1. Human Studies Program Office of Research Compliance Vice Chancellor for Research and Graduate Education CTE DCS IRB Series – Event 3 December 1,2014 Denise Lin-DeShetler

2. Human Studies Program Office of Research Compliance  Why do we need to discuss internet research? ◦ Research about internet and using internet is increasingly popular and important ◦ Federal regulations were written before internet became universal  They are currently silent about the use of internet for research involving human participants  Some guidance available, but they are ever-evolving; based on FAQs

3. Human Studies Program Office of Research Compliance “Internet Research” as a tool for research and as a locale or venue of research: ◦ Research involving study of information already available on the Internet ◦ Using Internet as a medium for recruiting or interacting with subjects ◦ Research about the Internet itself and its effects (e.g., popularity of social media types) ◦ Research about Internet users ◦ Internet used as an experimental intervention

4. As a tool…As a locale…. Research involving:  Survey instruments, databases, search engines, databanks  May not involve direct interaction with human participants, but PII may still be collected Research (qualitative and quantitative) that utilizes Internet “spaces” such as: Chat rooms, gaming world, other other simulated locales But…. Research methods using Internet phoning, video conferencing or online chat (i.e., Facetime, Skype) can be both use as a tool and a locale.

5. Human Studies Program Office of Research Compliance Stages in a Research Project 1. Recruitment 2. Data Collection As a tool…. Observations Data Mining 3. Publication of Results Possible re-recruitment

6. Human Studies Program Office of Research Compliance Advertising Consent Process Enrolling Participants

7. Human Studies Program Office of Research Compliance  The recruitment material placed on the internet should follow similar rules of any other recruitment material: ◦ Are not unduly coercive ◦ Do not promise or imply favorable outcomes or other benefits apart from what is written in the protocol ◦ Do not communicate that the study product (or intervention) is safe or effective for the purposes under investigation ◦ Do not make claims that the product or intervention is known to be equivalent or better to any other product or intervention ◦ Do not use language that regulatory authorities, such as the IRB, have approved the research ◦ Do not emphasize payment

8. IRB Should Review IRB Do Not Need to Review  Paid advertisements  In-text advertisements  Advertisements on social networks  Social network page to promote study  Any study-specific direct advertisements via blog, blog post, tweet, or text  Advertisement of study- specific information limited to basic trial information (title, purpose, and study locations)  Communication that are education or provide generation information (i.e., podcast describing symptoms of HIV)  Study-specific publicity intended for general audience (i.e., news stories )

9. Human Studies Program Office of Research Compliance  Types of internet-based recruitment methods: ◦ Email ◦ Online Advertising ◦ Chatroom Postings  All recruitment materials need to be reviewed and approved before use.  General listings of research studies on websites that provides limited information do not need prior approval from IRB (e.g., SONA, Clinicaltrials.gov) 1.Study Title 2.Purpose 3.Protocol Summary 4.Contact information

10. Human Studies Program Office of Research Compliance  Sending promotional messages (ads) about a study without using the medium in ways typical of a common user. ◦ Is this appropriate use of the website? ◦ Intrusive to potential participants?  Advertising in social network sites or Twitter groups, such as a cancer support group, may seem intrusive and inappropriate to members of that group

11. Human Studies Program Office of Research Compliance Appropriate methods for documenting consent should reflect the risk and complexity of the research ◦ For minimal risk: waiver of consent whereby participants click on the “I agree” statement on consent form to proceed to research activities  Must meet the regulatory criteria for a waiver of informed consent ◦ For more than minimal risk:  Traditional signed consent, returned to PI who will then give consenting participants password to access research material  E-signatures  Consent process through chat, email, or other online venue

12. Human Studies Program Office of Research Compliance  Child participants: ◦ Authentication of age with use of age verification systems ◦ When research involves participation of minors, both child assent and parental consent still applies, unless research meets appropriate criteria for waiver of parental permission  Readability ◦ It is more difficult for investigators to discern whether or not their participants understand the consent because process can be done asynchronous, and the opportunity to ask the researcher questions about the research is usually slim.

13. Human Studies Program Office of Research Compliance  When obtaining consent over the internet, we assume that potential participants at least 18 years old ◦ Age verification systems ◦ Questions that are more easily answerable to one who is at least 18 (i.e., identifying images of old items)  To authenticate identity when research involves more than one interaction: ◦ Provide study participants PIN to be used for subsequent computer and internet-based data collection.

14. Human Studies Program Office of Research Compliance Public vs. Private Domains

15. Human Studies Program Office of Research Compliance Data Mining Informational Risks

16. Human Studies Program Office of Research Compliance Case 2: A researcher wants to collect data from an HIV support group website on Facebook to examine how much perceived support participants are receiving from participating in different types of support (chat groups vs. support group sessions vs. blogs) they learn from subscribing to the website. The website allows users to make suggestions about the usability of the different resources the website provides. Does this study require IRB approval if no names or other identifiers are collected? Can this study be done without PII?

17. Human Studies Program Office of Research Compliance Per 45 CFR 46.101(b), research using only secondary data that is publicly available or de-identified do not need IRB approval However: Research that utilizes data from blogs, newspaper responses, and social media networks should not have the same rules for IRB approval because the expectations of privacy by participants varies depending on the venue

18. Human Studies Program Office of Research Compliance Is there unauthorized disclosure of illegal behavior, substance abuse, or chronic illness?  Legality/ Criminal acts  Stigmatization  Financial  Reputation We look at identifiable information that is being collected:  User posting on study-specific website in which user may be sharing PII  De-identified quotes gathered from blogs that can inadvertently be traced back to individual  Repurposed photograph of individuals or group posted on website without permission

19. Human Studies Program Office of Research Compliance  Publicly available means: ◦ Available at no charge to anybody with a computer ◦ Available to anybody willing to pay the requisite fee ◦ Available to anybody who meets the terms of a use agreement  Data that is publicly available qualifies for exemption

20. Human Studies Program Office of Research Compliance  Privacy: refers to individuals’ right to have control over access to themselves and their information  Confidentiality: refers to how information that is obtained from individuals is protected.

21. Human Studies Program Office of Research Compliance Private information (in research) is “information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonable expect will not be made public (e.g., medical records).  If the individual intentionally posts information on the internet, then this is public information, UNLESS the policies and/or terms of service of the entity hosting the information indicates this is “private.”  Some may assume their post is “private” but are in fact, not.  If in doubt, always go conservative. That is, consider it private information.