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.
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
Overview of HHS protection of human subjects regulations
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)
Regulatory requirements
3 basic requirements: Assurance of compliance
Federalwide Assurance (FWA) Institutional review board (IRB) review of
research Informed consent
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
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
Use of social media in research
Subject recruitment
OHRP considers subject recruitment part of informed consent Recruitment plan must receive IRB review/
approval prior to initiation
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.
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.
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.
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
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?
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?
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)
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
Research involving social media
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
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?
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.
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
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
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?
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
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
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
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)]
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
Children
Research With Children: Consider waiver of parental permission Where parental permission required,
consider previous options for consent flexibilities
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.
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
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.
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.
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
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
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