Using Social Media in Research

Transcription

Using Social Media in Research
Using Social
Media in Research:
Regulatory and
IRB Considerations
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About the Presenters
Regulatory Attorneys
 Mitchell Parrish, JD, CIP
 Claire Carbary, JD, CIP
Presentation Topics
 Webinar Overview
 What is Social Media
 Social Media &
Recruitment
 Social Media, Technology
& Communications
 Social Media &
Study Results
Webinar
Overview
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
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was supposed to release draft guidance on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it has not completed its draft guidance and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
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
Social Media
Defined
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
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
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
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
Social Media
& Recruitment
Regulatory & IRB Considerations
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 56.109(a),
21 CFR 56.107(a), 21 CFR 56.111, and
also DHHS regulation 45 CFR 46
• Also applicable: FDA Information Sheet –
A Guide to Informed Consent
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
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)
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
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?
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)
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
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
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
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
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 in-
text 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
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
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?
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
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
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?
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
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?
Social Media,
Technology &
Communications
Regulatory & IRB Considerations
Participant Communications
What do the FDA/OHRP say about
communications to participants?
 21 CFR 56.109(a)/45 CFR 46.109(a) IRB has authority to
approve/require modifications or disapprove all research
activities covered by these regulations
 56.107(a)46.107(a) also makes reference to reviewing
“specific research activities” as a function of the IRB
 56.111(7)/ 46.111(7) the IRB must ensure that the “there
are adequate provisions to protect the privacy of subjects
and to maintain the confidentiality of data”
Communications: IRB Review
Types of communications
during study participation:
 Online or phone-based
diaries, questionnaires
 Reminders through email, Facebook
messages, or textbook messages
 Information about study progress
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.
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
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
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
Social Media
& Study Results
Regulatory & IRB Considerations
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 § 56.109(a)/45 CFR 46.109(a)
and 21 CFR § 56.111/45 CFR46.111)
 However, if a study is closed,
IRB review is generally not required
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
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
Post-Study Communication: IRB Review
HIPAA – The Health Insurance
Portability and Accountability Act
(HIPAA) of 1996 (P.L.104-191)
 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
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
Webinar
Summary
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
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