Surveillance Among High Risk Groups Ethical Considerations

1. David Borasky, Director of Office of International Ethics & Director of RA/QA dborasky@fhi.org Inoussa Kabore, Director of Strategic Information ikabore@fhi.org Surveillance Among High Risk Groups Ethical Considerations

2. Background - Overview • What groups usually are included? • Few countries examples • Informed consent process in the field • Accessing results • Acceptance and return rate

3. IRB Implications • IRB perspectives on surveillance • Application of ethical principles to the data collection • Informed consent process • Practical issues in achieving IRB expectation • Strategies for addressing the challenges

4. Target Groups Behavioral and Biological Surveillance data collection Behavioral surveillance Combined behavioral and biological surveillance (HIV , STI &… testing) Target groups are most of the time high risk groups (SW, clients of sex workers, MSM, IDUs,…)

5. Behavioral and Biological & Behavioral Surveys – PEPFAR Countries

6. Behavioral and Biological & Behavioral Surveys – PEPFAR Countries

7. Inform Consent Form : Field Perspectives Case of BBSS Consent form for behavioral and biological behavioral Surveillance Survey Administration: Behavioral Component Administration: Biological component

8. Accessing Results STI treatment on site Referral to VCT Centers to get results; if more than 30 days retesting: ID number with card Counseling and testing and rapid test with results on sites

9. Acceptance & Return Rate Average 80%-98% acceptance (behavioral and testing) Return rate for results: 3% - 30% (referral) Rapid test: much higher than referral: 50-60%

10. Acceptance & Return Rate: Nepal

11. IRB Perspectives on Surveillance Satisfaction of research ethics requirements: Respect for persons Beneficence Justice Practical issues How can the survey be constructed to maximize the implementation of the ethics principles What obstacles can be expected

12. Application of EthicalPrinciples to the Data Collection Respect for persons: Informed consent sought / documented Beneficence Risk of harms (physical, social) minimized Benefits maximized Justice Study conducted in an appropriate population

13. Inform Consent Process: Field Perspectives “Yesterday we completed the pre-testing of the FSW questionnaire.  Five women were interviewed.  The questionnaire took approx. 40 minutes to complete and the consent form took 30 minutes.  I have attached the preliminary results from the pre-testing in the hopes that we can discuss and finalize any pending issues on the FSW questionnaire.  We would like to finalize this by Thursday so that the final translation can be ready in time”.  “Do you have any guidance on the problem that the consent process (with the kinds of forms we are using) takes 30 minutes?  Are there things we can cut?”

14. Inform Consent Process: Field Perspectives “Most of the participants (from my experience) do not take the oral consent (narrative part explaining the research and the contact of key persons) form after obtaining their consent, because it is not discreet!  Some participants already complained for example that one member of their family can find this form in their wallet or trouser or....! We propose instead a card only with the tel. number/e-mail  of the persons to contact in case of questions or problems? Is that okay?”

15. Practical Issues in Achieving IRB Expectations Respect for persons: Meaningful informed consent prospectively sought from all participants Challenges Language Regulatory expectations vs. need to keep IC simple Issues of documentation social issues confidentiality issues

16. Practical Issues in Achieving IRB Expectations (2) Beneficence: Minimizing risk of harm and maximizing benefit to participants Challenges Risk of social harm can be high hidden populations / stigmatizing behaviors Access to benefits is participant’s responsibility benefits (e.g. test results) may be difficult to access (e.g. highly mobile populations note – some benefits often available at time of data collection

17. Strategies for addressing the challenges Informed consent (process and form): Trained interviewers Private setting / coercive elements neutralized Documentation waived (“only record linking”) when permissible Parental permission waived when permissible Translations into local language from a simplified English document

18. Strategies for addressing the challenges (2) Beneficence: Provide results immediately when possible Simple referral process for tests/results when immediate notification is not possible use of discreet referral cards with no identifier Ancillary care provided for STI Other reasonable benefits provided Measures in place to protect confidentiality

19. Thank you!