Using Social Media in Research: Regulatory and IRB Considerations

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2 Using Social Media in Research: Regulatory and IRB Considerations

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5 About Quorum Review IRB Accredited Fully Accredited by the Association for Accreditation of Human Research ProtectionPrograms (AAHRPP) through 2014 Fully compliant with FDA and OHRP requirements International Boards available for the review of US and Canadian Studies Strong Framework Approx. 180 employees one of the largest IRBs in the US Certified IRB Professionals (CIP) 60% of Affiliated IRB members, 40% of Regulatory staff and 20% of study management & study support positions

6 About Quorum Review IRB 8 Board meetings each week 24-hour site turnaround, 36-hour amendment review, and same day site changes One time CV and audit documentation submission Support available 8am-8pm ET Dedicated Study Manager

7 About Quorum Review IRB Convenient Canadian review Secure portal with Smart Forms, status reports, and approval documents Customized Phase I and Post-Marketing processes Flexible, customized process for AMCs 100% Quality Control on all documents

8 About the Presenters Regulatory Attorneys Mitchell Parrish, JD, CIP Claire Carbary, JD, CIP

9 Presentation Topics Webinar Overview What is Social Media Social Media & Recruitment Social Media, Technology & Communications Social Media & Study Results

10 Webinar Overview

11 About Social Media & Research Why do we need to discuss using social media in research? Social media is being viewed as an increasingly popular and effective tool for recruitment and for communications during research The FDA and OHRP have not produced any guidance on the use of social media

12 FDA Guidance The FDA s Division of Drug Marketing, Advertising, and Communications (DDMAC) was supposed to release draft guidance on the internet and social media by the end of 2010, then first quarter 2011 As of March 30, 2011, the FDA indicated that it has not completed its draft guidance and did not commit to a timetable for completion

13 IRB Issues Even if the FDA does produce guidance, it s unlikely that such guidance will unravel IRB issues relating to the use of social media in research

14 Social Media Defined

15 What is Social Media Social media is an Internet-based mode of communication that allows users to interact with the medium (typically a website) and/or other users of the medium Social media is a broad term that includes social networking (e.g. Facebook and Twitter), social photo and video sharing (e.g. Shutterfly and YouTube), and interactive websites

16 Other Forms of Social Media Blogs An online journal or chronicle updated on a regular basis, which can be published by any individual or company Subject recruitment advertising on blogs can be targeted to specific audiences and topics may seem more personal than with other social media advertising

17 Other Forms of Social Media Podcasts A podcast is a recording of an audio or video broadcast created for downloading onto a digital player for playback Messages about study participation can be part of the actual broadcast (e.g., the principal investigator speaking about the study), or part of the promotion of the podcast

18 Other Forms of Social Media Mobile Technology Sending communications via mobile devices (e.g. text messaging, applications) Such technologies are being used to send study reminders for appointments or visit requirements

19 Social Media & Recruitment Regulatory & IRB Considerations

20 Participant Recruitment Recruiting activities are the beginning of the informed consent process Recruiting Study Subjects Information Sheet, Guidance for Institutional Review Boards and Clinical Investigators Most applicable guidance in knowing how to apply FDA regulations 21 CFR (a), 21 CFR (a), 21 CFR , and also DHHS regulation 45 CFR 46 Also applicable: FDA Information Sheet A Guide to Informed Consent

21 Review of Advertisements Based on FDA guidance, the IRB needs to review social media advertising and recruitment to ensure advertisements... Are not unduly coercive Do not promise or imply a favorable outcome or other benefits beyond what is contained in protocol Do not communicate that the study product is safe or effective for the purposes under investigation

22 Review of Advertisements Do not make claims that the study product is known to be equivalent or superior to any other study product Do not include language indicating that regulatory authorities, such as the FDA and IRB, have approved the research Do not cause therapeutic misconception (e.g. modify the word treatment with a word that does not imply a benefit or explain that a term like new drug means that the study product is investigational)

23 Review of Advertisements Do not promise or imply free medical treatment when the intent is only to say subjects will not be charged for participation in the investigation Do not emphasize the payment Provide information limited to that which subjects need to determine their eligibility and interest Do not include statements that are generally misleading

24 FDA Guidance What advertisements require review? IRBs will review the content of social media ads as they always have with print ads. The question is what social media advertising actually requires review?

25 FDA - Does Not Require Review Communications intended to be seen or heard by health professionals (e.g. doctor-to-doctor letters) News stories Publicity intended for other audiences (e.g. financial page advertisements directed toward prospective investors)

26 FDA - Does Require Review Direct advertising for research subjects, i.e. advertising that is intended to be seen or heard by prospective subjects to solicit their participation in a study Includes, but is not limited to, newspaper, radio, TV, bulletin boards, posters, and flyers

27 Recruitment: IRB Review Review generally is not required for: Information about relevant research conducted outside the study: Includes information on websites, blogs, Facebook, or Twitter General tips and/or resources containing information that is generally accessible on the internet: Copied information from or links to: blogs, news articles or new sources, websites, or other social media pages

28 Recruitment: IRB Review Signs and symptoms of the underlying disease or condition Information, pictures, videos, links or other information posted by a research participant Websites that contain only the following information: Study title, purpose of study, protocol summary, basic eligibility criteria, study site location(s), and how to contact the study site for more information (OHRP Guidance on IRB Review of Clinical Trial Websites) Ex. Clinicaltrials.gov

29 Recruitment: IRB Review Review generally is required for: Direct Advertising This information is presentable in many different forms and can be found on search engines, websites, Facebook, blogs, etc.: Display or Banner Ads Usually placed along the top or right hand side of a web page Rich Media Ads Similar to display or banner ads, but have an element of interactivity, such as a roll over, scroll bar or click for more information

