1. Using the Internet to Conduct Research What Investigators and IRB Members Should Know -- January 29, 2009 -- Lisa Shickle, MS Analyst, VCU Massey Cancer Center Member VCU IRB Panel E

2. 2 Popularity in Internet-based Research  Fast, simple, inexpensive way to reach potential participants  Increasing segments of population have access to computers/internet  May be less intrusive (for sensitive subjects)

3. 3 Discussion Overview  IRB’s role with Internet-based Research  Survey Design and Subject Recruitment  Informed Consent Issues  Data & Security Considerations

4. IRB Role in Internet Research

5. 5 IRB Role  VCU IRB Guidelines: Use of the Internet for Recruitment and/or Data Collection: http://www.research.vcu.edu/irb/wpp/flash/wpp_guide.htm  Essentially: Just as with other forms of research, for Internet-based research, the IRB is charged with ensuring that all guidelines for the protection of human subjects included in research are met.

6. 6 IRB Role – more specifically  Address/protect Risks Violation of privacy Harm (psychosocial stress) Legal  Protection of confidential data  Subject particpation Voluntary Informed Consent

7. 7 What the IRB will need to review  Much of what the IRB reviewers need to see is common to all modes of survey delivery and should be addressed as part of the project design.  The protocol needs to include all materials that will be presented to potential participants, includin g: Recruitment ads or invitation to participate Informed consent elements Introduction and “Thank You” pages Survey instructions and “Pop-up” help Survey questions and response choices Graphics, audio, video content Links to other web sites/content

8. Survey Design & Recruitment

9. 9 Survey design  Good practices of survey design and administration should be applied to Internet- based research just as they are applied to other modes of survey research (telephone, in person, or self- administered surveys).  Include “prefer not to respond” options or allow skipped questions.  Web-based – offer seamless skip patterns/branching

10. 10 Study sample  Adequate population list and sample size  Exclusion of ineligible participants (e.g. minors)  Withdraw from the survey

11. 11 Subject Recruitment  Passive (ad resides on a website, targets visitors to that site)  versus Active (send out information/ad using e-mail list)  IRB needs to review all materials that potential research subjects will see. Recruitment advertisement/letters, etc.—including any interactive parts/functionality E-mail invitation and reminder text E-mail sender and subject lines

12. 12 Active Recruitment Considerations  E-mail lists for potential subjects-obtained from public sources or with documented permission of the owner.  May need to inform recipients how e-mail addresses, cell phone numbers (for text messages) were obtained  Reminders only to non-responders  Opt-out lists

13. Informed Consent

14. 14 Informed Consent  Federal regulations require investigators to obtain informed consent for human subjects research.  The IRB may approve consent procedures that do not include, or that alter, some or all of the elements of consent and the requirements for documentation of consent as outlined in CFR 46.116 (d) and CFR 46.117(c).

15. 15 Elements of Informed Consent (still required for Internet-based research)  Purpose of the research  Risks, discomforts, and benefits  Activities required to participate in the research (eg, what they are being asked to do; how long it will take)  Participation is voluntary-subject actively affirms/opts in to participation  Confidentiality of responses - what is in place to protect confidential data  Contact information for PI and IRB

16. 16 Challenges for Internet-based research: Getting Consent  No direct researcher – subject interaction.  Often not feasible to obtain signed consent.  For internet-based research, typically alterations or waivers of some elements of consent are requested (as appropriate to type of research review). Waiver of elements of consent Waiver of documentation “Implied consent” (never allowed)

17. 17 Challenges for Internet-based research: Getting Consent  Make the consent “active” for the participant: “By completing this survey, you are agreeing to participate in this research.” Click buttons – “I agree”, “Accept”, etc to opt in to the research. http://exercise.lbl.gov/consent.html

18. 18 Challenges for Internet-based research: Confidentiality  The Internet is not a secure medium—transmission of data may be vulnerable.  Explain process of data transmission/encryption. Is a third party software (eg Survey Monkey) used? How will the researcher/survey collection method ensure confidentiality of data collected?  Best not to make guarantees of anonymity or confidentiality. Address the efforts in place to protect the data/offer a disclosure where subject matter is sensitive: “Although every reasonable effort has been taken, confidentiality during actual Internet communication procedures cannot be guaranteed.”

19. 19 Informed Consent: Key Points to remember  Is online consent appropriate for the research subject matter?  Provide information for potential subjects to make an informed decision about their participation.  Fulfill commitments to protect the privacy of subjects and the confidentiality of data—and fully disclose the extent to which that can be ensured.

20. Data Security

21. 21 Data Security  Several secure data transmission protocols exist that encrypt data (eg Secure Sockets Layer (SSL))  Include information about level of data security/protections in place as part of informed consent

22. 22 Data Security Protocols need to describe how data will be managed during and after the project, including: Transmission of data Access to data Storage of data Security of network, servers, workstations, laptops, USB drives, etc. Archival and destruction of data

23. http://www.luc.edu/ors/irbonlinesurveysrequirements.shtml

24. 24 Conclusion  Good practices of survey research design and administration should be applied to Internet- based research, just as they are applied to other modes of survey research.  Issues unique to Internet-based research need to be addressed during the research design.  Informed Consent is part of Internet-based research. Potential participants need to be well- informed in order to make decision regarding participation—including issues specific to Internet-based research.