Implementing Male Circumcision Research or Programs: Bioethical Issues

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Implementing Male Circumcision Research or
Programs Bioethical Issues

• Ina Roy, M.D.,Ph.D.

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Focus

• Informed consent issues
• Choice of target population

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Related Issues

• Harms and benefits
• Female Genital Mutilation (FGM)

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Common Methods

• Weighing harms and benefits
• Focusing on basic principles

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Harms and Benefits
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Potential Benefits

• Helps prevent certain STDs including transmission
  of HPV
• Reduces UTIs in first year of life
• Decreases the rate of cervical cancer in female
  partners
• May help reduce the rate of HIV transmission

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Potential Harms

• Potential harms from surgery
• Bleeding
• Infection
• Damage to penile tissue and function
• Physical pain
• Emotional harms?
• Disinhibition and associated high risk
  behaviours?

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Implementing Health-Care Research and Policies
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Principles

• Autonomy and self-determination
• Bodily integrity
• Cultural self-determination

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Applying Principles to Policy

• Choosing an appropriate target population for the
  intervention
• Recognizing and integrating individual choices
• Adapting programs to the local cultural
  environment

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Target Population

• Adults or Children?

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Adults

• Understand information
• Have experience with comparing risks and benefits
• Can bring the values they hold to the weighting
  of risks and benefits

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Adults Additional Considerations

• Informed choice and/or consent less complex
• Current population of concern
• Sexually active

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Children Rationale for Intervention

• Circumcision less complex
• Prepubertal MC associated with reduced HIV
• Practioners of circumcision may have
  child-appropriate
• Equipment
• Experience
• Skills

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Children Intervention Criteria

• Immediate harm to the child
• Immediate harm to society

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Informed Consent

• Informed
• Educated about the procedure
• Aware of opportunities for follow-up care
• Consent
• Assent to exactly and only that procedure
• Assent to procedures costs

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Consent of the individual

• More important if the intervention
• Is irreversible
• Has a process that may involve emotional or
  physical pain
• May result in permanent damage including
  functional deficit

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Informed Consent Content

• Procedure description
• Risks
• Self
• Others
• Benefits
• Self
• Others
• Alternatives

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Informed Consent Context

• Language and level
• Appropriate to the person and culture
• Opportunity for questions
• Culturally appropriate environment

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Further considerations

• Should there be a waiting period?
• Should HIV positive persons be allowed /
  encouraged to participate?

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Cultural considerations

• Individual consent becomes more important if the
  intervention
• Is irreversible
• Involves process that may cause emotional or
  physician pain
• May result in permanent damage or functional
  deficit

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Concern about cultural hegemony

• Allow for choice
• Articulate both risks and benefits
• Verify overall benefit to culture
• Avoid creating coercive situation

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Female Genital Mutilation
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Special thanks to

• USAID and PATH for the invitation and assistance.
  
• Special thanks to Daniel Halperin, USAID, for his
  advice and encouragement during investigation of
  bioethical issues in HIV treatment and
  prevention.
• The researchers on MC, too numerous to count, who
  are working with me on a more comprehensive
  article on ethical issues related to circumcision
  and HIV.

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• Fink et al, "Adult circumcision outcomes study
  effect on erectile function, penile sensitivity,
  sexual activity and satisfaction" Journal of
  Urology, v. 167 issue 5 p 2113 2002
• Association between Male Circumcision and HIV
  transmission
• Buve at al, Letter re Male Circumcision Could
  Help Protect Against HIV Lancet v. 356 no 9235
  2000
• Bailey, Halperin, Male Circumcision and HIV
  Lancet v. 354 no 9192, 1999
• Gray et al, Male circumcision and HIV
  acquisition and transmission Cohort studies in
  Rakai Uganda AIDS v. 14 issue 15 p 2371
• To et al, Cohort study on circumcision of
  newborn boys and
  subsequent risk of urinary-tract infection
  Lancet, v. 352 no9143
• Weiss et al Male circumcision and risk of HIV
  infection in sub-Saharan Africa, AIDS v. 16
  number 5 p.810
• Randomized Controlled Trials
• Kisumu, Western Kenya, Funded by the NIH and the
  Canadian Institutes of Health Research
• Rakai, Uganda
• NIH, John's Hopkins University