This presentation discusses the intersection of social media and human subjects research regulations. It provides an overview of the scope and requirements of HHS regulations for protecting human subjects. It then examines how these regulations apply to using social media for subject recruitment and as a research tool, as well as conducting research on social media. Key issues addressed include informed consent, privacy/confidentiality, risks/benefits, and challenges for IRBs in evaluating this type of research.

1. The Intersection of Social Media
and Human Subjects Research
Laura Odwazny
Department of Health and Human Services
Office of the General Counsel
May 4, 2010
This presentation does not constitute legal advice. The views expressed are the presenter’s
own, and do not bind the U.S. Department of Health and Human Services or its
components.

2. Topics
 Scope of HHS protection of human subjects
regulations
 Application of regulations to the use of social
media in human subjects research
 Application of regulations to human subjects
research on social media

3. Overview of HHS protection
of human subjects regulations

4. HHS protection of human subjects
regulations
 45
CFR part 46 – HHS Protection of
Human Research Subjects
 Subpart A is the Federal Policy for the Protection
of Human Subjects – “Common Rule” (1991)
 Applies to 17 Federal Departments and
Agencies
 Subparts B (pregnant women, fetuses and
neonates), C (prisoners), D (children), E (IRB
registration)

5. Regulatory requirements
 3 basic requirements:
 Assurance of compliance
 Federalwide Assurance (FWA)
 Institutional review board (IRB) review of
research
 Informed consent

6. Scope of regulations
 HHS-conducted or -supported human
subjects research
 Human subjects research covered by an
applicable assurance of compliance (FWA)
 If research institution chooses to extend FWA to
all research regardless of funding source, includes
privately funded research

7. Criteria for IRB approval of research
 Determinations at 45 CFR 46.111
 risks minimized
 risk/benefit ratio reasonable
 subject selection equitable
 informed consent
 data monitored
 privacy and confidentiality
 Determinations under subparts
 If research involves pregnant women/fetuses, children,
prisoners

8. Use of social media in research

9. Subject recruitment
 OHRP considers subject recruitment part of
informed consent
 Recruitment plan must receive IRB review/
approval prior to initiation

10. Social media as recruitment tool
 Twitter app from TrialX (3/20/09)
 Sample tweet: @trialx CT studies for
diabetes male 45 in new york
 Stated benefits:
 use of Twitter
 tweets are public -- others can learn
about research by looking at searches,
which could potentially increase
awareness of trials and participation.

11. Social media as recruitment tool (2)
 Blog post from founder of Inspire.com (3/11/09):
I'm writing today to let you know about some new features we're
introducing related to clinical trials…This community was founded with
the promise that you are in control of your own privacy. We will never
provide personal information about you to another party without your
express permission.
What's new is that from time to time we'll tell you about clinical trials in
which you may be interested in participating. If you're not interested in
participating, simply do nothing. If you do think you might be interested,
we'll provide a link where you'll be able to read about a trial, decide if you
are interested in participating, and fill out a short survey to see if you
may qualify. If it appears that you may qualify, we'll put you in touch with
the physicians conducting the trial so that you can learn more and find
out if you do qualify.

12. Subject recruitment (2)
 OHRP guidance on IRB review of clinical trial
websites http://www.hhs.gov/ohrp/policy/
clinicaltrials.html
 No IRB review needed for descriptive information:
 study title
 purpose of the study
 protocol summary
 basic eligibility criteria
 study site location(s), and
 how to contact the study site for further information.

13. Subject recruitment (3)
 IRB review needed if additional information is
provided
 Description of research risks/potential benefits
 Solicitation of identifiable private information (e.g.
eligibility survey)
 Incentives – monetary and non-monetary
 What needs to be reviewed:
 Recruitment plan, not the actual webpage

14. Use of social media vs. traditional
recruitment tools
 Uncontrolled following discussion among
viewers/bloggers
 Interactive, not static
 Subsequent posts may in effect modify
posted information
 Must PI/IRB actively monitor social media
sites used for recruitment?

15. Subject networking
 A PI for a longitudinal study of a chronic
disease wants to establish a Facebook page
for study subjects to facilitate communication
between participating families.
 Confidentiality of participation?
 Privacy settings for FB?
 IRB understanding of FB operations?
 Monitoring? Regulatory considerations?
 Impact on subject retention or validity of data?

16. Social media as a research tool
 Using social media to evaluate effective
methods of communication regarding
consent, participation, and return of results
 May be new research study that needs IRB
review/approval if private identifiable information is
obtained for research purposes
 Same considerations as research involving mining
social media for information (see slides below)

17. Return of study results
 Return of study results to subjects through
social media vs. through publishing data
analysis in peer-reviewed journal
 Validity of conclusions – eliminates extra layer of
protection peer review provides

18. Research involving social media

19. Research on social media
 Research studying the impact of social media
on x
 Research mining information from social
media sites/archived posts
 Research using social media to interact with
subjects

20. Data mining of social media sites:
is it “human subjects” research?
 Human subject – living individual about whom
investigator obtains (1) data through intervention or
interaction, or (2) identifiable private information (45
CFR 46.102(f))
 Private information – includes information about behavior
that occurs in a context in which individual can reasonably
expect that no observation or recording is occurring, and
information provided for specific purposes which the
individual can reasonably expect will not be made public
 Is information on a Facebook page private? How
about a tweet? How about chat room discussions?

