Surveillance Among High Risk Groups

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• Surveillance Among High Risk Groups
• Ethical Considerations

David Borasky, Director of Office of
International Ethics Director of
RA/QA dborasky_at_fhi.org Inoussa Kabore, Director
of Strategic Information ikabore_at_fhi.org
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Background - Overview

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

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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

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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,)

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Behavioral and Biological Behavioral Surveys
PEPFAR Countries
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Behavioral and Biological Behavioral Surveys
PEPFAR Countries
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Inform Consent Form Field Perspectives
Case of BBSS
Consent form for behavioral and biological
behavioral Surveillance Survey
Administration Behavioral Component
Administration Biological component
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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

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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

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Acceptance Return Rate Nepal
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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

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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

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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?

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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?

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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

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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 participants
  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

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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

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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

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• Thank you!