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