Doing Virtual Research Virtuously: Online Research Methods, Risks and Ethics

1. Doing Virtual Research Virtuously: Online Research Methods, Risks and Ethics B. R. Simon Rosser, Ph.D., M.P.H. HIV/STI Intervention and Prevention Studies (HIPS) Program Division of Epidemiology and Community Health University of Minnesota School of Public Health Presentation to 2007 Social, Behavioral, Educational Research Conference, Broomfield, CO, May 10, 2007

2. Objectives • 1. To identify the key ethical considerations when designing an e-Public Health intervention • To review one case study example of how we addressed human consent and considerations. • 3. Addressing Ethical Dilemmas • 4. The importance of promoting an honest, productive, ethical relationship with your IRB • See: (1). Rosser, B.R.S., and Horvath, K. (2007). Ethical issues in Internet-based HIV • primary prevention research. In Loue, S & Pike, E. (eds). Case Studies in Ethics • and HIV research. In press. • (2). Rosser, B.R.S., Oakes, J.M., Konstan, J., Horvath, K.J., Gurak, L., Challenges of • Ensuring Participant Consent in Internet Studies: A Case Study of the Men’s • INTernet Studies (MINTS-I and II). In final preparation.

3. 1. Key Ethical Considerations

4. Key Considerations To be effective, a behavioral Intervention needs to be • Ethical • Informed by the epidemiologic profile • Target the real problem • Theoretically sound • Behaviorally effective / reduce the risk • Acceptable/sensitive to the target population

5. Ex. 2: What’s the first ETHICAL principle of public health?

6. What’s the first ETHICAL principle of public health (and all health)? "As to diseases make a habit of two things- to help, or at least, to do no harm" - Hippocrates “Primum, non nocere” FIRST, DO NO HARM. (recognizing that often, doing nothing is the most harmful response of all)

7. Q2. How do we apply FIRST, DO NO HARM to public health? Individual level • Be nonjudgmental • Be competent: know what works • Seek to understand the patient • Try to “walk in the patient’s shoes” • Take an adequate history • Work with the patient not on them • Do no harm to the patient • Intervene with the patient’s full and informed consent

8. Q3. How do we apply FIRST, DO NO HARM to public health? • Community Level • Be nonjudgmental • Be competent: know the science of your area • Seek to understand the community • Try to walk in the community’s shoes • Know the community’s history • Work with the community not on them • Do no harm to the community • Intervene with the community’s • input and be answerable to the community Individual level • Be nonjudgmental • Be competent: know what works • Seek to understand the patient • Try to “walk in the patient’s shoes” • Take an adequate history • Work with the patient not on them • Do no harm to the patient • Intervene with the patient’s full and informed consent

9. How can public health interventions be harmful? • 1. United States. Tuskegee syphilis study. Did not provide treatment to African American men with syphilis. • 2. Germany (1920-40). Forced people to perform and experimented upon prisoners without consent • 3. Milgram’s experiment. Used deception that led to stress. • 4. South Africa: IQ studies used biased methods to proves Black Africans less intelligent than Whites. Long-term consequence: Distrust of science, scientists, and medicine.

10. Implication • Public Health interventionists always think through the ethics of their interventions, and submit their work to outside review. • We work WITH populations, no ON them. E-Public Health interventionists may need training in: • Online communication • E-learning principles • Online behavioral differences (e.g., reading, surfing, lurking) • Virtual community identification • Virtual social cues, sex roles, language, communication styles • Talk to users

11. Human Subjects’ Considerations • Since many e-Public Health interventions are untested, they may fall under the ethical guidelines of research.

12. The 3 “Belmont” principles to guide developing ethical interventions • Respect for persons • individuals should be treated as autonomous agents; • persons with diminished autonomy are entitled to protection. • Beneficence – • Do no harm; • Maximize benefit and minimize harm • Justice – • Design in a manner that is just (e.g., give priority to those most in need; give access to all) http://ohsr.od.nih.gov/guidelines/belmont.html

13. Testing online interventions Wherever and whenever possible we test interventions to answer such questions as: • Identify what the community wants and needs? • Study whether the intervention is effective? • Identify unintended effects, especially any harm? • Is it acceptable to the target population?

14. 2. Practical considerations in online interventions

15. Step 1. • Sketch out how you will involve people in your intervention in an ethical way. • For example…answer questions such as: • How do I ensure those who want to access site can; • How do I ensure those who do NOT want to access site, or SHOULD NOT access site (possibility of harm) don’t?

16. Figure 1a. Flow Diagram of Consent Steps to Enter MINTS Study Banner links 3. Consent Form 4. Availability Criteria 5. E-payment Form 1. Title Page Bienvenidos a Menta Welcome to MINTS 2. Eligibility Study risks (chunk) Study Description Enroll in A • Name and email address option Person is counted as Subject in study from here • Inclusion Criteria • xxxxxxxxx • xxxxxxxxx • xxxxxxxxx Meets Criteria Enroll in B Benefits (chunk) Enroll in C • Charity option Opportunity to ask questions (Chunk) Enroll in D • No payment option Español English Back a Screen Enter Study Back Screen Next Screen I do NOT consent I consent Next Screen Back Screen Does NOT meet criteria 1a. Second Title Page (in chosen language) Person starts answering questions 3a. No Consent Page 2a. Refused Eligibility Page Page where person is thanked but told not eligible. Also told welcome to browse the study. 6. Identifier Screen 7. Study Screen 1 Welcome You have indicated you do not consent. Would you like to: • Enroll in study • Fill in survey • Learn about us • A. Somequestions • about you • xxxxxxxxxxxx • xxxxxxxxxxxx • xxxxxxxxxxxx Create identifier Return to previous screen Record email address Browse the Study Enter the Study Back Screen Next Screen • Email the study • coordinator E-mail Study Browse the Study Back a Screen Next Screen • Browse the Study More screens Browse: The person can LOOK through the study but cannot answer any boxes

17. 2. Design a recruitment plan.How do I recruit and get people to the health site?

