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Implementing Male Circumcision Research or Programs: Bioethical Issues. Ina Roy, M.D.,Ph.D. Focus. Informed consent issues Choice of target population. Related Issues. Harms and benefits Female Genital Mutilation (FGM). Common Methods . Weighing harms and benefits

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implementing male circumcision research or programs bioethical issues

Implementing Male Circumcision Research or Programs: Bioethical Issues

Ina Roy, M.D.,Ph.D.

focus
Focus
  • Informed consent issues
  • Choice of target population
related issues
Related Issues
  • Harms and benefits
  • Female Genital Mutilation (FGM)
common methods
Common Methods
  • Weighing harms and benefits
  • Focusing on basic principles
potential benefits
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
potential harms
Potential Harms
  • Potential harms from surgery
    • Bleeding
    • Infection
    • Damage to penile tissue and function
  • Physical pain
  • Emotional harms?
  • Disinhibition and associated high risk behaviours?
principles
Principles
  • Autonomy and self-determination
  • Bodily integrity
  • Cultural self-determination
applying principles to policy
Applying Principles to Policy
  • Choosing an appropriate target population for the intervention
  • Recognizing and integrating individual choices
  • Adapting programs to the local cultural environment
target population

Target Population

Adults or Children?

adults
Adults
  • Understand information
  • Have experience with comparing risks and benefits
  • Can bring the values they hold to the weighting of risks and benefits
adults additional considerations
Adults: Additional Considerations
  • Informed choice and/or consent less complex
  • Current population of concern
    • Sexually active
children rationale for intervention
Children: Rationale for Intervention
  • Circumcision less complex
  • Prepubertal MC associated with reduced HIV
  • Practioners of circumcision may have child-appropriate
    • Equipment
    • Experience
    • Skills
children intervention criteria
Children: Intervention Criteria
  • Immediate harm to the child
  • Immediate harm to society
informed consent
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
consent of the individual
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
informed consent content
Procedure description

Risks

Self

Others

Benefits

Self

Others

Alternatives

Informed Consent: Content
informed consent context
Informed Consent: Context
  • Language and level
    • Appropriate to the person and culture
  • Opportunity for questions
    • Culturally appropriate environment
further considerations
Further considerations
  • Should there be a waiting period?
  • Should HIV positive persons be allowed / encouraged to participate?
cultural considerations
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
concern about cultural hegemony
Concern about cultural hegemony
  • Allow for choice
  • Articulate both risks and benefits
  • Verify overall benefit to culture
  • Avoid creating coercive situation
special thanks to
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.
slide25
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

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