21. Research using social media to
interact with subjects
Initial question: does it involve ‘human
subjects’?
 May be exempt, under 45 CFR 46.102(b)(2),
as survey or interview research, unless:
information is recorded in a manner whereby
subjects can be identified AND disclosure of
the responses could reasonably place them
at risk of criminal or civil liability or be
damaging to the subjects’ financial standing,
employability, or reputation.

22. IRB approval of research -- again
 Determinations at 45 CFR 46.111
 risks minimized
 risk/benefit ratio reasonable
 subject selection equitable
 informed consent
 data monitored
 privacy and confidentiality

23. Challenges for IRBs in applying
criteria to research involving social media
 Maximize benefits and minimize harm
 Data sampling techniques
 Validity and reliability of data collected
 How to debrief and follow up to assess benefits or
harms?
 Fair, equitable and appropriate treatment… how do you
know?
 Anonymity and use of pseudonyms in cyberspace
 Constant flux of identities and number of members
 Economic and social disparity in internet access and
usage

24. Challenges for IRBs in applying
criteria to research involving social media (2)
 Informed Consent- how do you get it,
ensure it, validate it?
 Privacy/Confidentiality- how to secure data
and identity?
 Minors- how do you know?
 Vulnerable Populations- assessment of
understanding/capacity? Additional
protections?

25. Research involving social media
 Research involving social media presents
new considerations vis a vis the traditional
IRB issues of:
 Risk/Benefit
 Consent
 Research With Children
 Security Issues

26. Research involving social media (2)
 Risks-- Two main sources of harm:
 participation in the research
 No direct contact with subjects
 Can’t deal with individual reactions
(intervention or debriefing)
 breach of confidentiality
 Primary source of harm in most internet
research

27. Research involving social media (3)
Benefits (?):
 Conducting research on the Internet raises concerns
about the reliability and validity of the data
 skewed subject populations
 ease with which subjects can mislead investigators
 difficulty in preventing multiple submissions
 Invalid research can have no benefit
 inappropriate when there is risk to subjects

28. Informed consent
Informed consent:
 IRBs can waive the requirement for consent where
appropriate [45 CFR 46.116(d)]
Waiver of documentation of informed consent:
 If consent is required, IRBs can waive the
requirement for documentation of consent where
appropriate [45 CFR 46.117(c)]

29. Informed consent (2)
Points to Consider:
 Where consent required but documentation is
waived, a “portal” can be used to provide consent
information.
 e.g., subjects must click on consent page to get to
next page.
 Where documentation required – consider
alternatives to traditional documentation
--e.g., electronic signature

30. Children
Research With Children:
 Consider waiver of parental permission
 Where parental permission required,
consider previous options for consent
flexibilities

31. Children (2)
Research With Children
 Points to consider in “screening out” children:
 use internet monitoring software or adult check
systems
 none of these is foolproof.
 Since it may be difficult to guarantee that
children won’t access research, some research
may not be appropriate for social media.

32. Security
Security Issues:
 Two potential sources of breach of confidentiality
 inadvertent disclosure
 Investigator who sent out research database
to entire listserve
 Investigator whose computer was stolen
 deliberate attempts to gain access
 Hacking into research data
 Technology can provide reasonable security but
cannot guarantee absolute security

33. Security (2)
Security Issues:
 Data transmitted via e-mail is not anonymous
without the use of additional steps. Almost all forms
of e-mail contain the sender's e-mail address.
 use an "anonymizer" - a third party site that strips off the
sender's e-mail address
 Web servers automatically store a great deal of
personal information about visitors to a web site and
that information can be accessed by others.

34. Security (3)
Security Issues:
 Web sites can leave “cookies”, a small file left on the
user’s hard drive that is sent back to the web site
each time the browser requests a page from that
site. Cookies can record which computer the user is
coming from, what software and hardware is being
used, details of the links clicked on, and possibly
even email addresses, if provided by the user.

35. Security (4)
Security Issues:
 Degree of concern over confidentiality
depends on sensitivity of the information
 Since it is impossible to guarantee absolute
data security over the internet, some
extremely sensitive research may not be
appropriate for the internet

36. Care and feeding of IRB
Investigator and IRB Responsibilities:
 Investigators are going to have to provide technical
information on how they will deal with considerations
particular to the use of social media
 IRBs need to have sufficient expertise on the
technical aspects of social media in order to ask the
right questions and appropriately evaluate the
information provided

37. Resources
 AAAS Report on Internet Research
http://www.aaas.org/spp/dspp/sfrl/projects/
intres/main.htm
 Papers from “Research Ethics in the
Facebook Era” workshop http://
www.cc.gatech.edu/~yardi/ethics-
cscw2010_files/AcceptedPapers.htm