Social Media, Internet-based Research, and Ethics: Challenges and Strategies Stanley Estime, MSCI, CIP Senior QA/QI Specialist Tel: URL:

Outline What is internet research? How is social media used by researchers? What are the related challenges, ethical issues and regulatory considerations?

 When internet is used as a tool for conducting research  Examples: online survey, subject recruitment – Amazon Mechanical Turk (mTurk), or discussions/interviews, data mining  Internet as a location or site for conducting research  Examples: Collecting data about or observing online environments such as chatrooms, gaming sites, virtual worlds, social media video conferencing (Skype, Facetime), and use of “the Cloud” What is Internet Research?

What is Social Media? Social media – Internet-based applications that allow creation and exchange of user generated content Provide mechanisms for users to interact: --chat, instant messaging, , video, file sharing, blogging, discussion groups

Why are we here? We are seeing an increasing use of the internet and social media for research purposes There are no specific regulations outside of SACHRP recommendations governing internet research

 Capture data in real time  Paperless data collection  Easy communication and management of data (especially in multi-site environment)  Potential for increase subject recruitment Benefits to Internet Research

 No direct contact with participants  Validate individuals: inclusion/exclusion criteria  Validate integrity of the data (e.g. - falsifications/multiple submissions)  Inability to assist individual(s) if they become distressed (e.g. - UAP or AE)  Data security Risks to Internet Research

 Is the activity research?  Does the research involve human subjects?  Does the human subjects research qualify for exemption from the regulatory requirements?  Does the research present no more than minimal risk such that it may be reviewed via expedited review or does it need full board review?  How to handle informed consent? – can it waived, is a brief consent script sufficient? IRB Questions

 Category B1 – Online internet research, evaluation of a web-based classroom  Category B2 – Online surveys/interviews or observation of public behavior  Category B4 – Existing publically available, large datasets purchased/obtained from websites *Note these examples can be expedited if recording/use of identifiable info is involved. They may also require full board review if greater than minimal risk Examples of Internet Research

 What is “private?”  What is “identifiable” – current & future?  Avatars and Bots – “human subjects?”  How to protect subjects’ privacy and confidentiality interests?  Can risk be minimizing when using sensitive online data?  How should informed consent be handled or other study related communications (e.g. Tweets, posts, etc.)? Regulatory Challenges

 Is it “reasonable” to ensure privacy?  Investigators can’t promise expectation of privacy when social networks are involved (FB, Tweeter, Chat rooms) – Privacy settings (Terms of Service) always changing  Technical: Spyware, keystroke monitoring, video camera - Password protection doesn’t automatically ensure privacy  Can participant’s identity be readily ascertained through limited datasets?  Username, alias, s, IP address, partial identifiers (e.g. gender, DOB, race) Investigator Considerations: Data Privacy

 Is it feasible to ensure confidentiality?  Lock and key paper process doesn’t apply  Info stored “In the cloud” – de-identified or coded  Investigator should be mindful of participant retention/re- contact  Transmitted information may not be secure (encryption/firewalls between host and users)  Data sharing restrictions may be mandated by funding agency, data provider, or regulatory bodies (NIH, FDA, IRB)  De-identified data (even in aggregate) may potentially be re- identified now or in the future (e.g. for retention and/or follow-up) Investigator Considerations: Data Confidentiality

 If research population should not involve minors how do you verify (Adult Check, NetNanny)?  Children Online Privacy and Protection Act (COPPA) mandates children <13 provide parental permission  Can internet recruitment strategies increase risk?  Search engines can leave local pop-ups/cookies  Recruitment mailings/website contain stigmatizing information  “Private” social media discussions “going viral” or researchers manipulating conversations  Apps or browser cookies allowing automatic posting about the research on social websites Investigator Considerations: Eligibility and Recruitment

Investigator and IRB Collaboration: Informed Consent Both the investigators and the IRB must work together to ensure participants’ rights and welfare are protected: Online Consent Script w/ checkbox (I agree/understand statement) or eSignature Waiver or alterations (consents ed separately, comprehension quiz, separate Skype or Live Chat process)

Investigator and IRB Collaboration: Research Protocol  Consider including screenshots/data flow so IRB can understand recruitment process  Ensure PI/Staff involvement is clearly described (Lurking/Deception)  Debriefing  Elaborate on minimal risk associated with internet risk  “confidentiality can’t be guaranteed” “limited by technology being used” “data retention - may exist on back-up servers”

Investigator and IRB Collaboration: Research Protocol  Ensure participants are aware of research consent vs. any consent information on internet/social media sites  Ensure participants are aware of any 3 rd party data sharing arrangements  Ensure the IRB and participants have a thorough understanding of any encryption processes or coding /linking arrangements

More and more countries coming on-line!

Professor’s Smith’s graduate students would like to conduct research on individuals with a potential for exhibiting high risk behavior and/or contracting a sexually transmitted disease. The students plan on determining this by developing a web-based algorithm which will search across various social networks for posts, hashtags, tweets, emoji’s, and other information associated with usernames/internet profiles. What are some of the concerns with this study? Are there any recommendations for the investigator prior to approving this research? What type of review do you think this research would fall under (exempt, expedited or full board)? Case Study