18. Step 2. How to recruit? In MINTS-I, to recruit 1,000 Internet-using Latino MSM, we used banner advertisements • “Bullet point language.” • e.g. 5 words to establish • credibility. • “Instant” decision making is more similar to market research than conventional studies

19. which hyperlinked direct to our opening page

20. Put screen in here We also designed options for participants to enroll immediately, explore who we are, to browse the questions, and to change languages

21. We worried about validity issues and if subjects really were who they say they were. But subjects may have similar questions about us.

22. 3. Provide Credibility Checks In e-studies, sponsoring institution may need to be clearly identified and promoted. Information on the researchers may require more researcher disclosure than in conventional studies

23. Step 4. Design a plan to obtain and ensure informed consent? • We struggled with the problem of using consent forms which no one reads (especially online) and received permission from our IRB to experiment with “stepwise” or “chunked” consent forms. • See: Rosser, B.R.S., Oakes, J.M., Konstan, J., Horvath, K.J., Gurak, L., Challenges of ensuring participant consent in Internet studies: A case study of the Men’s INTernet Sex Studies (MINTS-I and II). In final preparation.

24. We started with a welcome page which briefly summarized the points of key interest

25. We brought our eligibility criteria forward so we did not waste non-eligible persons’ time.

26. We “chunked” consent into 6 main pages. When designing consent processes in the Internet, need to balance consent needs with needs to “translate” into Internet-appropriate forms.

27. Differences to be Mindful of when Obtaining Informed Consent • People read differently online than conventionally. • Non-linear, more hypertextual (linking, surfing, jumping around) • Bullets, not sentences • Don’t necessarily read in order • No one known to read long informed consent, leading to ethical challenge for researcher. • Text can be harder to read on screen • Shorter attention-span, more skim-reading • More bulleted language; less prose. FFI: See literature on human factors and hypertext theory.

28. Chunking Consent: How Internet consent differs from conventional Design considerations: Note common use of large portions of white space to focus

29. Visuals to draw eye into web page and key text…

30. In web consent, custom is to frame issues as questions (e.g., FAQs).

31. Technical communication: short, direct sentences; avoid nuances.

32. We used brief descriptions summarized by short 1-sentence summaries in different colors.

33. Chunk 1:

34. Chunk 2:

35. Chunk 3:

36. CONFIDENTIALITY CONCERNS • The dilemma for us in addressing confidentiality concerns was our expectation that most people just want to get into the study, but some may have significant confidentiality concerns. • So, we addressed this dilemma by having participants choose their level of informed consent.

37. Providing subjects with options to receive more information

38. Links to more detailed page:

39. Section 1: how we will treat the personal information provided

40. Section 2: Explaining a “Certificate of Confidentiality” and limits of confidentiality

41. Section 3: Teaching enrollees steps they can take to increase their confidentiality … from quitting web browsers to web anonymizers. Links back directly

42. Chunk 5

43. Chunk 6: Ways of asking questions prior to participation

44. Automatic closing off enrollment was also important

45. Lessons learned • Avoid absurdly inappropriate consent procedures (e.g., requiring signatures, legalese forms). • Avoid procedures that are more invasive than the study itself. • Internet consent is far more implied and continuous, and since most people can just leave, there is less risk of experimental pressures than offline studies. Online recruitment and consent: • Will likely transform current state-of-practice in offline studies as well. • Becoming more common for both online and offline studies.

46. 3. Ethical Dilemmas MINTS-II is a RCT of a highly-interactive Internet-based HIV prevention intervention to address sexual risk among MISM. Identified risks: (1) How explicit should online education be? (2) How do you overcome concerns about minors surfing onto a highly sexually explicit website? Ways to improve ethics • We conducted extensive formative evaluation to identify what level of explicitness was acceptable to the target population. • 97% of 2,700 MISM state they find highly explicit, direct, frank education acceptable.

47. Minors in Online Sex Studies • Initially, we spent hours worrying about minors either lying to get into our study and reading sex questions (MINTS-I) or receiving highly sexually explicit education (MINTS-II). • Note: not safe to seek consent from parents or to document assent of minors. Strategies: • We decided to recruit exclusively from within an adult sex site where any minor would be at greater risk already. • We argued that engaging in long surveys and receiving quality education would be lower risk than hanging out in adult sex sites. • For the intervention, we needed18 months in development. The chances of minors being in the RCT are minimal.

48. Deciding whether or not to do the research • The decision to engage in risky research comes down to: (a) how important is the research question to advancing science/truth? (b) how important is the research to promoting health and stopping the spread of HIV? When there’s opposition: • Listen and learn: I use the opposition to sex research as incentive to do my work better. • Be open and creative: Where appropriate I study their concerns • Do what’s right: I think a certain courage and healthy disrespect for one’s own career helps with ethics.

49. 4. Building a productive relationship with your IRB

50. IRB Considerations For experienced researchers, I think two questions are key to consider when thinking about IRBs and e-Public Health research: (1) How good/competent is the IRB (both in general and specifically regarding e-Public Health)? (2) How do I promote a healthy researcher-IRB relationship?