it.</p>
|
||
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<p>When considering whether a Third-Party Web site or Application (TPWA) is appropriate for NIH use, you must ensure all uses of Third-Party Web sites and Applications comply with existing OMB Guidance, HHS and NIH policies with respect to privacy, system security and data safeguarding standards.</p>
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<p><a href="http://www.whitehouse.gov/sites/default/files/omb/assets/memoranda_2010/m10-23.pdf">http://www.whitehouse.gov/sites/default/files/omb/assets/memoranda_2010/m10-23.pdf</a></p>
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</li>
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<li>
|
||
<p>I need to carefully consider how my materials will be used.</p>
|
||
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||
<p>Although there has been a historic division between ads that are "purely informational" and "recruitment" ads, in the social media environment, this is much harder to distinguish and monitor. The outreach itself to groups or individuals with disease-specific interest may already allow for intrusion into personal privacy and result in disclosure of personal medical information not only to the PI but others.</p>
|
||
|
||
<p>Investigators need to consider the possible venues of presentation of recruitment materials, including the ability of recruitment services to place ads on Web sites that the Investigators do not choose in advance. Might some of those Web sites be inappropriate for presentation of an NIH recruitment notice?</p>
|
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</li>
|
||
<li>
|
||
<p>Have I controlled my informational data in a locked format?</p>
|
||
|
||
<p>OHRP guidance provides that IRB review and approval is required for any information provided to potential participants beyond a directory listing that includes this basic descriptive information:</p>
|
||
|
||
<ul>
|
||
<li>Study Title</li>
|
||
<li>Purpose of the study (in plain language)</li>
|
||
<li>protocol summary</li>
|
||
<li>basic eligibility criteria</li>
|
||
<li>study site location(s), and</li>
|
||
<li>how to contact the study site for further information</li>
|
||
</ul>
|
||
|
||
<p>With interactive media, the location of the information is not static — (as it is in printed posters, flyers, Web sites), so it is recommended that this information be provided in a controlled, pdf or other locked format, for distribution. If a locked format is not going to be used, the PI should make the IRB aware of how the information will be presented.</p>
|
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</li>
|
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<li>
|
||
<p>Have I made the contact for further information site protected for the privacy of interested individuals?</p>
|
||
|
||
<p>Any contact information (such as a Web mailbox) should bring the interested person behind a security wall for any further information exchange. Until accepted in the study, individuals working on the study may not use intake and inquiry procedures for prior decision-making about potential subjects (e.g. using Google and commercial databases) to determine if someone appears to be an appropriate subject) until the individual has been fully consented.</p>
|
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</li>
|
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<li>
|
||
<p>Do I clearly understand that the interactive nature of social media escalates the speed of interaction, allowing for greater opportunities for errors in protecting private information? Have I planned to obviate those errors?</p>
|
||
</li>
|
||
<li>
|
||
<p>Have I accounted for problems related to the portability and secure handling of information, including the encryption of all government laptops, the encryption of sensitive information during transport, including but not limited to transport across the network or on portable media, and the reporting of unintended breaches of sensitive personal information in the government’s possession?</p>
|
||
|
||
<p><a href="http://www.whitehouse.gov/sites/default/files/omb/memoranda/fy2007/m07-16.pdf">http://www.whitehouse.gov/sites/default/files/omb/memoranda/fy2007/m07-16.pdf</a></p>
|
||
</li>
|
||
<li>
|
||
<p>Have I included my complete strategy for use of the social media and my strategies for protection of privacy and strategies for informed consent explicitly in my proposal to the IRB?</p>
|
||
</li>
|
||
<li>
|
||
<p>Have my team and I clearly understood the invasive nature of joining groups (i.e., support groups, disease groups, advocacy groups, etc.) for the purpose of recruitment? This can undermine the trust of government research and your IC.</p>
|
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</li>
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</ol></div></div>
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<div class="lastupdated">
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<p>This page last reviewed on February 16, 2016</p> </div> </div>
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