30 Recruitment: IRB Review Paid Search Ads Purchased keywords relevant to the research study, ad appears on the search engine near the search results Likely the information contained on the link page requires review, but not any paid search term In-Text Ads Relevant keywords are selected for intext ads, keywords are highlighted in relevant content throughout a network of sites and, as users roll over keyword, an ad pops up It is the ad that pops up that likely requires review

31 Recruitment: IRB Review Social Network Ads (Ads on Social Network Pages) Similar to paid search ads, these ads appear on social networks (Facebook, MySpace, LinkedIn) based on keyword searches by users, demographics from their profiles, geographic information from their computers, and more Social networks are very targetable given the amount of information users share on their accounts The ad or linked ad likely require review

32 Recruitment: IRB Review Social Network Pages Not only ads on social network pages, but also those pages themselves setup for a specific study Access or privacy settings of page? Is any Protected Health Information (PHI) being recorded? Partial HIPAA Waiver required? Prescreening form? Confidentiality of collected information?

33 Recruitment: IRB Review Blogs Blogs for a specific study containing direct advertising Blog Posts Posts on any blog containing direct advertising Tweets containing direct advertising Texts containing direct advertising

34 Beyond What Requires Review Sending promotional messages about a clinical trial without using the medium in ways typical of a common user Is this an appropriate use of new mediums? Intrusive to potential participants? Soliciting in social network sites or Twitter groups, such as breast cancer support groups, may seem intrusive and inappropriate to members of those groups

35 Beyond What Requires Review Collecting or obtaining PHI from social network sites implicates privacy, confidentiality, and potentially HIPAA concerns; such collection could be akin to collection of data via receptionist scripts FDA Information Sheet, Recruiting Study Subjects provides guidance about questions IRB s should ask when reviewing receptionist scripts: What happens to personal information gathered? Are the data gathered by a marketing company? If so, are names/other information sold to others?

36 Beyond What Requires Review How to review? Timing of review? When necessary, work together with the IRB to determine the best plan for reviewing advertising and recruitment that uses social media

37 Recruitment: IRB Review Key Take Away There are numerous social media formats in which to recruit and advertise, but it is the content of that recruitment that dictates whether IRB review is required There are issues beyond typical print advertisements that require consideration How is the advertising conducted? How to review? Timing of review?

38 Social Media, Technology & Communications Regulatory & IRB Considerations

39 Participant Communications What do the FDA/OHRP say about communications to participants? 21 CFR (a)/45 CFR (a) IRB has authority to approve/require modifications or disapprove all research activities covered by these regulations (a)46.107(a) also makes reference to reviewing specific research activities as a function of the IRB (7)/ (7) the IRB must ensure that the there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data

40 Communications: IRB Review Types of communications during study participation: Online or phone-based diaries, questionnaires Reminders through , Facebook messages, or textbook messages Information about study progress

41 Communications: IRB Review When do these communications require IRB Review? Reminders about a study may not require review (for example an IRB may not require you to submit the phone script for calling a subject to remind them of a study visit) However, if the reminders are sent in a way that increases privacy concerns, for example text message, the IRB may require review Typically, content of diaries and questionnaires requires review; the IRB should be provided information about how these tools will be administered.

42 Communications: IRB Review Where should these communications be described for the IRB? When the communications are going to be standard across the study they should be described in the protocol Sites may also submit their plans for communications to the IRB if they have specific practices

43 Communications: IRB Review Consent Form Notify subjects if these types of communications will be used There may be costs associated with text message for example There is arguably an increased risk to privacy with the use of any of this technology Consider whether an opt-out provision in the consent form is appropriate

44 Communications: IRB Review Key Take Away The IRB may require review of communications via social media or other technologies where they would not require review for using other communication methods The IRB s responsibility to assess risk to privacy is the chief concern when reviewing such communications descriptions of these communications should address privacy risks and steps taken to mitigate these risks

45 Social Media & Study Results Regulatory & IRB Considerations

46 Communicating Study Results Social media may be used to communicate results (e.g. YouTube video; posting on Facebook) If a study remains open while study results are communicated in social medial formats that are provided to participants, this requires review (21 CFR (a)/45 CFR (a) and 21 CFR /45 CFR46.111) However, if a study is closed, IRB review is generally not required

47 Communicating Study Results Using social media to report study results for a closed study may require IRB oversight IF the media functions as: 1) A recruitment tool 2) Re-initiates study activity, or 3) Implicates HIPAA

48 Post-Study Communication: IRB Review Recruitment Tool Social Media that appears to function as advertising or recruitment for a specific future research study are subject to IRB review (e.g. YouTube video presenting study results and providing information about an extension study) Re-initiation of study activity IRB review may be required under if the media re-initiates study activity Example: YouTube video provides information that subjects are required to know for medical or regulatory reasons relating to their participation in the study Example: Facebook message to a participant providing individual study results

49 Post-Study Communication: IRB Review HIPAA The Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L ) As a general rule, social media that reports general aggregate study results to subjects after the study has closed does not implicate HIPAA and IRB considerations of HIPAA-related issues However, release of individual or identifiable information may require further IRB oversight

50 Post-Study Communication: IRB Review Key Take Away A post-study communication may require IRB review depending on the context and content of the message

51 Webinar Summary

52 Webinar Summary In the absence of FDA/OHRP guidance related to social media and research, look to existing regulations and guidance It is important for the IRB and sponsor/cro/investigator to work together to determine what requires review, how the IRB will conduct its review, and the timing of review

53 Questions & Answers

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