Social Media as a Tool for Research Recruitment IRB Webinars- 11/10/2016

Topics To Be Covered What is social media? Social media as a useful recruitment instrument Examples of how social media could be used for recruitment What do the regulations say? Areas to consider before using social media for recruitment What the IRB needs to know before approval What the IRB does not need to review Questions

What is social media? Internet-based ways of communicating with the platform and its users. Includes social networking websites (Facebook, Pinterest, LinkedIn, Twitter, etc.), social photo and video sharing (You Tube), blogs, podcasts, etc.

Social media as useful recruitment instrument Social media can be a powerful tool for research! Subjects are easily reached and, in some cases, already engaged in the research topic (e.g. contacting a cystic fibrosis [CF] group about related study) Examples: Mayo clinic conducted a study using an online community of women with heart disease. They completed recruitment within a week.

Examples of how social media could be used for recruitment Investigator wants to reach a group of moms in Facebook to ask about their opinions on work/life balance via survey Investigator wants to reach a support group for parents of children suffering from CF to invite them to complete a survey about CF and family financial burdens

Examples of how social media could be used for recruitment Investigator wants to review twitter posts to recruit potential subjects discussing depression and suicidal thoughts VA study wants to use Craigslist to find potential subjects for a PTSD study -Insert your idea here-

What do the Regulations say? HHS regulations do not specifically discuss internet research or recruitment OHRP does not have an official guidance on internet research/recruitment other than placing the recruitment process in general under IRB oversight

What do the Regulations say? FDA prior guidance has stated that listings of clinical trials on websites where the system format limits the provided information to basic descriptive information does not have to be reviewed by the IRB OHRP-SACHRP released a document after a meeting in 2013 The document specified that direct subject recruitment using social media is part of the informed consent process, so should be reviewed by the IRB

What do the Regulations say? OHRP-SACHRP released a document after a meeting in 2013 (cont’d) Any recruitment plan must receive IRB review and approval before being carried out if the information describes research risks, potential benefits, incentives or where identifiable information is solicited to determine eligibility The recruitment tools mentioned: web ads, Twitter streams, blog postings, YouTube videos, push methods such as email solicitations and texts, links to online recruitment sites (e.g Patients Like Me, Inspire). Also other media (TV, newspapers, classified, public transit posters, robo-calls, etc.)

What do the Regulations say? FDA released a guidance in 2014 about use of social media The guidance was directed to the use of social media when promoting already approved products. The guidance information makes investigators responsible for how products are presented in social media, stating that the social media per se cannot be blamed for violations Social media mentioned: Twitter, Facebook, “sponsored links” on search engines such as Google and Yahoo, and other online platforms.

What do the Regulations say? In general, it is left to IRBs to review by following existing regulations, and investigators to consider potential harms.

Before using social media for recruitment… Can I do this? Is this information private? Social media could be considered as fair game, as users should understand that information is never “private” when the platform administrators have access to all data. Regardless, if you are doing research in a private group (for example, a group in Facebook discussing health matters) you should make sure you discuss your plans with the group administrators and IRB. Think what would make you comfortable about interactions you consider “private”. Am I deceiving people to get this information? Using the same example, joining a group under false pretenses, with the purpose of doing recruitment, might not be approvable by IRB.

Before using social media for recruitment… Protecting potential subjects’ privacy and confidentiality How is eligibility info being collected? Are you responding to the whole forum when discussing eligibility with individuals? Must have consent before collecting identifiable private information to screen subjects Is the data you are receiving sensitive or PHI? You may want to avoid receiving PHI and have a more private contact with subjects once they are interested in hearing more about your study

Before using social media for recruitment… Explaining study in a way subjects understand risks vs. benefits Similar to other recruitment materials, make sure you are clear about the purpose of the study, risk, benefits, etc. Take care that flashy marketing tricks do not interfere with necessary content Make sure information not presented in a coercive manner, does not emphasize compensation

What our IRB needs to know before approval? All recruitment materials, as presented to the subjects, need to be submitted to the IRB May get initial IRB approval of text before spending money on ad design – but IRB needs to also review and approve final format Make sure the information provided is accurate and not misleading (as with any recruitment document) If a researcher created a social page for study promotion, that needs to be reviewed There should not be any “spontaneous” contact with subject for recruitment without previous IRB approval

What the IRB does not need to review? Communications that are educational or provide general information about disease symptoms General study publicity: news stories or financial page advertisements Information not generated by sponsors, investigators or agents of either Testimonials, videos, links or other information by a third party (research participant’s post in sponsor webpage) CAUTION: Make sure you look at information posted by subjects to delete any information that could be seen as PHI or misleading

Closing Remarks Despite the lack of guidance on this topic, please work with your IRB in advance when planning to use social media for recruitment Make sure you are mindful of subjects’ privacy and confidentiality when discussing potential study eligibility Do not hesitate to contact us about your plans!

Questions? Your examples?

References SACHRP, Considerations and Recommendations Concerning Internet Research and Human Subjects Research Regulations, with Revisions. March 12-13, 2013 FDA guidance, Guidance for Industry- Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices University of Minnesota IRB, IRB Guidance on Using Social Media for Recruitment of Research Subjects University of Pennsylvania IRB, Guidance on Recruitment and Research using Social Media Gearhart C, IRB Review of the Use of Social Media in Research, Quorum Review Monitor, 2012 Poskin, R, Using Social Media for Participant Recruitment, University of Kentucky. Harvard Catalyst and Petrie-Flom Center, Social Media Use in Research Recruitment: A New Guidance Document, September 21, 2016.

Questions after the webinar Contact the QA and Education Team! Name Phone Maria Davila, MD, CCRC, CIP, Team Lead, QA and Education Consultant (404) 712-0724 Shara Karlebach, WHNP-BC, CIP, QA and Education Consultant (404) 712-0727 Jessica Baker, BS, QA and Education Research Protocol Analyst (404) 712-9698 Clarissa Dupree, BS, QA and Education Analyst Assistant (404) 727-8864