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Implementing Male Circumcision Research or Programs: Bioethical Issues

Implementing Male Circumcision Research or Programs: Bioethical Issues

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Implementing Male Circumcision Research or Programs: Bioethical Issues

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  1. Implementing Male Circumcision Research or Programs: Bioethical Issues Ina Roy, M.D.,Ph.D.

  2. Focus • Informed consent issues • Choice of target population

  3. Related Issues • Harms and benefits • Female Genital Mutilation (FGM)

  4. Common Methods • Weighing harms and benefits • Focusing on basic principles

  5. Harms and Benefits

  6. 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

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

  8. Implementing Health-Care Research and Policies

  9. Principles • Autonomy and self-determination • Bodily integrity • Cultural self-determination

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

  11. Target Population Adults or Children?

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

  13. Adults: Additional Considerations • Informed choice and/or consent less complex • Current population of concern • Sexually active

  14. Children: Rationale for Intervention • Circumcision less complex • Prepubertal MC associated with reduced HIV • Practioners of circumcision may have child-appropriate • Equipment • Experience • Skills

  15. Children: Intervention Criteria • Immediate harm to the child • Immediate harm to society

  16. 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

  17. 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

  18. Procedure description Risks Self Others Benefits Self Others Alternatives Informed Consent: Content

  19. Informed Consent: Context • Language and level • Appropriate to the person and culture • Opportunity for questions • Culturally appropriate environment

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

  21. 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

  22. Concern about cultural hegemony • Allow for choice • Articulate both risks and benefits • Verify overall benefit to culture • Avoid creating coercive situation

  23. Female Genital Mutilation

  24. 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.

  25. 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